Opportunity to comment on human subjects proposed rules

Improving Understandability of Informed Consent for Research

The Department of Health and Human Services is seeking comments on changing regulations that protect human subjects. New language would strengthen the informed consent requirements to make sure that the most appropriate information is presented to prospective subjects in sufficient detail and in a format that is tied to understandability. Commenters are asked to address the question, “What topics should be addressed in future guidance on improving the understandability of informed consent?”

The Notice of Proposed Rulemaking also proposes to exclude four categories of research activities from the Common Rule on human subject research that do not entail physical risk and are non-intrusive:

  • Educational tests
  • Survey procedures
  • Interview procedures
  • Observation of public behavior


Comments are due by 5 pm on December 7, 2015. To comment on the proposed rules, go to www.regulations.gov and search for HHS-OPHS-2015-0008.

To access the AHRQ Informed Consent and Authorization Toolkit, complete with samples of understandable forms, go to: http://www.ahrq.gov/funding/policies/informedconsent/index.html.