The Federal Government is revising the rules governing use of humans in research, specifically, Title 45 of the Code of Federal Regulations (CFR) part 46, Protection of Human Subjects. A Notice of Proposed Rulemaking (NPRM) was issued September 5, and comments are being accepted until December 7, 2015.
Changes in the rulings include new requirements for informed consent, including consent for the use of de-identified patient biospecimens, and the duties of Institutional Review Boards.
Title 45 CFR 46 began with what is now known as the Tuskegee Study, a survey of the natural history of syphilis conducted by the Public Health Services and Tuskegee University. The participants were 600 rural African-Americans who were told they were receiving free health care. They were never told the true purpose of the study or whether or not they carried the pathogen, and those who did were never treated. The public outrage led to the National Research Act of 1974, which has since become Title 45. Additional protections were added, and 45 CFR part 46 now has five subparts:
Although health and medical research has changed dramatically in recent decades—particularly with regard to reliance on biospecimen-based research—Title 45 has remained relatively unchanged since 1991.
The current form of the Common Rule has an exemption [46.101(b)(i)(4)] for research involving the collection or study of existing, de-identified, specimens—if identifiers are removed, biospecimens and data that have been collected for purposes other than the proposed research can be used without any requirement for informed consent. If identifiers are not removed, an IRB must determine if the original patient consent is satisfactory, and investigators and IRBs often find that requirements for informed consent can consume substantial time and resources.
The proposed new rules would change informed consent for use of specimens in several ways. For instance:
- Research on biospecimens originally collected for other purposes will now require informed consent. This consent may consist of a one-time, general, open-ended consent that could be obtained at the time of collection (the HHS has proposed to provide templates to be used for obtaining this broad consent).
- Researchers would be required to inform participants that their biospecimens might be used for commercial profit, whether they would be informed of clinically relevant findings, and ask them whether they could be contacted for additional research.
As required, an Advance Notice of Proposed Rulemaking (ANPRM) was posted In 2011, and comments collected on the topic of informed consent for use of biospecimens was wide-ranging, from those who indicated no additional regulations were needed, to those who stated clinicians should obtain study specific consent. Opinions on whether or not IRB review was needed for secondary use of specimens also varied widely.
The rules that are eventually enacted will apply only to research and biospecimens collected in the future, not to existing collections, and would not go into effect for three years.
With respect to the use of biospecimens, four specific questions have been posted in the NPRM for public comment, including questions regarding whether oral consent should be permissible in specific circumstances, time limits on broad consent for specimen use, and alterations to the definition of “legally authorized representative.” The full text of the NPRM can be found here. To submit comments go to www.regulations.gov and search on docket ID number HHS-OPHS-2015-0008.
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