Why Research Ethics Exists

The rules that govern research today were not drawn up in the abstract. Each one responds to cases in which real people were harmed by researchers who believed their work was important enough to justify the cost. This lesson describes that history, because the safeguards make sense only once you know what they were meant to prevent. It then sets out the three principles behind every ethics review, which the field adopted after those failures.

The studies that made the rules necessary

Three cases are taught again and again, because each exposed a different way that good intentions and scientific curiosity can override a person's dignity.

The Tuskegee Syphilis Study (1932–1972). The U.S. Public Health Service enrolled roughly 600 poor Black men in Alabama (about 400 of them already infected with syphilis) to observe the untreated course of the disease. The men were never told they had syphilis; they were told they were being treated for "bad blood." When penicillin became the standard cure in the 1940s, it was deliberately withheld so the observation could continue. The study ran for forty years and ended only in 1972, after a whistle-blower brought it to the press. Its exposure led directly to the law that created today's ethics-review system.

Milgram's obedience studies (1961–1963). Stanley Milgram told participants they were helping with a "learning" experiment and instructed them to deliver what they believed were escalating electric shocks to another person. There were no real shocks (the "learner" was an actor), but the participants did not know that. About two-thirds continued to what they thought was a dangerous 450-volt level while an experimenter urged them on. Many were visibly distressed. The findings about obedience were influential, but the study relied on deception, exposed people to real psychological strain, and made it hard for participants to simply stop and leave.

The Stanford Prison Experiment (1971). Philip Zimbardo assigned students to play "guards" and "prisoners" in a mock prison. Some guards became abusive and the study, planned for two weeks, was halted after six days. For decades it was told as proof that ordinary people slide into cruelty under a bad system. Modern scrutiny has complicated that story. Released recordings and interviews show that the guards were coached toward toughness. The sample was tiny and self-selected, Zimbardo ran the study while playing "prison superintendent," and later attempts to reproduce the effect (such as the BBC Prison Study) did not find the same slide. It remains a landmark, but today it is discussed as much for its methodological failures as for what it seemed to show.

From harm to code: the documents

Research ethics was written down in response to abuses like these. Three documents form its basis:

• The Nuremberg Code (1947) emerged from the trials of Nazi doctors who had experimented on prisoners. Its first and most famous line makes voluntary, informed consent absolutely essential: a person must understand what they are agreeing to and be free to refuse.
• The Declaration of Helsinki (1964), from the World Medical Association, extended this to medical research generally: independent review of study protocols, weighing risks against benefits, and special care for those who cannot fully consent. It has been revised many times as norms have sharpened.
• The Belmont Report (1979), written in the United States after Tuskegee by a national commission, distilled research ethics into three principles that still frame every ethics review today.

The three Belmont principles

Almost everything an ethics committee asks can be traced to one of these three ideas, and the rest of this course applies them:

• Respect for persons: treat people as autonomous agents who decide for themselves, and give extra protection to those with diminished autonomy (children, prisoners, patients who cannot consent). In practice this becomes informed consent.
• Beneficence: do no harm; maximize the possible benefits and minimize the possible harms. In practice this becomes the risk–benefit assessment that every review makes.
• Justice: distribute the burdens and benefits of research fairly, so the people who bear the risks are not a different, more vulnerable group than the people who stand to gain. In practice this becomes fair selection of participants.

From principles to the rules you actually work under

The Belmont Report is a statement of principles, and by itself it binds no one. In the United States the binding rules are the regulation written from it, 45 CFR 46. Its Subpart A was adopted in 1991 by fifteen federal departments and agencies at once, so it is called the Common Rule. Three further subparts add protections for groups the justice principle singles out: pregnant women, fetuses and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D). The first major revision in a generation took effect in January 2019. It requires consent forms to open with a concise summary of the key information and drops continuing review for most minimal-risk work. From January 2020 it also requires multi-site projects to use a single committee.

IRB is an American term. The same review happens nearly everywhere under other names (Research Ethics Committee, Human Research Ethics Committee, ethics board). It asks the same Belmont-based questions on different paperwork, so a form that looks nothing like the U.S. one does not mean a weaker review.

Regulation is also only one of the two sets of rules you work under. The other is your discipline's professional code, which covers more than the law does. The APA's Ethical Principles of Psychologists and Code of Conduct (adopted in 2002, amended in 2010 and 2017) opens with five General Principles. Set beside Belmont's three, they show what a professional code adds. Beneficence is there, but paired with nonmaleficence: a standing duty to avoid harm, not only to weigh it against benefit. Justice is there too, and so is respect for people's rights and dignity. Two principles have no Belmont counterpart at all: fidelity and responsibility, and integrity. Integrity covers honest reporting. That is why questionable research practices, authorship disputes and fabricated results are ethics violations in their own right, even when no participant is harmed by any of them.

Walk the timeline

Select any moment below to read what happened and, for the documents, what each one established. When you open one of the studies, the cards under the timeline show which of the three Belmont principles it failed to honor. There is no score.