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«Forms Approved Through 08/31/2018 Instructions for PHS 2590 Revised 03/2016 OMB No. 0925-0002 TABLE OF CONTENTS Notable and Upcoming Changes 1. ...»

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Collecting and Reporting Data on Participants at Non-U.S. Sites: If conducting NIH-defined clinical research outside of the United States, design culturally appropriate data collection instruments that allow participants to self-identify their ethnic and/or racial affiliation in a way that is meaningful in the cultural and scientific contexts of the study. However, investigators must use the OMB-defined categories for reporting sex/gender, race and ethnicity to NIH (see definitions for each ethnic and racial category above), which will allow completion of the inclusion enrollment forms(s). Since the OMB categories reference world-based geographic origin, this should facilitate completion of the form(s).

Enrollment of participants at non-U.S. sites should be reported to NIH on a separate NIH inclusion enrollment form from that for reporting participants at U.S. sites, even if they are part

of the same study. For additional guidance and FAQs related to this topic, please refer to:

http://grants.nih.gov/grants/funding/women_min/women_min.htm or contact the program officer.

Changes to Planned Enrollment: If there are changes from the planned enrollment originally approved for funding, contact the program officer to discuss updating/revising planned enrollment, address the change in the text of the progress report, and provide the updated PHS Inclusion Enrollment Report(s).

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 any data analysis has begun for the trial. If analysis has begun or data have been published, report any progress made in evaluating potential differences on the basis of sex/gender, race, and/or ethnicity.

Human Subjects Education Requirement PHS 2590 14 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 in the Progress Report Summary that they have completed an educational program in the protection of human subjects. This requirement may not apply to other awarding agencies. Non-NIH recipients should contact their awarding agency for guidance (refer to table in Section 1.1).

Vertebrate Animals 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 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.

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 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 Report publications resulting directly from this grant that you have not previously reported, including manuscripts accepted for publication. (If there are no publications to report, include such a statement.) PHS 2590 15 Using My Bibliography provide a My NCBI generated PDF list of publications (see http://www.nlm.nih.gov/pubs/techbull/nd12/nd12_myncbi_pdf.html for instructions). My Bibliography will display the correct text format, and if available, include the appropriate reference number (PMID, PMCID, or NIHMSID), and compliance status for NIH recipients. If a publication is not compliant with the NIH public access policy NIH staff will contact the PD/PI and business official to inform them that the award will be delayed until a reply to the email is received with evidence of compliance or a satisfactory explanation (e.g., the sole author has passed away before they were able to process the manuscript for posting to PubMed Central). Generally, it takes weeks to bring publications into compliance; therefore, PD/PIs are advised to do so as soon as possible to ensure their award is renewed in a timely manner.

For additional information on compliance with the NIH Public Access Policy and use of My Bibliography see NIH Guide Notices NOT-OD-08-119, NOT-OD-09-136, NOT-OD-10-103, NOT-OD-12-160, and NOT-OD-13-017.

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 NOT-OD-08-023 and NOT-OD-07-088).

2.7 Checklist FORM PAGE 6 Program Income See the competing application instructions and the NIH Grants Policy Statement for information on program income. If no program income is anticipated during the period(s) for which grant support is requested, no other action is necessary.

If program income is anticipated, use the format provided. If the progress report is funded, the Notice of Award will provide specific instructions regarding the use of such income.

Facilities and Administrative Costs Follow the instructions on the Checklist.

2.8 All Personnel Report Complete form page 7, and remember to include the PD/PI(s). In addition, list all other personnel (salaried and unsalaried) for the current budget period at the applicant organization or elsewhere, who participated in the project during the current budget period for at least one person month or more, regardless of the source of compensation. A person month equals approximately 160 hours or 8.3% of annualized effort. Include the Commons ID (when applicable) names of individuals, all degrees, the last PHS 2590 16 four digits of the Social Security number, role on project, date of birth (MM/YY), and number of person months devoted to the project (indicate academic, calendar, and/or summer).

When requesting the last four digits of the Social Security numbers from personnel, explain that provision of the Social Security number is voluntary, and the information will be used only for program management purposes. For progress reports submitted using the PHS 2590, the Commons ID is currently required for all PD/PIs, all individuals with a postdoctoral role, and all individuals supported by a Reentry or Diversity Supplement. For NIH recipients, the Commons ID will be required in the future for all individuals with a graduate student or undergraduate role. The Commons ID is strongly encouraged, but not required, for all other personnel.

Use the following categories for describing Role on Project:


• Co-Investigator

• Faculty

• Postdoctoral (scholar, fellow, or other postdoctoral position)

• Technician

• Staff Scientist (doctoral level)

• Statistician

• Graduate Student (research assistant)

• Non-student Research Assistant

• Undergraduate Student

• High School Student

• Consultant

• Other (please specify) If personnel are supported by a Reentry or Diversity Supplement please indicate such after the Role on

Project, using the following abbreviations:

• RS - Reentry Supplement

• DS - Diversity Supplement Individuals designated as “Other Significant Contributors,” (e.g., those that may contribute to the scientific development or execution of the project, but are not committing any specified measurable effort to the project), should not be included in this report unless their involvement has changed so that they are now participating in the project during the current budget period for at least one person month or more.

Recipients should not report personnel if they have submitted a 2271 Appointment form for those individuals (e.g., participants on R25 or R90 awards).

This is the last page of the hard copy progress report. Number all pages consecutively.

PHS 2590 17

3. General Information

3.1 Collection of Personal Demographic Data Federal Agencies have a continuing commitment to monitor the operation of its review and award processes to detect, and deal appropriately with, any instances of real or apparent inequities. In addition, section 403 of the 2007 NIH Reform Act requires NIH to report to Congress specifically on the outcomes and effectiveness of various types of training programs, including training supported through research grants; and section 489 of the PHS Act requires NIH perform a continuing assessment of research personnel needs. Personal demographic data on PD/PIs, students, and postdoctorates working on NIH research projects is vital to comply with these requirements.

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