Informed Consent, The Cancer Patient, And Phase I Clinical Trials

Abstract

The concept of informed consent, which acknowledges the rights of patients to voluntarily participate in health care, applies both to clinical practice and clinical research.^1,2 Informed consent in clinical research is related to, but recognized as being more stringent than, informed consent outside the context of clinical trials.³ This heightened consent standard exists for at least two reasons. First, from an ethical perspective, a patient considering clinical trial participation is always viewed as potentially vulnerable.⁴ As a result of this potential vulnerability, he or she may have great difficulty in appreciating the differences between the therapeutic and research aspects of a given alternative of care or treatment. Without this distinction, patients cannot make uncoerced and autonomous health care decisions. Thus, the informed consent process, and the ethics of clinical research, require that such a clear distinction be made.^5,6 Second, the physician-investigator is seen as having an intrinsic conflict of interest in their role both as a physician for an individual patient and as a scientific investigator attempting to develop improved methods of medical care and treatment.^3,4,7 Within the sole context of a therapeutic relationship, the physician places his or her patient’s interests above all else.⁸ However, within the context of clinical research, an investigator has additional interests which may not be relative to their patients’ interests.^{9,10,11,12,13} From an ethical perspective, many concerns exist about the ability of clinical investigators to provide the requisite information to patients regarding participation in research in such a way that allows patients to recognize the distinction between research and therapy.^6,14,15