Physician response to informed consent regulations for randomized clinical trials

Area of Science:

• Medical Ethics
• Clinical Trial Management
• Oncology

Background:

• Physician participation is crucial for randomized clinical trials (RCTs).
• Understanding physician reluctance to join RCTs is essential for trial success.
• Informed consent regulations may influence physician participation and practice.

Purpose of the Study:

• To investigate physician perspectives on written informed consent regulations.
• To identify factors contributing to physician reluctance in participating in clinical trials.

Main Methods:

• A purposive sample of 170 breast cancer specialists (medical oncologists, surgeons, radiotherapists) from eight countries was surveyed.
• Data collection occurred between June 1984 and February 1985 using self-administered questionnaires and follow-up interviews.

Main Results:

• Physicians perceived informed consent regulations as incompatible with their professional identity.
• Respondents reported a loss of autonomy and increased accountability due to these regulations.
• Informed consent procedures were seen to alter physician communication and the doctor-patient relationship in trials.

Conclusions:

• Physician reluctance in clinical trials may stem from perceived conflicts with professional roles and autonomy.
• Physicians develop coping mechanisms to reconcile informed consent requirements with their practice.
• Addressing physician concerns regarding informed consent is vital for enhancing clinical trial participation.