Research Compliance Services News

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

     

    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/

     

    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.

    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.