Primary Care Physician as Investigator

When the Primary Care Physician (PCP) also serves as the investigator in a clinical research study, special considerations arise. Patients have an ongoing relationship of trust with the PCP and may not exercise the same degree of independent judgment they would ordinarily in determining whether to participate in a clinical trial. In this context, certain measures may help to encourage the patient's independent consideration and to reduce the PCP's influence in recommending the study just by virtue of his/her participation therein. The best way to address this situation will depend on the investigator's office and the patient's own resources. These measures may include:

-- Having a friend or family member present during the informed consent process (ICP)

-- NOT having the PCP present during the ICP

-- Having the ICP be carried out by someone other than the PCP or a staff member dependent on the PCP

-- Having an independent witness to the ICP

The PCP's demeanor alone can influence a patient's decision. Patients should choose to enter a study on its own merits because they understand the risks and benefits (not simply because they value and trust the PCP's judgment). Please consider the options and decide how best to conduct the informed consent process.