Competence of the Investigator

Related to the norm of good research design is the norm that the investigator should be competent. IRBs should determine that the investigators responsible for conducting clinical trials are qualified by background and experience to manage the diseases being treated and the treatment regimens being tested. This can be accomplished by confirming that the investigators have met the standards for competence established by national groups that certify medical specialists. For example, several years ago an investigator sought to undertake a study that involved the administration of insulin using an insulin pump. A review of the investigator's credentials revealed that he lacked board certification in the subspecialty of endocrinology and had no prior experience with the use of an insulin pump or with performing clinical trials. The IRB voted not to approve the proposal because of its concern that the investigator lacked the qualifications for overseeing the proposed study.

IRBs should also certify that the investigators do in fact practice in conformity with the standards of the specialty in which the investigators are members. This can be both a delicate matter for inquiry and difficult to do. The difficulty can arise from the fact that much of an investigator's clinical practice may occur in an office setting, a setting not ordinarily subject to hospital peer review. In order to fulfill their obligations to safeguard the welfare of prospective subjects of clinical trials, IRBs should inquire from others within the professional community whether a particular person is qualified to act as an investigator. This inquiry can be facilitated by asking the chairperson of the department to which the investigator belongs to confirm that the investigator is qualified to assume the responsibility to conduct the research.

In addition to certifying that investigators possess the necessary medical qualifications for conducting clinical trials, IRBs should ascertain that the investi gators manifest ''a high degree of professionalism necessary to care for the subject'' (35). This determination requires an inquiry into the relationship of the investigator to the prospective subjects. Investigators can relate to subjects in two capacities: as physician and as investigator. In the traditional physician-patient relationship, the physician's primary concern is the patient's welfare. The physician acts as the patient's friend or ''advocate'' and seeks to do that which is in the best interest of the patient. In the investigator-subject relationship, the investigator has a major interest in the furtherance of the research goals. A potential conflict exists in which pursuing the goals of the research may conflict with actions that promote a patient's welfare. Although the conduct of the research is ideally a cooperative venture between investigator and subject, the physician acting as investigator has a potential conflict of interest between his or her allegiance to the patient and to the goals of the research.

An example of this conflict is a clinical trial of a new antineoplastic chemo-therapeutic agent for the treatment of newly diagnosed, nonresectable, non-small-cell carcinoma of the lung confined to the thorax. The physician-investigator knows that radiation therapy is considered to be standard treatment for this disorder. However, such treatment is only rarely curative. More commonly it provides only partial, short-lasting control. He may agree that the proposed drug regimen is at least rationally based and merits testing. But he also knows that hitherto non-small-cell carcinoma of the lung has been relatively unresponsive to chemotherapy. In determining whether to proceed with radiation therapy or enlist his patient into the clinical trial, the physician has to balance his primary duty to act in furtherance of his patient's best interest against his desire to contribute to the generation of new information regarding the treatment of this disease. A potential conflict may arise that affects the recruitment by the physician-investigator of the patient-subject into the clinical trial and the ability of the latter to exercise free and informed choice with respect to his or her participation in it.

It is important, therefore, for IRBs to inquire into the sensitivity of investigators to the existence of potential conflicts of interest and to the manner in which these conflicts can be minimized or avoided so that the interest in the research does not override the interest of the patient-subjects.

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