April 2019

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The IRB Review A compilation of information, announcements, & updates for UK Institutional Review Board (IRB) members, research investigators, & others involved with human subject research.

Ensure your biobank consent is up-to-date with the NIH Genomic Data Sharing (GDS) Policy update The National Institutes of Health (NIH) announced updates to the GDS policy in November 2018 in order to expand access to secondary research data while still respecting donors' privacy and confidentiality.  The change involves management and access to non-sensitive Genomic Summary Results (GSR) , which are aggregate and not individual-level results. The policy will allow unrestricted access to GSR from most NIH-supported studies for health or research purposes. Only GSR designated as sensitive (e.g., potential for stigmatization of populations from isolated geographic regions or with rare traits) will remain in controlled-access.   Research biobanks with specimens that may be used to generate genomic data, should ensure that the informed consent obtained from the donor addresses both controlled-access Genomic Data, and unrestricted access to Genomic Summary Results. For sample language, see the Sample Repository/Registry/Bank Consent Template .

Remembering an advocate for racial equality and social justice in health care  The epidemiologist who played a role in ending the Public Health Service “Tuskegee” Syphilis Study passed away February 17 th . Dr. William “Bill” Jenkins will be remembered for his efforts throughout his career to improve health disparities and end racial inequality in research and public health.  Read more from the University of North Carolina Gillings School.

First Continuing Review (CR) in E-IRB?  While the content of the report is similar, there are a few subtle differences in the CR in E-IRB versus the old paper version. Begin by selecting “Create New Continuation (CR)” and s elect the protocol for which you wish to submit a Continuation Review request. Complete the CR Report and update/correct all sections of the IRB application as applicable. Be sure to save the CR Report any time you leave the page to update information in the application.  Be sure to submit the CR Report in time to allow IRB review prior to the expiration date. Click to view a Sample CR Report .  Click here for Tips for Completing the CR report .

Is your research eligible for Exempt Review?  ORI is now beginning to receive protocols that meet the new Exempt Review category called “Benign Behavioral Intervention.” To qualify, the intervention must be behavioral (not medical) and include only adults who have prospectively agreed to participate. The intervention itself should be brief and unlikely to cause any physical or social harm. To see if your research may qualify for this or other Exempt Review Categories, see the UK ORI New Common Rule Exemption Categories Tool [ PDF ]. OCR Requests for Information on HIPAA’s unnecessary burdens On February 14 th , the Office of Civil Rights (OCR) released an announcement requesting information on how the HIPAA Rules present obstacles to, or place unnecessary burdens on, the ability of covered entities to conduct care coordination and/or case management. The Public Responsibility in Medicine and Research (PRIM&R) organization is using the opportunity to recommend OCR consider how to harmonize HIPAA rules with common rule human subject research regulations. The rational is for the regulations to facilitate vital research while continuing to protect privacy interests. Read more at https://blog.primr.org/comments-hhs-modifying-hipaa/