Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent)

Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent) is sponsored by National Institutes of Health (NIH). This grant focuses on career enhancement awards for individuals in mobile and wireless health technology and data analytics, particularly at the intersection of behavioral and social sciences and STEM disciplines.

Expired PAR-18-881: Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Institute on Minority Health and Health Disparities ( NIMHD ) National Center for Complementary and Integrative Health ( NCCIH ) National Cancer Institute ( NCI ) National Institute on Aging ( NIA ) All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers.

The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research ( OBSSR ) Office of Research on Women's Health ( ORWH ) Funding Opportunity Title Short-term Mentored Career Enhancement Awards in Mobile and Wireless Health Technology and Data Analytics: Cross-Training at the intersection of Behavioral and Social Sciences and STEM Disciplines (K18 Independent Clinical Trial Not Allowed) K18 Career Enhancement Award March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available.

See Notice NOT-OD-20-077 . January 22, 2020 - Additional Guidance on the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research. See Notice NOT-OD-20-058 .

Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128 .

July 22, 2019 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020. See Notice NOT-OD-19-109 . November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Career Development Award Applications.

See Notice NOT-OD-18-229 . October 29, 2018 - Notice of NIA Participation in PAR-18-881. See Notice NOT-AG-18-040 .

August 23, 2018 - Notice of NCI Participation in PAR-18-881. See Notice NOT-CA-18-099 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-18-882 , K18 Career Enhancement Award Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 213, 93. 279, 93.

242, 93. 307, 93. 313, 93.

398, 93. 866 Funding Opportunity Purpose The goal of the program is to support the development of research capability in mobile and wireless health technology (e.g., wearable devices, mobile applications, electronic health records, data analytics).

Special emphasis will be given to independent behavioral and social sciences investigators who seek to train in a STEM discipline (e.g., big data analysis, computational modeling, engineering, computer science, and mathematics) or to STEM scientists who which to train in a behavioral and social science discipline.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA ( PAR-18-882 ). Open Date (Earliest Submission Date) Letter of Intent Due Date(s) July 12, 2019; July 12, 2020;, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. AIDS Application Due Date(s) July 12, 2019; July 12, 2020, by 5:00 PM local time of applicant organization.

All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

October 2019; October 2020 It is critical that applicants follow the Career Development (K) Instructions in the SF424 (R&R) Application Guide , 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.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission 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 overall goal of the NIH Research Career Development program is to help ensure that a diverse pool of highly trained scientists is available in appropriate scientific disciplines to address the Nation's biomedical, behavioral, and clinical research needs.

NIH Institutes and Centers (ICs) support a variety of mentored and non-mentored career development award programs designed to foster the transition of new investigators to research independence and to support established investigators in achieving specific objectives. Candidates should review the different career development (K) award programs to determine the best program to support their goals.

More information about Career programs may be found at the NIH Extramural Training Mechanisms website. The objective of the Career Enhancement Award for Experienced Investigators (K18) is to provide support for experienced scientists who either wish to broaden their scientific capabilities or to make changes in their research careers by acquiring new research skills or knowledge.

The purpose of this FOA is to provide such investigators with support for an intensive period of mentored research experience to acquire new research capabilities in mobile and wireless health technology and data analytics that align with research areas supported by the sponsoring NIH Institute(s)/Center(s).

Such experiences will afford candidate investigators protected time to: 1) enrich and expand their expertise and research programs through retooling in new techniques, emerging technologies, and/or scientific areas; and/or 2) redirect their research programs in new trajectories; and/or 3) catalyze research collaborations in new research directions.

Candidates will not be required to have active research grant support at the time of application. However, they will be expected to identify one or more research mentors with the relevant expertise who are established, well-qualified, and willing to sponsor the short-term research career development experience.

It is expected that this initiative will lead to new and augmented research collaborations that will be competitive for future The goal of the program is to support the development of research capability in mobile and wireless health technology (e.g., wearable devices, mobile applications, electronic health records, data analytics).

Special emphasis will be given to independent behavioral and social sciences investigators who seek to train in a STEM discipline (e.g., big data analysis, computational modeling, engineering, computer science, and mathematics) or to STEM scientists who wish to extend their career development in a behavioral and social science discipline. of research topics include, but are not limited to, the following: 1.

A behavioral or cognitive scientist proposes to extend learning in the field of computational sciences to develop modeling skills (e.g., natural language processing, artificial intelligence, text mining) to understand interactions among biological, behavioral, and social processes. 2.

An epidemiologist partners with a data scientist to learn analytic and integration methods for processing digital traces (i.e., social media, internet searches, electronic health records) of multiple individuals to identify meaningful patterns of health behavior and disease outcomes. 3.

A clinician partners with a bioinformatician to learn how to integrate electronic health record data with data obtained from other mobile and wireless health technologies to develop phenotypic profiles of disease, treatment response, and models for clinical care. 4. A social scientist partners with a data scientist to learn how to integrate analysis of text images and natural language corpora in 5.

New approaches to research design and data collection, measurement and analysis that incorporate mobile personal data into research tools that could be used in behavioral science, public health surveillance and ICs participating in this FOA may have specific interests. Applicants are strongly encouraged to contact the Scientific/Research Contact (see Section VII.

, Agency Contacts) of the IC that most closely matches their research focus to determine the IC's interest in the proposed research topic.

Examples of high interest topics for participating ICs include but Center for Complementary and Integrative Health (NCCIH) NCCIH is interested in supporting applications that propose cross-training and collaboration among complementary and integrative health (CIH) researchers and STEM researchers to facilitate integration of mHealth technologies with mind-body interventions (e.g., yoga, tai chi, meditation, mindfulness, hypnosis, manual therapies, and complex interventions such as music and art-based approaches); cross-training of CIH researchers studying mind-body approaches in a STEM discipline, or vice versa; or, enhanced training of CIH researchers studying mind-body interventions in new mHealth approaches, measurement, and analysis.

Investigators are strongly encouraged to discuss their plans with NCCIH program staff prior to submitting their application.

Institue on Drug Abuse (NIDA) NIDA encourages submission of applications proposing cross-training to facilitate the integration of social and behavioral sciences methods and theory, and methods from STEM disciplines, including advanced data analytic approaches, to investigation of use of mHealth technologies and social media data in the study of epidemiology, prevention, treatment and services related to substance use and substance use disorders.

Studies of interest include, but are not limited to: Development of algorithms to detect population-based browsing, key words in posts, etc.) to enhance behavioral data collected using more direct survey methods.

Innovative approaches to the use and analysis of "big data," elucidate substance use patterns and trends and variation across geographic Development of methods and technologies (sensors) for real-time assessments of substance use, craving, withdrawal symptoms, etc., that includes information regarding geographic location, environmental influences/cues, social interactions/cues, mood, etc., that are reliable, valid, and user-friendly.

Development of methods and technologies (sensors) to assess real-time pharmacological effects of substances (e.g. portable Breathalyzer, assessment of compounds in sweat, etc.) that are reliable, valid, and user-friendly. Development of algorithms to assess individual risk of browsing, key words in posts, increase in stress level as detected in heart rate/blood pressure/vocal pitch, etc.).

Utilization of data from above to develop apps that provide supporting messages and information to help reduce the potential of engaging in risky behaviors (e.g. encouragements, alternative activities, helpline information, automatically connect with support network, etc.).

Utilization of information from above to determine potential for overdose or other acute negative consequences or risky behaviors (e.g. unprotected sex, driving, etc.) to encourage requesting help (or automatically contacting medical assistance) or warning against potentially risky behaviors.

Institue of Mental Health (NIMH) NIMH is interested in research areas consistent with the NAMHC workgroup report " Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research " to improve early detection of mental illness and improve access, continuity, quality, equity, and value of care.

NIMH mHealth priorities include but are not limited to: assessment (e.g., experience sampling) and automated collection of behavior in natural environments (e.g., via sensors for ambient monitoring); and research that combines data collected through mHealth approaches with data from other sources (e.g., clinical history, family history, cognitive testing) to create digital/behavioral phenotypes to: Accurately infer subjective mental states (e.g. mood states, heightened risk for self-harm, cognitive/thought processes, abnormal perceptions) from objectively observable behaviors (e.g. voice/speech samples, facial movement, locomotion, GPS, social sensing, device/electronic media use Test predictive models capable of identifying individual patterns of risk or dysfunction both within individuals (over time) and across individuals (finding similar clusters of predictors across a group).

Characterize dimensions of functioning (e.g. RDOC ) and complex behaviors (e.g. social perception) among typical and patient Characterize risk trajectories across development, including indicators early in life and before symptoms manifest.

Discover brain-behavior relationships in real life settings by developing analytic/computational approaches to fuse high dimensionality data derived from mobile sensors with simultaneously recorded biological/physiology Examine and predict illness course/trajectories, including research aimed at identifying at-risk individuals for early intervention/prevention and or monitoring and pre-empting deterioration in the context of self-management or clinician-moderated monitoring.

Test and validate sensor-based or other mobile health technology-assisted approaches to measure response to therapeutic interventions, including research that examines psychometric properties, sensitivity to change and correspondence with conventional clinical assessments.

Institute on Minority Health and Health Disparities (NIMHD) NIMHD seeks to increase and maintain a strong cohort of investigators in minority health and health disparities research. Applications are accepted for all areas of research including biomedical, clinical, population health, behavioral, and social sciences.

NIMHD supports the study of many aspects of minority health and health disparities from genetic, molecular, and biologic science to clinical, behavioral, and translational research, as well as research on health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. For more information on specific areas of research please see: https://www.

nimhd. nih. gov/programs/extramural/ of Research on Women's Health (ORWH) ORWH is interested in applications that build a well-trained, diverse, and vigorous women's health research workforce, in increased engagement of female faculty and mentors in research activities in any relevant health area are highly desired.

Support for the incorporation of sex/gender differences in the design and application of mHealth technologies is also encouraged, as women currently appear to lead men when it comes to mobile technology use, with more women having smartphone health applications (apps) compared to men.

Given the rise in the number of health-related smartphone apps, especially those related to women's health, there is a clear need for a strong, scientific evidence base to ensure that these apps deliver the desired Note: This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial.

Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor. Applicants proposing a clinical trial or an ancillary clinical trial as lead investigator, should apply to the companion FOA ( PAR-18-882 ). Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Glossary and the SF424 (R&R) Application Guide provide details on these Only accepting applications that do not propose clinical trials Note: Applicants may propose to gain experience in a clinical trial led by a mentor/co-mentor as part of their research career development. help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Award budgets are composed of salary and other program-related expenses, as described below. The total project period may not exceed 2 years.

The participating NIH Institutes and Centers will contribute up to $ 80,000 per year toward the salary of the career award recipient. Further guidance on budgeting for career development salaries is provided in the SF424 (R&R) Application Guide. See also NOT-OD-17-094 The total NIH contribution to salary, however, may not exceed the legislatively mandated salary cap.

See: http://grants. nih. gov/grants/policy/salcap_summary.

htm . Other Program-Related Expenses The participating NIH Institutes and Centers will contribute $25,000 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, secretarial and administrative assistants, Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.

gov registration. Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any candidate with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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 PDs/PIs are not allowed.

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). Candidates for the K18 award must have a research or health-professional doctoral degree.

This award is intended for well-established investigators who have established records of independent, peer-reviewed Federal or private research grant funding. Applicants are not required to have active research grant support at the time of application for This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct, and each is from a The NIH will not accept duplicate or highly overlapping applications under review at the same time. An individual may not have two or more competing NIH career development applications pending review concurrently.

In addition, NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). At the time of award, the candidate must have a "full-time" appointment at the academic institution. Candidates are required to commit a minimum of 75% of full-time professional effort (i.e., a minimum of 9 person-months) to their program of career development during the mentored phase.

Candidates may engage in other duties as part of the remaining 25% of their full-time professional effort not covered by this award, as long as such duties do not interfere with or detract from the proposed career development program. 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 After the receipt of the award, adjustments to the required level of effort may be made in certain circumstances. See NOT-OD-09-036 for more details.

Before submitting the application, the candidate must identify a mentor who will supervise the proposed career development and research experience. The mentor should be an active investigator in the area of the proposed research 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. 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 career development program. In such cases, one individual must be identified as the primary mentor who will coordinate the candidate's research.

The candidate must work with the mentor(s) in preparing the application. The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate's career stage. Where feasible, women, individuals from diverse racial and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

Peer Reviewed Research Support Applicants are not required to have active research grant support at the time of application.

Institutional Environment The applicant institution must have a strong, well-established record of research and career development activities and faculty qualified to serve as mentors in biomedical, behavioral, and clinical research or in a STEM (Science, Technology, Engineering, Mathematics; e.g., engineers, computer scientists, mathematicians, etc.) discipline; and vice versa, sufficient to cross-train independent investigators.

and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the Career Development (K) 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the SF424 (R&R) Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF 424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile Expanded All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide PHS 398 Career Development Award Supplemental Form The PHS 398 Career Development Award Supplemental Form is comprised of the following sections: Other Candidate Information Mentor, Co-Mentor, Consultant, Collaborators Environment & Institutional Commitment to the Candidate Other Research Plan Sections All instructions in the SF424 (R&R) Application Guide must All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Information and Goals for Career Development Describe the candidate's commitment to a career as a health related research scientist.

Describe the candidate's research efforts and accomplishments in health related research to date as an independent investigator, including publications, prior research interests and experience, and history of research Present evidence of the candidate's potential to augment his/her research career and to ultimately advance scientific progress through this Provide evidence of the candidate's ability to interact and collaborate with other scientists, particularly those from other Career Goals and Objectives Describe the candidate's research career trajectory to date and future career goals and objectives and explain how these relate to the proposed research career development enhancement program.

Justify the need for further career enhancement in order to achieve the candidate's future research goals. Demonstrate how the proposed career enhancement program and the research, educational and mentoring resources of the sponsoring laboratory and institution will further the stated research career goals.

Candidate's Plan for Career Development/Training Activities During Award Period The candidate and the mentor are jointly responsible for the preparation of the career development plan. The candidate and mentor may propose a mentoring team.

Describe the career development plan, tailoring it to the candidate's goals, prior experience and career level, as well as to the intent Provide a systematic plan for progression of career enhancement and research experiences for the period of the award and beyond, including a timeline for the phasing of the career enhancement and research activities.

Explain how the career development plan will enhance the candidate's independent research career trajectory, including a description of any cutting-edge research skills and conceptual knowledge that will be acquired during the career award period.

Describe any clinical, administrative, teaching, mentoring or grant-related research commitments the applicant will maintain during the period of the award, and the arrangements to be made with the applicant institution and/or the host institution to ensure the requisite protected time All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: A sound research project that is consistent with the candidate's level of research development and objectives of his/her career development plan must be provided.

The research description should demonstrate the quality of the candidate's research thus far and also the novelty, significance, creativity and approach, as well as the ability of the candidate to carry out The application must also describe the relationship between the mentor's research and the candidate's proposed research plan.

Although it is not expected that the description of the research would be as detailed as an application for an investigator-initiated research grant (e.g., R01), enough information should be provided to permit an evaluation of the scientific merit of the candidate's research activities and mentored research training.

If the applicant is proposing to gain experience in a clinical trial, ancillary study to a clinical trial or a clinical trial feasibility study as part of his or her research career development, describe the relationship of the proposed research project to the clinical trial.

in the Responsible Conduct of Research All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR). See SF424 (R&R) Application Guide for instructions.

Mentor, Co-Mentor, Consultant, All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: and Statements of Mentor and Co-mentor(s) The candidate must name a primary mentor who, together with the candidate, is responsible for the planning, directing, monitoring, and executing the proposed program.

The candidate may also nominate co-mentors as appropriate to the goals of the program. The mentor should be recognized as an accomplished investigator in the proposed research area and have a track record of success in training and placing independent investigators.

The mentor should have sufficient independent research support to cover the costs of the proposed research project in excess of the allowable Include a statement that the candidate will commit at least 3 person-months of professional effort to the career development program and related career The application must include a statement from the mentor providing: 1) information on his/her research qualifications and previous experience as a research supervisor; 2) a plan that describes the nature of the supervision and mentoring that will occur during the proposed award period; Similar information must be provided by any co-mentor.

If more than one co-mentor is proposed, the respective areas of expertise and responsibility of each should be