Introduction
Whether you’re conducting or reviewing human subjects research, federal regulations define who counts as a human subject. The Common Rule (45 CFR 46, Subpart A) defines a human subject as “a living individual about whom an investigator… obtains information or biospecimens.”
The keyword to highlight here is living.
This distinction is important because the Common Rule applies to a defined category of research, not to all federally funded research in the same way. Under the Common Rule, a human subject must be a living individual. Therefore, research involving only deceased individuals does not constitute human subjects research under that regulatory definition, although other laws, institutional policies, and ethical requirements may still apply. The Common Rule applies when a federal department or agency that has adopted the policy conducts, supports, or otherwise regulates applicable human subjects research. Institutions may also extend Common Rule requirements to additional research through policy, assurance commitments, or contractual arrangements. Research involving a deceased person’s records or specimens may nevertheless involve living human subjects if investigators obtain identifiable private information about living relatives or other living individuals. This leads to the primary question of this article: what research protections, if any, apply to deceased individuals?
What the Common Rule Says
The Common Rule is only one component of this regulation. Subparts B-D provide additional protections for certain populations in research. Under Subpart B (Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research), 45 CFR 46.206(a) states that research involving “the dead fetus” or cells, tissue, or organs excised from a dead fetus must be conducted in accordance with applicable federal, state, or local laws and regulations. Section 46.206(b) also provides an important qualification: if information associated with fetal material is recorded in a manner that identifies living individuals, those living individuals are research subjects.
What the Commission Decided
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published “Research on the Fetus: Report and Recommendations” in 1975, which was just four years before the Belmont Report was finalized.
Part VII of this report defines death of a fetus as the absence of four basic physiologic functions:
- Heartbeat
- Spontaneous respiratory movements
- Spontaneous movement of voluntary muscles
- Pulsation of the umbilical cord
Part VIII of this report draws two highly important conclusions:
- “A final class of investigation (falling outside the present mandate of the Commission) has made use of tissues of the dead fetus, in accordance with accepted standards for treatment of the human cadaver. The Commission finds that, to the best of its knowledge, these types of research have not contravened accepted ethical standards.”
- “The dying fetus cannot be ‘harmed’ in the sense of ‘injured for life.’… [But] considerations of respect for the dignity of the fetus continue to be of paramount importance… While dying subjects may not be ‘harmed’… issues of violation of integrity are nonetheless central.”
In essence, the National Commission concluded that research using tissue from a dead fetus fell outside its mandate when conducted according to accepted standards for treatment of a human cadaver. For a dying fetus, the National Commission distinguished between physical harm and concerns about dignity and integrity, emphasizing that nontherapeutic interventions should not alter the duration of life.
The National Commission’s 1975 report provides historical context for the treatment of fetal research. It should not, however, be understood as the foundation for the entire legal framework governing research involving deceased persons. The report predates the Belmont Report and addresses a narrower subject: research involving fetuses and fetal tissue.
What the HIPAA Privacy Rule and Other Requirements Say
It is worth mentioning that the Common Rule is codified in regulations of the U.S. Department of Health and Human Services (HHS). Although the Common Rule defines a human subject as a living individual, the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule generally protects a decedent’s identifiable health information for 50 years after death when that information is protected health information (PHI) maintained or transmitted by a HIPAA covered entity or business associate. HIPAA also includes a provision for research conducted solely on decedents’ PHI. Under 45 CFR 164.512(i)(1)(iii), a covered entity must obtain representations from the researcher that:
- The use or disclosure is sought solely for research on the PHI of decedents;
- Documentation of the individuals’ deaths will be provided if the covered entity requests it; and
- The PHI for which use or disclosure is sought is necessary for the research purposes.
When the HIPAA Privacy Rule applies, it protects qualifying identifiable health information, not every type of information about a deceased person. The legal treatment of a decedent’s body, body parts, and tissues depends on a broader set of federal, state, local, and institutional requirements.
The Uniform Anatomical Gift Act (UAGA) is one important component of this broader, state-dependent legal landscape. It is a model statute, not a federal regulation; in other words, states enact and may modify their own versions. The UAGA governs anatomical gifts of a decedent’s body or body parts for authorized purposes, which may include transplantation, therapy, research, or education, depending on the applicable enacted state law. It does not comprehensively govern every research use of deceased bodies or tissues. Other legal frameworks may address whole-body donation, autopsy authority, medical examiner or coroner authority, unclaimed bodies, disposition of remains, tissue banking, transplantation, and institutional specimen use. Federal organ donation and transplantation requirements, including the National Organ Transplant Act and the Organ Procurement and Transplantation Network framework, may also apply.
Closing Thoughts
When it comes to research, deceased individuals receive fewer specific protections than many people assume.
Research involving deceased individuals is not governed by a single, comprehensive protection framework. Under the Common Rule, research involving only deceased individuals falls outside the regulatory definition of human subjects research, although a study may still involve living human subjects if it obtains identifiable private information about living people. When HIPAA applies, a decedent’s PHI is generally protected for 50 years after death, and research solely on decedents’ PHI must satisfy specific representations. Physical remains are governed through a broader combination of state and federal law, including state-enacted versions of the UAGA, as well as local requirements and institutional policies. In short, protections exist, but their source and scope depend on the information, specimens, or remains involved and the jurisdiction in which the research occurs.
References
- Health Resources & Services Administration (HRSA). 2021. “Organ Donation Legislation and Policy.” Accessed August 25, 2026.
- National Academies of Sciences, Engineering, and Medicine. 2017. Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation. Washington, DC: The National Academies Press.
- National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1975. “Research on the Fetus.” DHEW Publication No. (OS) 76-127.
- Protection of Human Subjects, 45 CFR § 46 (2018).
- Security and Privacy, 45 CFR §164 (2024).
- Uniform Law Commission. 2006. “Anatomical Gift Act.” Accessed August 25, 2026.
