NIH Cancer Research Education Grants (R25 Clinical Trial Not Allowed)

NIH Cancer Research Education Grants (R25 Clinical Trial Not Allowed) is sponsored by NIH NCI. Supports educational activities that enhance the diversity of the cancer research workforce.

Expired PAR-21-278: Cancer Research Education Grants Program - Courses for Skills Development (R25 Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Cancer Research Education Grants Program - Courses for Skills Development (R25 Clinical Trial Not Allowed) NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available.

See Notice NOT-OD-22-018 . September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022.

See Notice NOT-OD-21-169 . August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170 April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel.

See Notice NOT-OD-21-109 NOT-OD-19-109 - Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020.

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-21-279 - Cancer Research Education Grants Program - Research Experiences (R25 Clinical Trial Not Allowed), R25 Education Projects PAR-21-065 - Cancer Research Education Grants Program - Curriculum or Methods Development (R25 Clinical Trial Not Allowed) See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on: Courses for Skills Development Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients, in order to advance the NCI mission .

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) Standard dates apply. The first standard application due date for this FOA is September 25. 2021.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). 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) Standard AIDS dates apply. The first AIDS application due date for this FOA is January 7, 2022. All applications are due 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 the listed date(s). 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. New Date September 29, 2023 per issuance of PAR-23-276 .

(Original Expiration Date: September 08, 2024) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from 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 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 The NIH Research Education Program (R25) supports research educational activities that complement other formal training programs in the mission areas of the NIH Institutes and Centers.

The overarching goals of the NIH R25 program are to: (1) complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs; (2) encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research; (3) help recruit individuals with specific specialty or disciplinary backgrounds to research careers in biomedical, behavioral and clinical sciences; and (4) foster a better understanding of biomedical, behavioral and clinical research and its implications.

The overarching goal of this R25 program is to support educational activities that complement and/or enhance the training of a workforce to meet the nation’s biomedical, behavioral and clinical research needs.

Applications are encouraged that propose innovative, state-of-the-art programs that address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients, in order to advance the NCI mission .

To accomplish the stated over-arching goal, this FOA will support creative educational activities with a primary focus on: Courses for Skills Development: The proposed course for skills development should provide innovative, state-of-the-art, evidence-based cancer research education that is derived from biomedical, behavioral and clinical cancer research findings. All instructional activities must be completed within a 12-month period.

Activities to evaluate the professional impact of the course on the participants may continue indefinitely, as feasible. The format of the course may involve a traditional in-person approach, online activities, or a hybrid of both approaches. The course must be offered during each year that R25 support is requested.

If the time required to develop the course would preclude this during the first year of support, applicants should instead consider applying for the companion funding opportunity, PAR-21-065 , Cancer Research Education Grants Program - Curriculum or Methods Development (R25).

Non-Responsive Applications Applications with one or more of the characteristics listed below will be considered non-responsive and will not be reviewed: Proposed course is not cancer-focused. Proposed course activities are not completed within a 12-month period. Proposed course is not offered each year that R25 support is requested.

Proposed course is an adaptation of a current or previous NCI R25-funded course that focuses on a different target population. Proposed Evaluation Plan describes collecting data from individuals other than course participants, such as their supervisors or patients, which is not considered appropriate for an education program and may require IRB approval at participants' institutions.

Research education programs may complement ongoing research training and education occurring at the applicant institution, but the proposed educational experiences must be distinct from those training and education programs currently receiving Federal support. R25 programs may augment institutional research training programs (e.g., T32, T90) but cannot be used to replace or circumvent Ruth L.

Kirschstein National Research Service Award (NRSA) programs. See Section VIII. Other 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. Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Only those application types listed here are allowed for this FOA. Not Allowed: Only accepting applications that do not propose clinical trial(s). Need 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. The maximum budget is $300,000 direct costs/year. The budget request for a given application needs to be adequately justified and reflect the actual needs of the proposed project.

Yearly fluctuations in the project workload should be reflected in the requested budget. The scope of the proposed project should determine the project period. The maximum project period is 5 years.

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). Salary support for the PD/PI (or combination of multiple PD(s)/PI(s)) may not exceed 3. 0 person months (25% full-time) effort per year.

The total Direct Costs for all personnel and consultants involved in the project may not exceed $150,000 per year. All personnel costs must be adequately justified and take into consideration yearly fluctuations in required effort. Participants are those individuals who are registered in the proposed course.

Participant costs must be itemized in the Participant/Trainee Support Costs (Section E) of the requested budget and sufficient justification must be provided. Participant costs are restricted and cannot be rebudgeted to non-participant costs. Allowable participant costs include: Round-trip travel to and from the R25 course site for non-local participants.

Note that travel funds may be requested for a limited number of individuals residing in a foreign country to participate in the course, but such costs must be adequately justified. A budget of up to $500 per participant for course-related expenses, such as books, course materials, tuition, continuing education units (CEUs), etc., can be requested as a lump sum.

A subsistence (or per diem) allowance of up to $300 per day of the course may be provided per participant for partial support of housing, meals, and local transportation.

Unallowable participant costs include: Salary and fringe benefits Gifts, such as hats, t-shirts, key rings, tote bags, etc. Social functions that include food and beverages outside of a major course-related event, such as a presentation by a keynote speaker Dues to professional organizations 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. Note that consultants may include individuals serving in a variety of roles, such as faculty, lecturers, advisors, etc., and that consultant costs are included in the $150,000 limit per year for total Direct Costs for all personnel and consultants involved in the project.

See Personnel Costs section above for details. Tuition and fee remission for personnel are not allowed. 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 FOA. Section III.

Eligibility Information 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 Institutions (AANAPISIs) 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) 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 Recognized) U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) 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. Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 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 possible.

The NIH 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 submission. Dun and Bradstreet 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) 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. NATO 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 to register in eRA Commons.

Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration, but 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 DUNS number and 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. 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 his/her organization to develop an application for support.

Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

The PD/PI should be an established investigator at the rank of Associate Professor or above (or equivalent) 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.

PD(s)/PI(s) with a currently funded NCI R25 award may submit an additional application to this FOA only if a new and innovative course that is distinctly different from their currently funded project is proposed. 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. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

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 NOT-OD-11-101 ). Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as preceptors/mentors. Mentors should have research expertise and experience relevant to the proposed program.

Mentors must be committed to continue their involvement throughout the total period of the mentee’s participation in this award.

Participants in R25 programs supported through this FOA should represent a regional/national pool that extends beyond the applicant institution(s) and may include biomedical researchers; health care providers; medical, dental, nursing, and other health professional students; graduate students; and members of the lay community involved in the dissemination of health information.

Unless strongly justified on the basis of exceptional relevance to NIH, research education programs should be used primarily for the education of U.S. citizens and permanent residents. 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 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 instructions in the Research (R) 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 will not be reviewed.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023 a Data Management and Sharing Plan is not applicable for this FOA. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

Follow all instructions provided in the SF424 (R&R) Application Guide. SF424(R&R) Project/Performance Site Locations Follow all instructions provided in the SF424 (R&R) Application Guide. SF424(R&R) Other Project Information Component Follow all instructions provided in the SF424 (R&R) 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 Support.

SF424(R&R) Senior/Key Person Profile Expanded Follow all instructions provided in the SF424 (R&R) Application Guide. Follow all instructions provided in the SF424 (R&R) 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/Trainee 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 SF424 (R&R) Application Guide.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The 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 Diversity Recruitment Plan 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. The description should include the educational and/or career level(s) of the planned participants.

Clearly state the goals and objectives of the proposed course for skills development and how they address the cause, diagnosis, prevention, or treatment of cancer, rehabilitation from cancer, or the continuing care of cancer patients and the families of cancer patients. Provide the underlying rationale and evidence supporting the need for the course.

Describe the importance of the course in meeting the needs of the intended participants and the likelihood of improving their skills. Describe innovative aspects and explain the significance of the course beyond the applicant institution to a regional or national level. Describe the educational concepts and principles on which the course is based and the overall strategy, methodology, and analyses to be employed.

Provide support for the feasibility of the proposed activities and describe the benchmarks to be used to assess the success of the course. Consider potential problems that may be encountered and describe alternative strategies that could be employed.

If applicable, explain how the scope of the proposed course extends beyond that of adapting of any of the current or previously supported NCI R25 awards of the PI(s)/PD(s) to focus on a different target population. For Renewals, describe the progress made in the last funding period. Highlight positive program outcomes and describe the need for continued support in advancing the NCI mission.

Include a description of how the proposed course content and/or methodologies have been updated since the previous application. 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.

Explain how the level of effort devoted by the program leadership to the program is sufficient to ensure that the program's intended goal is accomplished. Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty.

Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles. List Program Faculty whose role is to develop, implement, direct, monitor, mentor, evaluate, consult, etc., in the proposed course as Key Personnel and provide their biographical sketches.

Describe the experience of the participating faculty in teaching and mentoring, as well as their ability to serve as good role models for the participants by virtue of their own scientific accomplishments. 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. Identify the career levels for which the proposed program is planned. Provide details about the pool of expected participants in the course and the sources of the applicant pool.

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. Where appropriate, describe any unique features of the scientific environment, subject populations, or collaborative arrangements that may be leveraged to the advantage of the proposed course.

If multiple sites are participating, describe how this will enhance the quality of the course, as well as how activities will be coordinated and effective communication maintained among the multiple sites. Recruitment Plan to Enhance Diversity ( NOT-OD-20-031 ). The applicant must provide a recruitment plan to enhance diversity.

Include outreach strategies and activities designed to recruit prospective participants from diverse backgrounds, e.g., those from groups described in the Notice of NIH's Interest in Diversity . Describe the specific efforts to be undertaken by the program and how the proposed plan reflects past experiences in recruiting individuals from underrepresented groups.

Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period, including successful and unsuccessful recruitment strategies. Applications lacking a diversity recruitment plan will not be reviewed. 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).

For programs involving participants for more than 6 months on a full-time basis, the plan must address the five required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, 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 programs involving participants for 6 months or less on a full-time basis, see the subsection on "Short-term training and research education programs" within the section on "Special Considerations by Type of Award" in NOT-OD-10-019.

Renewal (Type 2) applications must, in addition, 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. A timeline for conducting the evaluation must be described.

Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements. Evaluation data should be appropriate for an education program. For example, surveys completed by participants and/or publicly available information about participants would be appropriate.

However, proposing to collect data from supervisors or patients of course participants to demonstrate a benefit of the education program could require IRB approval at participants' institutions and thus would not be appropriate for an education program. A letter of institutional commitment must be attached as part of Letters of Support (see section above: Institutional Environment and Commitment."

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide. When relevant, applications are expected to include a software dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. There is no prescribed single license for software produced.

However, the software dissemination plan should address, as appropriate, the following goals: Software source code should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories. Users should be permitted to modify the code and share their modifications with others.

The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Only limited Appendix materials are allowed. Follow the instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects Involved?

on the R&R Other Project Information form, you must