Legal and Ethical Considerations in Forensic Pathology Research

Abstract

A robust legal and ethical framework for biomedical research has developed with regard to living subjects. This framework applies incompletely to research on autopsies, particularly medicolegal autopsies authorized by law rather than the consent of the next-of-kin. Many patient rights extinguish at death. No traditional physician-patient relationship exists with regard to the pathologist and an autopsied body. U.S. federal biomedical research regulation, the “Common Rule”, is specifically limited to living human subjects. Nonetheless, it may be wise to obtain consent of the next-of-kin for research involving tissues, invasive procedures, and family interviews, unless an Institutional Review Board waives the requirement due to “minimal risk” of harm. Similarly, privacy laws and regulations may not apply fully, but maintenance of confidentiality and anonymization of data may be prudent. Compliance with other research concerns, such as avoidance of conflicts of interest, “good laboratory practice”, and adherence to ethical norms are important. We recommend legislation to clarify and facilitate research in forensic pathology.