Strengthening Institutional Review Board Review of Highly Innovative Interventions in Clinical Trials
- Bernard Lo, MD;
- Deborah Grady, MD, MPH
- Author Affiliations: Program in Medical Ethics (Dr Lo), Department of Medicine (Drs Lo and Grady), and the Eli and Edythe Broad Center for Regeneration Medicine and Stem Cell Research (Dr Lo), University of California, San Francisco.
Since this article does not have an abstract, we have provided the first 150 words of the full text.
- KEYWORDS:
- ACADEMIC MEDICAL CENTERS
- ADVERSE REACTION
- CLINICAL TRIALS AS TOPIC
- ETHICS COMMITTEES, RESEARCH
- ETHICS, MEDICAL
- GOVERNMENT REGULATION
- NATIONAL INSTITUTES OF HEALTH (U.S.)
- PATIENT SAFETY
- RESEARCH SUBJECTS
Highly innovative approaches to disease treatment offer hope for therapeutic breakthroughs but also may cause serious unexpected adverse effects. For instance, repeated transplantation of neural stem cells resulted in multiple donor cell tumors,1 and gene transfer using retrovirus vectors caused T-cell leukemia.2 Such interventions can be considered to be highly innovative because the biological mechanisms are not fully understood, animal models do not reliably predict human effects, adverse effects cannot be minimized by starting with a low “dose,” and the interventions have never or only rarely been previously used in humans.3
Opportunities to Protect Research Participants
Even after the design of a clinical trial of a highly innovative intervention has received regulatory approval, protection for study participants can be significantly strengthened. In a phase 1 trial of a monoclonal antibody that activates CD28 receptors on T lymphocytes, all of the first 5 participants who were administered the antibody simultaneously developed immediate life-threatening …
