NEUROLOGICAL SCIENCES ACADEMIC DEVELOPMENT AWARD (NSADA) (K12)

RELEASE DATE:  April 11, 2003

PA NUMBER:  PAR-03-103 - (Reissued as PAR-08-197)

(see NOT-NS-06-015 for Notice of Expiration effective 8/2/2006)

EXPIRATION DATE:  August 2, 2006

National Institute of Neurological Disorders and Stroke (NINDS)
 (http://www.ninds.nih.gov/)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.853

APPLICATION RECEIPT DATE:  October 1 each year

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Application Characteristics
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Special Application Instructions for K12 Applicants
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

The Neurological Sciences Academic Development Award (NSADA) (K12) is an award 
to an educational institution or professional organization to support career 
development experiences for pediatric neurologists leading to research 
independence.  This is a continuation of the original NSADA program, which was 
initiated by NINDS in October 1992.  Under this award, newly trained pediatric 
neurologists are to be selected and appointed to this program by the grantee 
institution.  It is expected that individuals appointed to the NSADA program 
will subsequently apply for their own Mentored Clinical Scientist Development 
Award (K08) or the Mentored Patient-Oriented Career Development Award (K23) to 
continue their research training (see "Research Objectives").

Candidates supported under this award should propose a research plan that has: 
(1) intrinsic research importance, and (2) will serve as a suitable vehicle 
for learning the methodology, theories, and concepts needed for a well-trained 
independent clinician-researcher.  The program should be designed to 
accommodate research candidates with varying levels of experiences.  For 
example, a prospective research candidate with limited experience in a given 
field of research may find it appropriate to engage in a structured, phased 
developmental program, including a designated period of didactic training 
followed by a period of supervised research experience.  The entire program 
should be comparable in scope and rigor to meeting the requirements for an 
advanced research degree.

RESEARCH OBJECTIVES

Program Environment and Components:

The applicant organization must have a well-established research and clinical 
career development program and qualified faculty to serve as mentors.  The 
research candidate, mentor, and institution must develop innovative programs 
to maximize the available research and educational resources.  The NSADA 
program may support research trainees for up to a maximum of three years 
consisting of consecutive 12-month appointments.  Depending on the needs of 
the individual candidate, support may be divided into two distinct phases: 
Phase I, the didactic component; and Phase II, an intensive research 
experience under the guidance of a qualified mentor.  During Phase I the 
candidate will acquire knowledge and research skills in scientific areas 
relevant to the career development goals of the research candidate.  This 
phase must include relevant didactic and laboratory experiences that are 
consistent with the research candidate's prior experience and needs.  During 
Phase II the candidates will carry out their research experiences.

The NSADA program award provides 5 years of potentially renewable support.  
The subsequent continuation of the NSADA program will in part depend on the 
progress made by trainees, both in terms of obtaining their own individual K08 
or K23 awards, as well as subsequent R01 or equivalent grants.  The NINDS 
considers an R01-equivalent grant to be an independent, peer-reviewed, multi-
year award with the awardee as PI, and the total award must be for a minimum 
of $75,000 per year for 3 years or $100,000 per year for 2 years.

Program Director:

The proposed Program Director should possess the scientific expertise, 
leadership and administrative capabilities required to coordinate and 
supervise an interdisciplinary research and development program.  The Director 
should be experienced in the design and management of programs for developing 
investigators, and should be able to demonstrate a superior record of 
preparation of clinicians for independent research.  In addition, applicants 
are encouraged to form a committee with representatives from appropriate basic 
and/or clinical science departments to advise the Program Director on 
management of the program. 

Mentors:

Each research candidate appointed in the program award must have a primary 
sponsor who: (1) is recognized as an accomplished investigator, (2) is 
actively involved in basic or clinical research, and (3) has a successful 
record of providing the type of training required under this award.  An 
assigned mentor will provide guidance for the development of each research 
candidate assigned to the program.  The mentor must be committed to continue 
this involvement throughout the candidate's total period of development under 
the award.

Candidates:

The NINDS expects trainees appointed to the NSADA program to have demonstrated 
potential to develop into successful researchers.  At least 75 percent of the 
candidate's full-time professional effort must be devoted to the program and 
the remainder devoted to developing other clinical and teaching pursuits 
consonant with the objectives of the award.  The NSADA may support up to a 
maximum of 3 years of research career development activities.

APPLICATION CHARACTERISTICS

NSADA Appointees:

A total of 4 trainees may be appointed to the program for the entire 5 year 
period.  Only 1 trainee may be appointed to the program in any given year.  
Any exceptions must be approved by NINDS Program staff.  No new appointments 
may be made during year 5 of the program.  However, NINDS will continue to 
support individual trainees for the full 3-year duration of their appointment.

Salary and Research Costs:

The maximum allowable salary is $75,000 per year, and the maximum allowable 
research costs are $20,000 per year for the didactic phase, and $50,000 per 
year for the research phase.  The total salary requested for each research 
candidate must be based on a full-time, 12-month staff appointment.  It must 
be consistent both with the established salary structure at the institution 
and with salaries actually provided by the institution from its own funds to 
other staff members of equivalent qualifications, rank, and responsibilities 
in the department concerned.  If full-time, 12-month salaries are not 
currently paid to comparable staff members, the salary proposed must be 
appropriately related to the existing salary structure.

Research funds may be used for: (a) tuition, fees, and books related to career 
development; (b) research expenses, such as supplies, equipment and technical 
personnel; (c) travel to research meetings or training; and (d) statistical 
services including personnel and computer time.  

Facilities and Administrative (F&A) Costs:

These costs, which were formerly called indirect costs, will be reimbursed at 
eight percent of modified total direct costs or at the actual F&A cost rate, 
whichever is less.

Under this PA, the K12 grant is not subject to the Streamlined Noncompeting 
Application Process (SNAP).  In general this means that all reporting of 
budgetary information and program progress are provided in greater detail in 
an annual progress report.  While the K12 is subject to Expanded Authorities, 
the one exception to this is that carryover of funds from one fiscal year to 
the next must be approved by the Grants Administration staff (see INQUIRIES).

Other Income:

The candidate may not retain any fees resulting from clinical practice, 
professional consultation, or other comparable activities required by the 
research and research-related activities of this award.  Such fees must be 
assigned to the grantee institution for disposition by any of the following 
methods: (1) expended by the grantee institution in accordance with the NIH 
policy on supplementation of career award salaries to provide fringe benefits 
in proportion to such supplementation.  Such salary supplementation and fringe 
benefit payments must be within the established policies of the grantee 
institution; (2) used for health-related research purposes; or (3) be paid to 
miscellaneous receipts of the U.S. Treasury. Checks should be made payable to 
the Department of Health and Human Services, NIH and forwarded to the 
Director, Division of Financial Management, NIH, Bethesda, Maryland 20892.  
Checks must identify the relevant award account and reason for the payment.

Candidates may retain royalties and fees for activities such as scholarly 
writing or service on advisory groups.  The candidate may retain honoraria 
from other institutions for lectures or seminars, provided these activities 
remain incidental and that the retention of such pay is consistent with the 
policies and practices of the grantee institution.

Usually funds budgeted in an institute-supported research or training grant 
for the salaries or fringe benefits of individuals, but freed as a result of a 
career award, may not be rebudgeted.  The NINDS will consider the approval for 
use of released funds only under unusual circumstances.  Any proposed 
retention of funds released as a result of an NIH career award must receive 
prior written approval of the institute awarding component. 

Award Termination:

The Director of the NIH may discontinue an award upon determination that the 
purpose or terms of the award are not being fulfilled.  In the event an award 
is terminated, the Director of the NIH will notify the grantee institution and 
career award recipient in writing of this determination, the reasons 
therefore, the effective date, and the right of the program director to appeal 
the decision.

MECHANISM OF SUPPORT 

This PA will use the NIH Mentored Clinical Scientist Development Program Award 
(K12).  As the applicant institution, you will be solely responsible for the 
planning, direction, and execution of the proposed program.  The program 
provides up to 5 years of support and is renewable based on a successful 
competing continuation application, programmatic needs and the availability of 
funds. The awards pursuant to this PA are contingent upon the availability of 
funds and the receipt of a sufficient number of applications of outstanding 
scientific and technical merit.

ELIGIBLE INSTITUTIONS 

You may submit an application if your institution is domestic and falls within 
one of the following categories:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
professional organizations, and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  

Foreign institutions are not eligible to apply.

The applicant institution or organization must have adequate numbers of highly 
trained faculty in clinical and basic sciences with interest and capability to 
provide guidance to clinically trained individuals in the development of 
research independence.  

Institutions with a NSADA may recruit and select candidates on a local basis 
rather than submitting a separate application on behalf of each prospective 
research candidate.  In all aspects, this PA is intended to provide support 
for the development of clinical scientists in the same manner and under the 
same conditions as the individual Mentored Clinical Scientist Development 
Award (K08) and the Mentored Patient-Oriented Research Career Development 
Award (K23).  Therefore, research candidates for support under this PA must 
have the following: (1) a clinical degree or its equivalent, (2) initiated 
internship and residency training (or its equivalent), (3) a mentor(s) who has 
extensive research experience and a record of providing the type of training 
required under this award, and (4) willingness to spend a minimum of 75 
percent of full-time professional effort conducting research, career 
development, and/or research related activities.

Minorities and women are encouraged to apply.  The following groups have been 
identified as underrepresented in biomedical and behavioral research 
nationally:  African Americans, Hispanic Americans, Native Americans, Alaska 
Natives, and Pacific Islanders. Use of the term "minority" in this 
announcement will refer to these groups.

Research candidates appointed under this program award must be U.S. citizens 
or non-citizen nationals, or have been lawfully admitted for permanent 
residence and possess an Alien Registration Receipt Card (I-151 or I-551) or 
some other verification of legal admission as a permanent resident.  Non-
citizen nationals, although not U.S. citizens, owe permanent allegiance to the 
U.S.  They are usually born in lands that are not states, but are under U.S. 
sovereignty, jurisdiction, or administration.  Individuals on temporary or 
student visas are not eligible.

Research candidates, who are or have been former principal investigators on 
NIH individual mentored career awards (K01, K08, K22, K23), research projects 
(R01), FIRST Awards (R29), sub-projects of program project (P01) or center 
grants (P50), or the equivalent, are not eligible for appointment under this 
program.  Exceptions may be made for individuals who are reentering the 
research field after an extended absence or are making a significant shift in 
their research focus that requires that they have additional training.  
Candidates who were former or who are current principal investigators on NIH 
small grants (R03) or exploratory/developmental grants (R21) remain eligible.  
Research candidates may not concurrently hold any other PHS award that 
duplicates the provisions of this award. MCSDPA research candidates are 
encouraged to apply for independent research grant support during the period 
of support under this award.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research career development program is invited to work with 
his/her institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into three 
areas:  scientific/research, peer review, and financial or grants management 
issues:

o Direct your questions about scientific/research issues to:

NINDS Training and Career Development Officer
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2154, MSC 9531
Bethesda, MD 20892 (for courier: Rockville, MD 20852)
Phone: (301) 496-4188
FAX: (301) 594-5929
Email: NINDSTrainingOffice@ninds.nih.gov

o Direct your questions regarding peer review issues to:

Raul A. Saavedra, Ph.D.
Scientific Review Branch
NINDS/NIH
Neuroscience Center, Suite 3208
6001 Executive Blvd.
Bethesda, MD 20892-9529
(For FedEx or other courier use Rockville, MD 20852)
Phone 301-496-7355 or 301-496-9223

o Direct your questions regarding financial or grants management matters to:

Jeffrey Domanski
Grants Management Officer 
NIH/NINDS/NSC Rm. 3290 
6001 Executive Blvd. 
Bethesda, MD  20892-9537 
(301) 496-9231   voice 
(301) 402-0219   fax 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email: GrantsInfo@nih.gov.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted on October 1 of each year.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by or mailed before the 
receipt date of October 1.  Applications submitted in response to this PA will 
be reviewed by an appropriate scientific review group convened by the NINDS in 
accordance with the standard NIH peer review procedures.  All applications 
will be reviewed in February, and will be considered by the National Advisory 
Neurological Disorders and Stroke Council in May.  Earliest funding will be 
July 1.

SPECIAL APPLICATION INSTRUCTIONS FOR K12 APPLICANTS

Applications should follow the PHS 398 (05/2001) instructions for research 
grants with the following variations:

Key Personnel:

Key personnel include the principal investigator and all other individuals 
contributing substantively to the mentoring activities.  They do not include 
the candidates.

Table of Contents:

Use the Substitute Form Page 3 Research Career Table of Contents.

Section 1: Basic Administrative Data

1-3. Face Page, Description and Key Personnel (Form pages 1 and 2 and this 
Table of Contents)

4. Detailed budget for initial budget period (Form Page 4)

5. Budget for Entire Proposed Period of Support (Form Page 5)

6. Biographical sketches (Candidates and faculty -- biographical sketch format 
page; not to exceed four pages.)

7. Resources (Resources Format Page)

Section II: Specialized Information

1. Introduction to Revised Application (not to exceed three pages).

2. Research Career Program Plan (Do not exceed 25 pages for items a through d.  
For revised or supplemental applications, use substitute title. 

a. Career Development Program:

The application should describe the overall theme of the program, the 
particular career development activities planned for candidates and the 
expected outcomes for candidates.  It should document the experience of the 
program director and other faculty as mentors including information on the 
career outcomes of former candidates. It should include a clear commitment of 
staff time.  Particular developmental activities mentioned such as seminars, 
scientific meetings, training in responsible conduct of research, and 
presentations should be linked to the overall theme and goals of the program.  
This section should identify explicitly the advantages to this site of a 
program-based career development award as opposed to, or in addition to, 
creating environments supportive of individual efforts by junior faculty to 
obtain career development and similar awards.

The application should indicate what other teaching and/or clinical 
responsibilities, if any, are expected of the candidates and the extent to 
which these activities complement or enrich the research and research 
development experiences proposed in the award.  

Responsible Conduct of Research: The application must describe plans to give 
instruction in the responsible conduct of research.  These plans must detail 
the proposed subject matter, format, frequency, and duration of instruction, 
and amount and nature of senior staff participation.  No award will be made if 
an application lacks this component.  Candidates and the sponsor may wish to 
explore the availability of the following courses offered by the Intramural 
Research Program (IRP): Introduction to the Principles and Practice of 
Clinical Research, the Clinical Electives Program Course on Bioethics, and the 
Ethics Training provided by each individual institute.  For more information 
visit the website of the Office of Research Integrity at 
http://ori.dhhs.gov. 

b. Research Activities:

Applicants should describe the funded research activities of the mentoring 
team.  The description should include an account of how the ongoing research 
offers opportunities for candidates to develop research ideas and strategies 
and offers ways for them to combine methods or concepts from different funded 
projects that will further their own research careers.  The research plan 
should show how the ongoing research exemplifies the organizing theme of the 
program and offers candidates ways to establish research consonant with that 
theme.

The research plan should detail how individual candidates' research 
experiences will be/have been solicited and evaluated prior to initiation.  If 
an outside advisory committee is used to select projects, applications should 
not name advisors in the application but describe how they will be chosen. 

Applications should describe research plans for at least one candidate.  The 
individual description should each be no more than three pages and should 
include: (1) a Statement of Hypothesis and Specific Aims, (2) Background, 
Significance and Rationale, and (3) Research Design and Methods.  No 
preliminary data or results are expected in these descriptions.  Literature 
citations may be included in a single section covering all citations in the 
application and are not a part of the three-page limit.  Supporting material 
(not part of the three-page limit) should include a description of how the 
individual plans relate both to the K12 program and to the career objectives 
of the candidate, and should describe the particular mentors and mentoring 
resources that will be assigned to the candidate during this project.

c. Progress Report/Ongoing Activities:

Existing resources and programs relevant to the program should be identified.  
These may include existing training grants, institutional clinical research 
curriculum awards or centers with resources for supporting junior faculty.  
The application should indicate how the K12 program will interact with these 
existing activities and add to existing capacity to advance clinical research 
at the institution.  Support letters from other resource directors should be 
included at this point in the application. The letters are not included in the 
25-page limit on items a through d.

Competing continuation and supplemental applications should use this section 
to provide a progress report on the current funded activities.  The aims of 
the current award should be briefly summarized.  Significant accomplishments 
of current and past candidates should be described, including present 
appointment, past faculty positions, and grant funding.  Published work 
relevant to their training should be summarized. Emphasis should be placed on 
how the program aspects of the K12 have facilitated or are facilitating the 
progress of the candidates.

Progress reports are submitted using the Form PHS 2590, which can be obtained 
at: https://grants.nih.gov/grants/funding/2590/2590.htm.

d. Environment and Institutional Commitment:

Beyond the research activities described in the research plan, the institution 
must describe what current and future resources are or will be used to 
encourage research by junior faculty and facilitate developing their research 
careers.  It should document what equipment, facilities and resources will be 
made available to the candidates (see Resource Format Page in PHS 398).  In 
addition, for the candidate identified in the application, and for future 
appointments to the K12 program, the institution must submit the Agreement to 
support the candidate as described in the PHS 398 form (05/2001) Section IV, 
pp. 60-61, with signatures as described in that section.  For the candidate 
named in the application, the form must be included with the application. It 
is not part of the 25-page limit for items a through d.

For the following sections, follow instructions on PHS 398 (05/2001) beginning 
on p.17 as appropriate.

e. Human Subjects Research:

o Special Populations
o Human Subjects Research Section

f. Vertebrate Animals

g. Literature Cited

h. Consortium/Contractual Arrangements

i. Consultants

Budget Instructions:

All applications should follow budget instructions for non-modular 
applications.

Personnel:

Starting with the principal investigator, list the names of all applicant 
organization employees who are involved on the project during the initial 
budget period, regardless of whether a salary is requested.  Include all named 
candidates. Indicate any remaining slots as "to-be-named".

Percent of Effort on Project:

Each candidate must spend at least 75 percent effort on this program.

Budget for Entire Proposed Period of Support:

All K12 applications should follow a non-modular format.

Biographical sketches:

Complete biographical sketches for all key personnel and any named candidate.  
Indicate on each candidate's biosketch whether the candidate is a U.S. citizen 
or a permanent resident.  If the candidate is a permanent resident of the 
United States, a notarized statement to that effect must be provided by the 
time of award.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review group 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a second level review by the National Advisory Neurological 
Disorders and Stroke Council

REVIEW CRITERIA

Although the goals of NIH-supported research are to advance our understanding 
of biological systems, improve the control of disease, and enhance health, the 
reviewers are reminded that the primary purpose of this PA is training rather 
than conducting research.  In the written comments, reviewers will be asked to 
discuss the following aspects of your application in order to judge the 
likelihood that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Candidates
o Program Directors/Mentors
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major impact and thus deserve a high 
priority score.

1.  SIGNIFICANCE:  Does the proposed program offer training and career 
development experiences in an important area of research and/or public health 
significance? Are the needs for additional researchers and a K12 program well 
justified?

2.  APPROACH:  Are the planned activities adequately developed, consistent 
with the theme of the program, and sufficient to achieve the aims of the 
program?  Are they appropriately tailored to the experience and interests of 
the candidates? Is the proposed training in the responsible conduct of 
research adequate? Competing continuations: Do current and past activities 
demonstrate prior success in advancing the careers of candidates?  

3.  CANDIDATES:  Are the recruitment and selection processes adequate to 
achieve high-quality candidates? Are the accomplishments of any named 
candidates and the quality of their planned research activities appropriate to 
their level of experience and expected progress during the award? Are the 
efforts to recruit candidates from racial or ethnic groups underrepresented in 
biomedical, behavioral or clinical research adequate? Competing continuations 
and supplements: Do current and past appointments show evidence of success at 
recruitment and training?

4.  PROGRAM DIRECTOR AND CO-MENTORS:  Is the proposed program director an 
acknowledged research leader/administrator with a track record of mentoring 
successful researchers? Do the proposed co-mentors complement the skills and 
experience of the principal investigator? Is their experience in research and 
prior success in training appropriate to their role? Is the need for 
particular mentors well justified by the aims of the program? Has the 
mentoring team committed sufficient time to ensure the success of the program?

5.  ENVIRONMENT:  Do existing facilities and resources enrich the potential of 
the proposed K12 award to provide strong research mentoring and development 
experiences for the candidates? Are support letters available from individuals 
who control access to these resources that show their willingness to 
collaborate? Does the institution indicate that the candidates will be 
provided a minimum of 75 percent time for the career development experiences 
and show how they will be protected from other administrative, teaching or 
clinical duties? 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS:  The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

INCLUSION:  The adequacy in the research plan of plans to include subjects 
from both genders, all racial and ethnic groups (and subgroups), and children 
as appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See Inclusion 
Criteria included in the section on Federal Citations, below)

BUDGET:  The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.  

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 
1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD
-02-001.html); a complete copy of the updated Guidelines are available at 
https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:  
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
https://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at  
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution.  The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.  All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.

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