Voluntary Participation

This section of the consent form should begin with a statement that participation in the research project 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 he or she is otherwise entitled. This section may also include anticipated circumstances under which the subject’s participation may be terminated by the investigator without the subject’s consent, e.g., when the subject’s best interest warrants or for other reasons such as termination of the protocol. For a protocol involving a drug or therapy, the subject must be advised as to any procedures, tests, or tapering of medications that may be necessary prior to or at the time of withdrawal from the study. This is called orderly termination. If, after the orderly termination procedures are completed, the subject’s medical condition requires treatment or care that the investigator cannot provide or that the individual does not wish the investigator to provide, then the physician-investigator has the duty to assist the subject in finding the appropriate health care. In addition, the subject should be told that he or she will be informed of any new findings that might relate to his or her willingness to continue participation. These assurances are particularly important when the subject is in a subordinate, or what might be considered a vulnerable position, with respect to the researcher, e.g., when a protocol involves a physician-investigator and a terminally ill subject. In this case, the subject should be assured that he or she will continue to receive all supportive and palliative therapies whether or not he or she participates in a particular study for the terminally ill. A general statement about the conditions for terminating the entire study should also be included in this section of the consent form.