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Press Release
PRIM&R Responds to New NPRM Delaying Revised "Common Rule"
May 14, 2018
Boston, MA—Public Responsibility in Medicine and Research (PRIM&R) recently responded to the new Notice of Proposed Rulemaking (NPRM) proposing to delay the general compliance date for the revised Federal Policy for the Protection of Human Subjects, or "Common Rule," six more months to January 21, 2019. In our submitted comments, PRIM&R endorses the proposal under the assumption that the agencies use the delay to produce guidance and make it available to the regulated community far enough in advance of the compliance date to be useful in guiding institutions’ implementation plans.
The new NPRM, released by the Department of Health and Human Services (HHS) and 16 other federal agencies in April, follows an almost seven-year revision process, including an Interim Final Rule in January, which had already delayed the compliance date from January 19, 2018, to July 19, 2018.
PRIM&R recognizes that the delay of implementation responds to concerns from the regulated community that there was insufficient guidance available to enable successful compliance with the revised Rule by the original compliance date, yet no guidance has been published to date. We urge the federal agencies to issue guidance at least three months in advance of the new compliance date to allow institutions time to make required changes. In creating guidance, we encourage the agencies to make use of existing resources, such as the recommendations already developed by SACHRP.
We also suggest four areas of highest priority when creating guidance:
The new requirement at §__.116(a)(5)(i) that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.”
New exemption category 3 at §__.104(d)(3)(i), involving “benign behavioral interventions.”
New exemption category 4 at §__.104(d)(3)(i), the “HIPAA Exemption,” according to which research using identifiable private information may be exempt as long as that information or its collection is covered by HIPAA.
“Limited IRB review,” a new concept introduced in four exemption categories (exemptions 2, 3, 7, and 8).
PRIM&R urges the agencies not to prioritize the creation of guidance on broad consent, given concerns that that option will require mechanisms for tracking consent and refusals to consent that are logistically burdensome or even prohibitive for many institutions.
Finally, if no guidance is forthcoming, PRIM&R suggests that the rule not be further delayed. Further delay would lead to more uncertainty, frustration, and burden for the research community. The regulated community needs confirmation of a compliance date so that it can refocus its energies on the important business of protecting the rights and welfare of research participants.
About PRIM&R
Since 1974, PRIM&R has advanced the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building. PRIM&R is a 501(c)3 nonprofit. Find out more at www.primr.org
Media Contact:
Daniel McLean
Public Engagement Manager
Public Responsibility in Medicine and Research (PRIM&R)
Direct: 617-303-1877
dmclean@primr.org
www.primr.org