The tasks and responsibilities of a treating physician are different from the responsibilities of an investigator, who is also a physician. The physician takes care of the patient, the investigator needs the cooperation of the subject for his/her research.
Clinical research distinguishes two situations:
- the investigator is also the treating physician of the patient/subject. In this situations the tasks and responsibilities of both functions come together in one person. From a medical-ethical point of view, this is not considered an ideal situation. It is possible that the benefit of the research does not coincide with the benefit of the patient. This dilemma may occur when selecting subjects or whether or not continued participation of the subject is in their best interest. The METc is of the opinion that, in principle, the roles of investigator and treating physician should not be carried out by a single person. However, in practice this principle is not always feasible. In this situation the treating physician/investigator should describe how the benefit of the patient is safeguarded. Of course, the head of the department has the general responsibility for the wellbeing of the patients in his/her department.
- the investigator is not the treating physician of the patient/subject. This prevents a possible conflict of interest. The investigator does need the cooperation of the treating physician for the recruitment of subjects. The physician should permit the participation of his/her patient in the research. The physician will establish contact between the investigator and the potential subject. Coordination between the physician and investigator is required.
In both situations article 9 of the WMO states that the subject should be able to contact an independent expert for information or advice. This independent person is not involved with the trial otherwise. The subject can ask the independent expert questions they would otherwise not ask the physician-investigator
The (contact) details of the independent expert must be listed in the subject information sheet (art. 11 WMO) and the clinical trial protocol.