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 Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)

Title: Limited Competition for Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research (RCTR) [U54]

Announcement Type

New

Update: The following updates relating to this announcement have been issued:

Program Announcement (PA) Number: PAR-08-262

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release Date: September 11, 2008
Letters of Intent Receipt Date: October 18, 2008
Application Receipt Date: November 18, 2008
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009
Online Technical Workshop: October 17, 2008 at 2:00 pm, Eastern Time
Additional Information To Be Available Date (Url Activation Date)
Expiration Date: November 19, 2008

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
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
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

Purpose

The purpose of this initiative is to support the development of infrastructure required for the conduct of clinical and translational research in institutions funded via the Research Centers in Minority Institutions (RCMI) Program. The RCMI Infrastructure for Clinical and Translational Research (RCTR) represents a re-organization of the existing RCMI programmatic activities in support of clinical and translational research.  These programs include the RCMI Clinical Research Infrastructure Initiative (RCRII) P20 Awards; Centers of Clinical Research Excellence (CCRE) U54 Awards; and Comprehensive Centers on Health Disparities (CCHD) U54 Awards. This re-organization also presents an opportunity to enhance research training and career development efforts across the institutions and enhance synergy with the Clinical Research Education and Career Development (CRECD) R25 awards and/or other institutional training programs.  The re-organization will effect improved coordination and synergy between the clinical and translational research and research training activities at grantee institutions.  In addition, using a single award mechanism will allow all of the clinical and translational research activities to be coordinated within a single administrative infrastructure.

The RCTR will better position institutions for conducting clinical and translational research, especially research that is focused on health disparities, and for competing for clinical and translational research funding by:

Background

One of the main conclusions from the “Unequal Treatment: Confronting Racial and Ethnic Disparities in Healthcare” report published by the Institute of Medicine (IOM) in 2002 was that a comprehensive, multi-level strategy is required to eliminate these disparities.  One component of the solution is to increase the proportion of underrepresented U.S. racial and ethnic minorities among health professions.  This important point was also emphasized in the Sullivan Commission on Diversity in the Healthcare Workforce report published in 2004 entitled “Missing Persons: Minorities in the Health Professions.”  In addition to increasing the numbers of minority healthcare professional staff, the IOM report also recognized that cross-cultural curricula should be integrated early into the training of future healthcare providers, and that patients can benefit from culturally appropriate education programs to improve their knowledge of how to access care and their ability to participate in clinical decision making.

Annual data compiled and published by the Centers for Disease Control and Prevention provide critical examples of racial and ethnic health disparities.  In response to these data, the Department of Health and Human Services (DHHS) has decided to focus on areas that have the highest level of disparities related to health access and outcome.  These areas include cancer, cardiovascular diseases (heart disease and stroke), diabetes, HIV/AIDS, infant mortality, mental health disorders, hepatitis, syphilis, tuberculosis, and chronic kidney disorders (http://www.cdc.gov/omh/AMH/dbrf.htm).

Examples of health disparities among members of racial and ethnic minority populations include:

African American women are more than twice-as-likely to die of cervical cancer than are white women, and are more likely to die of breast cancer than are women of any other racial group.  Vietnamese American women have a higher cervical cancer incidence rate than any ethnic group in the United States – five times the rate of non-Hispanic white women. 

Heart disease and stroke are the leading causes of death for all racial and ethnic groups in the United States.  Heart disease death rates are 30% higher for African-Americans than for whites and stroke death rates are 41% higher.

American Indians, Alaska Natives, African Americans, Pacific Islanders and Hispanics were at least 1.9 times more likely to have diagnosed diabetes compared to non-Hispanic whites.  Asians in California are 1.5 times more likely than whites to receive a diagnosis of type 2 diabetes.

Although African Americans and Hispanics represented only 26 percent of the U.S. population in 2001, they accounted for 66 percent of adult AIDS cases and 82 percent of pediatric AIDS cases reported in that year.  Although the estimated HIV/AIDS rate among Pacific Islanders is the lowest in the United States compared with all other racial and ethnic groups, the rate increased an average of 9% each year during 2001-2004.

African American, American Indian, and Puerto Rican infants have higher death rates than whites.

American Indians and Alaska Natives appear to suffer disproportionately from depression and substance abuse.

In 2002, 50 percent of those infected with Hepatitis B were Asian Americans and Pacific Islanders.  African American teenagers and young adults become infected with Hepatitis B three to four times more often than those who are white.

In 1999 cases of primary and secondary syphilis had the following ethnicity distribution: African Americans 75 percent, whites 16 percent, Hispanics 8 percent and others 1 percent.  In 2006, Virginia’s Public Health department reported a 30% increase in syphilis cases; African Americans accounted for 50 percent of these cases.

Of all the TB cases reported from 1991-2001, almost 80 percent were in racial and ethnic minorities.  Asian Americans and Pacific Islanders accounted for 22 percent of those cases, even though they made up less than 4 percent of the U.S. population.

African Americans and Mexican Americans have an approximately 15 to 20 percent higher disease rate than non-Hispanic whites for chronic kidney diseases.

Eliminating these and other health disparities requires research on the underlying causes of these diseases and development of new, cost-effective approaches for diagnosis, prevention, and treatment to improve patient outcome for these diseases. Culturally appropriate, community- driven prevention and intervention programs are also important for eliminating racial and ethnic disparities in health. 

The NCRR supports three programs to develop the infrastructure in minority institutions to conduct clinical and translational research. In the mid-1990s, the NCRR awarded P20 grants in response to the Research Centers in Minority Institutions (RCMI) Clinical Research Infrastructure Initiative to support the infrastructure needed to develop a clinical research center in medical schools affiliated with RCMI institutions.  These awards enabled grantee institutions to initiate outpatient clinical studies focused on diseases that disproportionately affect the populations served by host institutions, including cancer, cardiovascular disease, HIV/AIDS, infant mortality, and neurological and mental health disorders.  In 1999, the NCRR awarded U54 Cooperative Agreements in response to RFA-RR-99-005 to establish Centers of Clinical Research Excellence (CCRE) at RCMI-eligible institutions with medical schools.  The CCRE enabled these centers to recruit and hire senior clinical research investigators to conduct outpatient clinical research on early human development, diabetes, and cardiovascular diseases.  Subsequently in 2004, the NCRR awarded U54 Cooperative Agreements in response to RFA-RR-03-004 Comprehensive Centers on Health Disparities at RCMI-eligible institutions.  These Comprehensive Centers on Health Disparities focus on HIV/AIDS and Chronic Kidney Disease and associated co-morbidities and are developing replicable, culturally appropriate, community-based prevention and intervention approaches targeted to minority populations. 

These current programs utilize different grant mechanisms and are on different grant cycles, making coordination between activities/programs complex.  In addition, the current program structure makes it difficult for eligible health professional schools (nursing, dental, pharmacy) to compete for these individual programs.  The RCMI Infrastructure for Clinical and Translational Research (RCTR) program will improve coordination of clinical and translational research programs; result in more efficient management of awards; and improve coordination of administrative activities. The RCTR program will continue to facilitate and broaden the opportunities to conduct clinical and translational research, with an emphasis on reducing health disparities, using a single award mechanism that will maintain the flexibility of the current programs.  The RCTR will develop synergy between clinical and translational research activities in the RCMI program, and leverage NCRR investments in the Clinical and Translational Science Awards (CTSAs) and other NCRR programs. The RCTR will ultimately expand the pool of institutions to include the participation of RCMI-eligible Medical, Nursing, Dental, and Pharmacy schools. 

Definitions for the purpose of this initiative: ‘Clinical research’ comprises studies and trials in human subjects meeting the NIH definition in the PHS 398 instructions.  ‘Translational research’ includes research that ranges from the translation of basic to clinical research, to research aimed at the adoption of best practices in community healthcare.

The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented by this FOA.  NIH program staff will convene an on-line technical workshop to discuss the FOA on October 17, 2008 at 2:00 pm Eastern Time. A listserv (RCTR-L@nih.gov) will be used to notify applicants of the seminar.  Applicants are strongly encouraged to contact NIH program staff early in the application development process. 

Specific RCTR Objectives

The RCTR must provide infrastructure to:

1)       Study the underlying causes of diseases, including those diseases that disproportionately affect the U.S. minority populations;

2)       Develop approaches for the prevention, diagnosis and/or  treatment of diseases to improve health and reduce health disparities;

3)       Integrate basic, clinical and translational research by fostering collaboration among disciplines, departments and/or schools of an institution, and collaboration with investigators across institutions;

4)       Facilitate mentored clinical and translational research training and provide career development activities in clinical and translational science.

2. Key Functions/Activities of an RCTR

The RCTR must support clinical and translational research, particularly research focused on health disparities, and the needs of its researchers.  The RCTR must include infrastructure and/or activities that will support:

In addition to these requirements, applicants must also develop their own list of key functions/activities that will develop the infrastructure to achieve the specific objectives of the RCTR award. Potential key function/activities may include but are not limited to:

Acknowledging that existing resources vary among applicant institutions, the support requested for each of the proposed components is expected to vary, reflecting current and projected needs.  Applicants must demonstrate synergy between the RCTR and other RCMI-funded programs at the institution, and not reproduce activities of these programs.

3.  Descriptions of Required RCTR Key Functions/Activities

3.1. Collaborations and Partnerships 

All applicants must develop plans in the required area of collaborations and partnerships.  A key component of the RCTR is the integration of clinical and translational research through fostering collaborations between basic, clinical, and translational researchers from different disciplines, departments and/or programs within the institution, as well as collaborations with investigators at other institutions.  Applicants may propose activities that will facilitate intra-institutional and multi- or interdisciplinary collaborations if they do not currently exist at the applicant institution. If an institution has a current RCMI Center (G12) award that supports core infrastructure for basic research, the applicant must demonstrate how the G12 award interfaces with the RCTR.  The RCTR is intended to complement, but not reproduce activities funded via the G12 award. In addition, both research and research training partnerships with other academic organizations and/or CTSAs are strongly encouraged. 

Applicants must indicate how they will utilize the RCMI Translational Research Network consortium, CTSA consortium, or other consortia and resources to facilitate collaborations with investigators at other institutions that study diseases that disproportionately affect minority populations.  If proposing to conduct multi-site clinical or translational research studies on health disparities, the applicant must indicate how they will utilize the support services provided by the RCMI Translational Research Network (RTRN).  These services may include assistance with the development clinical research study plans; planning and conducting biostatical analyses; developing and implementing a data entry and management plan across participating sites; developing clinical research protocols, informed consent documents and case report forms for multi-site studies, especially those focused on health disparity areas; and developing and implementing quality control and quality assurance components of the project.  Applicants must include associated budget allocations to utilize the resources of the RTRN.

Each applicant is strongly encouraged to identify one or more collaborating domestic institution(s) that may include Federal or non-Federal, public or private, and for profit or non-profit organizations.  Applicants are also encouraged to partner with foundations, industry, and community organizations as appropriate.  In such cases, these partners must agree to follow NIH policies with respect to (1) listing of clinical trials at www.ClinicalTrials.gov; (2) sharing of resources; (3) data sharing and public access; and (4) establishing policies in support of investigator academic independence, reporting of patents or patentable concepts, and publication rights.

3.2. Multidisciplinary Training and Career Development Activities  

The RCTR environment must facilitate mentored clinical and translational research training and provide career development activities in the clinical and translational sciences across the institution and enhance synergy with the Clinical Research Education and Career Development (CRECD) R25 awards and other training programs.  Resources may be requested to develop or refine the training curriculum or support mentored research training and/or other career development activities for post-doctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PHD, Pharm D, RN).  Research education, training, and career development activities should promote the recruitment, training, advancement, and retention of new investigators in clinical and translational science careers.

4. Descriptions of Potential Key Functions/Activities

4.1. Recruitment and Hiring of Additional Faculty Investigators

This may include hiring of clinical and translational investigators who have a track record of independent research support that includes current or recent support (within the last two years) by NIH R-series, P-series, and/or U-series awards, or other federal or non-federal awards and can serve as mentors to junior investigators.  These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants.  If junior faculty members are hired, the application must contain detailed career development plans for each of these junior investigators.

4.2. Biomedical Informatics Resources

Biomedical Informatics is the cornerstone of communication within the RCMI Translational Research Network (RTRN) Consortium and with all collaborating organizations. Applicants should consider both internal, intra-institution and external interoperability to allow for communication among RCTR awardees through the RTRN and with other research partners (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards (e.g., identifiers, vocabularies, transactions, security measures) adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. All human subject data must be handled securely to ensure privacy and confidentiality.  Applicants should utilize the Biomedical and Clinical Informatics support services provided by the RCMI Translational Research Network (RTRN) when conducting multi-site clinical and translational research in health disparity areas, and leverage resources provided through CTSAs, the Biomedical Informatics Research Network (BIRN), and other NCRR and NIH-funded resources.

4.3. Research Design, Biostatistics, and Clinical Research Ethics

Applicants are encouraged to develop innovative research programs that bridge research in trial design, biostatistics, and clinical research ethics with other national activities, including those of the Clinical and Translational Science Award (CTSA) consortium. Topics for research might include, for example, limiting risk to participants, preventing bias, improving recruitment and retention, developing innovative methods of enhancing the statistical power of studies, gathering of appropriate data, developing design and analysis plans for studies of unique or vulnerable populations or very small numbers of subjects, informed consent, or issues in diseases with currently limited treatment options.

4.4. Participant and Clinical Interactions Resources

Participant and clinical interactions resources must provide an environment that promotes participation in out-patient clinical and translational research, especially out-reach that fosters participation of underrepresented minorities, in addition to providing resources for cost-effective research participant interactions.  Examples of resources that might be requested include (but are not limited to) the provision of out-patient, or community-based exam rooms, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, scheduling services, and services for research specimen collection and shipping. 

4.5. Community-Based Research

Community based research (CBR) may include planning, implementing, evaluating, and disseminating effective preventions and interventions for diseases, with an emphasis on those that disproportionately affect racial and ethnic minorities. Any proposed CBR key functions/activities must include partnerships between health disparity populations and academic researchers with the aim of reducing health disparities.

4.6. Regulatory Knowledge and Support

Regulatory knowledge and support activities should promote the protection of human subjects and facilitate regulatory compliance.  Institutions should develop best practices that reduce or remove institutional impediments to clinical and translational research and enhance inter-institutional collaborations.  RCTR regulatory support activities should assist investigators in their documentation requirements for the Institutional Review Boards (IRB) and institutional compliance or enforcement offices.

Regulatory support should include an individual who is independent of the IRB or compliance office and acts as a sounding board for potential research participants, serves as an advocate for research participants, and works with investigators and research teams to ensure that research involving human subjects accords the highest priority to human subject protections.

4.7. Technologies and Resources for Core Laboratories

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various disciplines in its institution (e.g., medicine, nursing, dentistry, pharmacy, public health, biostatistics, epidemiology, and/or bioengineering) for the benefit of researchers and research projects across disease areas.  Standard operating procedures are required as is participation in national or international quality control and standardization efforts where appropriate.  Items proposed should be fully justified within the context of the overall proposed program goals, and not duplicate local resources. The level of support requested must be justified by the projected use by clinical and translational researchers from within and outside the applicant institutions.  Laboratory equipment, supplies, and personnel are all acceptable costs.  Cost recovery for core support should be sought from funded investigators.

4.8. Development of Novel Clinical and Translational Methodologies

If the applicants propose to develop original research on novel methodologies and approaches for multidisciplinary clinical and translational research on health disparities, the RCTR proposal must contain detailed plans for making these methodologies available to the scientific community through the RCMI Translational Research Network (RTRN), CTSAs, and other networks.  Faculty members could pursue their funded research in areas that may include developing new phenotyping methods that are more objective and quantifiable, the development of biomarkers for research purposes, research into clinical trial designs, and predictive toxicology in human populations.  For example, if drugs are shown to be effective in certain racial and ethnic sub-populations it will be important to develop innovative designs for studies to identify biological, social, behavioral and/or environmental markers that may underlie the differential drug response, since these factors may be more meaningful predictors of drug response than race and ethnicity categories. 

4.9. Pilot Project Program

An applicant may request support for a pilot project program that 1) allows clinical and translational researchers to generate preliminary data for submission of grant applications particularly those that focus on research in health disparity areas; 2) develops new technologies; or 3) achieves other goals, as defined by the applicant, that will better position the institution to conduct clinical and translational research on health disparities.  Such funds must be readily available and be accompanied by an organizational structure that supports full compliance with regulatory requirements.

 5. Evaluation Milestones 

Applicants must provide detailed RCTR program evaluation milestones and detailed quantitative and/or concrete criteria by which milestone achievement will be assessed.

6.  Administration of RCTR Awards

NCRR will accept applications that name Multiple Principal Investigators: http://grants.nih.gov/grants/multi_pi/ as key personnel on applications. Each PI may have direct authority over a separate budget and infrastructure for research as may other PIs as described in NOT-OD-07-017 ‘Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).

Applications designating multiple PDs/PIs should include a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section I of the Research Plan in the PHS 398). A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

Multiple PDs/PIs, may be designated on the application for projects that require a “multidisciplinary team science” approach that clearly does not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at (http://grants.nih.gov/grants/multi_pi/). All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The clinical research experience of the PI(s), who is/are the Program Director(s), must be described, together with his/her/their involvement in the daily activities of the RCTR. It is expected that PI(s) must include an established clinician scientist and that the PI(s) have the ultimate responsibility for the implementation and function of the RCTR. The PI(s) may be assisted by co-Program Director(s) from the same institution or an affiliated institution. Co-Program Director(s) must also be experienced investigators who have administrative skills and backgrounds that complement those of the PI(s). The amount of effort for the PI and co-Program Directors must be commensurate with the requirements of the positions and not less than 20% each and sum to not less than 50%. This level of effort is required whether or not salary is requested. If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PDs/PIs must be delineated in the Leadership Plan.  In the event of an award, the requested allocations will be identified in the Notice of Award.

Applications must include a governance plan that defines the overall governance and organizational structure of the RCTR, including the relationships between the RCTR PI(s) and the Directors of Key Functions/Activities.  A plan to manage and, where necessary, reassign, institutional resources and RCTR resources among the schools, departments, specialties, affiliated hospitals, and affiliated independent research institutions that participate in the RCTR; and between the RCTR and outside foundations and/or industry should be described. Administrative policies and procedures should be described, including an evaluation component that will assess the administrative and scientific functioning and accomplishments of the RCTR.

The Directors of the Key Functions/Activities of the RCTR must be experienced personnel who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct the resource, and to speak for the RCTR institution in national forums. Applicants should explain how their multidisciplinary clinical and translational research communities would contribute to the selection and allocation of key resources, the implementation and self-evaluation of key functions/Activities and the prioritization of use.

An Internal Advisory Committee (IAC) that is advisory to the RCTR PI(s) should be established prior to submission of the application.  Depending on the scope and complexity of the RCTR program, the IAC may consist of six to eight members.  The IAC members should be named in the application.  Meetings of the IAC should be held at least quarterly.

It is anticipated that each RCTR will also have an External Advisory Committee (EAC) that would meet at least annually to review structure and progress and offer recommendations to the RCTR PI (s). Potential members of an EAC should not be named and should not be contacted prior to the review of an application.  The applicants must indicate the sorts of expertise of members that will be recruited for the EAC. Depending on the scope and complexity of the RCTR program, the EAC may consist of eight to ten members. Ideally, the members should be appointed on a rotating basis. 

The efforts and recommendations of the IAC and EAC should be coordinated.  Official minutes of committee meetings must be kept on file.  It is particularly important to document problems and issues, along with any necessary recommendations.  Plans for following-up on recommendations must be included.

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 U54 award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". RCTR awardees will work with NIH staff to ensure that milestones can be achieved within the budget periods of the award. If milestones are not met, funding can be limited until the milestones have been achieved.  

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). 

A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application. Applicants may request up to 5 years of support.

2. Funds Available

Current RCMI Clinical Research Infrastructure Initiative P20 Awards and U54 Cooperative Agreements to establish Centers of Clinical Research Excellence, or Cooperative Agreements to establish Comprehensive Centers on Health Disparities held by successful applicants will transition into the RCTR. 

Applicants must re-budget the funds from current awards to accomplish the goals of the RCTR application.  In developing the budget, applicants may request the direct costs of current P20 and U54 awards plus up to an additional $1 million dollars.  Total costs per year should not exceed $4.2 million (including F&A costs).   

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.

The estimated amount of funds available for support of up to 5 projects awarded as a result of this announcement is $21,000,000 for fiscal year 2009. Future year amounts will depend on annual appropriations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has the following characteristics:

Eligibility for this FOA is limited to those institutions currently funded via the Research Centers in Minority Institution (RCMI) Clinical Research Infrastructure Initiative (RCRII), Comprehensive Centers on Health Disparities (CCHD) and/or Centers of Clinical Research Excellence (CCRE) U54 awards.

Collaborations/partnerships with Clinical and Translational Science Awards (CTSA) are encouraged.  RCMI institutions that have successfully competed as the prime institution for another NCRR-funded clinical research center [e.g. General Clinical Research Center (GCRC) and/or Clinical and Translational Science Award (CTSA)] are not eligible to compete as the prime institution for an RCTR.  RCMI institutions that are collaborating or partnering institutions for non-RCMI support of a clinical research center (e.g. GCRC M01, CTSA and/or other awards) may not request any funds for components supported by these awards.

An institution may submit, or be part of, only one application in response this FOA.  Multiple applications from different departments, divisions, faculties, centers, schools, etc. of the same institution or professional school will not be reviewed.  At the time of the RCTR award, current NCRR P20 (RCRII) and U54 (CCRE or CCHD) awards to the institution(s) or affiliated institutions will be relinquished and any remaining funds, including unobligated balances, will be transferred to the new RCTR award. If the applicant is unsuccessful, the institution retains the current awards for the awarded project period. 

1.B. Eligible Individuals

1.B.1. Eligible Principal Investigators

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

The Principal Investigator(s) are expected to have institutional authority to direct the RCTR program.  Where multiple PIs are proposed, a governance plan must define their respective responsibilities and describe a reporting structure to an official with broad trans-institutional authority.  The governance plan must describe processes that will be used to resolve conflicts and to ensure implementation of the RCTR. 

Each PI must have administrative abilities to effectively accomplish the objectives and goals of the RCTR, direct knowledge and hands-on involvement in the daily activities of the RCTR and at least one PI is expected to be an established investigator.

1.B.2. Eligible Key Function/Activity Directors

All Directors of Key Functions/Activities and any co-Program Directors should have a clinical and translational research background and administrative qualifications and experience to provide scientific leadership, management, and coordination of the respective components.  The Directors of the Key Functions of the RCTR should, in general, be senior facility members who possess the knowledge, authority, and leadership skills necessary to direct the resource, and to speak for the RCTR institution in national forums.  The Principal Investigator of the RCTR award will coordinate the activities of all the Directors of Key Functions.

2. Cost Sharing or Matching

There is no requirement for cost sharing or matching for institutional eligibility.

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

An institution can submit, or be part of only one application in response to this FOA.

Resubmission applications will not be accepted in response to this FOA. 

Applicants may not submit a renewal application in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

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.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

Registration in the NIH eRA Commons

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the PHS398 forms. All other participating components requiring separate budgets (e.g. affiliated institutions) should also submit separate individual budgets on PHS398 forms.

The instructions in Form PHS 398 do not fully apply to the special needs of this grant application.  Therefore, follow the modified instructions below in preparing the application for an RCMI Infrastructure for Clinical and Translational Research (RCTR) award. 

3. Submission Dates and Times

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: October 18, 2008
Application Receipt Date: November 18, 2008
Peer Review Date: February 2009
Council Review Date: May 2009
Earliest Anticipated Start Date: July 1, 2009
Online Technical Workshop:  October 17, 2008 at 2:00 pm, Eastern Time

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.

The letter of intent should be sent by email to:

Shelia A. McClure, Ph.D.
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd., Room 932
Bethesda, MD 20892
Telephone: (301) 451-6536
Email: mcclursh@mail.nih.gov    

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 materials must be sent to:

Carol Lambert, Ph.D.
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1076
Bethesda, MD 20892-4878 (Regular Mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: (301) 435-0814
Email:  lambert@mail.nih.gov

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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.)

Awards will be made on the basis of Total Cost Commitment.  No component of a RCTR award will have automatic carryover authority. Approved carryovers will be provided in award notices.  Requests for cost-of-living increments with non-competing renewals will be handled according to prevailing NIH policy.

NIH support beyond the initial five-year project period is not guaranteed and is dependent upon the availability of appropriated funds, and success in any competition for renewed support. In the event that there is no further support, no phase-out funds will be provided.

6. Other Submission Requirements and Information

Format of the Application

All information must be contained within the body of the application; appendices are not allowed.

The application should be organized as follows:

Face Page: Use Form 1 of the PHS 398.  On Line 1, include the title that best represents the nature of the RCTR Program.  On Line 2, provide the number of this FOA, PAR-08-262 and the PAR title “Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research”.  When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered on the PHS398 face page. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Key Personnel Table” of the PHS398.  The budget figures should be taken from the consolidated program budget (see below).

Description, Performance Sites, and Key Personnel:  Key Personnel include the Principal

Investigators, co-Program Director(s), Director(s), and co-Director(s) of key resources, and other key professional and administrative members of this Program.  Do NOT include names of external advisory committee members.  Only include named individuals for whom salary support is requested.

Table of Contents

Detailed Budget Pages for Initial Budget Period and Entire Proposed Period of Support: Several sets of budget pages (Form pages 4 & 5) are required.  The first set is for the entire U54 budget that summarizes the total budget for the all of the Key Functions/Activities in the program and must include justification for equipment, personnel and supplies.  The subsequent sets of budget pages (Form pages 4 & 5) will contain the budgets required for each of the RCTR Key Functions/Activities included in the application and must include justification for equipment, personnel and supplies required for the Key Function. 

The RCTR Program budget should be constructed using the following general guidelines. Applicants must re-budget the total funds from current awards to accomplish the goals of the RCTR application.  In developing the budget, applicants may request the direct costs of current P20 and U54 awards plus up to an additional $1 million dollars.  Total costs per year should not exceed $4.2 million (including F&A costs).  

Funds provided via the RCTR award are intended to develop the institutional infrastructure of the prime grantee institution. Budget items should be requested for 12 months. NCRR will prorate these items accordingly at the time of award. Administrative Support Staff requested for the RCTR may not exceed 1.0 FTE. Most items in the program will be listed on pages 4 & 5 of the PHS 398 for the RCTR U54 budget including: Salary and fringe benefits for the RCTR PI(s), component directors(s) or co-director(s), professional and administrative staff, (personnel category of PHS 398 pages 4 & 5), consultant costs, equipment, travel, and supplies. Other Costs may include patient care costs, other expenses and consortium/contractual costs.

Applicants may request funds to support multidisciplinary pilot project programs. These funds can be used for research expenses, such as supplies, equipment, and technical personnel.   Funds requested for payment to a hospital for Participant and Clinical Interaction resources shall be requested on PHS 398-Form Page 4, as “Patient Care Costs.” If there is a negotiated Research Patient Care Rate Agreement established between the hospital and DHHS that will be applied to the provision of RCTR services, include a copy of that agreement with the application. Categories for which F&A costs are included in the negotiated research patient care agreement should be excluded from F&A costs in the U54 budget (i.e., F&A costs may not be charged twice.) 

Biographical Sketches and Research Support: are required in standard NIH format for Principal Investigator(s), Program Director(s), co-director(s), other listed key professional and administrative members of this Program, named members of significant internal committees, and external advisory committee members.  Do NOT include Biographical Sketches for those who do not have direct roles in the RCTR program.

RCMI Infrastructure for Clinical and Translational Research (RCTR) Program: The application MUST present all proposed activities of the RCTR within the page limits listed below.  Note that these are upper page limits: applicants are urged to be concise and to present information in tables where possible.  Applicants must not provide programmatic URLs in their applications, and reviewers are instructed not to view applicant’s web sites to review existing public information.  No appendices are allowed.  References are not included in the page limits and may be cited in the appropriate sections of the application or in Section H. 

The information should be arranged as follows:

1. Institutional Setting and Commitment (10 pages for single PI; 15 pages for Multiple PI applications)

2. Overall Approach and Governance (25 pages for single PI; 30 pages for Multiple PI applications and this section must include a Multiple PI leadership plan)

3. Required Key Functions/Activities (15 pages each unless otherwise noted)

4. Examples of Proposed RCTR Key Functions/Activities (15 pages each unless noted)

5. Evaluation Milestones (15 pages)

6. Tables (50 pages maximum). The organization and content of the tables is left up to the applicant; however, summary and graphical displays are strongly encouraged. Organization tables can be distributed throughout the application in proximity to their respective sections. Programs must comment on the past and current funding for and productivity of:

Literature Cited

Required Institutional Letters (see Special Programmatic Requirements below)

Human Subjects

Patient Care Rate Agreement (if applicable)

Vertebrate Animals

Checklist

Description of Special Programmatic Requirements

Section F.1. Institutional Setting and Commitment (10 pages for single PI; 15 pages for Multiple PI applications)

The application must include clear detailed evidence of institutional commitment to the RCTR Program.  Applicants must:

Section F.2. Overall Approach and Governance (25 pages for single PI; 30 pages for Multiple PI applications and this section must include a Multiple PI leadership plan)

F.2.1. Overall Approach

Applicants must use this section of the application to describe the following components and functions:

The applicant must describe the process by which the RCTR will be implemented and integrated into the strategic plan of the institution. Applicants must provide detailed performance milestones and a timeline that will be used to measure progress in each budget period towards the goals of each Key Function/Activity.  This section must include:

Applicants must relate the goals described above to the Key Functions/Activities proposed in their application.

F.2.2. Governance

Applicants must describe:

The rationale for these approaches should be described.

An Internal Advisory Committee (IAC) that is advisory to the RCTR PI(s) should be established prior to submission of the application.  Depending on the scope and complexity of the RCTR program, the IAC may consist of six to eight members.  Meetings of the IAC should be held at least quarterly.

It is anticipated that each RCTR will also have an External Advisory Committee (EAC) that would meet at least annually to review structure and progress and offer recommendations to the RCTR PI (s). Potential members of an EAC should not be named and should not be contacted prior to the review of an application. The applicants must indicate the sorts of expertise of the members that will be recruited for the EAC. Depending on the scope and complexity of the RCTR program, the EAC may consist of eight to ten members. Ideally, the members should be appointed on a rotating basis. 

The efforts and recommendations of the IAC and EAC should be coordinated.  Official minutes of committee meetings must be kept on file.  It is particularly important to document problems and issues, along with any necessary recommendations.  Plans for following-up on recommendations must be included.

Section F.3. Required Key Functions/Activities

F.3.1. Collaborations and Partnerships (15 pages) 

A required component of this initiative is collaboration between researchers from different disciplines, departments, or units within an institution, and collaborations with investigators in other institutions.  In addition, applicants are strongly encouraged to form partnerships with other academic and non-academic organizations.  The collaborating organizations or institutions must be domestic and may include Federal or non-Federal, public or private, and for profit or non-profit organizations. 

Applicants must describe how the RCTR environment facilitates intra-institutional collaborations.  In cases where an institution has a G12 award and/or other NIH-funded research capacity-building programs, RCTR grantees must demonstrate that there is collaboration and synergy between these program activities.  In addition, applicants must include plans for facilitating interactions between basic, clinical, and translational investigators across the institution.  Applicants must describe the academic qualifications, research experience, and productivity of collaborators from other institutions and describe their contributions to the success of the RCTR.

Applicants must describe how they will use the RTRN to facilitate collaborations focused on health disparity research. Applicants must describe how its researchers collaborate, share and disseminate resource tools and resources at institutional and national levels. Plans must be included to describe how regulatory hurdles related to collaborations will be addressed locally.  Applicants must indicate the institution's willingness to participate in the RTRN, CTSA, or other consortia focused on the development, adoption, and implementation of best practices in conducting clinical and translational research and research training.   

If partnering institutions/organizations are proposed, there should be a thorough description of the partnership as well as the administrative and fiscal relationships that have been established between the RCTR and the collaborating institution(s)/ organizations.

F.3.2. Multidisciplinary Training and Career Development Activities (15 pages)

Applicants must provide programmatic detail on the activities proposed (e.g., courses, curricula, seminars, workshops or other career development activities) to support research training and career development for post-doctoral level professionals and junior faculty from a variety of disciplines and clinical specialties (MD, DDS, PHD, Pharm D., RN).  In addition, the applicants must describe the plans for the administration of the proposed activities, and provide a description of the qualifications and role of the individual(s) providing scientific leadership, and administrative management and coordination of the proposed activities.  Applicants must provide evidence of how research training will be integrated across the institution.

If resources are requested to offer structured didactic course work and mentored clinical and translational research experiences leading to a degree program, applicants must:

If the institution currently has a Clinical Research Education and Career Development (CRECD) in Minority Institutions award, applicants must describe this program and indicate the program’s role in supporting the RCTR goals for clinical and translational research education and training.  Applicants must also describe how the proposed RCTR key functions/activities enhance the research training of the CRECD scholars.

If no currently funded training program exists at the institution, applicants should describe how the proposed RCTR activities will enhance their ability to apply for training awards, or partner with other institutions to leverage existing or proposed training activities.

Section F.4. Examples of Potential RCTR Key Functions/Activities (15 pages each unless noted otherwise)

F.4.1. Recruitment and Hiring of Additional Faculty Investigators (15 pages; 20 pages if this section includes a career development section for junior faculty hires)

Applicants should describe plans for recruiting and hiring additional research personnel that may be required to accomplish the goals of RCTR.  This may include hiring of senior “magnet” clinical and translational investigators who must have independent research support and can serve as mentors to more junior investigators.  These new faculty may receive support to establish their research laboratories, acquire specialized equipment, and support postdoctoral fellows and technical assistants.  If junior faculty members are hired, the application must contain detailed career development plans.  The career development section should be clearly identified with a heading and should not exceed five pages.  The career development section will not count against the 15 page limit. Applicants must include a proposed timetable specifying the expected hiring date for each new faculty and/or staff member.

F.4.2. Biomedical Informatics (15 pages)

Applicants should describe:

F.4.3. Research Design, Biostatistics, and Clinical Research Ethics (15 pages)

Applicants should describe:

F.4.4. Participant and Clinical Interactions Resources (PCIR) (15 pages)

Examples of resources to facilitate participation in clinical and translational research may include (but are not limited to) the recruitment of research participants, the provision of out-patient, or community-based exam rooms, medical vans, temporary research participant recruitment/enrollment sites, research nurses, research coordinators, phlebotomists, scheduling services, and services for research specimen collection and shipping.

Applicants should describe:

F.4.5. Community-Based Research (15 pages)

Applicants should describe:

F.4.6. Regulatory Knowledge and Support (15 pages)

Applicants should describe:

F.4.7. Technologies and Resources for Core Laboratories (15 pages)

Applicants should describe:

F.4.8. Development of Novel Clinical and Translational Methodologies (15 pages)

Applicants should describe the means for selecting Novel Clinical and Translational Methodologies that will receive core support, together with a plan for their governance, operation and evaluation.

If the application proposes to develop novel clinical and translational methodologies and/or biomedical informatics applications, etc., for health disparities research, the application must include plans and associated budget allocations to use the RTRN to make these available to the broader scientific community.

F.4.9. Pilot Project Program (15 pages)

Applicants should describe the plan to solicit proposals, prioritize the projects and to review their methodology and research performance.  The description of the Pilot Project program should include the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the solicitation, submission, review, and selection criteria and process; oversight and evaluation procedures; and assurances that all projects supported from this grant will comply fully with all applicable Federal policies, rules, and guidelines for research involving human subjects.  Applicants should not submit individual research projects. 

Section F.5. Evaluation Milestones (15 pages)

The proposal must include a detailed self evaluation plan to assess implementation of the short-term and long-term RCTR goals, including implementation of specific program activities; and document the accomplishments anticipated for each budget period and within the total award period.  For each proposed key function/activity, the plan should include the objectives of the evaluation or tracking activities, the principal measures or indicators, and potential data sources.

Listed below are examples of evaluation objectives for illustrative key functions/activities:

Assess the demand for, and effectiveness of, any Novel Clinical and Translational Methodologies, Pilot and Collaborative Translational and Clinical Studies, Community-Based Clinical and Translational Research, and Technologies and Resources for Core Laboratories.

Biomedical Informatics

Design, Biostatistics and Clinical Research Ethics

Regulatory Knowledge and Support

Participant and Clinical Interactions Resources

Overall Operational Functions

Section F.6. Tables

Section G.  Literature Cited

Section H.  Required Institutional Letters

Applicants must provide letters from the appropriate high-ranking institutional official(s) from the parent institution and its affiliates that:

Separate letter(s) co-signed by the RCTR Principal Investigator(s) and the Principal Investigator of each of the NIH-funded NCRR awards listed above (RCRII, CCRE or CCHD)  must be provided to acknowledge that each budget for these grants will be relinquished in the event this application is funded. A letter must also be included from the Principal Investigator of current CRECD Awards indicating the CRECD program’s role in supporting the RCTR goals for clinical and translational research training.  In cases where an institution has an RCMI G12 award, a letter must be included from the Principal Investigator that indicates the program’s role in supporting the institutions broader vision of clinical and translational research and how investigators from this program will be engaged in RCTR key functions/activities.  These letters must be co-signed by the appropriate business officials of each specific award and of this RCTR application.  Applications lacking these letters will not be reviewed.

Separate letter(s) co-signed by the PI and all the appropriate technology transfer offices must be provided to acknowledge that they will abide by the data and resource sharing plans specified in the application.  Applications lacking these letters will not be reviewed.

I. Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research must be described (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women, Minorities and Children in Research: Plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research must be included (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

J. Patient Care Rate Agreement:  If applicable, a patient care rate agreement must be included.

K. Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions must be included.

Research Plan Page Limitations

The Institutional Setting and Commitment and the Approach and Governance sections are limited to 10 and 25 pages respectively (if multiple PIs are proposed, these two sections are limited to 15 and 30 pages respectively). Each Key Function/Activity proposed as well as each section describing (1) Collaborations and Partnerships, (2) Multidisciplinary Training and Career Development, and (3) Evaluation Milestones is limited to 15 pages, unless noted otherwise in the FOA.

Appendix Materials

All information must be included within the body of the application. Appendices are now allowed.

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: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(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

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCRR 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 submitted in response to this FOA. 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 priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.  

Significance: Does this study address an important problem?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed RCTR have significant impact on the overall quality of clinical and translational research at the applicant institution? Are the overall program vision and strategy adequate to facilitate and sustain clinical and translational research in health disparity areas? Will the proposed RCTR have potential to enhance the competitiveness of the awardee institution to obtain additional funding for clinical and translational research?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Will the RCTR program enhance, complement, or extend the applicant's current resources for clinical and translational research in health disparity areas? Does the application identify key obstacles to the performance of translational and clinical research and then propose plans or means to overcome these? Will the proposed RCTR include relevant scientific disciplines and collaborations to maximize productivity? Does the application make efficient use of potentially unique resources, such as access to certain human subject populations or the provision of pre-clinical resources? Does the applicant indicate how the organization will be adapted to respond flexibly to changes in translational focus?

Innovation: Is the project original and innovative?  For example, does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Are new approaches proposed that would integrate basic, clinical, translational and other relevant (e.g., public health, bioinformatics, social and behavioral sciences) disciplines in research in health disparity areas? Is the program likely to develop novel approaches to increasing the ease and efficiency of clinical and translational research at the grantee institution?

Investigators: Are the PI/PD(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

Do the PIs have the experience, authority, and committed time to administer the proposed RCTR? Will the PI have sufficient authority and credibility in the institution to work across institutional boundaries? Will the PI(s) have the environment and institutional support necessary to be responsible for the resources committed by the institution(s) for the RCTR? Does the program leadership and management team bring complementary and integrated expertise to the project?  Will the proposed RCTR have the professional staffing to impact significantly the overall quality of clinical and translational science at the institution? If part of the proposal, do the Key Function/Activities Directors have the appropriate training, experience and resources to assume leadership roles? Have the Directors of the Key Functions/Activities committed sufficient time to this Program? Will the Directors have the authority to implement best practices identified at Steering Committees at their Institution? Are the administrative and professional staff appropriately trained and well suited to carry out this work?

Environment: Do the academic and scientific environments in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?

Does the proposal provide strong evidence that the addition of the RCTR will provide resources that would not otherwise be possible? If applicable, are there adequate cooperative arrangements between affiliated institutions to ensure that the RCTR program performs effectively as one activity across institutional boundaries? Are there unique features of the scientific environment or in the available human subject populations or collaborative arrangements? Will the resources be available to researchers in different disciplines (e.g., medicine, pre-clinical research, etc.) 

In addition to the above criteria, the following components of the RCTR application will be considered in the determination of the overall priority score for the application.

Institutional Setting and Commitment: Is there institutional commitment to establishing the RCTR program as an integral part of its overall clinical and translational research environment?  Will the institution align or adjust incentives and rewards to promote the academic mission and new modes of team-based research? Is there substantial commitment from the institutional leadership to protect the time of the investigators to pursue clinical and translational research and mitigate the demands of providing patient care? Is the institutional leadership committed to this program and its goals in terms of providing specific assets for the program, such as financial support, faculty support, specific equipment, dedicated space, or tuition rebates, as a few examples? Will existing NIH-supported Cores be appropriately shared with the RCTR program?

Approach and Governance:  How well will the components of the RCTR be coordinated and integrated with each other? Will this integration be reflected in the senior leadership and decision-making structure of the RCTR? Are there plans to coordinate RCTR activities across relevant disciplines, departments, schools and in the applicant institution? Is the RCTR program cohesive, synergistic, adaptable, and potentially more effective than what currently exists?

Is an implementation phase well described? Is the timeline for implementation feasible and are specific goals and milestones set? Are alternatives proposed should the goals and milestones not be reached in a timely manner? Is there a feasible time line for integrating RCTR resources with other complementary resources available to the institution?

Have the applicants described an effective administration and governance structure that will promote the discipline of clinical and translational research? For applications designating multiple PD/PIs, is the leadership approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the aims of the RCTR and the expertise of each of the PD/PIs? Is the governance structure designed to ensure both accountability of multiple PIs, and integration of the components of the RCTR into a coherent program? Will the leadership and governance plans accommodate changes in the direction of research and allow for the efficient use of funds? Will External and Internal Advisory Committees be constituted to provide critical, stimulating, and thoughtful advice for the overall RCTR performance and RCTR Key functions/Activities? Are there plans to resolve conflicts and implement recommendations?

Collaborations and Partnerships: Does the RCTR environment facilitate intra-institutional collaboration? Has the applicant included collaborations with the investigators from other institutions?  Do the investigators from the collaborating institution(s) have the appropriate academic qualifications, research experience, and productivity to make contributions to the success of the RCTR?  Has the applicant described how they will use the RCMI Translational Research Network (RTRN) to facilitate collaborations focused on health disparity research?  Are plans included to address regulatory hurdles? Is there a commitment to and plans for participating in the development, adoption, and implementation of best practices through the RCMI Translational Research Network (RTRN), National Clinical and Translational Science Award (CTSA) Steering committees, and other national consortia where appropriate?

If partnering institutions/organizations are proposed, is there an adequate description of the administrative and fiscal relationships that have been established between the RCTR and the collaborating institution(s)/ organizations?

Multidisciplinary Training and Career Development Program: Is there evidence of appropriate collaboration among programs and departments to integrate clinical/translational research training and career development activities across the institution? Is the approach feasible and appropriate to achieve the stated research training and career development goals?  If the applicant institution currently has funding for a Clinical Research Education and Career Development (CRECD) in Minority Institutions award, how do the RCTR activities enhance this program?  Is there evidence that the educational program of the CRECD will benefit the RCTR? If the applicant does not currently have this type of award or other training awards, does the applicant propose to utilize the RCTR to enhance its ability to apply for education and/or training awards (R25, T32, K12) or propose to partner with institutions with these types of awards?

If a research education program is proposed, does the program address scientific/education areas and/or topics important to clinical and translational science as it relates to health disparities? Does the proposed research education program benefit from unique features of the scientific environment, subject populations, or employ useful collaborative arrangements? If the proposed program will recruit participants, are the recruitment, retention, and follow-up activities adequate to ensure a highly qualified and diverse participant pool? Is the institutional commitment to the proposed program appropriate?

NOTE: Review Criteria for potential Key Function topics are described below. 

Recruitment and Hiring of Additional Faculty Investigators: Is the recruitment of additional faculty appropriately justified?  Will the new faculty/staff improve the capability of the RCTR to conduct research on diseases, with an emphasis on those that disproportionately affect minority populations?  Is there adequate potential for new junior investigators to achieve scientific independence under the mentorship of senior clinical investigators within or affiliated with the RCTR?  Has the applicant provided a timetable with appropriate expected hire dates for new staff?

Biomedical Informatics: Will the biomedical informatics resources offered be commensurate with the breadth of the RCTR program? Will the Biomedical Informatics support services provided by the RCMI Translational Research Network (RTRN) be utilized for multi-site studies on health disparities?  Will data security and privacy be safeguarded? Will the institution work toward interoperability of the informatics systems and participate in the development of national data standards? Will the Biomedical Informatics Director have the necessary authority to ensure the implementation of best practices? As applicable, will this resource be sufficient for intra- and inter-institutional operations?

Research Design, Biostatistics, and Clinical Research Ethics: What types of support and resources will be in place to ensure all clinical and translational research designs are sound and that statistical analyses are appropriate and rigorous? Will training include conflict of interest, federal codes requirements, guaranteeing privacy and safety of research participants, especially as pertaining to vulnerable populations? As applicable, will this resource be sufficient for intra- and inter-institutional operations? Will the Research Design and Biostatistics components of the RCMI Translational Research Network (RTRN) be utilized for multi-site studies on health disparities?

Participant and Clinical Interactions Resources (PCIR): Will participation of underrepresented minorities in clinical research protocols be encouraged? Has the applicant adequately described and justified the resources to be provided? Will PCIR resources meet the highest standards for subject safety, quality of science and statistical and ethical design? Is the application of Good Clinical Practices guidelines appropriate? Will resource utilization be tracked and are mechanisms proposed to adapt resources to the needs of investigators? Will the resources provided serve small as well as large studies or trials?

Community-Based Research (CBR): Will the CBR effectively involve the community in which the RCTR institution resides, both the public and/or practitioners, in clinical and translational research priority setting, participation, and follow-up? Are there adequate plans to train researchers and scholars in the methodology of community/population-based research and recruitment? Will the resource foster long-term bidirectional relationships between the RCTR institution and the community for their mutual benefit?

Regulatory Knowledge and Support: Will this resource provide “researcher-focused” support for regulatory compliance and management, including the development of data safety and management plans? Is the resource well integrated with participant and clinical interactions? Is there duplication of IRB responsibilities? Will RCTR staff members be available with the necessary experience in working with the FDA and in ensuring that standards for reporting adverse events are met? Are criteria for identifying a research participant advocate sound?

Technologies and Resources for Core Laboratories: Is the plan to identify technologies and or core resources to be offered appropriate? Will resource utilization and evaluation be adequate? Is there flexibility in types of resources to be offered?

Development of Novel Clinical and Translational Methodologies: Is the outcome likely to benefit the investigator’ ability to conduct clinical and translational research?  Is there a plan to involve new investigators? Are there detailed and realistic plans to make these methodologies available to the scientific community through the RCMI Translational Research network (RTRN)?

Pilot Project Program: Is there an adequate plan to solicit proposals, to prioritize the projects and to review their methodology and research performance? Will the expected benefits to the RCTR and to the wider research community be measured and tracked? Will lessons learned be shared?

Evaluation Milestones: Is the plan adequate to evaluate the short-term and long-term goals for each of the key proposed functions/activities? Are the measures valid for the programs' goals to be assessed and how accessible and practical are the available data sources? Do the milestones and timelines provide feasible objectives, detailed quantitative and/or concrete criteria by which milestone achievement will be assessed?

Key functions/activities that are not listed in the PAR will be reviewed using the standard review criteria in part 2 Review and Selection Process.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)   

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 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 of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Awards Involving Separate Budgets for Multi-PIs

Funds for PIs at the applicant institution who request direct authority over a separate budget will be indicated in the Notice of Award (NoA) and may be restricted to the use of the designated PI until options involving linked awards have been developed (see NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html)). Where multi-PIs are at different institutions, their budgets should be included as subcontracts to be administered by the applicant institution. These funds may be restricted for the use of the designated PI until options involving linked awards have been developed (see NOT-OD-07-017 Establishment of Multiple Principal Investigator Awards for the Support of Team Science Projects (http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-07-017.html).

The budgetary recommendations of the peer review committee and programmatic considerations will be taken into account in developing a funding plan for successful applicants. 

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).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The Principal Investigator will have the primary responsibility to define objectives and approaches of the RCTR.  The primary responsibilities of the awardees are to:

Awardees will retain custody of and primary rights to their data and intellectual property developed under the award subject to current government policies regarding rights of access as consistent with current HHS, PHS, and NIH policies and subject to the terms and conditions of this FOA.   

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

NIH Program Officials will be responsible for the normal programmatic and scientific stewardship of the award and will be named in the award notice. The program official(s) will:

Additionally, the RCTR Program Official(s) may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this initiative.

An NIH Project Scientist will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. NIH Project Scientists(s) will:

2.A.3. Collaborative Responsibilities

The goal of the RCTR program is to facilitate the development of each awardee institution’s clinical and translational research capacity. To assist RCTR institutions in achieving this goal, RCTR awardees are strongly encouraged to participate in national committees convened to advance collaborative clinical and translational research.

Each RCTR institution must agree to work toward developing, adopting, and implementing the best practices and policies identified through the RCMI Translational Research Network (RTRN) and other national consortia.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Progress Reports

Progress reports are submitted using the Form PHS 2590, which can be obtained at the following website address: http://grants.nih.gov/grants/funding/2590/2590.htm. The report should provide information about changes in the Program and a summary report of any key function/activity and, or program evaluations.

For NCRR-supported Center and Resource grants, the PHS form 2590 incorporates an Annual Progress Report (APR), which provides information in greater detail than the standard NIH form 2590.  The NCRR uses the information contained in the APR to facilitate programmatic stewardship of the grant and to respond to inquiries from other governmental agencies and the public. Specific instructions for completing an APR and including it with the NIH form 2590 can be found at http://aprsis.ncrr.nih.gov

The PHS form 2590 application for continuation should contain the following information:

A brief description of the Objectives and Goals of the Program

Summary of progress in meeting expected accomplishments outlined in application, including institutional commitments.

Summary of progress in program integration and innovation.

Additional information that should be reported in concert with the PHS 2590 Progress Report:

Biographical sketches/other support information for any new Key Personnel added from the last application and justification for these new personnel.

Report on each RCTR component and key function/activity

Report information regarding self-evaluation activities. Include:

a. Evaluation objectives to be addressed

b. Logic Model being used as a conceptual framework for the self-evaluation activities

c. Variables being measured

d. Data collection methods being employed (include instruments that were used)

e. Interim findings

f. Timeline for future activities

g. Issues or barriers encountered in implementing the program activities and plans for addressing these issues or barriers

h. List of publications from studies benefiting from RCTR resources.

These Progress Reports will be closely monitored by NIH staff to ensure that the awardee is achieving the program goals. A final progress report, invention statement, and Financial Status Report are required when an award is relinquished or when an award is terminated.

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:

Shelia A. McClure, Ph.D.
Division of Research Infrastructure
National Center for Research Resources
6701 Democracy Blvd., Room 926
Bethesda, MD 20892
Telephone:  (301) 451-6536
Email:   mcclursh@mail.nih.gov

2. Peer Review Contacts:

Carol Lambert, Ph.D.
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., Room 1076
Bethesda, MD 20892-4878 (Regular Mail)
Telephone: (301) 435-0814
Email:  lambert@mail.nih.gov

3. Financial or Grants Management Contacts:

Amy McGuire
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd., Room 1052
Bethesda, MD 20892
Telephone: (301) 435-0853
Email: mcguirear@mail.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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: 
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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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