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ARCHIVED - NIH Regulatory Burden
I. Introduction

Background

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.

While NIH has already undertaken a variety of initiatives to increase the efficiency and effectiveness of its extramural grants administration and internal administrative operations, the impetus for this specific effort was stimulated by Congressional interest. In its report on the FY 1998 budget, the House Committee on Appropriations (House Report No. 105-205, p. 98) stated: "The Committee applauds NIH's efforts to streamline and rationalize its intramural and administrative operations, and believes that a similar effort should be applied to duplicative and unnecessary Federal regulations which govern the conduct of extramural scientific research. The Committee readily acknowledges the necessity of Federal regulations in the oversight and conduct of Federally sponsored research, but urges NIH to contract with a private sector firm for a study of these regulations, similar to the research management and support study that is currently being carried out under contract at NIH. Such a study might focus on cost-accounting standards, regulations governing the use of animals and human subjects in research, and regulations covering the use and disposal of hazardous and radioactive materials. "

Committee and NIH leadership subsequently agreed that the effort would take a direct approach by identifying opportunities and solutions to streamline these regulatory processes, rather than attempting to identify costs. Agreement was also reached that five areas would be 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). These areas were chosen to assure that this effort is focused on regulations that are specific to researchers; because the burden is thought to be significant; and because some of these regulations are ones over which NIH has some measure of control, although this varies by regulation.

This initiative is a natural extension of the many efforts that NIH has undertaken to simplify and streamline its extramural grants administration activities. In 1994, the NIH extramural programs were designated as a Reinvention Laboratory under Vice President Gore's National Performance Review (now the National Partnership for Reinventing Government) to "create a government that works better and costs less." Since that time, NIH has undertaken and completed a variety of efforts to simplify the submission, review, and administration of its $13 billion extramural research portfolio; many others are also underway.

While concern about the growth of regulation in science within the research community is significant, it mirrors the growth of regulation in general. In 1986, the Office of Technology Assessment (OTA) published The Regulatory Environment for Science Link to Non-U.S. Government Site - Click for Disclaimer , which examined the social and legal forces that act to restrict scientific research. This study traced the beginning of this regulatory oversight of research activities to a response to an increasing awareness of examples of abuses of human subjects, the identification of research with government-sponsored activity, and the political climate of the 1960s and 70s. In some cases, the target of concern was not necessarily the regulation of science but the regulation of other activities, of which science tangentially was included. This would encompass many of the regulations of the Occupational Safety and Health Administration (OSHA), the Nuclear Regulatory Commission (NRC), and the Environmental Protection Agency (EPA) that are applied to various industries and affect research laboratories. Issues emerging subsequent to the OTA report, which are pertinent to this study, are those related to the integrity of science, and the need to assure that scientific decision-making is not being influenced by financial considerations.

Over this period of time, and despite the efforts of various Administrations to reduce the number of government regulations, the number that impact on research and research institutions has grown dramatically. Directly preceding the request for this study, the General Accounting Office (GAO), also at the request of the House Committee on Appropriations, attempted to assess the cost of regulatory compliance to ascertain the amount of NIH grant funds that were being spent to comply with regulatory activities. While they couldn't quantify their cost, they did publish a listing of 60 federal regulations that affect researchers, such as NIH grantees, that had been compiled by the Council on Governmental Relations (COGR). They also published a list of the types of regulations that they concluded the research community perceived to be the most costly or burdensome. Four of the five regulations that are the focus of this effort - human subjects protections, animal care and use protections (including permitting requirements for the import and export of biological materials from non-human primates), hazardous waste disposal, and financial conflict of interest regulations - are included on GAO's listing. Also included on the GAO list, but not a focus of this effort, are worker protection regulations, cost accounting standards, and the construction and renovation requirements resulting from the Americans with Disabilities Act.

Before examining each of these five sets of regulations in detail, it is important to mention a caution often reiterated by members of the research community. Regardless of the burden that an individual set of regulations may or may not impose, 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 the research program, 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.

Methodology

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 in identifying innovative solutions. To understand the views of the research community, interviews were conducted and facilitated workgroups were formed.

Interviews have been conducted with the Federal staff administering these regulations at NIH, the Food and Drug Administration (FDA), the Office of Public Health Service (OPHS), the National Science Foundation (NSF), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). Interviews were also conducted with selected NIH Extramural Research Program Directors, 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. A compete listing of these, and other individuals with whom interviews were conducted, is presented as Appendix 1.

Structured workgroups also were formed to identify issues perceived to be burdensome to the research community and to identify potential solutions to relieve this burden. Workgroups for each of the five areas under study were formed. Each group consisted of about 10 members who are expert in one of the five areas identified for study. Research professional groups assisted in identifying potential members across the wide spectrum of the research community. In each workgroup, care was taken to include both active researchers as well as officials having institutional responsibility for the administration of the Federal regulations. Finally, it should be noted that the purpose of the workgroups was not necessarily to come to consensus. While there was general agreement on the issues and the proposed solutions, there was not necessarily unanimity on each. A more detailed description of these workgroups and their membership are presented as Appendix 2.

The issues identified by these workgroups, and the potential solutions to relieve this regulatory burden, are presented in this Report. 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. 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. However, the community views the interest of NIH and the Congress as an opportunity to gain relief that has been sought for some time. The issues that have been raised deserve both serious consideration and speedy resolution.

Structure of Report

The issues and the proposed solutions that emerged from the workgroups are summarized in section II. The full reports of the workgroups for these five areas are presented in sections III through VII. These sections provide the interested reader with substantial detail on the legislative and regulatory requirements that are imposed, as well as the issues of concern and the solutions proposed by the workgroups to reduce regulatory burden. Section VIII presents an analysis of the common themes that emerged from the examination of the five sets of requirements as well as principles that NIH might adopt as it pursues implementation of this initiative. This is followed by some concluding thoughts in section IX.


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