Discussion of the ethical considerations related to non-therapeutic research biopsies that are becoming a common mandatory component of some clinical trials. As the scientific value of tissue has expanded, it has become increasingly common for clinical trials to require research subjects to also agree to undergo research biopsies, with known risks, and no expectation of direct benefit. As this practice has increased, some have questioned whether this practice is ethical, and identified recommendations for how to improve the ethical conduct of such studies. This session is pre-recorded.
Learn about the current practice of requiring mandatory, non-therapeutic research biopsies as a condition of participation in a clinical trial.
Discuss the ethical concerns raised by such mandatory research biopsies
Identify the relevant regulatory provisions that IRBs should consider when reviewing such studies