Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
Title: Design,
Measurement, And Statistics In Community Mental Health Research (R01)
Announcement Type
This is a reissue of PA-04-150,
which was previously issued on August 24, 2004.
Update: The following update relating to this announcement has been issued:
Looking Ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number:
PA-06-474
Catalog of Federal Domestic Assistance Number(s)
93.242
Key Dates
Release Date: June 23, 2006
Letters of Intent Receipt Date(s): Not applicable.
Application Submission Date(s): Standard dates apply,
please see http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
AIDS Application Receipt Date(s): Not applicable.
Peer Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s):See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (Url Activation
Date): Not applicable.
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible
Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission
Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review and Anticipated
Start Dates
1. Letter of Intent
B. Sending an Application to the
NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section VIII. Other Information
- Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The purpose of this Funding Opportunity Announcement (FOA) is to encourage research grant applications for work on the design, measurement, and statistical challenges inherent in conducting mental health services research in community settings. The goal of this initiative is to build and diversify the methodological infrastructure of community-based mental health services prevention and intervention research. The FOA is designed to encourage methodologists from diverse academic backgrounds, including mathematical and educational statistics, biostatistics, software engineering, behavioral and social science, and business, to focus on the challenges inherent in this type of research.
Background. Advances in mental health community-based research are highly dependent on the quality and applicability of research designs, measures, and data analytic strategies. Innovative methods are needed now, as never before. With the rapidly expanding mental health services research knowledge base, community-based interventions have become a central focus for future research. To extract the most useful information from these trials, the field requires the development and/or adaptation of increasingly more sophisticated and precise designs, measures, and analytic strategies, some of which do not come from the areas of science most familiar to health services researchers. Given the challenges inherent in community-based research, such as cultural differences among participants, widely variant preferences for treatment, losses to follow-up, and the need for short assessments, it is imperative that investigators conducting community-based research consider and test advances that emanate from any scientific discipline.
The NIMH is issuing this FOA to ensure that those who are currently working on the methodological issues in mental health community-based research will continue to do so and that those methodological experts who are not working on mental health services issues will be encouraged to enter the field, bringing with them the insight that a fresh perspective can provide in finding solutions to problems.
This FOA makes explicit the determination of NIMH to support the basic methodological work, qualitative and quantitative, necessary for the advancement of mental health community-based research.
Research Issues. Listed below are examples of research topic areas that focus on design, measurement, and statistical analysis in mental health community-based research. The list of examples is illustrative, not exhaustive; it is expected that additional important research topics will be identified by researchers who respond to this FOA.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This FOA will use the NIH Research Project Grant (R01) award mechanism. As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project. The total project period for an R01 application
submitted in response to this FOA may not exceed 5 years.
This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.
2. Funds Available
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization
has any of the following characteristics:
1.B. Eligible Individuals
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 support.
2. Cost Sharing or Matching
Cost sharing is not required. The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.
3. Other-Special Eligibility Criteria
Not applicable.
Section IV. Application and Submission Information
1. Address to Request Application
Information
The PHS 398 application instructions are available
at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. Applicants must use the currently approved version
of the PHS 398. For further assistance contact GrantsInfo, Telephone (301)
435-0714, Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application
Submission
Applications must be prepared using the most current
PHS 398 research grant application instructions and forms. Applications must
have a D&B Data Universal Numbering System (DUNS) number as the universal
identifier when applying for Federal grants or cooperative agreements. The
D&B number can be obtained by calling (866) 705-5711 or through the web
site at http://www.dnb.com/us/. The D&B
number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications submitted
by foreign organizations:
Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.
3. Submission Dates and Times
See Section IV.3.A for
details.
3.A. Submission,
Review and Anticipated Start Dates
Application Submission Date(s):
Standard dates apply. See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Peer Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm.
Council Review Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is not required for the funding opportunity.
3.B. Sending an Application to the
NIH
Applications must be prepared using the research grant
application forms found in the PHS 398 instructions for preparing a research
grant application. 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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS
service)
Personal deliveries of applications are no longer
permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C. Application Processing
Applications must be submitted on or before the application receipt dates described above (Section IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt, applications will be evaluated for completeness by CSR. Incomplete applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The NIH 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.
Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.
4. Intergovernmental Review
This initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are subject to the
terms and conditions, cost principles, and other considerations described
in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are allowable. A grantee may,
at his/her own risk and without NIH prior approval, incur obligations and
expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing continuation award if such costs:
are necessary to conduct the project, and would be allowable under the grant,
if awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more
than 90 days before the beginning date of the initial budget period of a new
or competing continuation award.
The incurrence of pre-award costs in anticipation
of a competing or non-competing award imposes no obligation on NIH either
to make the award or to increase the amount of the approved budget if an award
is made for less than the amount anticipated and is inadequate to cover the
pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award
costs result in borrowing against future support and that such borrowing must
not impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific Instructions for Modular Grant Applications:
Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting $500,000
or more in direct costs for any year must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before
submitting the application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC
will accept your application for consideration for award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.
Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a plan for sharing
research data in their application. The funding organization will be responsible
for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan
for sharing research resources addressing how unique research resources will
be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will
be considered in the review process.
2. Review and Selection Process
Applications submitted for this funding opportunity
will be assigned to the ICs on the basis of established PHS referral guidelines.
Appropriate scientific review groups 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:
The following will be considered in making funding decisions:
The goals of NIH supported research
are to advance our understanding of biological systems, to improve the control
of disease, and to enhance health. In their written critiques, reviewers will
be asked to comment on each of the following criteria in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, weighting them as appropriate for each application.
Note that an application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field forward.
Significance: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge or clinical practice
be advanced? What will be the effect of these studies on the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?
Approach: Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well reasoned, and appropriate
to the aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the
project challenge existing paradigms or clinical practice; address an innovative
hypothesis or critical barrier to progress in the field? Does the project
develop or employ novel concepts, approaches, methodologies, tools, or technologies
for this area?
Investigators: Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers? Does the investigative
team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations,
or employ useful collaborative arrangements? Is there evidence of institutional
support?
2.A. Additional Review Criteria:
In addition to the above criteria, the following
items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).
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 the Research Plan, Section
E on Human Subjects in the PHS Form 398).
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the percent effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and justified
in terms of the aims and methods? The priority score should not be affected
by the evaluation of the budget.
2.C. Sharing Research Data
The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score. The presence of a
data sharing plan will be part of the terms and conditions of the award. The
funding organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication (See
the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr.
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The effectiveness
of the resource sharing will be evaluated as part of the administrative review
of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA Commons.
If the application is under consideration
for funding, NIH will request "just-in-time" information from the
applicant. For details, applicants may refer to the NIH Grants
Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via
email notification from the awarding component to the signing official shown
on the electronic application.
Selection of an application for award is not an authorization
to begin performance. Any costs incurred before receipt of the NoA are at
the recipient's risk. These costs may be reimbursed only to the extent considered
allowable pre-award costs. See Also Section IV.5.
Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS Non-Competing
Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning
this funding opportunity 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:
1. Scientific/Research Contacts:
Ann A. Hohmann, Ph.D., MPH
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7135, MSC 9631
Bethesda, MD 20892-9631
Telephone: (301) 443-4235
Email: ahohmann@nih.gov
2. Peer Review Contacts:
N/A
3. Financial or Grants Management
Contacts:
Joy R. Knipple
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD 20892-9605
Telephone: (301) 443-8811
FAX: (301) 443-6885
Email: jk173r@nih.gov
Section VIII. Other Information
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 (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The establishment
of data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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 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 funding opportunity
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.
Inclusion of Women And Minorities
in Clinical Research:
It is the policy of the NIH that women and members
of minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators
proposing clinical research should read the "NIH Guidelines for Inclusion
of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 SF424 (R&R); 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 Clinical
Research:
The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all clinical research, conducted
or supported by the NIH, unless there are scientific and ethical reasons not
to include them.
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 (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 applications
for research involving human subjects and individuals designated as key personnel.
The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. The author's final manuscript is defined
as the final version accepted for journal publication, and includes all modifications
from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service
Awards, as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in
whole or in part with direct costs from NIH, but it does not apply to book
chapters, editorials, reviews, or conference proceedings. Publications resulting
from non-NIH-supported research projects should not be submitted.
For more information about the Policy or the submission
process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual
(http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and enforced
by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and research
contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must
be self-contained within specified page limitations. Unless otherwise specified
in an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This FOA
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.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment
from qualified health professionals who have made a commitment to pursue a
research career involving clinical, pediatric, contraception, infertility,
and health disparities related areas. The LRP is an important component of
NIH's efforts to recruit and retain the next generation of researchers by
providing the means for developing a research career unfettered by the burden
of student loan debt. Note that an NIH grant is not required for eligibility
and concurrent career award and LRP applications are encouraged. The periods
of career award and LRP award may overlap providing the LRP recipient with
the required commitment of time and effort, as LRP awardees must commit at
least 50% of their time (at least 20 hours per week based on a 40 hour week)
for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Office of Extramural Research (OER) |
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National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
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Department of Health and Human Services (HHS) |
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