Case Study - Ethics in Clinical Research
Note: This should be a discussion. Do not just say, I agree or good post, etc - That would not be a discussion.
Refer to the article: What Makes Clinical Research Ethical and the Handbook for GCP to answer this discussion prompt.
Case: SM (patient's initials) is a 46 year old post-menopausal mentally disabled woman with lobular carcinoma in situ (LCIS). The caregivers from her group home with power of attorney for health care decisions, bring her to the clinic for enrollment in the STAR (Study of Tamoxifen and Raloxifene) trial, a randomized trial of tamoxifen v. raloxifene for the prevention of breast cancer in high risk women. SM fulfills all entry criteria but cannot provide informed consent (due to her mental disability). The physician who saw SM wants the IRB to reconsider the subject selection criteria for the STAR trial. The IRB debates the question: Is it ethical to enroll a mentally incompetent patient in a Phase III randomized chemoprevention trial?
Original post: You are on the IRB that is considering the doctor's request to reconsider the subject selection criteria for the STAR trial. Discuss the ethical concerns with enrolling SM in the trial.