PROGRAM ANNOUNCEMENT (PA) TITLE: CAREER DEVELOPMENT AWARD FOR MINORITY 
SCHOLARS IN NEUROSCIENCE  

PAR NUMBER:  PAR-02-106 (This PA has been reissued, see PAR-05-071)

RELEASE DATE:  May 3, 2002

EXPIRATION DATE:  March 18, 2005

PARTICIPATING INSTITUTES AND CENTERS (ICs):  

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

THIS PAR CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PAR
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PAR

The National Institute of Neurological Disorders and Stroke (NINDS) is 
committed to maintaining a diverse scientific and technology workforce as 
part of the NIH Action Plan for Addressing Health Disparities.  The purpose 
of the Career Development Award For Minority Scholars In Neuroscience 
(referred to in the remaining text as the Neuroscience Scholars Award) is to 
support an intensive, supervised career development and scientific mentoring 
experience for promising minority investigators to obtain research 
independence during the performance period of the award. The proposed career 
development experience is expected to substantially contribute to the 
research capabilities of the applicant, and research should be in an area of 
interest to the NINDS.  It is envisioned that funding support from the 
Neuroscience Scholars Award will bolster efforts to address the under-
representation of minorities in biomedical and behavioral research by 
increasing the pool of well-trained minority research and health 
professionals who are competitively funded to conduct neuroscience research. 

RESEARCH OBJECTIVES

Presently, there is an under-representation of minorities recruited to, and 
retained in, faculty neuroscience careers.  For example, only 8% of tenure-
stream faculty surveyed by the Association of Neuroscience Departments and 
Programs in 2000 were minorities (http://www.andp.org/).  The objective of 
the Neuroscience Scholars Award is to increase the representation of 
minorities in faculty-level neuroscience positions who are competitively 
funded to conduct independent research. To achieve this objective, the 
Neuroscience Scholars Award will support an intensive, supervised research 
career development experience for minority career neuroscientists.    

MECHANISM OF SUPPORT  

This PAR will use the Mentored Research Scientist Development Award (K01) 
mechanism. Planning, direction, and execution of the program will be the 
responsibility of the candidate and her/his mentor on behalf of the applicant 
institution.  Salary up to $85,000 per year plus related fringe benefits will 
be provided.  A research allowance of up to $50,000 per year will be 
provided.  The project period may be 3, 4, or 5 years and will depend upon 
the number of years of prior research experience, and the need for additional 
experiences to achieve independence.  Awards are not renewable.  This PA uses 
just-in-time concepts and the streamlined budgeting format described in 
Section IV "Research Career Award" of the PHS 398 application instructions 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,                    
and medical, dental, or nursing schools or other institutions of higher 
education involved in neurological research 
o Units of State and local government
o Domestic

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

For the purpose of this PA, minorities are defined as individuals belonging 
to a particular ethnic or racial group that has been determined by the 
grantee institution to be underrepresented in biomedical or behavioral 
research.  Candidates for this award may be non-tenured minority faculty in 
their first or second faculty position who have earned a doctoral degree 
(Ph.D., M.D., D.Sc., etc.) by the time the award is made.  An award activated 
shortly after appointment to a faculty position is encouraged, since it would 
allow for a period of independent and possibly funded research prior to a 
tenure review.  Candidates who have a commitment of a faculty appointment may 
apply for this award prior to the receipt of the doctorate, by providing 
certification by an authorized official of their degree-granting institution 
that all degree requirements have been met prior to the award issuance 
beginning date.  

The applicant institution must provide evidence that a commitment of a full-
time faculty position has been made to the candidate, and that the candidate 
can commit a minimum of 75 percent professional effort (of a full-time 
position) to the career development plan.  Candidates must be U.S. citizens 
or non-citizen nationals, or must have been lawfully admitted for permanent 
residence by the time of award.  Individuals admitted for permanent residence 
must be able to produce documentation of their immigration status such as an 
Alien Registration Receipt Card (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 
for this award.  

A person who has been principal investigator on a Public Health Service (PHS) 
research grant or who has had equivalent research support is not eligible for 
this award.  The only exceptions to this rule are R03 and R21 grants.  In 
addition, individuals who are in training status and are being supported by 
National Research Service Awards (NRSA) are eligible to apply, however, they 
may not activate the Neuroscience Scholars Award until the NRSA research 
training program has been completed or terminated.  This award is intended 
for persons who plan to pursue careers in the neurological sciences and 
applies to all areas of research supported by NINDS.  

Note: Recipients of K01 awards are eligible for the NIH loan repayment 
program, if they are engaged in clinical and/or Health Disparities research 
(see http://www.lrp.nih.gov). 

SPECIAL REQUIREMENTS 

(1) Mentor

Candidates must name a primary sponsor (or mentor), who together with the 
applicant is responsible for the planning, direction, and execution of the 
program. The mentor should be recognized as an accomplished investigator in 
the proposed research area and have a track record of success in training 
independent investigators. The mentor should have sufficient independent 
research support to cover the costs of the proposed research project in 
excess of the allowable costs of this award. The mentor"s role involves a 
substantial commitment of time on behalf of the candidate, therefore, persons 
with extensive administrative responsibilities (e.g., chairpersons, deans) 
should not be selected as mentors without adequate justification.

Candidates may choose more than one mentor, additional mentors may be at the 
candidate"s institution or elsewhere within the United States, if a strong 
case is made for their contribution to the research career development of the 
candidate.  The principal mentor should be in the candidate"s home 
institution or be available locally.  The typed name and signature of the 
principal mentor should appear at the end of the mentor"s statement.  "Per" 
signatures are not acceptable.  Mentors are not funded for their role on the 
award. Where feasible, women, minority individuals and individuals with 
disabilities should be involved as mentors to serve as role models.  

(2) Duration of Award

The award provides three to five consecutive 12-month awards. Because of the 
focus on progression to independence as a researcher, candidates for the 
Neuroscience Scholars Award should propose a period of study and career 
development consistent with their previous research experience.  For example, 
a candidate with limited experience in the proposed field of research may 
find a phased developmental program lasting five years the most efficient 
means of attaining independence.  This period could include a designated 
period of didactic training followed by a period of closely supervised 
research.  A candidate with previous research experience in a related field 
may not require extensive additional didactic preparation and a program that 
focuses on an intensive, supervised research experience may be appropriate.  
All programs must be tailored to meet the individual needs of the candidate 
ensuring that he/she will gain the skills and knowledge necessary to carry 
out high quality health-related research.  Awardees may not apply for another 
mentored award at the conclusion of their support.  

(3) Time and Effort

Recipients of this award must devote full time (at least 75 percent of a full 
time 12 month position) to career development activities, research, or other 
research-related activates relevant to their career goals.  Activities such 
as participation in workshops, scientific meetings, or academic activities 
are encouraged if they contribute to the purpose of the award.  Providing 
health care is acceptable only when it is necessary to maintain and enhance 
skills required for the conduct of research.  

(4) Salary Support

The NINDS will provide up to $85,000 per year for salary support. The grantee 
institution may supplement the NINDS salary contribution up to a level that 
is consistent with the institution"s salary scale.  However, supplementation 
may not be provided from Federal funds unless specifically authorized by the 
Federal program from which such funds would be derived.  In no case may other 
funds from the National Institutes of Health (NIH) be used to supplement the 
salary.  Institutional supplementation of salary must not require extra 
duties or responsibilities that would interfere with the purpose of the 
award, i.e., full-time commitment to supervised research and related 
activities.  Individuals receiving salary support under the Neuroscience 
Scholars Award are employees of the grantee institution and are subject to 
its established personnel policies dealing with professional status, title, 
salary, and related staff privileges and obligations.  The salary proposed 
must be consistent with the established salary structure for full-time, 12-
month staff appointments at the grantee institution.

(5) Fringe Benefits  

Fringe Benefits are paid out of grant funds in proportion to the salary 
contribution.  Practices related to payments of fringe benefits shall be 
consistent with grantee institution policies and not be altered for these 
awards.  

(6) Allowance for Research and Career Development Costs  

In addition to salary support, funds up to $50,000 direct costs in the 
aggregate may be requested for each year to support research and/or career 
development activities.  The support for research activities is intended to 
enable the awardee to conduct research until regular research support can be 
obtained.  Research costs include equipment, laboratory supplies, research 
assistants, and travel to scientific meetings and research workshops.  

Career development costs may include travel, per diem, tuition, or fees for 
study at centers other than the grantee institution.  Funds requested must be 
carefully justified for each year and must be consistent with the stage of 
development of the candidate and the proportion of time to be spent in 
research or career development activities.  Salary for mentors, secretaries 
and administrative assistants is not allowed.  

(7) Facilities and Administrative Costs  

Applicants may request up to 8% of direct costs for Facilities and 
Administrative Costs (F&A).  F&A costs are not provided on tuition and 
related fees or on equipment expenditures.  

(8) Professional Income Other Than Salary  

Fees resulting from clinical practice, professional consultation, or other 
comparable activities required by the research and research-related 
activities of this career development award may not be retained by the career 
award recipient.  Such fees must be assigned to the grantee institution for 
disposition by any of the following methods:  (1) The funds may be used to 
supplement the NINDS contribution up to a level that is consistent with the 
institution"s salary scale, (2) the funds may be used for other health-
related research purposes, or (3) the funds may be paid to the miscellaneous 
receipts of the U.S. treasury.  Thorough records of disposition of such 
income must be maintained and summarized as requested in progress reports.  
Awardees may retain royalties and fees for activities, such as scholarly 
writing, or honoraria from other institutions, provided these activities 
remain incidental and provided that the retention of such pay is consistent 
with the policies and practices of the grantee institution.  

(9) Concurrent Application  

At the time of application submission, a candidate for the Neuroscience 
Scholars Award may not concurrently apply for any other PHS grant, nor may 
there be another application pending funding.  However, it is expected that 
awardees seek independent extramural research support (e.g. R01) by the end 
of the award period. 
  
(10) Special Leave and Reduction in Percent Effort  

Subject to institutional policy applicable to all employees regardless of the 
source of funds, a leave of absence may be arranged (with continued salary 
support from the award) for purposes of engaging in research or career 
enhancement activities related to the award.  Prior written approval of the 
NINDS awarding component is required for leave in excess of three months.  
Leave without award salary support may be taken for a period not to exceed 12 
months, subject to prior approval by the NINDS awarding component and the 
awardee"s institution.  The award termination date will be adjusted to allow 
a full period of recommended support.  Under unusual and pressing personal 
circumstances, an awardee may submit a written request to the awarding 
component requesting a reduction in professional effort below 75 percent.  
Such requests will be considered on a case-by-case basis during the award 
period.  In no case will it be permissible to work at a rate of less than 50 
percent effort.  

The nature of the circumstances requiring reduced effort might include 
medical conditions, disability, or pressing personal or family situations 
such as child or elder care.  Permission to reduce the level of effort will 
not be approved to accommodate other sources of funding, job opportunities, 
clinical practice, clinical training, or to adapt to any assigned duties 
associated with the employment role at the grantee institution.  In each 
situation, the grantee institution must submit documentation supporting the 
need for reduced effort along with assurance of a continuing commitment to 
the scientific development of the awardee.  Further, the awardee must submit 
assurance of his or her intention to return to full-time professional effort 
(at least 75 percent) as soon as possible.  During the period of reduced 
effort, the salary and other costs supported by the award will be reduced 
accordingly.  

(11) Termination or Change of Institution  

When a grantee institution plans to terminate an award, the NINDS funding 
component must be notified in writing at the earliest possible time so that 
appropriate instructions can be given for termination. 

Neuroscience Scholars Awards are not transferable to another individual but 
may be transferred to another institution.  In the latter case, the awardee 
must contact the responsible NINDS Program Director to fully discuss the 
circumstances of the transfer, and must subsequently provide a written 
justification and rationale for the transfer.  The period of support 
requested can be no more than the time remaining within the existing original 
award project period.  Further, no transfer will be allowed for awards with 
less than six months remaining in the project period.  

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity 
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:

David A. Jett, Ph.D.
Program Director
Office of Minority Health and Research 
National Institute of Neurological Disorders and Stroke
NSC, Suite 2149
Bethesda, MD  20892
Rockville, MD 20852 (For Express/Courier Service)
Telephone:  (301) 496-3102
FAX:  (301) 594-5929
Email: dj140o@nih.gov

o	Direct your questions about peer review issues to: 
 
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Suite 3208
Bethesda, MD 20892-9529 
Rockville, MD 20852 (For Express/Courier Service)
Telephone:  (301) 496-9223
Fax:  (301) 402-0182
 
o Direct your questions about financial or grants management matters to:

Ken Bond
Grants Management Branch 
National Institute of Neurological Disorders and Stroke 
The Neuroscience Center, Suite 3290
6001 Executive Boulevard
Bethesda, MD 20892-9537
Rockville, MD 20852 (For Express/Courier Service)
Telephone:  (301) 496-9231
Fax:  (301) 402-0219

SUBMITTING AN APPLICATION

Applications must be prepared using Section IV of the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is available 
at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The essential elements of the Neuroscience Scholars Award are an 
individualized, well-thought-out career development and research plan, a 
committed, capable mentor, and a commitment on the part of the applicant 
institution to the development of the candidate.  Documentation concerning 
each of these essential elements must be included along with the other 
requirements listed in Section IV-D "Specialized Information" of the 
application instructions. Use the information provided in the PHS 398 
application instructions and the supplemental information provided below to 
address the following elements:

o The Candidate (Prepared by Candidate)

The candidate should provide an overview of his or her prior research and 
clinical (if any) training experience.  Detailed justification must be 
provided of the need for a mentor and for a 3-5 year award.  In addition, 
this section should contain a statement of short-term and long-term research 
and career goals relevant to the neurological sciences, and how this award 
will contribute to their attainment.  Three letters of recommendation are 
required of each candidate.  Letters from previous research mentors or 
supervisors are especially helpful.  These letters must be attached to the 
application in sealed envelopes.  The candidate"s statement must also contain 
a description of specific career development activities.  It should include a 
statement of the knowledge and skills that the candidate proposes to acquire 
or enhance during the period of the award and the proposed activities and 
arrangements for accomplishing these goals.  The career development plan 
should describe what will be learned, how and where this will take place, and 
why it is important for the candidate"s development.  The plan should contain 
a realistic time frame for achieving scientific independence, taking into 
account the research experiences and career goals of the candidate.

o The Sponsor(s) (Mentor), Cosponsor, Consultant(s), and Collaborator(s) 
(Prepared by Sponsor)

Dependence upon a mentor early in the award period will be related to the 
extent of the candidate"s previous research experience, increased 
independence is expected during the course of the award.  The mentor must 
document that he or she is prepared to personally supervise the candidate"s 
research.  The application must describe the specific role of the mentor and 
identify the proposed commitment of effort to assist the candidate in 
carrying out his or her career development plan.  

o Environment and Institutional Commitment to the Candidate (Prepared by 
Sponsoring Program or Department)

Evidence must be provided that the candidate will have a full-time regular 
faculty appointment at the time an award is activated.  The level (e.g., 
assistant professor) and effective date of this appointment must be provided.  
This appointment must not be contingent on the receipt of an award.  Evidence 
also must be provided to insure the feasibility of the proposed research 
development plan, including the availability of office and laboratory space, 
equipment, and other resources, and access to clinical and/or other research 
populations.  This section should contain a description of the candidate"s 
teaching load, committee and administrative assignments, and clinical or 
other professional activities, if applicable, for the current academic year.  
These statements should bear the typed name and signature of the head of the 
department, program or comparable organizational unit in which the candidate 
will be working.  "Per" signatures are not acceptable.  In those instances in 
which a candidate will be working away from the home institution, the head of 
the host department, program, or laboratory should also attest, by signature, 
to the agreement to accept the candidate and provide the necessary resources 
for his or her development.      

o Research Plan (Prepared by the Candidate and the Sponsor)

The Research Plan should contain a specific statement of research career 
interests in the area of neurological science.  It must include a description 
of the research areas to be investigated, the research aims, a summary of 
current knowledge in the area, and methods to be employed.  The candidate 
should use the format cited in the application form PHS 398 (rev. 5/2001) 
"Research Plan" in the presentation.  Although it is understood that the 
Neuroscience Scholars Award does not require the extensiveness or detail 
necessary in regular research grant applications, a fundamentally sound 
research plan must be provided.  In general, less detail will be expected 
with regard to research planned in the later years of the award, but the 
candidate should outline the general plans for these years.  The candidate 
should make certain that the relationship between the career development plan 
and the research plan is clearly described.  The proposed research should 
complement the career development plan and provide a vehicle for the 
applicant"s development as a scientist.  Candidates must describe plans to 
receive instruction in the responsible conduct of research.  These plans must 
detail the proposed subject matter, format, frequency, and duration of 
instruction as well as the amount and nature of faculty participation. 

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

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)

In order to facilitate the review of applications, the applicant should, at the 
same time, submit one copy of the application to:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD  20892
Rockville, MD  20852 (for express/courier service)

The number and title of this program announcement should be typed in item 2 
on the face page of the application, and the "Yes" box should be checked.  

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the 
same as one currently pending initial review unless the applicant withdraws 
the pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an application already reviewed, but 
such application must include an Introduction addressing the previous 
critique.

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 at NINDS 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 appropriate National Advisory Council

REVIEW CRITERIA

Applications for this mentored research career development award will also be 
reviewed for the candidate"s potential to develop into a productive 
neurological sciences researcher.  Reviewers will consider: (1) the 
qualifications of the candidate, including the suitability of the candidate 
relative to the eligibility criteria and purposes of this program, (2) the 
soundness of the proposed career development plan, (3) training in 
responsible conduct of research, (4) the nature and scientific/technical 
merit of the research plan, (5) the mentor, and (6) the institutional 
environment, including the commitment of the institution to the candidate"s 
career.  The following review criteria apply to all applicants:

(1) Qualifications of the Candidate

o Quality of the candidate"s research, academic and (if relevant) clinical 
record, 
o Potential to develop as an independent researcher, and
o Commitment to a research career.

(2) Career Development Plan

o Appropriateness of the content, the phasing, and the proposed duration of 
the career development plan for achieving scientific independence,
o Consistency of the career development plan with the candidate"s career 
goals, 
o Likelihood that the plan will contribute substantially to the achievement 
of scientific independence.

(3) Training in the Responsible Conduct of Research

o Quality of the proposed training in responsible conduct of research.

(4) Research Plan

o Scientific and technical merit of the research question, design and 
methodology, 
o Relevance of the proposed research to the candidate"s career objectives, 
o Appropriateness of the research plan to the stage of research development 
and as a vehicle for developing the research skills described in the career 
development plan, and
o Adequacy of the plan"s attention to children, gender and minority issues 
when human subjects are involved.

(5) Qualifications and Appropriateness of Mentor/Co-Mentor

o Appropriateness of mentor(s) research qualifications in the area of this 
application,
o Quality and extent of mentor(s) proposed role in providing guidance and 
advice to the candidate,
o Previous experience in fostering the development of researchers, 
o History of research productivity, and
o Adequacy of support for the proposed research project.

(6) Environment and Institutional Commitment

o Adequacy of research facilities and training opportunities,
o Quality and relevance of the environment for scientific and professional 
development of the candidate, 
o Applicant institution"s commitment to the scientific development of the 
candidate and assurances that the institution intends the candidate to be an 
integral part of its research program, and
o Applicant institution"s commitment to an appropriate balance of research 
and clinical responsibilities including the level of 75 percent effort 
proposed by the candidate.

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

o 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.

o INCLUSION:  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.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

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

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 

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: http://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 AMENDMENT "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 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), 
a complete copy of the updated Guidelines are available at 
http://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 
http://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 
http://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 http://grants.nih.gov/grants/stem_cells.htm and at  
http://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 
http://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.

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 No. 93.853, and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284)and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm  and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92. 

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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