4
NIH POLICIES AND STRUCTURE

Reproductive researchers and investigators in academic departments of obstetrics and gynecology (OB/GYN) have long felt themselves to be the neglected stepchildren of the National Institutes of Health (NIH). The complaints axe numerous: not only do they lack their own institute, but they axe poorly represented among NIH staff and are absent from the intramural program. Furthermore, several major areas of OB/GYN interest, including fetal research, cannot currently receive federal funding. In addition, it is said, OB/GYN as a clinical discipline suffers the same difficulties in garnering NIH funds that are experienced by all clinical investigators, including review by study sections on which basic scientists outnumber clinical scientists. However, there is also a belief that OB/GYN is particularly underrepresented.

This chapter addresses two questions: whether the complaints are valid, and if so, whether these factors have an impact on the support of research in departments of OB/GYN. There is no rigorous way to test the hypothesis that the factors believed to create difficulties for OB/GYN research in fact do so. Problems in attempting to study the impact of these factors include the large number of variables that would need to be controlled if one was to compare one field of science with another. TherefOre the discussion and findings of this chapter are based on the few available systematic reviews, on interviews with individuals at NIH and in departments of OB/GYN, and on the expertise and judgment of committee members.

Absence of OB/GYN in the NIH Intramural Program

The NIH intramural program, located mainly on the NIH campus in Bethesda, Maryland, absorbs roughly 11 percent of total NIH funds. However, the importance of the intramural program is not in its size. A 1988 study by the Institute of Medicine (IOM) described the intramural program as having multiple



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments 4 NIH POLICIES AND STRUCTURE Reproductive researchers and investigators in academic departments of obstetrics and gynecology (OB/GYN) have long felt themselves to be the neglected stepchildren of the National Institutes of Health (NIH). The complaints axe numerous: not only do they lack their own institute, but they axe poorly represented among NIH staff and are absent from the intramural program. Furthermore, several major areas of OB/GYN interest, including fetal research, cannot currently receive federal funding. In addition, it is said, OB/GYN as a clinical discipline suffers the same difficulties in garnering NIH funds that are experienced by all clinical investigators, including review by study sections on which basic scientists outnumber clinical scientists. However, there is also a belief that OB/GYN is particularly underrepresented. This chapter addresses two questions: whether the complaints are valid, and if so, whether these factors have an impact on the support of research in departments of OB/GYN. There is no rigorous way to test the hypothesis that the factors believed to create difficulties for OB/GYN research in fact do so. Problems in attempting to study the impact of these factors include the large number of variables that would need to be controlled if one was to compare one field of science with another. TherefOre the discussion and findings of this chapter are based on the few available systematic reviews, on interviews with individuals at NIH and in departments of OB/GYN, and on the expertise and judgment of committee members. Absence of OB/GYN in the NIH Intramural Program The NIH intramural program, located mainly on the NIH campus in Bethesda, Maryland, absorbs roughly 11 percent of total NIH funds. However, the importance of the intramural program is not in its size. A 1988 study by the Institute of Medicine (IOM) described the intramural program as having multiple

OCR for page 109
Strengthening Research in Academic OB/GYN Departments roles in support of the NIH mission. While none of the roles or elements of the program is unique, the aggregate—comprising research laboratories, a clinical center, freedom from the competition for grants, a large group of scientists working together on a campus that provides opportunities for collaboration and interchange, a site for research training—creates a distinctive research environment.1 Over the years, the intramural program has made large contributions to basic and clinical research, as well as providing training for some of the nation's most distinguished biomedical scientists. A 1969 review of its purposes and objectives noted its contribution to the overall NIH mission by providing ''comprehensiveness of approach, scientific guidance, prestige and an unequalled opportunity for the development of future leaders.''2 But these purposes and accomplishments do not completely illustrate why it is important for a discipline to be represented in the intramural program. To answer that question, one must look at some of the tangible and intangible elements in the relationship between the intramural and extramural programs, and at some of the notions about the intramural program that prevail among NIH staff. Despite the fact that the administration of extramural grants is kept at arm' s length from the rest of NIH, there is a widely held belief that the coexistence of the two programs, intramural and extramural, at the same location and under the same overall control is vitally important.3 Some commentators cite the benefit that when intramural scientists are ready to leave the laboratory, a few transfer to the extramural program, bringing their knowledge and experience to grants and contracts administration; others note that some intramural scientists go on to become NIH leaders. According to one NIH extramural staff member, the virtually total absence of OB/GYN from the intramural program creates a sense of isolation and a vacuum where important communication should be occurring.* Another intangible result of being excluded from the intramural program is the sense, reflected both within and outside of NIH, that the excluded discipline is held in low esteem. Some current and former NIH repre-sentatives, however, dispute the notion that this is the case for OB/GYN They point to an attempt in the early 1970s to establish OB/GYN in the intramural program as aa indication that NIH supports the idea of OB/GYN intramural research.** *    Some research in reproductive endocrinology is conducted in the NIH intramural program, and a little OB/GYN-related laboratory research is conducted by visiting fellows from overseas. **   Beds for OB/GYN to collect data on normal pregnancy and delivery, as well as a perinatal unit, were designed and constructed in the Clinical Center at NIH, but the beds were never opened Reasons for the failure to follow through on the plans included a lack of needed 24-hour blood bank and anesthesia services, expected problems in patient recruitment, and difficulty in recruiting

OCR for page 109
Strengthening Research in Academic OB/GYN Departments The multidisciplinary scientific "culture" at NIH provides a distinctive training environment that is not fully duplicated in any other setting. More than 2,000 U.S. and foreign fellows (staff fellows, visiting fellows, Intramural Research Training Award fellows, etc.) are present on the NIH campus at any one time. Since the founding of the intramural program, approximately 25,000 M.D.s and Ph.D.s have received their training at NIH. Roughly one-third of the membership of the past 30 years of the American Society for Clinical Investigation received a portion of their training at NIH.4 OB/GYN may be the only major medical discipline that does not have a training program at NIH.* This exclusion is particularly disadvantageous to OB/GYN, since only a few of its academic departments have the critical mass of investigators needed to provide a stimulating, dynamic research training environment. Exclusion from the intramural program also has repercussions, as some legislators note, for the furtherance of the arch programs of existing investigators. The Senate Appropriations Committee, in its fiscal year (FY) 1992 report, cited a direct connection between the state of OB/GYN research and its representation in the intramural program: [The Committee] is concerned that while there are more than 2,000 researchers at the NIH there are only 3 in obstetrics and gynecology. The Committee urges the NICHD to increase the number of OB/GYN researchers at NIH and expand the OB/GYN research program. Research in this area has been severely hampered by the lack of highly qualified research scientists and doctors. In order to provide for both services and research needs in this area the Committee directs the National Institutes of Health to establish a clinical research program in gynecology and obstetrics within the National Institute of Child Health and Human Development.5     OB/GYN clinicians because of the differential in pay between the NIH and private practice (based on personal communications from Duane F. Alexander, Director, National Institute of Child Health and Human Development, National Institutes of Health, and Ronald A. Chez, Professor and Director of Ambulatory Care, Department of Obstetrics and Gynecology, University of South Florida College of Medicine, 1990 and 1991). *    The important role that NIH training can play in the development of research manpower is exemplified by dentistry. A dearth of scientists working in dentistry had plagued efforts to expand dental research since the inception of the National Institute of Dental Research. To rectify the situation, the institute (which, of course, includes an intramural research program) was used as a training ground for dental scientists through Public Health Service postdoctoral fellowships and guest worker positions (Ruth Roy Harris, Dental Science in A New Age: A History of the National Institute of Dental Research, Rockville, Md., Montrose Press, 1989, pp. 168–169).

OCR for page 109
Strengthening Research in Academic OB/GYN Departments The House Appropriations Committee agreed that "progress in gynecology and obstetrics research has been hampered by the absence of such a comprehensive program and a lack of emphasis on these fields of research."6 The Senate report also made a specific connection between lack of research and high rates of infant mortality: The research of the NICHD in this critical area holds the promise of developing new knowledge to prevent or treat many of the conditions which result in infant death.... The Committee requests that NICHD develop a plan to initiate an intramural research effort to conduct research on pregnancy and perinatology....7 The National Institute of Child Health and Human Development (NICHD) is establishing a gynecologic intramural research program, based at the NIH clinical center, that will conduct both basic and clinical research on gynecologic disorders. In addition, a Perinatal Research Program is being put into place. This program will have three components: a clinical research program, based at a D.C. hospital, focusing on preterm labor and intrauterine growth retardation; a laboratory research component, based in a D.C. medical school; and a program of clinical trials focusing on service delivery and support systems designed to reduce infant mortality. The latter component will be established under a cooperative agreement with three medical schools and the D.C. Health Department. Eventually, 20 to 30 professionals at NIH will be involved in the program, as well as the staffs of the hospitals. However, although the House FY 1992 appropriations report earmarked $5 million for these activities, the Senate report did not mention an appropriation. NICHD leadership does not believe that there are funds in ongoing programs that could be used for this initiative. If the programs are to reach their intended potential, approximately $35 million will be needed within five years.8,9 At the National Cancer Institute (NCI), initial explorations are under way to establish the feasibility of a gynecologic intramural program. The initiative for this effort came from leaders in the Society of Gynecologic Oncologists who

OCR for page 109
Strengthening Research in Academic OB/GYN Departments launched a series of conversations with NCI staff, during which they made the case for participation in the intramural program.* As a result of the influence of two very different groups, two institutes can be expected in the near future to have formed the nucleus of an OB/GYN intramural program. (There is, however, some question as to whether NICHD's emphasis on work conducted off the NIH campus, and on service delivery, constitutes a true "intramural program" that will bring to OB/GYN the full array of benefits described above.) Whether these activities will grow beyond the symbolic to the meaningful—that is, to the point where the NIH intramural program becomes a significant force in OB/GYN training and research—cannot today be prophesied. But even if the intramural OB/GYN effort remains relatively small, some of the disadvantages of operating in the absence of an intramural program should be diminished: there will be at least a few intramural OB/GYN investigators with whom the extramural staff can confer; limited training opportunities will become available; and the status of OB/GYN investigation will be upgraded. FINDINGS: The absence of an OB/GYN intramural program at the NIH places OB/GYN at a disadvantage in several ways. Some NIH extramural staff who work in OB/GYN feel that they lack a community of scientists on the NIH campus with whom they can communicate. Progress in OB/GYN research may be held back because the discipline is deprived of a unique environment for the conduct of research. Most important for OB/GYN, which has few outstanding sites for research training, is the loss of the exceptional training environment that has produced many of the nation's outstanding biomedical scientists. NIH has responded to initiatives from Congress and from OB/GYN leaders by setting in motion the beginnings of OB/GYN intramural activities, but these efforts are not likely to grow to a meaningful size unless they are appropriately supported. RECOMMENDATIONS: Congress should ensure the success of recent initiatives to establish intramural programs in OB/GYN by appropriating the necessary funds. If efforts to obtain additional funds for intramural *    The society's leaders also argued for increased representation of gynecologic oncology on the extramural staff and on NCI advisory committees, and for modification of training grants to make them more accessible to gynecologic oncology fellows.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments OB/GYN programs fail, however, NICHD and NCI should use existing money to establish intramural research and training programs in OB/GYN. Leaders of the profession of OB/GYN have the responsibility to educate and inform those in decision-making positions about the importance and promise of an intramural program of OB/GYN research. Interest groups that have adopted women's health as an important issue have also been major players in the movement to establish OB/GYN intramural programs. OB/GYN leaders have participated in these groups and can continue to align themselves with these groups when their interests are parallel. (See Chapter 5 for further discussion of leadership issues.) OB/GYN leaders should also work with NIH staff to identify key issues and otherwise encourage OB/GYN research. The success of a small group of OB/GYN leaders in persuading NCI leadership to launch intramural activities demonstrates the importance and effectiveness both of leadership initiative and of working closely with NIH staff. OB/GYN professionals and professional groups should work to identify issues that fall within the control of NIH staff, identify the pertinent staff members, and initiate exchanges with these individuals with a view to highlighting ways in which OB/GYN research can address important issues and is therefore worthy of encouragement and investment. Absence of a Focal Point for OB/GYN Research at NIH Pros and Cons of Creating New Institutes Unlike diseases such as cancer and heart disease, and unlike medical practice areas such as dentistry and nursing, the reproductive sciences do not have an NIH institute or an independent NIH center whose sole or primary mission is the furtherance of knowledge in this area. Rather, OB/GYN and the reproductive sciences are part of the mission of NICHD, which is responsible for research on child and maternal health. NICHD is also the principal source of NIH support for OB/GYN departments. Other institutes come into play only to the extent that their interests overlap with OB/GYN—for example, reproductive cancers at NCI, infectious diseases of the reproductive system at the National Institute of Allergy and Infectious Diseases (NIAID), and so on. Having an NIH institute or center devoted to a research area is not a prerequisite to the generation of major funding for that area. For example, neither AIDS nor Alzheimer's disease has an institute, but both are funded at

OCR for page 109
Strengthening Research in Academic OB/GYN Departments high levels. Nevertheless, many believe that a categorical institute provides a strong impetus to funding—which is why advocates for research in specific areas often lobby to establish institutes. This belief may not always be correct. In 1984, an IOM committee examining the organizational structure of NIH found it difficult to evaluate the impact of a new institute, concluding that it does not always result in a major acceleration of research. This committee was better able to evaluate the impact on funding of establishing a new institute out of a previously existing one—the closest analogy to separating OB/GYN research from NICHD to form an institute. It found that when the National Eye Institute split off from the National Institute of Neurological Diseases and Blindness, its funding grew faster than the rest of NIH—but only for one year. The new institute did have a substantial impact in qualitative terms: by expanding the intramural program and developing workshops and programs emphasizing interdisciplinary research, the scope of vision research was considerably expanded. By contrast, when the National Institute on Aging split off from NICHD, funding for the new institute grew faster than the remainder of NIH for several years.10 In short, splitting off a research field from an existing institute to form a new institute is no guarantee that additional funds will accrue to the field in the long run. On the other hand, activities such as those that expanded vision research at the new National Eye Institute can occur within an existing institute, if the leadership becomes engaged in promoting a research field. This occurred when the Heart Institute established the Lung Division, transforming lung research from an undeveloped area to a thriving research field. The 1984 IOM committee concluded that the scientific readiness of a field, together with dynamic leadership, can be more important than institute status as a catalyst for growth.11 Structure and Priorities of NICHD NICHD, as the principal source of NIH support for OB/GYN departments, plays an important role in the welfare of OB/GYN research. NICHD was formed after a 1960 Presidential Task Force on Health and Social Security recommended the establishment of a child health institute to focus on the normal processes of maturation. Subsequent discussion broadened the scope of the proposed institute so that when NICHD was established in 1963 it was structured to support four areas of research: reproduction, growth and development, aging, and mental retardation. In 1968, the establishment of the Center for Population Research brought increased prominence to problems of fertility and infertility. In 1975, the Center for Research for Mothers and Children was put

OCR for page 109
Strengthening Research in Academic OB/GYN Departments in place to provide a focus for research and research training in the health problems of pregnancy, infancy, childhood, human learning, and behavior.12 Statements of the mission of NICHD unfailingly emphasize research on reproductive processes and the management of fertility, along with the physical and mental changes that are continuous throughout life. However, there are only three OB/GYNs on the staff of the NICHD extramural program, and all the directors of NICHD have been pediatricians. The same low priority for OB/GYN research is reflected in the composition of the councils and committees that advise the directors of NICHD and its centers on program planning directions:* The National Advisory Child Health and Human Development Council identifies promising areas of research and defines program priorities, primarily by awarding extramural grants and contracts in areas deemed to be of high priority.13 The council also reviews the long-term plans of each of the NICHD centers. It is chaired by the director of NICHD (a pediatrician) and includes three other pediatricians and two OB/GYNs. The Maternal and Child Health Research Committee includes five pediatricians and two OB/GYNs. The Population R earth Committee, which emphasizes basic sciences and includes members with expertise in biochemistry, physiology, sociology, and demography, has one OB/GYN.14 The Board of Scientific Counsellors, which advises on the intramural program, lacks any OB/GYN reputation. This should come as no surprise, since there is no OB/GYN intramural program. In sum, the voice of OB/GYN is not loud in the councils of NICHD, particularly when compared with the voice of pediatrics; yet it is from these councils that the director and his staff receive advice for program plans. Institute staff can also play an important role in promoting a research area. Staff are responsible for eking the input of the research community into the development of the research plans that determine funding priorities. They identify the topics that are the subject of conferences used to highlight research areas and to showcase multidisciplinary approaches to problems, thus allowing investigators to take advantage of relevant advances in other fields. Staff can *    The composition of NIH advisory committees is circumscribed by the charter of the committee Sometimes the charter specifies that holders of a certain position (e.g., NIH director) should be members; at other times it specifies particular expertise as a membership criterion.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments also initiate requests for applications (RFAs) to prompt applications in priority areas and can use many other mechanisms to stimulate interest from the research community. There are few OB/GYN staffers at NICHD, however, and therefore few people whose primary interest is likely to be stimulating vigorous interest in OB/GYN research or supporting the OB/GYN research community in its endeavors to obtain funding. FINDINGS: Being funded primarily by an institute whose chief focus is not OB/GYN puts OB/GYN research at a disadvantage. While the committee recognizes that the level of support received by departments of OB/GYN reflects in some measure the paucity and quality of applications, it also finds that NIH has a role in the process of developing research strength in OB/GYN departments. A scientific discipline can thrive in the absence of an NIH institute devoted to its field but only if the enthusiastic attention of NIH leaders is provided. Thus, the very small number of OB/GYNs on NICHD staff, the low representation of OB/GYN on NICHD councils and committees compared with pediatrics, and the pediatric leadership of NICHD are significant and suggest that OB/GYN research lacks visibility at that institute. Other institutes also have responsibility for areas of science that fall within OB/GYN research, such as the work of NCI on neoplasias of reproductive organs and that of the National Institute on Aging, which encompasses topics dealing with menopause. The committee urges all institutes to respond to the spirit of the recommendations below. RECOMMENDATIONS: Institutes at NIH whose missions include areas of science to which OB/GYN contributes should affirm their commitment to reproductive health and ensure its appropriate priority in their programs. The committee believes that there is an urgent need for changes that emphasize the importance of OB/GYN research. Actions that would help overcome some of the problems OB/GYN research now confronts might include the National Institute of Child Health and Human Development changing its name to signal to the public and institute staff its commitment to and responsibility for reproductive health. NICHD could also recognize the importance of programs in reproductive health by establishing the position of deputy director for reproductive health or by appointing a board-certified OB/GYN to the position of deputy director. Further actions that might be considered by NICHD include increased representation of

OCR for page 109
Strengthening Research in Academic OB/GYN Departments OB/GYN on its staff, and the development of requests for applications (RFAs) on high-priority OB/GYN research topics identified in institute plans. Study Sections Like many investigators who seek NIH funding, clinical investigators in departments of OB/GYN believe that the playing field is tilted against clinical research. They claim that the membership of the study sections that review their grants is overwhelmingly composed of basic scientists who not only fail to appreciate the scientific worth of clinical studies but also fail to understand that clinical investigation is necessarily less rigorous than bench science: the clinical investigator cannot control all the characteristics of the study population; ethical constraints, such as patients not receiving state-of-the-art treatment, make it difficult to select appropriate controls; confounding variables axe difficult to eliminate; and the costs of clinical investigation tend to be high in comparison with the costs of basic science. The evidence is mixed on whether basic investigation does better than clinical investigation in NIH grants review. An unpublished study of 75,611 competing research applications found no statistically significant difference between the priority scores or funding of applications revolving human subjects compared with those that did not, and no statistically significant difference between applications from M.D.s and those from other applicants; however, the approval rate was 11 percent higher for applications that did not involve human subjects. This latter finding was confirmed by two other studies, and two out of three other studies also found differences in priority scores. In one, applications involving human subjects (evaluated by a review group on mammalian genetics) were 20 percent less likely to receive priority scores in the top quartile than were basic science applications—but the type of degree of the investigator was not related to the rating.15 Using the degree of the investigator as an indicator of clinical versus basic research,* between 1975 and 1989, Ph.D.s had slightly better priority scores than M.D.s on RO1 applications, but in 1989, M.D.s had slightly higher success rates than Ph.D.s.16 *    Since physicians may be principal investigators on basic science studies, and vise versa, this is by no means a perfect measure of clinical and basic science.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments Given the unity about whether clinical investigation is disadvantaged in the review process,* one might ask whether the composition of the review groups makes a difference and whether the composition of the groups that review applications from departments of OB/GYN puts that discipline at a disadvantage. Assuming a relationship between the degree of the reviewers and the ability of the group to conduct fair reviews, there is some reason for increasing concern. Between 1979 and 1989, M.D.s fell from 42.2 percent to 28.4 percent of study section members (a drop of 13.8 percent), while applications from M.D.s fell from 30 percent to 25.6 percent of all applications (a drop of 4.4 percent).17 If proportional representation is the issue, however, M.D. membership still slightly exceeded M.D. applications in 1989. There is suggestive evidence that these data are irrelevant. An unpublished study of clinical research applications sent to six NIH review groups between 1977 and 1980 showed that approval rates and priority scores were not affected by the percentage of M.D.s among reviewers.18 Nevertheless, many clinical investigators believe that NIH study sections as presently constituted are not appropriate for the evaluation of clinical investigation. Over the years they have called for separate review of basic and clinical investigations, by study sections composed of experts in such work. The concern with the composition of study sections has to do with whether members have the expertise to evaluate the grant applications properly. It is often assumed that to fully understand the science and the context of the applications they review, study section members must be specialists in the relevant medical or scientific disciplines. In 1989, only 3 of the 1,434 study section members had OB/GYN as their primary area of expertise. The representation of OB/GYN was only a little better in other years (Table 4-1). More interesting is the representation of OB/GYN on the four study sections to which most applications from departments of OB/GYN go for review: biochemical endocrinology, human embryology and development, reproductive biology, and reproductive endocrinology. Together these study sections review about 50 percent of all applications from departments of OB/GYN. Of the 60 members of these study sections, three listed OB/GYN as their primary area, and an additional four listed other clinical areas.19 *    The question of whether applications for clinical research fare as well as applications for basic research is complicated by differing definitions of clinical investigation. Many people believe that only a subset of what is broadly defined as clinical investigation—that is, only clinical trials—have particular difficulty in getting funded.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments TABLE 4-1: Primary Area of Expertise of NIH Initial Review Group Members—Selected Areas, 1977–1989 Specialty 1977 1981 1985 1989 Anesthesiology 2 2 4 5 Clinical Dentistry 5 6 9 14 Internal Medicine 111 105 135 117 Maternal/Child Health 0 0 0 1 Neurology 6 7 12 16 OB/GYN 8 4 6 3 Ophthalmology 10 10 8 7 Otorhinolaryngology 3 3 7 4 Pediatrics 12 23 26 19 Radiology 6 13 11 9 Surgery 20 15 26 21   SOURCES: DRG Peer Review Trends 1977–1986; DRG Peer Review Trends 1979–1989. Information Systems Branch, Division of Research Grants, National Institutes of Health. What this means for OB/GYN is difficult to determine. The relatively low success rate of applications for grants from departments of OB/GYN (noted in Chapter 2) could be due to the poor quality of the work being proposed, a lack of understanding on behalf of the study section members, or some other reason. To try to get a bell (although limited and subjective) grasp on whether the composition of study sections is serving OB/GYN well, informal interviews were conducted with some past and present members of the reproductive biology study section. All of the members interviewed were OB/GYNs, on the assumption that they would be most sensitive to the evaluation of OB/GYN applications. The results of the interviews were inconclusive, revealing wide differences of opinion. On the one hand, some of those interviewed said that the Scientific Review Administrator (who is responsible for recruiting review group members and ad hoe members when needed) is sensitive to the need to bring in outside reviewers, especially for clinical proposals. In addition, according to this view, the basic scientists in the study section are responsive to explanations of the complexity of clinical investigation and will score applications appropriately when they understand that a proposed methodology is the best that can be formulated and that an important topic is being investigated. On the other hand, some interviewees said that OB/GYN is

OCR for page 109
Strengthening Research in Academic OB/GYN Departments particularly underrepresented and that clinical research does not get equal consideration because of the preponderance of Ph.D. members of the study section. On one point there was agreement among those interviewed: that the quality of applications from departments of OB/GYN is at least partly responsible for their low success rate, even taking into account the multiple problems that axe inherent in OB/GYN clinical investigation (e.g., the limit on invasive procedures that can be done on healthy, pregnant populations). Some NIH staff emphasize that they can help investigators learn how to succeed in the grants process. While there is undoubtedly variation in the enthusiasm of NIH staff for such tasks as attending professional meetings to discuss grants procedures or convening groups of leaders and investigators at NIH to develop rapport with the research community, the committee is convinced that opportunities exist and that if they are used, they could make a difference in the success of applications from departments of OB/GYN. FINDINGS: OB/GYN is sparsely represented in the membership of study sections, but it cannot be established that applications from OB/GYN receive unbalanced reviews. It is also clear that Scientific Review Administrators have a valuable fund of knowledge that, if tapped, might enable investigators to improve their grant-writing abilities and guide them to apply for different kinds of grants. RECOMMENDATIONS: To ensure the dissemination of knowledge about grants processes, and to enable applicants to improve their applications and make full use of the many NIH funding mechanisms, members of academic departments of OB/GYN and members of professional societies concerned with OB/GYN research should explore all avenues of communication with NIH staff. Scientific Review Administrators, in particular, those of the four study sections in which the majority of applications from departments of OB/GYN axe reviewed, should continue to ensure that applications for grants in OB/GYN research are reviewed by individuals who are sensitive to the particular difficulties of working in OB/GYN clinical investigation and who have the in-depth knowledge of OB/GYN needed to ensure appropriate review. OB/GYN leaders can help by inviting Scientific Review Administrators to professional association meetings. NIH staff axe also urged to commit time and to use the mechanisms at their command to sustain such communication.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments Restrictions on NIH Research Support Chapter 1 of this report noted that examination of the ethical implications of fetal research is beyond the scope of this study. The committee is concerned, however, with factors that have an impact on the vitality of the OB/GYN research enterprise and on the decisions of individuals to enter or remain in OB/GYN research. It therefore questioned whether a policy that in effect prohibits federal funding of arch in an area of growing clinical importance deters would-be investigators, and whether advances in the health of patients are adversely affected. In 1989, an Institute of Medicine committee developed a large clinical and basic research agenda that would further the practice of in vitro fertilization. Some of the scientific questions included in that agenda could only be answered through research using the human fetus.20 The committee found it difficult to find evidence that either contradicted or supported the notion that the lack of federal funds for fetal research deters people from OB/GYN research careers. Therefore it was forced to rely on the sense of its members—that numerous interesting research areas are not being funded and that thwarting the interest of young physicians in medically assisted conception and its supporting research deters individuals from a career in investigation. The committee concluded that federal funding of fetal research offers the promise of significant advances in understanding implantation, developmental biology, and prenatal genetic diagnosis. The committee was also convinced that federal funding of such research would also significantly strengthen research initiatives in departments of OB/GYN by opening up new areas of investigation that would draw additional OB/GYN professionals into research. References 1. Institute of Medicine. A Healthy NIH Intramural Program: Structural Change or Administrative Remedies? 1988. Washington, D.C.: National Academy Press, 1988. 2. National Institutes of Health. NIH Intramural Research for Increasing knowledge. Program Report and Plan. Bethesda, Md.: Office of the Associate Director for Program Planning and Evaluation. Office of the Director, May 1, 1969, p. 12. 3. Institute of Medicine. A Healthy NIH Intramural Program. Structural Change or Administrative Remedies? Washington, D.C.: National Academy Press, 1988. 4. Ibid. 5. U.S. Senate. Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriation Bill, 1991. Report 101–516. 101st Cong. 2d sess. October 10, 1990, pp. 121–122.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments 6. U.S. House of Representatives. Departments of Labor Health and Human Services, and Education and Related Agencies Appropriations Bill, 1992. Report 102–121. 102nd Cong. 1st seas. June 20. 1991, p. 86. 7. U.S. Senate. Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriation Bill, 1991. Report 101–516. 101st Cong. 2d seas. October 10, 1991, p. 121–122. 8. Gaines, George W. Legislative Liaison Officer, National Institute of Child Health and Human Development, personal communication, July 1991. 9. Telephone interview with Alexander, Duane, Director, National Institute of Child Health and Human Development, September 27, 1991. 10. Institute of Medicine. Responding to Health Needs and Scientific Opportunity: The Organizational Structure of the National Institutes of Health. Washington, D.C.: National Academy Press, October 1984. 11. Ibid. 12. National Institutes of Health. Child Health and Human Development: An Overview and Strategy for a Five-Year Research Plan. Bethesda, Md. 1981. 13. Institute of Medicine. Funding Health Sciences Research. A Strategy to Restore Balance, ed. Floyd Bloom and Mark Randolph. Washington, D.C.: National Academy Press, 1990. 14. Mary Plummer, National Institute of Child Health and Human Development, personal communication, July 1991. 15. Cited in Cuca, Janet Melei. Scientific, Social and Other Factors in the Evaluation of Applications for NIH Research Grants. A dissertation submitted to the Graduate School of Arts and Sciences, Catholic University of America ; 1990. 16. National Institutes of Health. DRG Peer review Trends. Workload and Actions of DRG Study Section, 1979–1989. Bethesda, Md.: Statistics and Analysis Branch, Division of Research Grants, pp. 71 and 83. 17. National Institutes of Health. DRG Peer Review Trends. Member Characteristics. 1979–1989. Information Systems Branch. Division of Research Grants. Bethesda, Md.: National Institutes of Health. 18. Cited in Cuca, Janet Melei. Scientific, Social and Other Factors in the Evaluation of Applications for NIH Research Grants. A dissertation submitted to the Graduate School of Arts and Sciences, Catholic University of America, 1990. 19. Walkington, Robert. National Institutes of Health Support of Research in Departments of Obstetrics and Gynecology. Appendix B, this volume. 20. Institute of Medicine, National Research Council. Medically Assisted Conception: An Agenda for Research. Washington, D.C.: National Academy Press, 1989.

OCR for page 109
Strengthening Research in Academic OB/GYN Departments This page in the original is blank.