Internal Communications

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

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.