Appendix C
Report of the Task Force on Clinical Research in Surgery

EXECUTIVE SUMMARY

Nearly all research performed by surgeons has a direct impact on or implications for patient care; therefore, the boundary between clinical and basic surgical research is almost nonexistent. In many areas of investigation, surgeons are uniquely positioned to bring the gains of fundamental advances in molecular biology and bioengineering to the patient's bedside.

Clinical research in surgery is currently inadequate in scope and, with some prominent exceptions, in quality. Greater and more meaningful collaboration between basic science and surgical departments needs to occur. The funding base in research is both inadequate and too narrow. One strategy is for surgeons and their professional associations to create a research foundation analogous to the Orthopaedics Research and Education Foundation (OREF). The OREF receives annual voluntary contributions from practicing orthopaedic surgeons and from industry. As an independent foundation with its own board of trustees, it undertakes peer review of both individual and institutional research proposals.

A second strategy for widening the base of surgical research is to develop collaboration between the military and civilian sectors. Military surgical training programs currently have inadequate experience for their residents in the management of major trauma, whereas civilian trauma centers, particularly those in central city areas, have inadequate personnel and funding. Training for military residents and continuing trauma and critical care experience for military surgeons can easily be provided in civilian trauma centers. All parties win in this arrangement: the military obtains the needed training in trauma, overworked



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Careers in Clinical Research: Obstacles and Opportunities Appendix C Report of the Task Force on Clinical Research in Surgery EXECUTIVE SUMMARY Nearly all research performed by surgeons has a direct impact on or implications for patient care; therefore, the boundary between clinical and basic surgical research is almost nonexistent. In many areas of investigation, surgeons are uniquely positioned to bring the gains of fundamental advances in molecular biology and bioengineering to the patient's bedside. Clinical research in surgery is currently inadequate in scope and, with some prominent exceptions, in quality. Greater and more meaningful collaboration between basic science and surgical departments needs to occur. The funding base in research is both inadequate and too narrow. One strategy is for surgeons and their professional associations to create a research foundation analogous to the Orthopaedics Research and Education Foundation (OREF). The OREF receives annual voluntary contributions from practicing orthopaedic surgeons and from industry. As an independent foundation with its own board of trustees, it undertakes peer review of both individual and institutional research proposals. A second strategy for widening the base of surgical research is to develop collaboration between the military and civilian sectors. Military surgical training programs currently have inadequate experience for their residents in the management of major trauma, whereas civilian trauma centers, particularly those in central city areas, have inadequate personnel and funding. Training for military residents and continuing trauma and critical care experience for military surgeons can easily be provided in civilian trauma centers. All parties win in this arrangement: the military obtains the needed training in trauma, overworked

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Careers in Clinical Research: Obstacles and Opportunities surgical residents and faculty members in trauma centers would have time to train in or conduct research, and the care of the underserved patients in county hospitals would improve. The arrangement could also lead to collaborative research between universities and the military, allowing academic surgeons access to research funds in the U.S. Department of Defense. The most important single reform necessary to promote clinical research by surgeons is for the National Institutes of Health (NIH) to implement true peer review. Of the more than 2,432 members of NIH study sections, only 21 are surgeons. There are only 5 surgeons among the 630 serving on institute review groups. Even in the surgery study sections, only a small minority are surgeons. Although surgeons have failed to take full advantage of NIH and U.S. Department of Veteran's Affairs (VA) career development awards, it should be noted that the guidelines for many of these grants appear to have been written with the express purpose of excluding surgeons. Career development awards must have the flexibility to allow surgeons the necessary time to enable them to maintain their operative surgical skills while developing academic careers. The barriers to a career path in clinical research in surgery are similar to those in other disciplines, with some important differences. The length of training in surgery is very long, and the life of the academic surgeon is very busy, since one must maintain one's surgical skills to have credibility among one's peers. Research funding is also much more difficult for surgeons to obtain. The task force makes the following recommendations: Increase meaningful collaboration between basic sciences and surgery by joint appointments of high-quality investigators. Propose to the American College of Surgeons the development of a research foundation, with contributions from surgeons and industry, to support research in surgery. Explore the development of collaboration between the military and civilian trauma centers; suggest that H. Mendez, Deputy Secretary of Defense for Health, be invited to testify before the full committee. NIH should undertake true peer review of proposals by surgeons by making the composition of surgical study sections at least 75 percent academic surgeons. Improve recruitment and retention of academic faculty in surgery through outreach programs to recruit students, minorities, and women; implementation of direct support of surgical research by the surgical community, and development of a formal program for the initial phase of faculty appointment of young academic surgeons. Special attention should be paid to the role of women in surgery; they should be recruited into Surgical Scientist Training Programs (SSTP) and given

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Careers in Clinical Research: Obstacles and Opportunities tenured positions, and special effort should be made to provide them mentors and role models. Similarly, minorities are underrepresented in surgery. The financial factor appears to be the absolute limiting factor for the career choices of minorities. Strategies are required to address this. Develop an NIH SST program and request that the Accreditation Committee for Graduate Medical Education (ACGME) facilitate development of accreditation of the SSTP track by the Residency Review Committee on Surgery. Shorten the length of clinical training in surgery and the surgical subspecialties. DEFINING CLINICAL RESEARCH IN SURGERY Nearly all research performed by surgeons can be regarded as clinical research. From the perspective of the task force, therefore, little is to be gained by trying to define the limits of clinical research in surgery. Examples of the kinds of research performed by surgeons are given below, and all are considered clinical research. Examples of Human Studies prospective clinical trials in some aspect of surgical therapy or cancer treatment, research on human subjects that examines physiological alterations caused by surgery, studies of immunosuppression or prevention of rejection in transplant patients, and outcome studies of clinical therapy. Examples of Animal Studies developing and testing of implantable devices, for example, artificial joints and prosthetic heart valves; developing new laparoscopic, endoscopic, and arthroscopic surgical instruments and procedures; organ, tissue, or cell transplantation with attendant studies in immunobiology and pathology; developing animal models of disease, for example, of acute pancreatitis or degenerative arthritis; and physiological studies of myocardial function, blood flow, gastrointestinal function, and so forth.

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Careers in Clinical Research: Obstacles and Opportunities Studies at the Tissue, Cellular, and Molecular Level mechanisms of immunological tolerance, endothelial biology, and healing of wounds, bone, tendon, muscle, cartilage, nerve. In all of the examples given above, the research is directly applicable to patient care. Nearly all surgical research is of this nature. As advances in molecular biology are made, surgeons must be ready to carry these advances to the bedside. Hence, a restrictive definition of clinical research that may have been appropriate 10 or 20 years ago is no longer acceptable. IMPROVING CLINICAL RESEARCH IN SURGERY The task force discussed the importance of having basic scientists as equal members in surgical departments. Having second-rate basic scientists that do research as ''hired guns" is unacceptable. Indeed, especially in the era of unprecedented advances in biology, an opportune time exists for clinical departments to develop special collaboration with basic science departments. Outstanding basic scientists should be recruited jointly with basic science departments to have joint appointments in the basic science and clinical departments. The clinical departments would provide full-time employment, space, and research support. Individuals recruited in this fashion would be prized both by the basic scientists and clinicians, and they would be ideally situated to help bring the advances of modern science to the clinical arena. RESOURCE BASE FOR CLINICAL RESEARCH IN SURGERY Orthopedic Surgery This surgical discipline has made impressive gains in providing a funding source and coordinating efforts to promote research, thanks to the vision of the leadership of the specialty. This effort is discussed as a potential model for other surgical disciplines. OREF has established a fund to award grants for orthopaedic research. Contributions to this fund come from two sources. Voluntary contributions are supplied by the membership of the American Academy of Orthopaedic Surgery. A substantial proportion of orthopaedic surgeons in the country make an annual contribution of $1,000 to the fund, thus joining the "Order of Merit." OREF also receives unincumbered industrial contributions.

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Careers in Clinical Research: Obstacles and Opportunities In 1991, OREF received $3.8 million in contributions and committed $3.7 million to 79 new grants. Although this funding amounts to only about 5 percent of all research expenditures in orthopaedics, it is being used in creative and effective ways including three career development awards, 23 individual investigator-initiated research grants, 9 resident research fellowships, 7 orthopaedic departmental progress grants, 19 state orthopaedic society grants, 4 clinical research lectureships, and 10 institutional grants. In addition, OREF will provide more than $55,000 to underwrite the American Orthopaedic Association Residents' Conference, the American Shoulder and Elbow Surgeons' Research Conference, and the 1992 Gordon Orthopaedic Conference on Orthopaedics. Recently, the OREF and the American Academy of Orthopaedic Surgeons have worked together to sponsor six two-year health services research fellowships that began in July 1993. All OREF grants are awarded following rigorous peer review. Institutional grants usually involve site visits. In general, grants are given without providing for indirect costs, with some exceptions, in which individual grants may include approximately 15 percent overhead. The American Academy of Orthopaedic Surgeons has established and supports a Center for Research and a Council for Research. These units within the Academy help support the OREF and coordinate efforts to strengthen orthopaedic research at all levels. The experience of OREF suggests a successful mechanism for distributing any unencumbered research support that may be obtained from industry. The task force believes that OREF, the American College of Surgeons, or similar organizations with proper peer review systems, rather than large organizations such as NIH, provide a better mechanism for allocating research endowment funds that may be developed with contributions from industry. Such a peripheral system of distribution is more likely to address the specific research needs of surgical disciplines. A brief description of the OREF is given at the end of this appendix. NIH A strong perception exists among surgeons that there is potential bias in the review process against proposals with surgeons as principal investigators. Fair critical review of surgical research proposals requires that review be conducted by individuals with appropriate surgical education and experience. In many instances the peer review process has not met this criteria and therefore is not true "peer review." Even when surgical study sections have been organized, the number of surgeons participating in these sections is frequently too small. For example, only three orthopaedic surgeons serve on the Orthopaedic and Musculoskeletal Study Section. While the total NIH funding for grants reviewed by the Orthopaedic and Musculoskeletal Study Section has increased, the number

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Careers in Clinical Research: Obstacles and Opportunities of grant awards with orthopaedic surgeons as principal investigators has declined over the past decade. Furthermore, of the 2,434 members of the NIH study sections, only 21 are surgeons, and only 5 of the 630 members of the institute review groups are surgeons. Even more critical, there are no surgeons on most of the NIH advisory councils that make final recommendations concerning funding. The task force feels that the bias against surgery must be removed. This is best done by having true peer review and by having surgeons in the councils. A mechanism that may expand the pool of surgeons in study sections is to have a large panel of surgical experts who could be invited to serve as necessary. A special problem was identified in trauma. Funding for research in trauma is shared by 3 federal agencies (NIH, the Centers for Disease Control and Prevention, and GMS). The arrangement is confusing to the investigator who wishes to apply for funding. Also, the responsibilities of each funding agency are unclear. Department of Defense Three compelling reasons were identified to support a proposal for cooperation between the U.S. Department of Defense and county hospitals. First, inadequate opportunities exist for the military to train in trauma during peacetime. Nationally, trauma care is concentrated largely in county hospitals. This vast experience could be made available for training of military residents and for providing continuing experience for surgeons in the military. Second, academic faculty members in county hospitals are overworked and have little opportunity to engage in research. The participation of military surgeons in trauma care in county hospitals would ameliorate this problem. Creative, collaborative research between the military and academic institutions could be developed in this way. The quid pro quo for resident training provided to the military might be direct provision of military funding for joint research efforts. Third, the large population of patients in county hospitals would be the beneficiary of such a collaboration. The problem of long delays experienced by patients who come to county hospitals could be alleviated. It should be relatively easy to arrange for periods of training of the military surgical residents in civilian trauma centers. This arrangement would provide the needed training for the military while alleviating personnel shortages in trauma centers. Such arrangements have already been made in selected instances, such as the Martin Luther King Medical Center in Los Angeles and the Washington Hospital Center in Washington, D.C. A second collaborative effort could be developed between the U.S. Department of Defense and VA hospitals. The task force suggests that VA hospitals are an ideal solution for the provision of care for the dependents of

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Careers in Clinical Research: Obstacles and Opportunities members of the military as the U.S. Department of Defense is closing down military bases and hospitals. This arrangement would reverse the declining census of many VA hospitals and would indirectly benefit clinical research. BARRIERS TO CLINICAL RESEARCH CAREERS IN SURGERY Surgery, perhaps more than any other clinical discipline, requires an increase in its base in clinical research. Several reasons may be cited: (1) clinical research in surgery is currently inadequate in scope and, with some prominent exceptions, in quality; (2) clinical practice in surgery is lucrative and attracts increasing numbers of young surgeons away from academic careers; (3) even when surgeons have made a commitment to an academic career, the demands of patient care interfere with their ability to spend adequate time in research; (4) a perception abounds among surgeons that they are not given a fair chance in competition for NIH funding; and (5) the need to subject modes of surgical therapy to randomized clinical trials at their inception is great because operations become all too frequently accepted for general use prior to adequate proof of their efficacy. Barriers Barriers at Entry Level General surgical residency is typically five years long. The programs that prepare residents for a career in academic surgery frequently require one or more additional years. If a resident wishes to specialize (for example, in cardio-thoracic, pediatric, vascular, plastic, or transplant surgery), a further two-year period of training is required. Young academic surgeon specialists usually start their careers between the ages of 34 and 36 years. The debt accumulated during medical school is significant, and the further indebtedness that must occur during specialty training is unappealing. Barriers During Residency Surgical residents have incurred debts of as much as $100,000 or more by the time they finish, and they frequently have spouses and children to support. The lure of a lucrative private practice is great. There are also few, well-established, productive clinician-scientists to serve as role models. Instead,

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Careers in Clinical Research: Obstacles and Opportunities residents see academic faculty members working very hard to fulfill their clinical and research commitments, and sometimes doing neither well. Training in clinical research is not structured, and it is often inadequately supervised. The mentor or supervisor is frequently so preoccupied with clinical, teaching, and administrative duties that little time is available to teach and supervise the fellow. This phenomenon leads to disillusionment. No structured curriculum exists. The period of research training is frequently too short. During their period of research training, surgical residents engage too frequently in "moonlighting." They can earn good sums of money staffing emergency rooms and intensive care units at night. This activity interferes with sound training in research and is detrimental to productivity in science. The optimal timing of research training is not clear. If residents go into the laboratory at the end of the second year of clinical training, then they will have to do three clinical years after they complete their time in the laboratory. By the time they finish their residency, the data they accumulated in the laboratory may be too old for use as preliminary results for grant applications. If they go to the laboratory after the third year, they feel clinically uncomfortable when they return to the senior years of residency, when they are given significant responsibilities. On the other hand, if research training is not provided until after the completion of clinical training, two potential problems exist. First, the recruitment of bright residents into an academic career will have been missed by waiting so long. Second, if they train in research for two or more years after they complete their clinical training, they will feel clinically inadequate when they begin their careers. Barriers After Residency The barriers after residency are even more important and include the following. Academic departments are unable to nurture young faculty, which is evidenced by inadequate protected time for research because of pressure to produce clinical practice revenues; inadequate start-up funds; inadequate mentoring and guidance; and inadequate provision of good clinical experience. This problem creates a feeling of inadequacy and disappointment. There is difficulty in obtaining research funding. There is perceived instability of research funding. Even if they obtain their first grant, young academic faculty members are very uncertain whether they will receive continued funding. There is a threat of isolation and loss of clinical skills—the fear of the "rat surgeon" syndrome.

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Careers in Clinical Research: Obstacles and Opportunities The lure of clinical practice includes the interesting cases, the financial reward, and the ego satisfaction, with referrals of complex cases. General Barriers to Surgical Research General barriers in the way of a career in research include the following. a perception that surgeons are less able to perform serious research than other physicians and scientists, inadequacy of the peer review system for surgeons and the perception by surgeons that their proposals are reviewed unfairly, reluctance of third-party payers to pay the costs of care for patients participating in clinical research protocols, lack of adequate support from industry without strings attached, and need for the surgical department to value research as much as clinical practice. Special Problems of Women in Surgery For women, the years of training and of serving as junior faculty members in academic departments coincide with the childbearing period. In many instances, women are simultaneously subjected to the ticking of both the biological and the tenure time clocks. No provisions are made to alter the training program or the tenure time clock to accommodate the needs of women in surgery. Women in surgery have few role models, are frequently outside the information network, and choose to occupy the lower-echelon academic tracks. Their husbands are almost always either physicians or professionals in other fields, and frequently, the career needs of the husbands take priority. Such important requirements as day-care centers are rarely available. All of these problems add a different level of complexity to the choice of clinical research as a career path for women in surgery. Minorities in Surgical Research Faculty Careers The number of minorities in academic surgery is extremely low. Of the estimated 64,456 academic faculty members in medical schools, only 2,996 (or 4.6 percent) are underrepresented minorities. The recruitment of African-Americans and Hispanics into academic careers is especially difficult because the pool of qualified candidates is small and the financial difficulties of minorities are particularly severe because they frequently come from poor families who have

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Careers in Clinical Research: Obstacles and Opportunities been eagerly waiting for them to graduate and earn money in clinical practice. Even when minorities enter training in clinical research and are recruited into an academic track, they frequently are unable to sustain this position because of the financial needs of themselves and their family. In predominantly white medical schools, they have an uphill fight against prejudice. All too frequently the atmosphere is unwelcoming, even hostile, and is certainly not conducive to the enjoyable and productive pursuit of science. A critical lack of role models also exists. Of 5,293 surgical faculty 255 (4.8 percent) are non-Asian minorities; in othopaedic surgery, this number is 25 of 800 (3.1 percent). HUMAN RESOURCES PROFILE AND TRAINING BACKGROUNDS OF THE PRESENT COHORT OF CLINICAL RESEARCHERS No data are available to define the profiles of present cohorts of clinical researchers in surgery. A review of the top 10 NIH-funded surgical investigators shows that all are men, all but one are white, and all obtained their M.D.s at an early age and became full professors by age 40. They were all either Alpha Omega Alpha or Markle fellows. Few took formal research training. Unlike internal medicine, in which some 50 percent of the successful investigators had training links with NIH, only 2 of the 10 surgeons had similarly close links with NIH. Indeed, the single most important characteristic of these successful surgical investigators is that they are driven individuals. This cursory review seems to indicate that the quality of the individual, rather than his or her research training, was the key predictor to success. The task force discussed the need for an NIH-sponsored surgical scientist development program. A key requirement of such a program would have to be flexibility: flexibility in the period of training, site of training, and program content. EDUCATION AND TRAINING REQUIREMENTS FOR CLINICAL RESEARCH IN SURGERY Three key requirements were considered essential in the training of surgeons in clinical research: motivated candidates, qualified and dedicated mentors, and flexibility. Unlike internists, surgeons need to maintain their technical skills. To do this, they must spend at least 50 percent of their time in clinical surgery. This requirement imposes the need for flexibility in designing training programs for surgeons. The definition of clinical research done by surgeons should be very broad, because most research done in this discipline is prompted by clinical problems,

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Careers in Clinical Research: Obstacles and Opportunities even though it may utilize the most sophisticated techniques. Because this type of clinical research may vary from basic molecular biology to the development of new operative procedures or longitudinal study of patient disease outcome, the requirements for education and training cannot be rigid. Although the motivation of young surgeons and the provision of proper mentors and role models are crucial to capturing and retaining surgeons in the research field, it is also important that their initial research experience be accompanied by some kind of formal training. It is believed that too few surgeons are receiving such training at present, especially in the basic sciences. This seriously limits their ability to apply the new biology to the problems of surgical patients. Mentors and role models can be identified in the backgrounds of most successful surgeon-scientists. This is perhaps the most important factor inspiring young surgeons to enter and succeed in research careers. The mentor and the role model may be the same or different people. For a young surgeon, role models within the field of surgery are indispensable, but they are suitable as mentors only if they are also scientists in the trainee's area of specific interest and are able to devote sufficient time to the task. In many departments of surgery they do not exist. In these instances mentors in other departments must be sought. They will often be Ph.D.s, and in any case they will usually be full-time, rather than part-time, scientists. Since being a mentor is a vital and time-consuming task, these individuals need to receive compensation, perhaps in the form of support of their own research programs. The locus of the research training is important. Although it may take place in either a clinical or a basic science department, it is important that the parent department of surgery retain close ties with the trainee and the ultimate responsibility for overseeing the young surgeons training experience. In most instances this experience should last at least two years and should include rigorous course work in the discipline of interest. The curriculum, however, must be a flexible one, depending on the trainee's educational background and goals. Courses might vary from those in molecular biology to epidemiology and data collection. Some experience in writing manuscripts and grants would be valuable to all trainees. Individual work with mentors on hypothesis formulation and testing is also important. Financial support for clinical research training in surgery is a major problem. Every advantage should be taken of existing sources of funding, such as Medical Scientist Training programs; National Research Service Award grants; NIH physician-scientist training programs; Howard Hughes medical student and postgraduate fellowships; Dana Foundation fellowships; VA grants; NIH research career development awards (RCDA), R29s, K04s, K08s, and K11s and various foundation-and industry-supported grants. Although surgeons have failed to take full advantage of these, it should be noted that many of them have guidelines that appear to have been written for the express purpose of excluding surgeons (on the basis of the fact that their clinical training is too long or that as

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Careers in Clinical Research: Obstacles and Opportunities junior faculty in surgical disciplines they now spend less than 75 percent of their time in research). It would be very helpful if some funding mechanisms that would be specifically intended to provide support for training in surgical research could be initiated. An NIH surgical scientist training program would be ideal. It is suggested that new grants be aimed at providing funding for technical help and supplies rather than stipends. Although the research training of young surgeons is important, it is equally important to overcome this tendency to drift away from research as they mature (see the section on barriers). Because very few individuals will pursue clinical training programs in surgery unless they intend to practice actively, it is necessary to accept the concept that if surgeons are to be involved with investigation, they will pursue it on a less than full-time basis. Although this has certain disadvantages, the clinician- or surgeon-scientist has a unique perspective that is of special value in the pursuit of clinical research. Thus, in this discipline, at least the leaders need to be supported in their pursuit of dual goals. Since it is not intended that the research of these individuals be evaluated on a different scale than that of full-time scientists, it is especially important that they have sound training and that this training have adequate support. It is unclear whether training should occur during or after residency. If research training does not occur during residency, the "entrapment" of bright individuals for academic careers might suffer. At the same time, the research training obtained and the data gathered during residency tend to lose currency by the time the clinical training is completed. Training ideally should occur during and immediately after the period of residency. A major problem in the retention of academic surgeons in research was identified. All too frequently, an inadequate support system exists for the young surgeon taking a first academic appointment. Yet, this is the most crucial phase of the career of an academic surgeon. All of the resources and efforts expended in training such an individual are useless unless a system is provided for the smooth "reentry" into clinical surgery. Research time as well as good clinical experience must be provided and protected. Adequate laboratory space and start-up funds must be provided. The initial funding must be given for some three years to enable the individual to obtain an independent research grant. Initial funding support is currently provided haphazardly and inadequately by departments of surgery. With the changing medical economy, the ability of surgery departments to sustain this effort, even at an inadequate level, is questioned. Funding for the reentry phase ideally should be part and parcel of the training grant. Such an arrangement would ensure the highest possible retention of individuals trained in clinical research.

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Careers in Clinical Research: Obstacles and Opportunities IMPLEMENTING CHANGES IN CLINICAL RESEARCH TRAINING Here, too, the unique needs of surgeons require flexibility. Important elements of the training program are as follows: Identification of a mentor: the individual must be well-qualified, dedicated, and able to provide the time needed for supervision. A minimum period of two years of supervised research is need. This period of time will need to be flexible to accommodate the needs of different surgical specialties. A didactic period of training appropriate for the unique needs of the specialty is needed. This aspect of the training should take place concurrently with the supervised research. Included here may be training in biostatistics, scientific instrumentation, scientific writing, computer science, and the auditing of graduate courses relevant to the individual's research needs. The training program would be significantly enhanced if collaborations were created with established investigators, especially basic scientists. The training, however, should occur as much as possible in the surgical department, because this is an important method of enhancing the research that occurs in departments of surgery. CHANGES IN SURGICAL RESIDENCY TRAINING Basic residencies in all surgical specialties are a minimum of five years long. Specialization (thoracic, pediatric, vascular, critical care) requires additional residency times of one or two years. Adding adequate research training of 2 to 3 years extends residency training to 9 to 10 years for many surgeons. Many surgical residents carry heavy indebtedness from undergraduate and medical school. Payback must begin at postgraduate year three (or sooner, if pending legislation is enacted). Research training is either omitted to facilitate earlier entry into practice to increase earnings and to pay back loans or it is chosen as a period of time to actively moonlight and earn money for debt repayment. If the research time is to be optimized, other mechanisms for payback should be initiated. Residency programs can be restructured to permit shortening. General surgery programs can be shortened to four clinical years if one or two years of research are added; clinical exposure during the clinical residency must be intensified, however, so that the research-track residents are at least as well prepared as others and are fully able to meet board requirements.

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Careers in Clinical Research: Obstacles and Opportunities RECOMMENDATIONS Collaboration Between Basic Sciences and Department of Surgery The quality of clinical research and training in surgery is significantly enhanced when basic scientists are full members of departments of surgery. The recruitment of such individuals should be made jointly with the basic science departments, and the recruits should have joint appointments in surgery and the basic science department. In this way, quality investigators can be recruited to surgery, which should provide full-time equivalents, space, and resources. These individuals will have credibility in the basic sciences and will be equal members in the department of surgery. They will serve as the vehicle for developing collaborative research between clinicians and basic scientists. The will also play an important role in the training of surgeons in clinical research. In the era of swift and explosive developments in biomedical science, collaboration between basic science and clinical departments is crucial to rapidly bringing advances in molecular biology to the bedside. Proposal to American College of Surgeons Board of Regents to Undertake Direct Support of Research by Surgeons The American College of Surgeons has demonstrated success in raising contributions from its members. The OREF has been highly successful in raising funds, improving the general funding of orthopaedic research, in greatly improving the amount of quality research, and in giving contributors a direct sense of pride and accomplishment in their contributions. The task force recommends that the American College of Surgeons should undertake direct support of research by surgeons. This can best be implemented through its Surgical Research and Education Committee (SREC). Funds should be raised directly and earmarked to be spent directly (not invested) on research. Allocation of funds should: be made to different disciplines (cardio-thoracic surgery, general surgery, ophthalmology, and obstetrics and gynecology, for example) in proportion to the amounts donated by members to these different disciplines;

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Careers in Clinical Research: Obstacles and Opportunities be limited (initially at least) to two years of support for the purpose of initiating research plans to secure preliminary data that would allow for application for NIH or other funding. These funds may also serve as bridging grants. (Initial amounts: $50,000–$70,000). Distribution of funds by independently appointed study sections with a small nucleus of experts and a large network of approved ad hoc reviewers. Plans would be to have a simple application form prepared for quick (within six months) review. Yearly research progress reports will go to the American College of Surgeons for distribution to SREC contributors. The reports should include lists of publications, reprints, and evidence of progress in securing further research support and in academic progress (promotion, new appointments, appearances at national meetings, and election to learned societies, for example). Contributors should receive highly visible recognition: letter of commendation, lapel pins (nine years or $1,000/yr, for example), banners with donor names ($5,000/yr), publication of the contributor's name in the College Bulletin. To raise funds, consider turning the project over to: new independent committee or department, or a committee of fellows (or fellowship contributors) with or without help from fundraising consultants already in place. NIH—Peer Review The single most important reform necessary to promote clinical research by surgeons is to implement what is already a salient principle of grant evaluation–peer review. This means not only that grant proposals from academic surgeons should go to surgical study sections but that the proposals should be evaluated by academic surgeons, even if the proposal deals with basic science, such as molecular biology, signal-transduction mechanisms, or ligand-receptor interactions in cellular or humoral immunology. The current composition of surgery study sections shows the following: in Surgery and Bioengineering Study Section, 8 surgeons of 18 members; in Surgery, Anesthesiology and Trauma Study Section, 7 surgeons of 18 members; in the Orthopaedic and Musculoskeletal Study Section, 4 surgeons of 18 members. Surgery study sections should be made up of at least 75 percent surgeons. The task force believes that it is no exaggeration to say that all progress in clinical research is contingent upon the basic premise of peer review, a premise on which all levels of NIH evaluation are posited. The executive secretary could obtain a list of qualified experts from the American College of Surgeons' Surgery Research and Education Committee. The explanation for failure of peer review classically

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Careers in Clinical Research: Obstacles and Opportunities given by executive secretaries is that the membership of surgical study sections is limited to only a few areas of basic science expertise. The answer, of course, is to get outside help. The executive secretary could identify a large group of experts on whom they could call. Collaboration Between Military and Civilian Sectors Discussion should be initiated among appropriate personnel in the U.S. Department of Defense, such as H. Mendez, Deputy Secretary of Defense for Health, and the Institute of Medicine Committee on Career Paths for Clinical Research to explore options for increased military-civilian coordination. An opportunity appears to exist to enhance the training as well as the research opportunities by using civilian trauma centers for the training of military surgical residents. Recruitment and Retention of Academic Faculty in Surgery Outreach programs should be developed to recruit medical students. Recruitment of underrepresented minorities is especially important and may require financial support during medical school, and every attempt should be made to secure role models and dedicated mentors. Instill flexibility into mechanisms of NIH support of clinical research: Develop a surgical scientist track (analogous to the pediatric track) at NIH. Institute a program for direct support of surgical research by the American College of Surgeons. (The Fellowship Committee could conduct a fundraising campaign to raise money to be spent directly—not invested—for support of research. Provide no funds for salary, and aim at $50,000–$70,000 for two years to allow start-up funds to be used to gather preliminary data, thus answering the most critical need of young investigators.) Funds will be allocated in proportion to discipline of origin. Funds should be distributed by independent reviewers, and money raised by private practitioners should be coordinated on a regional basis. Simplify and decentralize mechanisms for review of training proposals. Introduce flexibility in the duration of research and sites of training, and require an absolute divorce from clinical duties. Identify the mentor and, after proper vetting, reward the mentor with the money for research costs of the applicant. The importance of the mentor or role model (who are often not the same) is underappreciated.

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Careers in Clinical Research: Obstacles and Opportunities Mechanisms for the evaluation of success or failure must be structured into the program. This should go on for at least 10 years and should provide specific data on the scholarly contributions of trainees. To initiate formal programs for reentry, consider provision of a portion of grant funds for a three- to five-year period after the formal research years to support the continuation of studies. These funds might be crucial in locking the trainee into a lifetime of investigation. Provision of the salary will give the department a chance to demonstrate its commitment. There should be protection of time and effort in the years coming out of training. Women in Surgical Research Faculty Careers Recruitment of women into surgical scientist training programs (SSTPs) should be encouraged. Promising female students should be identified and actively recruited and supported in surgical residencies. Retention of female faculty in tenure-track positions should be facilitated through extensions of time to tenure by academic institutions and recognition of childbearing time demands. Mentors and sponsors for women in SSTPs should be actively sought. Female surgeons in tenure-track positions should be identified and sponsored in academic surgery by senior academic surgeons within and outside their institutions. Special seminars and training sessions for women surgical scientists should be regularly conducted by NIH and by surgical societies such as the Association of Academic Surgeons and Society of University Surgeons. These societies should develop a mechanism to assist in grant preparation and to conduct prereviews. Academic medical centers with women in tenure-track positions in surgery should be strongly encouraged to develop and provide readily accessible day-care facilities. A national system of identification of professional couples in which the wife is a surgical scientist should be developed to assist in spouse placement. Academic institutions should be encouraged to facilitate two-career appointments. Under-represented Minorities in Academic Surgery Targeted funds from government and the private sector should be established to enable poor but talented young men and women to enter training in clinical research in surgery. The financial factor is often the absolute limiting factor in the career choices of minorities. The need for mentors and role models is even greater for minority students and residents than for others. Robert Wood

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Careers in Clinical Research: Obstacles and Opportunities Johnson Foundation scholarships are a successful model for this purpose, but these scholarships may need to start early, perhaps in the last year of medical school. Development of NIH Surgical Scientist Training Program Current medical scientist training programs offered by NIH do not meet the needs for training physician-scientists in the surgical disciplines. Few surgeons have participated in these programs because the program time commitments required in each year make it difficult for awardees to develop and maintain surgical clinical skills and may extend the total length of training beyond medical school to as much as 10 years or more, leaving many individuals with substantial debt. Completion of surgical clinical education frequently requires seven years or more following medical school. Development and maintenance of the high level of technical skills and knowledge necessary for the practice of surgery requires commitment of 20 or more hours a week to clinical practice. The available NIH-sponsored research training programs specify that the awardees must dedicate substantially more than 50 percent of their time to research and therefore make it difficult for surgeons to develop and maintain their skills. Limitations on the levels of compensation awardees may receive make these programs substantially less attractive than full-time clinical practice. Recommendation NIH should develop SSTPs with the intent of increasing the number of independent clinical investigators in the surgical disciplines. To be effective these programs should include the following features: Integration into surgical education: SST programs should allow the awardees to continue to maintain and develop their clinical skills. Minimize increased length of training: SST programs should be organized so that the effect on the total length of training is minimized. This may be accomplished by developing combined clinical specialty and research training programs. Emphasis on research-related to surgical treatment: SST programs should emphasize surgical treatment of clinical problems such as traumatic injuries, cancer, and congenital deformities. Require close supervision by experienced scientists: SST awardees should work initially under the close supervision of an experienced scientist.

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Careers in Clinical Research: Obstacles and Opportunities Flexible time requirements: SST programs should allow awardees to begin the training program at different times during training, return to clinical training, and then return to research. During research training, awardees should be allowed sufficient time to maintain their clinical skills. Flexible levels of financial support: SST programs should allow awardees to receive levels of compensation that correspond to their level of education and experience. This may be accomplished through joint sponsorship of surgical scientist training programs by NIH and academic programs or surgical professional societies or foundations. Institution of Changes in Surgical Residency Training Institutions intending to implement an SST program in a residency program should define the structure of their program in their application to the Residency Review Committee (RRC). The RRC for surgery should define special requirements for such programs and include evaluation of this component of the program in its accreditation process. These requirements should include: criteria for the recruitment and selection of SSTP candidates, including identification of candidates in medical school; identification and description of research resources available to the SSTP, including the track record of the research program(s); identification of faculty mentors including established surgeon-scientists; description of the structure of the training program, including the proposed training in research methodology, techniques, and statistics; a plan whereby the clinical training, including the chief residency, will be accomplished in four clinical years; equivalency in surgical experience must be demonstrated, and requirements of the American Board of Surgery must be fully met; and a plan for retention of the SSTP appointee in academic surgery following completion of residency. ACGME should facilitate the development of accreditation of the SSTP track by the RRC for surgery. The research program itself will not be subject to accreditation; rather, the accreditation process should address (1) the plan for research training and resources, (2) the fulfillment of all RRC and American Board of Surgery requirements in a four-year clinical program, and (3) monitoring of the success of SSTP appointees in certification by the American Board of Surgery. Debt repayment, deferral, or forgiveness should be a foremost consideration in any SSTP.

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Careers in Clinical Research: Obstacles and Opportunities ORTHOPAEDIC RESEARCH AND EDUCATION FOUNDATION The Orthopaedic Research and Education Foundation (OREF) began as an effort by orthopaedic surgeons to increase support for orthopaedic research. It initially depended on voluntary contributions by practicing orthopaedic surgeons. Although it has been encouraged and supported by the American Academy of Orthopaedic Surgeons (AAOS) and the Orthopaedic Research Society (ORS), OREF is an independent foundation with its own board of trustees. OREF consists of a board of trustees, a paid executive director and several administrative support personnel. Volunteers serve on peer review panels for individual and institutional grants. The trustees are the governing body of OREF. They are independent of any other organization, and OREF is administratively and legally an independent foundation. OREF does accept recommendations for areas of research emphasis and types of programs from other orthopaedic organizations. OREF provides several different types of grants including: investigator-initiated grants, resident research grants, institutional grants to orthopaedic departments, and career development grants. All grants are reviewed by a peer review panel. These panels are independent of other orthopaedic organizations. In 1991, OREF received $3.8 million in contributions and committed $3.7 million to 79 new grants. AAOS supports the efforts of OREF by recognizing donors at the AAOS annual meeting and by supporting the efforts to increase contributions to OREF by orthopaedic surgeons and industry. AAOS may initiate a more direct effort to solicit contributions from AAOS fellows. AAOS has established and supports a Center for Research and a Council for Research. These units within the AAOS help to support OREF and coordinate efforts to strengthen orthopaedic research at all levels. ORS frequently supplies reviewers for OREF grants and supports the efforts of OREF to increase contributions to orthopaedic research. TASK FORCE MEMBERS HAILE T. DEBAS (Chair), Professor and Chairman, Department of Surgery, University of California at San Francisco, San Francisco, California CLYDE F. BARKER, Professor and Chairman, Department of Surgery, University of Pennsylvania Medical Center, Philadelphia, Pennsylvania JOSEPH BUCKWALTER, Professor, Department of Orthopaedics, University of Iowa Hospital, Iowa City, Iowa

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Careers in Clinical Research: Obstacles and Opportunities OLGA JONASSON, Professor and Chairman, Department of Surgery, Ohio State University, Columbus, Ohio FRANK R. LEWIS, Jr., Professor of Surgery, Chief of Surgery, San Francisco General Hospital, University of California at San Francisco, San Francisco, California JAMES C. THOMPSON, John Woods Harris Professor and Chairman, Department of Surgery, The University of Texas Medical Branch, Galveston, Texas SAMUEL A. WELLS, Jr., Bixby Professor of Surgery and Chairman, Department of Surgery, School of Medicine, Washington University, St. Louis, Missouri

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