Part I Overview Information


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-09-011.

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, 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-11-060

Catalog of Federal Domestic Assistance Number(s)
93.279 

Key Dates
Release Date: December 6, 2010
Letters of Intent Receipt Date(s): August 9, 2011, December 9, 2011, August 10, 2012, December 10, 2012, August 10, 2013
Application Receipt Dates(s): September 9, 2011, January 10, 2012, September 10, 2012, January 10, 2013, September 9, 2013
Peer Review Date(s): November-December 2011, March-April 2012, November-December 2012, March-April 2013, November-December 2013
Council Review Date(s):   February 2012, May 2012, February 2013, May 2013, February 2014
Earliest Anticipated Start Date:  April 2012, July 2012, April 2013, July 2013, April 2014
Additional Information To Be Available Date (Url Activation Date): Not applicable.
Expiration Date: September 10, 2013

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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 FOA issued by the National Institute on Drug Abuse (NIDA) is to increase the drug abuse and addiction research capacity of institutions that serve economically disadvantaged students and provide services to economically disadvantaged communities. Awards will be provided to foster the research career development of a diverse cadre of students, faculty and staff in drug abuse research (see Section III, 1.A. Eligible Institutions). 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 undergraduate institutions that educate students from economically disadvantaged backgrounds.  Reasons for this underrepresentation in research include the following: (1) the primary mission of many of these institutions 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.  Graduate institutions that focus on preparing students for careers dedicated to serving economically disadvantaged communities often do not have . strong, sponsored research programs.  Reasons for their lack of participation in sponsored research include their (1) concentration on preparing students for professional and community service, (2) investment of time and resources to maintain the professional certifications and standards required for their programs,  (3) heavy faculty teaching and clinical loads, and (4) inadequate support for research (e.g., equipment, release time).

The NIH is committed to increasing diversity in NIH-funded research (the Revitalization Act of 1993).  Supporting institutions with concentrations of students from disadvantaged backgrounds will make quality research opportunities available and assist the NIH in  fully achieving its goals “to develop, maintain, and renew scientific human and physical resources that will ensure the Nation's capability to prevent disease; to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research; and to  exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.“    Supporting research and research education for students from disadvantaged backgrounds will also increase the diversity of NIH’s scientific workforce.  Reports from the National Science Foundation (NSF), (see http://www.nsf.gov/statistics/wmpd/) and others provide strong evidence that diversity remains an important problem that the entire research enterprise must actively address.. Evidence indicates that the biomedical and educational enterprise will directly benefit from broader inclusion and that diversity enhances the quality of education.. Moreover, studies suggest that culturally concordant scientific staff may be more successful in recruiting individuals from underserved population groups into clinical trials and that similarity in  physician-patient dyads also may be related to greater patient satisfaction in ways that could enhance communication and participation in clinical research settingsDiversity is critical to the scientific mission of the National Institute on Drug Abuse.  Drug  addiction is a stigmatized disease that poses many challenges to the research enterprise. Difficulties associated with stigmatization include recruitment of scientists and institutions into the addiction research field,  recruitment of subjects, particularly individuals from disadvantaged populations into research and clinical trials,   and  the development of supportive resources and networks for research-based prevention, treatment and services.   Addiction patients are frequently economically disadvantaged often as a result of their addiction and delay seeking treatment. .When treatment is sought and available, it is frequently provided by providers working with disadvantaged populations in underserved areas.   Moreover, economically disadvantaged racial and ethnic minority populations experience disproportionate health, economic and social consequences of drug use and addiction including, for example, higher rates of HIV/AIDS associated with drug use within the African American and Hispanic populations and high suicide rates among  the American Indian population.   Culturally based mistrust and  reticence may affect their participation in research related to socially undesirable and possibly illegal behaviors like drug use.  Success in gaining these groups’ cooperation, inclusion and participation in research has been mixed and varies by group. For example, American Indian populations have high rates of drug related morbidity and mortality, higher overall than any other U.S. population group, but they have low representation in NIDA’s research portfolio.  Their sovereign nation status and policies regarding participation in research (e.g., involvement of the community, approval of protocols) has contributed to this low participation.  NIDA needs to develop programs and outreach to address issues affecting participation and inclusion of  all economically and other disadvantaged populations.   

There is general scientific consensus that increased diversity in individuals and institutions involved in research will improve the knowledge base and lead to better interventions and services.  For example, the community based participatory research (CBPR) model is a well recognized and accepted approach for addressing community health concerns that is increasingly being supported by NIH..  CBPR requires inclusiveness and diversity in its implementation.  NIDA supports the CBPR model especially in its epidemiology, prevention and services research. The field has also acknowledged the key role that primary care providers can play in the early identification of problem drug use and dependency and associated co-occurring disorders and the referral of patients to intervention and treatment services.  People from disadvantaged communities, in particular, are more likely to see a primary care provider before seeing an addiction specialist.   It is important to NIDA’s mission that these providers are knowledgeable about drug addiction  and become more involved in drug abuse research to broaden our knowledge of prevention  and interventions needed by the populations they serve. 

Key developments in research on  effective prevention and treatment attest  to the involvement of the broad community and the need to focus both on individual and environmental risk factors (e..g., available programs, risks in the environment, access to care).  For example, in NIDA’s Principles of Drug Addiction Treatment: A Research Based Guide, the best treatment programs were found to provide a combination of therapies and services to fit the individual’s needs which may relate to age, race, culture, sexual orientation, gender, pregnancy, other drug use, comorbid conditions (e.g., depression, HIV), parenting, housing, and employment, as well as physical and sexual abuse history.    In NIDA’s Principles of HIV Prevention in Drug Using Populations, the necessity of providing community-based interventions, addressing structural community concerns, knowing the local community needs, and attending to the sensitivities of culture, race, and gender are identified as critical.  

Diversity-promoting institutions are undergraduate institutions that educate high concentrations of students from economically disadvantaged backgrounds (as measured by Pell Grant recipients), and graduate institutions that prepare high concentrations of students who go on to provide needed services to economically disadvantaged communities.    A number of these institutions have become involved in various drug abuse programs and are particularly poised to expand these initiatives into the research arena. For example, many are engaged in on-campus drug and HIV/AIDS education, prevention, and training activities in addition to collaborating with schools and community-based organizations and agencies on drug related problems. Some have begun nascent research activities in drug abuse and are seeking ways to further their competency in this area.  This program is intended to provide support to these institutions that demonstrate a commitment to developing a supportive environment for fostering research and research careers in drug abuse and addiction.

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 with drug abuse research knowledge and skill development through the conduct of research projects and other professional development activities; (2) encourage students from disadvantaged backgrounds to pursue drug abuse research careers by providing them with educational enrichment and research experiences; (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 supports multi-disciplinary biomedical, behavioral, and clinical research on all aspects of drug abuse and addiction   including the broad areas of epidemiology, etiology, vulnerability, prevention, treatment, medications development, pharmacology, and genetics and services research.  Research areas of particular interest for the DIDARP program are health disparities concerns in drug abuse, particularly as they impact racial/ethnic minority  and rural populations, and HIV/AIDS and its relationship to drug use and abuse. Please note that studies that focus primarily on alcohol use may not be appropriate for primary assignment to NIDA; however, NIDA welcomes studies that address alcohol within the larger context of drug use. 

Each DIDARP application must have a thematic research focus around which all research and training activities are planned. 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 emerging adults, increasing adherence to treatment protocols in African Americans, or factors that predict the use of drug courts with diverse populations. Applicants are encouraged to consult with NIDA program staff before submitting an application to ensure that the research focus is appropriate to NIDA's mission.

Each application must contain the following information:  (1) a description of the institution's current drug abuse research capacity, (2) a faculty recruitment and development plan, (3) a student recruitment plan and development  plan, (4) primary and pilot research projects, (5) an institutional research infrastructure development plan, (6) justification for the choice of the proposed Principal Investigator/ Project Director, (7) the inclusion and description of an external advisory board, (8) a letter of institutional commitment signed by a Dean or other institutional official with authority to commit institutional resources, (9) an impact assessment statement, and (10) Progress Report for DIDARP Renewals (Competing Continuations).  Undergraduate institutions must provide a signed certification from the institution’s Financial Aid Office indicating the percentage of students who receive Pell Grants disaggregated by year in school (freshman, sophomore, etc.)  Graduate institutions must provide data indicating the percentage of graduates over the last five years who provide health care related services to economically disadvantaged and other underserved populations.

1. Current Drug Abuse Research Capacity (2 pages minimum, not to exceed 3 pages)

The strategy for building research capacity should be based upon assessments of the institution's current level of drug abuse research, its expertise and capacity for research in areas other than drug abuse, systemic and environmental factors that may impinge on research productivity, levels of commitment,  and availability of support. Assessments should identify critical research need and current   strengths and resources upon which increased capacity can be built. Examples of strengths and resources to consider include sponsored research office support, curricula offerings, faculty release time, student interest, and collaborative arrangements. 

2. Faculty Recruitment and Development Plan (3 pages minimum, not to exceed 6 pages)

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.   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 on research projects) 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. Plans should include support for research application/proposal development, research administration, 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 university service and committee obligations.  Plans should also demonstrate how the completion of the outlined activities is expected to result in career advancement for these faculty members.

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 diverse and disadvantaged undergraduate or graduate students to serve as research assistants on their currently funded projects. A strong explanation of the benefits and specific experiences to be gained by the students must be provided. DIDARP funds may not be used to replace any research assistant positions supported by other federal or non-federal awards.  

3. Student Recruitment and Development Plan (3 pages minimum, not to exceed 6 pages)

A recruitment plan for students who will serve as student research assistants on projects supported by the program should be detailed. The student selection criteria and process should be specified. 

The student development plan should describe the educational and mentoring experiences to be provided to the selected students. It is expected that students selected for participation in research activities will be provided with a  full range of  research development opportunities including participating in relevant conferences, training in scientific writing, and preparing for graduate school/postdoctoral training.  Training in the responsible conduct of research is expected (see Special Program Requirements).  In addition, a timeline and assessment/evaluation plan for satisfactory participation and completion should be described. 

Seminars and workshops should be indicated.  The student development plan should be a minimum of three (3) pages and a maximum of six (6) pages.

4. Research Projects (Research Strategy sections are limited to 12 pages for Individual Primary Research Projects and 6 pages for Individual Pilot Research Projects.)

The program will provide support for primary and pilot research projects. Projects must be clearly identified in the application as either primary or pilot 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.

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. Applicants must propose a minimum of two and a maximum of five projects in the DIDARP application; each proposed project must relate to the research theme or focus area. Participating faculty may serve as the lead investigator (also called the research project director) on only one research project. The Principal Investigator/Project Director may serve as the lead investigator on a primary 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 diverse/disadvantaged groups that are underrepresented in the biomedical and behavioral sciences.

The DIDARP must have at least one 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 project is active each year. Securing other support for research projects under the DIDARP umbrella such as from the university, foundations, or other NIDA mechanisms is encouraged.

5. Institutional Research Infrastructure Development Plan (2 pages minimum, not to exceed 3 pages)

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). 

6. DIDARP Principal Investigator/Project Director (PI/PD) (2 pages minimum, not to exceed 3 pages)

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 applicant 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.

7. External Advisory Board (2 pages minimum, not to exceed 3 pages)

Each DIDARP must have an advisory board whose composition includes a minimum of three (3) external research scientists with expertise in sponsored research relevant to the research focus of the proposed DIDARP including their role in the research projects. The applicant should describe the composition of the proposed advisory board, the specific functions of the board, the frequency of meetings, and how the board will interface with the DIDARP, including its role in the DIDARP research projects.  Applications should contain a biographical sketch and a letter of commitment from each proposed advisory board member.  

8. 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.

9. Impact assessment (2 pages minimum, not to exceed 3 pages)

The applicant should describe the anticipated outcomes of the proposed plan by describing the realistic changes that are expected to occur in institutional policies, procedures, resources, and programs germane to the proposed DIDARP, as well as in 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. 

10. Progress Report for DIDARP Renewals (Competing Continuations) (3 pages minimum, not to exceed 6 pages

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 DIDARP 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 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, the accomplishments of both primary and pilot research projects should be reported. 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 levels of 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 should be included. Faculty and students supported and mentored should be identified by disadvantaged/underrepresentation categories and gender. 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity announcement (FOA) will use the R24 award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project.  

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

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.

3. Other-Special Eligibility Criteria

Number of Applications. One application per institution is allowed.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications are permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 are permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date. 

Renewals. Renewals will be allowed for this FOA. The applicant, however, must demonstrate a need for continued support for drug abuse research capacity development at the institution.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398.

For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the PHS 398 application forms in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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.

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): August 9, 2011, December 9, 2011, August 10, 2012, December 10, 2012, August 10, 2013
Application Receipt Date(s): September 9, 2011, January 10, 2012, September 10, 2012, January 10, 2013, September 9, 2013
Peer Review Date(s): March-April 2011, November-December 2011, March-April 2012, November-December 2012, March-April 2013, November-December 2013
Council Review Date(s):  February 2012, May 2012,   February 2013, May 2013, February 2014
Earliest Anticipated Start Date:  April 2012, July 2012, April 2013, July 2013, April 2014

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.

Email:  NIDALetterofIntent@mail.nih.gov

Applicants are encouraged to send the letter of intent by email to the email address above but as an alternative the letter may also be sent to:

DIDARP Applications
Director
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Suite 4243, MSC 9550
Bethesda, MD 20892-9550

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 Applications
Director
Office of Extramural Affairs, NIDA
6001 Executive Boulevard, Suite 4243
Bethesda, Maryland 20892-9550
Telephone:  (301) 443-2755
FAX:  (301) 443-0538 

3.C. Application Processing

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/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

Applications submitted in response to this FOA must use the paper PHS 398 application package and instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html) and include the modifications to the instructions described below.  Applications must be complete at the time of submission.

The DIDARP is an approved multi-component application.  Recommended organization and page limitations for each required section of the DIDARP are as follows.

Organization

Applications should be organized as follows.

SECTION I

Certification of Eligibility

Face Page

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells

Table of Contents

Detailed Summary Budget for Program Project Initial Budget Period

Budget for Entire Proposed Program Project Period Direct Costs Only

Biographical Sketches and Research Support Information for all key personnel in the entire application.

SECTION II

Specific Aims (1 page maximum)

Current Drug Abuse Research Capacity (2 pages minimum)

Faculty Recruitment and Development Plan (3 pages minimum, not to exceed 6 pages)

Student Recruitment and Development Plan (3 pages minimum, not to exceed 6 pages)

Individual Primary Research Projects (12 pages maximum; repeat this section for each Research Project, numbering the Research Projects 1, 2, 3, etc consecutively)

Individual Pilot Research Projects (6 pages maximum; repeat this section for each core, naming the individual pilot research projects with capital letters A, B, C, etc consecutively)

Institutional Research Infrastructure Development Plan (2 pages minimum, 3 pages maximum)

DIDARP Principal Investigator/Project Director (2 pages minimum, 3 pages maximum)

External Advisory Board (2 pages minimum, 3 pages maximum)

Letter of Institutional Commitment

Impact Assessment (2 pages minimum, 3 pages maximum)

Progress Report (3 pages minimum, 6 pages maximum)

PHS398 Research Plan Sections

All application instructions outlined in the PHS 398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

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.

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 should 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

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review 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 peer review group convened by NIDA (n 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:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

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, how will it affect  the institution’s capacity for engaging in and sustaining drug abuse and addiction research activities? How will the proposed plan prepare 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, or in the early stages of independent careers, do they have appropriate experience and training?  If established investigators, 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  faculty and students from diverse and disadvantaged groups; 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 viable? 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) protection of human subjects from research risks, 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 institution’s current capacity, and will these plans contribute to individual career development and to institutional 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?

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 overall strengths of the institution? 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

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.

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.

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/priority score.

Applications from Foreign Organizations.   Foreign organizations are not allowed for this FOA.

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).

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 (Not Applicable); 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).

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.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended. The following will be considered in making funding decisions:

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 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 Notice of Award will be generated via email notification from the awarding component to the grantee business official.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm).

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, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Lula Beatty, Ph.D.
Director, 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: lb75x@nih.gov

2. Peer Review Contacts:

Mark Swieter, Ph.D.
Chief
Extramural Affairs Branch
Office of Extramural Affairs
National Institute on Drug Abuse, NIH, DHHS
6001 Executive Boulevard, Suite 424, MSC 9550
Bethesda, Maryland  20892-9550
Telephone:  (301)  435-1389
FAX:  (301) 443-0538
Email:  mswieter@nida.nih.gov

3. Financial or Grants Management Contacts:

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse, NIH, DHHS
Telephone: 301-933-6196
Email: aldersoc@nida.nih.gov

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.

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/archive/archive/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 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-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 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. 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/.


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