and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
General Medical Sciences (NIGMS) (http://www.nigms.nih.gov)
Title: Minority
Access to Research Careers (MARC) Ancillary Training Activities (T36)
Announcement Type
This is a reissue of PAR-03-026.
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 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. For more information and an initial timeline, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).
Program Announcement (PA) Number: PAR-08-118
Catalog of Federal Domestic Assistance Number(s)
93.859
Key Dates
Release Date: March 26,
2008
Letters
of Intent Receipt Date(s): Not required
Application Receipt or Submission
Date(s): September
11, 2008; January 8, 2009; September 11, 2009; January 11, 2010;
September 7,
2010; and January 11, 2011
Peer
Review Date(s): February/March and June/July
Council Review Date(s): May and October
Earliest Anticipated
Start Date: December/January
Additional
Information To Be Available Date (Url Activation Date): Not applicable
Expiration
Date: (Now Expired March 24, 2010 per NOT-OD-10-069), January
12, 2011
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The Minority Access to Research Careers (MARC)
Branch of the Minority Opportunities in Research (MORE) Division was
established to significantly increase the number and competitiveness of
underrepresented minorities engaged in biomedical research. To facilitate the
training and development of students, faculty, and/or researchers from groups underrepresented in
the biomedical research enterprise of this nation, the MARC Branch will provide program-related support in three key areas: a)
scientific conferences, b) scientific short courses, or c) other well-defined
ancillary training activities that further the MARC mission.
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Training Activities Objectives
Section
II. Award Information
1. Mechanism(s) 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. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and 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 and Information
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
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 Training Objectives
In the National Institutes of Health (NIH) Revitalization Act of 1993, NIH was encouraged to increase the number of nationally underrepresented minorities (URM) engaged in biomedical and behavioral research. Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans, Alaska Natives, Native Hawaiians, and Natives of the US Pacific Islands. However, it is incumbent on the applicant institution/organization to determine whether a group is underrepresented in biomedical and/or behavioral research fields in establishing its institutional objectives. In response to a 1993 Congressional act the Minority Access to Research Careers (MARC) Branch of the Division of Minority Opportunities in Research (MORE) of the National Institute of General Medical Sciences (NIGMS) offers an opportunity to facilitate the training and development of students, faculty, and/or biomedical researchers from underrepresented minority groups for research careers and leadership positions in these fields through its MARC Ancillary Training Program.
The goal of the MARC Ancillary Training Program is to provide support for the attendance and participation of underrepresented individuals and/or faculty from minority serving institutions in program-related scientific conferences, short courses, or other well-defined ancillary training activities that provide participants with the knowledge, skills, and/or networking capabilities to pursue and thrive in biomedically related research careers. The ancillary training may include support for student academic development and enrichment activities that are designed to improve critical thinking skills, communication skills, and time management; and may also provide group learning opportunities, interdisciplinary or advanced course training where students learn quantitative skills to analyze biomedical and behavioral problems, and opportunities to meet and discuss career choices with appropriate role models.
Various strategies may be employed to attain the objective of significantly increasing the number and competitiveness of underrepresented minorities pursuing leadership positions in biomedical research careers. Examples of scientific- or program-related conferences, short courses, or other ancillary training activities that could support the overall goals of the MARC Ancillary Training Program are listed below. This list is not intended to be comprehensive or directive.
The MORE Division recognizes the heterogeneity in institutional/organizational settings and missions, therefore the scope, purpose, and objectives of the MARC Ancillary Training proposals are anticipated to be very diverse. Each applicant will be required to clearly state his/her own specific goals and measurable objectives and to provide an evaluation plan that explains how the applicant will assess that the objectives have been met. The relevance of the proposed conference, short course, or other ancillary training activity to the MARC program goals should be explained in detail in the application. A description of the proposed goals and objectives, plans, and logistics of the ancillary activity, along with a description of the methodology proposed to obtain the desired outcomes (i.e., lectures, presentations, seminars, poster sessions, etc.) should be stated. Any other pertinent information that contributes to a clear description of the training activity, such as qualifications and previous experience of activity coordinators or other personnel, and characteristics of the targeted participants is advised. Lastly, a plan for evaluating the proposed activity and the extent to which the proposed goals and objectives will be accomplished should also be included, as well as samples of the evaluation instruments to be used for the different activities, if applicable. Additionally, applicants submitting competing renewals should describe in detail the progress accomplished to date and results of the evaluation performed to determine if the originally proposed goals and objectives have been accomplished.
Participants for the MARC Ancillary Training Program are selected by the applicant institution/ organization. There is no specific eligibility requirement for participation in MARC-supported activities. The program should not deny participation to anyone based solely on his/her race, religion, gender or ethnicity. However, to receive support from the MARC program, participants must be U.S. citizens, or non-citizen nationals (a non-citizen national is a person who, although not a citizen of the United States, owes permanent allegiance to the US. This is generally a person born in a land that is not a state, but that is under U.S. sovereignty, jurisdiction, or administration -- for example, American Samoa), or permanent residents. An individual lawfully admitted for permanent residence must possess an alien registration receipt card (I-551) prior to participation. Individuals on temporary visas, those seeking asylum, or refugees are not eligible for support from this MARC Program. It is the responsibility of the applicant institution to establish the qualifications of participants prior to their MARC Ancillary Training.
The purpose of the MARC Branch is to achieve greater participation in the biomedical and behavioral research enterprise of this country by individuals from underrepresented minority groups as described above. Therefore, participant selection should take into consideration whether an individual’s participation would help achieve the overall goals and objectives of the proposed program.
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the T36 award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
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 NIGMS provides support for this
program, awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation; see NOT-OD-05-004.
NIH
grants policies as described in the NIH Grants Policy
Statement will apply to the applications submitted and awards
made in response to this FOA.
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:
Applications may only be submitted by domestic institutions, and foreign subcomponents are not permitted.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed ancillary
training 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.
The Program Director/Principal Investigator (PD/PI) should possess research credentials and/or be a science administrator with a successful past training record and have available resources to conduct the proposed ancillary training program. The PD/PI will be responsible for the overall direction, management and administration of the ancillary training program and the submission of all required forms in a timely manner.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the NIH Grants Policy Statement.
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)
710-0267, Email: [email protected].
Telecommunications for
the hearing impaired: TTY 301-451-5936.
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 lines 1 and 2 of the face page of the application form and the YES
box must be checked.
3. Submission Dates and Times
See Section
IV.3.A for details.
3.A. Receipt, Review and
Anticipated Start Dates
Letter of Intent
Submission Date: Not Required.
Application Submission
Date(s): September
11, 2008; January 8, 2009; September 11, 2009; January 11, 2010; September 7,
2010; and January 11, 2011
Peer
Review Date(s): February/March and June/July
Council Review Date(s): May and September
Earliest Anticipated
Start Date: December/January
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 three
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).
At the time of submission,
two additional copies of the application and all copies of the appendix
materials must be sent to:
Helen Sunshine, Ph.D.
Office of Scientific Review, NIGMS
45 Center Drive
Natcher Building 45, Room 3AN.12F
Bethesda, MD 20892
Telephone:
(301) 594-2881
FAX:
301-480-8506
Email: [email protected]
3.C.
Application Processing
Applications
must be received on or before the application
receipt/submission 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 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. However, the NIH will accept a
resubmission application, but such application must include an Introduction
addressing the critique from the previous review.
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. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
ALLOWABLE COSTS
Allowable expenditures and the applicable policies are listed below. Any costs not listed below must be either approved at the time of award or, if after the award, have received prior written approval from the NIGMS staff.
UNALLOWABLE COSTS
Grant funds may not be used to provide stipends to participants or for entertainment, tips, bar charges, personal telephone calls, personal Internet connection, or laundry charges of participants, students, or guests.
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 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 and Information
Program
Evaluation
MARC Ancillary Training Activities (T36) applications must include a plan to evaluate the effectiveness of the proposed program. Evaluation is conducted for the purpose of providing useful information to the PI/PD and the institution for improving its program and to institutionalize the most effective activities supported by the MARC Branch. Program evaluation is also conducted for the NIH peer review process (see Section V.2.A. for details). A sound evaluation plan, with a timeline (milestones), that is in-line with the proposed measureable goals and objectives is required.
Research Plan Page Limitations
Follow the instructions on PHS 398 (http://grants.nih.gov/grants/funding/phs398/phs398.html).
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.
Appendix Materials
All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application. Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)
The following resource sharing policies do not apply to this FOA:
Section V. Application Review Information
1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
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 NIGMS on the basis of established
PHS referral guidelines.
Applications that are complete will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
NIGMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
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
goals of NIH supported activities are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. Furthermore, NIH’s mission includes
training the next generation of biomedical and behavioral scientists. 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 ancillary training 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 application address an important problem? What is the
importance or benefits of the proposed scientific conference, short course, or
other described ancillary training to the targeted community? What is the
adequacy of the goals and objectives, scope, and content of the proposed
activity?
Approach: Are the conceptual 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? What is the appropriateness of the proposed format for achieving the stated goals and objectives? What are the selection criteria (if any) and qualifications of the proposed participants?
Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms; 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
qualifications of the Program Director/ Principal Investigator(PD/PI) appropriate and
well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and others involved? Does the team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the proposed environment in which the work will be done contribute to the probability of success? Do the proposed activities benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? What is the adequacy of the resources and appropriateness of the proposed conference, short course, or other ancillary training activity site?
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:
Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?
Evaluation Plan. What is the validity and adequacy of the instruments to be used for evaluation of the activity?
For new applications: Is the evaluation plan based on appropriate literature and cited methodology? Does the evaluation plan and timeline adequately assess the effectiveness (process and outcome) of the program in achieving its goals and objectives? Is the planned evaluation consonant with the specific aims, measurable objectives, and goals of the proposed MARC Ancillary Training Program? Will the planned evaluation appropriately assess how the proposed MARC activities will enhance the academic preparation and competitiveness of the targeted population(s) of participants? Does the plan describe how the program outcomes will be determined and evaluated?
For renewal applications: Has the program been adequately evaluated and has the level of success been satisfactory? Do the results of the evaluation document a continued need for support for this program? Is the approach for the next project period responsive to the results of the program's evaluation? Do the results of the evaluation indicate that the program has been achieving the proposed goals and objectives and has had an institutional/organizational impact?
2.B.
Additional Review Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Resource Sharing
Plan(s)
The following
resource sharing policies do not apply to this FOA:
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).
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.
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 (designated in item 12 on the
Application Face Page). If a grantee is not email enabled, a hard copy of the
NoA will be mailed to the business official.
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).
2.A.1.
Project Director/Principal Investigator (PD/PI) Rights and Responsibilities
The
Principal Investigator will have the primary responsibility for: the overall direction, management,
and administration of the ancillary training program and the submission of all
required forms in a timely manner.
Awardees will
retain custody of and have primary rights to the data and software developed
under these awards, subject to Government rights of access consistent with
current HHS, PHS, and NIH policies.
2.A.2. NIH
Responsibilities
A NIGMS program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice.
2.A.4. Arbitration Process
Any
disagreements that may arise in scientific or programmatic matters (within the
scope of the award) between award recipients and the NIH may be brought to
arbitration. An Arbitration Panel composed of three members will be convened.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special arbitration procedure in no way affects the awardee's right to appeal
an adverse action that is otherwise appealable in accordance with PHS
regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial
statements as required in the NIH Grants
Policy Statement.
A final progress report and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.
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:
Adolphus Toliver, Ph.D.
MORE Division , NIGMS
Natcher Building 45, Room 2AS.37G
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-3900
FAX: 301-480-2753
Email: [email protected]
OR
Shawn Drew, Ph.D.
MORE Division , NIGMS
Natcher Building 45, Room 2AS.37B
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-3900
FAX: 301-480-2753
Email: [email protected]
2. Peer Review Contacts:
Helen Sunshine, Ph.D.
Office of Scientific Review, NIGMS
Natcher Building 45, Room 3AN.12F
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: 301-480-8506
Email: [email protected]
3. Financial or Grants Management Contacts:
Grace Olascoaga
Grants Management Branch, NIGMS
Natcher Building 45, Room 2AN.32G
45 Center Drive
Bethesda, MD 20892
Telephone: (301) 594-5520
FAX: 301-480-1969
Email: [email protected]
Section
VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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).
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.
Policy for Genome-Wide
Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, 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.
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 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 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 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 Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html),
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public Access
webpage at http://publicaccess.nih.gov/.
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. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 487 of the Public Health Service Act as
amended (42 USC 288) and under Federal Regulations 42
CFR 66. 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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