Is Off-Label Use “Human Experimentation” Such That It Triggers Human Subjects Protections?
In some cases, off-label use might seem to be human experimentation: The physician has no hard evidence that the product is safe and efficacious for the intended use but, based on an educated guess, decides to try it and see. The question is whether this triggers the elaborate safeguards designed to protect human subjects in medical investigations, including the need to obtain the approval of an institutional review board (IRB). In a 1998 article in the Food, Drug Law Journal, two lawyers who represented manufacturers of pedicle screws in products liability litigation argue that it does not.1 Citing the 1978 Belmont Report and other classic formulations of medical ethics, Beck and Azari point out that there is a distinction between research and therapy and make it sound like the distinction is clear. According to Beck and Azari, the key is the physician’s intent: If the intent is primarily to benefit the patient, the intervention is therapy. If the intent is solely to test an hypothesi
Related Questions
- How will the Office for Human Research Protections (OHRP) respond to queries from an FWA institution about human subjects research conducted or supported by a non-HHS department or agency?
- When does a research institution need to be covered by an assurance of compliance with human subjects research protections?
- Who does not need to complete training in human subjects protections?
