An institutional review board (IRB) is an administrative body that is charged with protecting the rights, privacy, and welfare of people who participate in any kind of clinical or other academic research. It is responsible for reviewing the planned procedures of a study and determining whether it is ethical to proceed with the study, or recommending changes to be made before the study begins.
Deeper dive
The history of medicine is full of sordid experiments, from the Nazi experimentation on concentration camp prisoners to the tragic and unethical Tuskegee syphilis study. Institutional Review Boards (IRBs) came about to prevent future unethical human research such as these incidents (and many others). Although the concept of having ethical standards for human experimentation dates back centuries, one of the most influential codified versions in recent history was the Nuremberg Code developed after World War II.
Today, countries throughout the world have laws regarding IRBs, also called independent ethics committees, ethical review boards, research ethics board or similar names. They all serve the same essential purpose: to look after the safety, welfare and rights of human participants in studies.
IRBs, which can be independent or formed by institutions such as universities and hospitals, are groups that formally convene to approve, review and monitor any kind of biomedical research involving living human subjects. Even studies which simply ask participants questions, whether through surveys or in-depth interviews, must undergo IRB approval. If the study contains “identifiable private information,” the researchers must seek IRB approval. Most biography, journalism, art and similar activities as well as research involving federal data sets do not require approval even if they involve people. Most social science research, such as psychology and sociology, does require approval, though studies might qualify for an exemption. Some research also qualifies for an expedited review.
IRB guidelines in the U.S. must follow regulations laid out by the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services (specifically Title 45 Code of Federal Regulations Part 46) and typically follow other institutional and ethical guidelines. The path to the federal regulations began with the National Research Act, passed in 1974 partly in response to the Tuskegee experiments. The resulting Belmont Report, a summary of ethical principles that formed the basis of current U.S. policy on human research, led to current law in 1981 (expanded in 1991). No trials for products governed by the FDA can proceed without IRB approval and oversight, and all IRBs overseeing FDA-regulated studies must register with the agency.
The key concepts underlying IRBs are informed consent of the participants (specific requirements here) and a risk-benefit ratio that involves significant benefit to society with acceptable levels of risk for the participants. IRBs consider a variety of factors in ensuring that research upholds these goals, such as how participants are recruited, for example.
An extensive (66-question) FAQ on IRBs is available at the FDA website here. Notable points include the following:
- The first priority of IRBs is to protect the welfare and rights of human subjects, not of the institution.
- Institutions without their own IRBs may use outside/independent ones, including those of hospitals.
- FDA regulations do not provide guidance regarding compensation for participant injury or regarding institutional liability for malpractice lawsuits, even if all IRB regulations were followed.
- IRBs must have a diverse membership that meets certain parameters, such as having members with a non-scientific background (such as lawyers, clergy or ethicists) and includes diversity in terms of “race, gender, cultural backgrounds and sensitivity to such issues as community attitudes.”
- If researchers submit a study for IRB approval that has been previously denied approval by a different IRB, their documentation for the new approval request must include this information.
- Clinical investigators must report all adverse events occurring during a study to the IRB overseeing that research.
- Parents must provide informed consent for their children’s participation in research, but FDA regulations do not necessarily require that the children themselves provide assent (agreement to participate).
- Some research for investigational drugs, biological products or devices may qualify for an exemption for IRB approval (see #56 in the FDA FAQ).
- Medical devices have their own set of requirements discussed here.
- Exceptions to IRB approval can be granted for humanitarian reasons, such as emergency use of a drug or biologic or for medical devices, discussed in the FDA FAQ here.
Any time a journalist is covering a study, he or she should check to see that the study received IRB approval (usually described in the methods section) or that the research qualified for an exemption. The study should note whether participants provided informed consent.