History of the Program

Originating Legislation and Facilities

Table 1-1 shows some of the administrative developments important for development of the RDRP. The Federal Coal Mine Health and Safety Act of 1969 prescribed a number of research, surveillance, and regulatory-related activities that were later assigned to NIOSH when it was formed by the Occupational Health and Safety Act of 1970. Adoption of the Mine Safety and Health Act of 1977 also had an impact on the RDRP mission. Because of the location of NIOSH coal mining research facilities—first in Beckley, West Virginia, and later in Morgantown, West Virginia—initial RDRP research focused almost entirely on CWP. Beginning in 1976, with the formation of the Division of Respiratory Disease Studies (DRDS), the scope of research on respiratory disease based in Morgantown expanded significantly to other forms of pneumoconiosis that included silicosis, beryllium disease, asbestosis, and other fibrotic lung diseases, and a focus on organic dusts and other respiratory irritants that result in occupational asthma, airway obstruction, and hypersensitivity pneumonitis.

TABLE 1-1

Timeline of Administrative Developments Related to NIOSH Respiratory Diseases Research.

Other elements of NIOSH that have had a role in respiratory disease activities are located in NIOSH facilities in Cincinnati, Ohio. These facilities include the Division of Applied Research and Technology, with expertise in exposure assessment, development of analytical methods, and control technologies; the Education and Information Division, responsible for health communication and coordinating development of recommendation documents; and the Division of Surveillance, Hazard Evaluations and Field Studies (DSHEFS), responsible for conducting short-and long-term field studies to evaluate health and safety issues including respiratory diseases. DSHEFS is the principal division that handles health hazard evaluations, although the DRDS in Morgantown has also been active in respiratory-disease-related health hazard evaluations.

Other facilities have performed activities related to respiratory disease. One of them is the Health Effects Laboratory Division, which focuses on basic bench laboratory research, including research in basic toxicology and in engineering and exposure assessment. The Pittsburgh Research Laboratory and the Spokane Research Laboratory are mining-focused research groups concerned with research on mining engineering control technology for respiratory hazards. Most recently, the National Personal Protective Technology Laboratory in Bruceton, Pennsylvania, has responsibility for research on respiratory protection and certification of respirators (NIOSH 2006a).

Strategic Planning

Occupational lung diseases have long been a top priority for NIOSH and were the subject of a proposed national strategy in 1986 (NIOSH 1986a). In this strategy, asbestosis, byssinosis (associated with cotton dust), silicosis, and CWP were cited as specific examples for action. The proposed strategy included the following elements: environmental hazard surveillance, medical hazard surveillance, hazard removal, control technologies, regulatory enforcement, worker education and training (includes respirators and other personal protective devices), and worker-oriented programs that include health promotion and smoking prevention (NIOSH 1986a).

In 1996, NIOSH worked with the occupation safety and health community to develop a National Occupational Research Agenda (NORA) (NIOSH 1996a). Seen as a way to better guide and organize research activities in a fiscally constrained environment, NORA identified 21 research priorities grouped into three categories: disease and injury, work environment and workforce, and research tools and approaches (Table 1-2). Under NORA, there were three priorities related to respiratory disease under the disease and injury category: allergic and irritant dermatitis,¹ asthma and COPD, and infectious disease. NIOSH’s objectives in creating the NORA approach were to

TABLE 1-2

NORA Priority Research Areas.

1.

Guide intramural and extramural funding decisions.

2.

Encourage and stimulate other government agencies to include NORA priorities in their internal and external research programs.

3.

Develop procedures and capacity to track the impact of NORA activities on health and safety outcomes using existing tracking models, if available.

4.

Provide for timely updates to the NORA priorities.

5.

Periodically review and communicate the overall role and effectiveness of NORA in occupational safety and health.

During development of the NORA agenda, the importance of industrial sector-specific research (for example, construction or agriculture) was consistently raised (NIOSH 1996a). It was decided that the most effective way to integrate this research was through a matrix approach of coordinated research in some or all of the 21 priority areas, as appropriate for each sector. An example of this approach is provided in Table 1-3.

TABLE 1-3

Example of NORA’s Matrix Approach to Coordinating Research.

Beginning in 2005, NIOSH introduced the second phase of the NORA process (NORA2), now organizing research priorities focused on eight key industry sectors. The sectors, listed in Table 1-4, are agriculture, forestry, and fishing; construction; health care and social assistance; manufacturing; mining; services; wholesale and retail trade; and transportation, warehousing, and utilities. Sector alignment is intended to provide direct occupational health and safety research and assistance to address specific issues as identified within each sector. Additionally, NORA2 identified 15 cross-sector programs and 7 coordinated emphasis areas, also shown in Table 1-4. The RDRP is one of the cross-sector programs. Each cross-sector program has a steering committee made up of staff from all NIOSH divisions and laboratories as well as the Office of the Director and the Office of Extramural Programs. According to NIOSH (2006a), the steering committee annually reviews and ranks competitive intramural funding requests, reviews all in-house projects relevant to its program, and provides feedback to divisions about each project’s relevance and level of priority.

TABLE 1-4

NORA2 Structure.

Respiratory Diseases Research Program Structure

As shown in Figure 1-2, the RDRP, as conceptualized, spans nearly all NIOSH units. In 2006, five divisions, three laboratories, and three offices were involved in the RDRP. The mission statement for the RDRP (Weissman 2006) is

FIGURE 1-2

Respiratory Diseases Research Program projects throughout NIOSH (does not include extramural, communications, research, and technology transfer offices). Source: NIOSH 2006a.

To provide national and international leadership for the prevention of work-related respiratory diseases, using a scientific approach to gather and synthesize information, create knowledge, provide recommendations, and deliver products and services to those who can effect prevention.

Within this overall mission five specific goals have been stated:

• Prevent and reduce work-related airways diseases.
• Prevent and reduce work-related interstitial lung diseases.
• Prevent and reduce work-related respiratory infectious diseases.
• Prevent and reduce work-related respiratory malignancies.
• Prevent respiratory and other diseases potentially resulting from occupational exposures to nanomaterials.

To pursue these goals, the RDRP activities include multidisciplinary approaches to respiratory diseases through laboratory studies and short- and long-term field studies; surveillance and reporting on disease frequencies; assessment of control technologies and respiratory protection; communication, education, and training; and recommendations on exposure and other practices. Facilities and equipment exist for biomedical research, development of analytical methods, research on exposure assessment, research on engineering and industrial hygiene, respirator research, mining research, and epidemiologic investigations. Ultimately, NIOSH provides the scientific underpinning for development of new or revision of existing standards by OSHA.

NIOSH’s Draft Fiscal Year 2008 Program Planning Guide, which describes the process for acquiring competitively awarded intramural research funds at NIOSH, outlines RDRP’s strategic and intermediate goals and their performance measures. The document has a high level of specificity, with measurable goals and target time frames. This document became available at the end of the committee’s deliberations; thus, the committee has not examined whether they are the correct performance measures or whether they are realistic. The committee notes, however, that because the RDRP is an “organizational unit” borne of the new matrix management approach that spans institutes and divisions, it is unclear whether funding and support are distributed based on whether a project satisfies RDRP’s strategic goals or whether RDRP’s goals do not matter because funding is distributed based on the goals of the divisions or institutes. Being “at the table” does not provide assurance to the RDRP or to the committee that appropriate weight is given to funding priorities. According to the evidence package, RDRP’s steering committee, with representatives from all divisions, “has been empowered to mold activities in respiratory diseases through its abilities to review and rank competitive intramural funding requests and through its access to the NIOSH Office of the Director.” (The committee did not attend or review minutes from steering committee meetings.) It is not clear what formal mechanisms exist to ensure that RDRP’s goals are supported by funding.

Program Resources

RDRP funding for the most recent fiscal year available (2005) was close to $29 million. Table 1-5 shows the funding levels for the RDRP intramural and extramural funded research for the years 1996-2005. Intramural funding supports staff salaries and benefits as well as goods and services related to staff research activities. Extramural activities are administered and funded through the NIOSH Office of Extramural Programs in Atlanta (greater detail, including by strategic goal, is provided in Chapter 2). Table 1-6 compares the fraction of the budget spent on intramural versus extramural research for the RDRP with several institutes or centers of the National Institutes of Health (NIH) and shows that the RDRP tends to spend about two-thirds of its budget on intramural projects. This is in contrast to research funding at NIH agencies, including the National Institute of Environmental Health Sciences, that tend to spend most of their research funding on extramural research. Given the relatively small research budget compared with other institutes whose research budgets are typically one to two orders of magnitude higher,² the committee considered the limited support allocated to extramural programs unfortunate but probably necessary. Because the committee was not asked to review the extramural program, the committee is not in a position to evaluate the balance between extramural and intramural funding. However, as Table 1-5 shows, the proportion of extramural funding has generally increased with time, from 24% in 1996 to 40% in 2005, the latest year for which complete data are available.

TABLE 1-5

NIOSH RDRP Funding by Fiscal Year, 1996-2005.

TABLE 1-6

NIH Versus NIOSH Extramural Funding.

Framework Document and Logic Model

The committee evaluated the relevance of RDRP research to improvements in occupational safety and health and the impact that NIOSH research has had in reducing occupationally related morbidity. In these efforts, the committee used the framework document (Appendix A) developed by the Committee for the Review of NIOSH Research Programs to provide structure and guidance to the individual evaluating committees (NAS 2005). Figure 1-3 outlines the general approach the framework document suggests using in evaluating the relevance and impacts of the RDRP.

FIGURE 1-3

Flowchart for evaluation of the NIOSH research program.

Relevance was evaluated in terms of the degree of research priority and connection to improvements in workplace protection. Factors taken into account include the frequency and severity of health outcomes and the number of people at risk, the structure of the program, and the degree of consideration of stakeholders’ input. The impact of the program’s research is evaluated in terms of its contributions to worker health and safety. The framework document recommends that the evaluation committee look at each strategic goal and present the committee’s assessments with regard to the relevance and impacts of the research completed or in progress for each separate goal. At the end of the review of the five strategic goals, the committee then develops a quantitative score for the relevance and impact of the program as a whole and provides its quantitative and qualitative evaluation of the relevance and impacts of the RDRP. The evaluation is to conclude with detailed qualitative assessments as well as the assignment of scores between 1 and 5 for the relevance and impact of the RDRP research and other activities. Box 1-1 and Box 1-2 provide the scoring criteria for rating the programs.

BOX 1-1

Criteria for Rating Relevance.

BOX 1-2

Criteria for Rating Impact.

The study charge also directs the committee to review the progress the RDRP has made in identifying new research and provides the committee the opportunity to identify emerging research areas relevant to the program’s mission. According to the framework document, the committee’s identification of emerging research areas was done using members’ expert judgment rather than a formal research needs identification effort.

The guidance in the framework document reflects the terminology and organization of a logic model adopted by NIOSH to characterize the steps in its work. The logic model used by the RDRP is shown in Figure 1-4, and examples of the terms used within the logic model are provided in Box 1-3. The committee reached consensus on its assessment of the individual activities of the RDRP and the program as a whole through deliberations at meetings and discussion on its written materials. This included a portion of one meeting spent devoted solely to develop ing scores for relevance and impact. Assessments of “goals,” “inputs,” “activities,” and “outputs” were used to evaluate the relevance of the program’s research. End and intermediate outcomes were the principal focus for evaluation of the impact of the program’s research. The committee’s scores for relevance and impact are presented and discussed in Chapter 2 of this report.

FIGURE 1-4

Logic model for the RDRP. Abbreviations: CDC, Centers for Disease Control and Prevention; NGOs, nongovernmental organizations; OSH, Occupational Safety and Health. Source: NIOSH 2006a.

BOX 1-3

Logic Model Terms and Examples. Planning Inputs: Stakeholder input, surveillance and intervention data, and risk assessments. Production Inputs: Intramural and extramural funding, staffing, management structure, and physical facilities.

Information Sources

The material for this review comes from: (1) the written documentation, known as the evidence package, provided by NIOSH to the evaluation committee before the first meeting of the evaluation committee (NIOSH 2006a); (2) presentations by NIOSH and stakeholders at the committee meetings; (3) responses to letters sent to NIOSH by the evaluation committee dated November 17, 2006, and December 6, 2006; (4) review of appendix material submitted with the original written documentation and a presentation at the October 26, 2006, meeting of the evaluation committee. The committee also drew on individual members’ knowl edge of NIOSH’s respiratory disease research and on standard literature searches (e.g., PubMed and other databases) where appropriate.