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) 710-0267,
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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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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