Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

NIH Basic Behavioral and Social Science Opportunity Network (OppNet; http://oppnet.nih.gov/) and its member institutes, centers and offices:
Fogarty International Center (http://www.fic.nih.gov/)
National Cancer Institute (NCI) (http://www.cancer.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI) (http://www.genome.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://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.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 on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Library of Medicine (NLM) (http://www.nlm.nih.gov/)
Office of AIDS Research (OAR) (http://www.oar.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)
Office of Disease Prevention (ODP) (http://prevention.nih.gov/)
Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/)

Funding Opportunity Title

NIH Basic Behavioral and Social Science Opportunity Network (OppNet) Short-term Mentored Career Development Awards in the Basic Behavioral and Social Sciences for Mid-career and Senior Investigators (K18)

Activity Code

K18 Career Enhancement Award

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DE-11-003

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestics Assistance (CFDA) Number(s)

93.121

FOA Purpose

This NIH Funding Opportunity Announcement (FOA), issued by the NIH Basic Behavioral and Social Science Opportunity Network [OppNet] solicits applications for short-term mentored career development (K18) awards in the basic behavioral and social sciences research (b-BSSR) from three months to one year in duration. The program targets established, mid-career and senior investigators, to support their development of research capability in b-BSSR. Two categories of candidates are targeted: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research who seek training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of basic-BSSR into their research programs. The intent of this FOA is to provide candidates with protected time to achieve a shift in the focus of their research direction in the basic behavioral and social sciences, or to substantially enrich a current b-BSSR research program through the introduction of tools, theories or approaches from another discipline or area of science; it is not intended as a substitute for research project support. This FOA is sponsored by the National Institutes of Health (NIH) Basic Behavioral and Social Science Opportunity Network ( OppNet ). OppNet strongly encourages investigators to consult NIH-OBSSR’s definitions related to b-BSSR for OppNet-related FOAs.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

December 24, 2010

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

January 24, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

April/May 2011

Advisory Council Review

August 2011

Earliest Start Date(s)

September, 2011

Expiration Date

January 25, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, especially Supplemental Instructions to the SF424 (R&R) for Preparing an Individual Research Career Development Award (CDA) Application ( K Series) except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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 Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This FOA, issued by the NIH Basic Behavioral and Social Science Opportunity Network (OppNet), invites applications for short-term mentored career development (K18) awards of up to 1 year duration, aimed at established, mid-career and senior investigators who seek an intense, mentored career development experience which will substantially improve their ability to pursue future research in the basic behavioral and social sciences. The intent of this FOA is to provide candidates with protected time to achieve a shift in the focus of their research direction in the basic behavioral and socials sciences, or to substantially enrich a current b-BSSR research program through the introduction of tools, theories or approaches from another discipline or area of science. Two categories of candidates are targeted: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research seeking training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of b-BSSR into their research programs. Illustrative examples include but are not limited to: a psychologist seeking training in econometrics in order to expand a research program on basic mechanisms of decision-making; a clinical epidemiologist seeking training in social network dynamics to better understand the spread of health behaviors in populations; a demographer seeking training in psychoneuroimmunology in order to understand the mechanisms whereby sociodemographic factors get under the skin to impact health disparities; an ethologist seeking training in neuroscience to facilitate examination of how patterns of maternal care result in epigenetic changes in brain regions and brain structure.

This FOA is not intended as a substitute for research project support. It is expected that either the candidate or the mentor has sufficient research funding to support the proposed project. It is not a requirement that the candidate or the proposed mentor receive their primary funding through the NIH.

Candidates must hold the rank of Associate Professor or Professor, or their equivalent in non-academic settings, and propose a mentored career development and career enhancement program, along with a research project, to be conducted in a different department within their home institution or different institutional setting from the location where they hold their primary appointment. The host mentoring laboratory/research program is expected to demonstrate appropriate research and resources to provide a new research direction for the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism. Candidates may propose an experience at a location which is geographically and physically separate from the candidate organization but this separation is not required or preferred. Departmental and School administrators for the Departments and Schools of the candidates should describe any institutional commitments the candidate will maintain during the period of the research career enhancement and any special provisions which will be made to provide appropriate release time. In particular, the administration should demonstrate their commitment to the candidate’s separation from current responsibilities during the sabbatical period.

Candidates should also describe any clinical, administrative, research, or grant related commitments they intend to maintain during the period of the award, and arrangements which will be made to provide protected release time. Candidates may propose a career development program of a minimum of three months and up to one year in duration and are expected to devote between 25% and 50% of total annual effort to this career enhancement program

About OppNet:

OppNet is a trans-NIH initiative that funds activities that build the collective body of knowledge about the nature of behavior and social systems, and that deepen our understanding of basic mechanisms of behavioral and social processes. All 24 NIH Institutes and Centers that fund research and four Program Offices within the NIH Office of the Director (ICOs) co-fund and co-manage OppNet. All OppNet initiatives invite investigators to propose innovative research that will advance a targeted domain of basic social and behavioral sciences and produce knowledge and/or tools of potential relevance to multiple domains of health- and life course-related research. Applicants should understand that the NIH Institute or Center (IC) that made this FOA available to the public is not necessarily the NIH IC that ultimately will manage a funded OppNet project. For more information about OppNet and all its funding opportunities, visit http://oppnet.nih.gov.

OppNet uses the NIH definition of (b-BSSR, http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspxto determine application responsiveness. Consequently, OppNet strongly encourages prospective investigators to consult this definition, OppNet’s answers to frequently asked questions about b-BSSR (http://oppnet.nih.gov/about-faqs.asp), and answers to frequently asked questions regarding this specific FOA. See this FOA’s Scientific Contacts section for individuals with expertise in the research subject matter and the OppNet initiative

Background:

The National Institutes of Health (NIH) Basic Behavioral and Social Sciences Opportunity Network (OppNet) has identified a gap in career development funding opportunities for mid-career and senior level investigators. Specifically, a program is needed that provides the flexibility to allow these established investigators the support and protected time to obtain the necessary training and research experience to expand their already productive research programs to explore new directions in basic behavioral and social sciences research (b-BSSR).

Research Scope:

The priority of OppNet is to build upon the existing body of knowledge about the nature of behavior and social systems by supporting initiatives that focus on basic mechanisms of behavior and social processes that are relevant to the missions and public health challenges addressed by multiple NIH ICOs. Basic behavioral and social science research includes research on behavioral and social processes, interactions between biology, behavior and social processes, and research on methodology and measurement as described below.

Examples of research topics include, but are not limited to, the following:

(A). Research on behavioral and social processes

Research on behavioral and social processes involves the study of human or animal functioning at the level of the individual, small group, institution, organization, community, or population. At the individual level, this research may involve the study of behavioral factors such as cognition, memory, language, perception, personality, emotion, motivation, and others. At higher levels of aggregation, it includes the study of social variables such as the structure and dynamics of small groups (e.g. couples, families, work groups, etc.); institutions and organizations (e.g. schools, religious organizations, etc.); communities (defined by geography or common interest); and larger demographic, political, economic, and cultural systems. Research on behavioral and social processes also includes the study of the interactions within and between these two levels of aggregation, such as the influence of sociocultural factors on cognitive processes or emotional responses. Finally, this research also includes the study of environmental factors (both natural and human created) such as climate, noise, environmental hazards, residential and other built environments and their effects on behavioral and social functioning.

(B). Interactions between biology, behavior and social processes

The study of the interactions of biological factors with behavioral or social variables and how they affect each other (i.e., the study of bi-directional multilevel relationships). Examples of research topics include, but are not limited to, the following:

(C). Research on methodology and measurement in the behavioral and social sciences

Research on methodology and measurement encompasses the development of new approaches to research design, data collection, measurement, and data analysis. This research is designed to develop research tools that could be used in the behavioral and social sciences or in biomedical research or their interaction.

Examples of research topics include, but are not limited to, the following:

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon funds available, and the submission of a sufficient number of meritorious applications.
OppNet and partner components intend to commit an estimated total of up to $1.5 million to capacity building grants in FY2011 which includes but is not limited to this FOA.

Award Budget

Award budgets are composed of salary and other program-related expenses, as described below.

Award Project Period

The total project period may not exceed 1 year.

Other Award Budget Information
Salary

NIH will contribute a minimum of 25% up to a maximum of 50% of full-time professional effort per year toward the salary of the career award recipient.

The total salary requested must be based on a full-time staff appointment. The salary must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned.

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 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 of salary must not require extra duties or responsibilities that would interfere with the purpose of the career award.

Other Program-Related Expenses

NIH will contribute up to $20,000 in direct costs per year toward the research development costs of the award recipient, which must be justified and consistent with the stage of development of the candidate and the proportion of time to be spent in research or career development activities.

Salary for mentors is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs.

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

Section III. Eligibility Information

1. Eligible Applicants
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her mentor and organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Multiple Principal Investigators are not allowed.

This award is intended for mid-career and senior investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor, or the equivalent in nonacademic settings, who have established records of independent research who seek an intense, mentored career development experience which will substantially improve their ability to pursue future research in the basic behavioral and social sciences. Targeted candidates include: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research who seek training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of b-BSSR into their research programs.

Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are well-qualified and willing to sponsor the short term research career development experience. It is expected that the proposed career development plan will represent a novel extension of the research of the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism

By the time of award, the individual must be a citizen or a non-citizen national of the United States or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or for non-U.S. citizen/permanent residents, requirements are described below.

Award recipients may hold concurrent NIH research project grant support as a PD/PI or subproject director, provided the aggregate effort does not exceed one-hundred percent.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed. An individual may not have two or more competing NIH career development applications pending review concurrently.

Candidates may only submit one application in response this FOA.

Level of Effort

At the time of award, the candidate must have a full-time appointment at the academic institution that is the applicant institution. Candidates who have VA appointments may not consider part of the VA effort toward satisfying the full time requirement at the applicant institution. Candidates with VA appointments should contact the staff person in the relevant Institute or Center prior to preparing an application to discuss their eligibility. Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in minimum required percent effort, which will be considered on a case-by-case basis. Details on this policy are provided in NOT-OD-09-036.

Mentor

Before submitting the application, the candidate must identify a mentor who will supervise the proposed training and research experience. The mentor should be an active investigator in the area of the proposed research training and be committed both to the career development of the candidate and to the direct supervision of the candidate’s research. The mentor must document the availability of sufficient research support and facilities for high-quality research. The mentor, or a member of the mentoring team, should have a successful track record of mentoring. Candidates are encouraged to identify more than one mentor, i.e., a mentoring team, if this is deemed advantageous for providing expert advice in all aspects of the research and training program. In such cases, one individual must be identified as the principal mentor who will coordinate the candidate’s research. The candidate must work with the mentor(s) in preparing the application.

The mentor should describe the research training plan for the candidate (coordinated with the candidate’s research strategy). The mentor and any co-mentors are also expected to provide an assessment of the candidate’s qualifications and potential for a research career. The research environment and the availability and quality of needed research facilities and research resources (e.g., equipment, laboratory space, computer time, available research support, etc.) must also be described. The description should include items such as classes, seminars, and opportunities for interaction with other groups and scientists. Training in career skills, e.g. grant-writing and making effective presentations, is strongly encouraged.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow the instructions in the SF 424 (R&R) to determine which components are required.

Page Limitations

All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed .

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Candidate’s Background (Component of Candidate Information)

Career Goals and Objectives (Component of Candidate Information)

Career Development/Training Activities During Award Period (Component of Candidate Information)

Statements by Mentor, Co-mentor(s), Consultants, Contributors (Component of Statements of Support)

Description of Institutional Environment (Component of Environment and Institutional Commitment to the Candidate)

Institutional Commitment to the Candidate’s Research Career Development (Component of Environment and Institutional Commitment to the Candidate)

Research Strategy (Component of Research Plan)

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

No supplemental/update information will be accepted.

Letters of Reference

Letters of reference are not required. However, the mentor should submit a letter outlining his/her support of the application.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.

Salary support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the sponsoring institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the applicant department. The candidate is required to devote between 25% and 50% of his or her total annual effort to this career enhancement program for a period of three to twelve months.

Research Development Support: The research development support costs may not exceed $20,000 and must be justified and be consistent with the project proposed and the proportion of time spent in research and career enhancement activities. Salary for ancillary personnel support, such as mentors, secretarial, and administrative assistants is not allowed.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by members of the OppNet K18 working group, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers should provide their assessment of the likelihood for the candidate to maintain a strong research program, taking into consideration the criteria below in determining the overall impact/priority score.

Scored Review Criteria

Reviewers will consider each of the 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.

Candidate

Describe the candidate’s commitment to a health- and lifecourse-related research scientist career with a focus on expected contributions in the basic behavioral and social sciences.
Discuss the candidate’s research efforts and accomplishments in health- and lifecourse-related research to this point as an independent investigator, including publications, prior research interests and experience and history of research support.

Discuss the candidate’s objectives and long term career plans, and how these relate to the proposed activities in the career enhancement award, with a focus on how the proposed work will advance understanding of basic mechanisms of behavioral and social processes that will have broad relevance to the NIH mission.

Present evidence of the candidate’s potential to augment his/her research career through this career enhancement award.

Include a statement that the candidate will commit 25-50% effort to the short-term career enhancement program and related activities. Include a description of the candidate’s professional responsibilities and show their relationship to the proposed activities of the career enhancement award.

Provide evidence of the candidate’s ability to interact and collaborate with other scientists.

Career Development Plan/ Career Goals & Objectives/ Plan to Provide Mentoring

Provide details of the career enhancement plan, tailoring it to the candidate’s goals, prior experience and career level, as well as the intent of the K18 award.

Provide a systematic plan for progression of research experiences for the period of the award and beyond to exploit the career enhancement activities provided by the K18, emphasizing the potential to advance knowledge about the nature of behavior and social systems or to deepen our understanding of basic mechanisms of behavioral and social processes.

Justify the need for further career enhancement in relation to the candidate s future research goals.

The candidate and the mentor are jointly responsible for the preparation of the career enhancement plan. A timeline for the phasing of the training and research phases of the K18 should be included.

Research Plan

A small scale/pilot research project in the basic behavioral and social sciences that is consistent with the goals of this FOA and the objectives of the career enhancement should be described. The project must include research in the basic behavioral and social sciences, and may take the form of a small scale or pilot project which would expand the research scope of a currently funded project(s).

Organize the research plan as indicated in the Form 398, following instructions for Specific Aims, Research Strategy, (Significance, Innovation, Approach) , to the extent possible and appropriate. The candidate should consult with the mentor regarding the development of this section.

Mentor(s), Co-Mentor(s), Consultant(s), Collaborator(s)

The mentor should be recognized as an accomplished investigator in his or her scientific domain, and have a track record of success in training independent investigators. Are the mentor's research qualifications in the area of the proposed research appropriate? Do(es) the mentor(s) adequately address the candidate’s potential and his/her strengths and areas of improvement? Is there adequate description of the quality and extent of the mentor’s proposed role in providing guidance and advice to the candidate? Is the mentor’s description of the elements of the research activities adequate? Is there evidence of the mentor s, consultant s, collaborator’s previous experience in fostering the development of independent investigators? Is there evidence of previous research productivity and peer-reviewed support? Is active/pending support for the proposed research project appropriate and adequate? Where feasible, women, individuals from diverse racial and ethnic groups and individuals with disabilities should be involved as mentors to serve as role models.

Candidates must name a primary mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. Candidates may also nominate co-mentors, as appropriate to the goals of the program.

The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a mentoring plan describing the content and nature of the mentoring that will occur during the proposed award period; and (3) The ongoing research activities and research grant support of the mentor, along with how the research activities of the candidate will dovetail with these.

Similar information must be provided by any co-mentor, if more than one mentor is proposed. The respective areas of expertise and responsibility of the primary mentor and co-mentor(s) should be described.

Signed statements should be provided by each consultant/collaborator confirming his/her role in the project.

Environment & Institutional Commitment to the Candidate

Describe the resources and facilities that will be made available to the candidate.

Describe how the research environment of the host laboratory/research program and institution is particularly suited for the advanced development of the candidate’s research career and the pursuit of the proposed research plan. A Resources format page is required for the host laboratory/research program.

The candidate’s institution must provide a clear and unambiguous statement of assurance that during the active period of the K18 award the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award, and that he/she will be able to devote a minimum of 25-50% total annual effort to the research career enhancement program in b-BSSR. The institutional statement should also indicate what, if any, duties or commitments the candidate will continue to maintain, and how any grant related responsibilities will be delegated.

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Resubmissions are not permitted in response to this FOA.

Renewals

Renewals are not permitted in response to this FOA.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider 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.

Training in the Responsible Conduct of Research

Taking into account the circumstances of the candidate, including the more senior level of experience of candidates for this award, the reviewers will address the following questions. Does the plan satisfactorily address the format of instruction, e.g. lectures, coursework, and/or real-time discussion groups that the candidate will participate in? Do plans include a sufficiently broad selection of subject matter, such as conflict of interest, authorship, data management, human subjects and animal use, laboratory safety? Do the plans adequately describe the candidate’s role in the participation in instruction in RCR? Does the plan meet the minimum requirements for RCR, i.e., eight contact hours of instruction every four years?. Plans and past record will be rated as acceptable or unacceptable, and the summary statement will provide the consensus rating of the review committee. Applications rated unacceptable will not be funded until the applicant provides an acceptable, revised plan.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications will:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

2. Administrative and National Policy Requirements

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

Transition to the Independent Phase

n/a.

Evaluation

In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement. The Additional Instructions for Preparing Continuation Career Development Award (CDA) Progress Reports, must be followed. The Mentor’s Report must include an annual evaluation statement of the candidate’s progress.

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

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center (IC) program requirements for this FOA, prospective applications MUST consult the Table of IC-Specific Information, Requirements, and Staff Contacts, to make sure that their application is responsive to the requirements of one of the participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

David Clark, Dr.PH
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4814
Email: David.Clark2@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Diana Rutberg
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: rutbergd@nidcr.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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