Biopsies from Healthy Volunteers to Advance Precision Medicine
NEJM: Paul L. Kimmel, M.D., and David S. Wendler, Ph.D
The New England Journal of Medicine has published an unusual Op-Ed (Kimmel & Wendler) discussing the ethical and scientific considerations of obtaining tissue biopsies (even renal biopsies) from healthy volunteers to advance precision medicine. This approach aims to compare healthy tissue with tissue from patients to gain insights into various diseases.
The article highlights the importance of ethical safeguards and IRB (Institutional Review Board) approval when considering such research. While obtaining research tissue from patients is more common, the article argues that obtaining tissue from healthy volunteers may be ethically acceptable, particularly when risks are low and the study has substantial social value. It emphasizes the need for careful risk assessment, informed consent, and compensation for research-related injuries in high-risk studies.
Overall, and not surprisingly, the article suggests that research procedures involving healthy volunteers require very careful evaluation and ethical analysis.