What is the NIH? The NIH is an agency of the Executive Branch of the Federal Government. It is a component of the Department of Health and Human Services whose mission is to protect health and give a special helping hand to those who need assistance. The mission of the NIH is to protect and improve human health by uncovering new knowledge that will lead to better health for everyone. By federal legislation, the NIH is composed of 24 Institutes and Centers. Each Institute & Center (IC) independently receives its federal appropriations from the Congress to pursue its unique mission. Each IC pursues its mission by conducting research at the NIH through an intramural program and by sponsoring research at universities through an extramural program.
How are research priorities set at the NIH? The Director of each IC receives advice and guidance from several sources. Among these are the senior intramural staff and a national advisory council established by law. New research directions are often explored through workshops which meet at NIH. Workshops can be a joint effort of both the intramural and extramural communities. A workshop can be sponsored by one or more IC. If the consensus of the workshop is to further explore the science then a program announcement (PA) for research applications in that area will be published in the NIH Guide. In another mode, an amount of money may be set aside for this research by the IC's. A request for applications (RFA) will be published in the NIH Guide and applications received by a specified date. However most research applications are investigator initiated.
How are funds provided to extramural scientists? Extramural research can be funded in several ways. The most common mechanism is the grant, which is a form of research assistance. Another mechanism is the contract, which is a type of procurement. There are also cooperative agreements, which involve both NIH and extramural scientists in a common project.
How are research applications reviewed? Review of applications can generally occur in one of two ways. The Center for Scientific Review (CSR) of the NIH is a "service center" which is divided into three general scientific divisions (Cell & Molecular, Physiological Systems, and Clinical & Population Based Studies). Each of these divisions has six or seven initial review groups (IRG), each of which in turn has ten to fifteen study sections. Each study section is supervised by an NIH employee who is called the scientific research administrator (SRA). These SRA's are usually doctoral level scientists who have previously conducted research in the scientific disciplines of their study section. The study sections are composed of ten to twenty extramural scientists who are able to evaluate the applications assigned to their study section. (Each member may serve up to three years or may be chosen as a reviewer for a single round of applications.) Applications from those extramural scientists are never reviewed by their own study sections. Study section members must leave the room and not participate in the evaluation of any applications from their home institutions, their relatives, or their recent students or mentors. Study sections may review different types of grant mechanisms.
How are research applications and institutes matched? These CSR study sections meet three times each year to evaluate applications using five review criteria (significance, approach, innovation, investigator, environment). The present practice at CSR is to not score ("unscored" or "streamline") applications which study section members have listed in the lower half of the applications under review for that time period. The study section provides an overall score for each application in the upper half. It must be noted that CSR is one of the three IC's which do not provide extramural funding.
The scored applications are now available to each of the IC's. The IC staff then selects applications for funding considering the mission of that IC and the scores provided by the study identified for many applications. Since a variable number of scored applications from each study section may be chosen for funding, the percentage of each study section applications which are funded also varies. (Hopefully this explains the confusion over why different applications with the same scores and different percentiles may or may not be funded.)
What is SEP? Another mechanism to evaluate research applications is through the use of special emphasis panels (SEP's). SEP's are generally used when an appropriate study section cannot be identified, or when a group of applications are received in response to an RFA. The RFA usually solicits applications for a specific scientific purpose and identifies a specific amount of money. Therefore SEP's are groups of extramural scientists convened for the specific expertise about applications in a narrow scientific area.
What are activity codes? The Office of Extramural Research in the Director's Office provides policy for the administration of funding mechanisms. NIH uses three funding mechanisms for extramural research awards: grants, cooperative agreements and contracts. Within each funding mechanism, NIH uses 3-character activity codes (e.g., F32, K08, P01, R01, T32, etc.) to differentiate the wide variety of research-related programs NIH supports. A comprehensive list of activity codes may be found on the Types of Grant Programs Web page.
Why are the NIH institutes different from each other? Each IC has a unique mission with special advice and guidance, so no two IC's have the same mix of mechanisms in their portfolio of awards. One IC may favor individual awards while another may favor institutional awards. One IC may favor training mechanisms while another IC has few training awards.
Issues involving the use of human subjects in research. NIH Trainees must exercise particular care when their research may involve Human Subjects. Under Department of Health and Human Services (HHS) regulations:
Human Subject means a living individual about whom an investigator conducting research obtains
data through intervention or interaction with the individual, or
identifiable private information.
Identifiable Private Information includes:
information about behavior that occurs in a context in which an individual can reasonably expect that no observation is taking place, and
information which has been provided for specific purposes by an individual and which the individual can reasonable expect will not be made public (for example, a medical record).
--- 45 CFR 46.102(f)(1),(2)
All NIH trainees must contact their local Institutional Review Board (IRB) before initiating human subjects research of any kind.
The HHS Human Subjects Regulations are enforced by the Office for Human Research Protections (OHRP). For additional information about the regulations, see OHRP's website.
Issues involving the use of live, vertebrate animals in research. The use of live, vertebrate animals in activities supported by the Public Health Service (PHS) is governed by the PHS Policy on Humane Care and Use of Laboratory Animals. All applications and proposals submitted to PHS that involve the care and use of animals must contain:
identification of the species and approximate number of animals to be used;
rationale for involving animals, and for the appropriateness of the species and numbers to be used;
a complete description of the proposed use of the animals;
a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and
a description of any euthanasia method to be used.
Activities involving animals may only be conducted at institutions with an approved Animal Welfare Assurance on file with OLAW. The Institutional Animal Care and Use Committee (IACUC) must reviewed and approved the proposed use of animals before the activity is initiated.
What is the NIH definition of a postdoctoral scholar? An individual who has received a doctoral degree (or equivalent) and is engaged in a temporary and defined period of mentored advanced training to enhance the professional skills and research independence needed to pursue his or her chosen career path.
Can time spent mentoring students and postdoctorates be counted toward percent effort reported on a research grant? Yes, to the extent that mentoring activities are not readily separable from activities related to supervising the participation of students and postdoctorates in the funded research project.
The mission of the NIH can only be accomplished if the NIH also provides support
for the training of the next generation of scientists. The mission of
OER/Training Office is to maintain a cadre of well-trained investigators by
offering a wide variety of research training and
career development programs.
The NIH is an evolving and valuable component of the federal government.
Today's NIH must grow and remain responsive to the health needs of the American
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