The rising cost of NIH-funded biomedical research?

During the last decade, total appropriations for the NIH have grown in current as well as constant dollars. Constant dollar expenditures for indirect costs and research project grants have increased, as also has the number of the latter, while such expenditures for research centers, training, and research contracts have shrunk. The most impressive redistribution in emphasis has been toward traditional research project grants (R01s). The size of the average R01 award, discounted for inflation, has grown at an annual rate of 1.1% during the last decade and 1.3% since fiscal year (FY) 1970; that of the average research program project (P01) has declined over the same periods, after a slight rise in the early 1970s. Factors contributing to the modest rise in the real (constant-dollar) size of the average R01 are explored. The regularity with which current-services-requirements estimates for the NIH exceed inflation reflects real growth in the program, particularly in the category of research project grants; the artifact of basing calculations on the post-rather than pre-"negotiated" levels of awards in the "current" year; and the extent to which the project periods of awards have been extended. The effect of lengthening project periods is slow to become manifest, but inexorably swells the pool of non-competing awards; decisions in this area undertaken in 1985, and continued at least through FY 1988, could very significantly increase current services requirements in FYs 1991 and 1992.     

The role of the general clinical research center in promoting patient-oriented research into the mechanisms of disease

 Patient- and proband-oriented research (POR) into the mechanisms of disease has been most successful in the United States over the past 50 years. To foster POR in universities across the country the National Institutes of Health (NIH) instituted 5-year renewable competitive grants for the establishment of General Clinical Research Centers (GCRCs). The number of GCRCs grew from 5 in 1960 to a maximum of 93 in 1969. Currently 74 GCRCs are in operation at 47 of more than 120 medical schools in the United States. They range in size from 4 to 30 beds, with an average of about 10. Each GCRC supports a Program Director, diet kitchens, core laboratory, biostatistical and computing support, nursing staff, and an administrative assistant. The GCRC is available to enable and facilitate POR of faculty investigators based at the parent university. Investigators make applications to the GCRC for support of a given project, the project is evaluated by the GCRC institutional advisory committee and ethics committee, and if found acceptable the resources of the GCRC including bed space, nursing support, laboratory, and statistical capabilities are made available. The GCRC grant supplies the university with overhead support, but more importantly GCRC-supported investigators regularly bring in grant support from NIH far and above that provided by the GCRC grant itself. NIH also provide for research fellowships through the GCRC, including salary support to encourage young physicians to participate in basic POR. These grants are competitive and last for a 3-year funding cycle. The costs of the GCRCs in terms of beds per day are less than those of the Clinical Center at NIH and the overall scientific productivity has been greater. Further, the prestige of having a GCRC and the resources a GCRC provides, have been a major impetus for university support. Despite general problems in terms of recruiting young physicians to careers in basic POR, the GCRC has been a stellar success scientifically, fiscally, and also in facilitating the separation between patient care costs and those engendered by research. Received: 2 April 1997 / Accepted: 15 May 1997     

Barriers to racial/ethnic minority application and competition for NIH research funding

BACKGROUND: Despite recognition of the need to increase the pool of racial/ethnic minority investigators, racial/ethnic minority representation among National Institutes of Health (NIH)-funded investigators remains low. Racial/ethnic minority investigators bring unique perspectives and experiences that enhance the potential for understanding factors that underlie racial/ethnic variation in health and health status. Identification of barriers to successful minority competition for NIH funding and suggestions for strategies to overcome them were obtained from a concept mapping project and a meeting of minority investigators and investigators at minority-serving institutions. METHODS: Concept mapping, a mixed-methods planning approach that integrates common data collection processes with multivariate statistical analyses, was used in this exploratory project. The concept mapping approach generated a series of related "concept maps" that were used for data interpretation and meeting discussions. RESULTS: Barriers to minority investigator competition for NIH funding identified by concept mapping participants include: (1) inadequate research infrastructure, training and development; (2) barriers to development as independent researchers; (3) inadequate mentoring; (4) insensitivity, misperceptions and miscommunication about the specific needs of investigators involved in research with minority communities; (5) institutional bias in NIH policies; (6) unfair competitive environment; (7) lack of institutional support; (8) lack of support for research topics/methods relevant to research with minority communities; and (9) social, cultural and environmental barriers. DISCUSSION: Data from both the concept mapping and the meeting discussions suggest the need to use a multilevel approach to increase minority representation among funded NIH investigators. Specifically, the NIH should use strategies that overcome barriers at the home institution, within NIH and at the investigator level.     

Modulated Raman spectroscopy for enhanced identification of bladder tumor cells in urine samples

Standard Raman spectroscopy (SRS) is a noninvasive technique that is used in the biomedical field to discriminate between normal and cancer cells. However, the presence of a strong fluorescence background detracts from the use of SRS in real-time clinical applications. Recently, we have reported a novel modulated Raman spectroscopy (MRS) technique to extract the Raman spectra from the background. In this paper, we present the first application of MRS to the identification of human urothelial cells (SV-HUC-1) and bladder cancer cells (MGH) in urine samples. These results are compared to those obtained by SRS. Classification using the principal component analysis clearly shows that MRS allows discrimination between Raman spectra of SV-HUC-1 and MGH cells with high sensitivity (98%) and specificity (95%). MRS is also used to distinguish between SV-HUC-1 and MGH cells after exposure to urine for up to 6 h. We observe a marked change in the MRS of SV-HUC-1 and MGH cells with time in urine, indicating that the conditions of sample collection will be important for the application of this methodology to clinical urine samples.     

A program to facilitate clinical research in an AHC: the first five years.

The authors describe the first five years, 1996-2000, of the Clinical Research Program (CRP) at the Massachusetts General Hospital (MGH). The CRP was established to improve the quality and increase the quantity of clinical research within the MGH, and has concentrated on three areas: translational research, clinical trials, and outcomes research/epidemiology. The authors describe the CRP's efforts and strategies in these areas in detail, and explain the nature of the workforce, training, resources, and other factors that the CRP has brought to bear in fostering the goals in each area. The CRP's organization is also described, focusing on its administrative core and five units (e.g., the Education Unit), each of which has a distinct function in fostering clinical research. The success of the CRP's work can be measured in several ways, including greatly increased revenues from clinical trials and a large jump in the numbers of registrants for CRP courses. The authors state that CRP-type programs are essential for academic health centers (AHCs) that wish to maintain a balanced portfolio in clinical investigation in the future. They believe that AHCs that can afford to should invest in fostering their unique ability to train clinical investigators and generate new therapies for the future.     

Comparison of two computational formulas for a WAIS-R seven subtest short form

Several validity studies for a seven subtest WAIS-R short form have been conducted with patients from different populations as participants. All of these studies demonstrated high correlations between the short form IQ estimates and the actual VIQs, PIQs, and FSIQs (i.e., .90 to .98). In general, there also were small mean differences in the short form versus actual IQs across samples. There currently are two computational formulas for the seven subtest short form. The original weighted formula and a revised proration formula. This study investigated the accuracy of the two short form computational formulas in samples of patients with brain impairment. It was found that the two formulas produced nearly identical results from both statistical and clinical perspectives. Given that the formulas produce nearly identical results and the majority of published studies with this short form have used the weighted formula, we recommend that future investigators use the original weighted formula to maintain clinical and scientific consistency. © 1997 John Wiley & Sons, Inc. J Clin Psychol 53 : 465–470, 1997.     

A comprehensive space management model for facilitating programmatic research.

In FY04, the authors developed and implemented models to manage existing and incremental research space, and to facilitate programmatic research, at the University of Arizona College of Medicine. Benchmarks were set for recovery of total sponsored research dollars and for facilities and administrative (F&A) dollars/net square foot (nsf) of space, based on college-wide metrics. Benchmarks were applied to units (departments, centers), rather than to individual faculty. Performance relative to the benchmark was assessed using three-year moving averages, and applied to existing blocks of space. Space was recaptured or allocated, in all cases to programmatic themes, using uniform policies. F&A revenues were returned on the basis of performance relative to a benchmark. During the first two years after implementation of the model (FY05 and FY06), and for the 24 units occupying research space, median total sponsored research revenue/nsf increased from $393.96 to $474.46 (20.4%), and median F&A revenue/nsf increased from $57.42 to $91.86 (60.0%). These large increases in median values are driven primarily from redistribution and recapturing of space. Recruiting policies for unit heads were developed to facilitate joint hires among units. In combination, these policies created a comprehensive space management model for facilitating programmatic research. Although challenges remain in implementing the programmatic recruitment strategy, and selected modifications to the original policy were introduced later (e.g., research space for newly recruited junior faculty is now exempted from calculations for three years), overall, the models have created a climate of transparency that is now accepted and that allows efficient and equitable management of research space.     

Investing in research: the impact of one academic health center's research grant program.

External research funding provides the core support for a medical center's research enterprise, and is a major or sole criterion for comparing and ranking institutions. Most grant programs are sufficiently competitive that awards are not granted without the availability of preliminary data. Therefore, institutions may find it necessary to supplement external research funds, particularly as matching funds or as seed funds. The authors report their experience at the University of Minnesota Academic Health Center with two internal grant programs, a seed grant program and an interdisciplinary/intercollegiate Faculty Research Development (FRD) grant program. Seed grants are one-year, one-time $25,000 awards to investigators to initiate a new direction in research or to develop innovative projects allowing faculty to expand into new research areas. FRD grants are one-time $200,000 awards for a one- to three-year project that support innovative interdisciplinary and interscholastic research with a high potential for future grants.The authors based their analysis of program outcomes on investigators' self-reports of subsequent external grants and peer-reviewed publications stemming from the initial grants. Six annual cycles of the seed grant program (1998-2003) yielded a financial return on investment (ROI) of 560%. Five annual cycles of the FRD grant program (1998-2002) yielded an ROI of 237%. The authors conclude that the AHC grant program has been successful in generating external research funds (primarily National Institutes of Health) and publications; stimulating risk-taking; and developing interdisciplinary and intercollegiate collaboration. They plan to continue the AHC grant program and recommend similar programs to other institutions.     

Distribution of research awards from the National Institutes of Health among medical schools

BACKGROUND: Previous studies have demonstrated that a small number of the 125 medical schools in the United States receive a disproportionately large share of the research awards granted by the National Institutes of Health (NIH). We assessed whether the distribution of NIH research awards to medical schools changed between 1986 and 1997. METHODS: We used NIH data to rank medical schools in each year from 1986 to 1997 according to the number of awards each school received (as a measure of each school's activity in research, also referred to as research intensity). The proportion of awards received by schools ranked 1 to 10, 11 to 30, 31 to 50, and 51 or lower in research activity was then calculated, and changes over time were examined. We also examined changes in the distribution of awards and changes in award amounts according to the type of department, the type of academic degree held by the principal investigator, and the awarding institute. RESULTS: Between 1986 and 1997, the proportion of research awards granted by the NIH to the 10 most research intensive medical schools increased slightly (from 24.6 percent of all awards to 27.1 percent), whereas the 75 least research intensive medical schools (those ranked 51 or lower) received proportionately fewer awards (declining from 24.3 percent to 21.8 percent). The increased proportion of awards to top-10 schools consisted primarily of increases in awards to clinical departments, awards to physicians, and awards from highly competitive NIH institutes. Basic-science departments received a smaller proportion of awards than clinical departments, both in 1986 and in 1997. CONCLUSIONS: Research funded by the NIH is becoming more concentrated in the medical schools that are most active in research.     

Economic burden of schizophrenia in South Korea

This study estimates the treated prevalence of schizophrenia and the annual costs associated with the illness in Korea in 2005, from a societal perspective. Annual direct healthcare costs associated with schizophrenia were estimated from National Health Insurance and Medical Aid records. Annual direct non-healthcare costs were estimated for incarceration, transport, community mental health centers, and institutions related to schizophrenia. Annual indirect costs were estimated for the following components of productivity loss due to illness: unemployment, reduced productivity, premature mortality, and caregivers' productivity loss using a human capital approach based on market wages. All costs were adjusted to 2005 levels using the healthcare component of the Consumer Price Index. The treated prevalence of schizophrenia in 2005 was 0.4% of the Korean population. The overall cost of schizophrenia was estimated to be $ 3,174.8 million (3,251.0 billion Won), which included a direct healthcare cost of $ 418.7 million (428.6 billion Won). Total direct non-healthcare costs were estimated to be $ 121 million (123.9 billion Won), and total indirect costs were estimated at $ 2,635.1 million (2,698.3 billion Won). Unemployment was identified as the largest component of overall cost. These findings demonstrate that schizophrenia is not rare, and that represents a substantial economic burden.     

NIH Funding and Career Development Opportunities for Women in Reproductive Immunology

The National Institutes of Health (NIH) has a number of mechanisms available to support research, research training and research career development. The various institutes, centers and special offices within the NIH have, as part of their missions, a diverse array of basic and clinical research goals. Much of the scientific spectrum of reproductive immunology, however, falls within the mission of the National Institute of Child Health and Human Development (NICHD). There have been a number of recent innovations in the preparation, review and funding of NIH grant applications. Specific opportunities, such as fellowships, career awards, and new investigator status, are available for investigators at different career stages. A wealth of information is available on the NIH website at www.nih.gov. NIH staff are available to answer your questions and to provide administrative guidance in preparing grant applications.     

Reported goals for responsible conduct of research courses.

PURPOSE: To identify existing responsible conduct of research (RCR) instructors' goals for RCR education. METHOD: E-mail requests were sent to the 116 recipients of National Institutes of Health (NIH) training grants awarded in 2000. Contacts were successfully made with 92 of the recipients, and 84 (91%) identified one or more RCR instructors for their grants. Of the 115 named instructors, 67 were correctly identified as RCR instructors and responded to our e-mail messages. RESULTS: Of the 67 instructors, 50 (75%) from 37 different institutions were interviewed. The reported goals were diverse: over 50 distinct goals were volunteered by the instructors. A secondary finding is that, despite having been identified by training grant directors as teachers of required RCR courses, nearly 25% of these individuals reported that they were not actually RCR instructors, and 22% of those interviewed were not aware that NIH trainees were required to take their courses. Further, whereas 80% of the respondents reported that RCR instruction was required for individuals other than NIH trainees, only 1 of the 50 reported that her/his course was required for all researchers within the institution. CONCLUSIONS: Identifying effective strategies for RCR education depends on first defining measurable outcomes based on well-defined goals. The findings of this study suggest a lack of consensus about those goals. In addition, the confusion about who teaches RCR courses and the rare expectation that RCR education is required for all researchers are disappointing reminders that RCR education is not universally viewed as central to research.     

A national survey of policies on disclosure of conflicts of interest in biomedical research

BACKGROUND: Conflicts of interest pose a threat to the integrity of scientific research. The current regulations of the U.S. Public Health Service and the National Science Foundation require that medical schools and other research institutions report the existence of conflicts of interest to the funding agency but allow the institutions to manage conflicts internally. The regulations do not specify how to do so. METHODS: We surveyed all medical schools (127) and other research institutions (170) that received more than $5 million in total grants annually from the National Institutes of Health or the National Science Foundation; 48 journals in basic science and clinical medicine; and 17 federal agencies in order to analyze their policies on conflicts of interest. RESULTS: Of the 297 institutions, 250 (84 percent) responded by March 2000, as did 47 of the 48 journals and 16 of the 17 federal agencies. Fifteen of the 250 institutions (6 percent)--5 medical schools and 10 other research institutions--reported that they had no policy on conflicts of interest. Among the institutions that had policies, there was marked variation in the definition and management of conflicts. Ninety-one percent had policies that adhered to the federal threshold for disclosure ($10,000 in annual income or equity in a relevant company or 5 percent ownership), and 9 percent had policies that exceeded the federal guidelines. Only 8 percent had policies requiring disclosure to funding agencies, only 7 percent had such policies regarding journals, and only 1 percent had policies requiring the disclosure of information to the relevant institutional review boards or to research subjects. Twenty journals (43 percent) reported that they had policies requiring disclosure of conflicts of interest. Only four federal agencies had policies that explicitly addressed conflicts of interest in extramural research, and all but one of the agencies relied primarily on institutional discretion. CONCLUSIONS: There is substantial variation among policies on conflicts of interest at medical schools and other research institutions. This variation, combined with the fact that many scientific journals and funding agencies do not require disclosure of conflicts of interest, suggests that the current standards may not be adequate to maintain a high level of scientific integrity.     

Building capacities in research for blood services in Africa

BackgroundCapacity building of African based blood services researchers has been identified as key in developing a sustainable programme of generation local evidence to support sound decision making. There are a number of research training programmes that have been instituted targeted at blood services in Africa. The article shares programme experiences of building research capacities for blood services in Africa.MethodologyThe Francophone Africa Transfusion Medicine Research Training network, the NIH REDS-III and NIH Fogarty South Africa programmes and T-REC (Building transfusion research capacity in Africa) have been the key research capacity programmes targeting blood services in Africa over the last decade. To understand their experiences on the implementation of the capacity building programmes, data were drawn from research outputs, publications and end of programme reports. The success, challenges and the main research outputs from their initiatives were highlighted.ResultsThe Francophone research network achievements included more than 135 trainees and in excess of 30 publications. The NIH REDS study the achievements included more than 12 research publications with South Africa junior investigators as lead authors. The NIH Fogarty program currently includes 56 short course trainees, 5 Masters and 6 PhD candidates. The four year (2011-2015, funding period) T-REC programme produced more than 20 publications, 4 PhDs, 42 in-service Diploma in Project Design and Management (DPDM), and supported bursaries for 60 Masters/undergraduate research. The main common challenges in the running of the research programmes include shortages of in-country mentoring and identified needs in high quality research grants writing.Discussion and conclusionThe key achievements for the blood services research capacity building include a mix of short courses, medium-term (epidemiology & biostats) and MS/PhD degree training. Also, having a "train the trainers' programme to develop in-country mentors has been instrumental. Overall, the key recommendations for blood services research capacity building include the need for research collaborations with high-income countries which can jump-start research,and for more in-country grant-writing capacity building, which would help sustainability.     

Economic impact of stable flies (Diptera: Muscidae) on dairy and beef cattle production

Stable flies, Stomoxys calcitrans (L.), are among the most damaging arthropod pests of cattle worldwide. The last estimate of their economic impact on United States cattle production was published 20 yr ago and placed losses at $608 million. Subsequently, several studies of effects of stable flies on beef cattle weight gain and feed efficiency have been published, and stable flies have become increasingly recognized as pests of cattle on pasture and range. We analyzed published studies and developed yield-loss functions to relate stable fly infestation levels to cattle productivity, and then estimated the economic impact of stable flies on cattle production in the United States. Four industry sectors were considered: dairy, cow-calf, pastured stockers, and feeder cattle. In studies reporting stable fly infestation levels of individual herds, median annual per animal production losses were estimated to be 139 kg of milk for dairy cows, and 6, 26, and 9 kg body weight for preweanling calves, pastured stockers, and feeder cattle, respectively. The 200,000 stable flies emerging from an average sized winter hay feeding site reduce annual milk production of 50 dairy cows by an estimated 890 kg and weight gain of 50 preweanling calves, stockers, or feeder cattle by 58, 680, or 84 kg. In 2009 dollars, the value of these losses would be $254, $132, $1,279, or $154, respectively. Using cattle inventories and average prices for 2005-2009, and median monthly infestation levels, national losses are estimated to be $360 million for dairy cattle, $358 million for cow-calf herds, $1,268 million for pastured cattle, and $226 million for cattle on feed, for a total impact to U.S. cattle industries of $2,211 million per year. Excluded from these estimates are effects of stable flies on feed conversion efficiency, animal breeding success, and effects of infested cattle on pasture and water quality. Additional research on the effects of stable flies on high-production dairy cows and nursing beef calves is needed to increase the reliability of the estimates.     

Biomedical Engineering and The Whitaker Foundation: A Thirty-Year Partnership

The Whitaker Foundation, established in 1976, will close in 2006. It will have made awards totaling $805 million, with over $710 million in biomedical engineering. Close to 1500 faculty members received research grants to help them establish academic careers in biomedical engineering, and over 400 graduate students received fellowship support. The Foundation also supported the enhancement or establishment of educational programs in biomedical engineering, especially encouraging the formation of departments. The number of biomedical engineering departments almost tripled during the past 10 years, now numbering close to 75. Leveraging of grants enabled the construction of 13 new buildings. With the field firmly established, the grant program supporting new faculty members will be the one missed the most. New opportunities, however, are emerging as interdisciplinary research is being embraced by both public and private funding sources. The life sciences will be increasingly incorporated into all areas of engineering, and it is expected that such “biofication” will pose both opportunities and challenges to biomedical engineering.Until June 30, 2006, address correspondence to Peter G. Katona, The Whitaker Foundation, 1700 N. Moore Street, Suite 2200, Arlington, VA 22209. Electronic mail: katona@whitaker.org. After July 1, 2006, see www.katonaconsulting.org     

Managed care consumer cuts

New York City Mayor Rudolph Giuliani issued a preliminary budget for FY 2000 that eliminates funding for the Managed Care Consumer Assistance Program (MCCAP). Last year, advocates fought to return partial funding to the $1.5 million program. MCCAP teaches Medicaid and private insurance users about managed care and helps them use their coverage and resolve disputes with HMOs. The City Council is holding hearings on the preliminary budget.     

Cost-effectiveness of syringe exchange as an HIV prevention strategy.

OBJECTIVE: To analyze the cost-effectiveness of New York State-approved syringe exchange programs (SEPs) and estimate the cost-saving potential of these programs. DESIGN AND METHODS: The cost-effectiveness analysis used cost and process data provided by seven SEPs for the calendar year 1996 or the most recent 12-month period available at the time of the study. Alternative estimates of the number of HIV infections prevented were calculated using published data and a simplified circulation model. HIV treatment costs were taken from the literature. RESULTS: A cost-effectiveness ratio of $20,947 per HIV infection averted was calculated based on an estimated 87 HIV infections averted across the seven programs and total program costs of $1.82 million (all amounts given in US dollars). Sensitivity analyses were also performed. Using imputed costs for donated services and estimates of lifetime costs to treat an HIV infection, syringe exchange was demonstrated to be a cost-saving strategy from a societal perspective. CONCLUSIONS: This research demonstrates that syringe exchange is a cost-effective and cost-saving strategy for reducing HIV transmission.