This document provides an ambitious list of issues and potential solutions that would reduce regulatory burden. This burden is real and relieving it will not be easy. It is the result of multiple and systemic factors that are listed above. A successful program of streamlining will require the leadership of the Federal agencies and a partnership with the research institutions to collaboratively develop solutions that enhance program objectives. There is an enormous reservoir of talent within the research institutions that is willing to be tapped to assist in this effort. In addition, there is enthusiasm that the time is right for this initiative, particularly given the commitment of NIH and the Congressional interest. The willingness of members of the community to participate in this initial effort has been noteworthy, and is an indication both of their frustration with the existing burden and their desire to constructively contribute to the solution.

NIH should designate an individual, or an Office, outside of the offices currently administering these regulations, to coordinate this overall effort to reduce regulatory burden. This would provide a continuing focal point for this effort within NIH and would provide a contact point for the research community. It would also ensure continuing coordination with the Congress and the Executive Branch. It would also be useful to establish an advisory committee or identify a group of advisors drawn from the research community to be advisory to the overall effort. This would also assist in focusing continuing attention on this issue, would draw on the expertise of knowledgeable members of the community, and would provide additional credibility for this initiative. Ultimately, if it is to be successful, it will require a concerted effort, not only by NIH and the research community, but also by other Federal agencies, the Executive Office, and the Congress. It is a difficult undertaking but substantial opportunities exist for short-term and long-term benefits to the research mission through successful implementation.