National Research Act of 1974

The National Research Act, Public Law 93-348, is the U.S. federal statute that created the modern legal architecture for protecting human research subjects. President Nixon signed it into law on July 12, 1974, after the 93rd Congress passed it with overwhelming bipartisan majorities (311-10 in the House, 72-14 in the Senate). It did two things that still structure human-subjects research administration today: it created a national commission charged with defining research ethics principles, and it made independent, institution-level review of human-subjects research a condition of federal funding for the first time.

Why Congress passed it

The Act followed congressional hearings on human-subjects research led by Senator Edward Kennedy, prompted directly by public exposure of the U.S. Public Health Service’s Tuskegee Study of Untreated Syphilis in the Negro Male. From 1932 to 1972, that study followed several hundred Black men with syphilis in Macon County, Alabama, without informing them of their diagnosis, and withheld penicillin from participants after it became the standard cure in the 1940s-50s so the disease’s untreated progression could keep being observed. An Associated Press report exposed the study in 1972, and the resulting public and congressional reaction produced the National Research Act two years later.

What the Act established

The National Commission

Title II of the Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, an eleven-member body appointed by the Secretary of Health, Education, and Welfare and drawn from medicine, law, ethics, theology, and the behavioral and social sciences. Congress charged the Commission with identifying the basic ethical principles that should govern research involving human subjects and recommending how those principles should be applied in practice. The Commission met from December 1974 through 1978; its work, carried out under the mandate this Act created, produced the Belmont Report, published in the Federal Register in April 1979.

Mandatory IRB review

Separately from the Commission, the Act amended the Public Health Service Act to direct the Secretary to require that any institution applying for federal grants or contracts for biomedical or behavioral research involving human subjects establish an Institutional Review Board (IRB) — a local, independent board empowered to review, approve, modify, or disapprove human-subjects protocols before the research begins. This is the statutory origin of the IRB system that is now near-universal at U.S. research institutions; it existed as a legal requirement before there was a single federal regulation codifying how IRB review should work, and before the Belmont Report had articulated the ethical principles IRBs would eventually apply.

The causal chain: Act to Report to Regulation

The three artifacts are frequently conflated but are legally and chronologically distinct, and the sequence matters for anyone tracing where a specific requirement actually comes from:

• 1974 — the Act (Public Law 93-348): the statute itself. Creates the National Commission’s mandate and requires IRBs to exist, but does not itself specify ethical principles or detailed review procedures.
• 1979 — the Belmont Report: the Commission’s response to the ethical-principles mandate the Act gave it. Sets out three principles — Respect for Persons, Beneficence, Justice — but is an ethics statement, not a regulation, and has no independent legal force.
• 1981 / 1991 / 2018 — 45 CFR 46, the Common Rule: the binding federal regulation that operationalizes Belmont’s principles into enforceable IRB procedures. First adopted by HHS in 1981, extended across roughly twenty federal departments and agencies in 1991 as the “Common Rule,” and substantially revised in 2017-2018.

In other words: the 1974 Act is the law that ordered the ethical principles to be written and ordered IRBs to exist; the 1979 Report is the ethical principles that were ordered; and the Common Rule is the regulation that later made those principles legally binding and specified how IRB review must actually be conducted. A research-administration citation to “the requirement for IRB review” is, strictly, a citation to the Common Rule’s procedural detail sitting on top of an obligation the 1974 Act created first.

Why this distinction matters in practice

Research administrators, compliance officers, and IRB members sometimes use “Belmont,” “the Common Rule,” and “the National Research Act” interchangeably as shorthand for “U.S. human-subjects protections.” They are not interchangeable when precision matters: only the National Research Act is an act of Congress; only the Belmont Report is the ethical-principles document; only 45 CFR 46 is the enforceable regulation an IRB cites when approving, modifying, or disapproving a specific protocol. An institution’s Federalwide Assurance and IRB standard operating procedures typically point to the Common Rule for procedural compliance, while training programs and IRB deliberation over genuinely novel ethical questions typically reach back further, to Belmont’s principles — but the statutory authority underneath both is still the National Research Act of 1974.

References

• National Research Act, Public Law 93-348, 88 Stat. 342 (July 12, 1974).
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (April 18, 1979).
• 45 CFR Part 46, Subparts A-E (Common Rule, as revised 2018).
• CDC, “The U.S. Public Health Service Untreated Syphilis Study at Tuskegee” (historical record, 1932-1972).