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 on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Title: Diversity-promoting Institutions Drug Abuse Research
Program (DIDARP) (R24)
Announcement Type
This Funding
Opportunity Announcement is a reissue of PAR-05-069.
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, seehttp://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-09-011
Catalog of Federal Domestic
Assistance Number(s)
93.279
Key Dates
Release
Date: October 21, 2008
Letters of
Intent Receipt Date(s): November
17, 2008, June 16, 2009, November 17, 2009, June 15, 2010, November 16, 2010, June 15, 2011
Application
Receipt Date(s): December 15, 2008, July 15, 2009, December 15, 2009, July 15, 2010, December 15, 2010, July 15, 2011
Peer Review Date(s): ): February 2009, October 2009, February 2010, October
2010, February 2011, October 2011
Council Review Date(s): May 2009, February 2010, May 2010,
February 2011, May 2011, February 2012
Earliest Anticipated Start Date: July 2009, April 2010, July 2010,
April 2011, July 2011, April 2011
Additional
Information To Be Available Date (Url Activation Date): Not Applicable
Expiration
Date: (Now Expired April 8, 2010 per NOT-DA-10-016), Original Date: July 16, 2011
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. 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 Objectives
The purpose of this program is to increase the drug abuse and addiction research capacity of institutions that historically and/or currently serve students from diverse and disadvantaged backgrounds. Grants will be provided to foster the research career development of a highly diverse cadre of students, faculty and staff who are underrepresented in drug abuse research. All capacity development and research activities must address scientific areas related to the mission and priorities of the National Institute on Drug Abuse.
Program Objectives
Participation in sponsored biomedical and behavioral research is low among some racial and ethnic groups and the academic institutions that serve them predominantly. Reasons for this underrepresentation in research include the following: (1) the primary, historic mission of many institutions with predominantly minority student bodies has been to provide excellent teaching in order to prepare its students for work and/or advanced studies at other institutions; (2) community service has been an important, time-consuming expectation of faculty and staff members; (3) many of these institutions have not had graduate research programs; and (4) support for research (e.g., facilities, equipment, release time, library resources, personnel) has been either unavailable or inadequate.
Diversity-promoting institutions, however, are redefining and expanding their mission to include a strong emphasis on research and have made strides in recent years to broaden and strengthen their research infrastructure and endeavors. In addition, these institutions have increased their interest and involvement in drug prevention and treatment programs and are particularly poised to expand these endeavors into the research arena. For example, many are engaged in various drug and HIV/AIDS education, prevention, and training activities; some have current but limited drug abuse research; some have strong ties to community-based organizations, agencies, and schools that are addressing drug abuse problems; and many have indicated interest in developing competency in drug abuse research. This program is intended to provide support to institutions that demonstrate a commitment to developing a supportive environment for fostering research and research careers in drug abuse and addiction.
Thus, the overall goal of the DIDARP is to develop the capacity of the applicant institution to support drug abuse research through the following objectives: (1) provide faculty from underrepresented groups with drug abuse research knowledge and skill development through the conduct of research projects and other professional development activities; (2) encourage students from underrepresented groups to pursue drug abuse research careers by providing them with educational enrichment and research experiences; and (3) strengthen the underlying institutional infrastructure needed to support drug abuse research.
Research in any area of drug abuse research supported by NIDA is permissible. NIDA is interested in biomedical, clinical, and behavioral research and supports research on drug abuse in the following broad areas: epidemiology, etiology, prevention, treatment and services, basic research, and medications development. Research areas of particular interest are HIV/AIDS and its relationship to drug use and abuse, and understanding the disparities in drug abuse and addiction-related health outcomes that are experienced by racial/ethnic minority populations. Some areas of research, such as studies that focus primarily on alcohol use, may not be appropriate for primary assignment to NIDA. Applicants are encouraged to consult with NIDA staff before submitting an application to ensure that the chosen area of research focus is appropriate to NIDA's mission.
Each DIDARP application must have a thematic research focus around which all research and training activities are directed. That is, there must be a common research issue or question that unites proposed institutional infrastructure development, faculty and student research development activities, and research projects. Examples of a research theme might include preventing drug abuse among young adults, or increasing adherence to treatment protocols in African Americans.
Each applicant must provide (1) a description of the institution's current drug abuse research capacity, (2) a faculty development plan, (3) a student recruitment plan, (4) a student development plan, (5) research projects, (6) an institutional research infrastructure development plan, (7) justification for the choice of the proposed Principal Investigator/ Project Director, (8) the inclusion and description of an external advisory board, (9) a letter of institutional commitment signed by a Dean or other institutional official with authority to commit institutional resources, (10) an impact assessment statement, and (11) Progress Report for DIDARP Renewals (Competing Continuations) and Former MIDARP Grantees.
1. Current Drug Abuse Research Capacity
The strategy for building research capacity should be based upon assessments of the institution's current level of drug abuse research, its capacity for research in areas other than drug abuse, environmental factors, levels of commitment, and availability of support. Assessments should examine not only needs but also strengths and resources which currently exist and upon which further capacity could be built. Other resources to consider include sponsored research office support, curricula offerings, faculty release time, students' interest, and collaborative arrangements.
2. Faculty Development Plan
The plan should detail the experiences and support intended for faculty members who are selected as individual research project directors, i.e., leaders of primary or pilot projects, and how providing these experiences will increase their ability to conduct drug abuse related research. Much of the faculty development is expected to come from active involvement in the primary and/or pilot research projects (see section below) supported by the program and through other career development activities such as workshops and training. Research activities should be clearly integrated with the faculty development plan. A recruitment plan specifying the criteria that will be used to select faculty members to serve as research project directors, and a brief individualized development plan must be submitted. Plans should include support for grant writing and development, research administration, effectively mentoring students in drug abuse and research, training in the responsible conduct of research (see Special Program Requirements), research design, data analysis, scientific writing and publishing. In addition, institutional support of the faculty project directors should be addressed including release time and committee obligations.
Faculty members who are currently conducting drug abuse research sponsored by other sources (e.g., federal, state, private sector) may be designated as associate project directors, and they may request funds to support minority undergraduate or graduate students to serve as research assistants on their currently funded projects. DIDARP funds may not be used to replace any research assistant positions supported by other federal or non-federal awards, and strong explanation of the benefits to be gained by the proposed research assistants and the research itself must be provided.
3. Student Recruitment Plan
A recruitment plan for students who will serve as student research assistants on projects supported by the program should be detailed. It is expected that students selected for participation in research activities will be provided with other research development opportunities such as participation in relevant conferences and mentoring in scientific writing. The student recruitment plan should be reasonable given the institutions current capacity, and it should contribute to the stated capacity building goals.
4. Student Development Plan
The student development plan should describe the educational and training experiences that will be provided to stimulate student interest in drug abuse and addiction research and to prepare students to pursue careers in drug abuse and addiction research, including training in the responsible conduct of research (see Special Program Requirements). Activities may be proposed to increase knowledge about drug abuse and career opportunities in drug abuse research for all students, e.g., classes and seminars. The student development plan should be within the institutions current capacity and must be clearly connected to the capacity building goals.
5. Research Projects
The program will provide support for primary and pilot research projects. Primary research projects refer to research studies that have well-specified specific aims, hypotheses, methods, and data analysis plans; however, they are not expected to provide the level of detailed description characteristic of R01 applications. Primary research projects should be contained within the 12 page Research Strategy. Pilot projects refer to research studies that seek to establish the feasibility or merit of a particular area of inquiry. They are expected to yield findings that address, for example, confirmation of the significance of the research, feasibility of the methods, and refinement/delineation of hypotheses. Convincing justification of the potential significance of the research should be made although methods and hypotheses may be in their early formative stages. Pilot projects should be contained within the 12 page Research Strategy. Projects must be clearly identified in the application as either primary or pilot projects.
Applicants must propose at least two and no more than five projects in the DIDARP application, and these projects must relate to the research theme or focus area. Additionally, these projects must be clearly connected to the faculty and student development plans. Participating faculty may serve as the lead investigator (also called the research project director) on only one research project.
Research project directors are responsible for the administration and implementation of their projects, with the guidance and support of the overall DIDARP Principal Investigator and the advisory board. In addition to costs associated with conducting the studies, research project directors may request support for undergraduate and graduate research assistants that come from racial/ethnic minority groups that are underrepresented in the biomedical and behavioral sciences.
The DIDARP must have at least one primary research project active in all years of support. This requirement may be met either by a single project for the full duration of the award, or by several projects running sequentially, as long as at least one primary project is active each year. The expectation is that this support, in concert with the institutional infrastructure enhancement, and the faculty development plans will eventually enable the individual research project directors to become competitive in sponsored research programs. Securing other support for research projects under the DIDARP umbrella such as from the university, foundations, or other NIDA mechanisms is encouraged.
6. Institutional Research Infrastructure Development Plan
The application must describe the support needed by the institution to meet the drug abuse and addiction research infrastructure capacity goals proposed, including resources and facilities needed for conducting the proposed research activities. The plan should address, for example, research equipment, laboratory space, research administration, collaborative arrangements, and data management and analysis support. A strategy for establishing and evaluating courses, curricula and seminars in areas relevant to research on drug abuse and addiction should also be included as well as plans, if needed, for the enhancement of business and research administration capacity (e.g., IACUC, IRB, grants administration).
7. DIDARP Principal Investigator/Project Director (PI/PD)
Each DIDARP application must have a designated PI/PD who will be responsible for the scientific and technical direction of the DIDARP. He/She should be a scientist with the appropriate training and experience, and the institutional authority and support to provide effective leadership and guidance to the program, and to support the individual research project director(s). He/She will be responsible for: (1) recruiting faculty to participate in the DIDARP research development activities; (2) assisting faculty in obtaining appropriate consultation and research mentoring during the grant period; (3) developing the institutional infrastructure required to implement drug abuse research; (4) providing needed fiscal and other project support; (5) recruiting students and providing them with drug abuse research career support and experiences; (6) providing scientific guidance in the research focus area; and (7) providing the overall administration of the grant.
The application should describe the qualifications of the proposed DIDARP PI/PD and the resources and support (e.g., release time, administrative support) that the institution will provide to facilitate his/her ability to perform effectively.
8. External Advisory Board
Plans should include details on establishing an Advisory Board to help guide the DIDARP, including development and mentoring activities in support of the research projects. Ideally such a panel would consist of three to five external individuals with the relevant expertise in drug abuse research and in the development of research capacity. Applications should contain a biographical sketch and a letter of commitment from each proposed advisory panel member.
9. Letter of Institutional Commitment
The application should include a signed letter from an institutional official with authority to commit the institution to the establishment of the DIDARP. It should detail the resources the institution is willing to provide including office and laboratory space, computer and internet access, library resources, and guarantees of protected time for faculty and students to perform the research and training activities described in the application. The letter should also describe the institution's level of confidence that the DIDARP, under the guidance of the proposed PI/PD, will be successful in achieving its goals.
10. Impact assessment
The application should describe the probable success of the proposed plan by describing the realistic changes that are likely to occur in institutional policies, procedures, resources, and programs germane to the proposed program for drug abuse research and faculty and student development. Applicants are expected to identify areas where development or change is desirable but may be difficult or not possible to address within the scope of the support provided under this program.
Describe, for example, how the proposed plan will change the institution's ability to develop a drug abuse and addiction research focus and agenda; seek and support drug abuse and addiction research; prepare its students and faculty for drug abuse and addiction research careers and for participation in sponsored research, in general; provide sufficient time and incentives for faculty to engage in drug abuse and addiction research; develop collaborations with established researchers/research institutions or drug abuse and addiction facilities; and expand library and resource materials.
A plan for conducting an annual impact assessment of the DIDARP is required (see Reporting Requirements). This assessment should document the actual impact of the program addressing factors described above and other qualitative and quantitative measures.
11. Progress Report for DIDARP Renewals (Competing Continuations) and Former MIDARP Grantees
DIDARP awards may be renewed through the competing renewal process. The application, however, must demonstrate a need for continued development of drug abuse and addiction research capacity at the institution.
A progress report must be included in competing continuation applications and new applications from institutions that have previously (within the last 5 years) received MIDARP funding. The progress report should describe the advances in drug abuse and addiction research capacity development that were achieved as a result of the prior DIDARP or MIDARP award using the originally proposed impact assessment criteria. Institutional, student, and faculty progress and accomplishments should be fully described in both qualitative and quantitative measures. In addition, report on results of primary research projects and what pilot research projects have accomplished. Examples of progress may include increased faculty publications on drug abuse and addiction related topics, increased applications submitted to funding sources, success in obtaining funding, faculty service as peer reviewers, evidence of growth in research skills, creation of new courses or seminars, participation of high quality underrepresented minority faculty and students in DIDARP activities, students pursuing graduate studies in research careers, and patents. A description of the accomplishments of each faculty and student supported by the prior DIDARP or MIDARP should be included. Faculty and students supported and mentored should be identified by race/ethnicity and gender.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism of Support
This
funding opportunity announcement (FOA) will use the R24 award mechanism. The
applicant will be solely responsible for planning, directing, and executing the
proposed project. An application may request three to five years of support.
DIDARP awards are renewable.
This FOA uses Just-in-Time information concepts.It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The amount
of funding to be awarded and the number of awards will depend on the number and
scientific merit of the proposals received. R24 awards have a budget of up to
$350,000 per year in direct costs for a period of three to five years.
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.
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
The following organizations/institutions are eligible to apply:
Foreign institutions are not eligible to apply.
Eligibility Requirements
Institutions applying for this award must demonstrate eligibility through minority designation or minority/disadvantaged status and demonstrated research capacity development need. Applications may be submitted by a university or college that meets one of the following criteria regarding minority classification:
A public or private nonprofit university, four-year college, or other institution offering undergraduate or graduate degrees with a traditionally high (more than 50 percent) minority (Black, Hispanic, Native American or Alaskan Native, Asian or Pacific Islander) student enrollment. This category of minority designated institutions comprises Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions (HSIs), and Tribal Colleges. An Indian tribe, which in conjunction with one or more institutions of higher learning, offers undergraduate and graduate degrees in disciplines relevant to drug abuse, which has a recognized governing body, and which performs substantial governmental functions, or an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims Settlement Act (43 U.S.C. 1601 et seq.) is eligible.
A college or university with an underrepresented minority/disadvantaged student enrollment of at least 25% in each of the previous five years is also eligible to submit an application. In addition, these minority/disadvantaged status applicants must demonstrate commitment to underrepresented minority/disadvantaged research development goals through (a) evidence of efforts to recruit faculty and students who are members of minority/disadvantaged populations nationally underrepresented in behavioral and biomedical research, and (b) demonstration of efforts to provide research support and resources to underrepresented minority/disadvantaged faculty and students.
Applicant institutions meeting the minority/disadvantaged status requirement in the second group must also demonstrate that they have a need for research capacity development in drug abuse and addiction. They cannot have received over $500,000 in direct costs from NIH per year in each of the previous five years for research or training in drug abuse and addiction. NIH awards that are specific to diversity-promoting institutions, such as research capacity development awards and support for current DIDARP or MIDARP grantees, are excluded in calculating this total. Excluding the PI/PD, faculty participating as individual research project directors in the proposed DIDARP cannot have been the PI on an NIH award in the last five years.
Applications must indicate which of the above two eligibility conditions applies to the institution and provide documentation in support of the eligibility claim.
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 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.
Each DIDARP application must have a designated PI/PD who will be responsible for the scientific and technical direction of the DIDARP. He/She should be a scientist with the appropriate training and experience, and the institutional authority and support to provide effective leadership and guidance to the program, and to support the individual research project director(s). Individual research project directors may not have been the PI on an NIH award in the last five years, however, NIH PIs may serve as associate project directors and request funds to support students on their currently funded project.
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 resubmit an application, but it must include an introduction (no more than 1 page) addressing the previous peer review critique.
Applicants may submit a renewal application. The applicant, however, must demonstrate a need for continued development of drug abuse research capacity at the institution.
Eligible institutions may not submit more than one application per institution.
Applicants must present a student development plan that is focused on students from groups currently underrepresented in the biomedical and behavioral sciences to prepare them for drug abuse and addiction research careers.
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 in item (box) 2
only of the face page of the application form and the YES box must be checked.
Additional information is available in the PHS 398 grant application instructions.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Receipt,
Review and Anticipated Start Dates
Letters
of Intent Receipt Date(s): November
17, 2008, June 16, 2009, November 17, 2009, June 15, 2010, November 16, 2010, June 15, 2011
Application
Receipt Dates(s): December 15, 2008, July 15, 2009, December 15, 2009, July 15, 2010, December 15, 2010, July 15, 2011
Peer Review Date(s): ): February 2009, October 2009, February 2010, October
2010, February 2011, October 2011
Council Review Date(s): May 2009, February 2010, May 2010,
February 2011, May 2011, February 2012
Earliest Anticipated Start Date: July 2009, April 2010, July 2010,
April 2011, July 2011, April 2011
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
DIDARP
Teri Levitin, Ph.D.
Director
Office of
Extramural Affairs
National
Institute on Drug Abuse/NIH/DHHS
6101
Executive Boulevard, Suite 220, MSC 8401
Bethesda,
MD 20892-8401
Telephone:
(301) 443-2755
Fax:(301)
443-0538
Email: [email protected]
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:
DIDARP
Teri Levitin, Ph.D.
Director
Office of
Extramural Affairs
National
Institute on Drug Abuse/NIH/DHHS
6101
Executive Boulevard, Suite 220, MSC 8401
Bethesda,
MD 20892-8401
Telephone:
(301) 443-2755
Fax: (301)
443-0538
Email: [email protected]
Applications
must be received on or before the application
receipt/ date(s) described above (Section
IV.3.A.). If an application is received after that date, it will be
returned to the applicant without review.
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.
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 renewal award if such costs: 1) are
necessary to conduct the project, and 2) 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 renewal 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.)
Allowable Costs
Up to $350,000 in direct costs per year may be requested for a period ranging from three to five years. Funds may be used for activities needed to implement the DIDARP including, but not limited to, such expenses as salaries and benefits of DIDARP faculty, students and staff at levels commensurate with percent effort expended on DIDARP related program administration, research and training activities; time devoted to developing, teaching or participating in courses and/or seminars in drug abuse and addiction; research project costs; travel by faculty and students to scientific meetings; consultant expenses; and advisory board costs. Equipment, administrative personnel, enhancement of IRB/IACUC expertise and other activities in support of research efforts may be funded, as congruent with the assessment of needs and development plans and NIH guidelines.
Applications should include an overall budget for the DIDARP as well as separate budgets for each research project. The total combined direct costs should not exceed $350,000 per year.
6. Other Submission Requirements and Information
6.A. Special Program Requirements
Research Strategy Page Limitations:
The Research Strategy should not exceed 12 pages in length each.
Training in the Responsible Conduct of Research:
Every faculty must be familiar with and every student must receive instruction in the responsible conduct of research. Describe a plan to provide students with formal and informal instruction on scientific integrity and ethical principles in research. The plan must address the rationale for the instruction, the format and subject matter, the degree of faculty participation, student attendance, and plans to assess the quality and the frequency of instruction. For Renewal applications, describe the type of instruction provided in the current project period, the degree of student participation, the results of any assessments and other relevant information.
There are no specific curriculum or format requirements for this instruction; however, it is strongly suggested that the instruction include: conflict of interest, responsible authorship and publication, peer review, policies for handling misconduct, policies regarding human subjects and live vertebrate animal subjects in research, data management, data-sharing, collaborative research and mentor-mentee relationships. Applicants may wish to consult the NIH web site at http://grants.nih.gov/training/responsibleconduct.htm and http://bioethics.od.nih.gov/researchethics.html for additional guidance.
Applications lacking a plan for instruction in the responsible conduct of research will be considered incomplete and will be returned to the applicant without review.
Students who will participate in research involving human subjects must meet the NIH policy requirement for education in human subjects protections (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html ). Students participating in research with live vertebrate animals must also be enrolled in the institutional animal welfare training program for personnel who have contact with animals. The requirements for specific human subjects education and participation in the institutional animal welfare training program may be included as elements of required training in the Responsible Conduct of Research.
6.B. Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. (See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.
6.C. Resource Sharing Plan(s)
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Not applicable.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for 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. A genome-wide association study is defined as any study of genetic variation across the entire 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. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
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 on the basis of established PHS
referral guidelines to the ICs for funding consideration.
Applications that are complete will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the NIDA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer 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 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, and weighted 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 meritorious impact/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 the
project address an important problem or a critical barrier to progress in
the field? If the aims of the project are achieved, how will scientific
knowledge, technical capability, and/or clinical practice be improved? How
will successful completion of the aims change the concepts, methods,
technologies, treatments, services, or preventative interventions that drive
this field?
Given the goals of the DIDARP program, does the main theme of the DIDARP application address an important area of drug abuse and addiction research? Given the current capacity of the institution, if the aims of the overall plan are achieved, will there be a significant impact on the institutions capacity for engaging in and sustaining drug abuse and addiction research activities? How will the proposed plan prepare minority/disadvantaged faculty and students from groups that are underrepresented in the biomedical and behavioral sciences to advance the field of drug abuse and addiction in significant ways?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Given that the PI/PD is critical to the sustainability of research efforts at the institution, how well does the PI/PD demonstrate commitment to drug abuse and addiction research and to faculty and student development? Are there clear indicators of institutional support (i.e., release time, letters from university leadership, courses already taught), and evident availability to lead the effort and mentor faculty and students? How adequate is the letter of institutional commitment, and does it address protected time for faculty to engage in drug abuse and addiction research, and research mentoring; opportunities to recruit and retain quality minority/disadvantaged faculty and students; and opportunities for career development for faculty engaged in drug abuse and addiction research? How well can the DIDARP PI/PD provide direction and leadership in the research proposed?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Given that the focus of this effort is the development of research infrastructure, does the applicant approach institutional capacity building in ways that are creative? Does the applicant propose to establish collaborations that can potentially lead to new discoveries? Does the applicant explore new approaches to attracting diverse faculty, staff, and students to drug abuse research and addiction? Will the faculty and student development plans stimulate innovative questions in drug abuse and addiction research? Do the research experiences provide faculty and students with opportunities to explore gaps in our understanding of drug abuse and addiction?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
In the context of infrastructure development efforts, how will the overall program be evaluated, both from a formative and a summative perspective? Is career development assistance provided to faculty and students in areas such as scientific writing and publication, research design and analyses, seminars on drug abuse and addiction topics; participation in meetings and conferences; mentoring; and research opportunities and support? Are the plans for faculty and student development feasible given the institutions current capacity, and will these plans contribute to capacity building goals? What is the quality of the design in the primary projects? Does the applicant address both the benefits and the limitations of the primary projects? How will the primary projects contribute to the field? Do the pilot research projects seek to establish feasibility, or the merit of a particular area of inquiry? Are the pilot projects firmly grounded in the current literature? What is the appropriateness of the approach in the pilot projects? Are enough resources and support available to the investigators leading the pilot projects? Do the primary and pilot research projects provide adequate opportunities for faculty and student mentoring and development?
Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Given that the PI/PD is critical to the sustainability of research efforts at the institution, how well does the PI/PD demonstrate commitment to drug abuse and addiction research and to faculty and student development? Are there clear indicators of institutional support (i.e., release time, letters from university leadership, courses already taught), and evident availability to lead the effort and mentor faculty and students? How adequate is the letter of institutional commitment, and does it address protected time for faculty to engage in drug abuse and addiction research, and research mentoring; opportunities to recruit and retain quality minority/disadvantaged faculty and students; and opportunities for career development for faculty engaged in drug abuse and addiction research? How well can the DIDARP PI/PD provide direction and leadership in the research proposed?
Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Since the DIDARP seeks to develop research capacity at the institutional level, what is the quality of the available resources at the institution? What are the institutions overall strengths? What is the quality of the scientific environment, including laboratory equipment and research space, and how is it linked to the capacity development plan? Is the scientific environment adequate for the proposed research projects? Is the external advisory board appropriate and adequately integrated into the plan? Are research administration, collaborative arrangements, and data management and analysis support adequate? How will new courses, curricula, and seminars in areas relevant to research on drug abuse and addiction be evaluated and established? What is the current faculty and student interest in drug abuse and addiction research and professional development activities? How will new faculty, staff, and students be recruited to the program and how they will be retained?
Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
For competing continuation applications only: To what extent has the program made progress in research capacity building, both in terms of infrastructure development and in the advancement of faculty and student careers, based on the original goals and the length of time that the program has been implemented? Does the progress report include examples such as faculty and student drug abuse and addiction research activities; increased support and conduct of drug abuse and addiction research; publication of manuscripts on drug abuse and addiction research; success obtaining other sources of funding; service in drug abuse and addiction related activities such as peer review; new seminars or courses; recruitment of students and researchers; improvements in institutional processes and procedures related to sponsored research such as IRBs; students entering graduate programs in drug abuse and addiction research; established collaborations with others related to drug abuse and addiction research or activities? What have the primary research projects and pilot research projects accomplished?
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Applications from Foreign Organizations. Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Training in the Responsible Conduct of Research:: Peer reviewers will assess the applications plan for training in the responsible conduct of research on the basis of the appropriateness of topics, format, amount and nature of faculty participation, and the frequency and duration of instruction.
The plan will be discussed after the overall determination of merit, and the review panels evaluation of the plan will not be a factor in the determination of the impact/priority score. Plans will be judged as acceptable or unacceptable, and the result will be described in an administrative note on the summary statement. Regardless of the impact/priority score, applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan. The relevant NIH staff will judge the acceptability of the revised plan
2.C. Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or impact/priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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.
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 ofAward (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).
3. Reporting
When multiple years are
involved, awardees will be required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually, including progress
on the impact assessment, and financial statements as required in the NIH Grants
Policy Statement.
A final progress report, invention statement, 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:
Lula Beatty, Ph.D.
Special Populations Office
National Institute on Drug Abuse
6001 Executive Boulevard
Room 4216, MSC 9567
Bethesda, MD 20892-9567
Telephone: (301) 443-0441
FAX: (301) 480-8179
Email: [email protected]
2. Peer Review Contacts:
Teresa
Levitin, Ph.D.
Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 443-2755
FAX: (301) 443-0538
Email: [email protected]
3. Financial or Grants Management Contacts:
Catherine
Mills
Grants Management Specialist
National Institute on Drug
Abuse/NIH/DHHS
6101 Executive Blvd., MSC 8403
Bethesda, MD 20892-8403
Telephone: 301-443-6710
Fax: 301-594-6849
Email: [email protected]
Section VIII. Other Information
Required
Federal Citations
Vertebrate Animals:
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 impact/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 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, Minorities, and Children:
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-09-116.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.
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 investigators 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. 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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