NINDS MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARDS IN TRANSLATIONAL RESEARCH

RELEASE DATE:  July 26, 2002

PA NUMBER: PAR-02-140 (This PAR has been reissued, see PAR-05-160)

EXPIRATION DATE:  July 31, 2005

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

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators (PIs)
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

Recent discoveries across a broad range of research areas in the neurosciences 
offer promising opportunities for improved therapies for neurological disorders.  
As part of its mission to reduce the burden of neurological disease, NINDS is 
committed to encouraging the "translation" of these basic discoveries into new 
treatments.  The goal of this PA is to announce a career development opportunity 
for new investigators to build a program of translational research in 
neurological disorders under the guidance of an experienced mentor.

This PA is one of three coordinated programs being released by NINDS to promote 
translational research, including "NINDS Exploratory/Developmental Projects in 
Translational Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-138.html), and "NINDS Cooperative 
Program in Translational Research" 
(http://grants.nih.gov/grants/guide/pa-files/PAR-02-139.html).

RESEARCH OBJECTIVES

The research project for this award must specifically be in the area of 
translational research.  For the purposes of this program translational research 
is defined as the process of applying new ideas, insights, and discoveries 
generated through basic scientific inquiry to the treatment or prevention of 
human disease.  Projects will typically include either a disease-relevant assay, 
or candidate therapeutics that have a significant effect in a disease model.

The career development and training experience must focus on translational 
research.  This should include the principles of therapeutics, candidate 
screening and evaluation, assay validation, the development and use of animal 
models of neurological disorders, toxicology and safety testing, biostatistics, 
the preparation of Investigational New Drug (IND) or Investigational Device 
Exemptions (IDE) applications, and interactions with private sector companies 
involved with the manufacture and marketing of therapeutic drugs or devices.  
Although all of these elements will not normally be included in the research 
project, experience and training in these areas should be built into the career 
development plan.

The rapid translation of basic neuroscience research findings into improvements 
in clinical neurology and neurosurgery practice and outcomes remains an 
important part of improving the quality, efficiency, effectiveness, and cost-
effectiveness of health care.  Significant hurdles exist, however, to 
implementing this goal.  There is broad agreement among researchers and health 
care providers about the urgent need to accelerate the application of evidence-
based findings and tools in clinical practice.  The overall objective of this 
program is to attract and encourage investigators at the postdoctoral or early 
faculty development stage to focus their efforts on translational research in 
neurological disorders.  This program is intended to promote more extensive 
interaction among basic and clinical researchers, and to accelerate the 
development of interventions and effective treatments that will improve the 
quality of life of persons with neurological disorders.

MECHANISM OF SUPPORT 

This PA will use the NIH Research Scientist Development Award – Research & 
Training (K01) mechanism.  Applicants will be solely responsible for planning, 
directing, and executing the proposed project.  These awards are intended to 
support a period of intensive supervised career development experiences in the 
development of treatments for neurological disease.  Candidates for the K01 
award normally will have some postdoctoral research experience at the time of 
application.  The candidate must be able to demonstrate the need for 3-5 years 
of additional supervised research, and the potential for a highly productive 
independent career.  K01 Awards are not renewable.

ELIGIBLE INSTITUTIONS 

You may submit an application 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 Domestic

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry out 
the proposed research is invited to work with their 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.  Candidates for NINDS K01 awards must have a Ph.D. or 
equivalent research-intensive degree (e.g., Pharm.D.) and must have demonstrated 
the potential for highly productive independent research in the period after the 
doctorate.  The candidate must identify a mentor(s) with extensive basic and/or 
clinical research experience.  Candidates must be willing to spend a minimum of 
75 percent of full-time professional effort conducting research and research 
career development during the entire award period.  The candidate must clearly 
describe the need for intensive research supervision for a period lasting 3-5 
years leading to research independence.  Current or past principal investigators 
on NINDS/NIH research grants are not eligible for this award (the only 
exceptions are the R03 and R21 awards).

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.

SPECIAL REQUIREMENTS

A. Environment: The institution must have well-established research and career 
development programs and qualified faculty in basic and/or clinical research to 
serve as mentors.  It is particularly desirable that the institutional setting 
be conducive to translational research and therapy development.  The institution 
must be able to demonstrate a commitment to research and to the continuing 
development of the candidate as an independent scientist.  Institutions with 
outstanding basic and clinical neurology researchers who can serve as mentors 
are particularly encouraged to take advantage of these career awards to train 
the next generation of translational neurological sciences researchers.

B. Program: The award provides up to 5 years of salary and research support.  At 
least 75 percent of the recipient"s full-time professional effort must be 
devoted to the goals of this award.  The remainder may be devoted to other 
scholarly activities and research pursuits consistent with the objectives of the 
award.  In particular, candidates for the K01 award must be able to devote 
substantial time and effort to achieve the objectives of the career development 
award.

C. Mentor(s): Candidates must name a primary 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 
area of therapy development 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 research costs of this award.  Because of the scope of this 
program, candidates may wish to nominate co-mentors that can provide particular 
expertise which will augment and balance the research strengths of the primary 
mentor.  NINDS strongly encourages outstanding research scientists with 
significant basic-clinical (i.e., translational) neurological sciences research 
experience to serve as mentors or co-mentors.

D. Allowable Costs:

1. Salary: The NINDS will provide salary of up to $85,000 plus fringe benefits 
for the career award recipient.  The total salary requested is normally 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.

The institution may supplement the NIH salary contribution up to a level that is 
consistent with the institution"s salary scale, however, supplementation may not 
be from federal funds unless specifically authorized by the federal program from 
which such funds are derived.  Because the salary amount provided by this award 
is based on the full-time institutional salary, no other NIH funds may be used 
for salary supplementation.  Institutional supplementation of salary must not 
require extra duties or responsibilities that would interfere with the purpose 
of the K01.  Under NIH grants policy, however, institutions may rebudget funds 
within the total costs awarded to cover salaries consistent with the 
institution"s salary scale up to the current legislated maximum salary. 

2. Research Development Support: In addition to salary, NINDS will provide up to 
$50,000 in research development support.  These funds may be used for the 
following expenses: (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, (d) statistical and computational 
services including personnel and computer time.  All expenses must be directly 
related to the proposed research career development program.

3. Ancillary Personnel Support: Salary for mentors, secretarial and 
administrative assistance, etc., is not allowed.

4. Facilities and Administrative Costs:  These costs will be reimbursed at 8 
percent of modified total direct costs.

E. Evaluation:  In carrying out its stewardship of human resource related 
programs, the NIH may begin requesting information essential to an assessment of 
the effectiveness of this program.  Accordingly, recipients are hereby notified 
that they may be contacted after the completion of this award for periodic 
updates on various aspects of their employment history, publications, support 
from research grants or contracts, honors and awards, professional activities, 
and other information helpful in evaluating the impact of the program.

F. Other Income: Fees resulting from professional consultation, or other 
comparable activities required by the research and research-related activities 
of this 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:

o The funds may be expended by the grantee institution in accordance with the 
NIH policy on supplementation of career award salaries and 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.

o The funds may be used for health-related research purposes.

o The funds may 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, Office of Financial Management, NIH, Bethesda, 
Maryland 20892.  Checks must identify the relevant award account and reason for 
the payment.

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

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

G. Special Leave: Leave to another institution, including a foreign laboratory, 
may be permitted if the proposed experience is directly related to the purpose 
of the award.  Only local, institutional approval is required if such leave does 
not exceed 3 months.  For longer periods, prior written approval of NINDS is 
required.  To obtain prior approval, the award recipient must submit a letter to 
NINDS describing the plan, countersigned by the department head and the 
appropriate institutional official.  A copy of a letter or other evidence from 
the institution where the leave is to be taken must be submitted to assure that 
satisfactory arrangements have been made.  Support from the career award will 
continue during such leave.

Leave without award support may not exceed 12 months.  Such leave requires the 
prior written approval of NINDS and will be granted only in unusual situations.  
Support from other sources is permissible during the period of leave.  Such 
leave does not reduce the total number of months of program support for which an 
individual is eligible.

Under unusual and pressing 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, or clinical training.  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 an 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. 

H. Termination or Change of Institution:  When a grantee institution plans to 
terminate an award, NINDS must be notified in writing at the earliest possible 
time so that appropriate instructions can be given for termination.

Awardees planning a change of institution, must submit to NINDS, in advance of 
the change, a written request for transfer, countersigned by the appropriate 
institutional business official, describing the reasons for the change and 
including the new sponsor"s name and biosketch.  The awardee must establish in 
this request that the specific aims of the research program to be conducted at 
the new institution are within the scope of the original peer reviewed research 
program.  Additionally, the new mentor must have the appropriate research 
expertise to supervise the program and sufficient research support to ensure 
continuation of the research program to the end of the award.  NINDS program 
staff will review this request and determine if it will require peer review 
and/or review by the NINDS Advisory Council.  A new career award application 
must be submitted by the new institution far enough in advance of the requested 
effective date to permit review.  The period of support requested in the new 
application must be no more than the time remaining within the existing award 
period.

When a mentor at the grantee institution is to be replaced, the institution must 
submit a letter from the proposed mentor documenting the need for substitution, 
the new mentor"s qualifications for supervising the program, and the level of 
support for the candidate"s career development.  The letter must also document 
that the specific aims of the research program will remain within the scope of 
the original peer reviewed research program.  NINDS staff will evaluate the 
request, and will notify the grantee institution of the results of the 
evaluation.  

A final progress report, invention statement, and Financial Status Report are 
required upon either conclusion of an award or relinquishment of an award in a 
change of institution situation.

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
Bethesda, MD 20892
Telephone: 301-496-4188
Fax: 301-594-5929
Email: NINDSTrainingOffice@ninds.nih.gov

o Direct your questions about peer review issues to:

Raul A. Saavedra, Ph.D.
Scientific Review Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3208
Bethesda, MD 20892
Telephone: 301-496-7355 or 301-496-9223
Fax: 301-402-0182
Email: rs362t@nih.gov

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

King P. Bond, Jr.
Grants Management Branch
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 3290
Bethesda, MD 20892
Telephone: 301-496-9231
Fax: 301-402-0219
Email: kb33s@nih.gov

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 
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.

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)

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.

The application must address the following issues:

Candidate

o Describe the candidate"s commitment to a career in translational research for 
neurological disorders, and his/her potential to make future contributions to 
the neurological sciences.

o Establish the candidate"s potential to develop into an independent 
investigator, describe the long-term career objectives, and explain how this 
award will contribute to these goals.

o Affirm a commitment of at least 75 percent effort to research career 
development activities.

o Include as part of the application three sealed letters of recommendation 
addressing the candidate"s potential for a research career.

Career Development Plan

o The career development and training experience must focus on translational 
research.  Describe the career development plan incorporating consideration of 
the candidate"s goals and prior experience.  A systematic plan should be 
presented for obtaining the necessary basic/clinical background and research 
experience to launch an independent research career.  The career development 
plan must be specifically tailored to the needs of the candidate and the 
ultimate goal of achieving independence as a researcher.

Research Plan

o The research project for his award must specifically be in the area of 
translational research.  The research plan must be described as outlined in form 
PHS 398 including sections on the Specific Aims, Background and Significance, 
Preliminary Studies, Research Design and Methods.  The K01 candidate should 
consult with the proposed mentor(s) regarding the development of this section.

Training in the Responsible Conduct of Research

o Candidates for K01 awards 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.  No award will be made 
if an application lacks this component.

Mentor"s Statement

o The application must include a statement from the mentor including information 
on the mentor"s experience in translational research for neurological disorders, 
and previous experience as a research supervisor.  The application must also 
include information to describe the mentor"s research support related to the 
candidate"s research plan and the nature of the supervision that will occur 
during the proposed award period.  Because this program is intended to provide a 
means to promote more extensive interaction among basic and clinical 
researchers, in some cases more than one mentor will be appropriate.  The co-
mentor(s) must provide similar information.  If more than one mentor is 
proposed, the respective areas of expertise and responsibility should be 
described.

Environment and Institutional Commitment

o The sponsoring institution must document a strong, well-established basic and 
clinical research program in neurological sciences including a high-quality 
research environment with faculty that have had productive collaborations in 
translational research.  The sponsoring institution also must provide a 
statement to document the level of commitment to the candidate"s development 
into a productive, independent investigator during the period of the award.  
This must include an indication of support for the candidate"s proposed level of 
effort (at least 75 percent), commitment to the necessary release time, as well 
as the availability of support and supervision during the award period.  

Budget 

Budget requests must be provided according to the instructions in form PHS 398, 
and the limitations referenced above.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines.  Applications in response to the NINDS K01 program will 
be evaluated for scientific and technical merit by a peer review group convened 
by the NINDS Scientific Review Branch in accordance with the standard NIH peer 
review procedures (http://www.csr.nih.gov/refrev.htm).

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 NINDS Advisory Council

REVIEW CRITERIA

Candidate

o Quality of the K01 candidate"s research in basic and/or clinical neurological 
sciences.

o Potential to develop as an outstanding, independent research scientist 
developing a program of translational research for neurological disorders, and 
making significant contributions to the neurological sciences.

o Commitment to a career in translational research.

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 
focused on translational research.
 
o Likelihood that the plan will contribute substantially to the achievement of 
scientific independence, and the extent to which the award will enable a 
candidate to devote full time (at least 75 percent effort) to research and 
related activities.

Research Plan

o Importance of the translational research objective to the neurological 
disorder under study.

o Scientific and technical merit of the research question, design and 
methodology, and potential for advancing the field of study.

o Relevance of the proposed translational research project 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.

Training in the Responsible Conduct of Research

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

Mentor/Co-Mentor

o Appropriateness of mentor(s) research qualifications in translational 
research.

o Quality and extent of mentor(s) proposed role in providing guidance and advice 
to the candidate, especially with regard to translational research.

o Previous experience in fostering the development of basic and/or clinical 
researchers.

o History of research productivity.

o Adequacy of support for the proposed research project.

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, and the extent to which it provides a means to 
promote more extensive interaction among basic and clinical researchers.

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.

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.

Budget

o Justification of the requested budget in relation to career development goals 
and research aims.

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 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)

RESOURCE SHARING: A sharing plan for the distribution of unique research 
resources developed through NINDS Mentored Research Scientist Development Awards 
in Translational Research activities should be included in the application.  The 
sharing plan should preserve research freedom and publication rights, while 
ensuring appropriate implementation of the Bayh-Dole Act (35 U.S.C. 200 et seq.) 
and dissemination of research resources.  A Federal Register Notice published on 
December 23, 1999, titled "Principles and Guidelines for Recipients of NIH 
Research Grants and Contracts on Obtaining and Disseminating Biomedical Research 
Resources: Final Notice," provides further information, and is available at 
http://www.ott.nih.gov/policy/rt_guide_final.html.  The application should 
include a request for the funds necessary to implement the sharing plan, as part 
of the $50,000 maximum for research development support.

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.

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 and Career Development potential of 
the applicant, 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://grants1.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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Research (OER)
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Bethesda, Maryland 20892
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and Human Services (HHS)
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