Announcement Type
This is a reissue of PA-04-007,
which was previously released October 10, 2003, and is now divided into
separate Funding Opportunity Announcements (FOAs) for the R03, R21, and R01
grant mechanisms.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply)
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the submission/receipt date (see “Key Dates” below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PA-06-310
Catalog of Federal Domestic Assistance Number(s)
93.279
Key Dates
Release/Posted
Date: March 31, 2006
Opening Date: May 2, 2006 (Earliest
date an application may be submitted to Grants.gov
Letters
of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard dates apply,
please seehttp://grants.nih.gov/grants/funding/submissionschedule.htm.
AIDS
Application Submission/Receipt Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL
Activation Date): Not Applicable
Expiration Date: October 10, 2006
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), is intended to support small research projects that address drug abuse aspects of HIV/AIDS and other infections. The small grant (R03) can be carried out in a short period of time with limited resources, such as pilot or feasibility studies, secondary analysis of existing data, or developmental studies of research methodologies or technologies. Of particular interest are innovative pilot and/or feasibility studies that have potential to lead to larger multidisciplinary, cross-cultural, domestic and international research projects on drug abuse aspects of HIV/AIDS, other blood-borne and sexually transmitted infections, and TB in men and women, adolescents and adults, and in majority and minority populations. Researchers are encouraged to utilize existing research infrastructures so that their small grants will complement, benefit from, and enhance available expertise in the fields of molecular epidemiology, ethnography and behavioral epidemiology, mathematical modeling and simulations, behavioral and prevention science, virology, bacteriology, and clinical medicine.
Table of Contents
1. Research Objectives
This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), is intended to support the R03 small research project, which can be carried out in a short period of time with limited resources. It seeks innovative pilot/feasibility studies, secondary analysis of existing data, or the development of new research methodologies or technologies that will complement and lead to larger research projects on drug abuse and HIV/AIDS. Researchers are invited to address aspects of drug abuse, HIV/AIDS, and infectious diseases that cross-cut multiple disciplines, including, among others, virology, bacteriology, molecular epidemiology, etiology, therapeutics and vaccines, ethnography and behavioral epidemiology, mathematical modeling and simulations, and the behavioral and social sciences. In particular, the FOA encourages the development of innovative scientific partnerships and collaborations to enhance the utilization of existing research infrastructures, networks, and scientific expertise.
In the early 1980s, HIV and AIDS were first identified in the U.S. among men who have sex with men (MSM), injecting drug users (IDUs), and the sexual partners of IDUs. It later became clear that the same risk behaviors for HIV (i.e., injecting drug use and unprotected sex) are associated with other blood-borne and sexually transmitted infections, such as hepatitis B (HBV) and hepatitis C (HCV), and with the spread of tuberculosis. Noninjecting drug use, particularly the use of crack cocaine, methamphetamine, and club drugs such as ecstasy or MDMA, GHB, and ketamine, is another major transmission risk for HIV and other infectious diseases. For example, research has shown that crack smokers may be three or more times more likely to be infected with HIV than nonsmokers. The context of risk, including crack and other drug use and drug-for-sex exchanges or risky, unprotected sex with multiple partners, is significantly associated with the rapid spread of HIV and other STIs through drug and sex networks. Age-discrepant relations also have implications for HIV transmission; young women and adolescents who use crack and other drugs are at high risk for HIV infection at an early age, especially when they use drugs and have sex with older, HIV-infected partners.
The NIDA encourages innovative Small Grant (R03) research applications for pilot/feasibility studies, secondary analysis of data, or the development of research methodologies or technologies in the examination of drug abuse aspects of HIV/AIDS, other blood-borne and sexually transmitted infections, and TB. In particular, this FOA is intended to advance scientific knowledge that builds upon and leads to larger research projects capable of utilizing and integrating complementary methodological approaches and disciplines, such as molecular epidemiology, ethnography and behavioral epidemiology, mathematical modeling and simulations, behavioral and prevention science, virology, bacteriology, and clinical medicine.
This FOA envisions cross-cultural, national and international R03 research projects within and across the priority areas for NIH research on HIV/AIDS (http://www.nih.gov/od/oar/index.htm), some examples of which are provided below.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding opportunity will use the NIH Small Research Grant (R03) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.
This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. All applications submitted in response to this FOA must use the modular budget format. Specifically, since you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
Competing renewal (formerly “competing continuation”) applications will not be accepted for the R03 grant mechanism. Small grant support may not be used for thesis or dissertation research. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed small grant application may be submitted. See NOT-OD-05-046, April 25, 2005.
For specific information about the R03 programs, see: http://grants.nih.gov/grants/funding/r03.htm.
2. Funds Available
Although
the financial plans of the NIH Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the submission of a sufficient number of
meritorious applications.
A project period of up to two years and a budget for direct costs of up to two $25,000 modules, or $50,000 per year, may be requested (i.e., a maximum of $100,000 over two years in four modules of $25,000 each). Commensurate F&A costs are allowed.
F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.
Section III. Eligibility Information
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution/organization 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
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided each application is scientifically distinct.
Section
IV. Application and Submission Information
PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) ) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request Application Information
Applicants
must download the SF424 (R &R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able to use
any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA),
although some of the "Attachment" files may be useable for more than
one FOA.
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
Prepare all applications using the SF424 (R&R) application forms and in
accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424 (R&R) (Cover
component)
Research & Related Project/Performance Site
Locations
Research
& Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS Modular Budget
Optional
Components:
PHS398 Cover Letter File
Research & Related
Subaward Budget Attachment(s) Form
Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R03 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed research should provide a unique research
opportunity not available in the United States.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: May 2, 2006 (Earliest date an application may be
submitted to Grants.gov
Letters
of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s): Standard dates apply,
please seehttp://grants.nih.gov/grants/funding/submissionschedule.htm.
AIDS
Application Submission/Receipt Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Date(s): Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Earliest Anticipated Start Date(s): See http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
3.A.1. Letter of Intent
A
letter of intent is not required for this funding opportunity.
3.B. Electronic Submission
of an Application to the NIH
To submit an application
in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT
BE ACCEPTED.
3.C.
Application Processing
Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application submission/receipt
date(s). (See Section IV.3.A. for all dates.) If an
application is not submitted by the receipt date(s) and time, the application
may be delayed in the review process or not reviewed.
Upon receipt,
applications will be transferred from Grants.gov to the NIH Electronic Research
Administration process for validation. Both the PD/PI and the Signing Official
for the organization must verify the submission via Commons within two (2) business
days of notification of the NIH validation.
Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review, NIH. Incomplete applications
will not be reviewed.
There will be an acknowledgement of
receipt of applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the
Commons.
The NIH will not accept
any application in response to this FOA that is essentially the same as one
currently pending initial merit 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 an application already reviewed with substantial changes, but
such application must include an “Introduction” addressing the previous
critique. Note that such an application is considered a "resubmission"
for the SF424 (R&R).
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.
Pre-Award Costs are
allowable. A grantee may, at its 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 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 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 the NIH
Grants Policy Statement.
6. Other Submission Requirements
The
NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE –
Project Director/Principal Investigator” section, “Credential” log-in field of
the “Research & Related Senior/Key Person Profile” component. The applicant
organization must include its DUNS number in its Organization Profile in the
eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For additional information, see “Tips and Tools
for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant
Applications.”
Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.
All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for R03 applications:
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
Plan
for Sharing Research Data
Not Applicable
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_2003/NIHGPS_Part7.htm#_Toc54600131).
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.”
Section V. Application Review Information
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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The NIH R03 small grant is a mechanism for supporting discrete, well-defined projects that realistically can be completed in two years and that require limited levels of funding. Because the research plan is restricted to 10 pages, a small grant application will not have the same level of detail or extensive discussion found in an R01 application. Accordingly, reviewers should evaluate the conceptual framework and general approach to the problem, placing less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or from investigator-generated data. Preliminary data are not required, particularly in applications proposing pilot or feasibility studies.
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 comments, 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. The scientific review group will address and consider each of these criteria in assigning the application's 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 scientific health 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 PD/PI 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 item 6 of the Research Plan component of the SF424 (R&R).
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 item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget
and Period of Support: The reasonableness of the proposed budget and the
appropriateness of 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?
2.C. Sharing Research Data
Not Applicable
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_2003/NIHGPS_Part7.htm#_Toc54600131). 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.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. 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.”
Model
Organism Sharing Plan: Reviewers are asked to assess
the sharing plan in an administrative note. The sharing plan itself should be
discussed after the application is scored. Whether a sharing plan is reasonable
can be determined by the reviewers on a case-by-case basis, taking into
consideration the organism, the timeline, the applicant's decision to
distribute the resource or deposit it in a repository, and other relevant
considerations. For the R03 mechanism, the presence or adequacy of a plan
should not enter into the scoring of the application.
3. Anticipated Announcement and Award Dates
Not Applicable
Section VI. Award Administration Information
After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH 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.
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 grantee business official.
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 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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing Grant
Progress Report (PHS 2590) annually and financial statements as required in
the NIH
Grants Policy Statement.
2. Peer Review Contacts:
Not
Applicable
3. Financial or Grants Management Contacts:
Gary
Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Blvd.,
Suite 242, MSC 8403
Bethesda, MD 20892-8403
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: gf6s@nih.gov
Section VIII. Other Information
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible ( http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
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) application; 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.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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 (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, 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.
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.
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 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 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 Part 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 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.
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NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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