NINDS/NIMH MENTORED RESEARCH CAREER DEVELOPMENT AWARDS IN AIDS RESEARCH

RELEASE DATE:  March 25, 2003  

PA NUMBER:  PA-03-086 

EXPIRATION DATE:  1 November 2005, unless reissued

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):  93.853 (NINDS), 93.242 (NIMH)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms 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 PA

The National Institute of Neurological Disorders and Stroke (NINDS) and 
the National Institute of Mental Health (NIMH) invite applications for 
Mentored Clinical Scientist Development Awards (K08s), or Mentored 
Patient-Oriented Research Career Development Awards (K23s) from 
physicians and basic scientists interested in pursuing research related 
to HIV infection of the nervous system.  The intent of this Program 
Announcement (PA) is to encourage research and career development for 
individuals with a strong commitment to a research career in the area 
of NeuroAIDS, either in one of the basic sciences relevant to NeuroAIDS 
or in clinically-oriented research.  Research related to the 
neuropathogenesis, the role of viral or host genetic factors, 
inflammatory mechanisms, peripheral neuropathy, or neurological 
dysfunction in the setting of anti-retroviral therapy is of particular 
interest.

RESEARCH OBJECTIVES

The objectives of this program announcement are to encourage
individuals to pursue research careers in the area of NeuroAIDS and to 
increase the number of trained physicians and basic scientists 
interested in pursuing research related to the elucidation of the 
pathogenesis, progression, and treatment of cognitive or motor 
dysfunction, or peripheral neuropathy, associated with HIV infection in 
the nervous system.  It has become clear that neurological and 
neuropsychiatric dysfunction associated with HIV infection may be 
caused by ongoing chronic inflammatory processes in the nervous system. 
Training in basic science areas of virology, immunology, glial cell 
biology, or genetics, as they relate to NeuroAIDS, or in clinical areas 
of the diagnosis and treatment for HIV associated dementia or 
peripheral neuropathy are encouraged.

MECHANISMS OF SUPPORT  

This PA will use the Mentored Clinical Scientist Development Award 
(K08) and Mentored Patient-Oriented Research Career Development Award 
(K23) mechanisms.  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, related fringe benefits, 
and research allowance will be provided as described 
(http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html, 
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html).  
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 laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic 
o Faith-based or community-based organizations

Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Candidates for this award must have earned a doctoral degree 
(Ph.D., M.D., D.Sc., etc.) by the time the award is made.  The 
applicant institution must agree 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 K08 or K23 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.  NIMH will support persons who plan to 
pursue careers in research relating to neurological and 
neuropsychiatric consequences of HIV-1 infection.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.  

Note: Recipients of K08 and K23 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 K08 and K23 awards 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 and NIMH will provide salary support as described, respectively
(http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html,
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html). 
The grantee institution may supplement the NINDS or NIMH 
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 K08 and K23 awards 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 may be requested for each year to 
support research and/or career development activities (see 
(http://grants.nih.gov/grants/guide/notice-files/NOT-NS-03-001.html, 
http://grants.nih.gov/grants/guide/notice-files/NOT-MH-02-001.html).  
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 or NIMH 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  

A candidate for the K08 or K23 award may not concurrently apply for or 
have an award pending for any other NIH career development award.  It 
is expected that K08 and K23 recipients will apply for independent 
research grant support during the period of this award. 

(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 or NIMH 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 or NIMH 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 
NINDS or NIMH 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 appropriate 
NINDS or NIMH funding component must be notified in writing at the 
earliest possible time so that appropriate instructions can be given 
for termination. 

NINDS or NIMH K08 and K23 awards are not transferable to another 
individual but may be transferred to another institution.  In the 
latter case, the awardee must contact the appropriate NINDS or NIMH 
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 two areas:  scientific/research and financial or grants 
management issues:

o Direct your questions about scientific/research issues to:

Michael Nunn, Ph.D.
Program Director
Neural Environment Cluster
National Institute of Neurological Disorders and Stroke
6001 Executive Blvd., Room 2118
Bethesda, MD  20892
Telephone: (301) 496-1431
FAX: (301) 480-2424
Email: mn52e@nih.gov

OR

Jeymohan Joseph, Ph.D.
Chief, HIV Neurovirology, Genetics 
and Molecular Therapeutics Program 
Center for Mental Health Research on AIDS
National Institute of Mental Health
6001 Executive Blvd., Room 6202
Bethesda, MD  20892
Telephone: (301) 443-3012
FAX: (301) 443-9719
Email: jjeymoha@mail.nih.gov

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

Mr. Ken Bond
Grants Management Branch 
National Institute of Neurological Disorders and Stroke 
6001 Executive Blvd., Room 3254
Bethesda, MD 20892
Telephone: (301) 496-9231
Fax: (301) 402-0219
Email: bondk@ninds.nih.gov

OR

Mr. Brian Albertini
Grants Management Branch 
National Institute of Mental Health 
6001 Executive Blvd., Room 6115
Bethesda, MD 20892
Telephone: (301) 443-0004
Fax: (301) 443-0219
Email: albertib2@mail.nih.gov

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.  Reference special K instructions.  For further 
assistance contact GrantsInfo, Telephone (301) 435-0714, Email: 
GrantsInfo@nih.gov.

The essential elements of the K08 and K23 awards 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 K08 and K23 awards do 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 for AIDS-related grant applications, 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)

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 on 
or 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.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.

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 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
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, , the 
following items will be considered in the determination of scientific 
merit and the priority score:

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.  

ADDITIONAL CONSIDERATIONS 

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

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

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: 
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 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 http://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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