The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was published in the Federal Register on September 8, 2015 (PDF 1063 KB). 

The Harvard University Office of the Vice Provost for Research (OVPR) has conducted a high-level review of the NPRM to determine potential areas of interest or concern for faculty members and drafted questions to both inform faculty members of these proposed provisions and collect their comments and input on the potential research impacts.  Below is set of questions for faculty that has resulted from this review.  This is not to preclude faculty members from submitting their own comments in their personal capacity, or as part of their discipline/affinity group, but merely to collect faculty feedback to better inform the Harvard institutional comment process.  If faculty or IRB members have raised concerns or expressed support in addition to areas covered in the questions, the OVPR is also open to learning about and understanding their perspectives on other issues as well.  The OVPR would be happy to participate in any faculty forums on the NPRM within your IRB community or meet with individual faculty members or groups of faculty members who have identified concerns.

Please send all comments to Melissa J. Lopes, J.D., Director of Research Policy and Compliance. Melissa may be reached at 617-496-0123 or by email at melissa_lopes@harvard.edu

Questions for Comment

For Faculty who conduct social-behavioral research:

• Is the concept “benign intervention” used in your research?  What would be considered a “benign intervention” within the context of your discipline?
• OHRP is recommending publishing a listing of research activities that should be considered to involve “minimal risks”; can you provide examples for your area of research that might fall under this category? {examples include…..}
• OHRP is recommending eliminating continuing review for minimal risk studies—do you agree or disagree with this proposal?
• OHRP is recommending that several categories of low risk human subjects research (e.g. certain surveys and interviews) be excluded from the Common Rule (i.e., excluded from IRB review), and that researchers make their own determinations that their projects fit the excluded categories. 
  • Do you agree that researchers are able to decide on their own that:
    • They are recording information in a way that subjects can’t be identified,
    • Subjects would not be at risk of criminal or civil liability, or damage to reputation, employability, financial standing or educational advancement, if their responses were disclosed?
• Should researchers have to document their Exclusion self-determinations, and if so, where should the documentation be kept?
• For low risk human subjects research that is excluded from the Common Rule, OHRP is considering a regulatory requirement that researchers provide participants notice, in lieu of the full Informed Consent requirement of the current Common Rule. 
• In principle, is such a requirement appropriate?
• If so, what elements should be included:
  • The fact that research is being done?
  • The purpose of the research?
  • That participation is voluntary and can be stopped at any time?
  • Confidentiality measures?
  • Contact information?
• If OHRP issues notice requirements, how can they be made flexible?

For Faculty who conduct research using bio-specimens:

• OHRP proposes to include non-identifiable bio-specimens within the definition of human subject, thus requiring IRB review and approval.  How would this impact your research?
• OHRP also proposes to severely restrict the application of waiver of consent to research involving bio-specimens.  How would this impact your research?
• OHRP proposes to require broad consent for research use of any bio-specimens collected for clinical purposes.  Would this impact your ability to secure bio-specimens for your research?  How so?
• OHRP contains a number of provisions that would require close tracking of consents and participant’s answers to specific questions in the consent process.  How would this tracking affect your research activities?