The National Institute of Health (NIH) defines a clinical trial as a biomedical or behavioral research study of human subjects designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, and devices.)
The FDA and the Office of Human Research Protection (OHRP) regulate clinical trials. An Institutional Review Board (IRB) reviews study-related documents, including protocols, informed consent forms, and physicians’ credentials. Clinical trials must past a vast number of examinations before they are allowed to commence, which lessens the chance of adverse effects.
Informed consent must include diagnosis of the patient’s condition, nature and purpose of the proposed treatment, risks and consequence of the treatment, probability of success, feasible alternatives, discussion of confidentiality, prognosis if treatment is not given, and a statement that participation is voluntary and may be discontinued at any time. Informed consent must be written in a language understood by the subject, and must be provided in writing.
According to the NIH, “Generally, today, regulatory requirements for informed consent in federally-funded and FDA-regulated research overlap with the elements for a legally effective consent.”
Unfortunately, some research has shown that the informed consent process is flawed. For example, studies have found that some participants are not aware they are involved in a research study, and many did not understand the informed consent form they signed. Another flaw in the system is when physicians recruit their ill patients for a research study, who in turn believe that the treatment will be a definite benefit to them.
In order to have a clinical trial, the FDA mandates that good clinical practices (GCP) and adequate human subject protection (HSP) be provided. Some regulations of GCP include electronic records, informed consent, financial disclosure by clinical investigators, and premarket approval of medical devices.
The Office of Good Clinical Practice is a part of the FDA. Its functions include leading the FDA’s Human Subject Protection/Bioresearch monitoring Council and assisting the Commissioner on GCP and HSP issues arising in clinical trials.
The FDA website also has a section on “Reporting Complaints,” and has separate phone and fax numbers for biological studies, drug studies, and medical device studies.
The Office for Human Research Protections (OHRP), a part of the Department of Health & Human Services, reviews compliance with federal regulations of human subject protection in research done by the DHHS.
The DHHS has a department called the Office of Research Integrity, which handles research misconduct and regulation.
Institutional Review Board
An Institutional Review Board (IRB) is mandatory under the FDA for every clinical trial. The IRB approves the protocol for the clinical trial and periodically reviews it to ensure human rights and welfare are being protected. The IRB reviews the informed consent documents and brochures of the clinical trial, and may make clinical site visits to determine if the studies are in compliance with regulatory requirements. However it is important to note that the FDA does not address IRB liability in the case of malpractice suits.
The FDA and Department of Health and Human Services regulate the structure and duties of IRBs. For example, “each IRB must be composed of at least five members with diverse cultural and ethnic backgrounds, and both men and women should be included.” At least one member must have a principal concern of science, and at least one member should have a nonscientific expertise. IRBs must monitor the trial at least once a year, or more if the risks are severe.
The IRB must ensure 1) risks to participants are minimized; 2) risks to participants are reasonable in light of anticipated benefits; and 3) selection of participants is equitable.
About fifteen states now have state regulation of clinical trials, requiring registration and disclosure of the trials. Maine has also adopted two laws regarding pharmaceutical research that prohibits pharmaceutical companies from advertising their drugs unless they have disclosed clinical trial information to the state health department.
In order to be given the “green light” by the FDA, companies wanting to run clinical trials must provide data saying the product’s benefits intend to outweigh potential adverse results, and that good clinical practices will be in place. However not all trials result in a new drug or treatment, as some clinical trials do not demonstrate a positive reaction. Even fewer studies result in harm to the human subject, but the informed consent clause usually protects pharmaceutical companies in that case. Federal and State regulations are in place, and are continuing to be implemented, to lessen negative effects of clinical trials.