National Research Act of 1974

The National Research Act of 1974 (Public Law 93-348, 88 Stat. 342) is the U.S. federal statute, signed by President Nixon on July 12, 1974, that created the modern American human-subjects research protection system. It has two operative titles: Title I established the National Research Service Award (NRSA) program, and Title II created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and separately required every institution receiving federal research funding to establish an independent review board — the statutory origin of the modern Institutional Review Board (IRB) requirement — before human-subjects research could begin. It is frequently referenced in CITI Program and other research-ethics training coursework as the founding legislation behind today’s IRB system, though the Act itself is a specific 1974 statute, not a training curriculum.

Why the Act was passed

The National Research Act followed congressional hearings, led by Senator Edward Kennedy, held in the wake of a 1972 Associated Press report exposing 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 after it became the standard, effective cure in the 1940s-50s so the untreated disease’s progression could keep being observed. Public and congressional reaction to that disclosure was the direct impetus for the Act. The 93rd Congress passed it with overwhelming bipartisan majorities — 311-10 in the House and 72-14 in the Senate — before President Nixon signed it on July 12, 1974.

Title I: National Research Service Awards

Title I created the NRSA program, administered through the National Institutes of Health and the (now-defunct) Alcohol, Drug Abuse, and Mental Health Administration, to fund predoctoral and postdoctoral training in biomedical and behavioral research at federal and non-federal institutions — covering stipends, travel, and institutional training costs. NRSA remains the statutory basis for NIH’s current institutional training grants (the T32 mechanism) and individual fellowships (F30/F31/F32), more than five decades after the Act created the program, though the details of service-payback obligations have been modified over time.

Title II: human subjects protection and the National Commission

Title II created the eleven-member National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, appointed by the Secretary of Health, Education, and Welfare from medicine, law, ethics, theology, and the behavioral and social sciences. The Commission was charged with identifying the basic ethical principles that should govern human-subjects research and recommending how those principles should be applied — including specific directives to study informed consent for vulnerable groups (children, prisoners, people institutionalized with mental illness), research involving fetuses, and psychosurgery. Separately, Title II required that any institution receiving federal research funding establish an independent board to review the risks and ethical acceptability of human-subjects research before it begins — the direct statutory origin of the IRB requirement.

The Commission met from December 1974 through 1978 and produced roughly ten reports, culminating in the Belmont Report (completed September 30, 1978; published in the Federal Register April 18, 1979), which distilled the Commission’s work into the three principles — Respect for Persons, Beneficence, and Justice — that remain the ethical foundation every U.S. IRB applies today.

From statute to regulation: the Common Rule

The National Research Act itself does not contain detailed procedural rules for IRB review — those came later, when the Belmont Report’s principles were codified into binding federal regulation at 45 CFR Part 46 (the Common Rule), first adopted by HHS in 1981 and extended across roughly twenty federal agencies in 1991, then substantially revised in 2018. So the lineage runs: National Research Act (1974, statute) → National Commission (created by the Act) → Belmont Report (1979, the Commission’s ethical framework) → Common Rule / 45 CFR 46 (1981/1991/2018, the binding regulation) → the IRB review process every federally funded human-subjects study goes through today. The Act is the origin point of that chain, not any single link further down it.

Why the 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; and 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 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).

Frequently asked questions

What did the National Research Act of 1974 establish?

Two things: the National Research Service Award (NRSA) training-grant program (Title I), and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, plus the requirement that federally funded institutions use an independent review board for human-subjects research (Title II).

Is the National Research Act the same as the Belmont Report?

No. The Act is the 1974 statute (Public Law 93-348). The Belmont Report is a 1979 document — the output of the Commission that the Act created. The Act is the legal cause; the Belmont Report is one of its products.

Did the National Research Act create the IRB system directly?

It created the legal requirement for federally funded institutions to use an independent review board, which is the origin of the modern IRB. The detailed procedural rules IRBs now follow were established later, in the Common Rule (45 CFR 46), which operationalized the ethical principles the Act’s Commission developed.

Why does CITI Program training reference the National Research Act of 1974?

CITI Program (Collaborative Institutional Training Initiative) human-subjects-protection courses, widely required for researchers and IRB members, teach the regulatory history behind current IRB requirements — and that history starts with this Act, since it is the statute that created both the National Commission and the federal IRB mandate.

What year was the National Research Act signed into law?

President Nixon signed the National Research Act, Public Law 93-348, on July 12, 1974, after the 93rd Congress passed it with overwhelming bipartisan majorities in both the House (311-10) and the Senate (72-14).

Why was the National Research Act passed?

Congress passed it after hearings on human-subjects research led by Senator Edward Kennedy, prompted by public exposure of the U.S. Public Health Service’s Tuskegee Study of Untreated Syphilis in the Negro Male, in which researchers withheld known treatment from participants without informing them of their diagnosis. An Associated Press report exposed the study in 1972, and the resulting public and congressional reaction produced the Act two years later.

Does the National Research Act require IRB review?

Yes. Title II amended the Public Health Service Act to direct that any institution applying for federal grants or contracts for biomedical or behavioral research involving human subjects establish an Institutional Review Board (IRB) empowered to review, approve, modify, or disapprove human-subjects protocols before research begins. The detailed procedures IRBs follow came later, in the Common Rule.