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ARCHIVED - REGULATORY BURDEN THREE-MONTH PLAN

SEPTEMBER/OCTOBER/NOVEMBER, 1999

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 have been identified from the report that the NIH can readily commit to pursuing in the immediate future. These activities lend themselves to immediate action and in addition, are selected because their promise in reducing regulatory burden for the research community, while continuing to provide the intended protections, is significant. As these activities get underway, it is expected that additional ones will be identified from the report and considered for pursuit.

Table of Contents:


Human Subject Protection
  1. During September, October, and November (Fall 1999), OPRR will continue to expand its educational outreach activities. Four additional full-time equivalents (FTEs) have been approved to support this expansion.
  2. The first of the four FTEs was filled with the recent hiring of a Human Subjects Associate Director for Education (HSADE). The 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 with these organizations will continue during Fall 1999. The first of a series of web-based tutorials has been drafted and will be brought on-line for testing in November. Fall 1999 activities will 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.

    Position announcements to fill the three remaining education FTEs have been prepared and forwarded for posting. Recruitment for these positions should be completed during Fall 1999.

    OPRR has recently prepared internal guidance on (i) IRB knowledge of local research context, and (ii) engagement in research, in order to ensure consistency in OPRR staff interpretation of regulatory requirements. Efforts will be made during Fall 1999 to disseminate this guidance to the research community. Monthly meetings of OPRR's Division of Human Subject Protections staff will be held over the next 6 months to address remaining areas of inconsistency. It is anticipated that guidance will be developed in Fall 1999 related to (i) conflict of interest for IRB members, and (ii) qualifications and responsibilities of Assurance Signatory Officials.

    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.

  3. Two professional organizations interested in human subject protection, Public Responsibility in Medicine & Research (PRIM&R) and the Applied Research Ethics National Association (ARENA), sponsored a meeting on May 12th 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 during Fall 1999, the Institute of Medicine will propose development of its own performance standards for human subject protections.
  4. OPRR will continue 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. During Fall 1999, OPRR will work with interested organizations to begin developing such a consensus.

  5. During Fall 1999, OPRR will meet regularly with FDA in an attempt to reconcile, within the constraints of their respective statutory mandates, any conflicting regulatory or policy guidance.

For example, OPRR currently permits use of telephone conferencing for IRB meetings in extraordinary or emergency situations, while FDA's policy on telephone conferencing is more liberal. OPRR will consult with FDA during Fall 1999 in order to develop reasonable and consistent guidance on IRB telephone conferencing. OPRR will also work with FDA during Fall 1999 to develop consistent guidance on quorum requirements for IRB meetings. November 9 has been tentatively set for the first meeting.

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 recently expanded significantly the categories of research that IRBs can review utilizing expedited procedures. During Fall 1999, OPRR will begin 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.

  1. OPRR will continue to work with the National Cancer Institute (NCI) to develop two to three demonstration projects on "Central IRB Review." During Fall of 1999, OPRR anticipates that NCI's Clinical Trials Evaluation Program (CTEP) will hire an IRB Administrator and establish an IRB for use by interested CALGB institutions in the first "Central IRB" demonstration project. OPRR also anticipates initiation during Fall 1999 of a second "Central IRB" demonstration project involving a large physician practice network. Discussions with NCI will continue during Fall 1999 regarding a third demonstration project to involve a geographically diverse health maintenance organization or similar organization.

  2. 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

During Fall 1999, OPRR will (i) finalize the redesigned Assurance document; (ii) pilot test the redesigned process; (iii) pilot test the Assurance tutorial; and (iv) develop an appropriate computer tracking system. OPRR anticipates implementing the redesigned Assurance process in Spring 2000.

Animal Welfare
  1. The Division of Animal Welfare (DAW) of OPRR 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, OPRR/DAW staff are scheduled to attend meetings of non-government organizations, including ILAR and AAALAC, on a regular basis to continue this dialogue. OPRR/DAW has currently scheduled a number of similar activities during the Fall, such as educational workshops throughout the country and presentations at professional society meetings, including:
  2. September 29 - National Capitol Area Branch of the American Association for Laboratory Animal Science.

    October 2-5 - UC Davis/Georgetown University/OPRR joint meeting in Lake Tahoe, CA

    October 8 - New Jersey Association for Biomedical Research

    October 17 - Society for Research Administrators in Denver, CO

    October 24 - Society for Neuroscience annual meeting in Miami, FL

    November 8-11 - National Meeting of AALAS in Indianapolis, IN

    December 6-7 - OPRR Workshop in conjunction with the University of Texas, San Antonio, and the Scientists Center for Animal Welfare (SCAW) in San Antonio

    This coming fiscal year and in subsequent years, two additional meetings are planned (with $35,000 per year being budgeted) for the expressed purpose of improved dialog with institutional representatives and the research community. In addition, OPRR/DAW and USDA are currently discussing the future inclusion of OPRR/DAW in USDA-sponsored public forums.

  3. Within the next three months, OPRR will issue a "Dear Colleague" letter 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. While the consideration of alternatives to procedures likely to produce pain and distress to animals is a regulatory requirement, OPRR has begun working with the Johns Hopkins University and a diverse project team to develop a user-friendly, web-based search engine to make the process more efficient and effective. A feasibility study is complete, and a contract to create the search engine is in place. One of the contract terms is that searches done with the final product must satisfy the USDA Policy 12 requirements.

  5. OPRR currently allows institutions to utilize their AAALAC program evaluation as one of the required semiannual IACUC inspections/reviews. To do that, IACUCs must endorse the findings and recommendations of the AAALAC evaluation and formally adopt the report as an IACUC report. Since many institutions seem to be unaware of this option, OPRR will coordinate with USDA to issue a "Dear Colleague" letter to inform them. Dr. Nelson Garnett of OPRR held an initial meeting with Dr. John Miller of AAALAC and Dr. Ron DeHaven of USDA on August 26 to discuss this issue. Agreement is anticipated, and a joint communication to the research community is expected to be published within the next three months.

  6. Also at the August 26 meeting, OPRR began discussions with USDA and AAALAC to develop a common annual modular reporting format, designed in such a way that certain sections of information could be easily omitted from reports to agencies that don't require them. A draft modular reporting format is anticipated that would be ready for discussion with the research community and field testing by the end of the calendar year.
Conflict of Interest
  1. As recommended in the report, the NIH will issue a policy statement within the next three months, re-affirming 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.

  2. The NIH will encourage, support and participate 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. Immediate plans include presentations at the SRA meeting in October in Denver, CO, and at the NCURA meeting in November in Washington, DC. Additionally, such presentations have become and will continue to be a regular part of the NIH regional seminars.
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 an August 23/24 workshop 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, will initiate contacts with EPA's new Associate Administrator for Reinvention, Dr. Richard Farrell, and Associate Administrator for Research, Dr. Norine Noonan. It is expected that a first meeting between Dr. Demsey and Drs. Farrell and Noonan to discuss mutual interests and possible future directions will occur within the next month.

Research Integrity

In the area of research integrity, the implementation of regulations to reduce regulatory burden is somewhat premature; activities are currently ongoing that will impact on the organization and functions of the Office of Research Integrity and on operational definitions and implementation.

NIH Advisory Working Group on Regulatory Burden

Discussions will begin immediately with the NIH Director on how best, most efficiently and effectively, to establish a Working Group of community experts to assist and advise the NIH Extramural Programs on issues related broadly to regulatory burden. Currently, this Working Group is envisioned as a subcommittee to an existing NIH FACA Advisory Committee.


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