Trans-Nih Plan For Hiv-Related Research Paper

Request for Information on the Development of the FY 2019 Trans-NIH Plan for HIV-Related Research

Notice Number:NOT-OD-17-053

Key Dates
Release Date: April 11, 2017
Response Date: May 15, 2017

Related Announcements
NOT-OD-15-137

Issued by
National Institutes of Health (NIH)
Office of AIDS Research (OAR)

Purpose

Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives, National Institutes of Health (NIH) invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, community, and other interested constituents on the development of the fiscal year 2019 Trans-NIH Plan for HIV-Related Research.  This plan is designed to identify and articulate future directions to maximize the NIH’s investments in HIV/AIDS research.

Background

OAR oversees and coordinates the conduct and support of all HIV/AIDS research activities across the NIH Institutes and Centers (ICs).  The NIH-sponsored HIV/AIDS research program includes both extramural and intramural research, buildings and facilities, research training, program evaluation, and supports a comprehensive portfolio of research representing a broad range of basic, clinical, behavioral, social science, and translational research on HIV/AIDS and its associated coinfections and comorbidities. 

OAR plans and coordinates research through the development of an annual Trans-NIH Plan for HIV-Related Research that articulates the overarching HIV/AIDS research priorities and serves as the framework for developing the trans-NIH HIV/AIDS research budget.  This Plan provides information about the NIH’s HIV/AIDS research priorities to the scientific community, Congress, community stakeholders, HIV-affected communities, and the broad public at large.  The fiscal year 2018 Trans-NIH Plan for HIV-Related Research was recently distributed on the OAR website: https://www.oar.nih.gov/strategic_plan/plan_18.asp.

New overarching priorities for HIV/AIDS research were defined in the NIH Director’s Statement of August 12, 2015 (https://grants.nih.gov/?grants/?guide/?notice-files/?NOT-OD-15-137.html).

High Priority topics of research for support include:

1) Reducing the incidence of HIV/AIDS
2) Developing the next generation of HIV therapies
3) Identifying strategies towards a cure
4) Improving the prevention and treatment of HIV-associated comorbidities, coinfections, and     complications
5) Cross-cutting basic research, behavioral and social science research, health disparities, and training
Information Requested 

Submitting a response

This Office of AIDS Research RFI is open for public comment from 03/29/2017 to 05/15/2017.  Comments must be received by May 15, 2017 to ensure consideration.  After the public comment period has closed, the comments received will be considered in a timely manner by the Office of AIDS Research in the Division of Program Coordination, Planning, and Strategic Initiatives.

View the information requested and respond electronically at http://grants.nih.gov/grants/rfi/rfi.cfm?ID=63 or, if needed, by mail to Paul Gaist, Ph.D., M.P.H. Office of AIDS Research, National Institutes of Health, Room 2E40, 5601 Fishers Lane, Rockville, Maryland 20852.

Responses to this RFI Notice are voluntary. The submitted information will be reviewed by NIH staff and may be made available to the public.  Submitted information will not be considered confidential.  This request is for information and planning purposes and should not be construed as a solicitation or as an obligation of the federal government or the NIH.  No awards will be made based on responses to this Request for Information.  The information submitted will be analyzed and may be used in reports or presentations.  Those who respond are advised that the NIH is under no obligation to acknowledge receipt of your comments or provide comments on your submission.  No proprietary, classified, confidential and/or sensitive information should be included in your response.  The NIH and the government reserve the right to use any non-proprietary technical information in any future solicitation(s).

Inquiries

Please direct all inquiries to:

Paul Gaist, Ph.D., M.P.H.
Office of AIDS Research
Email: ODOARRFI19@nih.gov

The effectiveness and success of the NIH AIDS research program depend in part on the adequacy of the administrative support the program receives in the form of staffing and facilities, a statement that applies to both the extramural and intramural programs. Like the funding of research projects, more personnel and facilities may not be sufficient to guarantee high-quality, productive research or swift scientific progress, but a minimum of such resources is necessary for NIH to carry out its mission. At NIH, these resources are provided through centralized processes somewhat separate from those for planning and funding research projects, which makes it a challenge to ensure that resources are matched with program needs, especially in a program that has grown as quickly as AIDS research.

Staffing

It takes people to award grants and contracts, evaluate the results, and determine new areas of research. It also takes people to staff the intramural research laboratories of the institutes and the research units of the NIH clinical center. Much concern has been expressed about the adequacy of the number of FTE staff at NIH for both AIDS and non-AIDS research. AIDS FTEs increased from 27 in fiscal year 1982 to 763 in fiscal year 1989 (Tables 4.14a and 4.14b). The administration proposed 887 AIDS FTEs in the fiscal year 1990 budget, but a year later, after allowing the Department of Health and Human Services and NIH to set staffing levels (within the overall NIH budget), the Office of Management and Budget raised the ceiling for 1990 to 1,072. The administration proposed 1,183 AIDS FTEs in its budget request for fiscal year 1991. Non-AIDS FTEs increased from 12,662 in 1982 to a high of 13,493 in 1984, but fell by 1,188 to 12,305 in 1986. The non-AIDS FTE level reached 12,712 two years later (fiscal year 1988) and was originally slated to decline to 12,327 in fiscal year 1990. The administration later revised the 1990 level upward to 12,707 and is proposing a total of 12,950 non-AIDS FTEs in its budget request for fiscal year 1991.

TABLE 4.14a

Cumulative Summary of AIDS Staffing (in full-time equivalents [FTE]) by Unit, National Institutes of Health.

TABLE 4.14b

Cumulative Summary of AIDS Staffing (in full-time equivalents [FTE]) by Administrative Area, National Institutes of Health.

In 1985, OTA's study of the PHS response to AIDS found that the administration had consistently suggested decreases in personnel ceilings for NIH institutes conducting AIDS research, even as AIDS funding increased. The OTA report concluded that personnel ceilings had been a "special problem" affecting AIDS and non-AIDS research (OTA, 1985:6). In late 1986, an NIH advisory group reported to Congress that there was a "clear-cut need for additional FTEs, both scientific and administrative, at the NIH," rather than redeployment of existing FTEs from other NIH programs. The advisory group concluded that ''the allocation of new monies for AIDS research will not achieve the desired goal without a parallel and proportionate increase in scientific and administrative FTEs" (Ad Hoc Consultants, 1986:29). In 1988, the Presidential Commission on the Human Immunodeficiency Virus Epidemic concluded that OMB was inappropriately trying to micromanage AIDS research at the NIH institute level through staffing ceilings and other regulations. The commission said these practices "prevent the deployment of a sufficient number of researchers to deal with pressing problems,'' force an incremental loss of personnel from other NIH research areas, and deny NIH the management flexibility called for in a scientific research effort (Presidential Commission, 1988:41-43). In 1988, the IOM committee to study the NIH intramural program criticized OMB-imposed FTE ceilings for inhibiting effective management: "The overall effect of FTE ceilings that grow more slowly than budgets is that managers who are best placed to make decisions about how to allocate money to fulfill congressional mandates are prevented from making the most productive decisions" (IOM/NAS, 1988:67).

The NIH AIDS effort has experienced two types of personnel problems that have hampered efforts to recruit and retain staff and thus hindered program managers from making the most effective use of public resources. One type is the traditional set of staffing problems faced by all organizations: having enough money to hire people, being able to find and hire people with the needed skills, motivating people to do their best for the program, and retaining the people who are hired by providing adequate working conditions and a competitive salary structure. These problems also include having an appropriate organizational structure, competent leadership, and a balance between the amount of work to be done and the staff to do it. NIH, however, has also faced a second set of problems caused by external limits on the number of people it can employ. These two types of problems are discussed below.

Traditional Personnel Problems

NIH and its AIDS research program have been constrained by government-wide personnel policies and procedures that have made it difficult for the agency to recruit and retain senior scientists, especially physicians, and some types of support personnel—for example, nurses, allied health workers, and secretaries (IOM/NAS, 1988:3-4; PHS, 1990a:61-62). NIH has not been able to offer competitive salaries for M.D. or Ph.D. senior-level scientists and science administrators or for mid-level physicians, and there have been significant pay problems with regard to research support personnel (IOM/NAS, 1988:64-65). In addition, personnel hiring procedures make timely appointments quite difficult: in fiscal year 1988, it took an average of 8.5 months to process senior-level appointments at NIH (IOM/NAS, 1988:65). Historically, good scientists have been willing to forego higher pay to enjoy the distinctive research environment at NIH, which they find conducive to scientific productivity and creativity. Others want to participate in an extramural program they believe makes a difference in addressing a major health problem. Increasingly, however, widening pay differentials, cumbersome personnel procedures, and other "barriers to a productive work environment" (IOM/NAS, 1988:68-72), such as inadequate space and equipment (discussed below), threaten NIH's ability to recruit and retain high-quality staff.

These problems have been especially severe for the AIDS program because of its fast growth, long work hours, and intense pressures associated with implementing AIDS research programs with inadequate numbers of staff. For example, congressionally mandated plans to double the AIDS outpatient and inpatient capacity of the NIH clinical center were slowed by problems in recruiting nurses and other support staff. The Division of AIDS at NIAID has experienced major problems in filling high-level positions and recruiting physicians as medical officers in its treatment research program. Staff turnover rates have been high at DAIDS—about 33 percent a year. Thus, NIH has had problems filling positions, and keeping them filled, even when they are made available. The AIDS FTE ceiling for fiscal year 1988 was 544, but NIH finished the year with 537; the ceiling for fiscal year 1989 was 780 positions, of which 763 were filled. Current plans call for an increase of 309 AIDS FTEs in fiscal year 1990, bringing the total to 1,072, and another 111 in fiscal year 1991, for a total of 1,183 slots. Both increases will pose additional challenges for the NIH personnel office.

Several steps have been taken to address personnel problems at NIH generally and for the AIDS program in particular.

  • Legislation passed in July 1986 permits NIH to offer more competitive salaries for nurses and (since September 1988) for 10 allied health personnel categories, a policy that has reduced position vacancies and turnover rates. Thus, the number of nurses at the NIH clinical center increased by 25 percent, vacancy rates decreased from 10 percent in early 1987 to 7 percent in January 1990, and the turnover rate fell from 25 percent in 1986 to 13 percent in 1989 (U.S. Congress, 1990a:93).

  • A pay raise in January 1990 and one scheduled for January 1991 will reduce much of the pay differential for Ph.D. scientists and some of the differential for physician researchers. According to NIH, its physicians in the Senior Executive Service are paid an average of 49 percent less than their peers in U.S. medical schools; NIH Ph.D. scientists average 19 percent less in pay than comparable scientists in research-intensive universities (U.S. Congress, 1990c:698).8

  • Physical working conditions will improve considerably if current construction and renovation plans are carried out (see the discussion later in this chapter).

  • In June 1988 NIH and the Office of Personnel Management (OPM) agreed that OPM would process and certify eligible candidates within 21 days; the Health Omnibus Programs Extension Act of 1988 (P.L. 100-607) subsequently granted authority to NIH to request expedited approval of requests for AIDS personnel and administrative support or space. Such requests are deemed to be approved if not denied by the director of OPM or administrator of the General Services Administration within 21 days.

Constraints of Federal Personnel Ceilings

In addition to the more traditional types of staffing issues discussed above, NIH has also faced a second set of problems caused by external limits on the number of people who can be employed. The limits set on the number of FTE positions an agency may support are a peculiarly governmental problem that is not directly related to sufficient funds for the positions or the ability to recruit and retain qualified staff. OMB sets overall FTE ceilings for each federal department and independent agency. The Department of Health and Human Services (DHHS) then allocates positions under its ceiling to the Public Health Service, which in turn subdivides its allocation among the various PHS agencies, including NIH. The NIH positions are allocated among its institutes and other organizational components by the NIH director, based on the recommendations of the Resource Allocation Group (RAG). The RAG is composed of senior staff in the Office of the Director and several institute directors.

The FTE ceilings have caused significant personnel problems for the AIDS research effort in several ways.

  • Although Congress controls appropriations and specifies them in some detail for each NIH component, OMB controls the allocation of FTEs. Until recently at least, OMB was unwilling to raise the NIH FTE ceiling to keep pace with the needs of the AIDS research program.

  • Cuts in its overall FTE ceiling since the early 1980s have left DHHS with little latitude to provide NIH with extra positions. Total FTE employment at DHHS has declined steadily, from 138,480 in fiscal year 1982 to 115,045 in fiscal year 1989. Although the majority of the cuts were in the Social Security Administration, every major component, including the PHS, lost FTEs. FIE employment in the PHS fell from 42,904 FTEs in 1982 to less than 40,000 in 1989.

  • NIH, together with CDC and ADAMHA, has maintained and even increased its FTE employment during the 1980s. Because the FTEs for AIDS research have come from the overall ceiling authorized for NIH, however, increasing AIDS FTEs has reduced the number of personnel available for non-AIDS research. In the early years, when the NIH AIDS effort was mostly intramural, most AIDS FTEs were shifted from other work. In 1986, for example, just 9 of the 235 AIDS FTEs were additions rather than transfers (U.S. Congress, 1988a:351). Since 1986, most but not all increases in AIDS FTEs have been additions. Nevertheless, as the number of FTEs related to AIDS increased from 0 in fiscal year 1981 to 780 in fiscal year 1989, the net number of non-AIDS FTEs declined by 165—from 12,637 to 12,472 (Table 4.15). (The decreases in non-AIDS staffing occurred while NIH's non-AIDS budget grew in constant dollars.)

TABLE 4.15

Staffing Levels (in full-time equivalents [FTE]) for the National Institutes of Health AIDS and Non-AIDS Programs, 1981-1991.

These personnel constraints have acted to redirect intramural staff from non-AIDS to AIDS research and to hold down the number of staff available to plan, implement, and monitor the extramural AIDS research programs. Initially, NIH institutes responded to the AIDS epidemic with their most flexible resource, the intramural program; FTE ceilings subsequently hampered needed adjustments to compensate for the shifts of intramural staff to AIDS work. This situation can be seen most clearly at NCI. In 1989, half of the 188 FTEs allocated to AIDS research had come from NCI's non-AIDS FTE allocation. That year the institute received 42 additional AIDS FTEs over its 1988 level, but instead of using them to free up staff to return to non-AIDS work, they were assigned to expanded AIDS activities—primarily the large-scale drug screening and development program initiated in 1988 (NIH, 1989b). Not surprisingly, the institutes are using much of the new flexibility allowed them in fiscal year 1990 to set personnel levels for "a restoration of the previous losses" (U.S. Congress, 1990a:63).

The constraints on FTE levels and problems in filling available positions were also acute on the extramural side, where funding growth has outstripped the available staffs ability to administer it. This problem has been most apparent at NIAID's Division of AIDS, which administers 60 percent of the extramural AIDS research dollars at NIH. DAIDS was established in January 1986 to develop and manage a large extramural AIDS research program, but it has been chronically understaffed and has had difficulty planning, implementing, and monitoring its many fast-growing activities. Most of its activities are supported by such mechanisms as cooperative agreements and contracts that involve more staff effort to develop, fund, monitor, and evaluate than is normally required to administer a portfolio of traditional individual investigator-initiated grants. For example, DAIDS took over the MACS and launched the multicenter ACTG and NCDDG programs. Funding for these efforts totaled $52.3 million in fiscal year 1986 and was administered by only a 4-person staff. In 1987, with a staff of 13, DAIDS expanded the ACTG greatly, added more NCDDGs, developed the NCVDG program, and put out a number of animal-model and other contracts totaling $129.6 million; in 1988 it launched additional programs, studies, clinical trials, and associated contracts for total expenditures of $203.2 million with 42 FTEs. To accomplish the work, 80-hour work weeks were typical—as was staff burnout and turnover of 33 percent a year.

In response to a congressional hearing on AIDS research needs, NIAID estimated it would need 116 more FTEs through fiscal year 1989, 63 for extramural research management and support (DAIDS), 40 for expedited review and award of AIDS research grants and contracts, and 13 for intramural research. Its projections also included a need for additional FTEs in fiscal years 1990 and 1991 (U.S. Congress, 1988a:329).9 Internally, NIAID was arguing that it was not receiving enough additional FTEs to manage its AIDS research activities, especially the ACTG program and the vaccine research and testing effort. Although it received an increase of 74 FTEs (for a total of 232) in fiscal year 1989, the institute estimated that it was 83 FTEs short of meeting its needs (NIH, 1989a). NIAID was given a further 31 FTEs (for a total of 263) in fiscal year 1990, but expanded activities as well as new responsibilities imposed by the Health Omnibus Extension Act of 1988 led NLAID to estimate that it was still 89 FTEs short at the beginning of the 1990 fiscal year (NIH, 1990a).

Faced with a health emergency, the small staff of DAIDS worked long hours to develop and issue RFAs and RFPs, usher them through the review and award process, help successful applicants set up and begin work on their projects, and coordinate the activities of multiple sites. The heavy workload took a heavy toll on staff members, however, at the same time causing delays and other implementation problems for the research projects.

OMB and DHHS recently gave the NIH director increased authority to determine NIH staffing ceilings, which will allow the agency to bring its staffing levels into line with program requirements. As a result of more realistic FTE planning, NIH increased substantially NIAID's allocation for fiscal year 1990 in January 1990, from 263 to 306 (3 more slots than were requested by the institute in its initial budget request for the 1990 fiscal year). The DAIDS ceiling increased from 95 to 115. The overall 1990 FTE ceiling for NIH, originally 38 FTEs smaller than in 1989, increased 527 FTEs; an additional increase of 354 positions has been requested for fiscal year 1991. A majority (292 of 527) of the additional FTEs in fiscal year 1990 are for AIDS research; a third (111 of 354) of the additional FTEs proposed for fiscal year 1991 would be for AIDS. These increases must be achieved, however, within NIH's overall budget total because NIH is not slated to receive additional funds for personnel and must pay for staffing increases out of program funds. Determining appropriate staffing levels for all NIH programs will require careful analysis of program needs and difficult choices. It will also require closer integration of program planning, budgeting, and personnel planning in the future.

In conclusion, OMB's imposition of arbitrary personnel ceilings for NIH as a whole has constrained the AIDS research program because the number of scientists and science administrators could not increase as quickly as the scientific opportunities for intramural AIDS studies or the number of extramural AIDS grants and contracts that had to be reviewed, awarded, and managed. This constraint in turn hampered NIH's ability to conduct AIDS research and adequately plan, administer, and evaluate its extramural AIDS programs.

Recommendation 4.5: The committee strongly opposes arbitrary restrictions on NIH staffing levels that are established without regard to program requirements because they hamper effective, efficient management. Personnel ceilings should be abandoned permanently, and future staffing decisions should be part of the strengthened program planning and budgeting processes as recommended in Chapter 2and coordinated by the Office of the NIH Director. Adjustments in staffing levels should be made carefully over several years to achieve appropriate balances between AIDS and non-AIDS programs, between the elimination of past deficits and the needs of new initiatives, and between the budgets for extramural grants and contracts and for staff to administer those grants and contracts.

The committee also supports broader efforts to maintain the excellence of the NIH staff by addressing personnel problems relating to compensation and to inflexible or cumbersome policies and procedures of government personnel systems. It endorses as well special efforts to resolve problems specific to the AIDS program, such as recruitment and retention of medical officers in the NIH AIDS treatment research (clinical trials) program.

Facilities

Over the years, NIH more than once has delayed construction of new facilities and maintenance and structural improvements in old buildings in the face of constrained budgets (U.S. Congress, 1990c:7). The resulting problems with inadequate space and deteriorated and obsolete facilities have hindered the agency's research efforts and added to problems in recruiting and retaining high-quality staff. Indeed, the IOM committee studying the NIH intramural program found that space was inadequate for a number of institutes, that facilities had deteriorated in recent years, and that scheduled improvements had been delayed (e.g., renovations of the six oldest laboratory buildings that were scheduled for completion in 1991 are now projected to take until 1997; IOM/NAS, 1988:69). Facilities problems have become quite serious in terms of obsolete laboratory space, deteriorated heating and cooling systems, substandard research animal facilities, and unsafe patient and research areas, as well as sheer lack of space for AIDS and other growing research areas.

These NIH-wide space limitations and inadequacies have affected the AIDS research program disproportionately because it is a new, fast-growing set of activities. Also, because of the general delays in renovating, modernizing, and expanding laboratory facilities on campus and in constructing a consolidated office building for 2,700 extramural program administrators and support staff now located outside NIH's main Bethesda campus, much of the AIDS space is scattered in off-campus sites. These dispersed locations hamper communication and collaboration between AIDS basic and clinical researchers and between AIDS and non-AIDS researchers involved in related studies; they also impede coordination among administrators of extramural AIDS and AIDS-related research programs in the different institutes, centers, and divisions.

To address these problems, NIH is preparing a comprehensive facilities plan for Congress and has made facilities modernization and improvement a high priority in its 1991 budget request. According to acting NIH director William Raub, NIH requires a building program that could cost up to $1 billion over the next 10 years (U.S. Congress, 1990a:51). The agency's 1991 budget request includes $88.6 million for buildings and facilities, including $16.5 million for AIDS facilities.10

The need for more—and more appropriate—facilities specifically for AIDS work was acutely apparent in early 1988 when NIH director James Wyngaarden and NIH AIDS coordinator Anthony Fauci testified before several congressional committees (U.S. Congress, 1988a:259, 1988c:331). Their concerns were echoed in the June 1988 report of the Presidential Commission on the HIV Epidemic. The commission noted that plans for AIDS office and lab space were seriously delayed, and recommended that intramural construction and instrumentation needs be assessed and made a high priority in future budget requests. They also called for expedited approval of the proposed consolidated office building (Presidential Commission, 1988:40-41, 44). In 1989, NIH outlined its AIDS facilities problems, noting that rapid scientific developments might require adjustments in these priorities:

0 thoughts on “Trans-Nih Plan For Hiv-Related Research Paper

Leave a Reply

Your email address will not be published. Required fields are marked *