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Last Updated: 06/14/21

Federal Regulations and the Ethical Collection of Specimens and Data

Ethical and regulatory 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 are codified at 45 CFR Part 46 (also called the federal-wide “Common Rule”).


The Common Rule codifies the federal regulations concerning human research.

The Final Rule revisions were published after an Advance Notice of Proposed Rulemaking issued July 26, 2011, followed by a Notice of Proposed Rulemaking issued September 8, 2015.

The Final Rule revisions were published after an Advance Notice of Proposed Rulemaking issued July 26, 2011, followed by a Notice of Proposed Rulemaking issued September 8, 2015.

The “Final Rule” revisions to the Common Rule were published January 19, 2017 after an administrative Notice and Public Comment period lasting more than five and a half years. The Final Rule was amended to delay the effective and compliance dates to January 21, 2019. The provisions of the revised Common Rule are also referred to as the “2018 Requirements”.

For more information about the revised common rule, see the Health and Human Services (HHS) Office for Human Research Protections (OHRP) Revised Common Rule Resources page. The HHS OHRP Secretary’s Advisory Committee on Human Research Protections (SACHRP) has issued a number of advisory documents on the revised Common Rule, which can be found here.

The HIPAA Privacy Rule, 45 CFR Part 160 and Subparts A and E of Part 164, establishes the conditions under which protected health information, or PHI, may be used or disclosed by covered entities for research purposes. While the NIH is not a HIPAA covered entity, institutions such as hospitals, health plans, and laboratories that provide and bill for health care generally are covered. Under HIPAA, covered entities and their business associates may not use or disclose PHI without patient authorization, unless it has been de-identified in accordance with a formal determination by a qualified expert, or by the removal of 18 specified identifiers. The HIPAA approach to de-identification notably differs from the Common Rule standard of identifiability, which is based on whether individual identity is "readily ascertainable" and is not linked to specified categories of information.

The Privacy Rule also defines how individuals will be informed about the uses and disclosures of their medical information for research purposes, and their rights to access information about them held by covered entities. If a patient requests their medical record or testing results from a HIPAA covered provider, they are entitled to access that information. Where research is concerned, the HIPAA Privacy Rule protects the privacy of individual PHI, while at the same time ensuring that researchers have access to medical information necessary to conduct vital research. For more information about the impact of HIPAA on research biorepositories, see this NIH website on HIPAA and research repositories, or more generally this NIH website on HIPAA and research.

For more information about federal regulatory provisions that impact the collection, storage, and use of biospecimens in research, please visit the site for the NIH Office of Intramural Research Office of Human Subjects Research Protections.

Ethical Guidance

Several commissions have published policy guidance related to the research use of biological specimens and associated data. The President’s Commission for the Study of Bioethical Issues issued two key reports in this area. In October 2012, the Commission published “Privacy and Progress in Whole Genome Sequencing,” Exit Disclaimer which included considerations of informed consent, privacy and data sharing. In December 2013, “Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts” Exit Disclaimer was published, offering recommendations on the ethical issues surrounding the return of incidental findings in research involving biospecimens.

In 1999, the National Bioethics Advisory Commission published the report "Research Involving Human Biological Materials: Ethical Issues and Policy Guidance," which initially addressed many of the issues that remain controversial today. The Archived publications from the National Bioethics Advisory Commission can be found here Exit Disclaimer .

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.