Informed Consent

Informed consent is a process whose purpose is to provide information to potential study subjects to enable these individuals to make an informed decision as to whether or not to participate in a research study. It also ensures that a subject’s rights are protected and that subjects understand that participation is voluntary. An investigator may not involve an individual in a clinical study without first obtaining an informed consent from the individual. Informed consent is a part of the recommendations included in procedures required to ensure subject safety in clinical trials. This was described in a set of ethical guidelines for the conduct of research on humans. This was first agreed to in 1964 by the World Medical Association in Helsinki, Finland, and was part of the Declaration of Helsinki.

There are conditions of informed consent. An individual must be given sufficient opportunity to decide whether to participate, without undue pressure or influence from the investigator. Informed consent may be obtained from an individual study participant or a legally authorized representative. If informed consent is to be obtained for the participation of a minor, the minor’s consent must be obtained in addition to the informed consent of the minor’s legal guardian. Informed consent must also be obtained before entry into a clinical trial or before procedures are to be performed. The language that must be used to obtain informed consent must be understandable. This entails that the language be in layperson’s terms. On the informed consent document must appear the signature of the subject or representative, witnessed by the clinical trial personnel. A copy of the informed consent document should be given to the subject.

The process of obtaining informed consent has several basic elements. First, it requires a statement that the study involves research, an explanation of the purposes of the research, the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental. Second, informed consent should have a description of any reasonably foreseeable risks or discomfort to the subject. Third, there must be a description of any benefits to the subject or to others that may reasonably be expected from the research. Next, there should be a disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject. Then, informed consent should include a statement regarding the extent to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records. Moreover, for research involving more than minimal risk, there should be an explanation regarding compensation and an explanation as to whether medical treatments are available if injury occurs and, if so, of what they consist or whether further information may be obtained. In addition, informed consent should provide an explanation of who is to be contacted for answers to pertinent questions about the research and research subject’s rights, and in the event of a research-related injury to the subject. Last, a statement should be included specifying that participation is voluntary, refusal to participate is allowable without penalty or loss of benefits to which the subject is entitled, and a subject may discontinue participation in the study at any time with impunity and without loss of benefits to which the subject is entitled. Informed consent is a vital part of the research process. It protects the rights of research subjects, and it allows them to question “what they’re getting into.” Informed consent procedures help ensure that subjects are treated in an informative and humane manner while they undergo a research study.

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