These simplified instructions apply to all grant mechanisms routinely covered under expanded authorities and Federal Demonstration Partnership terms and conditions, except for Program Project Grants (P01s) and Outstanding Investigator Grants (R35s). NIH routinely applies expanded authorities to Program Project Grants (P01s), Research Career Awards (K-Series), and all Research Project Grants (R-Series), except Phase I Small Business Innovation Research (R43) and Small Business Technology Transfer (R41) Awards. Any award excluded from expanded authorities is routinely excluded from SNAP. All NIH award notices identify whether the grant is subject to or excluded from SNAP.
Answer the following questions at the beginning of Form Page 5. Blank pages should be used for the Progress Report if inadequate space remains on Form Page 5 to answer the questions and to begin the report on the research progress. The questions to be addressed are as follows:
If a project or grantee organization requires closer monitoring by NIH staff, the project or organization may not use these simplified instructions.
If you have any questions, contact the grants management specialist identified on the current Notice of Grant Award.
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Note: | If the preprinted copy is not provided, or extensive corrections are necessary, use PHS 2590 Form Page 1, which is available in RTF or PDF format. |
Policy on research involving human subjects can be found in the NIH Grants Policy Statement or the PHS 398 application instructions. Definitions pertaining to Human Subjects Research, including clinical trials, may be found in Section III.A of the PHS 398. Check "No" if activities involving human subjects are not planned at any time during the proposed budget period. The remaining parts of Item 6 are then not applicable.
Check "Yes" if activities involving human subjects, whether or not exempt from the Federal regulations for the protection of human subjects, are planned at any time during the budget period, either at the applicant organization or at any other performance site or collaborating institution.
Appropriately designating whether human subjects are involved or not may facilitate processing of an award. Information about how the regulations apply to the proposed research may be obtained from the Office for Human Research Protections (OHRP), Department of Health and Human Services, or the program administrator in the awarding component. The PHS will make a final determination as to whether the proposed activities are covered by the regulations (i.e., non exempt) or are in an exempt category.
Exempt Research.
If the activities are designated to be exempt from the regulations, insert the exemption number(s) corresponding to one or more of the six exemption categories listed in the NIH Grants Policy Statement or the PHS 398 application instructions or the Protection of Human Subject regulations (45 CFR 46.101(b). The remaining parts of Item 6 are then not applicable.Non-Exempt Research.
If the planned activities involving human subjects are not exempt, complete the remaining parts of Item 6. If the applicant organization has an approved Human Subjects Assurance on file with the OHRP, insert the Assurance number and the most recent date of approval by the Institutional Review Board (IRB) for the proposed activities. This date must not be earlier than one year before the start date for which the Progress Report is submitted. No Progress Report for continuation support should be submitted until the necessary certification of annual IRB review has been obtained.Check the type of IRB review in the appropriate box. An IRB of an institution with an FWA or MPA may review a progress report through an expedited review procedure only if it complies with Section 46.110 of the human subject regulations at 45 CFR 46.
Check "Yes," if activities involving vertebrate animals are planned
at
any time during the budget period, either at the applicant organization
or at any other performance site or collaborating institution. Insert the
Animal Welfare Assurance number in Item 7b if the applicant organization
has an approved Assurance on file with the Office of Laboratory Animal
Welfare (OLAW). In addition, provide the latest date of approval by the
Institutional Animal Care and Use Committee (IACUC). Progress reports
for continuation support should NOT be submitted until the necessary verification
of IACUC review has been obtained.
Check "Yes," if any inventions were conceived or reduced to practice during the course of work under this project. Check the appropriate box to indicate whether this information has or has not been previously reported to the PHS or to the official responsible for patent matters at the applicant organization.
Recipient organizations must report these inventions promptly to the Extramural Inventions and Technology Resources Branch of the Office of Policy for Extramural Research Administration, OER, NIH, Bethesda, MD 20892-7750, (301) 435-1986. This should be done prior to any publication or presentation of the invention at an open meeting, since failure to report at the appropriate time is a violation of 35 USC 202, and may result in loss of the rights of the applicant institution, inventor, and Federal Government in the invention. All foreign patent rights are immediately lost upon publication or other public disclosure unless a United States patent application is already on file. In addition, statutes preclude obtaining valid United States patent protection after one year from the date of a publication that discloses the invention.
NIH has developed an optional on-line Extramural Invention Information Management System, known as "Edison", to facilitate grantee compliance with the disclosure and reporting requirements of 37 CFR 401.14(h). The internet address for this system is http://iedison.gov. Information from these reports is not made publicly available.
Human Subjects
Research on Transplantation of Human Fetal
Tissue
Women and Minority Inclusion Policy
Inclusion of Children Policy
Research Using Human Pluripotent Stem Cells
Vertebrate Animals
Debarment and Suspension
Drug-Free Workplace
Lobbying
Delinquent Federal Debt
Research Misconduct
Civil Rights
Handicapped Individuals
Sex Discrimination
Age Discrimination
Financial Conflict of Interest (except Phase I
SBIR/STTR)
Recombinant DNA and Human Gene Transfer Research
Certification of Research Institution Participation (STTR only)
Itemize the direct costs requested for the next budget period by budget categories. Use the recommended direct cost shown on the spreadsheet included with the Notice of Grant Award issued in the competitive year as the guide for developing the line item annual budget. Use Form Page 3 and continuation pages as necessary to provide required explanation of budget items.
For multiproject grants whose individual projects are budgeted separately, additional copies of Form Page 2 should be prepared for each project or core in the program. Number these pages consecutively. Do not use suffixes such as 2a, 2b. On the individual budget pages for each specific project, clearly identify the name of the project leader and the title of the project.
Certain conditions may change the funding requirements for a budget period from those originally recommended. Such proposed funding changes, particularly increases over the recommended level, must be explained and fully justified for PHS awarding component consideration.
Name and Role on Project. Starting with the principal investigator, list all employees of the applicant organization who will be involved on the project, regardless of whether or not salaries are requested.
Type of Appointment/Months. List the number of months per year
reflected in an individual's contractual appointment to the applicant organization.
PHS staff assume that appointments at the applicant organization are full
time for each individual. If an appointment is less than full time, e.g.,
50 percent time, identify with an asterisk (*) and provide a full explanation
under Justification on Form Page 3. Individuals may have split
appointments, for example for an academic period and a summer period.
For each appointment, identify and enter the number of months on separate
lines. In cases where no contractual appointment exists with the applicant
organization and salary is requested, enter the number of months for that
period.
Percent of Effort on Project. For each individual at the applicant organization, list the percent of each appointment to be spent on this project.
Salary Requested. Enter the dollar amounts for each position for which funds are requested. The salary requested is calculated by multiplying the individual's base salary, up to any imposed salary limitation, by the percent of effort on the project. Explain under Justification on Form Page 3 if a lesser amount is requested, e.g., endowed position, institutional sources, or other support.
Fringe Benefits. Fringe benefits may be requested in accordance with the institutional guidelines for each position, provided the costs are treated consistently by the applicant organization as a direct cost to all sponsors.
Totals. Calculate the totals for each position and enter the subtotals in each column where indicated.
Special Instructions for Individuals with Joint University and Department of Veterans Affairs Appointments
Individuals may request the university's share of the salaries in proportion to the effort devoted to the research project. The individual's salary with the university determines the base for computing that salary request. Signature by the institutional official on the progress report certifies that: (1) the individual is applying as part of a joint appointment specified by a formal Memorandum of Understanding between the university and the Department of Veterans Affairs (VA); and (2) there is no possibility of dual compensation for the same work, or an actual or apparent conflict of interest regarding such work.
Include information regarding projected patient accrual for the budget period and relate this information to the budget request for patient care costs.
Provide specific information regarding anticipated sources of other support for patient care costs, e.g., third party recovery or pharmaceutical companies. Include potential or expected utilization of General Clinical Research Centers.
Patient care costs do not include travel, lodging, and subsistence or donor/volunteer fees. Request these costs in the Other Expenses category. Request consultant physician fees in the Consultant Costs category. Patient care costs will be provided to foreign organizations only in exceptional circumstances.
List the Facilities and Administrative (F&A) costs, if any, and provide the basis for the rate in the Consortium/Contractual Costs category. Insert the page(s) for each consortium/contractual organization after Form Page 3 and number them consecutively. The sum of all consortium/contractual costs (direct and F&A) must be entered in the Consortium/Contractual Costs category of the applicant organization's budget.
Justification. Provide a detailed budget justification for those line items and amounts that represent a significant change from that previously recommended.
Current Budget Period. In the space provided, or on additional pages, explain any estimated unobligated balance of total costs (including prior year funds carried over) which is greater than 25 percent of the current year's total authorization. Explain why there is a significant balance and how it will be spent if carried forward into the next budget period.
Complete a Biographical Sketch for all new key personnel since the previous submission.
Key personnel are defined as, and should be limited to, individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested.
Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of key personnel. Consultants should be included only when their level of involvement meets the definition. Individuals providing technical services are not considered key personnel.
Well-planned Progress Reports can be of great value by providing records
of accomplishments, which serve as a basis for continued support of the
project. Furthermore, Progress Reports provide information to awarding
component staff that is essential in the assessment of changes in scope
or research objectives (as defined in the
NIH
Grants Policy Statement) from those actually funded. They are also
an important information source for the awarding component staff in preparing
annual reports, in planning programs, and in communicating scientific accomplishments
to the public and
to Congress.
The Progress Report should be a brief presentation of the accomplishments
on the research project during the reporting period, in language understandable
to a biomedical scientist who may not be a specialist in the project's
research field. The style used in
Scientific American articles would
be appropriate. Abbreviations and language that may not be known to the
broader scientific community should be avoided unless clearly
defined.
When submitting Progress Reports for program project grants, center grants, education grants, or other large multicomponent grants, contact the program official in the awarding component for specific instructions.
The entire Progress Report for regular projects, exclusive of the list of publications and the "Inclusion Enrollment Report," should not exceed two pages. The report should follow the outline and numbering system shown below. Continuation pages may be used as necessary.
Supplements: If applicable, include a separate section(s) describing the results obtained by individuals supported on this grant through various supplements. Examples include a Research Supplement to Underrepresented Minorities, a Research Supplement to Promote the Recruitment of Individuals with Disabilities into Biomedical Research Careers, and/or other similar supplements to support addition of an individual or a discrete project.
Summarize plans to address the Specific Aims during the next year of support. Include any important modifications to the original plans. Address any changes involving research using human subjects and/or vertebrate animals.
Complete Items A and B on Form Page 5 if the research involves Human Subjects or Vertebrate Animals. If "Change" is checked, provide the information below. Although no specific page limitation applies to the information on Human Subjects or Vertebrate Animals, be succinct.
Human Subjects (Item A)
Check "No Change" on the Progress Report Summary page (Form Page 5) if the protocols planned for the coming year are not different from the previous submission.
Check "Change" on the Progress Report Summary page if the protocols are different from those proposed in the previous submission. Include an explanation of how they differ and provide a new or revised Section E. "Human Subjects" from the PHS 398 instructions reflecting these changes; use the designated headings for Non Exempt or Exempt Human Subjects Research, as appropriate, including "Protection of Human Subjects", "Exempt Human Subjects Research", "Women and Minority Inclusion in Clinical Research", "Inclusion of Children", and "Data and Safety Monitoring Plan". New Protocols or Protocol changes will require IRB approval, in accord with the DHHS regulations for protection of human subjects. Provide a protocol upon request.
If human subject studies planned for the coming year were identified in the Research Plan of the PHS 398 application, but were not adequately described because they were planned for a later time within the project period, provide the "Human Subjects" information from the PHS 398 instructions as noted above.
If studies involving human subjects are planned, and they were not part of the originally proposed research design, then you must comply with the requirements of Section E. "Human Subjects" described in the PHS 398 instructions and provide the required information to NIH.
Women and Minority Inclusion in Clinical Research
Reporting Data on Inclusion to NIH:
If you are conducting clinical research (see definition in Section III. A., "DEFINITIONS" in the PHS 398), you must report the annual cumulative enrollment of subjects and their distribution by sex/gender and ethnicity/race, unless otherwise notified by your program official. For awards made as a result of New and Competing applications submitted after January 10, 2002, you should be using the 5/01 Inclusion Enrollment Report (MS Word or PDF) in progress reports. For awards made as a result of New and Competing Applications received before January 10, 2002, you may choose to report sex/gender and ethnicity/race composition using EITHER the format in the 4/98 Version of the Inclusion Table (MS Word or PDF) or the 5/01 Inclusion Enrollment Report (MS Word or PDF). If data were collected using two questions (one about ethnicity and one about race) and subjects were given the option of selecting more than one race, then the 5/01 Inclusion Enrollment Report (MS Word or PDF) should be used. If you choose to report information using the 5/01 Inclusion Enrollment Report, you must continue to use this format for the remaining years of the project. See detailed instructions and frequently asked questions in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.
Note: Reporting data on inclusion is not included in the two-page limit. If there is more than one study, provide a separate table for each study. Information about ethnic/racial subpopulations included in the study should be provided as an attachment to the table.
Changes to Targeted/Planned Enrollment. If there are changes from the Targeted/Planned Enrollment originally approved for funding, you should submit a revised Targeted/Planned Enrollment page (MS Word or PDF) and an inclusion enrollment report (MS Word or PDF) describing data collected to-date. Explain the changes in a footnote or attachment to the report.
NIH-defined Phase III Clinical Trial. If you are conducting an NIH-defined Phase III Clinical Trial (see definition in Section III A. "DEFINITIONS" in PHS 398), you must report on the annual cumulative enrollment (as described above) and indicate if data analysis has begun for the trial. If so, you should report on progress made in conducting valid analyses for sex/gender and ethnic/racial differences.
Foreign Populations: If you are conducting clinical research outside of the US, you should design culturally sensitive and appropriate data collection instruments that allow participants to self-identify their ethnic and racial affiliation. These items, however, should be designed in a way that allows you, the investigator, to aggregate the information into the OMB minimally required ethnic and racial categories and complete the Inclusion Enrollment report. When completing the Inclusion Enrollment report, you should add an asterisk and footnote the report to indicate that data is from foreign participants. If your study includes both domestic and foreign participants, we suggest submitting two separate reports - one for domestic data and one for foreign data, with an asterisk and footnote explaining the foreign data.
NOTE: The enrollment data by race may be lower than the Targeted/Planned enrollment by race because some individuals may designate that they belong to more than one race and will report under "More Than One Race" category. In this case, you may discuss these discrepancies in an attachment to the Inclusion Enrollment report.
Standards for Collecting Data from Study Participants:
When you are planning collection of data on ethnicity and race, as well as sex/gender, you should use the categories listed below in obtaining the data from individuals. The collection of greater detail is encouraged, e.g., on ethnic/racial subpopulations; however, any collection that uses more detail shall be organized in such a way that the additional categories can be aggregated into these minimum categories for reporting data on ethnicity and race. Using self-report or self-identification to collect this information, you should use two separate questions, with ethnicity information collected first followed by the option to select more than one racial designation. When reporting these data in the aggregate, you should report:
(a) the number of subjects in each ethnic category;
(b) the number of subjects who selected only one category for each of the five racial categories;
(c) the total number of subjects who selected multiple racial categories reported as the "number selecting more than one race"; and,
(d) the number of subjects in each racial category who are Hispanic or Latino.
NIH is required to use these definitions 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. (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html).
NOTE: The 5/01 Inclusion Enrollment Report format is not designed for use as a data collection instrument. You should collect the data using instruments prepared for the study and use the information from the study database to fill out the enrollment report. Study participants who select two or more racial categories should be reported in the aggregate in the "More Than One Race" category. An example of a format for collecting information from a study participant can be found in the "Ethnic Origin and Race" section of the Personal Data Form Page (PDF or MS Word) in the PHS 398.
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. NIH is required to use these definitions so that the data collected will allow comparisons to other Federal databases, especially the census and national health databases. The following definitions 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.
Ethnic/racial subpopulations. In addition to the OMB ethnic and racial categories, NIH uses the following definition for ethnic/racial subpopulations:
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. (http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm).
Vertebrate Animals (Item B)
If there has been no change, check "No Change" on the Progress Report page.
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 for use of vertebrate animals in research and check "Change" on the Progress Report page. Examples of significant changes might include substituting one animal model for another or changing from noninvasive to invasive procedures. If studies involving Vertebrate Animals are planned, and they were not part of the originally proposed research design, then you must comply with the requirements of Section F. "Vertebrate Animals" described in the PHS 398 instructions and provide the required information to NIH.
If program income is anticipated, use the format provided. If the progress report is funded, the Notice of Grant Award will provide specific instructions regarding the use of such income.
Human Subjects
Research on Transplantation of Human Fetal Tissue
Women and Minority Inclusion Policy
Inclusion of Children Policy
Research Using Human Pluripotent Stem Cells
Vertebrate Animals
Debarment and Suspension
Drug-Free Workplace
Lobbying
Non-Delinquency on Federal Debt
Research Misconduct
Civil Rights
Handicapped Individuals
Sex Discrimination
Age Discrimination
Recombinant DNA and Human Gene Transfer Research
Financial Conflict of Interest (except Phase I SBIR/STTR)
Certification of Research Institution Participation (STTR only)
Using the table, list all key 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. Include all degrees, role on project, date of birth, annual percent of effort, and Social Security number. When requesting 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.
This is the last page of the progress report. Number all pages consecutively.
[Table Of Contents] [Section I] [Section III.] [Section IV] [Section V]