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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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When submitting Progress Reports for program project grants, center grants, education grants, or other large multicomponent grants, contact the program official of the awarding agency for specific instructions.

The entire Progress Report for regular projects, exclusive of the list of publications and the inclusion enrollment report forms should not exceed two pages. The report should follow the outline and numbering system shown below. Continuation pages may be used as necessary. Tables and figures that summarize key accomplishments are not counted in the two-page limit.

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 the 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 PHS 2590 11 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 Complete item A on Form Page 5.

If the clinical studies planned for the coming year are different from those proposed in the previous submission, or if a new applicable clinical study or 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 of the Supplemental Grant Instructions for All Competing Applications and Progress Reports. 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 PHS Inclusion Enrollment Report(s) should also be provided if the study meets the NIH definition for clinical research. New studies or study 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 Protection of the Human Subjects and Inclusion sections as well as the PHS Inclusion Enrollment Report(s) as instructed in Part II of the Supplemental Grant Instructions for All Competing Applications and Progress Reports.

If studies involving human subjects are planned, and they were not part of the originally proposed research design, provide a Protection of Human Subjects as instructed in Part II of the Supplemental Grant Instructions for All Competing Applications and Progress Reports, 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 Phase III Clinical Trial (see definitions in Part III of the Supplemental Grant Instructions for All Competing Applications and Progress Reports). Also include a section addressing plans for the inclusion of women, minorities, and children and provide PHS Inclusion Enrollment Report(s) as described in Part II of the Supplemental Grant Instructions for All Competing Applications and Progress Reports.

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 ongoing 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 PHS 2590 12 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, the AOR of the recipient 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 Supplemental Grant Instructions for All Competing Applications and Progress Reports). See the NIH Office of Extramural Research ClinicalTrials.gov web site (http://grants.nih.gov/ClinicalTrials_fdaaa) for additional information.

Inclusion of Women and Miniorities in Clinical Research – Reporting Data on Inclusion to NIH Unless otherwise notified by NIH staff, 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. Update the PHS Inclusion Enrollment Report to reflect the total cumulative enrollment data collected to-date.

The progress report may include more than one inclusion enrollment form. If there are details or concerns related to the inclusion enrollment progress or if the enrollment data does not reflect the planned enrollment by sex/gender, race, and/or ethnicity, the explanation(s) for this should be addressed in the text of the progress report. If new clinical studies have started and planned enrollment was not previously provided, submit PHS Inclusion Enrollment Report(s) (also see Section

2.6.D., Plans – Human Subjects above for details on additional information that may be required).

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, non-U.S. populations, changes to planned enrollment 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 the 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 attachment.

Asian: A person having origins in any if the original peoples of the Far East, Southeast 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.” PHS 2590 13 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. The NIH inclusion enrollment format is not designed for use as a data collection instrument. Collect the data using instruments prepared for the study and use that information to complete the NIH inclusion enrollment form(s). Study participants who self-identify with more than one racial categories should be reported in the aggregate in the "More Than One Race" category.

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 socialcultural 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 form(s) and/or in the text of their progress report.

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