Before you join a clinical trial, the study team must explain what taking part involves and get your agreement in writing. That process is called informed consent. It is not a single signature. It is a conversation, a document you keep, and a right to change your mind at any point in the study.
What the law requires
In the United States, two sets of rules govern consent. FDA regulations apply to studies of drugs, biologics and medical devices (21 CFR 50.25). The “Common Rule” applies to research funded or conducted by federal agencies (45 CFR 46.116). Many studies fall under both. The two rules list very similar elements, and an ethics board (IRB) checks the consent form against them before a study can enroll anyone.
The FDA rules also set ground rules for how consent is obtained. It must be sought in circumstances that give you enough time to decide, without coercion or undue influence. The information must be in language you can understand. And the form may not include wording that waives your legal rights or releases the study team from liability for negligence (21 CFR 50.20).
What the consent form must tell you
FDA regulations list the basic elements every consent form must contain (21 CFR 50.25(a)). In plain terms, the form has to cover:
- That the study is research, what it is trying to find out, how long you would be involved, which procedures you would go through and which of them are experimental.
- The risks and discomforts that can reasonably be foreseen.
- Any benefits to you or to others that can reasonably be expected. Some studies offer no direct benefit to participants.
- Other treatments or procedures that might be available to you instead of joining.
- How your records will be kept confidential, and that the FDA may inspect them.
- For studies with more than minimal risk, whether compensation or medical treatment is available if you are injured, and where to get more information.
- Who to contact with questions about the study, your rights as a participant, or a research-related injury.
- That taking part is voluntary, that refusing carries no penalty or loss of benefits you are otherwise entitled to, and that you can stop at any time.
For trials that must be registered on ClinicalTrials.gov, the form also has to say that a description of the trial will be posted there, that the posting will not include information that can identify you, and that it may include a summary of results (21 CFR 50.25(c)).
Extra elements you may see
When they apply to a study, the regulations call for additional statements (21 CFR 50.25(b)). These include the possibility of risks that are not yet known, the circumstances in which the investigator might end your participation without your consent, any extra costs to you, what happens if you decide to withdraw and how to do so safely, a promise that you will be told about new findings that might affect your willingness to continue, and roughly how many people will be in the study.
The signed document
Consent is normally documented with a written form that you sign and date, and you must be given a copy (21 CFR 50.27). Keep it. It is the reference for what the study promised, who to call, and how to leave. Under the Common Rule, the form must also open with a concise, focused summary of the key information most likely to help you decide, before the detailed sections (45 CFR 46.116(a)(5)).
Signing is not the end of consent. If the study changes in a way that could affect your decision, you should be asked to consent again. Children generally cannot consent for themselves; a parent or guardian gives permission and, when they are able to understand, the child is asked to agree (assent). The FDA publishes guidance for study teams on how all of this should work in practice (FDA: Informed Consent guidance).
Questions worth asking before you sign
- What is the main question this study is trying to answer?
- What will I have to do, how often, and for how long?
- What are the most likely side effects, and what is the worst that could reasonably happen?
- Will I know whether I am getting the investigational product or a placebo?
- What are my options if I do not join?
- Who pays for study tests, and what might be billed to my insurance?
- What happens if I decide to leave partway through?
Take the form home if you want to. A study team that pressures you to sign on the spot is not following the rules. For background on who runs trials and how they are overseen, read how clinical trials work. For what to expect on payment and reimbursement, see compensation in clinical trials.
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.