Protecting the safety of people who take part in clinical trials is a high priority for clinical researchers. Each trial has scientific oversight, and patients also have rights that help protect them.
Institutional Review Board
Institutional review boards (IRBs) help provide scientific oversight for clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. IRB members are doctors, statisticians, and community members.
The IRB's purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins.
An IRB will only approve research that deals with medically important questions in a scientific and responsible way. The IRB also checks on results during the trial. All U.S. clinical trials are required to have an IRB.
Office for Human Research Protections
The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research done or supported by HHS.
The OHRP helps protect the rights, welfare, and well-being of research participants. They provide guidance and oversight to the IRBs, develop educational programs and materials, and offer advice on research-related issues.
Data Safety Monitoring Board
Every National Institutes of Health (NIH) phase III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists of a group of research and study topic experts.
The NIH also requires DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children).
A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results from other relevant studies. These results may reveal unknown patient risks, or they may even answer the NIH study's research question.
Scientific oversight informs decisions about a trial while it's under way. For example, some trials are stopped early if benefits from a strategy or treatment are obvious. That way, wider access to the new strategy can occur sooner.
Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects.
Food and Drug Administration
In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices.
The FDA reviews applications for new medicines and devices before any testing on humans is done. They check to make sure that the proposed studies have proper informed consent (see below) and protection for human subjects.
The FDA also provides oversight and guidance at various stages throughout the studies. For example, before large-scale phase III trials begin, the FDA provides input on how these studies should be done.
Informed consent is the process of giving clinical trial participants all of the facts about a trial. This happens before they agree to take part and during the course of the trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have.
Before you decide whether to enroll in a clinical trial, a doctor or nurse will give you an informed consent form that presents the key facts of the study. If you agree to take part in the trial, you'll be asked to sign the form.
You can and should ask questions about the trial to make sure you understand what's involved. Here are some questions to ask before enrolling in a clinical trial:
- What is the purpose of the study?
- Who is sponsoring the study, and who has reviewed and approved it?
- What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful?
- What are the possible risks, side effects, and benefits of taking part in the study?
- How might this trial affect my daily life? Will I have to be in the hospital?
- How long will the trial last?
- Who will pay for the tests and treatments I receive?
- Will I be reimbursed for other expenses (for example, travel and child care)?
- Who will be in charge of my care?
- What will happen after the trial?
Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the best choice for you.
The informed consent document is not a contract. You have the right to withdraw from a study at any time, for any reason. Also, during the trial, you have the right to learn about new risks or findings that emerge. If researchers learn that a treatment harms you, you'll be removed from the study.
Rights and Protection for Children
Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial.
When researchers think that a trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials.
Children and Clinical Studies: Messages for researchers08/14/2013
Children and Clinical Studies: For parents and caregivers08/14/2013