According to the terms of voluntary withdrawal, the subject may withdraw from participation at any time during the research and the researcher may likewise remove the participant, for certain reasons. With this in mind, the researcher must balance the subject’s autonomy with his or her safety. Since the subject’s safety is paramount, if subject removal from the study is medically, emotionally, or psychologically indicated, the researcher is obliged to speak with the subject regarding the terms of withdrawal and then remove him or her from the study. If there are reasons why the investigator might remove a participant from a study (e.g., reaction to an investigational drug; nonadherence to terms of the research procedures; ingesting of substances not allowed by the protocol), these should be listed in the voluntary participation section of the consent form.
According to federal regulations, the subject should be informed about the consequences of his or her decision to withdraw from the research and must be provided with procedures for orderly termination of participation. Therefore, if medical care or follow-up psychological care (e.g., debriefing) is indicated irrespective of the reason for the withdrawal, the investigator should schedule the subject for these visit(s) and document the results in the research record. This follow-up should occur for the necessary duration. Depending upon the terms of the consent agreement and the study procedures, the consent form may state that the researcher will refer the subject to a practitioner who has the capability of treating him or her. Again, the consent form is the covenant with the subject; therefore, if the consent form states that the subject will be referred for further medical care, then a plan must exist for this to occur. In studies where further clinical care may not be necessary, the subject is usually referred to his or her primary health care professional for any medical concerns. Of course, if any of these concerns are of an emergent medical or psychological nature, the appropriate emergency procedures should take precedence.