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Table of Contents
- What is the NIH?
- How are research priorities set at the NIH?
- How are funds provided to extramural scientists?
- How are research applications reviewed?
- How are research applications and institutes matched?
- What is SEP?
- What are activity codes?
- Why are the NIH institutes different from each other?
- Issues involving the use of human subjects in research.
- Issues involving the use of live, vertebrate animals in research.
- Where Is My Application?
- NRSA Fellowships Frequently Asked Questions
- NRSA Training Grants Frequently Asked Questions
Questions and Answers
- 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.
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- 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.
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- 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.
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- 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 devided 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.
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- 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.)
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- 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.
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- What
are activity codes?
The Office of Extramural Research in the Director's Office provides policy for
the administration of funding mechanisms. There are dozens of mechanisms for
distributing funds. Each mechanism has a letter and number called an activity
code. Some of the more familiar funding mechanisms are the R01 (investigator
initiated research grant), the T32 (institutional training grant), the K08 (the
individual clinical mentored career award), and the P01 (program project grant).
Remember that there are many of these mechanisms, each designed to accomplish a
specific goal. Furthermore within each mechanism there can be some flexibility.
For instance the duration of some awards can be for as short as three months or
as long as ten years. The funding amounts within each award can be variable
depending on the awarding IC.
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- 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.
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- 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.
Also see, Additional Frequently Asked Questions Related to the Requirement for Education on the Protection of Human Subjects.
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- 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.
The PHS Policy is administered by the Office for Human Research Protections (OHRP). OLAW's Office of Laboratory
Animal Welfare web site provides detailed information on PHS Policy
requirements and includes a PHS Policy
Tutorial.
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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
public.
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