Recently proposed changes to the “Common Rule” by the U.S. Department of Health and Human Services (HHS) and various other federal agencies, while aiming to enhance human subject protections for current and future research activities involving the ongoing storage and use of biospecimen materials, serve to de-incentivize the commitment to research by healthcare organizations.
The recommendations seek to provide better protections for human research subjects and to provide guidance on the facilitation of future biospecimen-related research activities. HHS details several significant changes to the Common Rule, including a requirement for “informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is.” The agency states that this will likely occur via a broad consent for future research, which it reports should represent an additional area of exempt research, thusly not requiring annual continuing review by an institutional review board (IRB).
Read full article in The Hill.