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 Cancer Institute (NCI) (http://www.cancer.gov)
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov)
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov ) 
National Institute of Mental Health (NIMH), (http://www.nimh.nih.gov/)
National Institute on Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov)
National Institute on Nursing Research (NINR) (http://www.ninr.nih.gov)         
National Library of Medicine (NLM) (http://www.nlm.nih.gov)                         

Title: Recovery Act Limited Competition: Institutional Comparative Effectiveness Research Mentored Career Development Award (KM1)

Announcement Type
This is a new announcement.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-OD-10-011

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF 424 Research and Related (R&R) forms and the SF 424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release Date: January 13, 2010
Opening Date: February 25, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date: March 25, 2010
Letters of Intent: Not Applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
AIDS Application Due Date: Not applicable
Peer Review Date: May/June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: August 31, 2010
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: March 26, 2010

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

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description



1.   Research Career Objectives

This FOA will support the expansion of the nation’s workforce of researchers with expertise and experience in comparative effectiveness research (CER). The mentored career development approach will permit research-intensive institutions to develop an interdisciplinary environment catering to the needs of diverse populations of scholars including (but not limited to) those with backgrounds in medicine, pediatrics, surgery, dentistry, nursing, allied health, pharmacology, health care administration and management, clinical research design, epidemiology, biostatistics, biomedical informatics, economics, quality improvement, modeling systems, ethics, behavioral science, engineering, and law. Scholars supported through this program could include recent doctoral graduates who are entering the research workforce as well as established investigators who are seeking to extend their expertise or experience in CER in a mentored environment. Scholars should, where appropriate, be encouraged to register for higher degrees or for certificate programs. Successful applicants will be expected to include course or curriculum development work in their applications and to make provisions for expanding the pool of experienced CER mentors at their institutions. NIH anticipates that mentored career development programs will ultimately lead to significantly greater efficiency and skills among CER researchers and will attract new researchers into this field to enhance the quality of the nation’s health.

Priority-Setting Process and Inputs for Use of OS ARRA Funds

There were four main inputs for priorities for Department of Health and Human Services (HHS) Office of the Secretary (OS) ARRA comparative effectiveness research funds: public input, an internal Departmental workgroup, the Federal Coordinating Council report, and the Institute of Medicine (IOM) report.  The Federal Coordinating Council identified the following as minimum threshold criteria which must be met to be considered for funding:

1) Included within statutory limits of ARRA and the Council’s definition of comparative effectiveness research;

2) Potential to inform decision-making by patients, clinicians or other stakeholders;

3) Responsiveness to expressed needs of patients, clinicians or other stakeholders;

4) Feasibility of research topic (including time necessary for research).

The Comparative Effectiveness Research-Coordination and Implementation Team (CER-CIT) will require the use of the Federal Coordinating Council’s prioritization criteria for scientifically meritorious research and investments for all projects funded with OS ARRA funds.  These criteria are:

1)  Potential impact (based on prevalence of condition, burden of disease, variability in outcomes, costs, potential for increased patient benefit or decreased harm);

2)  Potential to evaluate comparative effectiveness in diverse populations and patient sub-groups and engage communities in research;

3)  Addresses existing uncertainty within the clinical and public health communities regarding management decisions and variability in practice;

4)  Addresses a need or is unlikely to be addressed through other organizations; and 5)  Potential for multiplicative effect.

Finally, investments funded from this appropriation must address at least one of the following topic areas:

1) One of the 100 IOM recommendations;

2) An issue within one the MMA 14 Priority Conditions identified by Agency for Healthcare Research and Quality (AHRQ)(pursuant to Section 1013 of the Medicare Prescription Drug Improvement and Modernization Act of 2003) which are not currently addressed; and/or

3) Fall into one of the AHRQ identified evidence gaps.

A current list of priority conditions includes:

2.   Background

For the purposes of this FOA, the definition of comparative effectiveness research (CER) will adhere to that adopted by the Federal Coordinating Council given at http://www.hhs.gov/recovery/programs/cer/execsummary.html: “Comparative effectiveness research is the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in “real world” settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances.

To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations and subgroups.

Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.

This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness and actively disseminate the results.”

The term “comparative” refers to comparisons of interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The term “effectiveness” refers to applicability “to real-world needs and decisions faced by patients, clinicians, and other decision-makers” within “real-world settings,” i.e., not the ideal settings created in efficacy investigations. CER investigations compare two or more interventions and strategies that are currently available to practicing clinicians (i.e., not innovative or experimental drugs, devices, or approaches that might more typically be part of a Food and Drug Administration [FDA]-regulated efficacy study).  These interventions and strategies can include “medications, procedures, medical and assistive devices and technologies, diagnostic testing, behavioral change, and delivery system strategies.” As examples, CER investigations could:

For examples of CER topics and approaches a 2009 Institute of Medicine Panel consider to be of high national priority, applicants are also encouraged to consult the Panel’s report at http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx.

CER is increasingly recognized as an essential guide to health care delivery, yet the investment in human and scientific capital for multiple fields has to date been very limited. Greater investment is needed to develop education and training programs that support the development of professional talent. Recent growth in training for the related fields of health technology assessment, outcomes research, health economics, among others, has created a cohort of researchers who are well-positioned to become more expert in CER, but who as yet lack the required skills and/or practical experience that would bring them full proficiency in the discipline.

The success of CER initiatives will require a body of experienced researchers and a program that will sustain and support their numbers and expertise. This FOA therefore focuses on CER curriculum development, pilot testing of novel methods of CER training opportunities, and mentored career development activities designed to enhance scholars' potential as researchers in CER. It does not support methodology development (approaches to design, implement, analyze, and report CER) and CER projects that focus on comparing specific interventions for preventing or treating a given medical condition.

ARRA funds offer an extraordinary opportunity to invest in the training of investigators who could plan, design and execute future CER across the range of relevant health care specializations.

Scope and Specific Requirements

This FOA solicits applications for projects of up to 3 years (maximum duration) proposing mentored career development for investigators, both junior and established, who wish to develop or expand their ability to conduct CER. The proposed education and curriculum will need to accommodate investigators of different backgrounds, including those with previous experience in relevant fields such as economics or health care business management, those in allied-health fields and those with professional doctorates in medicine, dentistry, nursing, and pharmacy. The career development environment should be able to integrate multiple disciplines including (but not limited to) areas such as medicine, pediatrics, surgery, dentistry, nursing, allied health, pharmacology, health care administration and management, clinical research design, epidemiology, biostatistics, biomedical informatics, economics, quality improvement, modeling systems, ethics, behavioral science, engineering, and law.

A parallel program of CER education and curriculum development should be structured to promote the recruitment, training, advancement, and retention of researchers and mentors in CER careers. Applicants are encouraged to include relevant and appropriate didactic courses that might cover relevant topics including, but not limited to, biostatistics, bioethics, clinical trials design, informatics and information systems, communication and information dissemination science, management and administration skills, team leadership, health data standards and observational study design, scientific writing for publication and preparation of competitive grant applications. Education in business management and administration practices as related to health research may also be included. Workforce development outcomes might include (but are not limited) CER applied research skills and CER methodology skills development for researchers and mentors.

To develop a rigorous and robust academic discipline of CER, the applicant institution(s) is (are) encouraged to offer certificate programs and must offer links to a graduate school accredited to award higher degrees relevant to CER. Examples of acceptable higher degrees include Masters in Clinical Research, Public Health, or other relevant discipline.

Curriculum development leading to novel methods and approaches for integrated and flexible postdoctoral CER training, potentially with innovative hands-on practical experiences, is encouraged. Novel approaches may be pilot tested and evaluated for their wider applicability.

Section II. Award Information


1.   Mechanism(s) of Support

This funding opportunity will use the KM1 award mechanism that supports institutional K awards for a maximum duration of three (3) years. The Project Directors/Principal Investigators (PDs/PIs)(if multiple PD/PI option is used) will be solely responsible for planning, directing, and executing the proposed institutional career development program. 

This FOA uses “just-in-time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget format. Applicants must complete and submit detailed categorical budget requests using the SF424 Research and Related (R&R) Budget Component found in the application package for this FOA.

2.   Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. The total funds available for the new awards are approximately $25 million to fund up to 10 awards, contingent upon the submission of a sufficient number of meritorious applications.

Allowable Costs: Allowable costs must be consistent with NIH policy and be reasonable, allocable, well documented, and fully justified for the institutional career development program proposed in the application. Grant funds may not be used to supplant funds otherwise available at the applicant institution. Note that instructions for completing the budget information in the SF 424 (R&R) application, using the Research & Related (R&R) budget, are included in Section IV, “Selecting the Appropriate Budget Component.”

Personnel Support: The PD(s)/PI(s) may request salary and fringe benefits for effort between 10 and 20 percent for individuals designing, testing, directing, and implementing the career development program. Such requests should be fully justified and the salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

Mentors: If mentoring interactions and other activities with scholars are considered a regular part of an individual’s academic duties, then mentoring and other interactions with scholars are non-reimbursable from grant funds. However, mentors (up to two mentors per Scholar) may receive up to $5,000 per year for laboratory and other research costs associated with mentoring activities.

Scholar Costs: The mentored career development scholar support will provide for up to two (2) years of full time funding for each CER Scholar. The award will support the salary, fringe benefits, and research costs for scholars planning careers in comparative effectiveness research. The actual salary and benefits should be prorated according to the actual number of months worked.

The minimum scholar time commitment is 6 person-months, which may be distributed over a 6 month – 24 month period, as provides the individual with an optimal career development experience. Individual scholars are eligible for salaries up to the current NIH Salary Cap (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-035.html) plus fringe benefits based on the sponsoring institution's rate per year. However, the salary must be consistent both with the established salary structure at the institution and salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities. The sponsoring institution may supplement the NIH salary contribution up to a level that is consistent with the institution's salary scale; however, supplementation may not be from other Federal funds unless specifically authorized by the Federal program from which such funds are derived. In no case may PHS funds be used for salary supplementation. Institutional supplementation must not require extra duties or responsibilities that would interfere with the purpose of the KM1 component.

Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary, however, may not exceed the legislated maximum (http://grants.nih.gov/grants/policy/salcap_summary.htm).

Mentored career award recipients, including KM1 scholars, in the last two (2) years of career award support may reduce effort on the career award to a minimum of 50% and hold concurrent support from their career award and a competing NIH research grant when recognized as a Principal Investigator or subproject Director. This policy can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-08-065.html.

Pilot and Feasibility Project Research Development Support Costs

KM1 Scholars may receive funds to support pilot CER projects and career development activities. This support will range from $25,000 up to $50,000 per scholar per year to help defray the costs of the following expenses: (a) tuition and fees related to career development; (b) research expenses, such as supplies, equipment, and technical personnel; (c) travel, involving a maximum of $2,500 per scholar per year to attend up to two training and/or scientific/research meetings/workshops; and (d) statistical services including personnel and computer time.

Other Program-Related Expenses: Recruitment costs (up to $3,000 per year for costs such as brochures, recruitment-related travel, etc.) to attract participants who can excel in, and potentially become leaders in, comparative effectiveness research.

Items that may NOT be supported with KM1 funds include: Salaries for support of ancillary personnel, i.e., secretarial and administrative assistance, etc.

Facilities and Administrative Costs

Facilities and administrative costs, which were formerly called indirect costs, will be reimbursed at eight percent of total direct costs exclusive of tuition, fees, and equipment.

This program is supported by funds provided to the NIH under the Recovery Act.  The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, Domestic (United States) institutions/organizations planning to submit applications that include Foreign components should be aware that requested funding for any Foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

NIH grants policies as described in the 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 grant 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. When considering the multiple PDs/PIs option, 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.

For background information on the Multiple PD/PI initiative, see http://grants.nih.gov/grants/multi_pi/index.htm.

2.   Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3.   Other - Special Eligibility Criteria

Sponsoring Institution: The sponsoring institution must assure support for the proposed institutional career development program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and relevant resources that can contribute to the planned program. Applicant institutions must also guarantee the required protected time for the scholars selected for support. The application should include a letter explaining the institutional commitment to the proposed institutional research career development program.

Scholars: The scholar must have a research or health-professional doctoral degree or its equivalent. Candidates must be able to commit a minimum of 6 person-months over a 2-year project period to the CER career development and research activities associated with the program. This equates to a minimum of 25 percent of full-time professional effort of 2 years, 50 percent effort over 1 year or a full-time commitment for 6 months. The remaining effort can be divided among other research, administrative, consultative, clinical or teaching activities only if these activities are consistent with the proposed goals of the KM1 CER program.

The eligibility of potential scholar candidates holding VA appointments should be confirmed with NIH Scientific/Research staff (see Section VII.) prior to the individual being appointed to the program. The portion of the Memorandum of Understanding (MOU) that details the professional responsibilities of the candidate scholar at the VA and the sponsoring institution may be requested.

KM1 scholars may not simultaneously submit or have pending an application for any other PHS mentored career development award (e.g., K07, K08, K22, K23) that duplicates the KM1 program. For example, KM1 scholars may apply for K23 support and, if successful, may leave the KM1 program to accept K23 funding.

All KM1 scholar appointments should be made electronically using the xTrain system, if possible (see NOT-OD-09-121) and Section VI.3. Reporting

Scholar Citizenship and Residency Requirement: Only United States (U.S.) citizens or non-citizen nationals, or individuals lawfully admitted for permanent residence who have a currently valid Permanent Resident Card (USCIS Form I-551), or some other verification of legal admission as a permanent resident prior to admission into the K12 program, are eligible for scholar support from this program. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually persons born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Mentors: The KM1 component of the application must identify a core group of primary mentors for the career development program. Up to 2 mentors per scholar are permitted. Each mentor together with the scholar will be responsible for the planning, direction, and execution of each career development plan and research project. Mentors must be recognized as accomplished investigators in CER and have a track record of success in training new investigators and fostering their transition to independence. Mentors should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable costs of the KM1. The participation of more junior faculty in the mentoring process encouraged. Where feasible, women, minority individuals, and individuals with disabilities should be involved as mentors to serve as role models. X-train reporting requires that the progress of scholars is tracked and a written appraisal of their progress toward independence is submitted on an annual basis.

Training in Responsible Conduct of Research: Applicants are required to include a plan for Training in the Responsible Conduct of Research (see Section IV.6).

Evaluation Plan: Applications must contain an evaluation plan in order to determine their effectiveness. Any application submitted without inclusion of an Evaluation Plan section may be delayed in the review process or not reviewed.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, go to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

Registration: Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission). The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1.    Organizational/Institutional Registration in Grants.gov/Get Registered

2.    Organizational/Institutional Registration in the eRA Commons

Direct questions regarding the Commons registration to:

eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours: M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email: commons@od.nih.gov

3.    Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 Research & Related (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Training Program Plan Component (for Institutional Research Career Development Program)
PHS398 Checklist
SF424 (R&R) Budget
(See Section IV.6., “Supplementary Institutional Career Development Program Application Instructions,” Selecting the Appropriate Budget Component” regarding completing appropriate required R&R budget component forms.)  

Optional Components:
PHS398 Cover Letter File
Research and Related Training Subaward Budget Attachment(s) Form (when applicable)

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs: 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 in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/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 “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

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

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, the Research Training Program Plan and 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. A single Contact PD/PI must be designated for the purpose of communicating with the NIH, although other individuals may contact the NIH on behalf of the Contact PD/PI when necessary.

If budget allocation is planned, the distribution of resources to specific components of the program 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.

Applications Involving a Single Institution: When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R)

Application Involving Multiple Institutions: When multiple institutions are involved, one institution must be designated as the prime institution, and funding for the other institutions(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 Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Budget Sub-award Budget Attachments(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the sub-award budget form.

Components of the program

Overview of Institutional Career Development Program(s): Provide an overview of the proposed mentored career development program, describing the immediate and long-term objectives of the program, including strategies and career development activities that will be used to ensure that the objectives of the FOA are met. Include information about existing courses, curricula, seminars, workshops, and/or tutorials that support current NIH scholar and training awards at the institution. If applicable, explain how these programs will synergize with the CER program, indicating whether the mentoring faculty, potential scholars, and resources can support additional programs.

CER Mentored Career Development Component: Applicants should describe their proposed higher degree-granting programs such as those for Masters or Ph.D.s that include comparative effectiveness research. The description should include the institutional commitment to the program, the quality, innovation and content of courses and adequacy of the syllabus; the scientific qualifications and experience of the faculty; the criteria for selecting participants; efforts to publicize the availability of the program to potential participants. Additional potential topics include:

Scholars and Mentors: This section should describe:

Curriculum Development

Evaluation Plan: The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program.  This should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing the curriculum, career development activities, and scholars’ career development and progression, including degree completion (if applicable), publications, and subsequent positions.

The application should describe plans for a CER career development program advisory committee.

Recruitment and Retention Plan to Enhance Diversity: The NIH recognizes the need to: promote diversity in the biomedical, behavioral, clinical, and social sciences workforce leading to the recruitment of the most talented researchers from all groups; improve the quality of the educational and training environment; broadening research priorities; diversify the backgrounds of clinical research subjects; and improve the Nation’s capacity to address and eliminate health disparities.

The NIH encourages institutions to diversify their trainee and faculty populations to include individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. Plans for recruiting scholars should include accessing under-served and under-represented minority and ethnic populations.

The NIH is particularly interested in encouraging the recruitment and retention of the following classes of candidates:

A.   Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/). In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B.   Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C.   Individuals from disadvantaged backgrounds who are defined as:

1.   Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the HHS Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2.   Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement. Under extraordinary circumstances the PHS may, at its discretion, consider an individual beyond the undergraduate level to be from a disadvantaged background.  Such decisions will be made on a case-by-case basis, based on appropriate documentation.

A final report must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of scholars who were appointed to the research training grant.

This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity. If an application is received without a plan, the application will be considered incomplete and will not be reviewed.

Instruction in the Responsible Conduct of Research: Every scholar supported by this career award must receive instruction in the responsible conduct of research. Describe the plan to provide scholars with such instruction. The plan must address five components: format; subject matter; faculty participation; duration of instruction; and frequency of instruction. All training faculty who served as course directors, speakers, lecturers, and/or discussion leaders must be reported in the annual progress report of this award. Applications must include a description of a plan designed to provide instruction in the responsible conduct of research relevant to all CER activities.

Applications without plans for instruction in the responsible conduct of research will be returned to the applicant without review. For detailed guidance on Instruction in Responsible Conduct of Research, please refer to NOT-OD-10-019

3.   Submission Dates and Times

See (Section IV.3.A) below for details.

3.A.   Submission,  Review and Anticipated Start Dates
Opening Date: February 25, 2010 (Earliest date an application may be submitted to Grants.gov)
Application Due Date: March 25, 2010
Letters of Intent: Not Applicable
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
AIDS Application Due Date: (n/a)
Peer Review Date: May/June 2010
Council Review Date: August 2010
Earliest Anticipated Start Date: August 31, 2010
Additional Information To Be Available Date (URL Activation Date): Not applicable

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

3.C. Application Processing

3.C.1. Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”: 

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2. Two-Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3. Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, application will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons (https://commons.era.nih.gov/commons/). The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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.

4.   Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the  NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new  award if such costs: 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 award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see the NIH Grants Policy Statement at http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her/their Commons User ID(s) in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS 398 Research Training Program Plan Component Sections

The Research Career Development Program Plan must be uploaded using the PHS398 Research Training Program Plan Section. Supplementary Institutional Career Development Program Application Instructions

Page limitations of the Research Career Development Program Plan component must be followed as outlined in the SF424 (R&R) Application Guide, Section 8, with exceptions noted below.

While each section of the Research Training Program Plan (Institutional Research Career Development Program)  component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Training Program Plan (Institutional Career Development Program) component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide (MS Word or PDF) are to be followed, with the following requirements for KM1 applications:

Research & Related Project/Performance Site Locations Component

Indicate where the career development program described in the Research and Career Development Plans will be conducted. Include collaborating sites, if appropriate.

If multiple sites are involved in the institutional career development program, the applicant institution must be the primary site for the program. A justification must be included for sites other than the applicant institution in the program narrative.   

Research and Related Other Project Information Component

Item 7. Project Summary/Abstract: (Do not exceed 1 page): Provide an abstract of the entire application, including the long-term goals and objectives of the program, key elements of the career development plan, and brief descriptions of planned research projects. Include the rationale and design of the program, the planned duration and projected number of scholars, including their levels (i.e., predoctoral, postdoctoral, faculty).

Item 8. Project Narrative: Using no more than two or three sentences, describe the relevance of this institutional career development program to public health. In this section, use plain language that can be understood by a general, lay audience.

Item 9. Bibliography & References Cited: This section is limited to one page. This item should be used only to cite references supporting the need, rationale, and approach for the institutional career development program described in the PHS 398 Research Training Program Plan.  Note that the Literature Cited section is captured in this section (unlike the placement in the PHS 398). Do not include lists of publications of project directors, mentors and scholars in this section, as this information will be included in the biosketches.  Each reference must include names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication.  When citing articles that fall under the Public Access Policy, provide the NIH Manuscript Submission reference number or the PubMed Central (PMC) reference number for each article. If the PMCID is not yet available, indicate "PMC Journal - In Process."

Item 10. Facilities & Other Resources: Describe the institutional environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program.

Item 11. Other Attachments: Include documents requested in this FOA considered as “other attachments.”

Senior/Key Person Profile(s) Component

The PD/PI: The PD/PI must be registered in the eRA Commons and be assigned the PI role within the Commons. Follow the instructions in Part I.2 which provides information regarding required registration in the eRA Commons.

Key Personnel must include the PD/PI (or multiple PDs/PIs, if applicable) as well as any other key persons, involved in developing, implementing, directing, monitoring, evaluating, etc., who are integral to and have key roles in the proposed institutional research career development program.

See Section 4.5 of the Grants.gov Application Guide SF424 (R&R) http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf

Complete the Profile for the PD/PI according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R) (http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf).

If multiple PD/PIs are proposed, explain in the Program Plan your rationale for how this will facilitate program administration. If your application involves Multiple PD/PIs, follow the directions in Section 4.5 to designate the Contact PI and to assign the PD/PI role to other Senior/Key Persons. Additionally, the application must include a Multi-PD/PI Leadership Plan.

Complete the Profiles for Other Senior/Key Persons according to instructions in Section 4.5 of the Grants.gov Application Guide SF424 (R&R) (http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf).

The PD(s)/PI(s), applicable faculty, and any other individuals whose contributions are critical to the development, management, and execution of the Institutional Career Development Program Plan in a substantive, measurable way (whether or not salaries are reimbursed) should be identified as Senior/Key Persons. These would include the multiple PDs/PIs, if applicable, and other program staff. Since these efforts are not project related research endeavors, they should not be identified in Other Support information.

Selecting the Appropriate Budget Component

Only the R&R budget component is applicable. Instructions for completing the R&R Budget Component are provided below. The R&R Budget component includes three separate data entry screens (1) Sections A and B; (2) Sections C through E; and (3) Sections F through K. Applicants must complete a separate detailed budget for each year of support requested.

R&R Budget Component Research & Related Budget: Complete for each budget period requested.

A.    Budget Justification: provide a detailed justification for each category for which funds are requested. For Section F, itemize each category of support costs per scholar and justify. Provide an explanation for all scholar research development costs in the Budget Justification. 

Completing PHS398 Components

Applicants for this KM1 funding opportunity should follow specific instructions in the FOA for “Completing PHS 398 Components.”

Cover Letter Component

Not Applicable for this KM1.

Cover Page Supplement Component

The PD/PI should complete this section as directed in the SF424 (R&R) Application Guide.

Research Training Plan Component (KM1 Research Career Development Program Plan)

Do Not use the SF424 (R&R) Research Component Page.

KM1 institutional research career development programs should refer to the SF 424 (R&R) Application Guide, Section 8, “Supplemental Instructions to the SF424 (R&R) for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) Application (“T” Series),” and follow 8.7 Research Training Program Plan Component format for inclusion of information in the application. Note that there are page limits for certain sections (items 2. Background – 5 Plan for Instruction in the Responsible Conduct of Research) collectively, may not exceed 25 pages).

The following should be included as PDF attachments describing the Institutional Research Career Development Program Plan (see also Section 2.3.2 Creating PDFs for Text Attachments).

The PD(s)/PI(s) must change the title (item 2) to “Research Career Development Program Plan” and provided in PDF attachments items 1 through 12, item14, and if applicable item 15 providing the following information:

  1. Introduction to Application: Not applicable for NEW applications
  2. Background: Provide the rationale for the proposed program, relevant background history, and the need for the career development program proposed. Indicate how the proposed program will foster the research careers of selected individuals. Summarize the research career development activities of the major participating unit(s) and department(s) represented in the proposed program. Include the names and roles of participating faculty members planned to contribute to the program.
  3. Career Development Program Plan:
    1. Program Administration: Describe the PD(s)/PI(s) qualifications for providing leadership of the program, including relevant scientific background, current research areas, and experience fostering career development research experiences for potential highly trained researchers. Indicate the Program Director's percent effort in the proposed program.

                                          i.    Describe the administrative structure of the program and the distribution of responsibilities within it, including the means by which the program director will obtain continuing advice with respect to the operation of the program.

                                         ii.    If multiple PDs/PIs are proposed, explain in this section your rationale for how this will facilitate program administration. In addition, you must complete Section 8.10 Multiple-PD/PI Leadership Plan.

    1. Program Faculty: Describe each faculty member's research that is relevant to the program and indicate how selected scholars will participate in the research. Describe the extent to which participating faculty members plan to cooperate, interacte, and collaborate in the program, including plans for joint publications and joint sponsorship of scholars’ research.
    2. Proposed Career Development Program: Describe the career development program. State the doctoral level and number of planned scholars. Describe any course work and research opportunities, the extent to which scholars will participate directly in research, and the planned duration of the program.

                                          i.    Indicate how the individual disciplinary and/or departmental components of the program are integrated and coordinated and how they will relate to an individual scholar's experience. Describe how each scholar's program will be guided, and how the scholar's performance will be monitored and evaluated.

    d.     Program Evaluation: The application must describe an evaluation plan to review and determine the quality and effectiveness of the career development program.  This should include plans to obtain feedback from current and former scholars to help identify weaknesses in the program and to provide suggestions for program improvements, as well as plans for assessing the curriculum, career development activities, and scholars’ career development and progression, including degree completion (if applicable), publications, and subsequent positions. 

    1. Scholar Candidates. Describe: recruitment plans, including the sources and available pool of scholar candidates; the qualifications of prospective scholars; the criteria and procedures by which scholars will be selected; and the number of number of scholar positions requested.

                                          i.    Save this information in a single file in a location you remember. Click “Add Attachment,” browse to where you saved the file, select the file, and then click Open.

  1. Recruitment and Retention Plan to Enhance Diversity: Follow the instructional information in 8.7.4 ending with the paragraph that starts “New applications.”
  2. Plan for Instruction in the Responsible Conduct of Research: Follow the instructional information in 8.7.5, substituting the work “scholar” for “trainee.”
  3. Progress Report: Not applicable.
  4. Human Subjects: Follow the instructions in 8.7, substituting “scholar” for “trainee,” “Institutional Research Career Development Award” for “training Grant Award,” and “career development” for “training” program.
  5. Vertebrate Animals: Same as 7. above.
  6. Select Agent Research: Same as 7. above.
  7. Multiple PD/PI Leadership Plan: Same as 7. above.
  8. Consortium and Contractual Arrangements: Describe, if applicable.
  9. Participating Faculty Biosketches: Describe, if applicable. Each biographical sketch is limited to two pages. The number of publications cited in each biosketch is limited to ten or fewer items. Individuals should cite their most relevant publications and those that highlight the significance of past accomplishments.
  10. Data tables: Not Applicable.
  11. Letters of Support: Provide the sponsoring institution’s letter of commitment and support (see Section III.3.).

15. Appendix: Not Applicable.

Although many of the sections of this application are separate PDF attachments, page limitations referenced in the instructions and/or funding opportunity announcement must still be followed. Agency validations will include checks for page limits (and use of appropriate font). Some accommodation will be made for sections that, when combined, must fit within a specified limitation.

Text attachments should be generated using word processing software and then converted to PDF using PDF generating software. Avoid scanning text attachments to convert to PDF since that causes problems for the agency handling the application. In addition, be sure to save files with descriptive file names.

Separate Attachments

While each section of the Institutional Career Development Program Plan needs to eventually be uploaded separately, applicants are encouraged to construct the Institutional Research Career Development Program Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. In this way the applicant can better monitor formatting requirements such as page limits. When validating for page limits, the eRA Commons will not count the white space created by breaking the text into separate files for uploading.

When attaching a PDF document to the actual forms, please note you are attaching an actual document, not just pointing to the location of an externally stored document. Therefore, if you revise the document after it has been attached, you must delete the previous attachment and then reattach the revised document to the application form. Use the “View Attachment” button to determine if the correct version has been attached.

Appendix Materials

Not applicable.

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: Regardless of the amount requested, investigators are expected to include a 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.

The proposed sharing plan, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual non-competing progress reports will include assessment of the dissemination practice by the grantee. The adequacy of the resources sharing plan and any related data sharing plans (if applicable) will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., “Reporting.”

(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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by Center for Scientific Review in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.

As part of the initial merit review, all applications will:

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

Overall Impact: Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the institutional research career development  program to exert a sustained, powerful influence on the activities involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the proposed program).

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

1.    Mentored Career Development Program Plan and Environment

2.    Program Director(s)/Principal Investigator(s) (PD/PIs)

3.    Mentors

4.    Candidate Scholars

5.    Training Record

Institutional mentored career development program grant applications submitted in response to this funding opportunity announcement should be characterized by responsiveness to the FOA. Applicants are strongly encouraged to contact NIH program staff for current information about targeted priorities and policies before preparing an application (see Section VII).

Mentored Career Development Plan and Environment:

Program Director(s)/Principal Investigator(s) (PD/PI or PDs/PIs):

Mentors:

Candidate Scholars:

Training Record: This criterion evaluates the past research training record of the designated mentors.

Additional Review Criteria

As applicable for the program proposed, reviewers will consider the following additional items in the determination of scientific merit, but will not give separate scores for these items.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects; 2) adequacy of protection against risks; 3) potential benefits to the subjects and others; 4) importance of the knowledge to be gained; and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials.

Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals: If applicable, the committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards: Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations 

As applicable for the program proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Diversity Recruitment and Retention Plan: Peer reviewers will separately evaluate the diversity recruitment and retention plan after the overall score has been determined.  Reviewers will examine the strategies to be used in the recruitment and retention of individuals from underrepresented racial and ethnic groups, individuals with disabilities, and individuals from socially, culturally, economically, and/or educationally disadvantaged backgrounds. The review panel’s evaluation will be included in an administrative note in the summary statement. If the diversity recruitment and retention plan is judged to be unacceptable, funding will be withheld until a revised plan (and report) that addresses the deficiencies is received. Staff within the relevant IC, with guidance from the appropriate national advisory committee or council, will determine whether amended plans and reports submitted after the initial review are acceptable.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address five Instructional Components (Format, Subject Matter, Faculty Participation, Duration and Frequency), taking into account the characteristics of institutional programs, detailed in NOT-OD-10-019. Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.  Applications with unacceptable plans will not be funded until the applicant provides an acceptable, revised plan.

Select Agents Research: Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans:

When relevant, reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

Budget and Period Support: Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed institutional career development program and the number of proposed scholars.

Selection Process
The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities

Change of Institution: The institutional career development program may not be transferred from one institution to another.

Change of Program: Awards are made for a specific program under the guidance and leadership of a particular PD/PI. A change in any of these parameters requires prior approval by the responsible program officer in the NIH funding component. A rationale must be provided for any proposed changes in the aims of the original, peer-reviewed program. If the new program does not satisfy this requirement, the award will be terminated.

Change of PD/PI: If change of the PD/PI is necessary, support of the award is not automatic but may be continued with prior written approval by the NIH funding component, provided that the following conditions are met. The current PD/PI or the grantee institution must submit a written request for the change, signed by the appropriate institutional business official, to the responsible program officer of the NIH funding component that describes the reasons for the change. The Biographical Sketch of the proposed PD/PI, including a complete listing of active research grant support, must be provided. The information in the request must establish that the goals of the original peer-reviewed institutional career development program will remain unchanged under the direction of the new PD/PI and that the new PD/PI has the appropriate research and administrative expertise to lead the program. This request must be submitted sufficiently in advance of the requested effective date to allow the necessary time for review.

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Funds budgeted in a KM1 component that are freed as a result of a career award change may be rebudgeted to support a new Scholar who meets the eligibility criteria specified in the FOA and the selection criteria specified in the application. The Grants Management Specialist and the Program Officer of the award must be notified within thirty days of the change of supported scholars and new appointment form must be provided.

Termination: When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Grant Award must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. Complete applications with detailed budgets and progress reports are required annually. KM1 awards are NOT subject to the streamlined non-competing application process (SNAP).

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

The Progress Report should provide information on the development and implementation of the proposed career development program (including training and education in the responsible conduct of research), any modifications to the career development program as originally proposed, details about the applicant pool and the participating scholars including their career level(s), gender, and racial/ethnic backgrounds (if applicable), updates on the evaluation of the program (if applicable), and a list of any publications and/or other materials arising from the program.

This report should provide information about changes in the Program, a summary of any ongoing evaluation results , a summary report from the Program Advisory Committee (including information about newly selected candidates, if applicable), and a description of the research and career progress of each candidate. An overview of each scholar's research accomplishments and goals for the coming year should be clearly stated. These Annual Progress Reports will be closely monitored by NIH staff to ensure that the grant is achieving the goals of the program and to confirm that the institution is continuing to meet its goal of recruiting promising investigators, and facilitating their career development.

Examples:

Scholar Selection Requirements: The institution must submit a completed Statement of Appointment (PHS Form 2271) for each scholar selected or returning to the KM1 program. This form must be submitted to the awarding IC at or before the start of each scholar’s appointment or re-appointment. When applicable, a notarized statement verifying possession of permanent residency documentation must be submitted with the Statement of Appointment (PHS Form 2271). Forms may be found on the NIH Website at http://grants.nih.gov/grants/forms.htm.

If registered in the NIH eRA Commons, grantees may submit the PHS 2271 data electronically using the xTrain application. More information on xTrain is available at https://commons.era.gov/commons/.

3.A. Additional Reporting Requirements

Financial Status Report (FSR): An annual FSR is required and must be submitted within 90 days of the end of each budget period. Continuation support will not be provided until the required form is submitted and accepted. When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of the CER career development program. Accordingly, recipients of CER Mentored Career Development support are hereby notified that they may be contacted after completion of this award for periodic updates on various aspects of program development, implementation, and other information helpful in evaluating the impact of this program.

Publication and Sharing of Research Results: Investigators are encouraged to submit reports of their findings for publication to the journals of their choice. For each publication that results from this award, NIH support should be acknowledged by a footnote in language similar to the following: “This project was supported by NIH grant number ________.  Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.”

Final Reports: A final progress report, invention statement, and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section VII. Agency Contacts

This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application[1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist.1 This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

[1] Formal application includes the preliminary application and letter of intent phases of the program.

For additional information, go to http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf.

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:

Ming Lei, Ph.D.
Chief, Cancer Training Branch
Center for Cancer Training
National Cancer Institute
National Institutes of Health
6116 Executive Boulevard, Suite 700
Rockville, MD 20852
Tel:   301-496-8580
Fax:  301-402-4472
Email: leim@mail.nih.gov

Partap S. Khalsa, D.C., Ph.D.
Division of Extramural Research
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475 (for express couriers use 20817)
Telephone: (301) 594-3462
Fax: (301) 480-1587
Email: khalsap@mail.nih.gov

Rosemarie Filart MD, MPH, MBA
Division for Clinical Research Resources
National Center for Research Resources
National Institutes of Health
One Democracy Plaza
6701 Democracy Boulevard, MSC 4874
Bethesda, Maryland 20892-4874
Email: filartr@mail.nih.gov

Sidney M. Stahl, PhD
Chief, Individual Behavioral Processes Branch
Division of Behavioral and Social Research
National Institute on Aging/NIH
7201 Wisconsin Avenue, #533
Bethesda, MD  20892-2292
Telephone:  301/402-4156
Fax:       301/402-0051
Email:    Sidney_Stahl@nih.gov

Raye Z. Litten, Ph.D.
Division of Treatment Recovery and Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 2041
Bethesda, MD 20892-9304
For express mail, use Rockville, MD 20852
Telephone: (301) 443-0636
Fax: (301) 443-8774
Email: rlitten@mail.nih.gov

Patricia Haggerty, Ph.D.
Associate Director, Operations Infrastructure
Office of the Director, Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive, Room 2139
Bethesda, MD 20892-7610
Telephone: (301) 451-2615
Fax: (301) 402-0369
Email: haggertp@niaid.nih.gov

Laura K. Moen, Ph.D.
Director, Division of Extramural Research Activities
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 594-2463
Fax: (301) 480-1284
E-mail: moenl@mail.nih.gov

Christine M Colvis, Ph.D.
National Institute on Drug Abuse (NIDA)
Neuro Science Center, 5261
6001 Executive Boulevard, MSC 9581
Rockville, MD 20892
Telephone: 301-443-6480
Email: ccolvis@nida.nih.gov

Kevin S. Hardwick, DDS, MPH
Chief, Research Training and Career Development Branch
National Institute of Dental and Craniofacial Research (NIDCR)
6701 Democracy Boulevard
Room 690, MSC 4878    
Bethesda, MD  20892-4878 (Courier 20817)
Telephone: 301-594-2765
Fax: 301-402-7033
email: hardwick@mail.nih.gov

Tracy L. Rankin, Ph.D.
Division of Kidney, Urologic, and Hematologic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 623
Bethesda, MD  20892-5458
Telephone:  (301) 594-4748
Fax:  (301) 480-3510
Email:  tr128b@nih.gov

Deborah Hirtz, M.D.
Clinical Trials Group Science Leader, Office of Clinical Research
National Institute of Neurological Disorders and Stroke (NINDS)
6001 Executive Boulevard, Rm. 2212  MSC 9520
Bethesda, Maryland  20892-9531
Telephone: 301-496-5821
Fax: 301-480-1080
E-mail: dh83f@nih.gov

Dr. Joan Wasserman, Dr.PH
Program Director, Office of Extramural Activities
National Institute of Nursing Research (NINR)
6701 Democracy Boulevard, Suite 710
One Democracy Plaza
Bethesda, MD 20892-4870
Telephone: (301) 594-5971
Fax: (301) 480-8260
Email: wassermanje@mail.nih.gov 

Valerie Florance, Ph.D.
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892-
Telephone: (301) 496-4621
Fax: (301) 402-2952
Email: florancev@mail.nih.gov

2. Peer Review Contacts:

Kate Bent, Ph.D.
Healthcare Delivery and Methodologies IRG
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 3160
Bethesda, MD 20892
Telephone: (301) 435-0695
Email: bentkn@csr.nih.gov

3. Financial or Grants Management Contacts:

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-8634
Fax: (301) 496-8601
E-mail: wolfreyc@mail.nih.gov

George Tucker, M.B.A.
Chief Grants Management Officer
National Center for Complementary and Alternative Medicine (NCCAM)
6707 Democracy Boulevard, Suite 401, MSC 5475
Bethesda, MD 20892-5475 (for express couriers use 20817)
Telephone: (301) 594-9102
Fax: (301) 480-3504
Email: gt35v@nih.gov

Linda Whipp
Grants Management Officer
Grants Management Branch
National Institute on Aging/NIH
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892 -2292
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: Linda.Whipp@nih.gov

Judy Fox
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
5635 Fishers Lane, Room 3023
Bethesda, MD 20892-9304
For express mail, use Rockville, MD 20852 (omit MSC 9304)
Telephone: (301) 443-4704
Email: jfox@mail.nih.gov

Julie Waugh
Grants Management Specialist
Grants Management Program
DEA, NIAID, NIH, DHHS
6700B Rockledge Drive Room 2239
Bethesda, MD  20892
Telephone:  301-451-7381
Email: WaughJ@niaid.nih.gov

Carol Alderson
Grants Management Branch
National Institute on Drug Abuse (NIDA)
6001 Executive Boulevard, MSC 9541
Rockville, MD 20892-9541
Telephone: 301-594-5614
Fax: 301-594-6849
Email: aldersoc@nida.nih.gov

Dede Rutberg
Lead Grants Management Specialist
National Institute of Dental
and Craniofacial Research (NIDCR)
6701 Democracy Boulevard.
Room 656, MSC 4878
Bethesda, MD  20892-4878 (Courier 20817)
Telephone: 301-594-4798
Fax: 301-480-3562
Email: rutbergd@mail.nih.gov

Carey M. Beckley
Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Boulevard, Room 725
Bethesda, MD 20892-5456 (use 20817 for express mail)
Telephone: (301) 594-8833
Fax (301) 594-9523
Email: beckleyc@mail.nih.gov

Ms. Tijuanna DeCoster, MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Grants Management Officer
Division of Extramural Research
Neuroscience Center
6001 Executive Boulevard, Room 3258
Bethesda, MD  20892
Telephone: 301-496-9531
Fax: 301-402-0219
E-mail: Tijuanna.DeCoster@ninds.nih.gov

Kelli Oster
Grants Specialist, Office of Grants and Contracts Management
National Institute of Nursing Research
Bethesda, MD  20784
Telephone: (301) 594-2177
FAX: (301) 451-5651
Email: Osterk@mail.nih.gov

Dwight Mowery
Chief, Grants Management Division
NLM Extramural Programs
6705 Rockledge Drive
Rockledge 1, Suite 301
Bethesda, MD 20892-
Telephone: (301) 496-4221
Fax: (301) 402-0421
Email:moweryd@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf.

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); and 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 (see the 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.

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

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

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

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from: 1) currently funded NIH research projects; or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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. The National Research Service Award (T32) component is supported under the authorization of Section 487 of the Public Health Service Act as amended (42 USC 288) and under Federal Regulations 42 CFR 66. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for 2 years to the research. For further information, please see http://www.lrp.nih.gov/.


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