After several delays, the new regulations that govern human subjects research will go into effect on January 21, 2019. The following are the elements of the Final Rule that will most affect the Princeton research community:
- The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
- Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
- The expansion of exempt categories of research based on the level of risk they pose to participants. It is important to note that exempt studies are human subjects research and require IRB approval before implementation.
Research Integrity and Assurance has revised its website to provide guidance on the Final Rule.