Attention to impeccable ethical standards is mandatory for all clinical research, especially research involving human individuals. The ethical landscape associated with clinical trials can be particularly nuanced and complicated. As such, researchers have a fundamental duty to safeguard the welfare of study participants and conduct research with risks that are proportional to the expected benefits.
The scientific question of interest must justify the risk or need for a clinical trial. Equipoise is the concept that a clinical trial is needed due to the collective uncertainty about the superiority of one treatment vs an alternative.1 While equipoise may not be present at the individual practitioner level, equipoise to justify a clinical trial must exist at the collective level among experts in the medical community with respect to the treatments being compared. The clinician should always be aware of their potential role as a double agent—that is, both researcher and treating health care professional. At times there may be a conflict between patient care and the needs of the trial. In all instances, the needs and care of the patient or trial participant must predominate. All human individuals in clinical trials have certain rights, including the ability to discontinue the clinical trial and continue with standard of care treatment, privacy and confidentiality, and informed consent. Informed consent must include not only the patient’s permission, but also assurances that the individual understands all the risks and benefits. Informed consent should include disclosure (ie, discussion of relevant and germane information such as risks and benefits), confirmation of patient understanding (ie, a probative question-and-answer period to ensure the patient has achieved thorough understanding), and patient decision-making (ie, patient analysis of the information and discussion of goals, potential outcomes, and ultimately the choice to participate or not).2 From a practical perspective, information required in a consent document should include the nature of the research, its purpose, and alternatives to participation in the study. To verify that consent is given voluntarily, the conditions under which it is obtained should be free of undue influence.1 As such, the person obtaining consent should not be the patient’s treating physician; rather, an objective third party who is knowledgeable and involved with the trial is generally best to discuss the trial and obtain consent. Deferred consent—whereby patients are enrolled first and then asked to provide informed consent later—may be allowed under specific conditions. Specifically, deferral of consent to participation in a study is permitted to avoid delaying emergency interventions; however, in such cases, proxy consent is preferred and should be sought. Children younger than 18 years are generally not permitted to give consent for medical procedures and treatments. Rather, parents are typically the primary decision-makers for their children. Children who are old enough to understand medical discussions should be asked to give assent for care. Assent means that the child is agreeing to the treatment or procedure. Children being asked to participate in a clinical trial should have the research and treatment as well as risks and potential benefits explained to them and their parents.