9
Aug2011

by Elisa Hurley, PhD
PRIM&R Education Director

On July 26, 2011, the Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, proposing substantial changes to the federal regulations governing human subjects protections known as the 'Common Rule.’
 
The public comment period is scheduled to be open through September 26, 2011, and PRIM&R is acting quickly to organize a response. As part of this effort, PRIM&R has convened an ANPRM Task Force, composed of 17 members of PRIM&R’s Board of Directors, public policy committee, and staff. The Task Force’s first undertaking was to submit a letter to OHRP requesting an extension of the comment period from the scheduled 60 days to 120 days (ending on November 24, 2011). If any organization you are affiliated with would like to send a similar request, please feel free to use this letter as a template.
 
At the same time, the Task Force is preparing its comments. PRIM&R will not attempt to respond to all 74 questions embedded in the ANPRM, though. Instead, PRIM&R will think in terms of what it can offer that others groups cannot, namely, a broad, impressionistic, conceptual view of the major topics around which changes are being proposed (e.g. privacy and confidentiality, data protection, minimization of risk, informed consent), rather than detailed proposals of how to achieve particular standards.
 
PRIM&R’s comments will focus on questions such as: Do the proposed changes go in the right direction? What are the potential problems and benefits associated the proposed changes? Are there considerations that have been left out of the ANPRM?
 
As PRIM&R’s ANPRM Task Force sets out to answer these questions, the group will follow a specific plan of action:
  • The Task Force will be divided into four sub-task forces of approximately four to five people each. Each will have a group leader and will be assigned to draft comments on one of the major substantive sections of the ANPRM by early September.
  • In early September, the sections will be compiled into one document, which will be circulated, edited, and submitted for approval or revisions to PRIM&R’s Executive Committee.
  • Upon approval of the Executive Committee, PRIM&R’s comments will be submitted to OHRP, by September 26, 2011 (assuming the deadline does not change).
We will update you on our progress in this space, on our Twitter feed, and on our website. In the meantime, we’d love to hear what you and your colleagues are thinking about the proposed changes in the ANPRM.

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One thought on “Update on PRIM&R’s response to the ANPRM

  1. Anonymous

    There are a number of suggestions that could be resolved very easily with guidance. (Who defined existing as already on the shelf anyway? Why can't it be re-interpreted as easily?)

    There are a number of things that should be done to modernize without disruption of the system. (The internet could be added to the list of categories.)

    There is nothing inherently wrong with exemptions that would require subdivision into registration and excuses. (You are excused from the table or after burping!)

    There are allegations made (exemptions delay research) that are unsupported and may be individual to specific institutions.

    Only a few of the suggestions would require changes to the regulations. (Exemption categories should be by list the same way that expedited categories are.)

    Can the government really tell an institution not to exceed the baseline rules?

    Reply