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Press Release
PRIM&R Statement on Secretary’s Advisory Committee on Human Research Protections Addressing IRB Effectiveness
March 23, 2023
BOSTON—The Secretary’s Advisory Committee on Human Research Protections (SACHRP) spent a large portion of its meeting on Wednesday discussing the recent Government Accountability Office report titled, “Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness,” and focused on one of the recommendations of the report.
The specific recommendation in the GAO report, which was requested by Sens. Sherrod Brown (D-OH), Bernie Sanders (I-VT), and Elizabeth Warren (D-MA), directed the Secretary of HHS to “ensure that OHRP and FDA convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects and implement the approaches as appropriate.” The GAO reached out to PRIM&R for input as it produced its 97-page report.
Elisa A. Hurley, PhD, Executive Director of PRIM&R, issued the following statement in response to SACHRP’s meeting:
“Ensuring the protection of human subjects is the most important responsibility of an IRB. I am pleased SACHRP is moving quickly to begin to address some of the recommendations in the GAO’s report. PRIM&R stands ready and willing to contribute as SACHRP identifies key stakeholders for examining approaches to assess IRB effectiveness.
“While the report highlights the critical need for methods to evaluate IRB effectiveness, the GAO missed an opportunity to call for additional resources for FDA and OHRP to enhance their inspection and other oversight activities. The OHRP budget, for example, has been flat for more than a half-dozen years, undermining its ability to function effectively. As part of our collective efforts to build trust in the scientific process, Congress should prioritize adequately funding and otherwise supporting agencies charged with ensuring the protection of the rights and welfare of human research subjects.” To read the GAO report, click here
The specific recommendation in the GAO report, which was requested by Sens. Sherrod Brown (D-OH), Bernie Sanders (I-VT), and Elizabeth Warren (D-MA), directed the Secretary of HHS to “ensure that OHRP and FDA convene stakeholders to examine approaches for measuring IRB effectiveness in protecting human subjects and implement the approaches as appropriate.” The GAO reached out to PRIM&R for input as it produced its 97-page report.
Elisa A. Hurley, PhD, Executive Director of PRIM&R, issued the following statement in response to SACHRP’s meeting:
“Ensuring the protection of human subjects is the most important responsibility of an IRB. I am pleased SACHRP is moving quickly to begin to address some of the recommendations in the GAO’s report. PRIM&R stands ready and willing to contribute as SACHRP identifies key stakeholders for examining approaches to assess IRB effectiveness.
“While the report highlights the critical need for methods to evaluate IRB effectiveness, the GAO missed an opportunity to call for additional resources for FDA and OHRP to enhance their inspection and other oversight activities. The OHRP budget, for example, has been flat for more than a half-dozen years, undermining its ability to function effectively. As part of our collective efforts to build trust in the scientific process, Congress should prioritize adequately funding and otherwise supporting agencies charged with ensuring the protection of the rights and welfare of human research subjects.” To read the GAO report, click here
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