What Did the National Research Act of 1974 Do?

The National Research Act of 1974 established the first federal framework for protecting people who take part in biomedical and behavioral research. Signed into law on July 12, 1974, as Public Law 93-348, it did two things that reshaped American research: it required any institution receiving federal research funding to set up an independent review board to screen studies before they begin, and it created a national commission to define the ethical principles those reviews would rest on.¹ It also restructured federal research training through a new fellowship program. The regulatory system that governs human subjects research in the United States today traces directly to this statute.

Why Congress Passed It

The immediate catalyst was the U.S. Public Health Service’s Tuskegee syphilis study. For 40 years, researchers had tracked the progression of untreated syphilis in hundreds of Black men in Alabama without informing them of their diagnosis or offering available treatment. Associated Press journalist Jean Heller broke the story in July 1972. Congressional hearings followed, and they exposed a broader pattern of research abuses across federally funded institutions. By 1973, legislative proposals had consolidated around three goals: an expert commission to develop ethical guidance, mandatory institutional review boards at research sites, and federal regulations binding on anyone receiving government research money. President Nixon signed the resulting bill on July 12, 1974.¹

The IRB Requirement

Before 1974, no federal law required research institutions to independently screen studies for ethical problems. Some had review committees. Many did not. The National Research Act directed the Secretary of Health, Education, and Welfare to issue regulations requiring any institution applying for a federal grant, contract, or cooperative agreement involving human subjects research to certify it had established an Institutional Review Board. That requirement is now codified at 42 U.S.C. § 289.²

IRBs function as local ethics committees. They review research proposals before a study begins and can approve, require changes to, or reject it. They conduct continuing reviews of approved research at least once a year,³ and they can suspend or terminate a previously approved study if the researcher deviates from the board’s requirements or if the research causes unexpected serious harm.⁴

What the Board Looks At

Federal regulations spell out the approval criteria. Risks to participants must be minimized through sound research design and, where possible, through procedures already being performed for diagnosis or treatment. Remaining risks must be reasonable relative to anticipated benefits. Subject selection must be equitable, with particular attention to people vulnerable to coercion, such as children, prisoners, and economically disadvantaged individuals. The plan must include informed consent procedures and, where appropriate, provisions for monitoring participant safety and protecting data confidentiality.⁵

Who Sits on the Board

An IRB must have at least five members with enough variety in background, expertise, and demographic makeup to conduct thorough reviews. At least one member must come from a scientific field and at least one from a nonscientific field. At least one must have no other affiliation with the institution, an outside voice meant to guard against institutional blind spots. When the board regularly reviews studies involving vulnerable groups, it should include someone with expertise in working with those populations.⁶

The National Commission

The Act’s second title created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Secretary of Health, Education, and Welfare appointed eleven members from medicine, law, ethics, theology, and the social and behavioral sciences. At least five had to be active researchers working with human subjects. Members took office on December 1, 1974, and were given two years to complete their work.¹

Congress gave the Commission a focused and politically charged agenda. It was directed to investigate informed consent specifically for children, prisoners, and people institutionalized with mental illness, all groups recognized as particularly vulnerable to coercion. It was also required to study research involving living fetuses and the use of psychosurgery. Each assignment reflected a documented abuse or an active public controversy of the era.

Between 1975 and 1978 the Commission produced ten major reports covering research on fetuses, prisoners, children, the institutionalized mentally infirm, psychosurgery, institutional review boards, and broader ethical principles. Congress extended its mandate by one year through Public Law 94-573, and its charter expired in October 1978 after 43 meetings.

The Belmont Report

The Commission’s most consequential output was the Belmont Report, published on April 18, 1979. It was named for the Smithsonian’s Belmont Conference Center, where a four-day working session took place in February 1976, and it distilled nearly four years of deliberation into three foundational ethical principles for human subjects research.⁷

Respect for persons. Individuals must be treated as capable of making their own decisions about whether to participate in research, and people with diminished capacity to make those decisions, such as children, prisoners, and people with cognitive disabilities, deserve additional protection.⁸
Beneficence. Researchers have an obligation to avoid harm and to maximize potential benefits while minimizing risks.⁸
Justice. The benefits and burdens of research must be distributed fairly. No group should be systematically selected as subjects simply because of convenience, vulnerability, or social disadvantage.⁸

The report did not carry the force of law on its own, but it became the intellectual foundation for virtually every federal regulation on human subjects research that followed. Every IRB in the country operates under principles it articulated.

From Statute to the Common Rule

The National Research Act told the government to regulate human subjects research and left the details to rulemaking. Those details eventually became 45 CFR Part 46, with Subpart A known as the Common Rule because it was adopted across federal agencies rather than only within Health and Human Services. The Common Rule directly cites the National Commission and the Belmont Report as its foundation.⁹

As of early 2026, twenty federal departments and agencies are Common Rule signatories, including the Departments of Defense, Education, Energy, Veterans Affairs, and Homeland Security, along with NASA, the National Science Foundation, and the Environmental Protection Agency. Two additional intelligence agencies follow the Common Rule under a separate executive order.¹⁰ The current version, sometimes called the 2018 Requirements, took effect on January 21, 2019, after a major revision that updated informed consent, exempt research categories, and continuing review.⁹

The Reach Into Private Research

The 1974 Act’s original mandate covered federally funded research. The principles spread to private research through FDA rulemaking. In 1981, the FDA adopted parallel rules at 21 CFR Parts 50 and 56, requiring IRB review and informed consent for all clinical investigations subject to FDA oversight regardless of whether federal funding is involved. That includes drug trials under Investigational New Drug Applications, medical device studies, and any clinical investigation whose data will support a marketing application.¹¹

If a clinical trial was not reviewed and approved by a qualified IRB, the FDA can refuse to consider the resulting data when evaluating a drug or device application, which renders the study useless for regulatory purposes.¹¹ The practical result is that nearly all clinical research in the United States, whether publicly or privately funded, operates under IRB oversight traceable to the framework the National Research Act created.

National Research Service Awards

The Act’s first title restructured how the federal government funded research training. It created National Research Service Awards, a fellowship and grant program administered through the National Institutes of Health and the Alcohol, Drug Abuse, and Mental Health Administration. The awards supported predoctoral and postdoctoral researchers at federal and nonfederal institutions conducting biomedical and behavioral research, and covered stipends, travel, subsistence, dependency allowances, and institutional costs like faculty salaries and equipment.¹

Recipients took on a service obligation. For each year of award funding, a recipient had to spend twelve months in health research or teaching, or, if authorized, twenty months in the National Health Service Corps or a related health activity. Funds could be recovered by the government if the obligation was not met. Awards could not fund medical residencies, and no individual award could last more than three years without a special waiver.¹

What Changed in Practice

Before 1974, ethical oversight of research was largely voluntary and inconsistent. The National Research Act made independent ethical review a precondition for federal research dollars, which meant any university, hospital, or research organization receiving government grants had to build the infrastructure for it. That requirement reshaped how studies are designed, how consent forms are written, and how data is monitored over the life of a project.

The Commission’s focused reports on prisoners, children, fetuses, and people with mental disabilities led directly to the additional regulatory protections at Subparts B through D of 45 CFR 46 that govern research with those populations today.⁹ Researchers and ethicists continue to debate whether IRB review has become too bureaucratic or too uneven across institutions, but the architecture of independent, prospective ethical review that the National Research Act mandated in 1974 remains the foundation of human subjects protection in the United States.

1
GovInfo. Public Law 93-348 – National Research Act
2
GovInfo. 42 USC 289 – Institutional Review Boards; Ethics Guidance Program
3
eCFR. 45 CFR 46.109 – IRB Review of Research
4
eCFR. 45 CFR 46.113 – Suspension or Termination of IRB Approval of Research
5
eCFR. 45 CFR 46.111 – Criteria for IRB Approval of Research
6
eCFR. 45 CFR 46.107 – IRB Membership
7
HHS Office for Human Research Protections. The Belmont Report
8
HHS Office for Human Research Protections. The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research
9
eCFR. 45 CFR Part 46 – Protection of Human Subjects
10
HHS.gov. Common Rule Departments and Agencies
11
eCFR. 21 CFR Part 56 – Institutional Review Boards