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Identification of Issues and Potential Solutions

The following is a report provided to the NIH by a consultant, Mr. John Mahoney. This report was originally posted on March 10, 1999, for a public comment period of 60 days.

Table of Contents

NIH Regulatory Burden Executive Summary

The National Institutes of Health (NIH), has undertaken an initiative to improve the effectiveness and efficiency of its overall research mission by reducing regulatory burden being experienced by the research community. This paper is the initial step in this effort. Its purpose is to identify items considered to be burdensome by the research community and to begin the process of identifying potential solutions for the issues that emerged.

The impetus for this effort was stimulated by Congressional interest. In its report on the FY 1998 budget, the House Committee on Appropriations requested an effort to streamline and rationalize duplicative and unnecessary Federal regulations which govern the conduct of extramural scientific research. Committee and NIH leadership agreed that the effort would identify opportunities and solutions to streamline selected regulatory processes, with five areas comprising the initial focus of the effort - financial conflict of interest, research integrity, human subjects protections, animal care and use, and disposal of hazardous wastes (other than radiation).

For each of the five sets of regulations, the legislative and regulatory requirements, and the policies that implement them, were studied. In addition, considerable effort was expended to understand the views of the research community since they confront these issues on a daily basis and offer considerable expertise for identifying innovative solutions. To understand the views of the research community, interviews were conducted and facilitated workgroups were formed.

Interviews were conducted with the Federal staff administering these regulations at the Department of Health and Human Services, the National Science Foundation, the Department of Agriculture, and the Environmental Protection Agency. Interviews were also conducted with officials of research professional organizations, and scientists, administrators, and institutional officials at four research institutions - the University of Florida, Washington University in St. Louis, Johns Hopkins University, and the University of Maryland, College Park. In addition, facilitated workgroups were formed, with each workgroup consisting of about 10 members expert in one of the five areas identified for study. These workgroups were tasked with identifying issues perceived to be burdensome by the research community, and with identifying potential solutions to relieve this burden. For the purposes of this assessment, regulatory burden is defined as any aspect of Federal legislation, regulation, or policy, or Federal/research institution practices that could be made more efficient without diminishing the intended level of protections.

The issues identified by these workgroups to be burdensome, and their potential solutions to relieve this regulatory burden, are summarized in section II. The full reports of the workgroups are presented in Sections III through VII. Using this format has the advantage of allowing a structured presentation of issues and solutions as they were identified by this broad spectrum of the research community. It is important to emphasize, however, that the issues and solutions emerging from these groups are strikingly consistent with those gleaned from the individual interviews.

While the potential for streamlining varies considerably across the five sets of regulations that comprised the study, opportunities exist to make all more efficient. All members of the community with whom these issues were discussed feel strongly, even passionately, about the need to address these issues, and to address them quickly. Many of these issues are complex, and many are not new, often having been identified by other studies. It also should be noted that it is somewhat misleading to look at each in isolation of all regulations imposed on research. With the 60 or so sets of regulations being imposed on research programs, it is important to be sensitive to the cumulative impact that these have on the institution and its investigators to fully appreciate the impact of regulatory burden.

Several crosscutting factors associated with burden emerge in examining the five sets of regulations. In many instances these factors are interrelated and may be synergistic in a negative sense. These factors are important as they define the implementation approach for resolving the issues that have been identified. Those that emerged are as follows:

  1. Regulations that dictate process often limit flexibility without enhancing results.
  2. Regulations administered by multiple agencies impose inconsistent requirements.
  3. The regulation of science by non-science agencies often results in additional regulatory burden.
  4. Better communication between Federal agencies and research institutions can be expected to reduce regulatory burden.

The specific instances of regulatory burden that have been identified in the five areas under examination are consistently associated with more than one of these factors. In some cases, all four factors may be at play. As NIH develops its strategy for relieving regulatory burden, it must take these factors into consideration.

A reading of this document confirms that the current system of regulation for each of the five areas is in need of change, and in some cases, dramatic change. At the same time, NIH faces a difficult challenge as it undertakes this initiative. The factors that cause this burden are multiple and systemic. Addressing them will require concerted action and sustained attention if this initiative is to be successful. The solutions offered by the research community require changes to legislation, regulation, policy, and practice. NIH's strategy for implementation should be guided by at least three considerations - the merit of the proposal, the difficulty of implementing change, and the degree to which NIH, or its parent organization, the Department of Health and Human Services (DHHS), has the authority to effect this change. Though perspectives may vary on the relative merit of each proposal presented in this paper, each represents the considered judgment of thoughtful members of the research community and deserves similar serious consideration by the Federal agencies and, where appropriate, the Congress.

The following principles are offered as NIH begins its program of regulatory reform.

  1. Take both immediate and long-term action to focus regulatory oversight on results, not process.
    1. In the short-term, take action to relieve burden resulting from process restrictions that do not facilitate program results; in doing so, act quickly to create momentum for change.
    2. Over the long term, foster paradigm changes to implement results-oriented oversight.
  2. Take concerted action to eliminate conflicting requirements.
    1. NIH/DHHS should take action to eliminate conflicting requirements for programs under its control.
    2. The Office of Science and Technology Policy and the Congress must take action where conflicting requirements cannot be resolved by NIH/DHHS.
  3. Refocus the role of Federal agencies to give higher priority to partnership functions.
    1. Foster model programs of education and training.
    2. Encourage, identify, and disseminate best practices.
    3. Facilitate paradigm shifts.
  4. Expand existing channels of communication between the research community and the organizations providing oversight.
  5. Formally recognize institutions that have established superior programs of protections

The Report concludes that regulatory burden is real and relieving it will not be easy. 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. At the same time, 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 interest of Congress.

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 assist in the overall effort. This would focus 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.

This report was prepared by John D. Mahoney.

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