AEA Colleagues,

 

This email is to alert you to an opportunity to comment on, and perhaps thereby to influence, evolving Federal government policies related to the protection of human research subjects.

  

The Secretary of Health and Human Services (HHS), in concert with the Office of Science and Technology Policy (OSTP), has issued an advance notice of its intention to  update the protections for human research subjects. The notice invites public input at this time, preparing to issue a proposed rule on this matter. HHS will solicit comments again on the proposed new rule when it is published, but even now it is inviting public input on the underlying broad policy. We encourage AEA members to submit their own comments directly to HHS, not speaking for AEA but only for themselves. At the same time, AEA would appreciate receiving copies of AEA member comments to help inform our preparation of official AEA comments at the time that the proposed rule is published.

                                                       

SUMMARY

 

The current regulations governing human subject research were issued in 1991 and are often referred to as the Common Rule. Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways.

Comment is sought on the following:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.
  3. Updating the forms and processes used for informed consent.
  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.
  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
  7. Providing uniform guidance on federal regulations.

  

OF SPECIAL INTEREST TO EVALUATORS

 

Social and Behavioral Research. Most federally-supported research involving human research subjects must be approved by an institutional review board (IRB). However most research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior is exempt. HHS is considering whether to also exempt social and behavioral research, conducted with competent adults, that would involve other specified types of commonly used benign interventions. See QUESTION 17.

Evaluation.
HHS is seeking comment on whether and, if so, how, the Common Rule should be changed to clarify whether oversight of quality improvement, program evaluation studies, or public health activities are covered. See QUESTION 24.

Individually Identifiable Data. HHS is considering establishing mandatory data security and information protection standards and rules protecting against the inappropriate re-identification of de-identified information to minimize informational risks. See QUESTION 54. 

  

Multi-site Reviews. HHS is considering limiting to a single IRB the review of research conducted at more than one site. See QUESTIONS 30-34.

 

And Much More. We selected the above provisions as possibly of broad interest to evaluators. However, this is a long and complicated policy document. Evaluators should decide for themselves what is important to them. Please do not limit your review to the items above.

  

MORE INFORMATION

 Comparison of Existing Rules with Some of the Changes Being Considered 

 Full Text (PDF) of the Proposal (Advance Notice of Rule Making) 

  

HOW TO SUBMIT COMMENTS TO HHS

Access http://www.regulations.gov/  

  • Enter the following docket ID number in the "Enter Keyword or ID" field,: HHS-OPHS-2011-0005, then click "Search" and follow the prompts
  • Note that the system gives the user 20 minutes to complete the comment form. If you need more time, be sure to continue your session when prompted.. 

HOW TO SEND A COPY OF YOUR COMMENTS TO the AEA EVALUATION POLICY TASK FORCE

Send an email to  [email protected]   

  

DEADLINE: The deadline for comments is 5:00 PM on October 26.

  

Thank you for sharing your insights with HHS and with AEA's Evaluation Policy Task Force

  

George F. Grob

Senior Advisor, AEA Evaluation Policy Task Force

 [email protected]