HSPP- July, August, September, 2022 – Newsletter
Revision to Exemption Category 4 (iii)
To ensure the protection of identifiable private information (IPI) at UConn Health in compliance with The Privacy Rule, the HSPP will limit use of the exemption 45 CFR 46.104(d)(4)(iii):
Secondary research uses of identifiable private information, [when] the research involves only information collection and analysis involving the investigator’s use of identifiable health information (not biospecimens) when that use is regulated under [HIPAA].
Exemption 4(iii) applies to secondary research ‘use’ of the IPI which is protected under HIPAA, however the release, transfer or provision of access to a non-covered entity / third party would constitute a ‘disclosure’ where the IPI is no longer protected and the exemption would not apply.
Effective October 1, 2022, to ensure compliance with HIPAA and the Common Rule (45 CFR 46), the UConn Health HSPP will restrict the use of exempt category 4(iii) to studies where the Principal Investigator is UConn Health faculty (whose home/primary institution is UConn Health) and the data is not shared outside UConn Health or with non-UConn Health personnel.
New applications to the IRB seeking approval for secondary research use of identifiable private information which do not qualify for exemption under category 4 should request expedited review by the IRB. More information on exempt and expedited submissions can be found on the HSPP website or by contacting the HSPP Education Specialist, Mayra Cagganello at x8802 or firstname.lastname@example.org.
National Institute of Health (NIH) Policy for Data Management and Sharing
The National Institute of Health (NIH) Data Management and Sharing policy was published on October 29, 2020, and will go into effect on January 25, 2023. The two year delay in implementation was planned to give time to institutions to learn and prepare for enactment of the policy.
This policy applies to all research funded (in whole, or in part) or conducted by NIH that results in generation of scientific data. The goal of this NIH Data Management and Sharing policy is to benefit everyone, namely investigators, funding agencies, the scientific community, and, most importantly, the public. Data sharing provides more effective use of NIH resources by avoiding unnecessary duplication of data collection. It also conserves research funds to support more investigators. As stated in this policy “data sharing enables researchers to rigorously test the validity of research findings, strengthen analyses through combined datasets, re-use hard-to-generate data, and explore new frontiers of discovery.”
The NIH DMS Policy requires researchers to submit a plan to preserve, to share the data and to show compliance with said plan.
The NIH has made available multiple educational materials to inform and educate researchers about this policy at sharing.nih.gov. Below please find the links to the webinars
Webinar II: Diving Deeper into the New NIH Data Management and Sharing Policy
o Resource Slide Deck
To access the frequently asked questions regarding this policy please click on 2023 Data Management & Sharing Policy
Uconn Health – Research Participant Feedback Form
Now available in Redcap
The Human Subjects Protection Program (HSPP) is responsible for ensuring that studies are conducted in compliance with internal policies, federal regulations and ethical standards. When research participants complete and submit a Research Participant Feedback Form, the HSPP is able to learn about the study volunteer experiences.
Participants can access the Research Participant Feedback form in two ways:
1) Download the form from the IRB website at http://research.uchc.edu/rcs/hspp/volunteers/. Forms must be completed and emailed or faxed following the instructions on the form.
2) *NEW* Research participants may submit this form electronically by accessing the REDCap form at https://redcap.link/UConnHealth-Feedback-Research from a computer or mobile device.
The IRB and HSPP encourage the research community to help research volunteers to complete this form.
IRB Forms – Update
The following updates have been made to IRB forms:
Added new contact information to the following forms:
• Application Checklist for Initial and Continuing Review Full Board.docx (09/02/2022 – New Contact Information for Institutional Biosafety Committee)
• IRB Website : Related Departments and Committees-
Institutional Biosafety Committee (IBC): Investigators must obtain approval from the IBC prior to seeking local IRB approval for research studies that deal with recombinant DNA. Investigators may contact Vijayasmitha Rayadurg in the Office of Research Safety for additional information.
Added new template language to the following form:
• Sample Cover Letter for a Survey Study.docx (09/02/2022)
Changes to the Requests for Exemption form to limit Exempt Category 4 (iii) to researchers and activities internal to UConn Health.
• Request for Exemption Form .doc (09/30/2022)
Continuing Review Guidance
Considerations for When the IRB Evaluates the Progress of a Research Study
According to Robert J. Amdur & Elizabeth A. Bankert. IRB Management and Function. 2nd Edition., Jones & Bartlett, 2006, “Continuing review is a monitoring mechanism that assures that continuing safeguards are in place to protect the rights and welfares of research participants.”
When a Protocol/study is submitted for renewal or continuing review the investigator is to report the study progress and findings. When conducting the continuing review, OHRP recommends that IRBs evaluate the following issues to determine whether the study’s approval should be renewed:
Consistent with the IRB-approved Protocol
The IRB should confirm that the information provided by the investigator at the time of continuing review is consistent with the research protocol previously approved by the IRB.
Total Subject Enrollment
Evaluating information about the number of subjects enrolled in the research at the time of continuing review may allow the IRB to ascertain whether enrollment is consistent with the planned number of subjects described in the IRB-approved protocol. Has accrual progressed as planned? If not, will this affect the ability of the researchers to complete the study?
A marked difference between the actual and expected rates of enrollment may indicate a problem with the research project that requires further evaluation, including whether the research project is likely to provide sufficient data to answer the scientific question(s) being posed.
Subjects may discontinue their participation in research at any point for various reasons (e.g., serious adverse events, conflicts with the investigators, transportation problems, etc.).
The IRB’s continuing review procedures in general should provide for review of:
• The number of subjects who discontinued their participation; and
• A summary of the reasons for the withdrawals, if known.
IRB review of this information may shed light on problems related to the conduct of the research.
To provide an accurate account of the enrollment data, UCONN Health IRB recommends that prior to completing a Continuation form in the iRIS submission system, the Principal Investigator should have the enrollment information for the study available. If this is not the first request for continuation (e.g. study has been open form more than one year), the enrollment data should build off of the previously submitted request for continuation. Investigators should use the enrollment data in the previously approved continuation form as a starting point. The Enrollment Guidance.docx should be reviewed to provide an accurate account of enrollment numbers, screen failures or withdrawals.
Office of Human Research Protection (OHRP) – Resources
Luminaries Lecture Series
OHRP continues to add new videos to help the research community learn about multiple topics.
Click here to view the latest videos of distinguished speakers from OHRP’s Research Community Forum co-sponsored with Northwell Health this past May.
New additions include:
• The COVID Drug Wars That Pitted Doctor vs. Doctor
• Improving Health Equity in Clinical Research
• Vulnerability, Justice, Equity, and Engagement, A Conversation Public Health and Human Subjects Research
• Unusual Practices Masquerading as Usual Care