Ethical Collection of Specimens
Ethical issues related to the collection and use of human specimens for research purposes have been the subject of considerable discussion. Although the human subjects regulations detailed in the federal-wide “Common Rule” (45CFR46) have not changed substantially since their enactment in 1991, the regulations are currently undergoing revision1. Moreover, 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”2 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 sharing3. The second (December 2013) explores the ethical issues surrounding the return of incidental findings in research involving biospecimens4.
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:
- Office for Human Research Protections (OHRP)
- NIH website explaining the HIPAA privacy rule and its application to research involving biospecimens
- NIH brochure: How the Human Subjects Regulations Apply to the Use of Specimens for Research