Limited Competition: Growing Great Ideas: Research Education Course in Entrepreneurship and Product Development for Researchers Studying Drug Use, Drug Misuse, and Drug Addiction (UE5 Clinical Trial Not Allowed) is sponsored by National Institute on Drug Abuse (NIDA). Supports educational courses in entrepreneurship and product development for researchers focusing on drug use and addiction.

RFA-DA-27-007: Limited Competition: Growing Great Ideas: Research Education Course in Entrepreneurship and Product Development for Researchers Studying Drug Use, Drug Misuse, and Drug Addiction (UE5 Clinical Trial Not Allowed) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) Funding Opportunity Title Limited Competition: Growing Great Ideas: Research Education Course in Entrepreneurship and Product Development for Researchers Studying Drug Use, Drug Misuse, and Drug Addiction (UE5 Clinical Trial Not Allowed) UE5 Education Projects - Cooperative Agreements Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information.

In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. This NOFO seeks to establish a course to equip researchers studying drug use, drug misuse, and drug addiction with the skills, knowledge, and practical tools needed to translate their scientific discoveries into impactful real world solutions.

The course is envisioned to focus on building capacity in product development, entrepreneurship, and innovation pathways so participants can more effectively move biomedical ideas from early research toward implementation, or commercialization.

By combining structured training, mentorship, and hands-on experience, the course is envisioned to accelerate the development of biomedical products that address the complex challenges of drug use, drug misuse, and drug addiction, while fostering an interdisciplinary community of investigators prepared to navigate the scientific, regulatory, and business aspects of this unique research field.

To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on: Courses for Skills Development Curriculum or Methods Development Specifically, Curriculum Development involves the design or refinement of a customized curriculum in biomedical entrepreneurship, and product development for researchers studying drug use, drug misuse, and drug addiction, and Courses for Skills Development involve implementation of education program or short courses, including outreach strategy and networking infrastructure.

Eligible institutions must have established entrepreneurship education programs with demonstrated capacity to deliver integrated curriculum for researchers studying drug use, drug misuse, and drug addiction. The Principal Investigator must be from the school of business or entrepreneurship, with multidisciplinary collaboration strongly encouraged.

Funding Opportunity Announcement Goal(s) To support basic, clinical, translational, and implementation research in the field of substance use. To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS. To support research training and research scientist development.

Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization. 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO). Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review. There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners.

You must use one of these submission options to access the application forms for this opportunity. Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.

gov and eRA Commons to track your application. Check with your institutional officials regarding availability. Use Grants.

gov Workspace to prepare and submit your application and eRA Commons to track your application. Part 1. Overview Information Part 2.

Full Text of Announcement Section I. Funding Opportunity Description Section II. Award Information Other Award Budget 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 is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III.

Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. Drug use, drug misuse, and drug addiction continue to create a profound public health and economic burden in the United States.

Despite major scientific advances supported by the National Institute on Drug Abuse (NIDA), many promising discoveries do not progress into practical tools, treatments, or technologies that can be used in real world settings. This gap between research and impact persists in part because biomedical products in addiction science face unique scientific, clinical, and commercial challenges.

Researchers often lack formal training in product development, regulatory strategy, commercialization, and other early stage decisions that determine whether an idea can ultimately reach patients and communities. As a result, many innovations stall before they can be translated into meaningful solutions.

To address these barriers, NIDA created the Growing Great Ideas (GGI) program to provide researchers with structured training in biomedical entrepreneurship and early product development. Since 2017, the program has equipped hundreds of investigators with the skills needed to identify unmet needs, evaluate innovation opportunities, and advance early stage concepts toward viable biomedical products.

Participants have gone on to launch companies, secure follow-on funding, and continue developing technologies that address drug use, drug misuse, and drug addiction. The program has also strengthened the national research community by fostering a shared translational mindset and building networks of scientists, educators, and innovators committed to advancing addiction-related biomedical solutions.

This NOFO seeks to sustain and expand this successful training model. NIDA invites applications from institutions capable of developing and delivering a high quality, multidisciplinary curriculum that prepares researchers to engage in early stage translational science and product development relevant to drug use, drug misuse, and drug addiction.

The goal is to ensure that new cohorts of investigators gain the entrepreneurial skills necessary to move promising ideas toward real world impact. Applicant institutions are expected to: Develop or refine a tailored curriculum in biomedical entrepreneurship and product development that addresses the scientific, regulatory, clinical, and market considerations specific to drug addiction-related biomedical product development.

Deliver this curriculum through structured education programs or short courses that provide researchers with foundational skills, practical tools, and opportunities to initiate early translational and product development activities.

Applications Not Responsive to this NOFO The following types of applications are not responsive to this NOFO and will not be reviewed: Applications that propose research objectives that are not aligned with the mission of the participating ICs Applications that propose a clinical trial and only align with the mission of an IC that does not support clinical trials under this NOFO, including; See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI. 2 for additional information about the substantial involvement for this NOFO.

Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trial(s).

Note: Applications may propose activities involving human subjects that are not deemed clinical trials. Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NIDA intends to commit $350,000 in FY2027 to fund one award.

Applicants may request up to $325,000 in direct costs per year. The maximum project period is 5 years. The first year may be devoted to curriculum development and planning, with courses held annually thereafter.

Other Award Budget Information Individuals designing, directing, and implementing the research education program may request salary and fringe benefits appropriate for the person months devoted to the program. Salaries requested may not exceed the levels commensurate with the institution's policy for similar positions and may not exceed the congressionally mandated cap.

(If mentoring interactions and other activities with participants are considered a regular part of an individual's academic duties, then any costs associated with the mentoring and other interactions with participants are not allowable costs from grant funds). Participants may be compensated for participation in activities specifically required by the proposed research education program, if sufficiently justified.

Participant costs must be itemized in the proposed budget. Allowable participant costs depend on the educational level/career status of the individuals to be selected to participate in the program. While generally not an allowable cost, with strong justification, participants in the research education program may receive per diem unless such costs are furnished as part of the registration fee.

Participants may also receive funds to defray partial tuition and other education-related expenses. Expenses for foreign travel must be exceptionally well justified.

Individuals supported by NIH training and career development mechanisms (K, T, or F awards) may receive, and indeed are encouraged to receive, educational experiences supported by an R25 program, as participants, but may not receive salary or stipend supplementation from a research education program.

Because the R25 program is not intended as a substitute for an NRSA institutional training program (e.g.,T32), costs to support full-time participants (supported for 40 hours/week for a continuous, 12-month period) are not allowable. Other Program-Related Expenses Consultant costs, equipment, supplies, travel for key persons, and other program-related expenses may be included in the proposed budget.

These expenses must be justified as specifically required by the proposed program and must not duplicate items generally available at the applicant institution. The cost of travel and housing must be covered for all the eligible participants and should be included as part of the budget in the grant application.

Indirect Costs (also known as Facilities & Administrative [F&A] Costs) are reimbursed at 8% of modified total direct costs (exclusive of tuition and fees, expenditures for equipment and consortium costs in excess of $25,000), rather than on the basis of a negotiated rate agreement. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) Applicant institutions must have an established and well-recognized business and/or entrepreneurship teaching program, as well as demonstrated capacity and commitment to adapting and delivering an integrated curriculum for researchers studying drug use, drug misuse, and drug addiction.

The sponsoring institution must assure support for the proposed program. Appropriate institutional commitment to the program includes the provision of adequate staff, facilities, and educational resources that can contribute to the planned program. Institutions with existing Ruth L.

Kirschstein National Research Service Award (NRSA) institutional training grants (e.g., T32) or other Federally funded training programs may apply for a research education grant provided that the proposed educational experiences are distinct from those training programs receiving federal support.

In many cases, it is anticipated that the proposed research education program will complement ongoing research training occurring at the applicant institution. Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement , are not allowed. Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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 possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2. 3.

9. 2 Electronically Submitted Applications for additional information. System for Award Management (SAM) – 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. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM. gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registration; all registrations must be in place by time of submission. 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 SAM registration in order to complete the Grants. gov registration.

Program 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. All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID.

For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide .

The PD/PI should be an established investigator in the scientific area in which the application is targeted and capable of providing both administrative and scientific leadership to the development and implementation of the proposed program. The PD/PI will be expected to monitor and assess the program and submit all documents and reports as required.

The Principal Investigator must be a faculty member of the school of business or entrepreneurship of the applicant institution. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the 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 (A1) application. 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 NIH Grants Policy Statement 2. 3.

9. 4 Similar, Essentially Identical, or Identical Applications ) The Principal Investigator must be a faculty member of the school of business or entrepreneurship of the applicant institution.

The program faculty should consist of experts with various backgrounds (e.g., biomedical product development, regulatory, reimbursement, entrepreneurship) and should have research expertise and experience relevant to the proposed program, and demonstrate a history of, or the potential for, their intended roles in the program.

The faculty must be committed to continuing their involvement throughout the total period that the participants are engaged in this award. Because this UE5 program is intended to facilitate the transition of the participants to entrepreneurship and primarily to the NIDA small business program, the participants must be U.S. citizens or permanent residents and have not received previous small business grant funding.

The expected primary program participants are researchers studying drug use, drug misuse, and drug addiction interested in translating scientific knowledge and discoveries into biomedical product development (e.g., pharmacotherapies, medical devices, digital wellness applications). The participants should be interested in launching a small business company or currently working in a for-profit corporation.

Individuals employed by not-for-profit or non-profit organizations and who are not interested in transitioning to a for-profit corporation are excluded as participants. Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. 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 instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed in this Notice of Funding Opportunity to do otherwise (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ).

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions will not be reviewed. All page limitations described in the How to Apply - Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply - Application Guide and should be used for preparing an application to this NOFO. Follow all instructions provided in the How to Apply - Application Guide . SF424(R&R) Project/Performance Site Locations Follow all instructions provided in the How to Apply - Application Guide .

SF424(R&R) Other Project Information Component Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications: Facilities & Other Resources. Describe the educational 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.

List all thematically related sources of support for research training and education following the format for Current and Pending (Other) Support. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

SF424(R&R) Senior/Key Person Profile Expanded Follow all instructions provided in the How to Apply - Application Guide . Follow all instructions provided in the How to Apply - Application Guide with the following additional modifications: Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

Use the section on Participant Support Costs to include all allowable categories of funds requested to support participants in the program. PHS 398 Cover Page Supplement Follow all instructions provided in the How to Apply - Application Guide .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Research Strategy section must be used to upload the Research Education Program Plan , which must include the following components described below: Proposed Research Education Program Program Director/Principal Investigator Institutional Environment and Commitment Plan for Instruction in the Responsible Conduct of Research Research Education Program Plan Proposed Research Education Program.

While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support.

When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. As a reminder, applicants may choose to address one or more of the activities listed in Section I. Funding Opportunity Description.

Proposed research plans must describe the following components: 1. Curriculum Development Design or refinement of a customized curriculum in biomedical entrepreneurship, and product development specifically tailored for researchers studying drug use, drug misuse, and drug addiction interested in translating their research into commercial products (e.g., pharmacotherapies, medical devices, digital wellness applications).

Accessibility Requirements: The course should be designed to accommodate program participants with wide-ranging expertise and training levels, ensuring accessibility across career stages and disciplinary backgrounds. Program Focus.

The program should train researchers studying drug use, drug misuse, and drug addiction, including NIDA-funded investigators, to: (1) understand the market value of their research inventions; (2) develop early-stage biomedical technologies; and (3) advance technologies from the research laboratory to the commercial marketplace. Core Curriculum Content.

The curriculum should address the following critical competency areas, with special emphasis on challenges in the early stages of product development: Opportunity Recognition and Evaluation - Recognizing whether a research idea represents a genuine product development opportunity and critically evaluating the commercial potential of technologies.

Stakeholder Understanding and Customer Discovery - Understanding end-users and purchasers of biomedical technology and the distinctions between them; conducting customer discovery; developing regulatory and reimbursement strategies.

Intellectual Property and Commercialization Pathways - Protecting intellectual property (IP) and understanding commercialization options for biomedical technology (e.g., licensing through university technology transfer offices, establishing a startup). Venture Formation and Team Building - Establishing a small business for biomedical products and assembling a qualified, multidisciplinary team.

Funding and Business Sustainability - Identifying and securing sources of capital (e.g., NIDA small business programs, angel investors, venture capital, corporate venture capital) and sustaining business operations. Market Analysis and Strategy - Conducting market evaluation and developing viable commercialization pathways. Instructional Approaches.

The curriculum may employ multiple delivery formats, including reading materials, videos, exercises, lectures, and case studies.

The curriculum should incorporate experiential learning approaches such as 1) case studies specific for drug use, drug misuse, or drug addiction, 2) one-on-one consultations with faculty experts, 3) meetings with individuals with lived experience of drug use, drug misuse, or drug addiction, and 4) site visits to gain insights into target markets and end-user needs.

The curriculum should enable participants to develop compelling pitches for their proposed technologies and to articulate clear value propositions that address real-world problems, critical barriers, or unmet needs in the field of drug use, drug misuse, or drug addiction. 2.

Courses for Skills Development A plan for implementing the curriculum through education programs or short courses, including outreach strategies, participant engagement and selection, and opportunities for networking and mentorship. Outreach and Recruitment Strategy: Applications must propose a comprehensive national outreach strategy targeting researchers studying drug use, drug misuse and drug addiction across the United States.

The strategy must describe specific approaches to identify, engage, and recruit participants from various institutional types, career stages, and geographic locations. Recruitment methods may include dissemination through NIDA and NIH communication channels, professional networks, academic institutions, entrepreneurship programs, and relevant scientific and translational research communities.

Engagement with Entrepreneurial Community: The program must provide opportunities for participants to engage with the biomedical entrepreneurial community, including successful technology entrepreneurs, investors, venture capitalists, and regulatory experts, and must offer mechanisms for ongoing training and collaboration beyond the initial course.

Participant Selection: Selection will be conducted by the Program Director/Principal Investigator in collaboration with NIDA using publicly documented selection criteria and standardized scoring rubric. The selection criteria should emphasize alignment with NIDA goals, applicant's demonstrated interest in biomedical entrepreneurship and product development, and readiness to benefit from intensive training.

Cohort Size and Composition: The recruitment plan must target an annual cohort of at least 25 NIDA-sponsored participants. Maximum cohort size will be determined by available institutional resources. After enrolling all NIDA-sponsored participants, additional non-NIDA-sponsored participants may be included.

The recruitment strategy must actively target both academic settings and non-academic settings (e.g., industry, clinical practice), to ensure various perspectives and expertise. The applicant must propose a mitigation plan to be implemented if recruitment falls below 20 NIDA supported participants prior to the start of the program. Digital Networking Platform.

Applicants should include a detailed plan to create and maintain a digital networking platform that connects program participants, alumni, faculty, and the broader biomedical community. The platform should: Utilize existing, off-the-shelf technologies or services. Foster ongoing exchanges about insights, trends, and developments in biomedical product development and entrepreneurship.

Facilitate collaboration, knowledge sharing, and peer networking. The plan should demonstrate both how the platform will be developed initially and how it will be sustained throughout the project period and beyond. Course Access and Fees.

The course must be provided at no cost to NIDA-sponsored participants selected by the Principal Investigator in collaboration with NIDA. Applicants may propose mechanisms to allow additional participants to attend at their own expense as non-NIDA-sponsored participants, provided this does not compromise the core program objectives or participant experience. Delivery Format and Timeline.

A face-to-face, in-person component is required to ensure the most effective learning and networking opportunities. The recommended length of the in-person component is five days. Additional online programming may be proposed to extend learning, provide preparatory content, or offer follow-up support.

The first project year may be devoted to curriculum development and planning, with courses to be held annually thereafter. Program Director/Principal Investigator. Describe arrangements for administration of the program.

Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs, their leadership approach, and governance appropriate for the planned project.

Program Faculty. The Principal Investigator must be a member of the school of business or entrepreneurship of the applicant institution. The faculty should be multidisciplinary and could consist of experts from the schools of business, entrepreneurship, medicine, engineering, pharmacy, and sciences.

The faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program.

The selection process and selection criteria for program participation should be clearly described. Identify the career levels for which the proposed program is planned. Institutional Environment and Commitment.

Describe any additional aspects of the Institutional Environment and Commitment not addressed under "Facilities & Other Resources" or the required "Institutional Commitment Letter of Support," described below. Appropriate institutional commitment should include the provision of adequate staff, facilities, and educational resources that can contribute to the planned research education program.

This section should not duplicate information provided elsewhere. Plan for Instruction 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).

The plan must address the five required instructional components outlined in the NIH policy: 1) Format - the required format of instruction. (A face-to-face in-person component is necessary. A plan with a hybrid of in-person and online training is acceptable.

A plan with only online instruction is not acceptable; 2) Subject Matter - the breadth of subject matter (e.g., conflict of interest, authorship, data management, human subjects, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction – instruction must occur during each career stage and at least once every four years.

See also NOT-OD-10-019 . The plan should be appropriate and reasonable for the nature and duration of the proposed program. For Renewal (Type 2) applications: Describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan.

All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application. Applications lacking a plan for instruction in responsible conduct of research will not be reviewed. Evaluation Plan.

Applications must include a plan for evaluating the activities supported by the award. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives.

Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and