HHS revising human research regulations, seeks public comment
The U.S. Department of Health and Human Services (HHS) is contemplating various ways of enhancing the regulations overseeing research on human subjects and is seeking public comment on improving rules to protect human research subjects.
The changes to the regulations—which have been in place since 1991—under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.
The expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is keeping up with the needs of researchers and research subjects, the agency stated.
Comment is sought on the following:
In a July 25 online article in the New England Journal of Medicine, authors Ezekiel J. Emanuel, MD, PhD, and Jerry Menikoff, MD, JD, wrote, “The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. ... But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.”
The ANPRM can be found here.
Comment will be taken until 5 p.m. 60 days after the date of publication in the Federal Register.
The changes to the regulations—which have been in place since 1991—under consideration can be found in an Advance Notice of Proposed Rulemaking (ANPRM), "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," published in the July 25 Federal Register. The proposed changes are designed to strengthen protections for human research subjects.
The expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is keeping up with the needs of researchers and research subjects, the agency stated.
Comment is sought on the following:
- Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.
- Using a single Institutional Review Board for all domestic sites of multi-site studies.
- Updating the forms and processes used for informed consent.
- Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.
- 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.
- Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.
- Providing uniform guidance on federal regulations.
In a July 25 online article in the New England Journal of Medicine, authors Ezekiel J. Emanuel, MD, PhD, and Jerry Menikoff, MD, JD, wrote, “The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. ... But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.”
The ANPRM can be found here.
Comment will be taken until 5 p.m. 60 days after the date of publication in the Federal Register.