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Coordinates: 39°00′02″N 77°06′09″W / 39.000443°N 77.102394°W / 39.000443; -77.102394

National Institutes of Health
National Institutes of Health logo
Aerial photo of the NIH Mark O. Hatfield Clinical Research Center, Bethesda, Maryland
Agency overview
Formed	1887 (1887)
Preceding agency	Hygienic Laboratory
Headquarters	Bethesda, Maryland
Annual budget	US$30.9bn (as of 2010[update])[1]
Agency executive	Francis S. Collins, Director
Parent agency	Department of Health & Human Services
Child agencies	National Cancer Institute National Institute of Allergy and Infectious Diseases National Heart, Lung, and Blood Institute National Library of Medicine
Website
www.nih.gov

Clinical Center – Building 10

The National Institutes of Health (NIH) is an agency of the United States Department of Health and Human Services and is the primary agency of the United States government responsible for biomedical and health-related research. Its science and engineering counterpart is the National Science Foundation. It comprises 27 separate institutes, centers, and offices which includes the Office of the Director. Francis S. Collins is the current Director.

As of 2003, the NIH was responsible for 28%—about US$26.4 billion—of the total biomedical research funding spent annually in the U.S., with most of the rest coming from industry.^[2]

The NIH's research is divided into two parts: the NIH Extramural Research Program is responsible for the funding of biomedical research outside the NIH, while the NIH Intramural Research Program (IRP) is the internal research program of the NIH, known for its synergistic approach to biomedical science.^[3] With 1,200 principal investigators and more than 4,000 postdoctoral fellows in basic, translational, and clinical research, the IRP is the largest biomedical research institution on earth.^[4] The unique funding environment of the IRP facilitates opportunities to conduct both long-term and high-impact science that would otherwise be difficult to undertake. With rigorous external reviews ensuring that only the most innovative research secures funding,^[5] the IRP is responsible for many scientific accomplishments, including the discovery of fluoride to prevent tooth decay, the use of lithium to manage bipolar disorder, and the creation of vaccines against hepatitis, Haemophilus influenzae (HIB), and human papillomavirus.^[6] Intramural research is primarily conducted at the main campus in Bethesda, Maryland, and the surrounding communities. The National Institute on Aging and the National Institute on Drug Abuse are located in Baltimore, Maryland, and the National Institute of Environmental Health Sciences is located in the Research Triangle region of North Carolina. The National Institute of Allergy and Infectious Diseases (NIAID) maintains its Rocky Mountain Labs in Hamilton, Montana,^[7] with an emphasis on virology.

The goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by conducting research in its own laboratories, supporting the research of non-federal scientists (in universities, medical schools, hospitals, and research institutions throughout the country and abroad), helping in the training of research investigators, and fostering communication of medical and health sciences information.

Institutes[link]

Centers of the NIH[link]

In addition to being divided by research area, NIH has many operating groups called centers operating across all of the Institutes.

Office of the Director[link]

The Office of the Director is the central office at NIH. The OD is responsible for setting policy for NIH and for planning, managing, and coordinating the programs and activities of all the NIH components. Program offices in the Office of the Director are responsible for stimulating specific areas of research throughout NIH and for planning and supporting research and related activities. Current program areas are: minority health, women's health, AIDS research, disease prevention, and behavioral and social sciences research.^[13] In July 2009, President Barack Obama nominated Dr. Francis S. Collins, M.D., PhD, to be the Director of the NIH. On August 7, 2009, the US Senate confirmed Dr. Collins by unanimous vote.

Program offices within the Office of the Director fund research through the institutes:

Ida A. Bengtson, a bacteriologist who in 1919 was the first women hired to work in the Hygienic Laboratory.^[17]

History[link]

The predecessor of the NIH began in 1887 as the Laboratory of Hygiene.^[18][19] It grew and was reorganized in 1930 by the Ransdell Act into the National Institute of Health (singular at the time).

To better understand the NIH’s funding policy, a better understanding of this federal agency’s history is helpful. NIH’s roots extend back to a Marine Hospital Service in the late 1790s that provided medical relief to sick and disabled men in the U.S. Navy. By 1870, a network of marine hospitals had developed and was placed under the charge of a medical officer within the Bureau of the Treasury Department. In the late 1870s, Congress allocated funds to investigate the causes of epidemics like cholera and yellow fever, and it created the National Board of Health, making medical research an official government initiative.^[20] In 1887, a laboratory for the study of bacteria, the Hygienic Laboratory, was established at the Marine Hospital in New York. In the early 1900s, Congress began appropriating funds for the Marine Hospital Service. By 1922, this organization changed its name to Public Health Services and established a Special Cancer Investigations laboratory at Harvard Medical School. This marked the beginning of a partnership with universities. In 1930, the Hygienic Laboratory was re-designated as the National Institutes of Health and was given $750,000 to construct two NIH buildings. Over the next few decades, Congress would increase its funding tremendously to the NIH, and various institutes and centers within the NIH were created for specific research programs.^[21] In 1967, the Division of Regional Medical Programs was created to administer grants for research for heart disease, cancer, and strokes. That same year, the NIH director lobbied the White House for increased federal funding in order to increase research and the speed with which health benefits could be brought to the people. An advisory committee was formed to oversee further development of the NIH and its research programs. By 1971, cancer research was in full force and President Nixon signed the National Cancer Act, initiating a National Cancer Program, President’s Cancer Panel, National Cancer Advisory Board, and 15 new research, training, and demonstration centers. In 1984, National Cancer Institute scientists found implications that “variants of a human cancer virus called HTLV-III are the primary cause of acquired immunodeficiency syndrome (AIDS),” a new epidemic that gripped the nation.^[22] In July 1987, as NIH celebrated its 100th anniversary, President Reagan announced a committee to research the HIV epidemic. By the 1990s, the focus of the NIH committee had shifted to DNA research, and the Human Genome Project was launched. In 2009, President Obama reinstated federally funded stem-cell research, revoking the ban imposed by President Bush in 2001. From logistical restructuring, to funding increases, to research prioritization, to government expansion and political influence, the history of the National Institutes of Health is extensive and full of change. The NIH has grown to encompass nearly 1 percent of the federal government’s operating budget. The NIH now controls more than 50 percent of all funding for health research, and 85 percent of all funding for health studies in universities.^[23]

How NIH Obtains Funding[link]

To allocate funds, the NIH must first obtain its budget from Congress. This process begins with IC leaders collaborating with scientists to determine the most important and promising research areas within their fields. IC leaders discuss research areas with NIH management who then develops a budget request for continuing projects, new research proposals, and new initiatives from the Director. NIH submits its budget request to HHS, and HHS considers this request within the parameters of its overall budget. Many adjustments and appeals occur between NIH and HHS before the agency submits NIH’s budget request to the Office of Management and Budget (OMB). OMB determines what amounts and research areas are approved for incorporation into the President’s final budget. The President then sends NIH’s budget request to Congress in February for the next fiscal year’s allocations.^[24] The House and Senate Appropriations Subcommittees deliberate and by fall, Congress usually appropriates funding. This process takes approximately 18 months before the NIH can allocate any actual funds.^[25]

How NIH Allocates Funding[link]

NIH employs five broad decision criteria in its funding policy. First, ensure the highest quality of scientific research by employing an arduous peer review process. Second, seize opportunities that have the greatest potential to yield new knowledge and that will lead to better prevention and treatment of disease. Third, maintain a diverse research portfolio in order to capitalize on major discoveries in a variety of fields such as cell biology, genetics, physics, engineering, and computer science. Fourth, address public health needs according to the disease burden (e.g., prevalence and mortality). And fifth, construct and support the scientific infrastructure (e.g., well-equipped laboratories and safe research facilities) necessary to conduct research.^[26]

Funding Policy Changes[link]

The NIH funding policy has changed in several significant ways over time. First, the amount of money given to the NIH has increased, most significantly in the last few decades. For example, in 1999, Congress increased the NIH’s budget by $2.3 billion.^[27] In 2009 Congress again increased the NIH budget to $30.3 billion.^[27] These budgetary increases have allowed NIH to fund more research. The proportion of funding allocated to the individual ICs does not change much over time, but the overall amount of funding each IC receives has increased significantly.^[28] Second, with the creation of the various ICs, the responsibility to allocate funding to researchers has shifted from the OD and Advisory Committee to the individual ICs. Additionally, Congress increasingly sets apart funding for particular causes. In the 1970s, Congress began to earmark funds specifically for cancer research and in the 1980s there was a significant amount allocated for AIDS/HIV research.^[27] Congress has continued to play an active role in allotting funds for specified research. These are some of the most significant changes in NIH funding policy over the last century. A few of the key issues in evaluating NIH funding policy were previously mentioned in the paper as the five criteria the NIH has established. Three of the criteria are particularly relevant. First, is the NIH ensuring the highest quality of research by fairly implementing their peer review process and allocating extramural research funds? Second, is the NIH maximizing opportunities to produce research that yields new knowledge that will lead to better disease prevention and treatment? Next, are public health needs being addressed according to the public disease burden; in other words, are the most important needs of society being met rather than those of special interest groups. These are the most important issues in evaluating NIH funding policy.

Stakeholders[link]

Many groups are highly invested in NIH funding. Two key stakeholders will be addressed in the following portion of this paper; namely the general public and extramural researchers. Extramural researchers are directly impacted by NIH funding and the general public is providing the funds and should be receiving the benefits.

General Public: One of the goals of the NIH is to “expand the base in medical and associated sciences in order to ensure a continued high return on the public investment in research.”^[29] Taxpayer dollars funding NIH are from the taxpayers, making them the primary beneficiaries of advances in research. Thus, the general public is a key stakeholder in the decisions resulting from the NIH funding policy. Congress theoretically represents the public interest as the NIH Advisory Committee allocates to the NIH, and the funds to the Director.^[30] However, many in the general public do not feel their interests are being accurately represented. As a result, individuals have formed patient advocacy groups to represent their own interests.^[31] Patient advocacy groups tend to focus on specific aspects of health care or diseases. Advocates get involved in many different areas such as organizing awareness campaigns, promoting patients’ rights, and enhancing health policy initiatives. Most importantly, patient advocacy groups are oftentimes involved with advisory panels to ensure that current projects and those projects being considered for funding will directly impact patients’ lives, improve delivery of care, and provide support for tertiary care. Advocacy groups strive to promote a health care system that is beneficial for all parties involved. Through congressional representation, NIH Advisory Committee efforts, and patient advocacy groups, the public is able to influence funding allocation as well as the policy itself.^[32]

Extramural Researchers and Scientists: Other important stakeholders of the NIH funding policy are the researchers and scientists themselves. Extramural researchers differ from intramural researchers in that they are not employed by the NIH but must apply for funding. Throughout the history of the NIH, the amount of funding received has increased, but the proportion to each IC remains relatively constant. The individual ICs then decide who will receive the grant money and how much will be allotted. Research funding is important to extramural researchers for multiple reasons. Without the help of an NIH grant (or a similar type of funding), researchers and scientists are unable to pursue their own research interests but are obliged to follow the agenda of the company or university for which they work. This could potentially hinder discoveries in novel research areas. In 2000, Brian Jacobs and Lars Lefgren researched extensively the impact of NIH grants on basic research and development, and the careers of grant recipients. For the period of 1980–2000, they reviewed all postdoctoral research grants and standard research grants for those who received funding and those who did not.^[33] Jacobs and Lefgren found that scientists who received postdoctoral research grants were 20 percent more likely to be published within the first five years after receiving the grant.^[33] They also found that scientists who received grants were 11 percent more likely to have one publication and 23 percent more likely to have five publications. Due to the ‘publish or perish’ standard that many researchers face, NIH funding can have a great impact on researchers’ careers.^[33] Receiving a standard research grant also has a significant impact on researchers. Young scientists who receive a first-time grant (R01) usually produce more than one additional publication in the five-year period after they receive the grant. Those who receive an NIH grant will typically receive $252,000 more in NIH funding in the following six to ten years,^[33] and a statistically significant relationship exists between scientists receiving NIH grants and their research productivity throughout their careers. Policy changes on who receives funding also significantly affect researchers. For example, the NIH has recently attempted to approve more first-time NIH R01 applicants, or the research grant applications of young scientists. To encourage the participation of young scientists who potentially think outside the box, the application process has been shortened and made easier.^[34] In addition, first-time applicants are being offered more funding for their research grants than those who have received grants in the past.^[35] Although this change provides greater opportunities for young scientists, it also places older, more experienced scientists at a funding disadvantage.

Research[link]

This section requires expansion.

NIH devotes 10% of its funding to research within its own facilities (intramural research). They give 80% of its funding in research grants to extramural (outside) researchers. The extramural funding consists of about 50,000 grants to more than 325,000 researchers at more than 3000 institutions.^[36] In FY 2010^[update], NIH spent US$10.7bn (not including temporary funding from the American Recovery and Reinvestment Act of 2009) on clinical research, US$7.4bn on genetics-related research, US$6.0bn on prevention research, US$5.8bn on cancer, and US$5.7bn on biotechnology.^[37]

In 2011, a paper published in Science found that black researchers were 10% less likely to win NIH R01 grants (the oldest and most widely-used) than white researchers, after controlling for "educational background, country of origin, training, previous research awards, publication record, and employer characteristics." It also found that black researchers are significantly less likely to resubmit an unapproved grant than white researchers.^[38] The study lead and economist Donna Grant said that grant reviewers do not have access to the applicant race, but may infer it from biographies or names. She also speculated that the decreased re-submission rate may be due to lack of mentoring.^[39]

NIH Interagency Pain Research Coordinating Committee February 13, 2012 the National Institutes of Health (NIH) announced a new group of individuals assigned to research pain. This committee is composed of researchers from different organizations and will focus to “coordinate pain research activities across the federal government with the goals of stimulating pain research collaboration… and providing an important avenue for public involvement” ("Members of new," 2012). With a committee such as this research will not be conducted by each individual organization or person but instead a collaborating group which will increase the information available. With this hopefully more pain management will be available including techniques for arthritis sufferers.

Literature Review[link]

1. Cardiovascular Disease Burden Increases NIH Funding Decreases Breslow, JL. “Cardiovascular Disease Burden Increases, NIH Funding Decreases,” Nature Medicine 3(6): 600–601.

Heart disease and stroke are among the leading causes of death in the United States. The rates of these problems have drastically increased. With the baby-boomer generation recently reaching age 65, the number of problems is expected to increase even more. However, the extramural heart research funding program decreased 5.5 percent during the period of 1986 to 1996, while the overall NIH budget increased 36 percent.

Breslow provides more statistics about the growing problem of cardiovascular disease, the economic burden it has on our society, and the shortcomings of NIH funding policy that prevented funding increases. Though this article is dated, the consequences of the funding shortage 15 years ago have implications for today’s level of understanding. NIH policy should reflect the burden of disease, but in this case, it clearly does not.

This article appears in the peer reviewed journal, “Nature Medicine.” This journal is consistently ranked as one of the most influential scientific journals published by the Institute for Scientific Information. Breslow provides excellent insight to heart disease’s burden on society and the lack of funds to match the burden. Additional research should be done to determine the burden of specific diseases over time. This data can be compared to the NIH funding changes for that disease to determine how well the NIH is using burden of disease as a resource to guide funding allocation.

2. NIH Disease Funding Levels and Burden of Disease Gillum LA, Gouveia C, Dorsey ER, Pletcher M, Mathers CD. “NIH Disease Funding Levels and Burden of Disease,” Plos One (February 2011).

According to the authors, during the 1990s, Congress and the public raised concerns that the NIH was not appropriately distributing funds according to burden of disease. As a result, Congress arranged for the Institute of Medicine (IOM) to examine how the NIH was allocating funds. The IOM concluded that the NIH should improve the process of earmarking funds for specific diseases.

This article examines if the NIH has better aligned the amount of funding with burden of disease by comparing results that were reported in 1999. This study’s results show that some conditions received an abundance of funding based on disease burden such as AIDS, diabetes mellitus, and perinatal conditions. On the other hand, Depression and Chronic Obstructive Pulmonary Diseases (COPD) received inadequate funding. Despite some disparities, the conclusion is that NIH’s disease-specific research funding generally correlates with U.S. disease burden. However, when comparing results from 10 years ago, the overall funding process has not improved. Diseases that were previously overfunded and underfunded largely remain the same. Further research needs to address the reason for why this trend continues. Another recommendation for future research is to help implement better NIH disease-specific accounting methods.

This research article is credible and was peer-reviewed by the journal, Public Library of Science that publishes original research from all disciplines within science and medicine. This research was conducted by a collaboration of scientists from various universities who received funding through a grant from NIH’s National Center for Research Resources (NCRR).

3. Race, Ethnicity, and NIH Research Awards Ginther, et al. “Race, Ethnicity, and NIH Research Awards,” Science 333(6045), (Aug. 19, 2011) 1015–1019.

This article explains the research efforts to determine the allocation of research funds to scientists and their race. The data indicate that Asian researchers are 4 percent less likely to obtain federal funding and African-American researches are 13 percent less likely to obtain funding for their research proposals. Even after controlling for educational background, country of origin, training, previous research awards, publication record, and employer characteristics, African-Americans were still 10 percent less likely to be awarded funds from NIH. Ginther, et al., highlight a problem in the review process that prevents equal distribution of funds. The research proposes several potential causes for these discrepancies, but does not conclude on a direct cause.

This article was recently published in the journal “Science,” which is the premier journal published by the American Association for the Advancement of Science.

The article calls for more research to be conducted on this issue to further understand the source of this problem and find an adequate solution to these discrepancies. Interestingly, there is no correlation between quality of proposal and research funds approval. This may be the next step in the research; to determine if Asians or African-Americans are less likely to receive high scores on their proposals.

4. American Science in Crisis: The Need to Revise the NIH Funding Policy Musacchio, Jose M. “American science in crisis: the need to revise the NIH funding policy,” The FASEB Journal 8 (July 1994): 679–683.

This article states that The National Institutes of Health (NIH) has experienced less effective funding mechanisms over the years. The problems are attributed to the small percentage of applications that can be supported by limited funds. This problem additionally affects the ability and quality of the peer-review process. Dr. Musacchio also observes that the applications that are accepted and rejected are insignificantly different.

In order to solve the crisis, the author suggests that NIH policy should regulate the amount of funding and effort required for projects.

This research was conducted by Dr. Musacchio of the Department of Pharmacology at New York Medical University Center. Dr. Musacchio is the Chairperson of the Molecular, Cellular and Developmental Neuroscience Review Committee. The article is credible and was reviewed by the journal, The Federation of American Societies for Experimental Biology. The FASEB journal is recognized as the policy voice of biological and biomedical researchers.

5. NIH Peer Review of Grant Applications for Clinical Research Kotchen, Theadore; Lindquist, Teresa; Malik, Karl; Ehrenfeld, Ellie. “NIH Peer Review of Grant Applications for Clinical Research,” JAMA 291, (2004), 836–843.

In this article from JAMA (the leading peer-reviewed medical journal), the authors discuss the issue of bias in the grant-funding process. The highest priority of the NIH is to facilitate the translation of scientific discoveries to the prevention and treatment of human disease (837). However, it is a concern among many in the medical community that the peer review process discriminates against clinical research. It is possible that concerns about safety and privacy of human subjects may have contributed to the less favorable outcomes of clinical research applications. It is unclear whether this correlation has a causal relationship, but the fact remains that clinical studies are less likely to be awarded funding than laboratory research.

This is troubling for several reasons, including the fact that a bias against clinical research alienates physicians whose research and input is critical to address human disease. Laboratory research is never going to generate the same results as clinical trials. If the ultimate goal of NIH research funding is to prevent and treat human disease, then physicians and clinical research are a vital part of the equation. Any bias in the peer-review process that is not conducive to that end is problematic.

While this article addresses the important issue of keeping the peer review process unbiased and mission-driven, it is in and of itself not completely unbiased. Since it is from the JAMA, a credible source notwithstanding, it is clearly from the perspective of advocating for the physician’s perspective. More investigation of this issue would need to be conducted by other stakeholders in order to verify the concerns raised in this article.

6. Peer Review at NIH Scarpa, Tony. “Peer Review at NIH,” Science Magazine Vol. 311, (January 2006): 41.

When the NIH grants program was established 60 years ago, it processed only 800 applications. With a dramatic influx to more than 80,000 applications a year, the demand for a timely review process is critical. Each year, more than 15,000 outside experts are needed to review grant applications, many of whom spend more than a month assessing applications. In addition to the pressure of processing thousands of applications, the NIH has also experienced stagnation in funding. Previously, the NIH would have steady and generous budget increases that kept up with inflation, but this is no longer the case. Worse yet, the funding model of universities and organizations is still framed around the assumed growth of the NIH.

Recently a committee was formed to evaluate the efficiency of the grant review process of the NIH. However, the recommendations of this committee were neither progressive nor timely. This article from Science Magazine, the official publication of the American Association for the Advancement of Science, discusses the need for aggressive assessment and action to bring the peer review process up to speed. The only way the NIH can keep up with the demand of the rising disease burden and population in a climate of budget cuts is to improve the efficiency with which they process grants, without compromising quality or integrity.

7. NIH Peer Review Reform—Change We Need, or Lipstick on a Pig? Casadevall, Arturo; Fang, Ferris; “NIH Peer Review Reform—Change We Need, or Lipstick on a Pig?” Journal of Infection and Immunity 77(3), (Mar 2009): 929–932.

This article raises questions regarding the peer review process, and outlines issues that persist despite reforms. For example, the article questions the new “two strikes and you’re out” policy that rejects a third submission for a grant application that has been turned down twice before. The authors argue that science evolves and new data can shine a favorable light on a proposal that was discounted previously. History shows that grant applications approved on the third submission have a much higher success rate than proposals approved on the first or second submission.

The authors suggest another issue is that the peer review process remains “unscientific.” For example, the system is statistically weak in that there is little correlation between proposals that receive high scores through peer review and significant scientific breakthroughs. Additionally, the system is imprecise in that the scientists who make up the peer review panel, although outstanding in his/her particular field, are under-equipped to review the ever-increasing range of research proposals. Instead of evaluating a proposal for its scientific merits, they oftentimes focus on the completeness of the application. Their efforts are often biased in that they tend to favor topics that are well understood and disfavor ideas that are less conventional.

This article was published in the Journal of Infection & Immunity. The journal’s credibility is evidenced by the following: it is the number one cited journal in infectious diseases and the number three cited journal in immunology.

Future research could look to identify connections or commonalities between those research proposals that have led to significant scientific breakthroughs. This information could help the peer review process become more effective in selecting research proposals that are more likely to yield improvements to public health.

8. NIH Funding Reform Strauss, Jerome F. III, “NIH Funding Reform,” Science, New Series 309(5736), (Aug. 5, 2005):851.

This article is an editorial discussing the changes that have taken place since the doubling of the NIH budget that ended in 2003. He compared the ending of the doubling period not as a soft landing but as an uncontrolled crash. He points out that the NIH will be unable to keep up with all of the financial commitments it has made. The primary problem is that the NIH has committed funding so many existing projects that they will struggle to find funding for new research proposals. The author offers a few suggestions to help control the let down from the doubling era. One suggestion is that the NIH should stop the annual cost of living increases for research grants. Another suggestion offered was that Congress should stop burdening the NIH with mandates that are not funded. Finally he suggests that the NIH learn to push back on the special interest groups that unduly pressure the NIH without providing funding or any other contribution.

The article was published by a credible and peer-reviewed journal, Science. It came to no quantitative conclusions and followed the general sentiment of various articles published during the beginning of the century. Higher quality articles addressing NIH funding with more research and less anecdotal evidence would benefit the biomedical research field, rather than more editorials. In this article Strauss explains his opinion of the topic but makes no attempt to validate it with evidence.

9. The NIH: Organization, Funding, and Congressional Issues Johnson, Judith; Smith, Pamela. “The NIH: Organization, Funding, and Congressional Issues,” Congressional Research Service (March 16, 2011): 21–38.

This report gives an overview of NIH’s organization, how NIH’s funding is derived and distributed, and outlines Congressional issues affecting NIH’s funding policy. This review focuses on the issues. One issue is the federal government’s involvement in setting research priorities. For example, the Obama administration has set specific funding levels for specific diseases, and has proposed earmarks on two-thirds of NIH’s budget increase for research on cancer and autism. In response to high constituent interest, the House and Senate reports that accompanied the 2010 Labor-HHS appropriations bill encouraged the NIH to place emphasis on the study of gastrointestinal cancers. Also in response to constituent pressure, Congress has attempted to cancel grants for research currently in progress. They question the value of particular studies (e.g. in mental health and human sexuality) and argue that NIH’s limited funding would be better applied in other “specific” fields. These activities establish a dangerous precedent. It is certain advocates for other diseases and interests will pressure their congressional representatives for similar treatment. Instead of research being directed by an objective peer review process, growing political interference would jeopardize scientific integrity and manipulate funding for selfish, political gains.

A major issue that persists, despite reforms to the peer review process, is the imbalance of Congressional funding in light of the number of worthy research proposals. Since 2003, Congress has consistently increased NIH appropriations below the rate of inflation. These insufficient increases have strained NIH’s ability to not only fund existing budget commitments but new research as well. This has resulted in intense competition amongst scientists who, instead of doing research, spend the majority of their time writing and rewriting grant applications in hopes of being awarded NIH’s diminishing funds. Less research (because of insufficient funding and time devoted elsewhere) does not bode well for reducing the burden of diseases on the American public.

This report was produced by Judith Johnson, a Biomedical Policy Specialist, and Pamela Smith, a Biomedical Policy Analyst, of the Congressional Research Service (CRS). The CRS is a legislative branch agency that is responsible for providing policy and legal analysis that is authoritative, objective, and non-partisan. The CRS is a very credible source.

Future research could look to determine ways to mitigate the public pressure that is driving the federal government’s growing influence in setting research priorities. Two possibilities could be to increase public awareness of the benefits of an objective peer review process in allocating funds; or increase awareness of the fortuitous outcomes of research in seemingly unrelated fields. An issue that was not addressed was how to ensure that the NIH receives the optimal level of funding. Research in this area would be most beneficial.

10. Political Influence behind the Veil of Peer Review: An Analysis of Public Biomedical Research Funding in the United States Hedge, Deepak. “Political Influence behind the Veil of Peer Review: An Analysis of Public Biomedical Research Funding in the United States,” Journal of Law and Economics 52(4), (November 2009): 665–690.

This article was written to further explore the relationship between pork barrel politics and the NIH peer review process. Hedge argues that although the House Appropriations Committee has no power or right to decide who should receive the NIH grants (for primarily extramural research) they still manage to influence the process so that their constituents are more likely to receive a NIH research grants. Members of Congress do this by transferring funding to areas of the biomedical field that are most likely to arrive to researchers in their constituencies. In the final stages of budget appropriations the subcommittees of the HAC write reports recommending how the budget be spent within each IC. The reports are not lawfully binding but failure to follow the recommendations does affect the ICs likelihood of receiving their requested funding in the future.

Hedge conducted his research by reviewing peer review grants from 1984–2003 and found that researchers in the states of the members of the House Appropriations Committee received roughly 6–10% more funding than researchers in states that were not represented on the HAC. His article also discusses multiple ways in which members of the House of Representatives and the Senate on the HAC manipulate the appropriations bills to make it more likely that money will go to their constituents. This pork barrel often goes unnoticed by other members of Congress as well as the public, increasing the incentive for members of the Appropriations Committee to try and benefit their constituents in the funding allocation process. The article explains how the research was conducted and further findings.

The article was found after a broad search of the academic JSTOR article finder. Hedge’s article was selected because it was written within the last three years and was published in the Journal of Law and Economics, one of the most frequently cited journals in its field (according to JSTOR). The research methodology used is sound in its logic and interpretation. It touches on a topic that receives very little attention from researchers within and without the biomedical research community. Further research on the role that politics play in NIH funding would be highly valuable and is very much needed.

ADDITIONAL RESEARCH NEEDED: After careful analysis of the existing literature on this topic, we have concluded that more extensive research is needed to generate a complete assessment of this policy. Greater research on the role of politics in the NIH funding policy is needed. Not only does it reveal the role that pork barrel and politics play within the biomedical field. Follow-up research to confirm Hedge’s previously discussed research would shed further light on the role the House Appropriations Committee plays in grant allocation. More research similar to the work of Hedge would provide greater transparency in government as well as more equity in the NIH funding process. Further research on the role that politics play in NIH funding would also be helpful. We know the outlined process for budget approval, but no objective research exists that inspects the role partisan politics play in what diseases are funded and by how much. Trends over the past few decades show that research funding tends to be tied to disease burden, and patient advocacy groups, but to what extent lobbying takes place at the political level, we have not been able to assess.

Another area that is lacking in data and research is assessing the inefficiencies of the NIH funding model. The article from Science Magazine by Tony Scarpa did address the time-frame for processing grant applications (although no follow-up reports could be found), but no information existed that addressed the budgeting process for individual diseases at the federal level. Our assumption is that there is a correlation between political loyalties and where NIH funding is directed, but without the availability of more credible research, it is difficult to accurately assess the impact.

More peer-reviewed content from the American Medical Association regarding the impact NIH funding has on the medical profession would also be beneficial. Especially information regarding the impact NIH funding has on individual patients. If the goal of health research is to ultimately improve the health of individuals, then doctors would likely have relevant anecdotal evidence of the impact of funding. There does not seem to be any data that tracks the dollars spent by NIH down to the doctor/patient level and identifies correlations at this level. Overall, our assessment of the NIH budgeting process and funding policy requires us to make a fair amount of assumptions that would be strengthened with scholarly research on this subject.

CONCLUSION: With a growing world population, and constant strain for limited resources, effective research aimed at eliminating disease is more critical than ever. Understanding the current policy is important, and this comprehensive review of the existing literature is just the first step. Through extensive research, we were able to identify and assess a broad range of credible and scholarly works that shed light on the NIH funding policy. From the medical, government and science journals reviewed, three main themes emerged from the literature: the burden of disease, problems with the review process, and ethical issues from congressional involvement. These themes encapsulated the pertinent issues, and provided a frame for evaluating the trends and for recommending further research. While the existing literature is credible and informative, there is still a need for current literature on the intricacies of the NIH funding policy.

Economic impact[link]

In 2000, a report from a Joint Economic Committee of Congress outlined the benefits of NIH research. It noted that some econometric studies had given its research, which was funded at $16 billion a year in 2000, a rate of return of 25 to 40 percent per year. It also found that of the 21 drugs with the highest therapeutic impact on society introduced between 1965 and 1992, public funding was "instrumental" for 15.^[40]

See also[link]

• Unethical human experimentation in the United States
• Guatemala syphilis experiment
• National Institutes of Health Director's Pioneer Award
• The Proteolysis Map
• United States Public Health Service

References[link]

External links[link]

Wikimedia Commons has media related to: National Institutes of Health

• Official website
• US Scientific Grant Funding Database

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Francis Collins
Director of the National Institutes of Health
Incumbent
Assumed office August 7, 2009
President	Barack Obama
Preceded by	Raynard Kington (Acting)
Personal details
Born	(1950-04-14) April 14, 1950 (age 62) Staunton, Virginia, U.S.
Alma mater	University of Virginia Yale University University of North Carolina, Chapel Hill

Francis Sellers Collins (born April 14, 1950), is an American physician-geneticist, noted for his discoveries of disease genes and his leadership of the Human Genome Project (HGP). He currently serves as Director of the National Institutes of Health in Bethesda, Maryland. Prior to being appointed Director, he founded and was president of the BioLogos Foundation. Collins has written a book about his Christian faith, and Pope Benedict XVI appointed Francis Collins to the Pontifical Academy of Sciences.^[1]

Early years[link]

Raised on a small farm in Virginia's Shenandoah Valley, Collins was home schooled until the sixth grade.^[2] He attended Robert E. Lee High School. Through most of his high school and college years, he aspired to be a chemist, and had little interest in what he then considered the "messy" field of biology. What he refers to as his "formative education" was received at the University of Virginia, where he earned a B.S. in Chemistry in 1970. He went on to attain a Ph.D. in physical chemistry at Yale University in 1974. While at Yale, however, a course in biochemistry sparked his interest in the subject. After consulting with his old mentor from the University of Virginia, Carl Trindle, he changed fields and enrolled in medical school at the University of North Carolina at Chapel Hill, earning there an M.D. in 1977.

From 1978 to 1981, he served a residency and chief residency in internal medicine at North Carolina Memorial Hospital in Chapel Hill. He then returned to Yale, where he was named a Fellow in Human Genetics at the medical school from 1981 to 1984. He worked under the direction of Sherman Weissman, and in 1984 they published an important work, a paper titled Directional cloning of DNA fragments at a large distance from an initial probe: a circularization method.^[3] This method was named chromosome jumping, to remark the contrast with the then current method of chromosome walking, that required to walk along the DNA chain.^[4]

He joined the University of Michigan in 1984, rising to the rank of Professor of Internal Medicine and Human Genetics. He heightened his reputation as a gene hunter. That gene-hunting approach, which he named "positional cloning",^[5][6] developed into a powerful component of modern molecular genetics.

In the 1980s, several scientific teams were working to identify the genes for cystic fibrosis. Toward the end of the decade, progress had been made, but Lap-Chee Tsui, heading the team working at Toronto's Hospital for Sick Children, considered that a shortcut was needed, to speed up the process. For this purpose, he contacted Francis Collins, who joined the team and used his chromosome jumping technique. subsequently, the gene was discovered in June 1989.^[7][8] The discovery was covered by Science Sept 8, 1989.^[9] This was soon followed by other scientific teams genetic discoveries, including isolation of the genes for Huntington's disease,^[10] neurofibromatosis,^[11][12] and multiple endocrine neoplasia type 1.^[13]

Mention of his guitar playing and motor-cycle riding can often be found in articles about him.^[14] Collins' music draws on a sense of humor and fun. While directing the National Human Genome Research Institute, he formed a rock band with other NIH scientists. In its rare appearances, the band entertained selected Maryland and Washington, D.C.-area audiences, such as science writers. Sometimes the band, called "The Directors", dueled with a rock band from Johns Hopkins University, led by cancer researcher Bert Vogelstein. Lyrics of The Directors' songs included spoofs of rock and gospel classics re-written to address the challenges of contemporary biomedical research.^[15]

Leadership at NHGRI[link]

Collins accepted an invitation in 1993 to succeed James D. Watson as Director of the National Center for Human Genome Research, which became National Human Genome Research Institute (NHGRI) in 1997. As Director, he oversaw the International Human Genome Sequencing Consortium.

In 1994, he founded NHGRI's Division of Intramural Research (DIR),^[16] a collection of investigator-directed laboratories that conduct genome research on the NIH campus and has developed into one of the nation's premier research centers in human genetics.

The milestones of NHGRI during the time Collins was director are documented in the article List of events in NHGRI history.

A working draft of the human genome was announced in June 2000, and Collins was joined by US President Bill Clinton and biologist Craig Venter in making the announcement.^[17] Venter and Collins thus shared the "Biography of the Year" title from A&E Network.^[18] An initial analysis was published in February 2001. HGP scientists continued to work toward finishing the sequence of all three billion base pairs by 2003, coinciding with the 50th anniversary of Watson and Crick's seminal publication of the structure of DNA. In 2005 Collins and Venter were also honored as two of "America's Best Leaders" by U.S. News & World Report and the Harvard Center for Public Leadership ^[19] Collins's commitment to free, rapid access to genomic information helped to make all data immediately available to the worldwide scientific community.

One of the main activities at NHGRI during his tenure as director was the composition of the haplotype map of the human genome. The now-completed "hap map" project produced a catalog of genetic variations—called single-nucleotide polymorphisms (SNPs)—which is now being widely used to discover genetic variations correlated with disease risk.

In addition to his basic genetic research and scientific leadership, Collins is known for his close attention to ethical and legal issues in genetics. He has been a strong advocate for protecting the privacy of genetic information and has served as a national leader in efforts to prohibit gene-based insurance discrimination.^[20] Building on his own experiences as a physician volunteer in a rural missionary hospital in Nigeria,^[21] Collins is also very interested in opening avenues for genome research to benefit the health of people living in developing nations.

Collins announced his resignation from NHGRI on May 28, 2008, saying he would continue to lead an intramural research laboratory as a "volunteer"; this will allow several graduate and postdoctoral students to complete projects undertaken under his tenure.^[22]

He has received numerous awards and honors, including election to the Institute of Medicine and the National Academy of Sciences. He was a Kilby International Awards recipient in 1993. In 2007, he was presented with the Presidential Medal of Freedom.^[23] And, in 2008, he was awarded the National Medal of Science.^[24]

NIH Director[link]

Collins being sworn in.

On July 8, 2009 President Barack Obama nominated him to the position of Director of the National Institutes of Health.^[25] The US Senate unanimously confirmed him for this post, announced by HHS Secretary Kathleen Sebelius on August 7, 2009.^[26]

According to Science,^[27] Collins "is known as a skilled administrator and excellent communicator" and President Obama's nomination of him to lead the NIH "did not come as a big surprise", and produced many praising analysis from researchers and biomedical groups. It also found critics, mainly due to his outspoken Christian faith. Others think that this fact may prove to be positive to establish bridges with those that see gene-based research as contrary to religious values.^[28] His appointment was welcomed by the CEO of the AAAS^[28] and by Bernadine Healy.^[29]

In the summer of 2009 some preeminent scientists were meeting in Cambridge, England, celebrating the hundred-and-fiftieth anniversary of publication of "The Origin of Species" and word arrived that President Obama had chosen Collins to head the NIH, and, according to Nobel laureate Harold Varmus who was also present, some of them were alarmed. Varmus had been a NIH director under Bill Clinton, and as such, Collins' boss. He tried to calm the distress by saying that he "is a terrific scientist, and very well organized and a great spokesperson for the N.I.H., has terrific connections in Congress, and is a delightful person to work with".^[30] In November 2011, Collins was included on The New Republic's list of Washington's most powerful, least famous people.^[31]

In October 2009, shortly after his nomination as NIH director, Collins stated in an interview in the New York Times,“I have made it clear that I have no religious agenda for the N.I.H., and I think the vast majority of scientists have been reassured by that and have moved on.”^[32]

On October 1, 2009, Collins appeared for the second time on The Colbert Report, discussing his leadership at the NIH and other topics such as personalized medicine and stem cell research.^[33]

Collins was nominated by the National Institutes of Health to be one of the USA Science and Engineering Festival's Nifty Fifty Speakers to speak about his work and career to middle and high school students in October 2010.^[34]

A new center at NIH was slated to open in October 2011, and to be called the National Center for Advancing Translational Sciences (NCATS) to help develop new drugs. Dr. Collins, frustrated by the declining productivity in the pharmaceutical industry, is leading the effort. For it to work, they have to close one of the 27 institutes already at NIH and give its functions to the new center—something that has never been done before. The idea is to downgrade the National Center for Research Resources, and give some of its functions to NCATS.^[35] As of January 2011, over 1000 comments were archived about the proposed NCATS.^[36] Nevertheless, in September 2011 there were doubts about the possibility to meet the deadline, because of delays in Congressional approval.^[37]

Christianity[link]

Collins has described his parents as "only nominally Christian" and by graduate school he considered himself an atheist. However, dealing with dying patients led him to question his religious views, and he investigated various faiths. He familiarized himself with the evidence for and against God in cosmology, and used Mere Christianity by C. S. Lewis^[38] as a foundation to re-examine his religious view. He eventually came to a conclusion, and became an Evangelical Christian during a hike on a fall afternoon. He has described himself as a "serious Christian".^[20]

In his 2006 book The Language of God: A Scientist Presents Evidence for Belief, Collins considers scientific discoveries an "opportunity to worship". In his book Collins rejects Young Earth creationism and intelligent design. His own belief is theistic evolution or evolutionary creation which he prefers to term BioLogos. He appeared in December 2006 on The Colbert Report television show and in a March 2007 Fresh Air radio interview to discuss this book.^[39][40] While not outspoken on the subject, Collins seems to hold a pro-life view of the abortion issue. In a 1998 interview with Scientific American, he stated that he is "intensely uncomfortable with abortion as a solution to anything" and does not "perceive a precise moment at which life begins other than the moment of conception".^[41]

In an interview with National Geographic in February 2007, John Horgan, an agnostic journalist, criticized Collins' description of agnosticism as "a cop-out". In response, Collins clarified his position on agnosticism so as not to include "earnest agnostics who have considered the evidence and still don't find an answer. I was reacting to the agnosticism I see in the scientific community, which has not been arrived at by a careful examination of the evidence. I went through a phase when I was a casual agnostic, and I am perhaps too quick to assume that others have no more depth than I did".^[42]

Collins rejects intelligent design, and for this reason was not asked to participate in the 2008 documentary Expelled: No Intelligence Allowed. Walt Ruloff, a producer for the film, claimed that Collins was "toeing the party line" by rejecting intelligent design, which Collins called "just ludicrous".^[43] In 2009, Collins founded the BioLogos Foundation to "contribute to the public voice that represents the harmony of science and faith". He served as the foundation's president until he was confirmed as director of the NIH.^[44]

Publications[link]

Books[link]

• The Language of God: A Scientist Presents Evidence for Belief (Free Press, 2006), which spent many weeks on The New York Times Best Seller list
• The Language of Life: DNA and the Revolution in Personalized Medicine (HarperCollins, published in early 2010)^[26]
• Belief: Readings on the Reason for Faith (HarperOne, March 2, 2010).^[45]
• The Language of Science and Faith: Straight Answers to Genuine Questions with Karl Giberson IVP Books (February 15, 2011)

References[link]

External links[link]

Wikiquote has a collection of quotations related to: Francis Collins

• The BioLogos Foundation
• NIH Bio
• NHRGI Bio