The Basics: National Institutes of Health (NIH)

Monday, May 2, 2022

As part of the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH) works to further humanity’s understanding of life in relation to health. NIH is deeply ingrained in the research processes, often overseeing long-term developments of groundbreaking medical discoveries. This is accomplished largely through grants, but NIH contracts support NIH’s overall mission as well.

History, Mission, and Organization

NIH started in 1887, as a one-room Laboratory of Hygiene for the Marine Hospital Service (MHS), the U.S. Public Health Service’s predecessor. The lab was run by Joseph Kinyoun, an MHS physician focused on proving that bacteria are responsible for infectious diseases to better protect the public’s health. MHS’ responsibilities soon expanded to checking people arriving on ships for infectious diseases, particularly cholera and yellow fever.

A 1901 supplemental appropriations act delegated $35,000 to build a new laboratory for researching infectious diseases and public health matters, becoming the foundation for NIH. At the time, Congress was unsure of the long-term usefulness of scientific agencies, so they created most of them using these temporary funding bills, or “money bills.” The 1902 Biologics Control Act gave the Hygienics Laboratory the responsibility of regulating the production of vaccines and antitoxins, four years before the passage of the Pure Food and Drug Act.

A 1912 reorganization act expanded the laboratory’s research to include non-contagious diseases and water pollution in the United States. The 1930 Ransdell Act renamed the Hygienics Laboratory to the National Institute of Health and created fellowships for biology and medicinal research. This was driven by chemists who had worked in the Chemical Warfare Service in World War I who tried to establish a private institution to apply chemistry research to medicine and turned to federal funding after they could not find a private investor. This was a turning point as the U.S. government embraced publicly funded medicinal research.

NIH really began to grow after World War II. The National Cancer Institute’s grant program was expanded to the entirety of NIH in 1946, increasing from a $4M program to $1B by 1974, with the first grants going to foreign universities. Called “the golden years” of NIH, new institutes were added and funding and public favor increased. NIH began conducting clinical research and built the Warren Grant Magnuson Clinical Center in Bethesda. The 1948 National Heart Act pluralized the agency’s name to the current National Institutes of Health. This rapid growth slowed by the 1960s, as resources were being delegated to new programs like Medicare and Medicaid.

NIH is dedicated to “helping Americans live longer, happier, and healthier lives” as the largest funder of biomedical research in the world. A medical research agency, NIH’s mission is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.”

NIH’s goals are to:

  • foster fundamental creative discoveries, innovative research strategies, and their applications as a basis for ultimately protecting and improving health
  • develop, maintain, and renew scientific human and physical resources that will ensure the nation’s capability to prevent disease
  • expand the knowledge base in medical and associated sciences in order to enhance the nation’s economic well-being and ensure a continued high return on the public investment in research
  • exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science

NIH’s headquarters are in Bethesda, Maryland. It is organized into 27 Institutes and Centers, each focusing on its specific disease or body system. Each body has its own mission, priorities, budget, and funding strategy. Institutes and centers receive funding directly from Congress and administer their own budgets, except for the NIH Clinical Center, Center for Information Technology, and Center for Scientific Review. NIH leadership, namely the Office of the Director, sets the overall direction, planning, and activities.

Below is an organizational chart for NIH that lists all of the institutes and centers.

NIH in Action

NIH has contributed to innumerable scientific accomplishments. It contributed to a 70% decrease in heart disease and a 27% decrease in cancer deaths. 168 NIH-supported researchers have received Nobel Prizes. NIH also holds Consensus Development Conferences, where investigators and physicians from around the world gather to discuss new therapies. These are only some of the types of projects NIH undertakes.

Types of Projects NIH Conducts:

  • causes, diagnosis, prevention, and cure of human diseases
  • processes of human growth and development
  • biological effects of environmental contaminants
  • understanding of mental, addictive, and physical disorders
  • directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists

The following are select NIH projects and institutions that showcase the diversity of the types and subjects of NIH-funded work.

NIH Almanac

The NIH Almanac contains information about NIH’s budget, leadership, legislation, and activities of all NIH institutions and centers, in addition to a complete history of the organization. This acts as a one-stop shop for a basic overview of NIH. The almanac is produced by the Office of Communications and Public Liaison and updated annually.

National Library of Medicine (NLM)

The NLM is the world’s largest medical library, containing 5.1 million items. It started in 1836 as the library of the general surgeon of the Army and came under NIH supervision in 1968. The library moved to NIH’s Bethesda campus in 1962, consolidating the entire collection. However, the information is available globally through public online databases. The library itself features an herb garden that has been there since 1976.

The NLM has 3 Goals:

  • Accelerate discovery and advance health through data-driven research
  • Reach more people in more ways through enhanced dissemination and engagement
  • Build a workforce for data-driven research and health

The NLM is focused on expanding its digital presence and accessibility, particularly its Intramural Research Program, which provides research and training in computational health and computational biology research. Its topics include natural language processing, evolutionary genomics, clinical image processing, sequence statistics, and more. The NLM also offers research, development, and training in biomedical informatics and health information technology. The Network of the NLM has 6,500 members and provides health information in U.S. communities.

Understanding Immune Cells and Inflammation

NIH played a crucial role in the discovery of the JAK-STAT molecular pathway in the 1990s. This was one of the earliest demonstrations of how outside molecules can control gene expression inside a cell and led to the development of a new class of drugs called Jakinibs. In 1994, two NIH-funded research groups discovered JAK3, which is expressed primarily in immune cells, and linked it with immune suppression. This research showed how cells sense and respond to their immediate environment. NIH-funded investigators discovered and researched the molecular interactions of tofacitinib, resulting in new treatment opportunities for rheumatoid arthritis (RA). This research will benefit the 1.5 million adults in the United States living with RA. JAK1, 2, and 3 have been used in clinical trials for autoimmune diseases and even have applications for dogs with allergic dermatitis.

Tuberculosis Research Advancement Centers (TRACs)

Funded by the National Institute of Allergy and Infectious Diseases (NIAID), four new grants were awarded to build TRACs as part of NIH. This project involves cultivating new investigators, engaging in multidisciplinary and collaborative research, and training in laboratory and clinical settings. The awardees (Texas Biomedical Research Institute, Johns Hopkins University, Emory University, and University of Washington School of Medicine) are expected to receive $4.3M in the first year of the five-year grants. Tuberculosis is the 2nd leading cause of death, so enhancing research on the topic is important to NIH.

Racial and ethnic disparities in pediatric acute asthma care

NIH-funded research showed that racial and ethnic disparities in pediatric acute asthma care may be influenced by factors beyond affordability. Low clinic utilization by black children with asthma was accompanied by more frequent emergency department visits compared to Latino and white children. The study was supported by the National Institute on Minority Health and Health Disparities and used the electronic health record data of 41,276 children with asthma. The study found that 54% of black children did not meet the minimum standard of care for children with asthma, which is two visits per year. This is the first study to demonstrate that visitation patterns of clinic and emergency department acute-care utilization differ for Black and Spanish-preferring Latino children and white children. It also showed that Black children experienced more of a wealth gap, which could have been affected by greater financial instability, the inability of guardians to keep up with treatment plans, and increased situations that could require emergency care. Researchers hypothesize that eliminating this wealth gap could improve asthma outcomes for Black Americans. NIH is looking into future research on how to address this issue by modifying community health centers.

Contract Procurement and Acquisition

NIH uses fixed-price and cost-reimbursement contracts, although most Research & Development (R&D) contracts are cost-reimbursement. Awards are based on best value, and proposals are evaluated on technical criteria, cost, past performance, and small disadvantaged business participation. An independent peer-review process reviews technical evaluation criteria such as technical approach, personnel, and facilities.

NIH acquisitions must adhere to the Federal Acquisition Regulation (FAR). NIH has instructions for Business Cost Proposals and Technical Proposals for potential customers. The NIH Enterprise Document Generation System (DGS) Team maintains the contract and solicitation clauses and provisions used by the NIH Acquisition Community, called “Workforms.” NIH even has two Youtube Videos on contracting with them here!

Recent Contracts

The following are recent contracts NIH awarded:

  • Bioinformatics and Computational Biosciences Support Services: This year NIH issued a $99M contract award to Medical Science and Computing LLC for bioinformatics and computational biology analysis services.
  • Unified Communications & Collaboration Support Services: This year NIH issued an $87M contract award to Deloitte for unified communications and collaboration (UCC) professional support services. UCC allows NIH to collaborate and communicate in real-time, from anywhere securely.
  • Preclinical Toxicology of Large Molecule Drugs for Cancer and Other Indications: This year IIT Research Institute, based in Chicago, won a $9.4M contract that sought data on the essential characterization of the toxicological properties of potential investigational new drugs to treat cancer and other diseases. This data will be included in the government’s filing for an investigational new drug application to institute human clinical trials.
  • Support Services for The All of Us Research Program Institutional Review Board (IRB): This year The Emmes Company, LLC won a $6.1M contract award from All of Us, a part of the Precision Medicine Initiative (PMI) led by NIH. All of Us will expand precision medicine to all diseases by establishing a national research cohort of over one million U.S. participants with the goal of developing more effective ways to prolong health and treat disease. The Emmes Company will provide administrative, regulatory, and operation support for the IRB, which is expected to review up to 150 submissions annually. Accreditation by the Association for the Accreditation of Human Research Protection Programs was required to win this contract.
  • Professional Operations Support Services: In 2021, NIH issued a $50M contract award to Edgewater Federal Solutions to support the National Library of Medicine.
  • Office of Computer Infrastructure and Computational Biology (OCICB) IT Support Services: In 2019, NIH issued a $147.4M contract award to Booz Allen Hamilton to develop and maintain enterprise applications such as clinical regulatory support systems, learning management systems for international efforts, and electronic document management and document workflows to expedite and improve internal processes.
  • Medical Residents for Clinical Center: The George Washington University won a $3.5M contract in 2019 to provide Postgraduate Medical Residents through the NIAID. This was a re-competition of an existing contract with The George Washington University and Medical Research Institute, Inc. Residents will execute primary medical care for NIAID clinical research inpatients at the NIH Clinical Center.

Spending Trends

As mentioned in The Basics: Department of Health and Human Services, HHS’s grant obligations over the past 5 fiscal years have far exceeded its total procurement obligations by a whooping 670%. When looking at NIH – they have entered grant over procurement contracts by 454% from FY17 to FY21.

For FY22, Congress allocated $44.96B in discretionary dollars for NIH. This allocation includes funding for things like:

  • $1B to establish the Advanced Research Projects Agency for Health (ARPA-H)
  • $289M for Alzheimer’s disease and related dementias research
  • $6.9B for the National Cancer Institute
  • $25M for Accelerating Access to Critical Therapies for ALS
  • $30M to support research on maternal morbidity and mortality through the Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) initiative
  • $50M for research related to opioids, stimulants, and pain/pain management
  • $50M for health disparities research
  • $12.5M for firearm injury and mortality prevention research
  • $245M for Universal Flu Vaccine Research
  • $75M for INCLUDE Down syndrome research initiative
  • $59M for Office of Research on Women’s Health
  • $10M to strengthen the Office of the CIO for Scientific Workforce Diversity

Grants

NIH invests approximately $41.7B in medical research each year, with 80% of its total annual funding going to outside research. Only 10% of its total funding is for NIH laboratories, which are mostly in Bethesda, MD, and comprised of 6,000 scientists. NIH boasts that 50,000 competitive grants have already been awarded to 300,000 researchers across 2,500 institutions in all 50 states.

Grant funding is done through the NIH institutes and centers. NIH looks for projects of high scientific caliber, requested research, unsolicited research, and unique research projects. By law, NIH cannot support a project already funded or pay for research that has been done before. Grantees are subject to the NIH Grants Policy Statement.

The following is an outline of NIH’s grant process.

The peer review portion of the process really stresses the scientific merit of a proposal. Scientific Review Officers are responsible for reviewing applications for completeness, conformity, and scientific and technical review, in addition to being the contact point for applicants during the review process. Grants Management Officers evaluate applications for administrative content and compliance with policy, negotiate awards, and interpret grant administration policies. The various roles needed on an applicant’s team include an E-Business Point of Contact, Authorized Organization Representative, Signing Official, and Principal Investigator.

Types of Grant Programs:

  • Research Grants
  • Career Development Awards
  • Research Training and Fellowships
  • Program Project/Center Grants
  • Resource Grants
  • Trans-NIH Programs

Each type of NIH grant program has its own set of eligibility requirements, which can be found in section III of each FOA. Individual eligibility refers to scientists at different stages in their careers, but especially New and Early Stage Investigators. Institutional eligibility applies to domestic, foreign, public, private, non-profit, and for-profit applicants. Applicants should understand what type of budget or documentation is required for the contents of your proposal. Collaborators, new investigators, foreign institutions and investigators, and resources require various documentation or pre-approval. Human subjects or vertebrate animals require assurances by Institutional Approvals. These requirements can also benefit the applicant, as new investigators are given special attention to their proposed approaches.

Types of Applications:

  • New
  • Renewal
  • Competing revision
  • Extension
  • Noncompeting continuation
  • Change of Organization Status (Successor-in-Interest)
  • Change of Recipient or Training Institution
  • Change of Institute or Center
  • Resubmission

The type of application can impact the due date, eligibility, and applicable business rules. An application may need prior approval from NIH before submission, such as when the budget is over $500,000 or it is a conference grant application. NIH maintains strict ethical regulations when using animal or human subjects in clinical testing by creating policies, inspecting facilities, and requiring grant applicants to justify the use of animal or human subjects.

Interested applicants can find grant funding by searching the NIH Guide for Grants and Contracts for Funding Opportunity Announcements (FOAs) and Notices of Special Interest (NOSIs), in addition to the more general Grants.gov. The RePORTER’s Matchmaker interface can also be used to find relevant projects. Applications are submitted through the Application Submission System & Interface for Submission Tracking (ASSIST) system. eRA Commons is also used for pre-and post-award submissions and services. Institutional Solutions can also be used to submit certain applications. The Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC), a specific database with funding organized by subject, features 299 various research/disease areas NIH funds. The NIH Grants Youtube Channel has information on grant applications, advice for scientists, NIH policy and compliance, and special funding programs.

NIH in 2023 and Beyond

The FY23 Congressional Justification requests $62.5B for NIH. This includes a 7.2% increase for Research Project Grants, a 50% increase for Buildings & Facilities Appropriation, and $12.1B in new mandatory funding for NIH to prepare for pandemics and other biological threats.

Research topics that NIH has identified as needing more attention in the future are mental health, climate change, nutrition science, firearms, sex, gender identity, and sexual orientation. NIH aims to address health challenges such as heart disease and stroke, cancer, opioid addiction, infectious diseases, and diabetes. NIH is also working on specific outcomes such as using a novel, non-hormonal pharmacologic treatment for endometriosis and developing a universal coronavirus vaccine.

National Priorities:

  • combatting the acute and lasting effects of the COVID-19 pandemic
  • fighting the opioid epidemic
  • eradicating HIV in the United States
  • expanding mental health research
  • addressing health disparities and inequities
  • researching the human health impacts of climate change
  • contributing to the HHS Pandemic Preparedness Plan
  • continuing to fund the newly established Advanced Research Projects Agency for Health (ARPA-H)

The NIH-Wide Strategic Plan for FY21–25 provides objectives that align with NIH’s goals:

  • Advancing Biomedical and Behavioral Sciences: driving foundational science; preventing diseases and promoting health; developing and optimizing treatments, interventions, and cures
  • Developing, Maintaining, and Renewing Scientific Research Capacity: enhancing the biomedical and behavioral research workforce; supporting research resources and infrastructure
  • Exemplifying and Promoting the Highest Level of Scientific Integrity, Public Accountability, and Social Responsibility in the Conduct of Science: fostering a culture of good scientific stewardship; leveraging partnerships; ensuring accountability and confidence in biomedical and behavioral sciences; optimizing operations

NIH also has cross-cutting approaches that apply to all of the objectives:

  • Improving minority health and reducing health disparities
  • Enhancing women’s health
  • Addressing public health challenges across the lifespan
  • Promoting collaborative science
  • Leveraging data science for biomedical discovery

 

Researched and authored by Haley Boulanger, Pulse Analyst.

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