Justice in Research: Belmont Report Rules and Protections

The justice principle of the Belmont Report requires that the burdens and benefits of human research be distributed fairly, so that people are not chosen as subjects because they are poor, confined, or easy to reach, and so that the eventual benefits of the research reach the communities that took on its risks.¹ It is one of three principles the Report laid out in 1979, alongside respect for persons and beneficence, and it is the one that governs recruitment ethics, vulnerable-population protections, and equitable access to what research produces.

What the Justice Principle Says

The Report frames justice as a question about who deserves the benefits of research and who should bear its burdens. An injustice occurs in two directions: when someone is denied a benefit they are entitled to without good reason, or when a burden is imposed on them unfairly.¹

The Report grew directly out of the U.S. Public Health Service’s 40-year study of untreated syphilis in hundreds of Black men in rural Alabama, in which researchers withheld effective treatment long after it became available.² Congress responded with the National Research Act of 1974, which created the commission that drafted the Report.³ That study became the standing example of what the justice principle exists to prevent: a disadvantaged community was selected because it was available, and the individuals in it were denied care they were owed.

Individual Selection and Social Selection

Instead of choosing a single formula for fair distribution, the Report applies justice to research through two practical lenses.

Individual selection asks whether specific participants are chosen fairly within a study. Researchers cannot reserve promising treatments for favored patients while steering riskier procedures toward people they consider expendable. A physician who enrolls only wealthy private patients in a beneficial drug trial and recruits only uninsured patients for painful biopsies is committing the individual-level injustice the principle targets.

Social selection asks whether entire classes of people — defined by race, income, institutionalization, or health status — are being systematically targeted or excluded. The Report explicitly warns against choosing groups “simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.”¹ Historically, poor ward patients bore the risks of experimental 19th-century surgery while wealthier patients received the refined treatments; prisoners and residents of state institutions were treated as captive research pools well into the 20th century.

How Justice Shapes Who Gets Recruited

The Common Rule, codified at 45 CFR Part 46, translates the Belmont principles into enforceable federal law. It requires every Institutional Review Board to confirm that subject selection is equitable before approving a study. The IRB must consider the purpose of the research, the setting where it will take place, and whether the recruitment plan is particularly likely to sweep in people who are vulnerable to coercion.⁴

In practice, investigators must justify why they are recruiting from any particular population. A study on a disease that primarily affects elderly women should not recruit young men from a homeless shelter because they are easier to find. Documented inclusion and exclusion criteria are the tool that keeps personal relationships, financial status, and institutional convenience out of enrollment decisions.

The IRB itself is structured to enforce this. Each board must have at least five members with diverse backgrounds, including diversity of race, gender, and cultural perspective; at least one member from outside the institution; and at least one whose primary work is in a nonscientific field. When a board routinely reviews studies involving prisoners, children, economically disadvantaged individuals, or people with impaired decision-making capacity, it should include members with direct experience working with those groups. Outside consultants can be brought in for specialized expertise, but they cannot vote.⁵

Extra Protections for Vulnerable Populations

The Common Rule creates specific regulatory subparts for groups the justice principle identifies as especially susceptible to coercion or exploitation. These are not guidelines; they impose additional approval criteria an IRB must satisfy before a study can proceed. One boundary matters here: FDA regulations for human subjects research do not include these same subparts. The protections for prisoners, children, and pregnant women exist under 45 CFR 46, not under FDA’s rules.⁶

Prisoners

Subpart C exists because incarcerated people face pressures that can undermine voluntary consent. Modest incentives, such as slightly better food, a break from routine, or small payments, can carry outsized weight in a confined environment. The IRB must evaluate whether any advantage a prisoner might gain from participating is so significant relative to their living conditions that it would distort their ability to weigh the risks. The research must also be relevant to the health needs of the prison population, not just convenient for the investigator.⁷

Children

Subpart D sorts research involving children into four categories based on how much risk the study carries and whether the child might directly benefit. Minimal-risk studies can proceed with parental permission and the child’s assent. Research that does not fit any standard category can still be approved through a special federal review process if it addresses a serious health problem affecting children. The higher the risk and the less likely the child is to benefit directly, the more justification the IRB demands.⁸

Pregnant Women and Fetuses

Subpart B requires that investigators generally have preclinical data, including animal studies, assessing potential risks before involving pregnant participants. If the research offers no direct benefit to the woman or the fetus, the risk to the fetus cannot exceed minimal, and the study must aim to produce important biomedical knowledge unavailable by other means. The regulation also prohibits offering any inducement to terminate a pregnancy and bars researchers from involvement in decisions about the timing or method of termination.⁹

Adults With Impaired Decision-Making Capacity

There is no dedicated subpart for cognitively impaired adults, but the general safeguards address them. When a study is likely to enroll people who cannot fully evaluate the risks themselves, the IRB must require additional protections. Informed consent must come from a legally authorized representative empowered under applicable law to consent on the subject’s behalf.⁴

Participant Payment: Fair Pay Versus Coercion

Payment is one of the harder justice questions. Pay too little and only the financially comfortable can afford to participate, skewing enrollment away from the populations that often need the research most. Pay too much and people may ignore genuine risks because they need the money.

The Secretary’s Advisory Committee on Human Research Protections distinguishes four types of payment. Reimbursement covers out-of-pocket costs such as transportation and meals and raises no coercion issues, because it simply restores participants to where they started financially. Compensation for time and effort is generally acceptable. Appreciation gifts are too small to distort decision-making. The category that demands scrutiny is incentive payments — amounts designed to boost enrollment — which can cross into “undue influence” if they are likely to cloud a participant’s judgment about the study’s actual risks.¹⁰

The advisory committee warns against simply slashing payments whenever an IRB feels uncomfortable. Cutting compensation can itself create a justice problem by making studies inaccessible to lower-income participants. The recommended approach is to keep payment fair while strengthening informed consent, using comprehension checks and waiting periods before enrollment.¹⁰ For tax purposes, the NIH reports participant payments to the IRS when total compensation reaches $2,000 or more in a calendar year, though reimbursements for reasonable out-of-pocket expenses are excluded from that threshold.¹¹

Making Sure the Benefits Reach People

Justice does more than block exploitation. It also demands that the results of research reach the people who took on its risks.

Inclusion in Clinical Trials

Under 42 U.S.C. § 289a-2, the NIH cannot approve a clinical research proposal unless it specifies how the study will include women and members of minority groups as subjects, and trials must be designed to allow analysis of whether the treatment affects these groups differently. Exceptions are narrow: inclusion must be inappropriate for subject health, irrelevant to the research purpose, or otherwise impractical under circumstances the NIH Director designates.¹² The Food and Drug Omnibus Reform Act of 2022 additionally directed the FDA to require diversity action plans for certain clinical trials. As of mid-2024, the FDA published a draft guidance describing format and submission requirements, but the guidance has not yet been finalized.¹³

Public Reporting of Results

Most clinical trials must be registered on ClinicalTrials.gov within 21 days of enrolling the first participant, and results must generally be posted within one year after the study’s primary completion date. Noncompliance can trigger civil monetary penalties, and for federally funded studies the government can withhold remaining or future grant funds.¹⁴

Post-Trial Access

When a study ends, participants who responded well can lose access to the treatment. The FDA’s expanded access pathway, sometimes called compassionate use, allows patients with serious or life-threatening conditions to continue receiving an investigational product outside of a clinical trial when no comparable alternative exists. Under the 21st Century Cures Act, companies developing investigational drugs must publicly post their policies for evaluating expanded access requests.¹⁵

March-In Rights

When a publicly funded invention results in a patent held by a university or company, the Bayh-Dole Act gives the funding agency a backstop. Under 35 U.S.C. § 203, the federal government can require the patent holder to license the invention to others, or license it directly, if the holder has not taken reasonable steps to make the product practically available, or if action is needed to address unmet health or safety needs.¹⁶ These rights have been invoked rarely, but they are the legal mechanism against publicly funded discoveries being locked away from the participants and taxpayers who made them possible.

What Happens When the Rules Are Broken

The Office for Human Research Protections oversees compliance with the Common Rule. Its response scales with the severity of the violation. Lower-level findings can require corrective action plans. More serious violations can lead OHRP to restrict or attach conditions to an institution’s Federalwide Assurance, the agreement every institution must have in place to conduct federally supported human subjects research. A restricted FWA can require the suspension of all covered studies until OHRP’s conditions are met.¹⁷

At the most serious level, OHRP can recommend that an institution or individual investigator be temporarily suspended or permanently removed from specific projects, or debarred from receiving federal funding entirely. Separately, the head of any federal department or agency can terminate or suspend funding for a research project when the institution has materially failed to comply with the Common Rule.⁴

How to Report a Suspected Violation

If you are a participant or a whistleblower who believes a study is violating ethical protections, the first step is usually contacting the institution’s own human research protection office or the IRB that approved the study. That contact information should be in the informed consent document you signed. If that route does not resolve the issue, you can file a written complaint directly with OHRP through the online form on the HHS website. Include the institution’s name, the researcher’s name, the project name or number, and the funding source if you know it.¹⁸

OHRP accepts anonymous complaints, though identifying yourself lets the office investigate more thoroughly. If you do identify yourself, OHRP will ask whether you consent to sharing your identity with the institution under review. One limitation matters: OHRP itself does not have legal authority to provide whistleblower protections. Employees of HHS contractors, grantees, or subgrantees who fear retaliation can seek whistleblower protections by reporting to the HHS Office of Inspector General instead. HHS employees who face adverse personnel actions after reporting misconduct can file retaliation complaints with the OIG or the U.S. Office of Special Counsel.¹⁸

1
U.S. Department of Health & Human Services. The Belmont Report
2
U.S. Department of Health and Human Services. National Research Act 50th Anniversary
3
Centers for Disease Control and Prevention. Effects on Research
4
eCFR. 45 CFR Part 46 – Protection of Human Subjects
5
eCFR. 45 CFR 46.107 – IRB Membership
6
U.S. Food and Drug Administration. Comparison of FDA and HHS Human Subject Protection Regulations
7
eCFR. 45 CFR Part 46 Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
8
eCFR. 45 CFR Part 46 Subpart D – Additional Protections for Children Involved as Subjects in Research
9
eCFR. 45 CFR 46.204 – Research Involving Pregnant Women or Fetuses
10
U.S. Department of Health & Human Services. SACHRP Recommendations – Attachment A – Addressing Ethical Concerns, Offers of Payment to Research Participants
11
National Institutes of Health. Notification About Changes to IRS Tax Reporting – Starting January 1, 2026
12
Office of the Law Revision Counsel. 42 USC 289a-2 – Inclusion of Women and Minorities in Clinical Research
13
Federal Register. Diversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies
14
ClinicalTrials.gov. FDAAA 801 and the Final Rule
15
U.S. Food and Drug Administration. Expanded Access Information for Industry
16
Office of the Law Revision Counsel. 35 USC 203 – March-in Rights
17
U.S. Department of Health and Human Services. OHRP Compliance Oversight Assessments
18
U.S. Department of Health and Human Services. Submitting a Complaint About Research Involving Humans