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ArtSci IRB Human Subject Researchers IRB Announcement on Upcoming Regulatory Changes

Rutgers University ArtSci IRB Human Subject Researchers artsci_irb_all_pis at email.rutgers.edu
Tue Jan 9 14:49:02 EST 2018


IRB ANNOUNCEMENT
For All RU Researchers - All Campuses



The Human Subjects Regulations Are Changing.

At this time, the federal government remains on track to implement the proposed regulatory changes to the Common Rule on January 19, 2018.  Although the Office for Human Research Protections proposed a one-year delay of the general implementation date<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.reginfo.gov%2Fpublic%2Fdo%2FeoDetails%3Frrid%3D127614&data=02%7C01%7Cbkhaitma%40ored.rutgers.edu%7C3e618e8b51074eecad3108d548b12167%7Cb92d2b234d35447093ff69aca6632ffe%7C1%7C0%7C636494847972616905&sdata=3qlRR6T89Lt%2BEt4L4NcEbtEmgMxcOet3evxALPClBmw%3D&reserved=0>, there have been no further announcements from HHS to suggest that a delay will be approved.  Therefore Rutgers will continue to proceed, anticipating an implementation date of January 19, 2018.



The proposed changes will only impact new protocols: meaning those approved after the revised Common Rule goes into effect.



IRB Review Type Changes In Effect On January 19th



Exempt Category List:

o   The Exempt Category list has been revised.  Some studies previously required Expedited Review may now be eligible for exemption.  Your IRB approval letter will indicate the IRB review level.

Continuing IRB Review Requirements:

*        Continuing IRB Review will no longer be required for many studies that are minimal risk and approved through the Expedited IRB review process. Your IRB approval letter will indicate whether a Continuing Review or merely an annual Status Report will be required.



Additional Consent Form Elements Required On January 19th For Federally Funded Studies (Non-Federally Funded Studies Have Until April 1, 2018 To Include These Elements).



*        Consent form must begin with a concise summary of essential study info that individuals would want to know in order to make an informed decision about participation.



*        Consent form must disclose any plans to conduct future research using info and/or biospecimens collected during the research.



*        If applicable, consent form must disclose whether: (a) subjects will share in commercial profit; (b) clinically relevant research results will be returned; and (c) research will or might include whole genome sequencing.

Please see the HSPP/IRB website for the revised consent form template: https://orra.rutgers.edu/formsandtemplatesirb<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Forra.rutgers.edu%2Fformsandtemplatesirb&data=02%7C01%7Cbkhaitma%40ored.rutgers.edu%7C3e618e8b51074eecad3108d548b12167%7Cb92d2b234d35447093ff69aca6632ffe%7C1%7C0%7C636494847972616905&sdata=WyopO5yOzHw2n1wEyJIjreJqMahV3vS1twiYFL1QkgU%3D&reserved=0>


Use of a Single IRB (sIRB) for Cooperative Research:


As of January 25, 2018, all NIH-funded multi-site research must rely on a single IRB-of-Record (sIRB) for review. As of January 19, 2020 all multi-site research that is federally funded-not just NIH-funded-must rely on a single IRB-of Record for review. (Learn More on NIH.gov<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fpolicy%2Fclinical-trials%2Fsingle-irb-policy-multi-site-research.htm&data=02%7C01%7Cbkhaitma%40ored.rutgers.edu%7C3e618e8b51074eecad3108d548b12167%7Cb92d2b234d35447093ff69aca6632ffe%7C1%7C0%7C636494847972616905&sdata=ajpV06bYUboGdHuuFcmLEHKxqDP%2BmEp8LyGRBpx0%2F0A%3D&reserved=0>; View NIH's Single IRB FAQ<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fgrants.nih.gov%2Fgrants%2Fpolicy%2Ffaq_single_IRB_policy_research.htm&data=02%7C01%7Cbkhaitma%40ored.rutgers.edu%7C3e618e8b51074eecad3108d548b12167%7Cb92d2b234d35447093ff69aca6632ffe%7C1%7C0%7C636494847972616905&sdata=ZNrGfuUbUhvnXsCAFK5Z19cCtg5UYsLpEkCmIHIRIdQ%3D&reserved=0>).


Human Subjects Protection Program,
Rutgers University

[cid:F31AB4F1-1884-4773-811E-AA1B4B684F96]
https://orra.rutgers.edu/hspp<https://na01.safelinks.protection.outlook.com/?url=https%3A%2F%2Forra.rutgers.edu%2Fhspp&data=02%7C01%7Cbkhaitma%40ored.rutgers.edu%7C3e618e8b51074eecad3108d548b12167%7Cb92d2b234d35447093ff69aca6632ffe%7C1%7C0%7C636494847972616905&sdata=nmkVbr3rrVjlp7TxIF4HJOxKdg7%2FBmll84RY7GutH4w%3D&reserved=0>


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