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Informed Consent and Review Boards (IRBs)
What an IRB does before and during a clinical trial, what informed consent must cover, why consent is an ongoing process rather than a single signature, and how to protect your rights as a research participant.
People who have been approached about participating in a clinical trial, patients currently enrolled in a study who want to understand their rights, and caregivers evaluating a trial on behalf of a family member who cannot give consent independently.
Two interconnected systems protect people who volunteer for clinical research: the Institutional Review Board (IRB), which reviews and oversees research before and during its conduct, and informed consent, the process that ensures every participant understands what they are agreeing to — and retains the right to change their mind. Neither system is a bureaucratic formality. Together they form the ethical foundation that makes clinical research trustworthy.
This page focuses on how these protections work in practice. For an overview of trial phases and what it means to be in a trial, see the clinical trials and how research studies work guide.
The ethical principles behind research oversight
The modern framework for protecting human research participants traces directly to historical abuses — the Nuremberg trials revealed the wartime medical experiments conducted on prisoners without consent; the Tuskegee syphilis study exposed decades of deception of Black American men who were denied treatment. In response, the Belmont Report (1979) articulated three guiding principles:
- Respect for persons — individuals must be treated as autonomous agents; those with diminished autonomy deserve protection
- Beneficence — researchers must maximize benefits and minimize harms to participants
- Justice — the benefits and burdens of research must be distributed fairly
These principles are codified in federal regulations — primarily 45 CFR 46 (the Common Rule, governing federally funded research) and 21 CFR 50 and 56 (FDA regulations governing drug and device trials). All institutions receiving federal research funding and all sponsors conducting FDA-regulated trials must comply.
What an IRB is and how it is structured
An Institutional Review Board is a committee that reviews proposed research before it can begin and monitors ongoing research throughout its conduct. Federal law requires that any research involving human participants that is either federally funded or seeks FDA approval must have IRB oversight.
IRB membership requirements include:
- At least five members with diverse backgrounds
- At least one member whose primary expertise is scientific
- At least one member whose primary expertise is non-scientific (often an ethicist, lawyer, or community member)
- At least one member who is not affiliated with the institution
- Members of both sexes and, when relevant, members with knowledge of and experience working with vulnerable populations such as children, pregnant women, or people with cognitive impairments
IRBs may be convened by a single institution (a university hospital or research center) or may be independent commercial IRBs that serve multiple sites. Multi-site trials often use a single IRB to reduce redundancy and improve consistency.
What an IRB reviews and approves
Before a trial begins, the IRB reviews the complete study protocol. Key elements include:
| Review area | What the IRB assesses |
|---|---|
| Scientific design | Whether the study design is sound enough to answer the research question and justify exposing participants to risk |
| Risk-benefit ratio | Whether the risks to participants are reasonable in relation to the expected benefits to participants and to society |
| Participant selection | Whether inclusion and exclusion criteria are appropriate and whether vulnerable populations are protected |
| Consent process | Whether the proposed consent form and procedure are understandable, complete, and free of coercion |
| Data confidentiality | What protections will safeguard participant identity and sensitive health information |
| Conflict of interest | Whether investigator relationships with sponsors could affect participant safety or study integrity |
The IRB can approve the study, require modifications before approval, or disapprove it outright. No study may enroll its first participant until IRB approval is in place.
The eight required elements of informed consent
Federal regulations specify eight basic elements that must appear in every informed consent form for research. They are:
- A statement that the study involves research, an explanation of its purposes, and the expected duration of participation
- A description of the procedures to be followed, and identification of any that are experimental
- A description of reasonably foreseeable risks or discomforts to the participant
- A description of benefits to the participant or to others that may reasonably be expected
- Disclosure of appropriate alternative treatments or procedures that might be advantageous
- A statement describing the extent to which confidentiality will be maintained
- For greater-than-minimal-risk research, an explanation of whether compensation and medical treatment are available if injury occurs, and how to obtain them
- Contact information for questions about the research, participant rights, and research-related injuries
Regulations also list additional elements that must be included when applicable — for example, disclosure if the research involves commercial profit from participant data, or disclosure of the possibility of unforeseeable risks.
Documents and terms you’ll see
Reviewing the consent form and research paperwork, you will encounter:
- Informed consent — the specific form you sign and the process surrounding it; the form is a required document, but the real process includes the conversation before you sign
- Institutional review board — the oversight committee; the consent form will list the IRB and provide contact information for participant rights questions
- Protocol — the master plan for the study; you will not receive the full protocol, but the consent form must accurately summarize what the protocol requires of participants
- Principal investigator — the lead researcher responsible for your care and safety in the trial; their name and contact information must appear in the consent form
Consent is a process, not a signature
A common misconception is that informed consent ends when you sign the consent form. In practice, consent is an ongoing process:
- Before you sign, the study team must give you adequate time to read the form, ask questions, discuss with family or advisors if you wish, and decide without pressure. You cannot be rushed.
- During the study, if new information emerges — new risks identified in other studies, unexpected findings from interim safety reviews, changes to study procedures — the IRB may require the team to re-consent participants with an updated form.
- At any point, you retain the right to ask questions, request updated information, or decide to stop participating. Withdrawal cannot affect your medical care or insurance.
The quality of informed consent varies in practice. Research has shown that consent forms are frequently written at reading levels above what the average participant can comfortably comprehend. If you receive a consent form that is difficult to understand, ask the study coordinator to walk through it with you section by section, and ask to take a copy home before deciding.
Questions to ask before you consent
If you are considering a trial, use the consent discussion as an opportunity to get complete information. Useful questions include:
- What is the purpose of this study, and who is funding it?
- Which procedures are required by the study versus part of my standard care?
- What are the most common and most serious risks associated with the experimental treatment?
- Will I know which arm of the trial I am assigned to? If not, when will I find out?
- What happens if I experience a side effect or injury during the trial?
- Will my standard medical care be affected if I choose not to participate or choose to withdraw?
- Will the study pay for any costs — travel, tests, study visits — related to participation?
- Who should I contact if I have concerns about how the study is being run?
Your rights as a research participant
Federal protections for research participants include the right to:
- Receive complete information about the study in language you can understand, including information about risks, benefits, and alternatives
- Decide freely without coercion or undue influence; financial incentives must be fair and not so large as to impair voluntary decision-making
- Withdraw at any time without penalty or loss of benefits — this is non-negotiable and is stated explicitly in every consent form
- Privacy and confidentiality — identifying information from research must be protected; many clinical trials use a Certificate of Confidentiality (issued by NIH) to provide additional legal protection against compelled disclosure
- Access to information about your own results when clinically relevant findings emerge from the research
- Contact the IRB if you have concerns about your rights that the study team is not addressing
If you believe your rights have been violated or that the research is being conducted improperly, you can file a complaint with the Office for Human Research Protections (OHRP) at hhs.gov/ohrp, or with FDA for FDA-regulated trials. These offices investigate complaints and have authority to require corrective action.
Key terms
| Term | Plain meaning | Glossary |
|---|---|---|
| Informed Consent | The process by which a potential research participant is given complete, understandable information about a study and voluntarily agrees to participate, with the ongoing right to withdraw at any time | → |
| Institutional Review Board (IRB) | An independent committee required by federal law to review and approve research involving human participants before it begins, and to monitor it throughout its conduct | → |
| Protocol | The detailed written plan of a research study, describing its objectives, design, methods, statistical considerations, and participant safeguards | → |
| Principal Investigator | The researcher who leads and takes overall responsibility for conducting a clinical trial at a given site | → |
Common questions
- What does an IRB review before approving a trial?
- An IRB reviews the study protocol in full — the scientific rationale, the procedures participants will undergo, the risks and potential benefits, the proposed consent form and process, the qualifications of the research team, and plans for protecting vulnerable populations. The IRB must determine that risks to participants are minimized, that risks are reasonable in relation to anticipated benefits, and that the consent process is adequate.
- Can I be enrolled in a clinical trial without my consent?
- In almost all circumstances, no. Federal regulations require informed consent before enrollment in research. Limited exceptions exist — for example, research on emergency interventions when the person is unconscious and a legally authorized representative is unavailable — but these exceptions require specific FDA and IRB approval and community notification. You should never find yourself enrolled in a trial without being aware of it.
- What happens if I want to withdraw from a trial?
- You have the right to withdraw at any time and for any reason without penalty or loss of benefits to which you are otherwise entitled. Withdrawing from a trial cannot cause your doctor to drop you as a patient or affect your insurance coverage. Some withdrawal processes require you to notify the study team and may involve a final safety visit; the consent form should explain the withdrawal procedure.
- What information must appear in an informed consent form?
- Federal regulations (45 CFR 46 and 21 CFR 50) require consent forms to include: a description of the study's purpose and procedures; a disclosure of reasonably foreseeable risks; a description of potential benefits; disclosure of available alternatives to participation; a statement of confidentiality protections; an explanation of available compensation or treatment if injury occurs; contact information for questions; and a statement that participation is voluntary and can be withdrawn without penalty.
- Who sits on an IRB?
- Federal regulations require that an IRB include at least five members with varying backgrounds. The committee must include at least one scientist and at least one person whose primary concerns are in non-scientific areas. The IRB must also include at least one member who is not affiliated with the institution and at least one member from the local community. The goal is a balanced perspective that considers both scientific merit and community values.
- What is continuing review?
- An IRB's approval is not a one-time event. At minimum annually — and more often for higher-risk studies — the IRB must conduct a continuing review of ongoing research to ensure conditions have not changed in ways that alter the risk-benefit calculation. The IRB can modify, suspend, or terminate approval at any time if it determines that participant safety requires it.
- Can the consent process be waived?
- In narrow circumstances, an IRB can waive the requirement for written consent or even for consent itself — for example, in minimal-risk research using existing records where requiring consent would make the research impracticable. Emergency research waiver is a separate regulatory category with additional requirements. These exceptions do not apply to most clinical trials involving investigational treatments.
- Who do I contact if I have concerns about my rights as a trial participant?
- Every institution conducting federally funded or FDA-regulated research must have an IRB contact who is available to participants. This contact is listed on the consent form. For concerns about federally funded research, you can also contact OHRP (the Office for Human Research Protections) within HHS. For FDA-regulated trials, FDA's Office of Good Clinical Practice handles complaints.
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Last reviewed: September 2026