APPLICATION GUIDELINES

Who must complete the "Introduction to Application" attachment:

An "Introduction to Application" attachment is required only if the type of application is resubmission. An introduction is not allowed for new applications.

Format:

Not to exceed one page in length.  Attach this information as a PDF file. 

Content:

Resubmission applications: See specific instructions on the content of the Introduction on the NIH's Resubmission Applications page.

Format:

Page Limit: 12 pages (for both Candidate Information and Goals for Career Development AND Research Strategy)

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Organize your attachment into three sections, following the headings and specified order below, and discuss each of the points listed below. Start each section with the appropriate section heading - Candidate's Background, Career Goals and Objectives, and Candidate's Plan for Career Development/Training Activities During Award Period.

Candidate's Background:

• Describe your past scientific history, indicating how the award fits into past and future research career development.

• If there are consistent themes or issues that have guided previous work, these should be made clear. Alternatively, if your work has changed direction, indicate the reasons for the change.

Career Goals and Objectives:

• Describe your short-term and long-term career goals.

• Justify the need for the award by describing how the career development award will enable you to develop and/or expand your research career.

• Provide your timeline and plans to apply for further additional and subsequent grant support for your research, including the specific grant mechanisms.

Candidate's Plan for Career Development/Training Activities During Award Period:

Describe a 3-year career development plan with a timeline and objectives that will advance your career goals. Present a systematic plan to obtain the necessary educational background, research experiences and skills, and mentoring necessary to launch an independent career in clinical/translational research. Describe your proposed research project.

• Describe how the educational plan you propose supplements your previous educational background and the new or enhanced research skills and knowledge you will acquire as a result of the proposed award.

• Describe any structured activities that are part of the developmental plan, such as coursework or workshops that will help you learn new techniques or develop needed professional skills.  If coursework is included, provide course numbers (if available) and descriptive titles.

• Briefly discuss each of the activities, other than research, in which you expect to participate.  

• For each activity, other than research, explain how it relates to the proposed research and to the career development plan. Include a percentage of time involvement for each activity by year, expressed in person months. For more information about calculating person months, see NIH's Frequently Asked Questions on Person Months.

• Give an outline of other projects or studies you plan to pursue over the three years of K12 funding 

• Describe why interdisciplinary approaches and mentorship are critical to your research area. Describe what you intend to learn from each proposed mentor as well as how the mentors will interact with you as a team (i.e. meeting schedule, format, etc…)

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.  Append biosketch and curriculum vitae and upload as a single PDF file.

Content:

Customize your NIH Biosketch to support this K12 application.

Your curriculum vitae should be current as of date of application submission.  Include manuscripts In Press and Submitted (no abstracts).  Include all current, pending, and previous research funding.  Include NIH Other Support form if that information is not listed in your CV.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.  

Content:

Short paragraph on how your non-professional traits, experience or background will contribute to our scholars community.

The Research Plan is a major part of the overall career development goal. It is important to relate the proposed research to the candidate's scientific career goals. Describe how the research, coupled with other developmental activities, will provide the experience, knowledge, and skills necessary to achieve the objectives of the career development plan. Also describe how the research and other developmental activities will enable the candidate to launch and conduct an independent research career or enhance an established research career.

For most types of research, the Research Plan Section should include:

• a specific hypothesis,

• a list of the specific aims and objectives that will be used to examine the hypothesis,

• a description of the methods/approaches/techniques to be used in each aim,

• a discussion of possible problems and how they will be managed, and

• alternative approaches that might be tried if the initial approaches do not work.

A K12 Research Plan is expected to be tailored to the experience level of the candidate and to allow him/her to develop the necessary skills needed for further career advancement. Reviewers will evaluate the plan accordingly. The plan should be achievable within the requested time period. Pilot or preliminary studies and routine data gathering are generally not appropriate as the sole part(s) of a K12 Research Plan.

Although candidates for mentored career development awards are expected to write the Research Plan, the mentor should review a draft of the plan and discuss it in detail with the candidate. Review by other knowledgeable colleagues is also helpful. 

Format:

Not to exceed 1 page

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will have on the research field(s) involved.

List succinctly the specific objectives of the research proposed (e.g., to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology).

Format:

Page Limit: 12 pages (for both Candidate Information and Goals for Career Development AND Research Strategy).  References do not count toward the page limit.

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Organize the Research Strategy in the specified order and use the instructions provided below. Start each section with the appropriate heading - Significance, Innovation, Approach.

Cite published experimental details.

Note: Explain the relationship between the candidate's research on the K12 and the mentor's ongoing research program.

1. Significance

• Explain the importance of the problem or critical barrier to progress that the proposed project addresses.

• Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.

• Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields.

• Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved.

2. Innovation

• Explain how the application challenges current research or clinical practice paradigms.

• Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions.

3. Approach

• Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project. Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Unless addressed separately in the Resource Sharing Plan section, include how the data will be collected, analyzed, and interpreted, as well as any resource sharing plans as appropriate. Resources and tools for rigorous experimental design can be found at the Enhancing Reproducibility through Rigor and Transparency website.

• For trials that randomize groups or deliver interventions to groups, describe how your methods for analysis and sample size are appropriate for your plans for participant assignment and intervention delivery. These methods can include a group- or cluster-randomized trial or an individually randomized group-treatment trial. Additional information is available at the Research Methods Resources webpage.

• Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.

• If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.

• Explain how relevant biological variables, such as sex, are factored into research designs and analyses for studies in vertebrate animals and humans. For example, strong justification from the scientific literature, preliminary data, or other relevant considerations, must be provided for applications proposing to study only one sex. Refer to NIH Guide Notice on Sex as a Biological Variable in NIH-funded Research for additional information.

• Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. A full discussion on the use of select agents should appear in the Select Agent Research section below.

• If research on Human Embryonic Stem Cells (hESCs) is proposed but an approved cell line from the NIH hESC Registry cannot be chosen, provide a strong justification for why an appropriate cell line cannot be chosen from the registry at this time.

As applicable, also include the following information as part of the Research Strategy, keeping within the three sections (Significance, Innovation, and Approach) listed above.

Preliminary Studies:

Include information on preliminary studies. Discuss the PD/PI's preliminary studies, data, and or experience pertinent to this application.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Briefly describe (3-5 sentences) the specific steps you will take in the first three months of the award to operationalize your research project. Please include IRB submission plans.

Format:

Not to exceed one page in length. Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

A brief description of the translational, clinical or public health impact of your research. Clearly state how a disease or group of diseases will be better diagnosed, treated or prevented, or how the successful completion of your research will improve human health.

Format:

Complete Data Science Support Plan form.  Attach this information as a PDF file. 

Content:

Using the Data Science Support Plan form, describe the level of biostatistics, methodological, or informatics support  required by the project and the amount, if any, needed to budget in the research proposal. Include name of faculty-level data scientist mentor or consultant-recommended data scientist mentor.* To be completed during consultation - handwritten is acceptable.

Instructions on identifying a data scientist mentor and instructions to connect with the CTSI Biostatistical and Analysis Center (BDAC) can be found here.

It is strongly recommended that scholars schedule or connect with their Data Scientist Mentor at the beginning of the application process to ensure a meeting occurs before the application deadline.  

Format:

Complete the budget template.  Attach this information as a PDF file. 

Content:

Use budget template for each year of the grant and provide a short justification narrative.  Any scientific or budgetary overlap with the K12  project should be explained.  Be sure to budget for required ACTS conference travel and include any costs for statistical support services. *Your salary  should not be included in the budget.  Please note, primary mentor stipends are not allowed.

Expenses should adhere to both NIH and UMN policies. 

NIH Grant Policy Statement (https://grants.nih.gov/policy/nihgps/index.htm)

-Section 7.9.1 has a selected list of items and explanation of allowability

-Section 12.8 has information on allowable and unallowable costs specific to Career Development (K) awards

UMN policy - Direct Costs on Sponsored ProjectsUMN policy (https://policy.umn.edu/research/directcosts) 

Format:

Not to exceed 1 page in length.  Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Attach a description of plans for obtaining or providing instruction in RCR. This section should document prior instruction or participation in RCR training during the applicant's current career stage (including the date instruction was last completed). This section should also propose plans to either receive instruction or provide instruction (e.g., to participate as a course lecturer) to meet the frequency requirement of RCR training (see the "For more information section" below).

The plan must address the five required instructional components outlined in the NIH Policy on Instruction in the Responsible Conduct of Research (RCR), as more fully described in the NIH Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of Research. :

1. Format: Describe 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: Describe 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: Describe the role of the mentor(s) and other faculty involvement in the instruction;

4. Duration of Instruction: Describe 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. Document any prior instruction during the applicant's current career stage, including the inclusive dates instruction was last completed.

The plan may include career stage-appropriate individualized instruction or independent scholarly activities. Instruction and activities should enhance the applicant's understanding of ethical issues related to their specific research activities and the societal impact of that research. The role of the mentor in RCR instruction must be described.

For more information:

See the NIH Grants Policy Statement, Section 12.4.1.4: Training in the Responsible Conduct of Research. 

All K12 applications should identify a primary mentor, secondary, and biostats/informatics mentor. All mentors  must provide a statement as described below, along with an NIH Biosketch, Other Support Page (if applicable), and NIH Training Table for each mentor.  The entire mentoring team can sign one statement/plan or submit separate statements/plans.  

The Training Table should list 5-10 trainees (postdoctoral students and junior faculty) the mentor has advised in the past 10 years in chronological order beginning with the most recent. 

Format:

Not to exceed 6 pages .  The page limit does not include the mentors’ biosketch, other support page, and training table. Training Table form can be here.  Append plan, statement, biosketch, other support, and training table together and upload as a single PDF file for each mentor.

Other Support Content: 

Provide information on the following items for each of the mentor’s and co-mentor’s current and pending research support relevant to the candidate’s research plan. Each mentor/co-mentor(s)’s “Current & Pending Support” attachment is limited to 3 pages.

• • • Project Number: Provide the project number. If applicable, include a code or identifier for the project.

    • Source: Identify the agency, institute, foundation, or other organization that is providing the support. Include domestic, foreign, institutional, federal, public, and private sources of support.

    • Major Goals: Provide a brief statement of the overall objectives of the project, subproject, or consortium/contractual arrangement or a description of the activity.

    • Project / Proposal State and End Dates: Indicate the inclusive dates of the project/activity as approved/proposed. For example, in the case of NIH support, provide the dates of the approved/proposed competitive segment. For in-kind contributions, provide project dates when applicable.

    • Total Award Amount: For active projects, provide the total award costs for the period of performance, including indirect costs. For example, in the case of NIH support, provide the total award costs for the competitive segment. For a pending project, provide the proposed total costs for the period of performance.

    • Do not include information on “percent effort/person months” or on “overlap.”

Content:

Each must document their role and willingness to participate in the project, and explain how they will contribute to the development of the candidate's research career. Each statement should include all of the following:

1. Describe an evaluation of the candidate's background and potential for a successful academic clinical/translational research career.

2. The plan for the candidate's training and research career development. Include information not only about research, but also about other developmental activities, such as seminars, scientific meetings, training in RCR, and presentations. Discuss expectations for publications over the entire period of the proposed project. Define what aspects of the proposed research project the candidate will be allowed to take with him/her to start their own research program.

3. The source of anticipated support for the candidate's research project for each year of the award period.

4. The nature and extent of supervision and mentoring of the candidate, and commitment to the candidate's development that will occur during the award period.

5. Agreement to complete Optimizing the Practice of Mentoring online module prior to applicant's start date.  Applicant funding is contigent on module completion.

6. The candidate's anticipated teaching load for the award period (number and types of courses or seminars), clinical responsibilities, committee and administrative assignments, and the portion of time available for research.

7. A plan for transitioning the candidate from the mentored stage of his/her career to the independent investigator stage by the end of the project period of the award. Describe the mentor's (or co-mentor's) previous experience as a mentor, including type of mentoring (e.g., graduate students, career development awardees, postdoctoral students), number of persons mentored, and career outcomes.

Note for co-mentor statements: Co-mentors must also address the nature of their role in the career development plan and how the responsibility for the candidate's development is shared with the mentor. Describe respective areas of expertise and how they will be combined to enhance the candidate's development. Also describe the nature of any resources that will be committed to this award.

Format:

Complete Mentor-Mentee Compact form.  Attach this information as a PDF file. 

Content:

Mentors and scholars will complete this compact, designed to help facilitate the discussion of expectations and goals. We also encourage you to refer to the program expectations as you work through this form. Step 1) The mentor and scholar should electronically fill out their respective columns Step 2) Set up a meeting with your scholar to discuss the compact Step 3) Work together to create a final compact Step 4) Mentor and Scholar both sign the compact.

From whom are letters of support required? From whom are letters not required?

Letters of support from collaborators, contributors, and consultants will be required for any such person who will contribute to the K12 application's proposed project in any substantive, meaningful way.   Biosketches for each collaborator/contributor are required.  Consultants are not required to submit a Biosketch. Biosketches will not count towards the page limit.

Format:

Not to exceed 6 pages.

Attach all appropriate letters of support. The letters must be appended together and uploaded as a single PDF file. See NIH's Format Attachments page.

Content:

Letters from consultants should include rates/charges for consulting services.

Applications should identify collaborators, contributors, and consultants involved with the proposed research and career development program not already included in the "Plans and Statements of Mentors" section. Letters should briefly describe their anticipated contributions and document their role and willingness to participate in the project.

Format:

Not to exceed 1 page.  Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Describe the institution's research and career development opportunities related to your area(s) of interest, including the names of key faculty members and other investigators relevant to your proposed developmental plan and capable of productive collaboration with the candidate. Indicate how the necessary facilities and other resources will be made available for both career enhancement and the research proposed in this application - refer to the Facilities and Resources description below in your "Description of Institutional Environment" attachment. Describe opportunities for intellectual interactions with other investigators, including courses offered, journal clubs, seminars, and presentations. 

Facilities and Resources Description

Describe how the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport). In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from features of the scientific environment or from unique subject populations or how studies will employ useful collaborative arrangements. 

If there are multiple performance sites, describe the resources available at each site. 

When working with biohazards and any other potentially dangerous substances, describe any special facilities and measures implemented to mitigate threats to human health and the environment. Note: Information about select agents must be described in the Research Plan, Select Agent Research.  

For early stage investigators (ESIs), describe institutional investment in the success of the investigator.  See NIH's Early Stage Investigator (ESI) Policies. Your description may include the following elements:

• resources for classes, travel, or training; 

• collegial support, such as career enrichment programs, assistance and guidance in the supervision of trainees involved with the ESI’s project, and availability of organized peer groups; 

• logistical support, such as administrative management and oversight and best practices training; 

• financial support, such as protected time for research with salary support.

Signatures:

Statement needs to be signed by a Division Head or Departmental Chair.  Electronic signatures are acceptable.

Format:

Not to exceed 1 page.  Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

The institution should provide a document on institutional letterhead that describes its commitment to the candidate and the candidate's career development, independent of the receipt of the K12. It is also essential to document the institution's commitment to the retention, development, and advancement of the candidate during the period of the award.

The "Institutional Commitment to Candidate's Research Career Development" attachment should generally document the institution's agreement to provide adequate time, support, equipment, facilities, and resources to the candidate for research and career development activities. See the list below for specific items to include in the document.

In the document describing its institutional commitment, the applicant organization must:

1. Agree to release the candidate from other duties and activities so that the candidate can devote the required percentage of time for development of a research career.

   • Commitment of at least 75 percent or nine person months of time is required.

• NIH and other PHS agencies use the concept of "person months" as a metric for determining percent of effort. For more information about calculating person months, see NIH's Frequently Asked Questions on Person Months.

2. Describe actions that will be taken to ensure that the candidate can devote the required time to research career development (e.g., reduction of the candidate's teaching load, committee and administrative assignments, and clinical or other professional activities for the current academic year). If the candidate's clinical or teaching responsibilities will be reduced, describe how this will be accommodated (e.g., hiring additional staff, reassigning staff, etc).

3. Describe the candidate's academic appointment, bearing in mind that the appointment must be full-time, and that the appointment (including all rights and privileges pertaining to full faculty status if in an academic setting) and the continuation of salary should not be contingent upon the receipt of this award.

4. Describe the proportion of time currently available for the candidate's research and what the candidate's institutional responsibilities will be if an award is made.

5. Describe how the institution will provide the candidate with appropriate office and laboratory space, equipment, and other resources (including access to clinical and/or other research populations) to carry out the proposed Research Plan.

6. Describe how the institution will be supportive of any proposed mentor(s) and/or other staff consistent with the career development plan.

Signatures:

The institutional commitment must be dated and signed by applicant’s Division Head or Departmental Chair. The signatures must appear over the signers’ name and title at the end of the statement. 

Format:

Attach this information as a PDF file.

Content:

Are human subjects involved?

Need help determining whether your application includes human subjects? Check out the NIH Research Involving Human Subjects website for information, including an Infopath Questionnaire designed to walk applicants through the decision process.  

• If "Yes," complete the Protection of Human Subjects content below.

• If "No," answer the following question(s) about the use of human specimens and/or human data.

Does the proposed research involve human specimens and/or data?

Applications involving the use of human specimens or data may not be considered to be research involving human subjects, depending on the details of the materials to be used. To help determine whether your research is classified as human subjects research, refer to the Research Involving Private Information or Biological Specimens flowchart.

• If "No," this section is not required.

• If Yes, provide an explanation of why the application does not involve human subjects research.

You must provide a justification for your claim that no human subjects are involved.

Attach the justification as a PDF file. See NIH's Format Attachments page.

This justification should include:

• • • information on who is providing the data/biological specimens and their role in the proposed research;

    • a description of the identifiers that will be associated with the human specimens and data;

    • a list of who has access to subjects' identities; and

    • information about the manner in which the privacy of research participants and confidentiality of data will be protected.

Protection of Human Subjects 

Content:

Organize your attachment into three sections, following the headings and specified order below, and discuss each of the points listed below. Start each section with the appropriate section heading - "Inclusion of Women and Minorities", "Inclusion of Children", and "Inclusion Enrollment Report."  Note that you may need to include multiple IERs for each study. Refer to the instructions for the IER below for more information.

1. Inclusion of Women and Minorities

Address the following points:

• • • Describe the planned distribution of subjects by sex/gender, race, and ethnicity.

    • Describe the rationale for selection of sex/gender, racial, and ethnic group members in terms of the scientific objectives and proposed study design. The description may include, but is not limited to, information on the population characteristics of the disease or condition under study.

    • Describe proposed outreach programs for recruiting sex/gender, racial, and ethnic group members.

    • Inclusion and Excluded Groups: Provide a reason for limiting inclusion of any group by sex/gender, race, and/or ethnicity. In general, the cost of recruiting certain groups and/or geographic location alone are not acceptable reasons for exclusion of particular groups. See the Inclusion of Women and Minorities as Participants in Research Involving Human Subjects - Policy Implementation Page for more information.

Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may have been collected as part of a different study, you must address inclusion, following the instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity of the existing dataset/resource and justify the details as appropriate to the scientific goals of the proposed study.

For more information about what is considered an existing dataset or resource for inclusion policy, see the NIH FAQs on Inclusion- Basis of Sex/Gender and Race/Ethnicity.

NIH-Defined Phase III Clinical Trials. If the proposed research includes an NIH-Defined Phase III Clinical Trial, the "Inclusion of Women, Minorities, and Children" attachment MUST address plans for how sex/gender, race, and ethnicity will be taken into consideration in the design and valid analysis of the trial. See the instructions for "Valid Analysis" and "Plans to test for Differences in Effect among Sex/gender, Racial, and/or Ethnic Groups" below.

Additional information about valid analysis is available on the NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research page.

Valid Analysis (for NIH-Defined Phase III Clinical Trials only):

Address the following issues for ensuring valid analyses:

• • • • Inclusive eligibility criteria - in general, the cost of recruiting certain groups and/or geographic location alone are not acceptable reasons for exclusion of particular groups;

      • Allocation of study participants of both sexes/genders and from different racial and/or ethnic groups to the intervention and control groups by an unbiased process such as randomization;

      • Unbiased evaluation of the outcome(s) of study participants; and

      • Use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects by sex/gender, race, and/or ethnicity, particularly if prior evidence strongly suggests that such differences exist.

Plan to Test for Differences in Effect among Sex/gender, Racial, and/or Ethnic Groups (for NIH-Defined Phase III Clinical Trials only):

Applicants also should address whether they plan to test for differences in effect among sex/gender, racial, and/or ethnic groups and why such testing is or is not appropriate.

This plan must include selection and discussion of one of the following analysis plans:

• • • • Plans to conduct analyses to detect significant differences in intervention effect among sex/gender, racial, and/or ethnic subgroups when prior studies strongly support these significant differences among one or more subgroups, or

      • Plans to include and analyze sex/gender, racial, and/or ethnic subgroups when prior studies strongly support no significant differences in intervention effect between subgroups. (Representation of sex/gender, racial, and ethnic groups is not required as subject selection criteria, but inclusion is encouraged.), or

      • Plans to conduct valid analyses of the intervention effect in sex/gender, racial, and/or ethnic subgroups (without requiring high statistical power for each subgroup) when the prior studies neither support nor negate significant differences in intervention effect among subgroups.

2. Inclusion of Individuals Across the Lifespan

For the purposes of the Inclusion of Individuals Across the Lifespan, exclusion of any specific age or age range group (e.g., children or older adults) should be justified in this section. In addition, address the following points:  

• Individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to include them. Discuss whether individuals will be excluded based on age and provide a rationale for the minimum and maximumageofstudy participants, if applicable. Additionally, if individuals will be excluded based on age, provide a scientific or ethical rationale for their exclusion. See the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects for additional information about circumstances that may justify the exclusion of individuals based on age.  

• Include a description of the expertise of the investigative team for working with individuals of the ages included, the appropriateness of the available facilities to accommodate individuals in the included age range, and how the age distribution of participants will contribute to a meaningful analysis relative to the purpose of the study. 

When children are involved in research, the policies under HHS’ 45 CFR 46, Subpart D- Additional Protections for Children Involved as Subjects in Research apply and must be addressed in the Protection of Human Subjects attachment. 

Existing Datasets or Resources. If you will use an existing dataset, resource, or samples that may have been collected as part of a different study, you must address inclusion, following the instructions above. Generally, you must provide details about the sex/gender, race, and ethnicity of the existing dataset/resource and justify the details as appropriate to the scientific goals of the proposed study. 

For more information about what is considered an existing dataset or resource for inclusion policy, see the NIH FAQs on Inclusion- Basis of Sex/Gender and Race/Ethnicity. 

For more information, see: 

• NIH Policy Implementation Page on Inclusion Across the Lifespan 

• Inclusion Across the Lifespan: Guidance for Applying the Policy infographic 

• NIH FAQs on Inclusion Across the Lifespan 

• HHS’ 45 CFR 46 Subpart D–Additional Protections for Children 

• NIH Grants Policy Statement, Section 4.1.15.7: Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects

3.  Inclusion Enrollment Report

Format: Complete the Inclusion Enrollment Form.  

Content: 

All studies must enter planned enrollment counts unless your proposed study will use only an existing dataset or resource. Planned enrollment generally means that individuals will be recruited into the study and/or that individuals have already been recruited and continue to be part of the study.

You must enter cumulative enrollment counts if your proposed study will use an existing dataset or resource.

For more information about what is considered an existing dataset or resource for inclusion policy, see the NIH FAQs on Inclusion on the Basis of Sex/Gender and Race/Ethnicity.

For more information on racial categories, see the NIH Glossary definition of Racial Categories.

For more information on ethnic categories, see the NIH Glossary definition of Ethnic Categories.

Racial Categories

American Indian/Alaska Native:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both American Indian/Alaska Native and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both American Indian/Alaska Native and Hispanic or Latino.

Asian:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Asian and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Asian and Hispanic or Latino.

Native Hawaiian or Other Pacific Islander:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Native Hawaiian or Other Pacific Islander and Hispanic or Latino.

Black or African American:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both Black or African American and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both Black or African American and Hispanic or Latino.

White:

These fields are required.

Enter the expected number of females and males (in the respective fields) who are both White and Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who are both White and Hispanic or Latino.

More than One Race:

These fields are required.

Enter the expected number of females and males (in the respective fields) who both identify with more than one racial category and are Not Hispanic or Latino. Enter the expected number of females and males (in the respective fields) who both identify with more than one racial category and are Hispanic or Latino.

Total:

The total fields at the bottom will be automatically calculated and reflect the totals of all racial categories for females, males, and individuals of unknown/not reported sex/gender who are Not Hispanic or Latino and of all racial categories for females, males, and individuals of unknown/not reported sex/gender who are Hispanic or Latino. The "Total" fields in the right column will be automatically calculated to total all individuals.

Who must complete the "Vertebrate Animals" attachment:

Include the "Vertebrate Animals" attachment if activities involving vertebrate animals are planned at any time during the proposed project at any performance site.  Note that the generation of custom antibodies constitutes an activity involving vertebrate animals.  Include an attachment if animal involvement is anticipated within the period of award but plans are indefinite.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Do not use the Vertebrate Animals section to circumvent the page limits of the Research Strategy.

Content:

If vertebrate animals are involved in the project, address each of the following criteria:

1. Description of Procedures: Provide a concise description of the proposed procedures to be used that involve vertebrate animals in the work outlined in the "Research Strategy" section. Identify the species, strains, ages, sex, and total numbers of animals by species, to be used in the proposed work. If dogs or cats are proposed, provide the source of the animals.

2. Justifications: Provide justification that the species are appropriate for the proposed research. Explain why the research goals cannot be accomplished using an alternative model (e.g. computational, human, invertebrate, in vitro).

3. Minimization of Pain and Distress: Describe the interventions, including analgesia, anesthesia, sedation, palliative care and humane endpoints that will be used to minimize discomfort, distress, pain, and injury.

Each of the criteria must be addressed. Failure to adequately address the criteria may negatively affect the application’s impact score. In addition to the 3 criteria above, you should also:

• Identify all project/performance or collaborating site(s) and describe activities of proposed research with vertebrate animals in those sites.

• Explain when and how animals are expected to be used if plans for the use of animals have not been finalized.

See the following pages for more information:

• NIH's Office of Laboratory Animal Welfare website

• NIH's Vertebrate Animals Section Worksheet

•  NIH Grants Policy Statement, Section 4.1.1: Animal Welfare Requirements (an applicable Animal Welfare Assurance will be required if the recipient institution does not have one)

Who must complete the "Select Agent Research" attachment:

Include the "Select Agent Research" attachment if your proposed activities involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any performance site.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

For more information:

Select agents are hazardous biological agents and toxins that have been identified by HHS or the U.S. Department of Agriculture (USDA) as having the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products. The Centers for Disease Control and Prevention (CDC) and the Animal APHIS Select Agent Programs jointly maintain a list of these agents. See the Federal Select Agent Program website.

See also the NIH Grants Policy Statement, Section 4.1.24.1: Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents).

Content:

Excluded select agents: If the activities proposed in your application involve only the use of a strain(s) of select agents which has been excluded from the list of select agents and toxins as per 42 CFR 73.3, the select agent requirements do not apply. Use this "Select Agent Research" section to identify the strain(s) of the select agent that will be used and note that it has been excluded from this list. The CDC maintains a list of exclusions which is available on the Select Agents and Toxins Exclusions website.

Applying for a select agent to be excluded: If the strain(s) is not currently excluded from the list of select agents and toxins but you have applied or intend to apply to HHS for an exclusion from the list, use this section to indicate the status of your request or your intent to apply for an exclusion and provide a brief justification for the exclusion.

All applicants proposing to use select agents: Address the following three points for each site at which select agent research will take place. Although no specific page limitation applies to this section, be succinct.

1. Identify the select agent(s) to be used in the proposed research.

2. Provide the registration status of all entities* where select agent(s) will be used.

   • If the performance site(s) is a foreign institution, provide the name(s) of the country or countries where select agent research will be performed.

   • *An "entity" is defined in 42 CFR 73.1 as "any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity."

3. Provide a description of all facilities where the select agent(s) will be used.

   • Describe the procedures that will be used to monitor possession, use and transfer of select agent(s).

   • Describe plans for appropriate biosafety, biocontainment, and security of the select agent(s).

   • Describe the biocontainment resources available at all performance sites.

Who must complete the "Consortium/Contractual Arrangements" attachment:

Include the "Consortium/Contractual Arrangements" attachment if you have consortium/contracts in your budget.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

Note: The signature of the authorized organization representative signifies that the applicant and all proposed consortium participants understand and agree to the following statement:

The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency's consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy.

For more information:

Refer to the NIH Grants Policy Statement, Section 15: Consortium Agreements for more information.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state why such sharing is restricted or not possible. For more information, see the NIH Grants Policy Statement, Section 8.2.3.2: Sharing Model Organisms.

Research Tools:

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds, and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. For more information, see the Research Tools Policy on the NIH Scientific Data Sharing Website and the NIH Grants Policy Statement, Section 8.2.3: Sharing Research Resources.

Who Must Complete This Section:  Applicants proposing to conduct research that will generate scientific data are subject to the NIH Data Management and Sharing Policy and must attach a Data Management and Sharing (DMS) Plan. Scientific data is defined as the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data includes any data needed to validate and replicate research findings. Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens. 

The NIH Genomic Data Sharing Policy expects applicants seeking funding for research that generates large-scale human or non-human genomic data to provide a plan for sharing of these data as part of their DMS Plan. 

Applicants subject to both the NIH Data Management and Sharing Policy and the NIH Genomic Data Sharing Policy must attach a single Plan including elements for both policies. For more on applicability of each policy, see research subject to the NIH Data Management and Sharing Policy and the research subject to the NIH Genomic Data Sharing Policy.

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.  A sample format is provided on the Data Management and Sharing Plan Format Page to assist applicants with preparation of this attachment. Do not include hyperlinks in this attachment. Recommended not to exceed two pages.

Content: Follow the expectations of the NIH Policy for Data Management and Sharing and address the Elements of an NIH Data Management and Sharing Plan described below.

Additional expectations: A Data Management and Sharing Plan should reflect the proposed approach at the time the application is prepared. For some programs and data types, NIH and/or NIH Institutes, Centers, Offices, or programs have developed additional data sharing requirements (e.g., specifying which scientific data to share, relevant standards, repository selection, timelines) that apply and should be reflected in a Plan. These additional requirements may be listed on NIH Institute and Center Data Sharing Policies or in specific Notice of funding opportunities. Note that some NIH Institutes, Centers, Officers, or programs have developed additional expectations for sharing genomic data that may be listed on NIH Institute and Center Genomic Data Sharing Expectations or in specific funding opportunities.

Elements of a Data Management and Sharing Plan: 

Data Type: Briefly describe the scientific data to be managed, preserved, and shared, including a general summary of the types and estimated amount of scientific data to be generated and a description of which scientific data from the project will be preserved and shared as well as the rationale for doing so. Briefly list the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be madeaccessible to facilitate interpretation of the scientific data. 

Related Tools, Software and/or Code: State whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software. If specialized tools or software are needed, provide the name(s) of the needed tool(s) and software and specify how they can be accessed. 

Standards: State what common data standards will be applied to the scientific data and associated metadata to enable interoperability of datasets and resources (e.g., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation), and provide the name(s) of the data standards that will be applied and describe how these data standards will be applied to the scientific data generated by the research proposed in this project. If applicable, indicate that no consensus standards exist. 

Data Preservation, Access, and Associated Timelines: Provide plans and timelines for data preservation and access, including the name of the repository(ies) where scientific data and metadata arising from the project will be archived (do not include hyperlinks); how the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools; and when (i.e., no later than time of an associated publication or end of the performance period, whichever comes first) the scientific data will be made available to other users (e.g., the larger research community, institutions, and/or the broader public) and for how long. See Selecting a Data Repository on the NIH Scientific Data Sharing website. 

Access, Distribution, or Reuse Considerations: NIH expects that in drafting Plans, researchers maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research, consistent with privacy, security, informed consent, and proprietary issues. Describe and justify any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to informed consent, privacy and confidentiality protections, any restrictions imposed by federal, Tribal, or state laws, regulations, or policies, or existing or anticipated agreements, or any other considerations that may limit the extent of data sharing. See Data Management &Sharing Policy FAQ for examples of justifiable reasons for limiting sharing of data. State whether access to the scientific data will be controlled (i.e., made available by a data repository only after approval). 

Genomic Data Sharing Policy: For proposed research subject to the GDS Policy, state whether data, including genomic summary results, will be made available through controlled or unrestricted access; see instructions for describing Genomic Summary Results in Data Management and Sharing Plans. 

If generating scientific data derived from humans, describe how the privacy, rights, and confidentiality of human research participants will be protected (e.g., through deidentification, Certificates of Confidentiality, and other protective measures). See NIH’s Scientific Data Sharing page for additional information on protecting human research participant privacy when sharing data. 

Genomic Data Sharing Policy: For proposed research generating human genomic data within the scope of the GDS Policy, applicants should complete the Data Management and Sharing Plan anticipating sharing according to the assurances of the Institutional Certification. 

If there is any element of the Institutional Certification that the institution (in consultation with the IRB) has determined cannot be met, please state which element and provide a detailed explanation for why the element cannot be met. In such cases, the data management and sharing plan should describe how genomic data will be shared to the maximal extent possible (for example, sharing data in a summary format). 

Oversight of Data Management and Sharing: Describe how compliance with the Plan will be monitored and managed, frequency of oversight, and by whom at the applicant institution (e.g., titles, roles). 

For more information on developing a Data Management and Sharing Plan, see Writing a Data Management and Sharing Plan on the NIH Scientific Data Sharing website. 

For more information on the DMS Policy, including expectations for data management and sharing, protecting research participant privacy, and identifying data repositories, see the NIH Data Management and Sharing Policy on the NIH Scientific Data Sharing website and the NIH Grants Policy Statement, Section 8.2.3.1: Data Sharing Policy. See also Data Management & Sharing Policy FAQ for additional information on the DMS Policy on these and other topics. 

For more information on the GDS Policy see the NIH Genomic Data Sharing Policy on the NIH Scientific Data Sharing website and the NIH Grants Policy Statement, Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/ Policy for Genome-Wide Association Studies (GWAS).

Format:

Attach this information as a PDF file. See NIH's Format Attachments page.

Content:

If applicable to the proposed science, briefly describe methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed studies. A maximum of one page is suggested.

More information:

Key biological and/or chemical resources are characterized as follows.

• Key biological and/or chemical resources may or may not be generated with NIH funds and: 1) may differ from laboratory to laboratory or over time; 2) may have qualities and/or qualifications that could influence the research data; and 3) are integral to the proposed research. These include, but are not limited to, cell lines, specialty chemicals, antibodies, and other biologics.

• Standard laboratory reagents that are not expected to vary do not need to be included in the plan. Examples are buffers and other common biologicals or chemicals.

• See NIH's page on Rigor and Reproducibility for more information.