The above history illustrates that the RCR policy fits into a pre-existing regulatory and policy framework that has been reaffirmed time and again by the research community. The PHS working group discussed various approaches to implementing the RCR education program, including whether to go through rulemaking, and opted to issue a PHS policy as it was a natural extension of the pre-existing RCR requirement for NIH training grants. 42 CFR ' 52.9. Moreover, by giving institutions broad discretion to determine how virtually every aspect of the educational program will be implemented, the RCR policy lacks the normative standards typically associated with a substantive rule. Institutions can use PHS resources to provide education or develop their own approach.
Institutions can decide whether to require recipients of instruction to demonstrate competency.
Institutions can even determine the method for documenting that the RCR instruction has taken place. As a result of the considerable leeway given to the institutions, we believed that the RCR initiative was appropriately considered a policy. Indeed, extensive efforts were made to ensure that the extramural research community had ample notice and opportunity to comment on the draft RCR policy. See 65 Fed. A request for comment was also posted in the NIH Guide for Grants and Contracts , the ORI website, and in a direct notice to almost 2000 research institutions.