AIDS Research at the NIH: A Critical Review

etc. Y01s are interagency agreements between NIH and another PHS agency. Some awards are
institute-specific. Only NCRR awards M01s, which are General Clinical Research Center (GCRC)
grants. Five mechanisms account for most (>90%) of the NIH extramural AIDS awards: M01s, N01s,
P01s/P3Os, R01s and U01s. Another special category is intramural research projects. These are
sometimes available through CRISP as "Z01" projects, which do not have a budget dollar figure. Some
institutes (e.g., NIAID), publish annual directories of their intramural research and tabulate the work of
the various laboratories in 'man [sic] years" rather than dollars. It's innovative, but they should call
them "person years." The final category of NIH spending is on in-house staff who administer
extramural awards. This is known as "research management and support."
The Grant Cycle. Grant proposals are solicited with RFPs (Requests for Proposal); contract bids with
RFAs (Requests for Application). RFPs and RFAs use the same form. Researchers file applications
with the NIH Division of Research Grants (DRG), which refers grants to the appropriate Institute and to
a suitable Study Section (peer review committee). The Study Section is chaired by a Scientific Review
Administrator (SRA). Institutes submit names of qualified potential reviewers. The SRA assigns a
primary and secondary reviewer for each application from the Study Section. Reviewers have 6 weeks
to review the applications. AIDS-related grants are considered in a separate, expedited 6-month review
process. This was mandated by Congress, and NIH is pretty good at meeting the 6-month limit. Study
Sections allow for 1-3 days to review up to 100 applications. There are 12-18 members per study
section. ICD staff attend the review, looking at the primary reviewer's comments so that they may
informally discuss the result with the applicant. In addition, formal responses are contained in the Pink
Sheet, or summary statement, of the Study Section's decision. Study Section members award each
application a rating of outstanding, average, etc. Numbers are then assigned to each score, with 100
being the best and 500 the worst. Grants are funded down to the line at which funds run out.
Applicants whose final score is close to payline are encouraged to rewrite and resubmit their application
for the next grant cycle. The Study Section does not consider overall research needs, but rather
reviews each proposal solely in terms of its scientific merit. Funded grantees file annual progress
reports. While basic research on AIDS primarily utilizes grants, treatment research uses mainly
contracts and cooperative agreements. Under the "select pay" mechanism, a grant close to but under
the funding line may be selected for special review and award if it concerns a priority area. The select
pay process is invoked in case there are outstanding projects worthy of funding which didn't make the
cut. Select pay allows discretionary funding of grants for program-related reasons.
As can be seen, OAR has a heavy workload. Tracking the money is hard enough, tracking the science
(in its entirety) virtually impossible. This, therefore, became our task.
Why Fiscal Year 1991? For our unit of analysis, we selected FY 1991. This was the most recent year
for which complete budgetary information and reasonably complete award information was available.
Looking at programs halfway through an ongoing year might provide a distorted picture. Therefore, we
had ARIS send us a 750-page list of the 2,625 extramural awards by institute, and two boxes of
abstracts from CRISP. The two systems did not entirely match, and ticking them off manually was
tedious. We reviewed these materials and solicited additional information from AIDS coordinators at
the various institutes. Most responded with alacrity, though some failed to provide all the information
requested.
The OAR DRAFT "NIH Strategic Plan for HIV-Related Research." The Congress' and the Institute
US Congress, H.R.2507, "NIH Revitalization Amendments of 1991'; House Committee on Government
Operations, "Obstacles to Drug Development for HIV-Related Opportunistic Infections, " House Report
102-410, 2 Dec. 1991.

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