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ArtSci IRB Human Subject Researchers Rutgers University HSPP/IRB: Announcement About Upcoming Regulatory Changes

Rutgers University ArtSci IRB Human Subject Researchers artsci_irb_all_pis at email.rutgers.edu
Fri Oct 12 11:14:36 EDT 2018


IRB ANNOUNCEMENT

For All Researchers - All Campuses

Human Subjects Protection Program



For more information, please visit:

https://orra.rutgers.edu/revisedcommonrule

This Webpage Will Be Updated As New Information Becomes Available



The human subjects regulations are changing. The federal Office for Human Research Protections (OHRP) has scheduled the regulatory changes to be implemented on January 21, 2019. These changes have been referred to as the "Revised Common Rule."



Although these regulations were delayed twice in the past, the regulations appear to now be ready for implementation in January.



What this means to you: Changes have been underway to the eIRB system, institutional policies, and templates in preparation for the Revised Common Rule. Some of the key proposed revisions to the Common Rule are listed below.



PROPOSED CHANGES

The proposed changes will only impact new protocols: meaning those submitted after the Revised Common Rule goes into effect.  There are changes that will reduce the burden on researchers, and other requirements that will increase researcher responsibilities. New protocols include all types of new submissions (e.g. NHS, exempt, expedited, etc.).



New Requirements Include:

*         Consent form informational elements:

*         NEW! The consent form must begin with a concise summary of essential study information that individuals would want to know in order to make an informed decision about participation.

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

*         NEW! 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.



Key Revisions* Include:

*         Exempt Category List*:

*         NEW! With safeguards in place, studies using benign behavioral interventions may qualify for Exempt Review.

*         NEW! With a "Limited IRB Review" of a protocol plan to safeguard subjects' privacy and confidentiality, more studies will qualify for exempt review.

*         Continuing IRB Review requirements*:

*         CHANGE! Continuing IRB Review may no longer be required for many studies that are approved as minimal risk.



*(Please note that the FDA and DOJ have not yet signed onto these revisions, therefore, if your study falls under their jurisdiction you will not be able to implement these revisions. However, you will still need to the new consent form required elements).








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