Announcements

Revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule)

The U.S. Department of Health and Human Services’ and fifteen other Federal Departments and Agencies’ revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule) were included in the Federal Register on January 19, 2017. These revisions are an effort to modernize, simplify, and enhance the current system of oversight. The Final Rule and additional related information can be accessed at: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html.

You can also read a summary of the changes from HHS here:
https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html

NIH Mandate-Single Review Board for Multi-Site Research

On June 21, 2016, the NIH published its Final Policy on the Use of a Single Institutional Review Board for Multi-Site Research. This policy establishes the use of a single IRB (sIRB) for domestic sites involved in multi-site research that is funded in whole, or in part, by NIH.

This policy, which will go into effect on May 25, 2017, applies to research supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. (This policy does not apply to career development, research training or fellowship awards.)  Further, it will apply to all competing grant applications (new, renewal, revision, re-submission) that have a receipt date of May 25, 2017 or later and all contract solicitations issued after May 25, 2017.

The use of a single IRB for multi-site human research is not a new mechanism for the Harvard LMA Office of Human Research Administration.  We have served as the single IRB for external institutions engaged in multi-site human research and have also ceded IRB review to external IRBs.

OHRA’s updated Investigator Manual (expected October 2016) is expected to address this NIH policy. If you have any immediate questions, you can contact OHRA Managing Director Leslie Howes at lhowes@hsph.harvard.edu or 617-432-2153.

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