Informed Consent for clinical trials

About 3% of the US population participate in Clinical Trials. Also, new treatments or interventions under study are not always better than, or even as good as, standard care. Even if a new treatment has benefits, it may not work for every patient. In addition, health insurance and managed care providers do not always cover clinical trials. It is therefore essential for patients to understand all the risks involved in a clinical trial before being a part of it. The FDA requires that all subjects of a clinical study sign an informed consent before starting the clinical trial.

Informed Consent (21 CFR Part 50) is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to participate in the study. The basic elements of an informed consent are:

1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject.
4. Disclosure of appropriate alternative procedures or courses of treatment.
5. A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

The FDA follows strict regulations for clinical trials. No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject.