Oversight Boards
Return to Main Page
Institutional Review Boards (IRBs) IRBs are made up of people who are qualified to evaluate new and ongoing clinical trials on the basis of scientific, legal, and ethical merit. The board members determine whether the risks involved in a trial are reasonable with respect to the potential benefits. IRBs also monitor the ongoing progress of trials from beginning to end. Federal regulations require that each IRB be made up of at least five people; one member must be from outside the institution conducting the trial. IRBs are usually made up of a mix of medical specialists and lay members of the community, and many include members from diverse occupations and backgrounds. In most cases, IRBs are located where the trial is to take place. Many institutions that carry out clinical trials have their own IRBs. Federal law requires IRB approval for clinical trials that are: 1) Federally funded 2) Evaluating a investigational drug, agent, or medical device or a new indication or method of administration of a marketed drug or device, subject to FDA regulation A number of institutions require that all clinical trials, regardless of funding, be approved and reviewed by local IRBs. Potential participants considering a clinical trial should ask if it has been approved by an IRB.
During the Trial: IRB Monitoring If the IRB grants approval for a trial, it also must decide how frequently the trial should be reviewed once it is underway. Frequency is usually determined according to the degree of risk the trial involves. At least once a year, the IRB must review a progress report provided by the clinical researcher in charge of the trial. The report features information about how many people are enrolled and how many have withdrawn, a description of participants’ experiences, including benefits and adverse effects, and the progress to date. Based on this information, the IRB decides whether the trial should continue as described in the original research plan, and, if not, what changes need to be made. An IRB can decide to stop a clinical trial at any time if the researcher is not following requirements or if the trial appears to be causing unexpected harm to participants.
Data and Safety Monitoring Boards, DSMBs For phase 3 trials, DSMBs are appointed to help ensure participants’ safety. A DSMB may also be appropriate and necessary for certain phase 1 and 2 clinical trials. The DSMB is an independent committee made up of statisticians, physicians, and other expert scientists. The data and safety monitoring board must: • Ensure that any risks associated with participation are minimized to the extent practical and possible • Avoid exposing participants to excessive risk • Ensure the integrity of data • Stop a trial if safety concerns arise or as soon as its objectives have been met
DSMBs also monitor all trial results. If early results show clear advantages of a new drug, the sponsor of the study may choose to end the trial early and establish a protocol allowing wider use of the drug before final approval for marketing. If a drug is shown to have a strongly negative effect, the trial is stopped immediately. For example, in 1995, a trial of the drug tamoxifen (tamoxifen citrate) showed that the drug dramatically reduced the short-term risk of breast cancer. The DSMB and the researchers assessed the data and halted the trial so that the results could be made widely available and all women in the trial could have the opportunity to take the drug. Researchers submitted a new application to FDA, which expedited its review status. The new application was the basis for FDA approval of tamoxifen for reducing breast cancer risk.
Office of Human Research Protection OHRP Regulations Office of Human Research Protection protects those participating in research and provides leadership for all Federal agencies that carry out research involving people. The OHRP enforces important regulations for participant protection in clinical trials called the Common Rule. These regulations set standards regarding the: • Informed consent process • Formation and function of IRBs • Involvement of prisoners, children, and other vulnerable groups in research
FDA Regulations FDA enforces another set of regulations on participant protection in clinical trials. It concerns any clinical trial that involves an FDA-regulated drug or device, regardless of whether the trial receives Federal funding. FDA periodically inspects IRB records and operations to certify the adequacy of approvals, participant safeguards, and conduct of business.
FAQ
- Can a person be put in a clinical trial without his or her knowledge?
No ! The researchers running the trial are required by law to present and explain the study as part of the informed consent process. This process includes: • Signing an informed consent document (so that people know they are entering a study); • Discussing with the research team what the trial entails; • Understanding the potential risks and benefits of participating
Although reputable researchers do not fool people or sign them up against their will, sometimes people have difficulty understanding the information they need to know about a trial before agreeing to join. For many people, it is important to ask a friend or family member to come with them to be sure that all important questions are raised. Taking notes or using a tape recorder can also help.
- If someone is in a phase 3 trial and it is found that there is a clear advantage for the participants in the other group, what happens?
The DSMB would report the information to the study sponsor. If early results show that there is a clear advantage for one of the groups, the sponsor may choose to end the trial early and establish a protocol allowing wider use of the drug before final approval for marketing.
- What happens if someone wants to stop participating in a trial?
Under the informed consent process, a person has the right to discontinue their participation in a trial at any time. A participant’s decision to leave a clinical trial does not jeopardize future treatment, and the participant will have the chance to discuss other treatments, or care with a doctor from the trial.