G.220 - R&R Other Project Information Form

1. Are Human Subjects Involved?

This field is required.

If activities involving human subjects are planned at any time during the proposed project at any performance site, check "Yes." Check "Yes" even if the proposed project is exempt from regulations for the Protection of Human Subjects, or if activities involving human subjects are anticipated within the period of award but plans are indefinite, or if the proposed activities include public health surveillance activities described in 45 CFR 46.102(l)(2).

If activities involving human subjects are not planned at any time during the proposed project at any performance site, select "No" and skip the rest of the "Are Human Subjects Involved" section.

Whether you answer "Yes" or "No" to the "Are Human Subjects Involved?" question here, your answer will populate the relevant field in the G.500 - PHS Human Subjects and Clinical Trials Information form (see exception for Training Applications in the Training-specific instructions). Follow the G.500 - PHS Human Subjects and Clinical Trials Information form instructions to complete the relevant questions in that form.

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.

Note on the use of human specimens or data: Applications involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used. If you check "No" to "Are Human Subjects Involved?" but your application proposes using human specimens or data, you will be required to provide a clear justification about why this use does not constitute human subjects research. Follow the G.500 - PHS Human Subjects and Clinical Trials Information form instructions.

For more information on human biospecimens or data: Refer to the NIH page on Frequently Asked Questions on Human Specimens, Cell Lines, or Data and the Research Involving Private Information or Biological Specimens flowchart.

1.a. If YES to Human Subjects

Your answers here in question "1.a. If YES to Human Subjects" will populate the corresponding fields in the G.500 - PHS Human Subjects and Clinical Trials Information form.

Is the Project Exempt from Federal regulations? Yes/No

If the project is exempt from federal regulations, check "Yes" and check the appropriate exemption number.

Human subjects research should only be designated as exempt if all of the proposed research projects in an application meet the criteria for exemption.

If the project is not exempt from federal regulations, check "No."

For more information, see the NIH's Exempt Human Subjects Research infographic.

If yes, check appropriate exemption number 1, 2, 3, 4, 5, 6, 7, 8:

If you selected "Yes" to "Is the Project Exempt from Federal Regulations," select the appropriate exemption number.

The categories of research that qualify for exemption are defined in the Common Rule for the Protection of Human Subjects. These regulations can be found at 45 CFR 46.

Need help determining the appropriate exemption number? Refer to NIH's Research Involving Human Subjects Frequently Asked Questions.

The Office for Human Research Protections (OHRP) guidance states that appropriate use of exemptions described in 45 CFR 46 should be determined by an authority independent from the investigators (for more information, see OHRP's Frequently Asked Questions). Institutions often designate their Institutional Review Board (IRB) to make this determination. Because NIH does not require IRB approval at the time of application, the exemptions designated often represent the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is evaluated during peer review. See NIH Grants Policy Statement Section 4.1.15 for more information.

4. Human Fetal Tissue Section

Notes on public health surveillance activities: Projects involving public health surveillance activities described in 45 CFR 46.102(l)(2) must answer questions in Section 1.a. as if the exclusion does not apply. In rare circumstances, applicants may request NIH approval for use of the exclusion in accordance with Just-in-Time procedures.

If no, is the IRB review Pending? Yes/No

If IRB review is pending, check "Yes."

Applicants should check "Yes" to the question "Is the IRB review Pending?" even if the IRB review/approval process has not started by the time of submission.

If IRB review is not pending (e.g., if the review is complete), check "No."

IRB Approval Date:

Enter the latest IRB approval date (if available). Leave blank if IRB approval is pending.

An IRB approval date is not required at the time of submission when IRB review is pending. This may be requested later in the pre-award cycle as a Just-In-Time requirement. See the NIH Grants Policy Statement, Section 2.5.1: Just-in-Time Procedures for more information.

Human Subject Assurance Number:

Enter the approved Federalwide Assurance (FWA) number that the applicant has on file with OHRP. Enter the 8-digit number. Do not enter "FWA" before the number.

Enter "None" if the applicant organization does not have an approved FWA on file with OHRP. In this case, the applicant organization, by the signature in the Certification section on the G.200 - SF424 (R&R) Form, is declaring that it will comply with 45 CFR 46 and proceed to obtain a FWA (see Office for Human Research Protections website). Do not enter the FWA number of any collaborating institution.

2. Are Vertebrate Animals Used?

This field is required.

If activities involving vertebrate animals are planned at any time during the proposed project at any performance site, check "Yes." Otherwise, check "No" and skip the rest of the "2. Are Vertebrate Animals Used?" section.

Note that the generation of custom antibodies constitutes an activity involving vertebrate animals.

If animal involvement is anticipated within the period of award but plans are indefinite, check "Yes."

2.a. If YES to Vertebrate Animals

Is the IACUC review Pending?

If an Institutional Animal Care and Use Committee (IACUC) review is pending, check "Yes."

Applicants should check "Yes" to the "Is the IACUC review Pending?" question even if the IACUC review/approval process has not started by the time of submission.

If IACUC review is not pending (e.g. if the review is complete), check "No."

IACUC Approval Date:

Enter the latest IACUC approval date (if available). Leave blank if IACUC approval is pending. IACUC approval must have been granted within three years of the application submission date to be valid.

An IACUC approval date is not required at the time of submission. NIH does not require verification of review and approval of the proposed research by the IACUC before peer review of the application. However, this information is required under the NIH Grants Policy Statement Section 2.5.1: Just-in-Time Procedures.

Animal Welfare Assurance Number

Enter the federally approved assurance number, if available.

Enter "None" if the applicant organization does not have an Office of Laboratory Animal Welfare (OLAW)-approved Animal Welfare Assurance.

To determine whether the applicant organization holds an Animal Welfare Assurance with an associated number, see the lists of Domestic and Foreign Assured institutions. Do not enter the Animal Welfare Assurance number for a Project/Performance Site of a collaborating institution.

When an applicant organization does not have an Animal Welfare Assurance number, the authorized organization representative's signature on the application constitutes declaration that the applicant organization will submit an Animal Welfare Assurance when requested by OLAW.

If the animal work will be conducted at an institution with an Animal Welfare Assurance and the applicant organization does not have the following:

• an animal care and use program;
• facilities to house animals and conduct research on site; and
• IACUC;

then, the applicant must obtain an Inter-institutional Assurance from OLAW prior to an award.

3. Is proprietary/privileged information included in the application?

This field is required.

Patentable ideas; trade secrets; or privileged, confidential commercial, or financial information should be included in applications only when such information is necessary to convey an understanding of the proposed project.

If the application includes such information, check "Yes" and clearly mark each line or paragraph on the pages containing the proprietary/privileged information with a statement similar to: "The following contains proprietary/privileged information that (name of applicant) requests not be released to persons outside the government, except for purposes of review and evaluation." This statement can be included at the top of each page as applicable.

If a grant is awarded as a result of or in connection with the submission of this application, the government shall have the right to use or disclose the information to the extent authorized by law. Although the grantee institution and the PD/PI will be consulted about any such disclosure, the NIH and other PHS agencies will make the final determination. Any indication by the applicant that the application contains proprietary or privileged information does not automatically shield the information from release in response to a Freedom of Information Act (FOIA) request should the application result in an award (see 45 CFR 5). Additionally, if an applicant fails to identify proprietary information at the time of submission as instructed here, a significant substantive justification will be required to withhold the information if requested under FOIA.

4. Environmental Questions

Question 4 pertains to the environmental impact of the proposed research.

4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the environment?

This field is required.

Indicate whether or not this project has an actual or potential impact on the environment.

Most NIH research grants are not expected to individually or cumulatively have a significant effect on the environment, and NIH has established several categorical exclusions allowing most applicants to answer "No" unless a specific FOA indicates that the National Environmental Policy Act (NEPA) applies. However, if an applicant expects that the proposed project will have an actual or potential impact on the environment, or if any part of the proposed research and/or project includes one or more of the following scenarios, check "Yes."

1. The potential environmental impacts of the proposed research may be of greater scope or size than other actions included within a category.
2. The proposed research threatens to violate a federal, state, or local law established for the protection of the environment or for public health and safety.
3. Potential effects of the proposed research are unique or highly uncertain.
4. Use of especially hazardous substances or processes is proposed for which adequate and accepted controls and safeguards are unknown or not available.
5. The proposed research may overload existing waste treatment plants due to new loads (volume, chemicals, toxicity, additional hazardous wasted, etc.).
6. The proposed research may have a possible impact on endangered or threatened species.
7. The proposed research may introduce new sources of hazardous/toxic wastes or require storage of wastes pending new technology for safe disposal.
8. The proposed research may introduce new sources of radiation or radioactive materials.
9. Substantial and reasonable controversy exists about the environmental effects of the proposed research.

4.b. If yes, please explain:

If you answered "Yes" to Question 4.a., you must provide an explanation here as to the actual or potential impact of the proposed research on the environment. Your entry is limited to 55 characters.

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or environmental impact statement (EIS) been performed? Yes/No.

This field is required if you answered "Yes" to Question 4.a. Check "Yes" or "No."

4.d. If yes, please explain:

Enter additional details about the EA or EIS here. Your entry is limited to 55 characters.

5. Is the research performance site designated, or eligible to be designated, as a historic place?

This field is required.

If any research performance site is designated, or eligible to be designated, as a historic place, check the "Yes" box. Otherwise, check "No."

5.a. If yes, please explain:

If you checked "Yes" to indicate that any performance site is designated, or eligible to be designated, as a historic place, provide the explanation here. Your entry is limited to 55 characters.

6. Does this project involve activities outside of the United States or partnerships with international collaborators?

This field is required.

Indicate whether this project involves activities outside of the United States or partnerships with international collaborators. Check "Yes" or "No."

Applicants to NIH and other PHS agencies must check "Yes" if the applicant organization is a foreign institution or if the project includes a foreign component. See NIH Glossary for a definition of a foreign component.

If you have checked "Yes" to Question 6, you must include a "Foreign Justification" attachment in Field 12, Other Attachments. Describe special resources or characteristics of the research project (e.g., human subjects, animals, disease, equipment, and techniques), including the reasons why the facilities or other aspects of the proposed project are more appropriate than a domestic setting. In the body of the text, begin the section with a heading indicating "Foreign Justification" and name the file "Foreign Justification."

6.a. If yes, identify countries:

This field is required if you answered "Yes" to Question 6. Enter the countries with which international cooperative activities are planned.

You may use abbreviations. Your entry is limited to 55 characters.

6.b. Optional Explanation:

This field is optional. Enter an explanation for involvement with outside entities. Your entry is limited to 55 characters.

7. Project Summary/Abstract

The "Project Summary/Abstract" attachment is required.

The project summary is a succinct and accurate description of the proposed work and should be able to stand on its own (separate from the application). This section should be informative to other persons working in the same or related fields and understandable to a scientifically literate reader. Avoid both descriptions of past accomplishments and the use of the first person. Please be concise.

Format:

This section is limited to 30 lines of text, and must follow the required font and margin specifications. A summary that exceeds the 30-line limit will be flagged as an error by the Agency upon submission. Use of hyperlinks and URLs in this section is not allowed unless specified in the funding opportunity announcement.

Attach this information as a PDF file. See the Format Attachments page.

Content:

State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe the research design and methods for achieving the stated goals. Be sure that the project summary reflects the key focus of the proposed project so that the application can be appropriately categorized.

Do not include proprietary, confidential information or trade secrets in the project summary. If the application is funded, the project summary will be entered into an NIH database and made available on the NIH Research Portfolio Online Reporting Tool (RePORT) and will become public information.

Note that the "Project Summary/Abstract" attachment is not same as the "Research Strategy" attachment.

8. Project Narrative

The "Project Narrative" attachment is required.

Content:

Describe the relevance of this research to public health in, at most, three sentences. For example, NIH applicants can describe how, in the short or long term, the research would contribute to fundamental knowledge about the nature and behavior of living systems and / or the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Use of hyperlinks and URLs in this section is not allowed unless specified in the funding opportunity announcement. If the application is funded, this public health relevance statement will be combined with the project summary (above) and will become public information.

9. Bibliography & References Cited

Who must complete the "Bibliography & References Cited" attachment:

The "Bibliography & References Cited" attachment is required unless otherwise noted in the FOA.

Format:

Attach this information as a PDF file. See the Format Attachments page. Use of hyperlinks and URLs in this section is not allowed unless specified in the funding opportunity announcement.

Content:

See the following instructions for which references to include in the "Bibliography and References Cited" attachment.

When citing articles that fall under the Public Access Policy, were authored or co-authored by the applicant, and arose from NIH support, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567) for each article. 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." NIH maintains a list of such journals.

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. Active hyperlinks in this section are not allowed. The references should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research.

You are allowed to cite interim research products. Note: interim research products have specific citation requirements. See related Frequently Asked Questions for more information.

10. Facilities & Other Resources

Format:

The "Facilities & Other Resources" attachment is required unless otherwise specified in the FOA. Use of URLs and hyperlinks in this section is not allowed unless specified in the funding opportunity announcement.

Content:

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 unique 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.

Describe any special facilities used for working with biohazards and any other potentially dangerous substances. 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 New and Early Stage Investigator 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.

11. Equipment

The "Equipment" attachment is required.

Format:

Attach this information as a PDF file. Use of URLs and hyperlinks in this section is not allowed unless specified by the funding opportunity announcement.

Content:

List major items of equipment already available for this project and, if appropriate, identify the equipment's location and pertinent capabilities.

12. Other Attachments

Attach a file to provide additional information only in accordance with the FOA and/or agency-specific instructions.

If applicable, attach a "Foreign Justification" here. (See Question 6 above).