The FDA has released for comment a draft guidance about the inclusion of research-specific biopsies in research. The draft guidance addresses the issues of risk v. benefit and informed consent, and outlines the differences between adult and minor patients when it comes to research-specific biopsies. It outlines some of the considerations investigators and IRBs must take into account when proposing and reviewing research involving biopsies. Comments on the draft guidance will be accepted through March 10.
While this is only a draft guidance, the principles it outlines related to risks and informing participants are applicable to many different kinds of research.