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HSPO Newsletters

NSF 2026 Idea Machine

Dear Colleagues,

In the summer of 2018, the National Science Foundation (NSF) launched an innovative competition, the NSF 2026 Idea Machine, to crowdsource big challenges and big ideas that could help tackle them. The Idea Machine aimed to set the stage for breakthrough research in science, technology, engineering, and mathematics (STEM) and STEM education through the nation’s 250th anniversary in 2026 and beyond. NSF received around 800 entries from established researchers, students, teachers, and even high school and middle school students from all across the country. Those 800 big ideas have now been narrowed down to seven finalists, which were announced last week.

As we continue to work towards fulfilling President Katsouleas’ bold vision to boost research, scholarship, and creative works at UConn, I encourage you to visit the NSF 2026 Idea Machine site and learn about the program’s goals and the recently selected finalists. This provides UConn’s research community with an opportunity to see what is next for the NSF’s long-term agenda and align our activities based on our existing and emerging strengths.

Thank you for your continued commitment to grow UConn’s profile in research, scholarship, and the arts.

Cheers,
Radenka

Dr. Radenka Maric
Vice President for Research, Innovation and Entrepreneurship
UConn/UConn Health
Professor in Sustainable Energy
438 Whitney Road Ext., Unit 1006
Storrs, CT 06269
Storrs: 860.486.3621
UCH: 860.679.2230
research.uconn.edu

HSPP- October – November – December, 2019- Newsletter

Regulatory Framework for Research with Mobile Applications

 

The following information was drawn in large part from the CITI Program’s module titled “Mobile Apps and Human Subject Research.” The content of this module is copyright.  Uconn Health obtained permission to use this module from the CITI Program.

A mobile application (mobile app or app) is a type of application software designed to run on a mobile device, such as a smartphone or tablet computer.  Medical mobile apps (MMAs) are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Research with apps may be subject to multiple federal regulations such as 45 CRF 46 (The Common Rule), the U.S. Food and Drug Administration (FDA) regulations (including 21 CFR 11), and the Health Insurance Portability and Accountability Act (HIPAA) rule.  Specifically, the FDA regulates mobile health technologies that meet the definition of a medical device.  When a covered entities or business associates use software and mobile applications store or transmit protected Health information (PHI) this falls within the jurisdiction of the Office of Civil Rights (OCR) under the Department of Health and Human Services (HHS).   Researchers may use the information provided on the FDA website to determine if an app meets the definition of a medical device regulated by the FDA. Researchers may use the interactive tool developed by the Federal Trade Commission (FTC), in conjunction with HHS, the Office of the National Coordinator for Health Information Technology, the OCR, and the FDA to determine which laws apply to mobile health applications

 

When using apps in research investigators should consider the following points:

  • If Consent occurs via an app the investigator should be aware that the consent document must contains all the required elements required by the Common Rule. The risk of hacking posed by the electronic consent is to be described in the consent document.
  • The requirements of the IRB for an electronic informed consent process are described in the IRB Policy #  2011-008.1.pdf – Informed Consent – Process –page 4.
  • Ample time to contemplate participation and ask questions will also be applicable to electronic consent, therefore  app-based consent should contain a functionality to satisfy this requirement described in the IRB Policy # 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent  
  • Because mobile apps may use, collect, store, and share data, researchers should communicate the risks of the mobile device security to the subjects and the measures in place to minimize the chance of a breach of confidentiality.   If a mobile app is being used to collect protected health information the researcher must obtain an assessment from UConn Health’s I.T. department that the app is HIPAA compliant.

  

  • The “Terms of Services” (TOS) and/or “End-User License Agreements” (EULAs) associated with the mobile apps, and devices are between the user and the service/provider, not the user and the researchers.  Agreeing to TOS/EULA is different from consenting to participation in research. These agreements may require review by the IRB because they are materials for the subjects, and may include information that would affect a subjects’ decision to enroll in a study.  Differences between these documents and the consent form should be communicated to the subject.

 

  • When the research may result in collection of incidental data (e.g. use of a mobile fitness app), the researchers must indicate to the IRB what incidental data they may collect, and if this data will be disclosed to subjects.  In addition, investigator should clarify whether they will keep that data and if so provide the plans to protect that data.

 

UConn Health Institutional Policy for Mobile Devices &  Consequences of Non-Compliance with HIPAA Rules

 According to UConn Health Institutional Policy # 2008-03 –  Mobile Computing Devices (MCD) Security, confidential or restricted data is not authorized to be stored on either a UConn Health or non-UConn Health Mobile Computing Devices ( MCDs) unless all the criteria below are met:

 

  1. The device stores only the minimum data necessary to perform the function necessitating storage on the device.

 

  1. Information is stored only for the time needed to perform the function.

 

  1. The device requires a password for access and is encrypted using methods authorized by the UConn Health IT Department.

 

In addition, users may not bypass or disable UConn Health required security mechanisms, and unauthorized physical access, tampering, loss or theft of an MCD must be reported to UConn Health Public Safety.

 

Failure to adhere to this institutional policy and associated procedures may result in sanctions as per applicable UConn Health policy.   Failure to adhere to this policy could also lead to monetary fines imposed by the Office of Civil Rights  should a breach occur.  For example, the University of Rochester Medical Center ( URMC) filed a breach reports with the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) in 2013 and 2017 following its discovery that protected health information (PHI) was impermissibly disclosed through the loss of an unencrypted flash drive and theft of an unencrypted laptop, respectively.  To settle the violations of the Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules, the URMC agreed to pay $3 million to the Office for Civil Rights and follow a corrective action plan.  A description of their corrective action plan and the two years of compliance monitoring have been posted in the HHS website.

To learn the provisions/controls defined by UConn Health IT Security when using institutionally owned devices or personally owned devices and the MCD’ user responsibilities, please review the Mobile Computing Devices (MCD) Security Institutional Policy # 2008-03.

  

Clarifying the CDA Process: A  Researcher’s Guide to Handling Confidentiality Agreements

 By Dr. Cherron Payne, Esq.

  

Introduction

The administration of a research study may be an arduous process for researchers and staff.  Moreover, the legal aspect concerning research agreements may also be equally perplexing. Thus, this article is intended to clarify the proper procedure for handling confidentiality agreements.

 

Confidentiality Agreements

 The nomenclature of confidentiality agreements is varied; some agreements are called confidential disclosure agreements, non-disclosure agreements or NDAs, and mutual disclosure agreements.  Although the title of the agreement may vary, the agreement serves the general purpose of protecting the confidential information that is disclosed by research sponsors. Confidentiality agreements will hereafter be referred to as a “CDA”.

 

Before a study commences, the sponsor needs to disclose information for the researcher to evaluate his or her interest in the study.  The disclosed information is often confidential because it contains proprietary information or trade secrets often in the form of models, prototypes, notes, diagrams, documents, reports, memoranda, and other forms of intellectual property. Therefore, it is imperative that researchers manage confidential information in accordance with the terms and expectations of the CDA.  A researcher’s failure to properly safeguard confidential information may impose serious legal ramifications upon UConn Health.  Moreover, breaching the terms of a CDA, or improperly disclosing confidential information, may also cause study sponsors to cease sponsoring UConn Health’s research.

 

Procedural Steps for Researchers

 In order to avoid legal pitfalls, there are specific steps that a researcher or principal investigator “PI” must follow when a confidentiality agreement is received.

  1. The PI should first e-mail the CDA to the proper contract specialist.  The PI should also e-mail the research sponsor’s contact information to the contract specialist.  If the researcher is uncertain as to the appropriate contract specialist, then the researcher may contact Sponsored Program Services at 860-679-4040, by e-mail at sps@uchc.edu, or by reviewing the website of the Office of the Vice President for Research at   https://ovpr.uchc.edu.  The PI should never sign a CDA or agree to its terms without a contract specialist negotiating the agreement.
  2. If a PI receives a research study agreement without receiving a CDA, the researcher should (a) ask the study sponsor to send a CDA or (b) ask the contract specialist to request the CDA. The study agreement should not be negotiated before the CDA has been negotiated and signed.
  3. While negotiating the CDA, the contract specialist may have questions for the researcher or may require additional information. Researchers must furnish said information in a timely manner to avoid a delay in the negotiation.
  4. After the CDA has been negotiated, it is sent to the principal investigator for signature.  The PI should read the agreement before signing, in order to be cognizant of the CDA terms and to properly safeguard confidential information.  If there are any questions regarding the terms of the agreement, a PI may ask the following contacts for clarification:  (a) the contract specialist, (b) the Director of Sponsored Program Services at hudobenko@uchc.edu, or (c) the Executive Director, Sponsored Program Services and Faculty Services at laura.kozma@uconn.edu.
  5. After the CDA has been reviewed, the researcher signs the agreement and promptly returns it to the contract specialist.

     

    When the contract specialist receives the fully executed CDA, a copy will be returned to the researcher or the research staff.  A fully executed copy of the CDA should be retained by the researcher to ensure compliance with the agreement.

     Recent Articles Published by Central IRBs

    ADVARRA IRB:

    Reporting to the IRB: What NOT to Report:  This article provides an overview of what the regulations do and do not say about IRB reporting requirements. 

    Should Social Media Be Part of Your Research Toolbox?    This article discuss the benefits, the risk and the applicable regulatory requirement when using social media for recruitment and retention:

     

    Western IRB (WCG):

     An Overview of the Recent SACHRP Recommendations Around Payments in Clinical Research The U.S Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) has approved two sets of recommendations regarding payments in research.  The first set of recommendations identified a number of considerations for IRBs when evaluating the acceptability of incentives payments.   The second set of recommendations addresses those studies that ask potential research participants to bear some or all of the cost of the research.  SACHRP’s issued several questions prospective subjects and IRBs should ask when participants are required to pay for access to the experimental intervention.

     

    How to Mitigate Placebo Response, Test, Train and Control Expectations in Analgesic clinical trials   This article discusses the importance of training patients to be able to report their symptoms more accurately and the importance of staff training.

     

    IRB Forms – Update

    The Pharmacy section of Appendix A.to the application and the application checklists have been revised to reflect the change in pharmacy contact to Jennifer Czerwinski, 860-679-2085, jczerwinski@uchc.edu

     The HIPAA Request for Alteration or Waiver of Authorization.doc was modified to allow a brief description of the PHI to be used/accessed with reference made to documents within the submission that describe the information in more detail.

     The HIPAA authorization form was revised to delete reference to the Office of Research Compliance as it is no longer a stand-alone office and to change reference to John Dempsey Hospital to UConn Health and to change HSPO to HSPP.

     The Human Subject Research Determination form was revised to provide more instruction regarding the attachment of documents related to the funding source of a project.

    The instructions for reliance on ADVARRA IRB were revised to reflect changes to the consent language template and the instructions for reliance upon WIRB were revised to add reference to the site number assigned to UConn Health.

    Why should I register my study on ClinicalTrials.gov?

    • If you wish to comply with the ICMJE policy (followed by the BMJ, JAMA and many others journals) requiring registration as a condition of consideration for publication, you may voluntarily register your study with ClinicalTrials.gov. You must register prior to subject enrollment.

     

    • If your clinical trial is NIH funded, in whole or in part, you are required to register the study and report results on ClinicalTrials.gov.

     

    • If your clinical trial is funded by a Federal department or agency, the Revised Common Rule requires that your consent form be posted on a public platform, like ClinicalTrials.gov, after the trial is closed to recruitment, and no later than 60 days after the last subject visit.
    • If your clinical trial evaluates at least one drug, biological, or device product regulated by the FDA (See this decision checklist for more details), regardless of funder, you are required to register and post results on ClinicalTrials.gov.

     

    For assistance with ClinicalTrials.gov, see our webpages and contact UConn Health’s ClinicalTrials.gov Administrator, Ellen Ciesielski (860.679.6004) in Research Integrity and Compliance Services.

     

    Research Advertisement Reminder

     

    All methods and materials to recruit participants for research require IRB review prior to implementation. Please be sure all recruitment materials (e.g., text of announcement) are IRB-approved before submitting an announcement for publication.  Announcements must include IRB# and name of approving IRB (if not the UConn Health IRB).  For guidance, visit: UConn Health IRB  and  Guidelines for submitting recruitment announcements  

     

    Export of Research Materials Abroad

    To the UConn/UConn Health research community:

    The Council on Government Relations (COGR) has issued an alert regarding recent situations where researchers have attempted to export research materials abroad. The FBI and other federal law enforcement agencies have increased their surveillance efforts to identify transport of research materials and verify that those exports comply with federal laws. These efforts are believed to be part of a nation-wide enforcement action to control the transport of biological materials that may present a threat to our national security and/or reduce the theft of intellectual property developed in the US, much of it with federal funds.

    Transporting certain materials may require import/export permits or other documentation from federal agencies, including US Customs and Border Protection (CBP), the FDA, USDA, Fish and Wildlife, and the CDC.

    Anyone with questions should contact the applicable federal agency or the UConn Export Control Office (exportcontrol@uconn.edu) for assistance.

    Related news:
    – https://www.universalhub.com/2019/chinese-cancer-researcher-not-allowed-leave
    – https://www.universalhub.com/2019/chinese-researcher-nabbed-liquid-filled-vials

    Wesley G. Byerly, Pharm.D.
    Associate Vice President

    NIH Asks For Your Feedback

    The Office of the Vice President for Research would like to share some information regarding data sharing with researchers who may be affected.

    The National Institutes of Health (NIH) is requesting comments on the draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance.

    NIH will be hosting an informational webinar on the draft NIH policy and guidance on Monday, December 16th from 12:30-2:00 PM ET. The purpose of the webinar is to provide information on the draft policy and answer questions about the public comment process.

    Submit your comments to NIH by January 10, 2020. Additional information can be found in this NIH blog post. Questions about the draft may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov.

    For questions, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

    HSPP-July-August-September, 2019 Newsletter

    Managing Research Studies

     Managing research studies efficiently and effectively requires leadership, planning, collaboration, and communication.

    The Principal Investigator (PI) is responsible for the overall management of an approved study. Management of a study encompasses the ethical, technical, administrative and fiscal elements of the research study.

    The PI is responsible for ensuring that the research team is oriented to the protocol and aware of their responsibilities. The study team should have specific details about the plans to accomplish the goals and procedures of the study, inclusive of plans for recruitment, consenting of subjects, data and safety monitoring, and protections for privacy and confidentiality.

    The PI is also responsible for ensuring that adequate resources are available to conduct the study, including equipment, supplies, and storage space at UConn Health and in any outpatient facilities. Prior to seeking IRB approval, the PI should communicate with the leadership of any ancillary areas that may become involved with the research to ensure the area can commit the necessary resources (e.g. staff, hospital beds, equipment etc.).

    Communicating with appropriate areas to ensure resources are available and educating all members of the research team on their roles and responsibilities will help to ensure that the research is implemented in a safe and compliant manner.

     

    Human Subjects Training- Educational Requirements

     

    I completed CITI Training under my affiliation with a former institution.  Is that CITI Certificate valid at UConn Health?

    CITI Training completed within the last three years may satisfy the UConn Health IRB requirements.  However, the IRB reserves the right to require that an individual complete additional modules.

    The IRB encourages individuals who are new to UConn Health (e.g. a new student, new faculty member) to complete CITI training under their new affiliation with UConn Health. When completing modules under the new affiliation to UConn Health the CITI Program will provide credit for any overlapping modules completed under another institutional affiliation and will require completion of any modules that are specific to UConn Health requirements.

    To affiliate one’s account in the CITI Program with UConn Health, individuals should log into the CITI program, and click on “Add Affiliation” listed under the “Courses” Menu.  To find UConn Health in the drop down box, the following words “University of Connecticut” must be typed.  Then, select “University of Connecticut Health Center”.  To complete the process, check the box next to the statement: “I AGREE to the Terms of Service for accessing CITI Program materials”   and check the box with the statement: “I affirm that I am an affiliate of University of Connecticut Heath Center.” Last, click on “Continue.”

    To select the correct learning group and courses, follow the “Course Enrollment Questions” posted at  https://ovpr.uchc.edu/services/rics/hspp/citi-instructions/

     

    I will be conducting a Clinical Trial at UConn Health.  Should I complete the “Good Clinical Practice (GCP)” course?

    It depends on whether or not the clinical trial is supported by the National Institutes of Health (NIH). The GCP training is a requirement if the clinical trial is an NIH funded trial.  The Human Subjects Protection Program/IRB strongly encourages researches who are involved in clinical research trials not supported by the NIH to complete the GCP course.

     

    Reporting Non-Compliance to the IRB

    Principal Investigators are responsible for being knowledgeable of and following the IRB policy for reporting non-compliance (i.e.  Policy 2009-002.0.pdf – Reporting Non-Compliance to the Institutional Review Board).   Noncompliance is defined in Policy 2011-007.0 as any action that is taken or occurs that is not in accordance with an IRB approved study, IRB polices or regulations or that represents a failure to follow the requirements and/or determinations of the IRB.

    Principal investigators (PIs) should report to the IRB any non-compliance that was within the control of the research team within 5 business days of becoming aware of the event.  To do so, PIs should complete and submit a Problem Report Form through the IRB online submission system, iRIS.  When the non-compliance was not within the control of the research team it should be reported at the time of continuing review.  If continuing review is no longer a requirement, non-compliance that was not within the control of the research team should be documented and tracked by the study team and available for review should the study be selected for audit.

    Whenever any non-compliance is reported, the investigators should describe the details of the event, the underlying causes of the noncompliance and the actions that have been taken or will be taken to correct the problem and to prevent a subsequent occurrence. PIs should also describe whether the occurrence suggests that subjects or others are placed at an increased risk of harm.  This information allows the IRB to accurately assess the situation to determine whether the non-compliance rises to the level of serious and or continuing non-compliance as defined in IRB Policy 2011-007.0 – Definitions Applied to Policies. If the event does rise to the level of serious and/or continuing non-compliance there may be additional reporting required if the research is Federally funded or subject to FDA oversight.

    If there is any question about whether reporting is required it is always better to err on the side of caution and report the issue.   PI’s are also encouraged to contact one of the Regulatory Specialists to discuss any questions about reporting requirements.

     

     Are you responsible for updating a ClinicalTrials.gov record?

     Are you responsible for updating a ClinicalTrials.gov record? You may want to subscribe to the new ClinicalTrials.gov bulletin “Hot off the PRS!” The bulletin details recent updates to the Protocol Registration and Results System (PRS) as well as new resources for PRS users. Enter your email address next to “Receive Updates” at the top of their webpage to subscribe. For help with registering your record or related questions, contact UConn Health’s PRS Administrator, Ellen Ciesielski at 860.679.6004 or eciesielski@uchc.edu.

     

    IRB Forms – Update

     The Instructions for Requesting Reliance Upon Advarra IRB.docx  have been update to reflect the new contact names at Advarra IRB.  Investigators may contact Kathleen Rankin or Ashley Carpenter for guidance in making a submission to Advarra IRB.

     

    Recent Articles Published by Central IRBs

    Advarra IRB:

    • Gene Therapy: Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the  growth, risks, and regulatory requirements by reading How Centralized IBC Review Can Benefit Gene Therapy Research
    • IRB Review of Participant Compensation: IRBs are in charge of reviewing the amount of payment, as well as the method and timing of disbursement, to ensure that the payment plan does not present potential undue influence. Participant compensation is often a complicated matter, what an IRB should consider is discussed at Compensating Clinical Trial Participants: The Basics  

    Western IRB (WCG):

    • Participants Training has a direct impact in achievement the objectives in Clinical trials: Lack of training, particularly for patients, creates variability detrimental to trial findings, says Nathaniel Katz, founder and chief science officer of WCG Analgesic Solutions. To learn more about this topic click on: Lack of Training Compromises Trial Results.
    • Recruitment: Recruitment is what drives a study. No patients, no research, right? Sites, sponsors and CROs know they need to do it, but they don’t really consider all the implications or differing strategies to recruitment .To learn more about this topic click on: What You Don’t Know About Patient Recruitment Can Impede the Success of Your Trial

     

    Reporting Race and Ethnicity Data when Requesting Continuing Review

     “Researchers assumed that what they learned about white male participants could safely applied to anybody, regardless of gender, race, ethnicity or other variables.  We now know that this is not true.  When you are communication about research results, it’s vital not only to explain how a study was done, but was being studied,” says Dr. Eliseo J. Perez-Stable, Director of the National Institute on Minority Health and Health Disparities in his article titled: Communicating the Value of Race and Ethnicity in Research.

    In August of 2001, The National Institute of Health (NIH) issued a policy which adopted the 1997 Office of Management and Budget (OMB) revised minimum standards for maintaining, collecting, and presenting data on race and ethnicity for all grant applications, contract and intramural proposals and for all active research grants, cooperative agreements, contract and intramural projects.  The goal of this policy is to ensure that the distribution of study participants by sex/gender, race and ethnicity reflects the population needed to accomplish the scientific goals of the study.

    UConn Health IRB Main Consent Form Template .doc contains an Addendum Form titled “Personal Census Data”.  This form provides a mechanism for capturing the representation from  racial and ethnic groups in research studies conducted at UConn Health. This addendum form provide instructions to investigators, to present this form to subjects at the time of consent for completion.

    The categories and definitions in the “Personal Census Data Sheet” are commonly used for federal data collection purposes. The form’s standards consist of two categories for ethnicity: “Hispanic or Latino” and “Not Hispanic or Latino” and five categories for race: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White.

    Investigator with full board studies or expedited submissions requiring continuing review are required to report this data at the time of request for continuing review.

    Investigator should count all subjects who provided consent since the start of the study, including subjects who were screen failures or withdrew.  Investigators should indicate by gender the number in each racial/ethnic group. The total reported numbers should equal the total reported since the start of the study in the first table (e.g. first request for continuing review).

    The table to be completed within the continuation form in IRIS is provided here for reference.

     

    Ethnic Category Females Males
    Hispanic or Latino
    Not Hispanic or Latino
    Unknown
    Racial Category    
    American Indian/Alaska Native
    Asian
      Native Hawaiian or Other Pacific Islander
    Black or African American
    White
    More Than One Race
    Unknown or Not Reported

     

    START Preliminary Proof of Concept Fund

    Dear Colleagues,

    Through a generous grant provided by the CTNext Higher Education Fund last year, the Office of the Vice President for Research (OVPR) has been administering an early stage translational research funding program called the START Preliminary Proof of Concept (PPOC) Fund. Under the grant, funding is provided to investigators at Central Connecticut State University (CCSU), Southern Connecticut State University (SCSU), University of Bridgeport (UB), and UConn on a competitive basis.

    The START program aims to support the preliminary validation of innovative early stage technologies that have possible commercial potential and is designed to advance those technologies to be more attractive for additional funding. Proposals for the START PPOC Fund are welcomed from across all disciplines for early stage projects that may one day result in inventions and technologies that address unmet needs and have potential for commercial application.

    As we wrap up the first year on funding, I would like to take a moment to recognize recipients from these institutions and ask that you join me in congratulating them on their efforts to commercialize technologies developed in the course of their academic research. For a full list of recipients and project information, visit the OVPR website.

    For more information about the competition, visit the program website.

    Thank you for helping to foster the culture of excellence in your schools/colleges, departments, and centers that allows UConn faculty to engage in research, scholarship, and creative activities at the highest levels. 

     

     

    Cheers,

    Radenka

    Celebrating UConn Research, Scholarship, and Creative Activities

    As we begin a new semester at UConn, I would like to reflect on our past academic year and share with you the excitement, successes, and progress we made in that time. As a public research university that engages globally in the creation of new knowledge, we measure our success by the impact of our scholarly and educational outcomes, research, innovation, and the creative work of our students and faculty. In the last few years, we have brought people together around shared goals across campuses and disciplines, an accomplishment that is palpable at UConn and has been critical to the success of our land-grant mission.

    Our three consecutive years of growth in total awards have borne out the value of our collective efforts.

    Thanks to the tireless work of our faculty, postdocs, students, and staff, our new extramural awards for FY19 reached a three-year high of $266.2M. In FY17, our total new awards were $184.5M and in FY18, they were $258M. UConn Health received over $100M in new awards this past fiscal year reaching an all-time high. Our combined efforts represent a 44% increase over three years. We also saw upward trends in our entrepreneurship and innovation ecosystem, with a record 39 high-potential startup companies joining UConn’s Technology Incubation Program, and a ranking of 93rd worldwide in the number of US patents issued for UConn inventions. It is a matter of great satisfaction for me to have helped position entrepreneurship and innovation as an equal mission for our faculty alongside teaching, scholarship, research and creative work.

    Our committed focus on seed funding, proof of concept grants, and awards to support the arts and humanities has contributed to STEM and non-STEM excellence. In FY19, our office contributed $2.3M to internal funding programs and an additional $100K to support grant writing workshops and resources. We are thrilled to see engagement, collaboration, and distinction from all areas of the University, whether it be STEM, non-STEM, or a collaborative hybrid, and that these combined efforts are producing growth in research and extramural awards.

    I would like to highlight a few new initiatives launched by the OVPR in FY19 that supported faculty success:

    • Convergence Awards for Research in Interdisciplinary Centers (CARIC): Support development of collaborative interdisciplinary teams to bid for major (>$5M) federally funded initiatives, such as research centers.
    • Support of UConn Human Rights Institute with two postdoctoral fellowships in collaboration with the Schools of Engineering and Business.
    • Program in Accelerated Therapeutics for Healthcare (PATH): In partnership with the Schools of Pharmacy and Medicine, aims to accelerate the translational pathway to convert discoveries into new medical therapeutics. The program seeks to quickly develop novel approaches focusing on well validated molecular targets for a specific disease area with an unmet treatment need in the current commercial marketplace.
    • Scholarship and Collaboration in Humanities and Arts Research Program (SCHARP): In partnership with the Humanities Institute, SCHARP supports innovative works in scholarship and creative activities in the arts and humanities that have the potential to transform a field of study, impact the common good, or chart a new direction in scholarly, creative, or artistic direction.
    • STEAM Innovation Grant: In partnership with the School of Fine Arts, STEAM encourages innovative collaborations between the arts and STEM disciplines. Projects funded by this grant may result in publications, exhibitions, performances, academic symposia, or other research outcomes.
    • Stamford Innovate, a new internship program that connects talented UConn students with opportunities in startups in one of the fastest growing regions of the state.

    If you want to learn more, click here for a full list of our internal funding programs.

    As educators, we all take great pride in our students’ successes, and I wanted to take a moment to recognize some new student projects that are truly remarkable. In collaboration with the Office of the Provost, the OVPR supported a student-led podcast called In Vivo. With regular interviews about science, the arts, current events, and other topics, In Vivo highlights the amazing faculty, students, and staff that give UConn life. The show is conducted out of UConn’s WHUS studio and is run entirely by UConn students. Check it out and consider subscribing for future episodes to learn more about UConn researchers.

    Another new initiative is World Poetry Books to support its mission of publishing and vigorously promoting a minimum of six books of exceptional poetry in translation each year. This support offers our students the opportunity to gain hands-on, professional publishing skills, and establishes UConn as home of a preeminent publisher of exceptional world literature.

    While sharing accomplishments is important, we also want to increase transparency and continue to maintain open lines of communication as we push to raise UConn’s research profile. In addition to sharing research and tech transfer metrics on the recently revamped UConn Research website, we encourage faculty and staff to reach out with suggestions regarding new opportunities and unmet needs. It is only together – as a team – that we will continue to drive the growth of scholarship, research, and creative pursuits at UConn.

    I’d like to conclude with a personal note of gratitude. I cannot thank all of you enough for giving me the opportunity to work with so many talented, hardworking, and committed colleagues. To my staff, I am deeply honored to serve as VPR and grateful for your support, continued improvement, and service to our faculty and students. At the end of a hard day, I find great inspiration in the knowledge that UConn’s faculty and staff – whether they be musicians, chemists, or scholars of law or other disciplines – are some of the world’s most innovative and active researchers. Thank you for making UConn a special place with a vibrant community of caring, collaborative people.

    We are opening a new chapter for UConn with a new President who is focused on our excellence, strengths, and new opportunities. I look forward to this journey with all of you, and please remember my door is always open!

    Cheers,

    Dr. Radenka Maric

    Vice President for Research, UConn/UConn Health

    Prospective Basic Science Studies Involving Human Participants

    On July 24th, NIH published a Guide Notice (NOT-OD-19-126) announcing the extension of delayed enforcement of registering and results reporting of Basic Experimental Studies involving Humans (BESH trials) on ClinicalTrials.gov through September 24, 2021. BESH trials are basic research projects exploring fundamental aspects of phenomena that involve human participants.

    In a previous RFI (NOT-OD-18-217), NIH solicited feedback from the scientific community about challenges in reporting BESH trials on the ClinicalTrials.gov platform and several primary challenges were identified. Therefore, NIH has determined that more time is needed to address these challenges. In the interim, to meet NIH’s registration and results reporting requirement, alternative publicly available platforms should be used as described at the time of application in the Dissemination Plan attachment.

    Please note this extension does not change the requirement for clinical trials to be registered on ClinicalTrials.gov.

     

    For questions about this notice or your ClinicalTrials.gov requirement, please contact Ellen Ciesielski, 860.679.6004.

     

     

    Important Information from the NIH and NSF

    Dear Investigator,

    On July 10th, the National Institutes of Health (NIH) published a reminder on NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components.  This was followed on July 11th by a Dear Colleague Letter on protecting research funded by the National Science Foundation (NSF) from NSF Director, Dr. France Córdova. These notices relate to the ongoing concerns regarding foreign influence in federally funded research.

    In response to these publications, the OVPR recommends that any collaborations with foreign entities or individuals, or appointments with foreign entities (including foreign talent or similar programs) be disclosed to the NIH or NSF program officer, your Dean, and the OVPR (contacts and additional information listed below).

    The OVPR has posted additional guidance on our site regarding Active and Pending Support and Foreign Collaborations. For any questions or for guidance on this and other related matters, please contact:

    Thank you for your cooperation,

    Radenka Maric, PhD
    Vice President for Research
    UConn/UConn Health

    Important Information from the NIH and NSF for UConn/UConn Health Investigators

    The NSF Letter references the draft NSF Proposal and Award Policies & Procedures Guide published in May 2019.  Clarifications in the draft Guide related to current and pending support and biographical sketches include:

    • Providing information for all current and pending support irrespective of whether such support is provided through the proposing organization or directly to the individual.
    • Expanding examples of current and pending support to include non-profit organizations and consulting agreements.
    • Reporting all projects and activities requiring a time commitment (no minimum has been established), even if the support received is only in-kind.
    • Appointments should include any titled academic, professional, or institutional position whether or not remuneration is received.

    The Dear Colleague Letter also states the NSF will be issuing a policy that NSF personnel and Intergovernmental Personnel Act (IPA) assigned personnel cannot participate in foreign government talent-recruitment programs.

    The NIH Notice reminds applicants that in regards to Other Support, they must:

    • List all positions and scientific appointments, both domestic and foreign, held by senior/key personnel which are relevant to an application including affiliations with foreign entities or governments such as titled academic, professional, or institutional appointments whether or not remuneration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
    • Report all resources and other support for all individuals designated in an application as senior/key personnel – including the program director/principal investigator and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they request salaries or compensation. All current support for ongoing projects must be included, irrespective of whether such support is provided through the applicant organization, through another domestic or foreign organization, or is provided directly to an individual who supports the senior/key personnel’s research efforts.
    • Report all current projects and activities involving senior/key personnel, even if the support received is only in-kind (e.g. office/laboratory space, equipment, supplies, employees), including, but not limited to, foreign financial support, research or laboratory personnel, lab space, scientific materials, selection to a foreign “talents” or similar-type program, or other foreign or domestic support.
    • Provide the total award amount for the entire award period covered (including facilities and administrative costs), as well as the number of person-months (or partial person-months) per year to be devoted to the project by the senior/key personnel.

    The Notice also reminds applicants of the need to determine whether projects include a foreign component, defined as the existence of any “significant scientific element or segment of a project” outside of the United States including:

    • Performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or
    • Performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.

    If a significant portion of a project will be conducted outside the United States, then there is a foreign component and NIH prior approval is required.  If all project activity is conducted within the United States, but there is a non-U.S. resource supporting the project, it must be reported as other support.

    HSPP-April-May-June,2019 -Newsletter

    UConn Health’s Human Subjects Protection Program Receives Reaccreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP)

     The Association for Accreditation of Human Research Protection Programs (AAHRPP) completed a site visit at UConn Health in April 2019.  During this visit, IRB members and staff, investigators and study coordinators, and others involved with research oversight were interviewed, and study research records were reviewed.  In June 2019, the AAHRPP Council on Accreditation awarded full reaccreditation to UConn Health’s Human Subjects Protection Program (HSPP), confirming that all standards for re-accreditation were fulfilled.   This reaccreditation is for five additional years. The final report issued by AAHRPP commends the HSPP for demonstrating an unusually high degree of integration among the areas responsible for research oversight.

     

    Documentation of Consent

    Unless the requirement to document consent has been waived by the IRB, the IRB approved consent form must be signed and dated by the subject (or legally authorized representative) and the person obtaining consent.

    Notes in a research chart that indicate on-going discussions with the subject at subsequent study visits may supplement documentation of the initial informed consent process.

    The following are examples of issues found with documentation of consent during recent internal audits at UConn Health.

    • The date of consent differs between the subject and the person obtaining consent.
    • The date of consent is left blank by the subject and/or the person obtaining consent..
    • The date of signature is incomplete or incorrect.
    • The informed consent form is missing the signature of the person obtaining consent.
    • The person obtaining consent enters the date of the subject’s signature.
    • Consent for participation obtained from legally authorized representatives when the study approval requires the subject to provide consent.
    • Consent was obtained by people not approved as consenters by the IRB.
    • Subjects consented with expired consent documents.
    • Consent forms containing a correction to the signature and/or date which obscured the original entry.

    To ensure consent is appropriately documented the following points should be considered:

    • The principal investigator and study team members should use the most recently approved stamped and dated consent form when obtaining consent.
    • Subjects should sign the consent form in the presence of, and at the same time as, the consenter.
    • Persons obtaining informed consent should review the forms once they are signed/completed and before the subject leaves that day, to ensure that all signatures and dates are properly entered on the forms.
    • In the event that a form is found to be incomplete (e.g., a date is missing) if the error is not discovered while the subject is present, the research staff should prepare a note to file attesting to the fact that they witnessed the signing of the form, and the date that it was signed.  The original consent form must be retained, and the subject should make the corrections at the earliest opportunity.
    • Any problem with documentation of informed consent should be reported to the IRB using a problem report form within five days of becoming aware of the non-compliance.
    • Approved consenters should review HSPP Policy 2011-008.1.pdf – Informed Consent – Process  and Policy 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent  

     

    Guidance for Posting Clinical Trial Consent Forms

    Last January 2019, the revised version of 45 CFR 46, the federal regulation for the protection of human subjects in research, which is also known as the Common Rule, went into effect.  One of the revisions requires that for any clinical trial conducted or supported by a Common Rule department or agency, one IRB-approved consent form that was used to enroll subjects be posted on a publicly available federal website within a specific time frame.   UConn Health IRB has posted a Guidance for Posting Clinical Trial Consent Forms to help the research community to fulfill this obligation.

     

    IRB Forms – Update

     Investigators should always use the latest version of the IRB forms posted in the IRB website.  Listed below, are the forms revised during the past three months. Within the parenthesis is the date when forms were revised.

     

    Personnel Changes to the Scientific Review Committee

     Dr. Doug Peterson who has served as the Chair of the Scientific Review Committee (SRC) for over a decade has stepped down as Chair. Dr. Julie Wagner is now the SRC Chair and Dr. Peterson will continue to serve on the SRC as a member until November 1.

    The following three faculty members have been appointed to serve on the SRC.

    • Dr. Efthimia Ioannidou, Professor/Clinical, Periodontology
    • Dr. Ivo Kalajzic, Professor/Basic Science, Center for Regenerative Medicine
    • Dr. Tannin Schmidt, Associate Professor/Basic Science, BioMedical Engineering

     

    In Memoriam – Pamela Engelson Colwell

    Our dear friend and colleague, Pamela E. Colwell (Pam) passed away on Wednesday, June 26, 2019.  Pam worked for the IRB for the last 15 years as a Regulatory Specialist and IRB member. Pam was an amazing team member, taught multiple IRB members, and played a pivotal role in the implementation of the iRIS submission system.  Please refer to the following link for information regarding services and memorial donations. http://northhavenfuneral.com/obituary/pamela-engelson-colwell/

     

    UConn Health’s Human Subjects Protection Program Receives Reaccreditation from AAHRPP

    Dear Colleagues,

    It is my pleasure to inform you that we received official notification from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of continuing Full Accreditation for the UConn Health Human Subjects Protection Program. The process to obtain reaccreditation is an important, but complex one, which required team work from many stakeholders. I would like to take this opportunity to thank faculty and staff, IRB members and staff of the HSPP, members of the Scientific Review and Conflicts of Interest committees, Office of Clinical and Translational Research Services, Sponsored Program Services, Research Pharmacy and Research Safety, and many others who are committed to ensuring that we have an outstanding human subjects program every day. They are to be commended for their dedication and efforts in maintaining our continued accreditation. Their work ensures appropriate care of clinical trial participants, which in turn makes possible the high quality research conducted by UConn Health investigators.

    Sincerely,

    Wesley G. Byerly, Pharm.D.
    Associate Vice President

    Program in Accelerated Therapeutics for Healthcare (PATH) Awards

    Dear Colleagues,

    I’m very pleased to announce that the Office of the Vice President for Research (OVPR) has recently finalized award decisions for the inaugural cycle of the Program in Accelerated Therapeutics for Healthcare (PATH).  PATH is a partnership that includes the OVPR, the School of Pharmacy, and the School of Medicine to accelerate the translational pathway for researchers to convert their discoveries to new medical therapeutics. Under PATH, funding is provided to academic research programs designed to quickly develop novel therapeutic approaches focusing on well validated molecular targets for a specific disease area with an unmet treatment need in the current commercial marketplace. Projects focusing on a wide range of therapeutic interventions (small molecule, biologic, antibody, peptide, gene therapy) are eligible for consideration.

    Given your leadership role in the University, I want you to be among the first to hear the results of this competition so you can join me in congratulating the awardees.  Seven PATH grants were awarded in two categories after a highly selective competition:

     

    PATH Trailblazer Grants – $75,000

    Xiuling Lu, Pharmaceutical Science
    Cutting Cancer at Its Root: Inhibition of Acute Leukemic Stem Cells Using Doxorubicin-Loaded Nanoparticles

    Jessica Rouge, Chemistry
    Determining the Pharmacology of a Novel DNAzyme-therapeutic Formulation for the Treatment of Allergic Airway Disease

     

    PATH Ascent Grants – $10,000

    Brian Aneskievich, Pharmaceutical Science
    Establishing Protein Conformational Flexibility to Enhance Next-Step Drug-Screen Targeting

    Nicholas Leadbeater, Chemistry
    Towards Development of Novel Therapeutics for Treatment of Toxoplasmosis

    Rajkumar Verma, Neuroscience, UConn Health
    Discovery of Novel Purinergic P2X4 Receptor Antagonist for the Treatment of Ischemic Stroke

    Simon White, Molecular and Cell Biology
    Screening for Small Molecule Inhibitors against Enterovirus D68 2C Helicase

    Ming Xu, Genetics and Genome Sciences, UConn Health
    Discover Drugs Targeting Cellular Senescence to Improve Healthspan and Lifespan

    For more information about PATH, visit the program website.

    Thank you for helping to foster the culture of excellence in your schools/colleges, departments, and centers, that allows UConn faculty to engage in research, scholarship, and creative activities at the highest levels.

    Cheers,

    Radenka

    OVPR Quarterly Reports – FY19Q2

    Dear Colleagues,

    Now that data have been finalized, I would like to provide you with several reports relating to sponsored program activity—both research and education/service—managed by Sponsored Program Services within the Office of the Vice President for Research at UConn and UConn Health. Please visit the OVPR website to view the following reports: https://ovpr.uconn.edu/news/quarterly-reports/

    • List of Proposals Submitted: FY19 2nd Quarter
    • List of Awards Received: FY19 2nd Quarter
    • Proposals, Awards, Expenditures: FY14-FY19Q2

    In the reports, data are presented in two ways: by the PI’s Academic Home Department and by the Managing Department or Center/Institute. Please refer to the first pages of the reports for definitions and information regarding the data. Should you have any questions regarding these quarterly reports, please do not hesitate to contact me.

    Please note that we have included an additional Summary of Sponsored Program Activity, which includes the Effective F&A rate on awards. This information provides a snapshot of our activity as compared to the same period last year.

    The OVPR continues to seek creative solutions that allow UConn and UConn Health to grow our research enterprise through federal funding, industry partnerships, and collaboration with foundations. I am confident we can continue upward trends by continuing to work together, aggressively applying for extramural funding, and pursuing new channels of support for the tremendous research, scholarship, and creative activities taking place every day at UConn and UConn Health.

    Thank you for your continued commitment and contribution to our students, to your research and scholarship, and to UConn/UConn Health.

    Sincerely,
    Radenka

     

    Dr. Radenka Maric
    Vice President for Research
    UConn/UCH

    HSPP- Jan-Feb-Mar, 2019 – Newsletter

    Revised Common Rule (45 CFR 46)

    The revised version of the regulation governing human subjects research (i.e. 45 CFR 46 also known as the Common Rule) became effective January 21, 2019.  Due to this revision, several IRB forms, templates, and policies have been modified.  Always refer to the HSPP web site to ensure you are using the most recent version of a form.

    The following sections contain a summary of those changes.

      1. The Consent Form Template and Consent Checklist were revised to incorporate seven new elements of consent for federally funded/supported research. For those approved federally funded/supported research studies that are actively enrolling subjects, investigators should submit either at the time of continuation or through a request for modification a revised consent form with the new required elements.  Until such time as this review occurs studies are considered grandfathered under the current version of the Common Rule.  Subjects will not be required to be re-consented based solely on these changes.  For federally funded/supported studies that are closed to new enrollment the consent form will need to be revised only if there is another reason that triggers a change to the document.  For example if new risks are being disclosed, at the time the consent is revised to incorporate the new risk the consent would also have to be brought into compliance with the new requirements.    For previously approved non-federally funded/supported research, no changes are necessary; however, these new elements will be used as the guiding principle of consent elements moving forward.
      2. Waiver/Alteration of Consent:   If the research involves using identifiable private information or identifiable biospecimens, the investigator will need to explain in the waiver document why the research could not practicably be conducted without access to and use of the identifiable private information/biospecimens.If a waiver is necessary for federally funded/supported studies investigators must be sure to address the additional element describe above at the time the study is transitioned to the revised rule. Waiver of Documentation of Consent:  There is a new provision for allowing for waiver of documentation of consent.  Documentation of consent may also be waived if the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
      3. Changes to Continuing Review Requirement: Unless otherwise required and justified by the IRB, continuing review will no longer be required for non-FDA regulated federally funded research that meets the criteria for expedited review. Investigators who have non-FDA regulated federally funded research that qualifies for expedited review will be asked to provide an expected completion date of the research, which will become the expiration date of IRB approval.  For previously approved research this may be provided as part of one last request for continuation (e.g. if IRIS has already generated a continuing review due task) or as part of a request for modification.  The PI will be required to submit a request for modification to extend this expected completion date if necessary.   The IRB may require justification for the expected completion date as it deems appropriate.              Note:   Continuing review is still a requirement for all FDA regulated research even if all subjects are in long-term follow-up or the research is in data analysis.

    Any study that does not requires continuing review still need to submit a modification to the IRB prior to implementing changes to the conduct of that study except when the change is necessary to eliminate immediate hazards to subjects.  Modifications include, but are not limited to,  change in design, removal or change to survey tool, change in funding source, change to recruitment materials, adding or removing investigators, changing the title of the project, requesting additional subjects beyond the original approved number, changes to informed consent forms, or other correspondence with potential or current subjects.

    4. Changes to the Initial Application Form in IRIS:   The IRB application form in IRIS was edited. The request for Exempt status categories and Expedited review categories were removed from the application and are now described in two separate word documents to be attached to the application form in IRIS. The following forms have been published in the IRB website and should be submitted when requesting a determination for exemption  or review under an of the expedited categories:

    5.The following IRB forms have been updated and published in the IRB website:

    Points to Remember When Relying on an External IRB

    • With the exception of reporting changes in study personnel,  once the determination is made to accept the external IRB as the IRB of Record, from that point forward the UConn Health investigator only deals with the IRB of Record for the review of continuations, modifications, unanticipated problems and non-compliance.
    •  The Principal Investigator is responsible for knowing and following the requirements of the reviewing IRB, inclusive of requirements for reporting subject complaints, non-compliance, unanticipated problems and outcomes of audits and inspections. The PI is responsible for ensure that the research team is also aware of and follows such.
    • Research for which IRB oversight has been deferred to an external IRB may still be subject to audit by the UConn Health Research Compliance Monitor.

    Difference between Privacy and Confidentiality

    Privacy applies to the individual and confidentiality applies to the data obtained from the  individual.

    According to the IRB Guidebook, published by the Office for Human Research Protections (OHRP 1993): “Privacy can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission.”

    Therefore, the privacy of the subjects in a research study can be maintained by conducting the consent process, interviews, and procedures in a private room.  The confidentiality of the subjects’ data can be protected, for example, by storing the data on encrypted password protected computers.

    Expanded Definition of “Clinical Trial” & ClinicalTrials.gov

     The Revised Common Rule expanded the definition of “clinical trial” with the intention of harmonizing with the National Institutes of Health’s definition. The expanded definition includes any “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on biomedical or behavioral health-related outcomes.” Importantly, the revised definition includes studies that had not previously been considered clinical trials, like social and behavioral research.

    What if my study meets the expanded definition of a clinical trial?

    1) If your clinical trial is funded by a Federal department or agency, the Revised Common Rule requires that your consent form be posted on a public platform, like ClinicalTrials.gov, after the trial is closed to recruitment, and no later than 60 days after the last subject visit.

    2) If your clinical trial evaluates at least one drug, biological, or device product regulated by the FDA (See this decision checklist for more details), regardless of funder, you are required to register and post results on ClinicalTrials.gov.

    3) If your clinical trial is NIH funded, in whole or in part, you are required to register the study and report results on ClinicalTrials.gov.

    4) Regardless of funder, if you wish to comply with the ICMJE policy (followed by the BMJ, JAMA and many others journals) requiring registration as a condition of consideration for publication, you may voluntarily register your study with ClinicalTrials.gov.

    For assistance with ClinicalTrials.gov, see our webpages and contact UConn Health’s ClinicalTrials.gov Administrator, Ellen Ciesielski (860-679-6004) in Research Integrity and Compliance Services.

    2019 CARIC Award Recipients Announced

    Dear Colleagues,

    I am pleased to announce that two teams have been selected for funding in the inaugural cycle of CARIC (Convergence Awards for Research in Interdisciplinary Centers).

    CARIC supports the development of collaborative, interdisciplinary teams bidding for major federally funded research initiatives. These initiatives can include large, multi-million-dollar research grants or even entire research centers.

    2019 CARIC Awards:

    • David Rowe, Director of the Center for Regenerative Medicine and Skeletal Development
      Bed to Bench (BTB) Collaboration for Skeletal Research
    • Yu Lei, Castleman Distinguished Professor, Chemical and Biomolecular Engineering
      Exposure, Health Effects, Sensing and Remediation of Emerging Contaminants Superfund Research Program (SRP) Center

    The CARIC program will provide these projects with funding of up to $150,000 to support planning, outreach to strategic partners and proof-of-concept research for a year, with the possibility for renewal. This initial funding allows researchers to develop more competitive bids for prestigious national awards.

    To learn more about CARIC, visit the website of the Office of the Vice President for Research.

    Sincerely,

    Dr. Radenka Maric
    Vice President for Research
    UConn/UConn Health

    HSPP- October-November-December, 2018

    Overview of Major Changes to the Common Rule (45 CFR 46)

    The revised version of the regulation governing human subjects research (i.e. 45 CFR 46 also known as the Common Rule) became effective January 21, 2019. Accordingly, several IRB forms, documents templates, policies and the IRB applications in IRIS have been revised. It is the intention of the IRB that all federally funded/supported research will be brought into compliance with the revised regulation at the time of the continuing review that occurs on or after January 21, 2019.   Until such time as that review occurs those studies are considered grandfathered under the previous version of the regulation.  Investigators may request to transition to the revised regulation soon by submitting a request for modification.

     

    The following sections contain a summary of the major changes.

    The Consent Form Template and Consent Checklist have been revised to incorporate seven new elements of consent for federally funded/supported research. The new requirement regarding process and the new 7 elements of a consent are as follows

    • Consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension
    • Informed consent as a whole presents information in sufficient detail relating to the research, and is to be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate
    • One of the following statements if the research involves the collection of identifiable private information (IPI) or identifiable biospecimens (IB):
    • A statement that identifiers might be removed from the IPI or IB and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility;   OR
    • A statement that the subject’s information or biospecimens collected as part of the research, even if       identifiers are removed, will not be used or distributed for future research studies
    • If applicable, a statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
    • If applicable, a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions
    • If applicable, for research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

    For those approved federally funded/supported research studies that are actively enrolling subjects, investigators should submit either at the time of continuation or through a request for modification a revised consent form with the new required elements. Until such time as this review occurs studies are considered grandfathered under the current version of the Common Rule. Subjects will not be required to be re-consented based solely on these changes.

    For federally funded/supported studies that are closed to new enrollment the consent form will need to be revised only if there is another reason that triggers a change to the document. For example if new risks are being disclosed, at the time the consent is revised to incorporate the new risk the consent would also have to be brought into compliance with the new requirements.

    For previously approved non-federally funded/supported research, no changes are necessary; however, these new elements will be used as the guiding principle of consent elements moving forward.

    To learn more about the new elements of consent please review IRB Policy 2011-008.0.pdf– Informed Consent – Forms

    The revised regulation expands the definition of Legally Authorized Representative to now recognize that if State law is silent legally authorized representative means an individual recognized by institutional policy as acceptable for providing consent in the non-research context on behalf of the prospective subject to the subject’s participation in the procedure(s) involved in the research.

    To learn more about the new changes to the consent process please review IRB Policy 2011-008.5.pdf – Informed Consent – Providing and Obtaining Informed Consent

     

    Waiver/Alteration of Consent: When a waiver or alteration of consent is requested the following additional criterion must be met in order for the IRB to grant the waiver/alteration.

    • If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format.

    If a waiver is still necessary (see below) for federally funded/supported studies investigators must be sure to address this additional element at the time the study is transitioned to the revised rule.

    The revised regulation allows for certain activities regarding screening, recruiting or determining eligibility (e.g. telephone screening or chart reviews for the purpose of determining eligibility) to occur without a waiver/alteration if either of the following conditions are met:

    • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
    • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

     

    The above change has been already be implemented for non-federal studies, and as of January 21, 2019 will be implemented to federally funded studies. If a waiver had been previously approved but is no longer necessary, that document should not be included in the submission packet at the time the study is transitioned to the revised rule.

    Note:   There has been no change to HIPAA and there must be adequate measures in place to protect the confidentiality of any information collected for the purpose of screening, recruiting or determining eligibility prior to informed consent.

    To learn more about the new changes to the waiver of consent please review IRB Policy 2011-008.2.pdf – Informed Consent – Waivers and Alterations

     

    Waiver of Documentation of Consent: There is a new provision for allowing for waiver of documentation of consent. Documentation of consent may also be waived if the subjects or LAR are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

    To learn more about the new changes to the waiver of documentation of consent please review IRB Policy 2011-008.2.pdf – Informed Consent – Waivers and Alterations

     

    Changes to Continuing Review Requirement: Unless otherwise required and justified by the IRB, continuing review will no longer be required for non-FDA regulated federally funded research that meets the criteria for expedited review.

     

    Investigators who have non-FDA regulated federally funded research that qualifies for expedited review will be asked to provide an expected completion date of the research, which will become the expiration date of IRB approval.   For previously approved research this may be provided as part of one last request for continuation (e.g. if IRIS has already generated a continuing review due task) or as part of a request for modification. The PI will be required to submit a request for modification to extend this expected completion date if necessary.   The IRB may require justification for the expected completion date as it deems appropriate.

    Note:   Continuing review is still a requirement for all FDA regulated research even if all subjects are in long-term follow-up or the research is in data analysis. The IRB has already implemented this practice for expedited research that is not federally funded or subject to FDA oversight.

     

    New Exempt Categories : There have been several revisions to the types of research that may be exempt and the exemptions may now apply to research that only incidentally includes prisoners as subjects (e.g. the research is aimed at involving a broader subject population and only incidentally includes a subject who became incarcerated after providing consent). These categories are applicable regardless of funding source. The new exemption categories are described in the form titled Request for Exemption

    Any study previously granted an exemption remains grandfathered under that exemption.

    Studies that had been approved through the expedited process that may qualify for exemption under the revised regulation will be transitioned to exempt status on a case-by-case basis as requests for continuation or modifications are received.

    To learn more about the revised Exempt categories please review Policy # 2011-009.2.pdf – Institutional Review Board – Exemptions

     

    Changes to the Initial Application Form in IRIS:   The IRB application form in IRIS has been edited. The request for Exempt status categories and Expedited review categories have been removed from the application and are now described in two separate word documents to be attached to the application form in IRIS. The following forms have been published in the IRB website:

    1. The following IRB forms have been updated and published in the IRB website:
    • Application Checklist for Expedited Review (to reference request for expedited review form)
    • Application Checklist for Exemption (to reference request for exemption form)
    • Consent Checklist Addendum to Transition to Revised Rule (lists only new elements of 45 CFR 46 to incorporate into prior version of ICF for studies approved prior to 1/21/2019)
    • Human Subject Determination Form (based on updated definitions and activities that are deemed not to be research)

     

    RESEARCHMATCH NOW AVAILABLE IN SPANISH!

    ResearchMatch (RM) is the national online recruitment tool that matches people interested in participating in studies with researchers throughout the U.S. There is no cost to UConn Health researchers to use ResearchMatch. Once you register as a researcher, you can review the population characteristics of the ResearchMatch registry, which includes over 135,000 people from every state in the country.

    *NEW* ResearchMatch has just launched a Spanish version of the website inviting Spanish speakers to sign up in Spanish. Researchers from UConn Health are now able to connect with and recruit Spanish-speaking volunteers for their studies.

    If you would like to use ResearchMatch, you will need IRB approval for this recruitment method, including approval of the contact message emailed to volunteers. ResearchMatch can be added to an already-approved study via a modification.

    Interested in using ResearchMatch? Sign up now, attend an online training, or visit our webpage or contact Ellen Ciesielski for more information.

    Already registered with ResearchMatch and want to recruit Spanish-speaking volunteers? Submit your ResearchMatch contact message and other materials translated into Spanish (consent form, questionnaires, etc.) for IRB approval and ensure you are prepared for inquiries from Spanish-speaking volunteers.

    OVPR Quarterly Reports – FY19Q1

    Dear Colleagues,

    Now that data have been finalized, I would like to provide you with several reports relating to sponsored program activity—both research and education/service—managed by Sponsored Program Services within the Office of the Vice President for Research at UConn and UConn Health. Please visit the OVPR website to view the following reports:

    • List of Proposals Submitted: FY19 1st Quarter
    • List of Awards Received: FY19 1st Quarter
    • Proposals, Awards, Expenditures: FY14-FY19Q1

    In the reports, data are presented in two ways: by the PI’s Academic Home Department and by the Managing Department or Center/Institute. Please refer to the first pages of the reports for definitions and information regarding the data. Should you have any questions regarding these quarterly reports, please do not hesitate to contact me.

    Please note that we have included an additional Summary of Sponsored Program Activity, which includes the Effective F&A rate on awards. This information provides a snapshot of our activity as compared to the same period last year.

    The OVPR continues to seek creative solutions that allow UConn and UConn Health to grow our research enterprise through federal funding, industry partnerships, and collaboration with foundations. I am confident we can continue upward trends by continuing to work together, aggressively applying for extramural funding, and pursuing new channels of support for the tremendous research, scholarship, and creative activities taking place every day at UConn and UConn Health.

    Thank you for your continued commitment and contribution to our students, to your research and scholarship, and to UConn/UConn Health.

    Sincerely,
    Radenka

    Sponsored Program Guidance during the Partial Federal Government Shutdown

    Updated: 12/27/2018 with additional agency specific guidance and information.

    Effective Saturday, December 22nd at 12:00am, appropriations for fiscal year 2019 for approximately 25% of the federal government expired. Agencies who have full appropriations and are not currently impacted by the partial shutdown include Veterans Affairs, Department of Defense and Department of Health and Human Services (including NIH). Agencies that are impacted by the partial shutdown include the National Science Foundation, Department of Agriculture, Department of Transportation, Department of State, Department of Justice and NASA.

    Interim guidance for agencies impacted by the partial shutdown is provided below. Additional guidance will be provided if the shutdown persists. If you have specific questions about a proposal or award, please contact Sponsored Program Services.

    Proposals

    • If the electronic system for submission is operating, the proposal should be submitted by the deadline in the solicitation in accordance with standard practice.
    • If the electronic system for submission is not operational or offline, the proposal will not be submitted until further guidance is received from the federal sponsor. To be safe, SPS recommends that you prepare your proposal for submission as best you can by the published deadline, even if it cannot be submitted.
    • Currently Grants.gov and FastLane (NSF submissions) is available and operational.

    Award Management

    • Current funded awards may continue regular activities and incur normal expenses (exception: NSF payments systems are not operational – contingency plans will need to be further discussed if the shutdown persists longer than a couple weeks).
    • Contact SPS prior to charging any major or capital expenses.
    • UConn may not receive new awards during the shutdown.
    • Sponsor required prior approval requests (i.e. No Cost Extension requests) may not be approved during the shutdown.
    • Please contact SPS with specific questions about your award.

     

    Agency Specific Guidance during the Shutdown

    NSF

    https://www.nsf.gov/shutdown/grantees.jsp

    • No new funding opportunities will be issued.
    • FastLane and Research.gov is available for most functions but NSF will not process proposals or prior approval requests until normal operations resume.
    • Annual and final project reports should be submitted by the due date however they will not be processed and continuing grant increments will not be issued.
    • No new grants or cooperative agreements will be awarded.
    • No prior approvals and no payments will be made during the shutdown.

     

    Additional Agency Specific Guidance and Information

    UPDATE: Partial Federal Government Shutdown, 12/27/18

    NASA

    If your grant or cooperative agreement requires access to a NASA facility or participation from NASA personnel in order to perform the instrument’s stated research objectives, the guidance in paragraph (a) below is applicable.  If your grant or cooperative agreement does not require access to a NASA facility or participation of NASA personnel in order to perform the instrument’s stated research objectives, the guidance in paragraph (b) below is applicable.

     

      1. To the extent the grant or cooperative agreement includes work performed on-site at a NASA facility, the NASA facility will not be available for the performance of such work beginning on December 26, 2018.  You are instructed to commence an orderly shut-down of your onsite operations and you are to preserve resources and take all actions necessary to minimize costs incurred under the subject grant or cooperative agreement during this Government shutdown.  This includes notifying your employees immediately of this orderly shutdown. Contact Sponsored Program Services immediately if this applies to your award.

     

    1. Since your grant or cooperative agreement does not require access to a NASA installation, access to NASA IT resources and data, or participation of NASA personnel in order to perform the instrument’s stated research objectives, you are to continue to perform research under your grant or cooperative agreement as long you have available funding.  Special Condition 1260.53 Incremental Funding (for awards subject to 14 CFR Part 1260) or Term and Condition 1800.921 Incremental Funding (for awards subject to 2 CFR Part 1800) of your grant or cooperative agreement specifies the total amount of funding that has been allotted to your grant or cooperative agreement.  You are also reminded the Agency is not obligated to reimburse your institution for the expenditure of amounts in excess of the total funds allotted to this grant or cooperative agreement. Your institution is not authorized to continue performance beyond that period covered by the allotted funding and is cautioned to closely manage all available funding, as additional funding will not be provided while the Agency is without appropriations.  Any research performed during this time period should be carefully planned, taking into account that NASA technical and administrative personnel will not be available to support these activities during the Government shutdown. Expenses and work should not exceed the funding and time of the award even if additional funding and time is expected. Contact Sponsored Program Services if you have additional questions.

     

    National Endowment for the Humanities (NEH)

    NEH is currently shut down. We expect that grant proposals may still be submitted via Grants.gov but per their website, NEH will not update information, process transactions or respond to inquiries until funding is resumed. We also do not expect NEH to issue awards during this period.

     

    Department of Commerce

    https://www.commerce.gov/news/blog/2018/12/shutdown-due-lapse-congressional-appropriations

    The Department of Commerce includes the following bureaus which are all impacted by the partial shutdown (UConn Storrs and Regional Campuses has funding from agencies that are listed in bold):

    Bureau of Economic Analysis (BEA)
    Bureau of Industry and Security (BIS)
    U.S. Census Bureau
    Economic Development Administration (EDA)
    Economics and Statistics Administration (ESA)
    International Trade Administration (ITA)
    Minority Business Development Agency (MBDA)
    National Oceanic and Atmospheric Administration (NOAA)
    National Telecommunications and Information Administration (NTIA)
    National Institute of Standards and Technology (NIST)
    U.S. Patent and Trademark Office (USPTO)

    The following services and activities will not be available during a lapse except to the extent funded by other than current annual appropriations:

    • Most research activities at NIST and NOAA (excluding real-time regular models on research computers used for hurricane and FAA flight planning)
    • Assistance and support to recipients of grant funding
    • Technical oversight of non-mission essential contracts
    • Services and activities provided by:
      • Bureau of Economic Analysis (BEA)
      • Economic Development Administration (EDA)
      • Economics and Statistics Administration (ESA)
      • Minority Business Development Agency (MBDA)
      • U.S. Census Bureau with the exception of the support of the Decennial Census, which remains funded and activities funded by other agencies and non-Federal entities through reimbursable agreements.
    • Most services and activities provided by the International Trade Administration (ITA)

    Additionally, electronic systems utilized by the Department of may not be functional (Grants Online which supports EDA and NOAA is not currently functioning).

     

    National Endowment for the Arts (NEA)

    NEA is currently shut down. We expect that grant proposals may still be submitted via Grants.gov but per their website, NEH will not post messages or respond. We also do not expect NEH to issue awards during this period.

     

    Department of Transportation

    No cooperative agreements, contracts, purchase orders, travel authorizations, or other documents obligating funds will be executed by the Federal Railroad Administration and Federal Transit Administration

     

    USDA – NIFA

    NIFA program activities will be suspended during a shutdown. The scope of the activities includes all NIFA extramural funding programs supporting research, education, extension or a combination of two or more of these functions. This includes agency activities associated with competitively awarded, noncompetitive Federal financial assistance payments, capacity and infrastructure, endowment, and all other NIFA grant programs.

     

    Environmental Protection Agency (EPA)

    As a general rule, recipients of funded grants and cooperative agreements can continue work on their projects during any EPA shutdown. Grant recipients currently approved to utilize the Automated Standard Application Payment (ASAP) system may make drawdowns of authorized obligated levels during a shutdown. With the exception of grant recipients using ASAP, in the case of government shutdown no payment processing will be available for cost reimbursable or recipients with special award terms and conditions requiring EPA approval prior to payment disbursement (either by paper check, drawdown, or by ACT payment outside to the ASAP system). EPA staff will not be available to make payments until the shutdown ends. Recipients must stop work if they reach a point at which they require EPA involvement or approval.

    OVPR Quarterly Reports

    Dear Colleagues,

    Now that data have been finalized, I would like to provide you with several reports relating to sponsored program activity—both research and education/service—managed by Sponsored Program Services within the Office of the Vice President for Research at UConn and UConn Health. Please visit the OVPR website to view the following reports:

    • List of Proposals Submitted: FY18 4th Quarter
    • List of Awards Received: FY18 4th Quarter
    • Proposals, Awards, Expenditures: FY14-FY18Q4

    In the reports, data are presented in two ways: by the PI’s Academic Home Department and by the Managing Department or Center/Institute. Please refer to the first pages of the reports for definitions and information regarding the data. Should you have any questions regarding these quarterly reports, please do not hesitate to contact me.

    Please note that we have included an additional Summary of Sponsored Program Activity, which includes the Effective F&A rate on awards. This information provides a snapshot of our activity as compared to the same period last year.

    The OVPR continues to seek creative solutions that allow UConn and UConn Health to grow our research enterprise through federal funding, industry partnerships, and collaboration with foundations. I am confident we can continue upward trends by continuing to work together, aggressively applying for extramural funding, and pursuing new channels of support for the tremendous research, scholarship, and creative activities taking place every day at UConn and UConn Health.

    Thank you for your continued commitment and contribution to our students, to your research and scholarship, and to UConn/UConn Health.

    Sincerely,
    Radenka

    UConn Health, Jackson Lab To Collaborate On Statewide Pain Consortium

    UConn Health Hospital Tower

    UConn Health, UConn Schools of Medicine and Nursing, and The Jackson Laboratory (JAX) have announced the creation of the Connecticut Pain Consortium, a translational pain research and education collaboration which is the first of its kind in the Connecticut medical community.

    The Connecticut Pain Consortium will focus on a problem of national importance: the need for fundamental and translational research on the causes and manifestations of pain, pain management, and education about pain and its ramifications.

    The Connecticut Pain Consortium will examine this critical medical issue through several specific initiatives:

    • Establishing a portal for pain-related health care data in Connecticut
    • Providing a platform for basic and translational pain research collaborations that helps leverage state and national resources
    • Leveraging research to provide cutting-edge pain management solutions in clinical and population health settings
    • Raising awareness about the many facets of pain, its management, and the many possible related ramifications, such as opioid addiction
    • Developing a curriculum around pain research and management for health care providers

    The consortium will be led by Professor Dr. Reinhard Laubenbacher, a joint faculty member at UConn Health and The Jackson Laboratory, who also serves as Director of the Center for Quantitative Medicine at UConn Health.

    To learn more, visit the Connecticut Pain Consortium website.

    NIH Asks for Your Feedback on a Future Draft Data Management and Sharing Policy

    The Office of the Vice President for Research would like to share some information regarding data sharing with researchers who may be affected.

     

    The National Institutes of Health (NIH) issued a Request for Information (RFI) seeking feedback on proposed key provisions to help inform the development of a draft NIH policy for data management and sharing. Submit your comments to NIH by December 10, 2018. Additional information can be found in this NIH blog post, and questions about the proposed provisions may be sent to the NIH Office of Science Policy at SciencePolicy@od.nih.gov

     

    NIH will also be hosting a webinar on the proposed key provisions on November 7, 2018, from 11:30 a.m. – 1:00 p.m. ET.

     

    For questions, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

     

     

     

    Will NIH require you to register your basic science research in ClinicalTrials.gov?

    The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

     

    NIH has released a Request for Information (RFI), Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. This RFI seeks input from the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants. NIH is specifically interested in learning more about studies that meet the NIH definition of a clinical trial (NOT-OD-15-015) but are not defined as applicable clinical trials (42 CFR Part 11), and also meet the definition of fundamental research. You can submit your comments to NIH by November 12, 2018.

     

    For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

     

    Are you liable for ClinicalTrials.gov Civil Money Penalties?

    The Office of the Vice President for Research would like to share some information regarding ClinicalTrials.gov with researchers who may be affected.

     

    On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank. The guidance addresses how the FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results, or certifications, or knowingly submitted false or misleading information.

    The guidance explains that when a responsible party has potentially failed to comply with its disclosure obligations, the FDA will send a Preliminary Notice of Noncompliance Letter, and allow the responsible party 30 days to make corrections. If the FDA determines that the responsible party has still failed to comply, the FDA may issue a Notice of Noncompliance, assess civil monetary penalties, or seek an injunction and/or criminal prosecution. The statutory maximum for civil penalties is “not more than $10,000 for all violations adjudicated in a single proceeding,” plus “not more than $10,000 for each day that the violation continues” past the 30-day notification period.

    The deadline to submit your comments to the FDA on this draft is November 20, 2018.

     

    • To check if your trial meets the criteria for ClinicalTrials.gov registration and results posting set forth by the FDAreview this checklist. Applicable clinical trials include those evaluating at least one drug, biological, or device product regulated by the FDA.

     

    • If your NIH-funded study involves human subjects, review this checklist to see if it meets the NIH’s broad definition of a clinical trial and will require registration and results posting. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

     

    For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860.679.6004.

     

    HSPP- July-August-September, 2018- Newsletter

    AAHRPP Site Visit 2018

     The Association for Accreditation of Human Research Protection Programs (AAHRPP) is an independent, non-profit accrediting body that works to protect the rights and welfare of research participants and promotes high-quality research through an accreditation process.

    UConn Health’s Human Subjects Protection Program (HSPP) achieved AAHRPP accreditation in 2006.  As an accredited organization, our HSPP must periodically apply for re-accreditation.  This is a two-step process.  Step 1, which has been completed, consisted of AAHRPP reviewing all of our policies and procedures to ensure they meet regulatory and accreditation standards.  Step 2 is an onsite visit by AAHRP representatives to ensure that our policies and procedures are followed.  While specific dates have not yet been determined, the next accreditation site visit will occur in the spring of 2019.

    During the site visit, representatives from AAHRPP will conduct interviews and review studies records to ensure that policies and procedures have been implemented effectively.  AAHRPP representatives will interview the Institutional Official (Wesley Byerly), IRB members, HSPP staff, investigators and research study team members, and individuals that represent various research compliance functions, such as radiation safety, research pharmacy, scientific review, and conflicts of interest.  Individuals selected for such interviews will be asked questions about regulatory and ethical issues related to research with human participants and how they interact with the IRB. Investigators and research staff will also be asked about the conduct of their research studies.

    In general, topics that may be included during an AAHRPP interview process include:

    1. Familiarity and compliance with HSPP/IRB polices and procedures
    2. Roles and responsibilities of investigators and research staff
    3. Obtaining and documenting informed consent
    4. Conflict of interest disclosures
    5. Minimizations of risks to research participants and protecting human subject’s rights and welfare
    6. Types of training individuals have received in human subject’s protections.

    If you are selected for an interview, you will be notified a few weeks prior to the site visit.  An educational handout will be provided to help you to prepare.

    In addition, you can request an educational session with the Educational Specialist to learn more about the site visit and possible interview questions.

     

    Are you liable for ClinicalTrials.gov Civil Money Penalties?

     On September 18, 2018, the Food and Drug Administration (FDA) announced a draft guidance titled Civil Money Penalties relating to the Clinical Trials.gov Data Bank. The guidance addresses how the FDA Centers (Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, for drug, biological, and device products, respectively) identify whether parties have failed to submit required clinical trial registrations, results, or certifications, or knowingly submitted false or misleading information.

    The guidance explains that when a responsible party has potentially failed to comply with its disclosure obligations, the FDA will send a Preliminary Notice of Noncompliance Letter, and allow the responsible party 30 days to make corrections. If the FDA determines that the responsible party has still failed to comply, the FDA may issue a Notice of Noncompliance, assess civil monetary penalties, or seek an injunction and/or criminal prosecution. The statutory maximum for civil penalties is “not more than $10,000 for all violations adjudicated in a single proceeding,” plus “not more than $10,000 for each day that the violation continues” past the 30-day notification period.

    The deadline to submit your comments on this draft, electronically or by paper, is November 20, 2018.

    • To check if your trial meets the criteria for ClinicalTrials.gov registration and results posting set forth by the FDA, see the checklist found here. Applicable clinical trials include those evaluating at least one drug, biological, or device product regulated by the FDA.

     

    • If your NIH-funded study involves human subjects, check here to see if it meets the NIH’s broad definition of a clinical trial and will require registration and results posting. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
    • For questions about ClinicalTrials.gov, please contact Research Compliance Monitor, Ellen Ciesielski at 860-679-6004

     

    Does NIH require you to register your basic science research in ClinicalTrials.gov?

     NIH has released a Request for Information (RFI), Registration and Results Reporting Standards for Prospective Basic Science Studies Involving Human Participants. This RFI seeks input from the scientific research community and the general public regarding how best to implement the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NOT-OD-16-149) for prospective basic science studies involving human participants. NIH is specifically interested in learning more about studies that meet the NIH definition of a clinical trial (NOT-OD-15-015) but are not defined as applicable clinical trials (42 CFR Part 11), and also meet the definition of fundamental research. You can submit your comments here by November 12, 2018.

     

    Access to Investigational Drugs through  Clinical Trials, the Expanded Access Program, or  the Right-to-Try Law

    An investigational drug is one that has been tested in a laboratory and in animals and is being studied in human for efficacy and safety. Investigational drugs are not yet approved by the Food and Drug Administration (FDA) for use in the general population.

    There are various mechanisms through which patients may obtain access to an investigational drug. These mechanisms include 1) clinical trials 2) the FDA’s expanded access program or 3) the recently passed Federal law known as the Right to Try Law. Each of these mechanisms will be discussed below and then compared in table format.

    Clinical Trials: The standard mechanism for obtaining access to an investigational drug is through participation in a clinical research trial. A clinical research trial is conducted in accordance with a formal research protocol and its purpose is to evaluate the effectiveness and safety of an investigational drug. To participate in a clinical trial the patient must have the disease or disorder that is being studied and must also meet any specific inclusion or exclusion criteria defined in the research protocol. Patients can search for clinical trials that are being conducted at https://clinicaltrials.gov/.

    Expanded Access Program: If participation in a clinical trial is not possible, access to an investigational drug may be sought through the FDA’s Expanded Access Program (EAP).

    Access through the EAP may be appropriate when all of the following criteria are met:

    • The individual must have a serious/immediately life-threatening disease or terminal condition.
    • There must not be a comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
    • The individual is unable to participate in a clinical trial.
    • Potential patient benefit justifies the potential risks of treatment.
    • Providing the drug to the patient will not interfere with the conduct of the clinical trial.

    To apply for expanded access, the patient’s physician should first submit a request to the manufacturer of the investigational drug to obtain approval for the use of the product outside of the clinical trial setting. The manufacturer is under no obligation to approve such requests. If the manufacturer will provide the drug, the physician must then submit a request for approval to an Institutional Review Board (IRB) and to the FDA. An IRB is a committee that reviews the plan for the use of the drug to ensure that the rights and welfare of the recipient are protected. If FDA and IRB approval is provided, in the majority of cases the doctor must obtain informed consent from the individual who will receive the drug.  The individual’s consent is documented by signing an informed consent form that, among other things, describes the potential risks associated with the drug. More about the FDA’s Expanded Access Program is available at https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm

    Right to Try Law: The Right-to-Try Law (RTT) was enacted on May 30, 2018. It is intended to provide terminally ill patients a more streamlined mechanism for access to investigational drugs. The Right to Try Law provides a right to request access to the drug. The manufacturer of the drug is under no obligation to grant such requests.

    Like the EAP, the RTT law allows for the use of an investigational drug by a patient who has been diagnosed with a life-threatening disease or condition, who has exhausted approved treatment options, and who is unable to participate in a clinical trial involving the eligible investigational drug. An eligible investigational drug means a drug for which a Phase 1 clinical trial has been completed but the drug has still not been fully approved by the FDA. A Phase 1 clinical trial is done primarily to determine the dose of the drug that may be given safely to humans. Determining whether the drug is actually effective comes in later phases of the trial.

    Unlike the EAP, the RTT law eliminates the need for approval from the FDA and Institutional Review Board and it provides the sponsor and physician protection from liability associated with harm caused by use of the investigational drug. While the RTT law does specify that the treating physician must obtain the informed consent of the patient, unlike the EAP, the RTT law does not specify the required elements of that informed consent.

    Because the RTT law is fairly new, it is not yet clear whether this mechanism will be accepted by manufacturers of investigational drugs.

    The following table describes the major similarities and differences of the three current processes by which seriously ill patients may obtain access to investigational drugs.

     

    Clinical Trials Expanded Access Program Right –to Try-Law
    Who can participate? Patients with a condition for which a drug is being developed who meet the inclusion criteria for the trial.

     

    Patients with a serious/immediately life-threatening disease or terminal condition, unable to participate in a clinical trial. Patients with a serious/immediately life-threatening disease or terminal condition, unable to participate in a clinical trial.

     

    Investigational Drug Not FDA Approved Not FDA Approved Not FDA Approved, Phase 1 trial completed

     

    FDA Approval Required Required Not Required
    IRB Approval Required Required Not Required
    Informed Consent Required and must include specific elements required by regulation

     

    Required and must include specific elements required by regulation

     

    Required, but no specific elements are identified

     

     

    Manufacturer Obligated to Provide the Investigational Drug Yes, to those individuals  who provide informed consent to participate in the trial No No
    Liability waived for any risk associated with Drug No No Yes

     

    How can I learn about research studies that are looking for volunteers?

    To find ongoing studies that are currently recruiting participants at UConn, you can explore the following online listings:

    To search for trials recruiting nationally, please check out the websites below:

     

    New OVPR Website

    The Office of the Vice President for Research is pleased to present a new and improved website. The new site is still home to all of the important information you need to take care of the day-to-day of your research projects, just in a prettier package. There is some new information as well, including:

    • Cross Campus Collaboration resource page
    • Training page related to all types of research-related trainings

    Please note that the OVPR’s new sites for information pertaining to Storrs, the regional campuses, and UConn Health have new URLs. If you have bookmarked pages, you will need to update to the new URLs.

    If you are having trouble locating something you need, please don’t hesitate to contact the relevant service unit. Visit the OVPR Contacts page to find the office or OVPR team you need.

    HSPP- April- May-June, 2018 – Newsletter

    Clinical Trials – What you need to Know

    Did you know the public clinical trials registry, ClinicalTrials.gov, was created in February 2000 in support of a 1997 federal law requiring public registration of clinical trials? It was designed as a web-based catalog of clinical trials to serve as a resource for the patient and research community alike. The law has since expanded to require more types of clinical trials research to be registered, and for some trials, results are also required to be posted.

    Did you know there are at least 4 organizations that may require you to register your study on ClinicalTrials.gov? The FDA, National Institutes of Health (NIH), International Committee of Medical Journal Editors (ICMJE) and World Health Organization (WHO) each have rules about registering. For more details on each, please click here.

    Did you know the NIH and ICMJE have expanded their definitions of a clinical trial to include behavioral trials? Click here for NIH’s definition. Click here for the ICMJE definition.

    Did you know that for studies that require results to be posted per the federal law with completion dates after 1/18/17, a final version of the IRB-approved protocol document and statistical analysis plan must be uploaded to the ClinicalTrials.gov record? Limited information may be redacted. For details, click here.

    Should your study be registered with ClinicalTrials.gov?

    For more information, see our webpages or contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004) in Research Compliance Services.

     

    Inclusion of Children in Research

    When a Principal Investigator (PI) proposes a research project that will involve an intervention or interaction with children, the PI must demonstrate to the IRB that the additional protections afforded to children by regulations have been addressed. The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) have each established regulations governing the inclusion of children in research and the UConn Health IRB has incorporated these regulations into policy.  When proposing a research study that will include children as subjects investigators should review the following material:

    • IRB Policy 2011-006.0, Additional Protections for Certain Populations – General Policy,
    • IRB Policy 2011-006.3, Additional Protections for Certain Populations – Children,
    • Form D, Additional Protections for Children Involved as Subjects in Research

    In order for the IRB to approve a research protocol that will enroll children, the IRB must assess the information provided by the PI and be able to determine that the research falls within one or more of the following permissible categories and that the plans for obtaining the assent of the child and permission of the parents are appropriate. The examples provided within each category were taken from the Collaborative Institutional Training Initiative (CITI) Program.

    Category 1: Research not involving greater than minimal risk.

    Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

    To be approvable under this category, the IRB must find that the research presents no greater than “minimal risk” to children, and that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians. The IRB may determine that permission from one parent is sufficient.

    Examples of Research Projects That May Fall Within Category 1

    • A study to determine the relationship between maternal age and head circumference at birth. Measurement of head circumference is part of the normal newborn examination, and is therefore minimal risk.
    • A study to determine the incidence of asymptomatic proteinuria in school age children. The research involves the analysis of a voided urine collection, which is minimal risk.

    Category 2: Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

    This category is inclusive of research in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject’s well-being. The IRB may approve research under this category only if the IRB finds and documents that:

    (a) The risk is justified by the anticipated benefit to the subjects;

    (b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

    (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians.   The IRB may determine that permission from one parent is sufficient.

    Examples of Research Projects That May Fall Within Category 2:

    A pilot study of a shorter duration of antibiotic treatment for uncomplicated otitis media. The potential benefit associated with the shorter duration of treatment is increased compliance, and a reduced rate of antibiotic-related diarrhea. The risk associated with the shorter duration of therapy is a higher likelihood of treatment failure.

    The risk associated with this research (e.g. treatment failure) appears to be greater than minimal but can be justified by the anticipated benefit (reduce rate of antibiotic diarrhea); and there is the prospect of direct benefit to the child (increased compliance, shorter exposure time, and a reduced rate of antibiotic-related diarrhea). If the risk-benefit relationship is as favorable as the one seen with standard care (e.g. use of the antibiotic for standard time frame), this research would be approvable under this category.

    Use of a placebo, or routine monitoring for safety, is not considered to provide direct benefit to subjects.

    Category 3: Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition.

     

    This category is inclusive of research in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject. To be approvable under this category, the children to be enrolled must have the disorder or condition under study (i.e. a healthy control group would not be allowable) and the IRB must find and document that:

    (a) The risk represents a minor increase over minimal risk;

    (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

    (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; and

    (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians. In most cases permission from both parents is required.

    Examples of Procedures That May Involve Minor Increase Over Minimal Risk:

    • Catheterized urine collection
    • Skin biopsy or bone marrow biopsy
    • MRI scan with sedation

    Example of Research That May Fall Within Category 3:

    A study to determine the clinical relevance of a new technique to quantitate minimal residual disease (MRD) during therapy for acute lymphoblastic leukemia in children. The study requires one additional bone marrow aspirate be performed during the course of treatment. Therapy for the subject will not be altered based on the results of the assay. However, if it can be shown that the presence of MRD predicts poor outcome, in the future, patients with MRD can receive more intensive treatment and increase their chance of cure.

    It can be argued that the risk of a bone marrow aspirate in a child is only a minor increase over minimal risk. Further, the risk appears commensurate with risks inherent in the subject’s actual medical situation, and the research may yield knowledge of vital importance about the child’s disease (leukemia).

    Category 4: Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children

     

    For research not otherwise approvable that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children the IRB must find and document:

    1. That the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and
    1. b)   For studies funded or supported by DHHS, the Secretary, or for studies subject to FDA oversight the Commissioner, after consultation with a panel of experts in pertinent   disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

    (1)       that the research in fact satisfies the conditions of one of the aforementioned categories, as applicable, or

    (2)       (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) the research will be conducted in accordance with sound ethical principles; (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians.

    General Requirements for Assent and Permission:  

     Assent means an affirmative agreement to participate in research used with those who are not competent or not of legal age to provide informed consent. Failure to object may not be construed as assent.

     For children to participate in research, the IRB must determine that adequate provisions are made for soliciting the assent of the children when in the judgment of the IRB the children are capable of providing assent. The IRB will take into account the ages, maturity, and psychological state of the children involved. The judgment may be made for all children to be involved in research under a particular protocol, or for each child. When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

    The IRB may determine that assent is not a necessary condition for proceeding with the research if the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research.

    Permission is the agreement of parent(s) or guardian to the participation of their child in research. Permission is generally documented by have the parent(s)/guardian sign an informed consent document.

    For research studies not involving greater than minimal risk (Category 1 ) and research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects (Category 2) the IRB may find that the permission of one parent or guardian is sufficient. For research studies involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition (Category 3), and for research studies not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (Category 4), both parents/guardians must give their permission unless one is deceased, unknown, incompetent or not reasonably available, or unless only one parent has legal responsibility for the care and custody of the child.

    If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subject (e.g., neglected or abused children) it may waive the consent requirements provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law.

    The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity status and condition.

     

    Inclusion or Wards in Research

     Children who are wards of the state or any other agency, institution, or entity can be included in research involving greater than minimal risk and no prospect of direct benefit to the individual subjects, but likely to yield generalizable knowledge about the subject’s disorder or condition (Category 3) or research that is not approvable under a defined regulatory category but that presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children (Category 4) only if the research is related to their status as wards, or is conducted in schools, camps, hospitals, organizations, or similar settings in which the majority of children involved as subjects are not wards.

    Each child must have an advocate appointed who has the background and experience to act in, and agrees to act in, the best interests of the child, and who is not associated in any way with the research, researchers, or guardian organization.

     

    ResearchMatch training

    ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects researchers with individuals interested in participating in research studies, through its secure, online matching tool. There is no cost to UConn Health researchers to use ResearchMatch.

    To learn more about using ResearchMatch for your studies, register for the free ResearchMatch Researcher Webinar Training/Live Demo on Thursday, July 12, 2018 from 3:00 p.m. – 4:00 p.m. The training is open to all research staff. After registering, you will receive a confirmation email with instructions on joining the training.

    The team at ResearchMatch will show you how to register your studies, create a cohort of potential volunteers and send out contact messages and surveys. They will also cover how to send a pre-screening (eligibility) survey, contact the volunteers that replied ‘yes’ to your initial message, and manage your enrollment continuum.

    To register for the training, click here:

    https://attendee.gototraining.com/r/9112903382698216193

    For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu; 860-679-6004).

    Additional Information on Newly Published Research Policies

    The newly published policies for Animal Use in Research, Teaching and Testing and Research Involving Human Subjects revise the existing UConn Storrs policies to establish a uniform regulatory compliance statement that applies to all campuses under which the programs at UConn Health and Storrs operate.  A single, overarching policy will help in the development of other policies and procedures to help facilitate cross-campus initiatives.

    Key revisions:

    • Clarification of who the policies apply to (both policies)
    • Revisions to definitions to make them consistent with the regulatory definition (both policies)
    • Clarification regarding the role of the Institutional Official and committees (IACUC and IRB)
    • Clarification of the authority of the attending veterinarian to be consistent with regulatory requirements (Animal Use policy)
    • Clarification of the authority of the IRB to be consistent with regulatory requirements (Human Subjects Research policy)
    • Revisions to the enforcement section to make the sections consistent with other university policies (both policies)
    • Updated list of authorities (both policies)

     

    The Human Stem Cell Research policy clarifies and updates the existing University-wide policy regarding the type and scope of research to which the policy applies.

     

    The ClinicalTrials.gov policy establishes a new University-wide policy to address FDA, NIH and CMS requirements that applicable trials are registered.

     

    Animal Use in Research, Teaching and Testing: https://policy.uconn.edu/?p=113

    Human Stem Cell Research Approval: https://policy.uconn.edu/?p=2453

    Human Subjects Research: https://policy.uconn.edu/?p=406

    ClinicalTrials.gov: https://policy.uconn.edu/?p=7310

     

    For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004)

     

    Revised & New University-Wide Research Policies

     

    The Office of the Vice President for Research (OVPR) Research Compliance Services would like to share some important updates regarding university policies for animal use, human subjects, and stem cell research. These policies were revised to be consistent with federal requirements and are now in effect for all campuses, including UConn Health.  A new university-wide policy to address FDA, NIH, and CMS requirements for registration of applicable trials to ClinicalTrials.gov has also been published.

     

    Please see links to published policies below.

     

    ClinicalTrials.gov: https://policy.uconn.edu/?p=7310

    Animal Use in Research, Teaching and Testing: https://policy.uconn.edu/?p=113

    Human Stem Cell Research Approval: https://policy.uconn.edu/?p=2453

    Human Subjects Research: https://policy.uconn.edu/?p=406

     

    For additional information, contact Ellen Ciesielski (eciesielski@uchc.edu, 860-679-6004).

     

    Human Subjects Protection Program – January-February- March , 2018 -Newsletter

     

    Delay of Revised Common Rule and Revised UConn Health IRB Policies  

    Implementation of the revised version of the Federal regulation governing federally funded/supported research (i.e. 45 CFR 46, also known as the Common Rule) has been delayed until July 19, 2018. In spite of this delay, the UConn Health IRB has moved forward with implementing several changes that aim to reduce regulatory burden on investigators while still offering protection to research participants, complying with current regulatory requirements and being prepared to comply with the revised requirements.

    Several IRB forms, templates and policies have been revised. Understanding the reasons for these changes, what has been changed and to what type of research these changes apply may aid investigators in complying with IRB polices as well as with federal regulations.

    The following table lists the UConn Health IRB polices that have been changed, a description of the change and the IRB forms that have been modified due to the policy revisions.

     
    Name of the Revised Policy Description of the Policy Change IRB Forms changed due to this Policy Revision
    2011-008.0 -Informed Consent – Forms This policy has been revised to include the additional elements of consent put forth in the revised version of 45 CFR 46.

     

    These elements, while currently optional, will become required for Federal Funded /Supported (FFS) research only if the proposed revised regulation is implemented. If implemented these elements will be required for FFS research initially approved after the effective date of the regulation or for FFS research approved prior to the effective date of the revised rule that is still enrolling subjects and that is being transitioned to review under the revised rule.

     

    While the applicable regulatory criteria for consent will be used as the general premise for all consent forms, when the research is not federally funded or supported, nor subject to FDA oversight, the IRB may exercise judgement when determining if the elements of consent have been appropriately addressed.

     

    New elements of consent:

     

    *  The prospective subject or the LAR will be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and will be given an opportunity to discuss that information.

    *  The ICF must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.

     

    *  Informed consent as a whole presents information in sufficient detail relating to the research, and is be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or LAR’s understanding of the reasons why one might or might not want to participate.

     

    *One of the following statements if the research involves the collection of identifiable private information (IPI) or identifiable biospecimens (IB)

    (i) A statement that identifiers might be removed from the IPI or IB and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the LAR, if this might be a possibility;   OR

    (ii) A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

     

    *  A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.

     

    *  A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions.

     

    *  For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e. sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

     

    Consent Form Checklist 

     

    Consent Form Template

    Policy 2011-008.1 – Informed Consent – Process This policy has been changed so that the IRB may approve a non-federally funded or supported research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruitment or determining the eligibility of prospective subjects without the informed consent of the prospective subject (and without the need for waivers or alterations), if either of the following conditions is met:

    ·    The investigator will obtain information related to screening, recruiting or determining eligibility through oral or written communication with the prospective subject.

    ·    The investigator will obtain identifiable private information or identifiable biospecimens for the purpose of screening, recruiting or determining eligibility by accessing records or stored identifiable biospecimens.

    *  In order to access records or specimens for such purposes, there must be an established relationship between the investigator and the individuals whose records /specimens will be reviewed.

    *  The investigator may delegate the review to designated UConn Health research staff.

    *  Appropriate measures must be in place to protect the confidentiality of the data being utilized.

     

    If the revised regulation is implemented in July this provision will be extended to federally funded/supported research.

     

    Electronic Informed Consent (eIC) Process

    The investigator should give to the IRB access to the e-consent platform to review the usability of the eIC materials to ensure that they are easy to navigate and that the user may navigate forward or backward within the system, or stop and complete the process at a later time. The investigator must also ensure there is a mechanism in place whereby subjects may ask and obtain answers to questions.

     

    When eIC is proposes subjects must still be provided the option of the consent process occurring in person using a paper based consent form.

     

     

    Text in the IRB application in the section regarding confidentiality has been revised to make it clear that the provisions for protecting the confidentiality of the data as described in the IRB application extend data collected during screening.

     

    Policy 2011-008.2 – Informed Consent – Waivers and Alterations This policy has been changed to incorporate the new requirement for a waiver or alteration of consent. Per the new requirement, if the research involves using identifiable private information (IPI) or identifiable biospecimens (IB), the investigator must explain why the research could not practicably be carried out without using such IPI or IB.   This element is now applicable to all research requesting a waiver or alteration.

     

    This policy also now includes new option to grant a waiver of documentation of consent for non-federally funded or supported research. This new option may apply when the subjects are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting that informed consent was obtained. The IRB will evaluate alternative mechanisms on a case-by-case basis based on information put forth by the PI.  If the revised regulation is implemented in July this provision will extend to federally funded / supported non-exempt.

     

     

    Request for Full or Partial Waiver Informed Consent

     

    Request to Waive Documentation of Consent

    Policy 2011-008.5 – Informed Consent – Providing and Obtaining Informed Consent

     

    This policy has been modified to allow obtaining consent from a “next of kin” for adults who are not mentally retarded.

     

    If the potential participant does not have an appointed legally authorized representative (e.g., individuals designated as having power of attorney for health care, individuals designated as health care representatives) next-of-kin for adults who are not mentally retarded can consent on behalf of a prospective subject as defined in institutional policy 2012-05 titled Legal Representative for Health Care Decisions.

     

    None
    Policy 2011-023.0 – Educational Requirements. This policy has been changed so that human subjects protection training for all research (exempt, expedited, full board or facilitated review), will be verified for all study personnel at the time of initial approval and on an individual basis at the time a request for modification is received to add a person to the study. In order for training to be considered current it must have been completed within the past three years.

     

     

    none
    Policy 2011-009.3 –Institutional Review Board – Expedited Reviews This policy has been changed so that continuing review may not be required for non-federally funded/supported, non-FDA regulated research.

    When continuing review is not required, the approval period for an expedited study will be from the date of approval through the expected completion date of the project.   If necessary the PI may submit an expedited request for modification to continue the study beyond that date.

    none

     

    Frequently Asked Questions Related to CITI Training, IRIS System and Facilitated Review

     

    I completed my CITI human subject’s protection training recently.  Should I submit my CITI Training Certificate to the IRB?

    If an external investigator completed CITI training through another institution, s/he must submit proof of having completed human subject’s protection training to the IRB because the IRB does not get automatically notified of such completions.

    If the investigator is affiliated with UConn Health, he/she does not need to submit a certificate of completion. The IRB staff receives the CITI Training certificates one day after individuals have completed the training. Designated IRB staff enter the course completion information into a master training list (Excel) posted in the IRB website and into IRIS. This master training list (Excel) is updated every two weeks. Therefore, investigator should check this list often. In order for the IRB to update the training records in the IRIS system investigators affiliated with UConn Health must have logged into IRIS at least once. Therefore, investigator who have never before log into IRIS should do so right after they have completed the CITI Training. To log into IRIS investigator should click on the following link: https://imedris.uchc.edu , enter their UConn Health network credentials in the ID and PW boxes found in the IRIS logging page, and click on Log in.

     

    I am going to submit an application to UConn Health IRB for review and approval.

    Do I need to request an account in IRIS?

    Every individual who is affiliated with UConn Health can use the UConn Health ID and password to log into IRIS. Therefore, individuals affiliated with UConn Health (faculty, staff, students, residents, and fellows) do not need to request an account in IRIS.

     

    On the other hand, individuals external to the UConn Health will need to request an account in IRIS. To do so the external investigator must complete the online request form accessible from the IRIS home page. Investigators must complete all the required fields on the form indicating why the account is necessary and with whom at UConn Health he/she will be working. The IRB designated staff may contact the person in UConn Health to confirm that the creation of this account is necessary. Accounts will be created within 1-2 business days.

     

    I have completed an application for IRB review in IRIS. I do not see the sections that allow me to attach documents for review? What should I do?

    Unfortunately, the IRIS system currently has a glitch that does not transition the application form to the submission package where you can attach documents.  Follow the steps listed below when you get to the last section of the application for initial review and you see a sign stating: “Study Application Completion. You have completed the Study Application process. Click here to go to the …”

    • click on the “Back Button” ( located in the upper right hand corner)
    • Click on “Study Assistant” menu
    • click on “My Studies” sub-menu,
    • Open the study, and there you will find Section 1- Submission Packet to the Review Board.
    • Click on “Save and Continue to the Next Section” to build the following sections of the forms that will allow you to attach documents.

     

    I am affiliated with UCONN Health (e.g. faculty member, student, employee, or resident, fellow) and I will be part of a study conducted at another institution. That institution has reviewed and approved the study. Do I need approval from the UConn Health IRB?

    Yes, if you are affiliated with UConn Health and you are acting in that capacity, your involvement in a research study engages UConn Health in the research and therefore the UConn Health IRB must be involved.   However, as opposed to conducting a formal review the UConn Health IRB may elect to rely on the IRB of the other institution. To determine if the UConn Health IRB will do this you, you must submit an application for facilitated review to the UConn Health IRB. By submitting this application you will obtain an official determination from the UConn Health IRB as to whether oversight for the study will be deferred to the external IRB. In order for the UConn Health IRB to defer oversight a written agreement must exist between to the two institutions.  This agreement is referred to as an IRB Reliance Agreement.  Investigators may contact the IRB to determine if such an agreement is in place or needs to be established.

     

     

     

    Annual Individual Financial Disclosure in Research

    The Office of the Vice President for Research would like to announce that the 2017 Individual Financial Disclosure in Research reporting period has started today. In order to remain in compliance with university policy and federal regulations, UConn Health employees who are involved in research are required to complete an annual questionnaire in the UConn Health COI-SMART electronic disclosure system.

    An automated e-mail inviting applicable employees to complete the questionnaire should be in your inbox. The sender name on the e-mail is UConn Health Financial Disclosure in Research.

    If you did not receive an automated e-mail invitation and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or gfernandez@uchc.edu.

    Thank you for your cooperation.

    For more information, contact: Gus Fernandez-Wolff at x8125 or gfernandez@uchc.edu

    University Intellectual Property & Commercialization Policy Update

    October 22, 2015

     

    Dear Colleagues,

    I am pleased to announce that an updated version of the University’s Intellectual Property and Commercialization Policy was approved by the Board of Trustees in early October and is now available online. This comes as the result of a substantive collaboration between the Office of the Vice President for Research, the Provost’s Office, the Office of the General Counsel and faculty and staff at both UConn-Storrs and UConn Health.

    Although most of the substantive elements remain the same, the policy now provides a more comprehensive, consistent, and clear explanation of relevant issues, such as the use of University resources by a faculty-affiliated company, conflict of interest disclosures, and the hiring of students to work in faculty-affiliated companies, among others.

    We are confident that this streamlined policy document, which applies to faculty, staff, and students at all UConn campuses, more accurately reflects the University’s belief that teaching, research, and economic development are enhanced by the intellectual property generated at UConn.

    Should you have any questions related to the updated Intellectual Property and Commercialization Policy, please contact:

     

    Gregory Gallo, PhD
    Director
    Technology Commercialization Services
    Office of the Vice President for Research
    Tel. 860-679-3992
    gregory.gallo@uconn.edu

     

    Sincerely,

    Dr. Jeff Seemann
    Vice President for Research
    UConn/UConn Health

     

     

    UConn_research unleashed