In assessing the various suggestions and recommendations presented in the report entitled "NIH Initiative to Reduce Regulatory Burden" and after consideration of public comment on the report, a number of activities were identified from the report that the NIH could readily commit to pursuing in the immediate future. These activities lent themselves to immediate action and in addition, were selected because their promise in reducing regulatory burden for the research community, while continuing to provide the intended protections, was significant. A near-term plan was posted on September 14, 1999. At that time, we indicated that as these activities got underway, it was expected that additional ones would be identified from the report and considered for implementation. This update details our continuing progress.

Table of Contents:

• Human Subject Protection
• Animal Welfare
• Conflict of Interest
• Hazardous Waste Disposal
• Research Integrity
• NIH Advisory Working Group on Regulatory Burden

Human Subject Protection

1. The NIH has announced that it is providing greater flexibility to institutions regarding the timing of IRB approval for human subjects protocols in grant applications. While no grant award can be made without IRB approval, the current policy requiring IRB approval prior to peer review is being modified to permit IRB approval when the applicant is notified that their application is in the fundable range.



2. OPRR has been meeting regularly with FDA in an attempt to reconcile, within the constraints of their respective statutory mandates, any conflicting regulatory or policy guidance. Significantly, OPRR has recently harmonized its policy with that of FDA to permit the convening of IRB meetings via telephone conferencing. This new policy is expected to reduce burden greatly for IRBs with members at remote locations.
   
   The NIH has recently published guidance in the NIH Guide for Grants and Contracts (6/11/99) to promote more efficient and effective reporting to IRBs of adverse events in multicenter clinical trials. This issue is also a concern for FDA, which is in the process of developing Agency policy in this area. OER will continue to consult with FDA to ensure that the research community receives reasonable and consistent guidance on adverse event reporting.
   
   OPRR and FDA have expanded significantly the categories of research that IRBs can review utilizing expedited procedures. OPRR has begun to work with FDA and the Federal Policy (Common Rule) Agencies to develop and propose regulatory changes that would permit flexible timing of continuing IRB review, more flexible use of expedited IRB review procedures, and designation of additional exemption categories.



3. Two professional organizations interested in human subject protection, Public Responsibility in Medicine & Research (PRIM&R) and the Applied Research Ethics National Association (ARENA), have sponsored several meetings with representatives of OPRR, FDA, and the research community to explore the possibility of a third-party accreditation program for institutional human subject protections. PRIM&R and ARENA intend to develop a program that would be patterned after the AAALAC animal welfare accreditation program. In an independent effort, it is anticipated that the Institute of Medicine will propose development of its own performance standards for human subject protections.
   
   OPRR continues to consult with organizations interested in developing human subject protection accreditation programs. OPRR's goal is to foster development of a viable accreditation program that genuinely strengthens the protection of human subjects while reducing regulatory inefficiencies. OPRR recognizes that a successful accreditation program must incorporate meaningful outcome measures. Such measures must be developed through consensus building within the human subject protection community. OPRR has begun working with interested organizations to begin developing such a consensus.



4. OPRR has hired three professional staff and one program assistant exclusively for education activities. The Human Subjects Associate Director for Education (HSADE) has developed and begun to implement a program of educational outreach visits to awardee institutions and national professional organizations. Contacts have been established with organizations interested in developing "best practices" guidelines and dialogue has continued through Spring 2000. The first of a series of web-based tutorials has been drafted for on-line testing. Spring 2000 activities also include work on long-range projects such as revising the OPRR Institutional Review Board (IRB) Guidebook, updating the OPRR training videos, expanding the OPRR website, and increasing contacts with the smaller HHS Agencies.
   
   OPRR has recently prepared internal guidance on (i) IRB knowledge of local research context, (ii) institutional engagement in research, (iii) engagement of the pharmaceutical industry in HHS-supported research, and (iv) IRB continuing review periods in order to ensure consistency in OPRR staff interpretation of regulatory requirements. Efforts were made during Fall 1999 and Spring 2000 to disseminate this guidance to the research community. Monthly meetings of OPRR's Division of Human Subject Protections staff continue to be held to address remaining areas of inconsistency. Additional guidance being developed relates to (i) conflict of interest for IRB members, (ii) qualifications and responsibilities of Assurance Signatory Officials; (iii) research involving prisoners; (iv) IRB review of applications for HHS support; and (v) IRB interaction with Data and Safety Monitoring Boards (DSMBs).
   
   Additional education efforts are being undertaken by a bioethicist recently hired in the NIH Office of Extramural Research (OER), who has already established a bioethics resources website at http://www.nih.gov/sigs/bioethics.



5. OPRR continues to work with the National Cancer Institute (NCI) to implement demonstration projects on "Central IRB Review." In the largest such project, the NCI Clinical Trials Evaluation Program (CTEP) has hired an IRB Administrator and finalized an IRB management contract in order to establish a Central IRB for use on a voluntary basis by CALGB institutions. A May meeting is scheduled to discuss the project with representatives of interested institutions.



6. OPRR recognizes the many inefficiencies of the current Assurance process and is committed to reduce regulatory burden in this area. To this end, OPRR has initiated redesign of the Assurance process as follows:

• Elimination of MPAs, CPAs, and SPAs in favor of a single simple format
• Elimination of all collateral Assurance documents (IIAs, AIIs, CAs, NIAs)
• Simplified format = 1-page text, component list, IRB roster(s), signature page
• Web-based tutorial for Signatory Official, IRB Chair, and IRB Administrator
• Elimination of OPRR review of Informed Consent documents
• Brief (1-page) electronic renewal at 3-year intervals