Before you decide whether to join a clinical trial, the study team explains the study to you. This is called informed consent.

Many people think informed consent just means signing a form. But the signature is only one part of it. Informed consent is an exchange of information that goes on for as long as you are in the study.

A conversation, not just a form

Someone from the study team who knows the study well talks with you and answers your questions. The team explains the study’s purpose, what will happen, and the possible risks and benefits. You can ask about anything, including your other treatment options.

You also get a consent form to read. It puts in writing what you talked about, and it gives you contact information in case more questions come up later. If you agree to take part, you usually sign the form and get a copy of it.

The conversation does not end when you sign. As new information becomes available, such as new information about risks, the study team will tell you.

In the United States, FDA rules apply to the studies the FDA oversees, such as studies of new medicines and medical devices. These rules list eight things the consent information must include:

  1. That the study is research, why it is being done, how long you would take part, what will happen, and which parts are experimental
  2. The risks or discomforts that can reasonably be expected
  3. Any benefits to you or to others that can reasonably be expected
  4. Other procedures or treatments that might be good for you, if there are any
  5. How private your records will be, and that the FDA may look at them
  6. For studies with more than minimal risk, whether payment or medical treatment is available if you are hurt, and where to learn more
  7. Whom to contact with questions about the study or about your rights, and whom to contact if you are hurt because of the study
  8. That taking part is voluntary, and that saying no, or stopping later, carries no penalty and no loss of benefits you would otherwise have

In item 6, minimal risk means that harm or discomfort is no more likely, and no worse, than in daily life or during routine physical or psychological exams or tests.

When they apply, the form must also cover other points, such as extra costs you might have and what happens if you decide to leave.

Your rights

  • You can ask questions, before you decide and at any time during the study.
  • You can take your time. In the United States, FDA rules say you must have enough time to think about whether to join. The study team must take care not to pressure you. You may want to talk it over with your family, your friends or your doctor.
  • You can get the information in a way you understand. You have the right to hear and read the information in a language you understand. In the United States, FDA rules also say it must be at a level you can follow, with medical words explained. If you need it, ask for an interpreter or for the form in your language.
  • You can say no, or leave later. You can choose not to join. If you join, you can leave at any time and for any reason, even after you sign. Saying no or leaving carries no penalty, and you keep the care and benefits you would otherwise have. Talk with the study team before you stop, so that you can leave safely.

Who protects participants: IRBs

Most clinical studies are reviewed by a group of experts called an institutional review board, or IRB. It is also called an ethics review committee. Its job is to protect the rights, safety and well-being of the people in the research.

An IRB:

  • reviews the study plan and the consent form before the study can enroll anyone
  • checks that the study is well designed, legal and ethical, does not involve unneeded risks, and has a safety plan
  • weighs the study’s risks against its possible benefits, to make sure the risk to participants is acceptable and as low as possible
  • can approve a study or turn it down, and can ask for changes to the study plan before it approves the study
  • keeps reviewing the study after it starts, and can pause or end its approval to protect the people in it

In the United States, federal rules require each IRB to have at least five members. They include a scientist, someone who is not a scientist, and someone who is not connected to the place where the study is done.

The consent form tells you whom to contact with questions about your rights. FDA recommends that this person or office not be part of the study team. It may be the IRB office or a patient advocate office.

In the United States, the Office for Human Research Protections (OHRP) and the FDA set rules to protect people in research.

If you are thinking about joining a study, your care team can help you understand the consent form and decide what is right for you.