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APPENDIX B
NATIONAL INSTITUTES OF HEALTH SUPPORT OF RESEARCH IN DEPARTMENTS OF OBSTETRICS AND GYNECOLOGY*
ROBERT A. WALKINGTON
The National Institutes of Health (NIH) is the major supporter of biomedical research conducted in the nation's universities and medical schools. In 1989, 60 percent of funds for biomedical research in academic institutions came from NIH, compared with 8 percent from private, non-profit sources and 6 percent from industry.1 In medical schools, over 75 percent of funds for sponsored research comes from the federal government, the majority from NIH.2 NIH support in FY 1989 included over $500 million for clinical trials, $245 million to support research training, $90 million for career development awards and $120 million to support beginning researchers.3 Since it is peer reviewed in national competition, NIH support is considered a standard of excellence. For this reason it can be used to leverage other support: from the community, from private sources and from industry.
For more than a decade there has been concern that clinical research is not adequately supported. This is thought in part to be because physician-scientists are relatively unsuccessful in winning NIH peer awards. The following comments are indicative of interwoven concerns.
*
This paper was prepared for the Institute of Medicine, Committee on Research Capabilities of Academic Departments of Obstetrics and Gynecology.
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''Whether for lack of time, expectation of greater funding, more ability to control variables or other reasons, the physician-investigator has turned away from involvement in human research. Obtaining funding for human studies is considered so difficult that many investigators are discouraged and in some instances, bitter."4
"Concerns of insufficient access to research support have been voiced by a variety of individual surgical investigators. Frustrated by a perceived inability to successfully compete for NCI grant support, some surgical oncologists have criticized aspects of the current NCI peer-review mechanisms for awarding grants."5
"It is essential to understand that in 1988 it is effectively impossible for an individual investigator to obtain NIH funding for human investigation."6
"If I leave here (Intramural Program) I will leave research" [because its impossible to get a grant for clinical research].7
"Friedman told the board that clinical investigators do complain that is very difficult to get RO1 grants: 'The perception is that they receive poorer priority scores and inferior funding', he remarked. 'If one looks at...comparisons by program...it's evident, that year by year, there are inferior funding rates for the clinical proposals compared to the preclinical proposals' Friedman stated. 'This does not indicate whether the proposals are good or not'; 'I would argue that some of them are [good]. What we need is [the submission of] more good clinical proposals.'"8
The evidence to support these concerns is mixed. Different studies, using different data bases and or time periods, have produced different results. A study conducted at NIH in the early 1980s showed that between 1976–1981 only 63 percent of clinical applications were approved compared with 74 percent of basic science applications. The study also found that approved clinical applications received poorer priority scores than did those dealing with basic research.9 M.D. applicants in 1985 had a higher disapproval rate (9.1 percent) than Ph.D. applicants (6.8 percent). During the decade 1975–1985, Ph.D.s had consistently slightly better priority scores than M.D.s on competing RO1 applications. 10 Recent NIH data, however, indicate that between 1987 and
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1989 M.D.s had slightly higher success rates than Ph.D.s in competing for research-project grants, of which the majority are RO1s.11
A 1986 study indicated that between 1975 and 1985 the number of ROI applications from M.D.s and M.D./Ph.D.s increased by 30 percent, compared with an increase of 83 percent in applications by Ph.D.s. The proportion of new applications submitted by M.D.s dropped from 31 percent of total R01 applications in 1975 to 25 percent in 1986.
There is also concern that the number of physicians in clinical research is declining, though conclusive data are lacking.12,13,14,15, 16,17 Particular concern is expressed over the shortage of physicians involved in patient oriented clinical research. Reasons suggested for the decline include:
increasing indebtedness of medical school graduates;
increasing difficulty of maintaining competency in both science and medicine;
perceived insecurities associated with extramural research funding for clinical investigation;
problems associated with financial soundness of academic departments combined with increasing demands for faculty to engage in clinical practice;
expectations with less willingness to undergo relative deprivation;
the paucity of role models and inadequate mentoring; and
curriculum deficiencies in medical schools.18
In addition to the general problems related to NIH support of clinical research and the physician-scientist, specific concerns have been expressed about the paucity of research conducted in departments of OB/GYN. The IOM Planning Committee for the current study concluded that departments of OB/GYN lagged in receiving support from NIH for research and speculated that:
"possible causes related to the politicalization of problems relating to the status of the fetus, lack of organizational focus for reproductive research at NIH, the lack of a national consensus concerning the ethical issues raised by some reproductive research ... there is also the possibility that the absence of OB/GYN presence in the NIH intramural program results in a relative disregard of OB/GYN research."19
NIH support appears to be hindered by three interrelated problems: 1) the quality of the research being proposed 2) the nature of the research, and 3) the
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organizational structure and management of NIH in general and with regard to the review of grant proposals. There are a few studies that illuminate the quality of OB/GYN research, or research proposals: In 1986, research grant applications (competing RO1s) from OB/GYN departments had the poorest average priority scores of nine clinical departments studied—a decline from FY 1979 when OB/GYN ranked in the middle (5th of 9) of the clinical departments studied.20 A study focusing on clinical oncology support from the National Cancer Institute showed that between FYs 1980 and 1985 OB/GYN departments had success rates substantially lower than departments of medicine, pediatrics and radiology. While the success rated varied greatly from year to year, for 3 of the 6 years the rate for OB/GYN was substantially lower than that of the other departments. The decline in success rates between 1980 and 1985 was greater for OB/GYN than the three other departments studied.21
A measure of the research intensity of a department is the degree to which faculty are involved in research. A 1989 Association of American Medical Colleges (AAMC) study, analyzed the distribution of full-time faculty of U.S. medical schools who are principal investigators on NIH or Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) research awards by department and degree. The study linked the AAMC Faculty Roster (1988)—with records of NIH and ADAMHA research awards (FY 1987). This linkage allowed awards made to affiliated hospitals to be credited to the appropriate department. OB/GYN departments ranked 11th of 17 clinical departments with 9.8 percent of their faculty being principal investigators, compared with an average of 14 percent for all clinical departments. Examination of the data by the degree of the principal investigator reveals that the discrepancy between OB/GYN and more research intensive departments can be attributed to the M.D. and M.D./Ph.D. faculty. Ph.D.s in OB/GYN departments are principal investigators at a rate above the average for all clinical departments (Ph.D.s in OB/GYN departments ranked 6th of 17 clinical departments; M.D and M.D/Ph.D.s ranked 12th). (Table B-1).22
According to a 1986 survey of academic manpower in OB/GYN departments, almost all the Ph.D. faculty and 61 percent of the M.D. faculty reported involvement in research.23 A survey in 1990 asked faculty to indicate if they spent at least 20 percent of their time in research. Although 92 percent of the Ph.D. faculty indicated that they were so involved, only 38 percent
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TABLE B-1: Percentage of Full Time Faculty, in Clinical Departments Who are PIs on NIH/ADMHA Awards (1988)
Total Full Time Faculty
Total M.D.s
Department
No.
%PIs
No.
%PIs
Opthalmology
1,014
36.5
650
25.7
Neurology
1,637
23.9
1,101
18.4
Dermatology
365
22.5
291
20.0
Int. Medicine
13,448
19.9
10,894
17.7
Pathology
1,152
17.0
656
13.9
Public Health
1,127
15.7
445
10.6
Other Clinical
69
14.5
21
19.0
Otolaryngology
543
14.2
296
6.4
Pediatrics
5,724
13.4
4,503
11.9
Psychiatry
5,244
12.1
2,858
8.1
OB/GYN
2,265
9.8
1,687
5.9
Surgery
5,031
9.5
4,038
7.0
Radiology
3,884
8.3
2,786
3.2
Orthope. Surgery
730
7.8
569
4.4
Anesthesiology
2,649
3.5
2,186
1.6
Phy. Med/Rehab.
548
1.2
341
0.9
Family Medicine
1,539
1.2
1,127
0.7
Total/Average
45,969
14.0
34,449
11.1
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Total M.D./ Ph.D.s
Total Ph.D.s
Department
No.
%PIs
No.
%PIs
Opthalmology
61
39.3
245
69.4
Neurology
148
37.8
315
35.6
Dermatology
22
40.9
43
34.9
Internal Medicine
875
31.1
1,261
33.9
Pathology
122
25.4
280
22.1
Public Health
48
14.3
472
25.0
Other Clinical
2
0.0
41
12.2
Otolaryngology
28
25.0
171
27.5
Pediatrics
275
28.4
614
21.8
Psychiatry
197
18.8
1,728
20.2
OB/GYN
126
13.5
320
32.2
Surgery
268
17.9
540
25.9
Radiology
169
13.6
696
29.0
Orthope. Surgery
23
13.0
81
34.6
Anesthesiology
181
8.8
157
22.3
Phy. Med/Rehab.
18
5.6
97
6.2
Family Medicine
25
0.0
265
6.8
Total/Average
2,589
24.3
7,327
26.9
SOURCE: AAMC Medical School Faculty Roster (1988) linked with IMPAC record of research grants (NIH and ADAMHA) and Contracts (NIH) that received funds during FY 1987.
of the M.D. faculty were.24 Because of differences in the wording of questions the two surveys are not comparable. Roughly comparable data exist for departments of internal medicine. A study in the early 1980s indicated a more intense involvement in research of physician faculty in departments of internal medicine than in departments of OB/GYN in 1990, with 50 percent of internal medicine faculty with an M.D. degree spending at least 20 percent of their time
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engaged in research. Seventy seven percent of the faculty with Ph.D. degree spent at least 10 percent of their time in research.25
Although data are not available on the level of NIH support for research in reproductive issues, or for women's health in general, there are strongly held views about the interest of NIH in those topics. It should be remembered that human embryo research cannot be supported by federal funds. The following comments from letters from chairman of departments of OB/GYN to the IOM committee indicate some concerns:
''Funding has been confused by the political turmoil surrounding sex education, abortion and contraception. Because of this departments must seek funding outside the federal government; pharmaceutical and equipment companies etc. or find clinical income to support research".
"Funding has moved from NIH and NSF to pharmaceutical companies with interests in product development. Some types of clinical research (sohographic studies of the fetus in utero) are impossible to fund through NIH, despite their importance. These studies are conducted with support from clinical income, but not at the standard of peer reviewed funding".
In addition to the political, and ethical ramifications of some areas of OB/GYN research, many OB/GYNs in medical schools believe that NIH lacks interest in reproductive issues and women's health in general. Again, comments from some department chairmen indicate these concerns:
"Lack of NIH commitment to women's health research is evidenced by composition of study sections, no separate institute and few NIH OB/GYNs".
"The governance of NIH is neither responsive nor interested in women's issues. They will only act if they think they can direct funds to other specialties. An example is the lack of representation by chairman of OB/GYN departments in the governing councils of the NIH. The NIH Advisory Committees are comprised of approximately 3,056 individuals; of those only 26 are OB/GYNs yet the most common cause for admission to most acute hospitals are in OB/GYN. I would agree with the GAO that arrogance and indifference summarize the attitude of the NIH towards women's issues and departments of OB/GYN. The NIH is not "national" in that is not representative of
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the nation or its health issues, as more than half of the nation are women".
The data and beliefs cited indicate a need to examine more closely what has been happening to OB/GYN departments in the competition for funds, and a need to indicate where one might seek change to improve the outcome.
NIH Support for OB/GYN Research
Overview
"Federal funding of research in academic departments of OB/GYN in the United States has never been substantial and the situation is no different today."26
In FY 1978, the majority of federal support for OB/GYN departments came from the Department of Health, Education and Welfare (DHEW), now the Department of Health and Human Services, with a small amount coming from the Agency for International Development. Of the money from DHEW, over 90 percent came from NIH with small amounts from ADAMHA and the Bureau of Maternal and Child Health. The picture in FY 1989 was similar, with HHS providing the large majority of federal support, and most of that coming from NIH.
Figure B-1 shows total NIH support for OB/GYN departments in both current and constant (1968) dollars. Growth in constant dollars has been modest, from $7 million in 1968 to $12 million in 1989 (71 percent). Between 1968 and 1989 OB/GYN departments slightly increased their share of NIH funds—current dollar support to OB/GYN departments grew by 570 percent while overall NIH research support grew by only approximately 550 percent. Between 1978 and 1989, support to OB/GYN departments increased by approximately 190 percent while overall NIH support grew by approximately 150 percent. The increased support of departments of OB/GYN in the 1980s is actually more impressive than the percentages indicate since the two institutes providing the majority of the support the National Institute of Child Health and Human Development (NICHD) and the National Cancer Institute (NCI) both had budget increases below the NIH average for the decade.
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Figure B-1: NIH support of departments of OB/GYN, current and constant (1968) dollars.
SOURCE: Special tabulation by NIH.
OB/GYN departments received a fairly constant share of NIH funds going to medical schools—1.5 percent in 1968, 1.4 percent in 1978 and 1.5 percent in 1989. OB/GYN faculty received approximately 2.7 percent of the NIH/ADAMHA awards to clinical departments.* However, the departments received slightly less than would be expected on the basis of size of faculty, since OB/GYN departments had approximately 3.7 percent of the total full time medical schools faculty and 4.8 percent of the flail time faculty in clinical departments in 1988.
*
It should be noted that these figures understate the actual funds going to OB/GYN departments. This is caused by the fact that the NIH data system does not allocate funds awarded to separate administrative units to the department even though the research may be directly related. Thus if a medical school has a center for reproductive research or population studies which is not administratively part of the OB/GYN department, research conducted in the center will not appear in the departmental total. However, there is no reason to believe this under reporting has increased over time or is more common for OB/GYN departments than for other clinical departments and thus should not effect longitudinal or cross department comparisons.
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NICHD has been the major NIH supporter of OB/GYN departments, providing 69 percent of support in 1968, falling to 56 pete t in 1978, returning to 69 percent in 1989. Support from the NCI fell from 31 percent in 1978 to 9 percent in 1989, although in 1989 it was still the second largest NIH funder of OB/GYN departments. The National Institute of Allergy & Infectious Diseases (NIAD) increased its support of OB/GYN departments, mostly because of a $1.7 million contract to study prenatal transmission of HIV. The Heart, Lung and Blood Institute (NHLBI) and the Division of Research Resources (DRR) also showed major increases, the latter due largely to a grant and a cooperative agreement with Emory University for "support of animal resources available to all qualified investigators without regard to scientific disciplines or disease orientation." (Table B-2).
TABLE B-2: NIH Support of Departments of OB/GYN By Institute, FYs 1968, 1978, 1989
Institute
1968
1978
1989
NICHD
$4,793,336
$8,977,923
$32,023,354
NCI
823,276
4,997,132
4,362,099
NHLBI
213,314
451,276
1,859,406
NIA
—
448,292
774,409
NIADDK
898,441
930,580
1,656,883
NIDR
16,000
187,040
—
FIC
10,661
77,541
55,496
NIGMS
73,265
59,114
389,055
NIDCDS
—
15,200
1,013,612
NIAID
—
—
2,494,911
DRR
120,031
—
946,000
NIEHS
—
—
796,639
NEI
—
—
161,632
Total NIH Support
6,948,324
16,144,098
46,533,496
Percent of NIH Support to Medical Schools
1.5 %
1.4%
1.5%
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Table B-3 shows competitive and noncompetitive NIH awards to OB/GYN departments, 1980–1989, by number and type of award (later tables reflect only competitive awards—new or competing continuations). OB/GYN department support more than doubled ($22.8 million to $46.5 million), however, since the size of awards increased, the number of awards increased more modestly. The number of research grants increased, but the number of contracts declined from 11 to 7, although contract dollar support more than doubled. Awards for training grants and fellowships combined fell in both number and dollars. These trends generally reflect the overall NIH experience during the decade.
TABLE B-3: Total NIH Awards to OB/GYN Departments (By Major Type) Thousands of Dollars 1980–1989
Total Awards
Research Grants
Contracts
Year
No.
$
No.
$
No.
$
1980
246
22,764
202
20,676
11
1,373
1881
236
26,084
212
24,444
8
1,256
1982
232
26,009
203
23,871
9
1,601
1983
233
28,978
200
25,792
13
2,713
1984
251
33,479
222
29,869
11
3,112
1985
246
36,415
222
33,383
9
2,525
1986
256
36,947
222
34,563
10
1,694
1987
275
41,902
250
39,493
9
1,943
1988
272
45,454
247
44,602
9
3,184
1989
258
46,533
235
42,678
7
3,229
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the past six years more than two thirds of the awards have been either K08s or K11 (in approximately equal numbers).
Number of Individuals in Departments of OB/GYN with NIH Training Support
It is difficult to determine the number of people in departments of OB/GYN whose research training has been helped by NIH support. While NIH codes data on the recipients of traineeships and fellowships on its records, and also has data on career development awards, those at NIH most familiar with these data files do not consider them to be reliable. However, by using several different files and source some approximate numbers can be generated: Physicians m OB/GYN departments received 18 competing career development awards between 1980 and 1989 (individuals normally receive support for two to four years). In addition to individual awards there was one institutional K award during the decade, thus roughly 20 OB/GYN M.D.s were supported by NIH career development awards. In addition, nine individual physicians in OB/GYN departments received National Research Service Fellowships directly from NIH and eight OB/GYN departments received training grants from NIH. While it is not possible to determine how many individual M.D.s received support under the institutional awards, it is generally believed that most of the programs were small. This, coupled with the fact that four of the eight institutional grants were made in FY 1988 for awards to begin in FY 1989, make it unlikely that more than 20 to 25 individuals received support under the training program during the decade of the 1980s. Adding together the career development "K" awards (seventeen individuals, one institutional award) and the research training awards (nine individual fellowships and eight training grants under the National Research Service Awards Program) it is likely that approximately fifty OB/GYNs received research training from NIH during the decade of the 1980s.
Beginning Research Awards
To help new biomedical researchers develop from working under a mentor to independence, NIH uses the R-29 grant, the First Independent Research Support and Transition (FIRST). These grants are designed "... to underwrite the first independent investigative efforts of an individual; to provide a reasonable opportunity to demonstrate creativity, productivity, and further promise and to help in the transition to traditional types of NIH research project
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grants".27 The grants are for 5 years, are not renewable, are limited to $350,000 in total and $100,000 in a single year.
The R-29 (FIRST grants) replaced similar R-23 grants in the mid 1980s, therefore departmental comparisons below include both types of awards. In 1989, 1,711 R-29 awards were made in the amount of approximately $152 million. This represents an increase from 0.8 percent of the NIH extramural research budget in 1980 ($20 million) to 2.7 percent in 1989.
Like several other grant mechanisms, OB/GYN and radiology made little use of R-23 and R-29 grants between 1980 and 1989. OB/GYN submitted few applications and had low success rates, which declined during the second five years of the decade. OB/GYN had the lowest success rate of the five departments for both the periods, 1980–1984 and 1985–1989 (Table B-13). The number of applications from M.D.s, presents a similar picture to that for traineeships and fellowships, although it is not as extreme. Over half of the R23/R29 grants from departments of pediatrics, medicine and surgery came from M.D.s, while only 31 percent of those from OB/GYN departments and 13 percent of those from radiology were from M.D.s. M.D.s from OB/GYN had success rates significantly lower than any of the comparison departments.
Institutional Grants
In addition to individual awards, NIH supports larger multi-project research efforts. The two most important are program projects (P01s) and research centers, a generic term which includes a number of different types of centers-specialized, core, comprehensive, animal, and general clinical research centers.
Program project grants (PO1s) are broad-based, long term multidisciplinary research activities organized around a basic theme. The individual sub-parts or components '...must have scientific merit and essential elements of unity and interdependence that constitute a system of research activities and projects directed toward the overall goal of the program". These grants involve large numbers of researchers and in addition to supporting the interrelated research projects can also support both basic resources and clinical components used by the overall group. The number of program project grants awarded and funding rose in the past decade. The number of awards increased from 535 to 793 and funding increased from $297.5 million to $683 million. While few in number, compared for example to RO1s, they are the second largest grant in terms of funding.
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TABLE B-13: Success Rates of R23 and R29 Applications, Selected Clinical Departments, 1980–1989
Department
Number of Applications
No. of Awards
Success Rate
All Applications
OB/GYN
165
29
17.6%
Medicine
1,909
652
34.2*
Pediatrics
607
189
31.1*
Radiology
181
68
37.6*
Surgery
411
122
29.7*
Total
3,273
1,060
32.4
M.D.s
OB/GYN
51
4
7.8%
Medicine
1,024
345
33.7*
Pediatrics
344
114
33.1*
Radiology
23
7
30.4*
Surgery
213
60
28.2*
Total
1,655
530
32.0
* Significant at 95 % confidence level when compared with OB/GYN.
Between 1980 and 1989 OB/GYN departments were relatively successful in the competition for program project grants (P01), with success rates failing approximately in the middle of the five comparison departments (Table B-14). The number of applications from each department is small and none of the differences between OB/GYN and the other four departments is statistically significant. With the exception of an increase in the number of applications from departments of medicine there are no discernable trends over the decade. In fact the most significant fact about OB/GYN performance with regard to P01s is the small number of applications—on average less than 3 per year and a total for the decade of only 28. This is only a quarter of the number submitted by
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radiology, the department with the next fewest applications. Since program project grants are only awarded to institutions with developed research programs, the small amber of applications may indicate that few OB/GYN departments believe they have the research programs that would allow them to compete successfully.
Research center grants together are the third largest grant activity in terms of dollars awarded. While there are 10 different types of center grants, the two largest are the specialized (P50) and the core (P30) which between them accounted for approximately 60 percent of the number and 57 percent of the dollars for center grants in 1989. The core grants (P30s) are designed to provide "... shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common research problem".28 Specialized centers (P50s), on the other hand, not only provide supportive ancillary activities but also provide support for an overall set of research activities to mount "... a multidisciplinary attack on a specific disease entity or biomedical problem area.29 These latter grants are similar to program project grants except that awards are usually based on specific announcements from an NIH institute or division and are more closely monitored by NIH. The number of new center grants NIH can award is limited by Congress which also earmarks some specific center programs to receive awards. In some years in the 1980s, congressional floors on the number of RO1s reduced the number of center grants made by NIH.
OB/GYN departments were competitive for P30 and P50 grants, having had the highest success rate of any of the five departments between 1980 and 1989. However OB/GYN departments submitted on average only three applications per year (Table B-14). Of the five departments only departments of medicine made major use of center grants, submitting 71 percent of applications during the decade. Like program project grants (P01s) center grants are difficult to obtain. In general such grants go only to institutions with a successful research track record.
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TABLE B-14: Success Rates of Program Project and Center Grant Applications, Selected Clinical Departments, 1980–1989
Department
Number of Applications
No. of Awards
Success Rate
PO1s
OB/GYN
28
13
46.4%
Medicine
646
336
52.0
Pediatrics
121
57
47.1
Radiology
100
47
47.0
Surgery
140
65
46.4
Total
1,035
518
50.0
P30s – P50s
OB/GYN
33
24
72.7%
Medicine
601
334
55.6
Pediatrics
111
54
48.6
Radiology
9
5
55.5
Surgery
90
47
52.2
Total
844
464
55.0
Summary of NIH Support of Departments of OB/GYN
The previous sections presented information on NIH support of OB/GYN department research and research training activities. In this section the main points are summarized.
On the positive side, between 1980 and 1989 the increase in funding of OB/GYN departments exceeded the NIH increase in funding of all clinical departments. The percentage of NIH support to medical schools received by OB/GYN departments remained relatively constant since the late 1960s, at about 1.5 percent of the total. However, by one measure OB/GYN wins less
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than its share of funding—with about 4.8 percent of full-time faculty in clinical departments of medical schools OB/GYN receives only about 2.7 percent of the funds awarded by NIH/ADAMHA to clinical departments.
While there is no evidence that the ability of OB/GYN departments to compete for NIH support seriously deteriorated between 1980 and 1989, there is a reason to be concerned about several aspects including the low level of NIH funding compared to some other departments, and the competitive state of physician investigators in OB/GYN department.
NICHD has been, and continues to be, the major supporter of OB/GYN departments, providing nearly 70 percent of NIH funds to the departments in 1989. NCI is the second largest supporter, however, its contribution declined from approximately 30 percent in 1978 to less than 10 percent in 1989. No other institute provides as much as 5 percent of the total funding for OB/GYN departments.
The total number of NIH awards to departments of OB/GYN varied from year to year between 1980 and 1989, but was slightly higher in 1989 than in 1980. The increase was in research grants (primarily RO1s), and a slight decline occurred in the number of traineeships, fellowships and research contracts awarded. The number of OB/GYN departments receiving NIH awards in any one year ranged from a high of 72 (in 1984) to a low of 67 (in 1989).
It is important to remember that while the mix of M.D.s to Ph.D.s was similar in the five departments we analyzed, the mix of grant applications was not. M.D.s in the departments of internal medicine, pediatrics and surgery submitted between 58 percent and 65 percent of the departments' grant applications, and the proportion increased through the 1980s. M.D.s in departments of radiology submitted 28 percent, and those in departments of OB/GYN submitted 38 percent. M.D.s from departments OB/GYN and radiology had the fewest applications of the five departments, and for the decade OB/GYN departments had the lowest success rate. Ph.D.s from OB/GYN departments fared better, with a success rate that put them in the middle of the five departments analyzed.
The picture with regard to RO1s is similar. Between 1980 and 1989, applications from OB/GYN departments had the lowest success rates (the differences in success rates between departments of OB/GYN and internal medicine and radiology were statistically significant). The success rate of RO1 applications submitted by M.D.s from OB/GYN departments were significantly lower than submissions by M.D.s in the four other departments. Ph.D.s in OB/GYN departments had a success rate below that of internal medicine and radiology and above that of pediatrics and surgery. The differences between Ph.D.s from departments of OB/GYN and Ph.D.s from departments of internal
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medicine and radiology were statistically significant. The competitive position of the Ph.Ds from OB/GYN declined during the later years of the decade.
OB/GYN departments were more successful in obtaining training grants and fellowships. While none of the differences are statistically significant, OB/GYN was the most successful of the five departments with regard to awards for training grants to M.D.s during the period 1980–1984. The success rate declined during the second 5 years of the decade both absolutely and relative to the other departments. A smaller percentage of the trainees in OB/GYN and radiology are M.D.s, compared with internal medicine, surgery, or pediatrics.
The success rate of OB/GYN departments in winning career development awards improved during the second half of the decade rising from the lowest to the highest success rate among the five departments analyzed. This pattern holds both for all career development awards and for those going to M.D.s. However OB/GYN department M.D.s only submitted a total of 52 applications for career development awards in the 1980s.
Both M.D.s and Ph.D.s from OB/GYN departments have been relatively unsuccessful in obtaining R-29 (FIRST) awards. Moreover, M.D.s submitted few applications (51 from departments of OB/GYN compared with 1,024 from departments of internal medicine).
By contrast OB/GYN departments have been relatively successful in obtaining both program-project grants and center grants but submitted few such applications—on average three program-projects and three center grant applications a year between 1980 and 1989. This dearth of applications may reflect both the amount of effort required to develop these applications and the fact that NIH staff will, on occasion, discourage applications from clearly noncompetitive institutions.
NIH Administration and Structure
Two kinds of problems effect NIH support of research in departments of OB/GYN. One pertains to research grants submitted by M.D.s, particularly RO1s and R29s, which have a relatively low success rate. The second relates to program-project grants, center grants, career development grants, and to some degree fellowships, for which the problem is not success in obtaining funding but rather the fact that M.D.s from OB/GYN departments submit very few applications.
This review is not able to determine the reasons for the low success rates and, in some programs, low application rates. The causes could be quality of
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the research being proposed, the substance of the research (reproductive research and research into issues concerning women's health) or the nature of the review and the composition of the review committees. Most RO1s are reviewed in the individual study sections of the Division of Research Grants. A few RO1s, usually in response to specific announcements, may be reviewed by groups set up by the supporting institute. Of more than 50 members of the four initial review groups which together review approximately 50 percent of the applications submitted by OB/GYN departments only three list OB/GYN as a primary area of expertise and only four others listed another clinical area.
This review of data pertaining to applications for funding from departments of OB/GYN does not shed light on the concern that there are characteristics of NIH that create barriers to adequate funding of OB/GYN research and women's health issues in general. These characteristics include:
A paucity of women at high levels in NIH.
The lack of a women's (or OB/GYN focused) institute.
Lack of an OB/GYN intramural program.
The pediatric orientation of NICHD's leadership.
Moreover, the budgets of the two institutes that are the major funders of OB/GYN research have not grown as fast as the total NIH budget. For 8 of the 10 years between 1980–1989, NICHD had award rates for research grants below the NIH average. In 1989, 12 of the 14 institutes and other awarding units had award rates higher than NICHD. While the impact of these factors on the funding of OB/GYN is impossible to quantify, conversations with NIH staff and others indicate that some could be important.
The question of why there is no OB/GYN intramural program at NIH has been asked for some years—the answers most often heard are that obstetric patient accrual would be difficult, the range of ancillary services needed would be hard to support and OB/GYNs will not work for low federal pay. While its not clear if, or how, the lack of intramural OB/GYN affects extramural OB/GYN research, some people claim that it leads to a lack of internal advocates for OB/GYN and that NIH staff dealing with OB/GYN grants feel isolated. Moreover, since the OB/GYN research community is the NIH "client" contact between NIH staff and the investigators cannot achieve the informal collegial relationship needed to generate creative thinking and ongoing excitement about the discipline. However, as a result of Congressional pressure, NICHD is planning to establish an intramural gynecological research section on campus. They are recruiting for an individual certified in gynecology to head the research program, direct its clinical consultative service and its
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endocrinology fellowship program. NCI has also indicated a willingness to meet with leaders in academic gynecology to discuss the possibility of establishing a gynecology branch as well as increasing support for research in gynecological oncology.
Whether it would be helpful for OB/GYN or women's health to have an institute devoted to the discipline is debatable. It is argued that relying on an institute whose primary mission is children and development relegates OB/GYN to a secondary position. This is reinforce by the tradition of having a pediatrician direct the institute. Moreover, there is a lack of visibility and organizational identification that might attract the attention of Congress to issues in OB/GYN, and allow an NIH intramural constituency to systematically develop programs. On the other hand, it is argued that a women's or OB/GYN institute would relieve the existing funders (NICHD, NCI, NIA, etc.) of the obligation to pursue OB/GYN questions, and would create a "ghetto" for OB/GYN and women's issues. In the light of ongoing developments concerning issues in women's health, such as the establishment of the Office of Research on Women's Health, and with NIH in the process of generating a research agenda for women's health, there may exist now an impetus at NIH that will allow OB/GYN and other women's health research to flourish.
Actions and Further Analysis Needed to Improve NIH Support of OB/GYN Research
Study is needed to examine charges that clinical research does not receive a fair scientific review at NIH.
The charters of the study sections that review the majority of OB/GYN applications, their composition and the applications reviewed should be analyzed to determine whether there are problems with the composition of membership.
OB/GYN academic leaders should review the career development award (Ks) and the FIRST grants (R29) to determine if there axe features of the programs that are discouraging OB/GYN participation. If such features axe found, they should meet with appropriate NIH leaders to encourage necessary changes. NIH institutes have a great range of options in how programs are structured and which mechanisms are used.
It is appropriate that representatives of gynecological oncology continue to meet with NCI leadership given the institutes's decreasing support for OB/GYN research over the past decade. Given the range of women's health issues that axe the responsibility of NIA and its relatively low level of support
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for OB/GYN research, it might also be appropriate for OB/GYN leaders to meet with representatives of that institute.
The creation of the Office of Research on Women's Health is a positive step, and the office can play an important role as a coordinator, advocate and honest broker. It will also play a role in creating a research agenda and in monitoring the responsiveness of NIH to women's health needs. However, the major strength of NIH is in its individual institutes and increased support for OB/GYN can only come from increased awareness and support from the individual institutes.
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Representative terms from entire chapter:
clinical departments
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