NIH to Revisit Expanded Definition of Clinical Trial
The National Institutes of Health intends to issue a request for information by October 30 on its 2016 policy decision to expand the definition of a clinical trial to include basic studies involving human subjects. The action is in response to complaints from the basic research community, that its scientists did not have an adequate opportunity to weigh-in prior to implementation of the policy change, as well as to a congressional directive to delay particular aspects of implementation and gather input on alternatives. FSU will submit a response to the RFI. Examples and points to consider for the FSU response can be submitted to jnurse@fsu.edu.