Recently Filed Comments
March 2010 - PRIM&R developed these comments in response to the FDA's proposed rule on informed consent. PRIM&R supports efforts to fully inform potential research subjects of the risks, benefits and alternatives potentially encountered as a result of participating in research. However, PRIM&R has two serious concerns with this proposed rule.
January 2010 - PRIM&R recently filed comments in response to OHRP’s Draft Guidance on IRB Approval of Research with Conditions. PRIM&R believes this draft guidance document is helpful, but has a few questions to further clarify the guidance.
Similarly, PRIM&R commented this month on OHRP’s Draft Guidance on IRB Continuing Review of Research. PRIM&R asserted that the draft guidance was helpful in clarifying ambiguities and had several suggestions to make the document more clear.
July 2009 - Accreditation Standards
The Association for the Accreditation of Human Research Protection Programs (AAHRPP), of which PRIM&R is a founding member, recently issued a request for public comment on its "Proposed Revised Accreditation Standards." PRIM&R issued comments, along with those submitted by La Cesta Consultants, LLC and HRP Associates, LLP.
June 2009 - PRIM&R recently filed comments in response to OHRP's request for public comment on IRB Accountability. PRIM&R expressed support of the general proposal to hold institutional review boards (IRBs) and the institutions or organizations operating the IRBs, directly accountable for meeting regulatory requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects. However the comments state that "PRIM&R would not however, support a regulatory change primarily promulgated to reduce institutional administrative burdens, if they might diminish protections for human subjects. Cooperative review agreements should not be used to waive, transfer or weaken the responsibility of the institution or investigators conducting the research to protect human subjects and to comply with the federal regulations and ethical principles that govern human subjects research."
January 2009 - OHRP recently invited public comment on a draft guidance document entitled, "Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued.'' This draft guidance is intended to explain how to interpret the terms “participation” and “discontinuation of participation” in research. The guidance would also clarify that investigators may continue to analyze already collected individually identifiable private information about a subject even when the subject's participation has been discontinued, and that research may continue to involve human subjects even when the participation of all subjects has been completed or discontinued.
PRIM&R's Public Policy Committee developed comments that request further clarification about the ongoing responsibilities of the investigator and IRB toward subjects who's participation in a study has terminated. Please review PRIM&R's comments and let us know your thoughts.
The PRIM&R Public Policy Committee oversees the development of oral or written comments on particular policies that it determines are relevant to PRIM&R's mission and warrant PRIM&R's input. PRIM&R's most recent comments are listed below.
September 2008 - Read PRIM&R's comments on the Request for Information regarding the OHRP Implementation of Human Subjects Protection Training and Education Programs FDA: Draft Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting, June 7, 2007
New York Times: “Ethics Panels Expand Grip, No Field Is Off Limits,” By Patricia Cohen (Letter to the Editor), March 5, 2007
OHRP: Draft Guidance on Engagement of Institutions in Human Subjects Research, January 30, 2007
FDA: Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Exception from Informed Consent Requirements for Emergency Research, November 27, 2006
OHRP: Draft Guidance on Reporting Adverse Events, January 13, 2006
OHRP: Proposed Criteria for Determinations of Equivalent Protection, May 24, 2005
FDA: Reporting of Adverse Events to Institutional Review Boards, April 21, 2005
Questions?
Please contact us via e-mail or telephone at 617.423.4112, ext. 15. Thank you!