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ARCHIVED - REGULATORY BURDEN
JUNE 2000 UPDATE


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

  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

Animal Welfare

  1. Following discussions with USDA and AAALAC in August 1999 regarding the possibility of developing a common annual modular reporting form, and more recent discussions with AAALAC, OLAW determined that due to the significant differences in the information required by the different annual reports, it is not practical to develop one form. However, OLAW has developed and posted an annual report resource page that includes explanations of the reporting requirements and links to further guidance and to the Web-based versions of the reports.


  2. To facilitate OLAW's ability to communicate timely information about the PHS Policy and OLAW's educational efforts, OLAW has developed a LISTSERV that will be used exclusively for OLAW announcements. Members of the community are presently signing up to receive such announcements.


  3. A notice was published in the NIH Guide for Grants and Contracts to inform institutions that they may take advantage of the existing option to synchronize reporting periods and dates so that reporting is concurrent for OPRR, USDA and AAALAC.


  4. In order to make searching for alternatives in the Medline database easier and more productive for researchers and IACUCs, OLAW commissioned the National Library of Medicine to hold a meeting of an ad hoc Advisory Group on Animal Use Information. The group met on April 11 and recommended a number of journals for indexing and the addition of new MeSH terms for Medline, and discussed the possibility of developing alternatives search filters.


  5. Johns Hopkins University is nearing completion of an OLAW-sponsored user-friendly, web-based search engine to make database searches for alternatives more efficient and effective. One of the contract terms is that searches done with the final product must satisfy the USDA Policy 12 requirements.


  6. OLAW is actively planning two meetings for the expressed purpose of improving dialog with institutional representatives and the research community. One will be a workshop on the public policy implications of proposed new USDA policies, coordinated with ILAR; the other will be a meeting in conjunction with AAALAC.


  7. The Office of Laboratory Animal Welfare (OLAW) concurs that improved communication with institutional representatives and the research community is essential in the formulation and interpretation of policies and guidelines. The establishment of an NIH advisory committee is a long-range consideration. More immediately, OLAW staff regularly attend meetings of non-government organizations, including ILAR and AAALAC, to further this dialogue. OLAW has completed a number of similar activities during the Winter and Spring, such as educational workshops throughout the country, presentations at professional society meetings, and participation in a variety of other meetings with government and non-government entities, including:

January 27 - National Center for Research Resources Council

February 9-11 - OLAW-sponsored Educational Workshop with AALAS and the University of Florida

February 17 - OLAW meeting with AAALAC and Scientists Center for Animal Welfare

February 23 - IRAC meeting

February 28 - ALTWEB Project Team

February 28 - Preceptor program for USDA VMOs in conjunction with AAALAC, ILAR and NABR

March 7 - USDA public meeting

March 11 - IACUC 101 Educational Program

March 12 - ARENA meeting

March 13-14 - PRIM&R meeting

April 5 - IACUC Guidebook Editorial Committee of ARENA

April 22 - NLM meeting of the ad hoc Advisory Group on Animal Use Information

Conflict of Interest

  1. As recommended in the report, the NIH will issue a policy statement reaffirming the complementarity of the Conflict of Interest regulations and the Bayh-Dole Act. This will be done as an amendment to the NIH Grants Policy Statement and announced in the NIH Guide for Grants and Contracts, after consultation on appropriate language with staff of the Office of General Counsel. This policy statement has been drafted and is currently undergoing internal clearances.


  2. The NIH has encouraged, supported and participated in conferences and workshops organized by the NIH and/or research community to elucidate more clearly the Conflict of Interest regulations, and to disseminate "best practices" throughout the community. In the first half of calendar 2000, presentations have been made in: Austin, Dallas and Fort Worth, TX; Hyannis, MA; Baltimore, MD, Asheville, NC; Omaha, NE; Hawaii; Virginia Beach, VA; Washington, DC; and Kansas City, MO. Presentations are planned for the second half of the year in Washington, DC; Ithaca, NY; Las Vegas, NV; and St. Louis, MO. Such presentations continue to be a regular part of the NIH regional seminars.


  3. The NIH has implemented a proactive grants compliance program that has as its goals increased educational outreach, enhanced administrative oversight of sponsored research, and renewed institutional commitment to compliance. The program began with a series of proactive compliance site visits (formerly referred to as "not-for-cause site visits") to NIH-funded institutions, to review institutional understanding of and compliance with a range of NIH rules, regulations and guidance, including the PHS regulations relevant to research investigators' financial conflicts of interest. (See the NIH News Release of Tuesday, March 7, 2000.) Three visits are completed and seven more are scheduled to be made before October. During the visits, discussions are held with institutional staff concerning how to reduce institutional burden resulting from the imposition of the PHS regulations aimed at research investigator financial conflict of interest.

Hazardous Waste Disposal

The NIH is committed to working with EPA in facilitating recommended changes that would serve to reduce regulatory burden for the research community. The NIH has already initiated discussions with Dr. Emmett Barkeley of the Howard Hughes Medical Institute (HHMI), whose office is also committed to efforts at streamlining and reducing burden in the area of hazardous waste. The NIH participated, along with EPA, in a "Best Practices Workshop" February 29 and March 1-2 at HHMI to look at collaborative ways to identify and implement best practices for managing hazardous wastes in major academic institutions. In addition, NIH's responsible official for regulatory burden activities, Dr. Anthony Demsey, has initiated contacts with EPA officials to discuss mutual interests and possible future directions.

Research Integrity

In the area of research integrity, the implementation of regulations to reduce regulatory burden was somewhat premature while activities were ongoing that would impact on the organization and functions of the Office of Research Integrity (ORI). With the expected designation of a new director of ORI shortly, activity in this area can be expected in the near future.

NIH Advisory Working Group on Regulatory Burden

A Working Group of community experts has been established to assist and advise the NIH Extramural Programs on issues related broadly to regulatory burden. Its first meeting was held on January 21, and the results of several recommendations made at that meeting are included in the progress described above. The group will have its next meeting in July.


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