martes, 29 de septiembre de 2015

Opportunity to comment on human subjects proposed rules

Opportunity to comment on human subjects proposed rules

AHRQ--Agency for Healthcare Research and Quality: Advancing Excellence in Health Care

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 and search for HHS-OPHS-2015-0008.
To access the AHRQ Informed Consent and Authorization Toolkit, complete with samples of understandable forms, go to:

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