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Last Updated: 09/27/17

Federal Regulations and the Ethical Collection of Specimens and Data

Ethical issues related to the collection and use of human specimens for research purposes have been the subject of considerable discussion. The federal regulations protecting human research subjects at 45 CFR Part 46 (also called the federal-wide "Common Rule") were revised on January 19, 2017. The Final Rule revisions, which become effective as of January 19, 2018, were published after an administrative Notice and Public Comment period lasting more than five and a half years. This period included an Advance Notice of Proposed Rulemaking issued July 26, 20111, followed by a Notice of Proposed Rulemaking issued September 8, 20152.

Application of regulatory standards to the research use of biological specimens and associated data is complicated by a variety of ethical and policy factors. The National Bioethics Advisory Commission's 1999 report entitled "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance"3 initially addressed many of the issues that remain controversial today.

More recently, the President's Commission for the Study of Bioethical Issues issued two key reports in this area. The first (October 2012) examines the use of biospecimens to conduct whole genome sequencing, including considerations of informed consent, privacy and data sharing4. The second (December 2013) explores the ethical issues surrounding the return of incidental findings in research involving biospecimens5.

The National Cancer Institute has worked with other NIH institutes and centers and with a variety of other groups to help clarify these issues and to provide education and models to assist the research community.

For more information about federal regulatory provisions that impact the collection, storage, and use of biospecimens in research, please visit: