NEJM: Proposed human subject research regs may need revising
An HHS Advanced Notice for Proposed Rulemaking (ANPRM) suggests changes to the human subjects research regulations for studies posing minimal risk, as well as revisions to the exempt category and enhanced protections for research participants, noted the authors of a New England Journal of Medicine article published online July 25.
Despite a growing volume of research involving human subjects over the past 20 years, there have been almost no changes to the federal Human Subjects Protection, dubbed the Common Rule, since 1991, authors Ezekiel J. Emanuel, MD, PhD, and Jerry Menikoff, MD, JD, wrote.
The existing regulations have received criticism from the Institute of Medicine and the Government Accountability Office, as well as many scholars. Those complaints critique the regulations for “burdensome bureaucratic procedures that seem to do little to protect research participants,” as well as room for better participant protection under current regulations, according to authors.
Considered revisions to the Common Rule include changes to studies posing minimal risk—which should be handled “diligently, but expeditiously,” authors wrote—while high risk studies should receive the time and attention needed. Proposals for possible revisions include whether to update qualifying activities, whether studies with certain criteria should be deemed to be of minimal risk, or whether annual review should be eliminated except under extenuating circumstances.
The ANPRM also suggests exempting studies posing risks that are largely informational, and not physical—such as data security.
“In particular, the ANPRM asks whether all surveys, focus groups, and research methods, when conducted with competent adults, should be excused from Institutional Review Board review regardless of whether the information is collected with identifiers and regardless of the sensitive nature of the questions as long as the researchers are bound by strict standards of data security and information protection,” wrote Emanuel et al.
The ANPRM also proposes extending federal research protections to all studies conducted at U.S. institutions receiveing federal funding from a Common Rule agency, as well as establishing an electronic reporting system for adverse events. In addition, it indicated that informed consent documents may be written at “too high a reading level,” and should be written more clearly for prospective study participants.
“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,” the authors concluded. “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.”
Click here to read the NEJM article. The Advanced Notice for Proposed Rulemaking can be found here.
Despite a growing volume of research involving human subjects over the past 20 years, there have been almost no changes to the federal Human Subjects Protection, dubbed the Common Rule, since 1991, authors Ezekiel J. Emanuel, MD, PhD, and Jerry Menikoff, MD, JD, wrote.
The existing regulations have received criticism from the Institute of Medicine and the Government Accountability Office, as well as many scholars. Those complaints critique the regulations for “burdensome bureaucratic procedures that seem to do little to protect research participants,” as well as room for better participant protection under current regulations, according to authors.
Considered revisions to the Common Rule include changes to studies posing minimal risk—which should be handled “diligently, but expeditiously,” authors wrote—while high risk studies should receive the time and attention needed. Proposals for possible revisions include whether to update qualifying activities, whether studies with certain criteria should be deemed to be of minimal risk, or whether annual review should be eliminated except under extenuating circumstances.
The ANPRM also suggests exempting studies posing risks that are largely informational, and not physical—such as data security.
“In particular, the ANPRM asks whether all surveys, focus groups, and research methods, when conducted with competent adults, should be excused from Institutional Review Board review regardless of whether the information is collected with identifiers and regardless of the sensitive nature of the questions as long as the researchers are bound by strict standards of data security and information protection,” wrote Emanuel et al.
The ANPRM also proposes extending federal research protections to all studies conducted at U.S. institutions receiveing federal funding from a Common Rule agency, as well as establishing an electronic reporting system for adverse events. In addition, it indicated that informed consent documents may be written at “too high a reading level,” and should be written more clearly for prospective study participants.
“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,” the authors concluded. “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.”
Click here to read the NEJM article. The Advanced Notice for Proposed Rulemaking can be found here.