October 22, 2015

Revised regulations proposed for human subject research

Eighteen departments and agencies of the federal government have joined to propose revised regulations for scientific research involving human subjects.

Eighteen departments and agencies of the federal government have joined to propose revised regulations for scientific research involving human subjects.

This last occurred in 1991, with adoption of the Federal Policy for the Protection of Human Subjects, better known as the Common Rule.

The new proposed rule is approximately the length of “Oliver Twist,” taking up 131 pages of 10-point type in the Sept. 8 edition of the Federal Register. A three-month public comment period concludes Dec. 7, and a final rule is scheduled to come out next year.

Vanderbilt University Medical Center serves as the coordinating center for the Clinical and Translational Science Awards Consortium, or CTSA (CTSA) Consortium, which is comprised of 62 medical research institutions working to increase the efficiency and speed of clinical research and the application, or “translation,” of findings from the basic science domain to the domain of human health. The CTSA Coordinating Center and partners are sponsoring a series of public meetings — in Nashville, San Diego, Chicago and Philadelphia — to air the proposed rule and stimulate public comment.

The first of these meetings occurred Oct. 14 at the Student Life Center, where 115 attendees and 340 Web streamers focused on parts of the rule having to do with informed consent for research on biospecimens, including, for example, parts of blood samples left over after being drawn for clinical purposes.

Research on de-identified biospecimens currently is not considered human subjects research and does not pose informed consent from research subjects. Under the proposed rule, however, even if the investigator is not being given information that would help identify whose biospecimen it is, informed consent would generally be required for secondary research with a biospecimen. Such consent could be obtained using a broad consent form, in which a person would give consent to future unspecified research uses.

Lively discussion turned up a number of strengths, drawbacks and apparent oversights and inconsistencies in this part of the proposed rule. At the podium were speakers from VUMC, the National Institutes of Health and the University of Michigan; and chiming in over speakerphone from Washington, D.C., were representatives of the U.S. Dept. of Health and Human Services, Office for Human Research Protections.

Ellen Wright Clayton, M.D., J.D., the Craig-Weaver Professor of Pediatrics and professor of Law, outlined the proposed rule’s extensive content requirements for informed consent forms pertaining to secondary research use of de-identified biospecimens.

“This is a lot of information. I don’t know how you make this short. I don’t know how you make this comprehensible,” she said. The proposed consent form is intended to increase trust and participation, but, “We have a ton of data, over decades, that show that complex consent forms decrease comprehension,” she said. At places like VUMC, where de-identified clinical pathology specimens are used for research, these new consent forms likely would need to be included in standard consent processes for treatment in the hospital and clinic.

In an apparent jarring inconsistency, the proposed rule does not require informed consent for use of de-identified clinical data, including genetic data and other data derived from biospecimens.

For more information on the proposed rule, or to submit comments to the federal government, visit the Federal Register.

For more information on upcoming public meetings devoted to the proposed rule, visit StarBRIGHT.