Commenters Debating Changes in Human Subjects Research Rules

As HHS prepares to revise the Common Rule for the first time since its enactment 20 years ago, a host of scientific organizations are filing comments ahead of the Oct. 26 deadline.

A host of scientific organizations are submitting comments about the first revision proposed for the U.S. federal regulations for protecting human research subjects, known as the Common Rule, since they took effect 20 years ago. The comments by professors, educational institutions, and professional associations indicate the research community welcomes HHS' attempt to modernize the regulations but worries that some types of research may be slowed or hampered.

The Human Factors and Ergonomics Society's Government Relations Committee chair, William C. Howell, urged interested HFES members to file comments on the HHS Office for Human Research Protections (OHRP) advance notice of proposed rulemaking by the comment deadline, which has been extended until Oct. 26. The 155,000-member American Psychological Association submitted a letter July 27 asking for the extension and saying the revisions are "long overdue."

One of the comments posted in the rulemaking's docket came from Tom Boellstorff, a University of California, Irvine anthropology professor and editor-in-chief of American Anthropologist, saying the ANPRM should be changed to define "vulnerable" populations more clearly:

"The proposed revisions retain the concept of 'vulnerable' populations, but without ever providing a clear definition of what vulnerability might entail," he wrote. "As it stands, the examples provided of vulnerable populations are 'children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.' There are at least two issues here. First, social science researchers have long noted that we have a real dearth of quality research on children and prison populations due to the very high barriers IRBs [Institutional Review Boards] often place on conducting research on such populations, even when it is only informational risk that is at issue. In other words, the notion of 'vulnerable' needs to be recalibrated in light of research that carries only informational risk. Often, research on children or prisoners should qualify for Excused status. Second, the notion of 'economically or educationally disadvantaged persons' is so broad so as to include a majority of the world's population under its scope. The mere fact of being disadvantaged does not mean someone is 'vulnerable' with respect to social science research that carries only informational risk. It is crucial that the ANPRM be revised to reflect this fact. The notion of 'competent' may be more useful, though at present it is limited to 'adults who would be able to provide "legally effective informed consent." '

HHS proposed the changes in July 2011, saying the Common Rule is no longer adequate for the oversight of research as it is currently done, including multi-site studies, research involving biological specimen repositories, and the use of advanced technologies. Key proposed changes include the Common Rule's scope –- the existing Common Rule applies federal protections only to studies funded by certain federal agencies or clinical investigations involving FDA-regulated products, but the ANPRM would extend the protections to all studies, regardless of funding source, that are conducted by U.S. institutions and receive some federal funding for human subjects research from a Common Rule agency. Also, a single website would be created for electronic reporting of adverse events and unanticipated problems occurring in research involving human subjects, and consent forms would be changed to make them shorter, less confusing, and better at helping subjects make a good decision about whether to participate in a study.

OHRP's comparison table summarizing 19 proposed changes in the Common Rule is available here. To view comments or submit a comment, visit and search for docket number HHS-OPHS-2011-0005.

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