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As recipients of the T32 training grant, you are required to provide an update of your research as part of the progress report. Below you will find instructions that you can use as guidelines to provide the information requested.

Fellow's Name and year of fellowship:
Fellow's Division/Institution:
Email address:

Fellowship Director:

Mentor's Name:
Mentor's Department/Division:

Title of Project:

Followed by:

A.   Specific Aims
B.   Studies and Results
C.   Significance
D.   Plans
E.    Publications
F.    Project-Generated Resources
G.   Research Development
H.   Other Activities
I.    Research Development and other Activities Planned for the next year
J.    Mentor's Report

Guidelines:

A. Specific Aims                   

The aims, as actually funded, may differ in scope from those stated in the original, competing application, because of Scientific Review Group (SRG) and Council recommendations and/or budgetary modifications made by the awarding component. If the aims have not been modified, state this. If they have been modified, give the revised aims and the reason for the modification. 

 B. Studies and Results

Describe the studies directed toward specific aims during the current budget year and the positive and negative results obtained. If applicable, address any changes to the innovative potential of the project. If technical problems were encountered in carrying out this project, describe how your approach was modified.

Revisions (formerly Supplements): If applicable, include a separate section(s) describing the results obtained by individuals supported on this grant through various revisions. Examples include Research Supplements to Promote Diversity in Health-Related Research, supplements to enhance diversity and Re-entry and/or other similar supplements to support addition of an individual or a discrete project. 

 C. Significance        Emphasize the significance of the findings to the scientific field and their potential impact on health.
 D. Plans

Summarize plans to address the Specific Aims during the next year of support. Include any important modifications to the original plans.

Human Subjects
For eSNAPs, complete the Edit Business - Research Subject screen.
For non-SNAP awards, complete item A on Form Page 5.

If the protocols planned for the coming year are different from those proposed in the previous submission, or if a new applicable clinical trial is proposed, include an explanation of how they differ and provide a new or revised Protection of Human Subjects section as described in Part II.3 of the competing application instructions. Include designated headings, as appropriate, for Exempt Human Subjects Research, Non Exempt Human Subjects Research, Clinical Trial, or NIH Defined Phase III Clinical Trial, Data and Safety Monitoring, Inclusion of Women and Minorities, and Inclusion of Children. New protocols or protocol changes will require IRB approval, in accord with the DHHS regulations for protection of human subjects. Provide a protocol only upon request.

If human subject studies planned for the coming year were identified in the Research Plan of the competing application, but were not adequately described because they were planned for a later time within the project period, provide a Protection of the Human Subjects section as instructed in Part II of the competing application instructions.

If studies involving human subjects are planned, and they were not part of the originally proposed research design, provide a Protection of Human Subjects section as instructed in Part II of the competing application instructions, and also provide the following information: whether all of the research is exempt under 45 CFR Part 46, and if so, the exemption number, the Federalwide Assurance number, whether the research is a Clinical Trial and whether the research is an NIH defined Clinical Trial (see definitions in Part III of the competing application instructions).

Public Law 110-85, also known as the Food and Drug Administration Amendments Act (FDAAA) of 2007, mandates registration and results reporting of certain "applicable clinical trials" in ClinicalTrials.gov.

When submitting a non-competing continuation progress report for a project that includes applicable clinical trial(s):

  • If a new applicable clinical trial is proposed -OR- if the progress report includes an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first subject), the Human Subjects section of the progress report must include a clear statement, under a heading entitled "ClinicalTrials.gov", that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. Applicable clinical trials must be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled.
  • If the progress report includes an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the progress report must include, under a heading entitled "ClinicalTrials.gov", the ClinicalTrials.gov registry number ("NCT" followed by an 8-digit number, e.g. NCT00000418). If the grant number was entered into ClinicalTrials.gov, the NCT number may be readily identified by using the ClinicalTrials.gov Advanced Search and entering the grant number in the "Study IDs" field.

In signing the application Face Page or submitting the eSNAP to NIH, the AOR of the grantee organization certifies that if the research is an applicable clinical trial under Public Law 110-85, the applicant organization will be in compliance with the registration and reporting requirements of Public Law 110-85 (Part III, Section 2.1.6 of the competing application instructions). See the NIH Office of Extramural Research ClinicalTrials.gov web site (http://grants.nih.gov/ClinicalTrials_fdaaa) for additional information.

Women and Minority Inclusion in Clinical Research - Reporting Data on Inclusion to NIH:

Unless otherwise notified by the program official, reporting the cumulative enrollment of subjects and the distribution by sex/gender, race, and ethnicity is required for NIH-defined clinical research as defined in the competing application instructions. If you have inclusion enrollment, update the Inclusion Enrollment Report, with the total cumulative data collected to-date. You may have more than one Inclusion Enrollment Report. If there are details or concerns related to your inclusion enrollment progress or if the enrollment data does not reflect the targeted enrollment by race, ethnicity, and/or sex/gender, the reasons for this should be addressed in the text of the progress report.

Below are instructions for how to collect and report data on the basis of sex/gender, race, and ethnicity with additional guidance for handling subpopulations, foreign populations, changes to target data, and NIH-defined Phase III clinical trials.

For questions about the NIH policies for inclusion, please refer to: http://grants.nih.gov/grants/funding/women_min/women_min.htm or contact your program officer.

Standards for Collecting Data from Study Participants: The Office of Management and Budget (OMB) Directive No. 15 defines minimum standards for maintaining, collecting and presenting data on ethnicity and race for all Federal (including NIH) reporting purposes. The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. The standards were revised in 1997 and now include two ethnic categories: Hispanic or Latino, and Not Hispanic or Latino. There are five racial categories: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. Reports of data on ethnicity and race should use these categories. The definitions below apply for the ethnic and racial categories.

Ethnic Categories:

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, "Spanish origin," can be used in addition to "Hispanic or Latino".
Not Hispanic or Latino

Racial Categories:

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America and maintains tribal affiliation or community.
Asian: A person having origins in any if the original peoples of the Far East, Southern Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.
Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American."
Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.
White: A person having origins in any of the original peoples of Europe, North Africa, or the Middle East.

Reporting Data on Race and Ethnicity: NIH is required to use the above standards and definitions for race and ethnicity to allow comparisons to other federal databases, especially the Census and national health databases. Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards.

When collecting data on ethnicity and race, as well as sex/gender, use the categories listed to obtain the data from individuals on the basis of self-identification. Participants should be asked to identify their ethnicity and their race. The OMB recommends collecting this information using two separate questions, with ethnicity information collected first followed by race, with the option to select more than one racial designation (http://www.whitehouse.gov/omb/fedreg_directive_15). The Inclusion Enrollment Report format is not designed for use as a data collection instrument. Collect the data using instruments prepared for the study and use the information from the study database to fill out the Inclusion Enrollment Report. Study participants who self-identify with more than one race should be reported in the aggregate in the "More Than One Race" category.

When reporting these data to NIH, include the following items:

Part A of the Inclusion Enrollment Report:

  1. the total number of subjects in each ethnic category or who did not self-identify with an ethnic category (unknown or not reported);
  2. the total number of Hispanic or Latino and Not Hispanic or Latino subjects who selected only one category from each of the five racial categories;
  3. the total number of Hispanic or Latino and Not Hispanic or Latino subjects who selected more than one racial category reported as the number selecting "more than one race";
  4. the total number of Hispanic or Latino and Not Hispanic or Latino subjects who did not self-identify with any racial category (unknown or not reported); and,

Part B of the Inclusion Enrollment Report:

  1. the total number of Hispanic or Latino subjects who selected only one of the five racial categories as well as Hispanic or Latino subjects who selected more than one racial category or who did not self-identity with a racial category (unknown or not reported).

In completing the race sections of the Inclusion Enrollment Report, individuals who identify as Hispanic or Latino should be included in both race tables: the table where all participants' races are reported (Part A) and the table where only the race of individuals identifying as Hispanic or Latino is reported (Part B).

Collecting and Reporting Data on Subpopulations: Each ethnic/racial group contains subpopulations that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self identify with more than one ethnicity or race. These ethnic/racial combinations may have biomedical, behavioral, and/or social-cultural implications related to the scientific question under study. The collection of greater detail is encouraged, e.g., on ethnic/racial subpopulations; however, any collection that uses more detail needs to be organized in such a way that the additional categories can be aggregated into the OMB categories for reporting data on ethnicity, race, and more than one race. Investigators who have data on subpopulations are encouraged to provide that information in the Comments field of the Inclusion Enrollment Report and/or in the text of their progress report.

Collecting and Reporting Data on Foreign Populations: If conducting clinical research outside of the United States, design culturally sensitive and appropriate data collection instruments that allow participants to self-identify their ethnic and/or racial affiliation. These items, however, should be designed in a way that allows the information to be aggregated into the OMB minimally required ethnic and racial categories and which will allow you to complete the inclusion enrollment report(s). Enrollment of foreign participants should be reported to NIH in an Inclusion Enrollment Report separate from that for reporting domestic participants.

Changes to Targeted/Planned Enrollment: If there are changes from the Targeted/Planned Enrollment Table originally approved for funding, contact your Program Officer to discuss updating/revising your Targeted/Planned Enrollment Table and address the change in the text of your progress report. 

Reporting Data on NIH-defined Phase III Clinical Trials: If conducting an NIH-defined Phase III Clinical Trial, report on the cumulative enrollment (as described above) and indicate if data analysis has begun for the trial. If analysis has begun, report on progress made in conducting valid analyses for sex/gender, racial, and/or ethnic differences.

Human Subjects Education Requirement
If there are any new senior/key personnel or other significant contributors involved in the design or conduct of research involving human subjects, provide certification that they have completed an educational program in the protection of human subjects. This requirement may not apply to other awarding agencies. Non-NIH grantees should contact their awarding agency for guidance.

[For eSNAPs, provide this certification on the Edit Business - Research Subject screen in the Human Subjects Education text field box. For non-SNAP awards, provide this certification in the Progress Report Summary.]

Vertebrate Animals

For eSNAPs, complete the relevant question on the Edit Business - Research Subject screen.

For non-SNAP awards, complete item B on Form Page 5.

If vertebrate animals were not involved in the last application but are now to be included, or if significant changes regarding the use of animals are now proposed, provide a description of the intended involvement of animals in accord with the PHS Policy on Humane Care and Use of Laboratory Animals. Examples of changes considered to be significant include, but are not limited to, changing animal species, changing from noninvasive to invasive procedures, new project/performance site(s) where animals will be used, etc. If studies involving live vertebrate animals are planned, and they were not part of the originally proposed research design, you must comply with the requirements of the Research Plan, Item 5.5.10, "Vertebrate Animals," described in the competing application instructions, and provide the required information. Before activities with live vertebrate animals begin, the applicant must provide a valid Animal Welfare Assurance number and certification of current IACUC approval.

Select Agent Research

For eSNAPs, complete the relevant question on the Edit Business - SNAP and Other Progress Report Questions and Checklist screen.

For non-SNAP awards, complete item C on Form Page 5. If there are any changes involving use of Select Agents, include an explanation of how research plans differ and provide a new or revised Section 5.5 Select Agent Research of the Research Plan following the competing application instructions, reflecting the changes.

If Select Agent Research planned for the coming year was described in the Research Plan of the competing application, but had not been approved by regulatory authorities, provide the Select Agent Research information requested in the competing application instructions.

If studies involving Select Agents are planned, but were not part of the originally proposed research design, provide Section 5.5 Select Agent Research of the Research Plan following the competing application instructions.

Multiple PD/PI Leadership Plan

This section is only applicable if Multiple PD/PIs are part of the NIH approved project.

For eSNAPs, complete the relevant question on the Edit Business - SNAP and Other Progress Report Questions and Checklist screen.

For non-SNAP awards complete item D on Form Page 5.

If there has been any change in the governance and/or organizational structure of the Multiple PD/PI Leadership Plan, provide a description, including communication plans and procedures for resolving conflicts, any changes to the administrative, technical, and scientific responsibilities for the PD/PIs.

If the progress report submission includes a change in the contact PD/PI, address this change and the impact, if any, the change has on the administrative, technical, and scientific responsibilities for the PD/PIs.

Human Embryonic Stem Cell Line(s) Used

For eSNAPs, complete the relevant question on the Edit Business - SNAP and Other Progress Report Questions and Checklist screen.

For non-SNAP awards, complete item E on Form Page 5.

If the research involving hESCs planned for the coming year is different from that proposed in the previous submission, including use of a different cell line, include an explanation of how research plans differ, and if different cell lines are to be used, provide the cell line number(s). Only cell lines listed on the NIH hESC Registry as approved for use in NIH funded research may be used. 

E. Publications

For eSNAPs, in the lower half of the Upload Science screen, select any listed publication in order to associate a publication with the progress report.

For non-SNAP awards, citations must be provided in the Progress Report Summary (Form page 5).

Report publications resulting directly from this grant that you have not previously reported, including manuscripts submitted or accepted for publication. Provide the complete citation (author(s), title, journal or book, volume, page number, year). For each publication that falls under the Public Access Policy, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567), at the end of the citation. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm. Citations that are not covered by the Public Access Policy, but are publicly available in a free, online format may include URLs or PubMed ID (PMID) numbers along with the full reference. If not available electronically you may provide one copy with the progress report. State if there have been no publications.

A citation management tool "My Bibliography" is now integrated with eRA Commons and is to be used to manage publication citations in the eSNAP Upload Science screen. "My Bibliography" includes an export function, which allows the tool to be used for managing citations in biosketches and in progress reports for non-SNAP awards. My Bibliography will display the correct text format, and if available, include the appropriate reference number (PMID, PMCID, or NIHMSID). For addition information about "My Bibliography", see NIH Guide Notice NOT-OD-10-103.

For additional information on compliance with the Public Access Policy see NIH Guide Notice NOT-OD-08-119 and NOT-OD-09-136

 F. Project-Generated Resources

If the research supported by this grant resulted in data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information available to be shared with other investigators, describe the resource and how it may be accessed.

If the initial research plan included a formal plan for sharing final research data, describe progress in implementing that plan. A final statement on data sharing should be included in the final progress report or earlier, if the plan is implemented prior to closeout.

If the initial research plan included specifics for sharing model organisms, include information on the progress of that plan as well as information on the number of requests received and fulfilled.

If the initial research plan includes Genome Wide Association Studies and a plan to share data with the NIH centralized data repository, describe progress in implementing that plan. A final statement on submitting data to the repository should be included in the final progress report or earlier, if the plan is implemented prior to closeout (see NOTICE OD-08-023 and NOTICE OD-07-088).

 G. Research Development

Briefly describe the awardee's involvement in activities during the past year designed to increase research skills. Include formal course work, progress toward a research-related degree (if applicable), informal instruction in specific research skills, scientific seminars and meetings, training in the responsible conduct of research, visits to other laboratories, etc. Describe instruction, or participation as a course director, etc. in the case of senior career awardees, in both formal and informal instruction in responsible conduct of research in the past budget period, if applicable. If instruction, or participation as a course director, etc., occurred in a prior budget period, the PI should note the date of occurrence. Any activities undertaken to individualize instruction appropriate to the career stage of the PI should be discussed. (Additional detailed guidance on this requirement is found in the competing application instructions at Part III, Section 1.16.) Indicate any changes in senior/key personnel and other significant contributors (department head, sponsor, and collaborators) during the past year.

 H. Other Activities

Briefly describe the awardee's involvement in activities other than research and research training during the past year. Describe activities such as teaching, clinical care, professional consultation, service on advisory groups, and administrative activities. Indicate percent of time spent in each of these activities and the relationship to the awardee's research career development.
For awards that include a requirement to mentor others (e.g., K05 and K24), indicate the percent of time devoted to mentoring activities, individuals mentored during the reporting period, the frequency and kinds of mentoring, financial and other support provided to mentees, and the productivity of the mentoring relationship.

 I. Research Development and Other Activities Planned for the Next Year

Provide information on similar activities (to those provided in Item G and Item H for the past year) planned for the next year. Awardees should provide a timeline for these activities, including plans to apply for subsequent grant support. Recipients of transition awards (e.g., K22, K99) should report on their progress in identifying an independent research position. Additionally, awardees charged with mentoring others (e.g., K05, K24) should provide information describing planned mentoring activities and proposed mentees (e.g., backgrounds, interests, professional levels, etc.) sufficient to evaluate the quality of the mentoring.

 J. Mentor's Report
Prepare a statement assessing the awardee's progress and performance during the past year, both in research and in terms of development into an independent investigator in the area of the award. Include information on the availability of support for the candidate's research project during the next budget segment. For applicable career transition awards (e.g., K22, K99), describe the awardee's efforts to transition into a permanent research position and the sponsor's contributions to that process.