PRIM&R’s comments on the ANPRM

by Elisa Hurley, PhD, PRIM&R education director

On October 26, 2011, PRIM&R submitted to the Office for Human Research Protections (OHRP) comments in response to the Advance Notice of Proposed Rulemaking (ANPRM) titled, “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” published in the Federal Register on July 26, 2011.

In its comments, PRIM&R addressed many of the specific proposals and 74 questions embedded in the ANPRM. We also took this opportunity to highlight some broad themes that cut across specific regulatory proposals, including:

  • There is a need for more robust and effective education about the ethics and regulation of human subjects protections for IRB members, chairs, and investigators. Revised educational requirements should be placed on the regulatory agenda.
  • A human subjects regulation system should include and apply to all of the stakeholders in human subjects research, including institutions, investigators, and sponsors, as well as IRBs. The creation of such a system is, however, just one step in creating a research culture where everyone takes responsibility for human subjects protections.
  • Federal regulations should be understood to set a minimum standard for the protection of human subjects below which institutions may not fall, and should never be viewed as a ceiling an institution cannot surpass. Additionally, an institution should never be required to justify additional measures it adopts to augment the protection of human subjects.
  • While there are clearly potential benefits to making human subjects protections more efficient, efficiency itself is not a moral imperative or an ethical value. Human subject protections should never be compromised by a desire for increased efficiency.

In its comments, PRIM&R provides more detailed suggestions and recommendations, divided into the following five substantive sections:

  • Informed consent
  • Privacy
  • Centralized review
  • Calibrating level of review to level of risk
  • Post-IRB human subjects protections

You can read PRIM&R’s comments in their entirety here. We invite your reflections and responses.

If you are interested in browsing the over 700 responses submitted to OHRP during the comment period, please follow the instructions here.