Andrea L. Harabin, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
Department of Health and Human Services
Bethesda, MD20817

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services (DHHS), is the primary Federal agency for supporting medical research. NIH supports research to prevent and treat diseases as well as to study fundamental mechanisms for common and rare diseases that affect people of all ages. This document will briefly describe how critical care research is funded at NIH and provide resources for obtaining more information.

Background

The NIH consists of 27 Institutes and Centers (http://www.nih.gov/icd/) each with its own broadly defined mission. Each Institute determines how to allocate its own funds among many different activities of science. Research priorities are determined based on advice obtained from the scientific community, including individual researchers and professional societies; patient organizations and voluntary health associations; Institute and Center Advisory Councils; and the Congress and Administration.

For the National Heart, Lung, and Blood Institute (NHLBI), approximately 70% of the extramural research dollars are devoted to investigator-initiated research while the is spent on institute initiated grants and contracts and administration (http://www.nhlbi.nih.gov/about/factpdf.htm). This balance of investigator-initiated and institute-initiated research is typical of many Institutes and Centers of the NIH.

All applications for NIH funding are evaluated by peer review groups composed of scientists from outside the NIH. Most investigator-initiated applications are referred for assignment to review groups in the Center for Scientific Review (CSR) ( http://cms.csr.nih.gov/AboutCSR/OverviewofPeerReviewProcess.htm). Some Institute specific applications are referred to review groups formed by the Institutes. The peer review groups evaluate the scientific and technical merit of the proposed research. All projects undergo a second level of review by Institute and Center Councils. These peer review rankings are used by the Institutes to determine which applications are of sufficient merit to be considered for funding.

Which Institute or Center funds Critical Care research?

Critical Care research is not funded by just one Institute or Center because of the multi-disciplinary nature of critical illness. A search of funded NIH grants (http://crisp.cit.nih.gov/) shows that the majority of critical care research grants are funded by NHLBI, partially because of the high incidence of respiratory issues in critical illness. Other Institutes that fund critical care research include but may not be limited to the National Institute of General Medicine (sepsis, burn, surgery, and trauma), National Institute of Child Health and Human Development (pediatric issues), National Institute on Aging (issues affecting the elderly), National Institute of Nursing Research (issues of decision making in care), the National Institute of Neurologic Disorders and Stroke, and the National Institute of Diabetes and Digestive Diseases. Each Institute has a website with information on funding and staff contacts.

How do I find out if NIH is interested in a research idea?

It is often recommended that applicants should contact a Program Officer at the appropriate Institute to discuss a new research idea, whether it is a basic study or a clinical trial. Part of the job of an NIH Program Official is to field any questions, encourage new ideas, and guide investigators in getting an application submitted. Discussions may help in providing general advice about application preparation, the state of research funding in a particular field, and to navigate and understand the NIH organization and process. These discussions are encouraged and welcomed by NIH staff. Investigators should consult the NIH websites to identify Program Officials in appropriate scientific areas. Investigators may then get referrals to other Institutes as the research idea is discussed with staff.

NIH permission is usually not required for the submission of a grant application. As long as the direct costs requested are under $500,000 in each year, applications can be submitted directly to the Center for Scientific Review (CSR) at one of the three regular receipt dates ( http://grants2.nih.gov/grants/funding/submissionschedule.htm). The investigator-initiated research project is the cornerstone of NIH funding.

An applicant planning to submit a new investigator-initiated grant application requesting $500,000 or more in direct costs for any year must contact Institute or Center program staff and obtain permission to submit the application. For NHLBI (http://www.nhlbi.nih.gov/funding/policies/500kweb.htm), the investigator will be required to prepare a brief summary of the proposed research that provides enough information so that Institute staff can make an informed decision whether to accept the proposed application. Program project grants (http://www.nhlbi.nih.gov/funding/policies/ppg.htm) and often clinical trials http://www.nhlbi.nih.gov/funding/policies/clinical.htm) will be >$500,000 in any year, so Institute permission will be needed.

How do I find out which Institute is most appropriate for my research idea?

It is not absolutely necessary to determine which Institute could potentially fund your research. Research applications are submitted directly to the CSR. CSR Referral Officers will examine the application assign it to the NIH Institute (or Institutes, if appropriate) best suited based on the science area. If an applicant has had discussions with NIH Program Staff about a research idea, the Institute staff can request assignment for an incoming application. Also, an investigator may request assignment to a specific Institute in the cover letter. CSR will usually honor these requests as long as they are appropriate to the missions of the Institute.

Which study section should review my application in Critical Care?

Investigators do not need to determine which review group can or should review his/her application; this is the role of the CSR Referral Officer. It is a good idea for applicants to look at the rosters and scientific boundaries of the available review groups to see if there are study section members with an interest or expertise in the research being proposed. CSR maintains a detailed website http://cms.csr.nih.gov/ that describes the scientific boundaries of each review group, and lists rosters and dates of meetings. As with the Institute assignment, investigators may request assignment to a specific review group in the cover letter. Investigators can also mention specific expertise that would be needed to review the application if it is particularly unusual and is not included on a standing study section. The Scientific Review Administrators that organize the study sections usually invite a number of ad hoc reviewers to supplement the expertise of the group. The study section assignment for each application is provided to your NIH Commons account (https://commons.era.nih.gov/commons/) shortly after submission of the application. It is advisable to look at the roster quickly and communicate with the Scientific Review Administrator with any concerns.

NIH initiated programs in Critical Care

Some of the NIH research budget is spent on research programs initiated by Institutes as opposed to research initiated by investigators. These can be grant solicitations, called Requests for Applications, or contract solicitations, called Requests for Proposals. These solicitations are made when the scientific community identifies a need for research in a specific scientific area. These opportunities are published regularly on the NIH website (http://grants1.nih.gov/grants/guide/index.html). Each Institute and Center's website also maintains a list of its current and past research solicitations. Recent solicitations in critical care include the NHLBI ARDS Clinical Trials Network (see http://www.nhlbi.nih.gov/funding/inits/archive/index.htm) and the NICHD Pediatric Care Network ( http://grants2.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html).

The NIH Director has established a Roadmap Program to enhance medical research and encourage the translation of research findings to medical care (http://nihroadmap.nih.gov/). The Roadmap has provided opportunities for critical care researchers.

Investigators can be notified http://grants1.nih.gov/grants/guide/listserv.htm of new solicitations; it is likely that academic institutions regularly monitor these opportunities.

Training support for Critical Care researchers

NIH provides training support for new investigators (http://grants1.nih.gov/training/). This includes funding for individual postdoctoral fellowships for Ph.D. and M.D researchers, mentored career awards for clinical investigators, and institutional training grants that can all support investigators interested in the field of critical care. These awards provide salary support and a small amount of research support to provide time for development of research skills and ideas. Each Institute's website will describe its programs and requirements in detail. To find out about training programs, scientists should consult the Institute and Center websites to determine either the scientific area of interest or to locate the staff person that specializes in training. For example, NHLBI has an abbreviated staff directory that identifies key individuals that might be helpful (http://www.nhlbi.nih.gov/about/staff.htm). Finally, NIH has a loan repayment program for clinical researchers that wish to conduct research (http://www.lrp.nih.gov/).

New investigators

NHLBI and the other institutes have a special commitment to new investigators ( http://www.nhlbi.nih.gov/funding/training/redbook/newinvest.htm). The application form (http://grants.nih.gov/grants/funding/phs398/phs398.html) has a check box for new investigators. Study sections usually review new investigator applications as a group and members are instructed to be less demanding about preliminary data and detailed research plans for all years of the project. NHLBI has increased the pay line for new investigators to 5 percentage points above the regular pay line and is planning an expedited review procedure for applicants with scores just above the pay line. Watch the NHLBI website for details on this.

Other sources of federal support for Critical Care Research.

The Agency for Healthcare Research and Quality (http://www.ahrq.gov/) another agency within the DHHS also supports research related to healthcare delivery, effectiveness, and outcomes for critical care.

The Department of Defense will often have annual solicitations for research projects, some of which might be appropriate for critical care. The Army has a program in combat casualty care (http://www.usaccc.org/rf.jsp) and the Navy offers grants and contracts to extramural researchers (http://www.onr.navy.mil/02/baa/) some of which are medical.

Summary

Critical Care Research is often thought of as a discipline that does not have an NIH "home". This not a unique problem at NIH, however, and is true of many diseases and scientific endeavors that are increasingly multi-disciplinary. NIH is interested in funding all high quality research that can improve the health of the American population. There is increasing emphasis on clinical and translational research, but fundamental research remains important. Critical care research is flourishing because of recent successes in clinical trials and basic research. Use the websites and feel free to contact NIH staff for assistance, advice, and guidance.