Clinical Trials: How Are People Protected? What Is Informed Consent?

by Food and Drug Administration (FDA)

(Page 3 of 3)

How Are People Protected?

Most clinical trials are federally regulated with built-in safeguards to protect participants. Today, the Office for Human Research Protections (OHRP) in the Department of Health and Human Services (HHS) leads the department's programs for the protection of human research participants, and oversees human protection in HHS-funded research.

"It's important that we have the rapport with the public that allows them to trust us with this program," says Bernard A. Schwetz, D.V.M., Ph.D., acting director of the OHRP. He adds, "Without people willing to participate, there won't be any clinical trials."

The FDA has authority over clinical trials for drug, biologic and medical device products regulated by the agency. This authority includes studies that are HHS-funded (with joint oversight by the FDA and the OHRP), as well as studies that are solely funded by industry or by private parties. Many clinical trials are not subject to FDA regulation but are monitored by the institution sponsoring the trial, such as a hospital.

To help protect the rights and welfare of volunteers and verify the quality and integrity of data submitted for review, the FDA performs inspections of clinical trial study sites and anyone involved in the research, says David A. Lepay, M.D., Ph.D., director of the FDA's Good Clinical Practice Program. Lepay says that the quality of clinical trials has improved markedly since the agency started inspecting them back in 1977.

"Between FDA, the help of other government agencies, the review by Institutional Review Boards, the required monitoring of studies by industry or private sponsors, and the required oversight and reporting by investigators and their staff," Lepay says, "a lot of people are looking out for the research subject's safety."

What Is Informed Consent?

The FDA requires that potential participants be given complete information about the study. This process is known as "informed consent," and it must be in writing.

The informed consent process provides an opportunity for the researcher and patient to exchange information and ask questions. Patients invited to enter a trial are not obligated to join, but can consent to participate if they find the potential risks and benefits acceptable. A consent form must be signed by the participant prior to enrollment and before any study procedures can be performed.

Participants also have the right to leave a study at any time. At the same time, people need to know that circumstances may arise under which their participation may be terminated by the researcher, without their consent.

For example, Schwetz says that sometimes it becomes evident early on that a trial is not working and researchers know they are not going to get enough meaningful information to make continuation worthwhile. In addition, if an unexpected change occurs in the health status of a participant, such as toxic effects or sudden kidney problems that may have developed, it "would not be in the best interest of the patient to continue, and certainly not consistent with what the investigator is trying to study," he says. In any case, the circumstances must be described in the consent document.

Where To Get Information on Clinical Trials

It is often difficult for patients to learn about opportunities to participate in clinical trials. Doctors and patient advocacy groups can be valuable resources for patients in search of clinical trial information. Newspapers, particularly in large cities, often carry clinical trial recruitment advertisements. A call to the relevant department at nearby university medical centers can lead to information about clinical trials currently recruiting patients.

The Web site ClinicalTrials.gov also provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The NIH, through its National Library of Medicine, has developed this site in collaboration with all NIH institutes and the FDA.

The site currently contains information on about 8,200 clinical studies sponsored by the NIH, other federal agencies, and the pharmaceutical industry in over 99,000 locations worldwide. Studies listed in the database are conducted primarily in the United States and Canada, but include locations in about 90 countries. ClinicalTrials.gov gives information about a trial's purpose, who may participate, locations, and phone numbers for more details. In addition, a glossary is available that will help people become familiar with the most common clinical trial terms.

The Bottom Line

While it's true that clinical trials offer no guarantees, when standard treatments fail, or none exist, clinical research trials sometimes can offer hope. People can reduce the confusion and uncertainty that often comes with deciding whether or not to participate in a clinical trial by obtaining all the information available on various Web sites, through phone calls, within FDA, HHS, and NIH offices, and from patient advocacy organizations.

The bottom line: Know and understand the different types of trials, which questions to ask, and your rights as a trial participant. Find out what risks there may be, and determine what level of risk you are willing to accept before you agree to enroll in a clinical trial for medical research.

Institutional Review Boards

Clinical trial procedures are reviewed by Institutional Review Boards (IRBs). These boards are composed of at least five members that include scientists, doctors and lay people, and they must approve every clinical trial taking place within their jurisdiction — usually a hospital. The purpose of an IRB review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IRB will not approve the research or it will specify changes that must be made before the research can be done.

IRBs also review participant inclusion and exclusion requirements to be sure that appropriate people have been identified as eligible for the trial. They often look at how and where recruitment for clinical trials will occur. IRBs review the adequacy of the informed consent document to ensure that it includes all the elements required by law, and that it is at an appropriate reading level and understandable to study participants.

Information Required for Informed Consent

The FDA requires that people be told:

• That the study involves research of an unproven drug, biologic (such as a vaccine, blood product, or gene therapy) or device
• The purpose of the research
• How long the participant will be expected to participate in the study
• What will happen in the study and which parts of the study are experimental
• Possible risks or discomforts to the participant
• Possible benefits to the participant
• Other procedures or treatments that might be advantageous to the participant instead of the treatment being studied
• That the FDA may look at study records, but the records will be kept confidential
• Whether any compensation and medical treatments, if any, are available if the participant is injured, what those treatments are, where they can be found, and who will pay for the treatment
• The person to contact with questions about the study, participants' rights, or if the participant gets hurt
• That participation is voluntary and that he or she can quit the study at any time without penalty or loss of benefits to which the participant is otherwise entitled.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.