Instructions for phs 398 and sf 424(R&R) Form Approved Through 08/31/2015




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1. Introduction


A Protection of Human Subjects section of the Research Plan is required for all applications submitted using the PHS 398 and SF424 (R&R) instructions and forms. The information provided in the section on Protection of Human Subjects should be consistent with the information provided on the face page of the application.

For all research involving human subjects, the Scientific Review Group (SRG) will assess the adequacy of protections for research participants against research risks, and the scientifically appropriate inclusion of women, minorities, and children, based on the information provided in the application.

To assist in preparing the section on Protection of Human Subjects, six possible scenarios are provided in Section 2 below. All research projects will fall into one of these six scenarios. (To help determine whether research that involves the use of human data or biological specimens is human subjects research, refer to this Web site: http://grants.nih.gov/grants/policy/hs/.) Determine which scenario the proposed research falls into, then go to the specific instructions applicable to that scenario in Section 3. Where appropriate, Section 3 provides instructions on addressing the Inclusion of Women and Minorities, the Targeted/Planned Enrollment Table, and the Inclusion of Children (items 7, 8, and 9 of the Research Plan; for K applicants, items 15, 16, and 17 of the PHS Career Development Award Supplemental Form; for Fellowship applicants, items 10, 11, and 12 of the Research Training Plan). All definitions related to human subjects research are linked to text found in Part III.3 under Human Subjects Research Definitions and Terms. Section 5 of this Part includes descriptions of and links to the DHHS Human Subjects Protections regulations and NIH policies that apply to clinical research.

Do not use the human subjects section to circumvent the page limit of the Research Strategy.


2. Scenarios

Scenario A. No Human Subjects Research


If no human subjects research is proposed in the application, you will have designated “No” in Item 4. on the PHS 398 face page (or Item 1 on the SF424 R&R Other Project Information page). If your proposed research involves the use of human data and/or biological specimens, you must provide a justification for your claim that no human subjects are involved in the Protection of Human Subjects section of the Research Plan.

See the instructions for Scenario A.

Unless you are providing a special justification as described above, no additional information is necessary if no human subjects are involved.

Scenario B. Non-Exempt Human Subjects Research


If research involving human subjects is anticipated to take place under the award, you will have designated “Yes” in Item 4 on the PHS 398 face page (or you will have designated “Yes” Item 1 of the SF424 R&R Other Project Information Page and entered your OHRP assurance number in Item 1a). In the Protection of Human Subjects section of the Research Plan, you must provide sufficient information for reviewers to determine that the proposed research meets (1) the requirements of the DHHS regulations to protect human subjects from research risks (45 CFR part 46), and (2) the requirements of NIH policies on inclusion of women, minorities, and children. Research involving a clinical trial will fall under either Scenario E or F below.

See the instructions for Scenario B.


Scenario C. Exempt Human Subjects Research


If all of the proposed human subjects research meets the criteria for one or more of the exemptions from the requirements in the DHHS regulations (46.101(b)), “yes” should be designated in item 4 and in item 4a on the PHS 398 face page (or Yes should be designated in Item 1 on the SF424 R&R Other Project Information page, the appropriate exemption number checked in Item 1a, and “NA” entered for the Human Subject Assurance Number since no OHRP assurance number is required for exempt research). In the section on Protection of Human Subjects in the Research Plan (or Item 9 of the PHS Fellowship Supplemental form for Fellowship applicants), provide a justification for the exemption(s) containing sufficient information about the involvement of the human subjects to allow a determination by peer reviewers and NIH staff that claimed exemption(s) is/are appropriate.

The PHS will make a final determination as to whether the proposed activities are covered by the regulations or are in an exempt category, based on the information provided in the Research Plan. When in doubt, consult with the Office for Human Research Protections (OHRP), Department of Health and Human Services by accessing their Web site http://www.hhs.gov/ohrp/ for guidance and further information.

The exemptions appear in Part III under Human Subjects Research Definitions and Terms.

Unless the research meets the requirements for Exemption 4, the investigator(s) must address the requirements of NIH policies on the inclusion of women, minorities, and children.

Please note: if the proposed research involves only the use of human data or biological specimens, you should first determine whether the research involves human subjects. The exemptions do not apply if the research does not involve human subjects. For help determining whether research that involves the use of human data or biological specimens is human subjects research, please refer to this Web site: http://grants.nih.gov/grants/policy/hs/.

See the instructions for Scenario C.


Scenario D. Delayed-Onset Human Subjects Research


If human subjects research is anticipated within the period of the award but plans for involvement of human subjects cannot be described in the application as allowed by the DHHS regulations (45 CFR part 46.118), you will have designated “Yes” in Item 4. on the PHS 398 face page (or you will have designated Yes in Item 1 on the SF424 R&R Other Project Information page and entered your OHRP assurance number in Item 1a). In the section on Protection of Human Subjects in the Research Plan (or Item 9 of the PHS Fellowship Supplemental form for Fellowship applicants), you should either include an explanation of anticipated protections for human subjects or an explanation of why protections cannot be described.

Examples of delayed-onset of human subjects research include:



  • Human subjects research is dependent upon the completion of animal or other studies; or

  • Human subjects research protocols to be included will undergo an independent decision-making process (often defined by a FOA).

See instructions for Scenario D.

Scenario E. Human Subjects Research Involving a Clinical Trial


If research involving human subjects is anticipated to take place under the award, and you intend to conduct a clinical trial during the project period, you will have designated “Yes” in Item 4 on the PHS 398 face page, “No” in Item 4a on the PHS 398 face page, and “Yes” in Item 4c on the PHS 398 face page (or you will have designated Yes in Item 1 on the SF424 R&R Other Project Information page, entered your OHRP assurance number in Item 1a, and checked “Yes” to Clinical Trial in Item 2 on either the PHS 398 Cover Page Component or in item B.7 on the PHS Fellowship Supplemental Form).

In the section on Protection of Human Subjects in the Research Plan (or Item 9 of the PHS Fellowship Supplemental form for Fellowship applicants), you must provide sufficient information for reviewers to determine that the proposed research meets:

1) the requirements of the DHHS regulations to protect human subjects from research risks (45 CFR part 46);

2) NIH policy requirements for Data and Safety Monitoring for Clinical Trials;

3) the ClinicalTrials.gov requirements if applicable;

4) the requirements of NIH policies on inclusion of women, minorities, and children; and

5) the requirements of NIH policy on reporting race and ethnicity data for human subjects in NIH-defined clinical research.

See instructions for Scenario E.


Scenario F. Human Subjects Research Involving an NIH-Defined Phase III Clinical Trial


If research involving human subjects is anticipated to take place under the award, and you intend to conduct an NIH-defined Phase III clinical trial during the project period, you will have designated “Yes” in Item 4 on the PHS 398 face page, “No” in Item 4a on the PHS 398 face page, and “Yes” in Item 4d on the PHS 398 face page (or you will have designated Yes in Item 1 on the SF424 R&R Other Project Information page, entered your OHRP assurance number in Item 1a, and checked “Yes” to Agency-Defined Phase III Clinical Trial in either Item 2 on the PHS 398 Cover Page Component or in item B.8 on the PHS Fellowship Supplemental Form). In the section on Protection of Human Subjects in the Research Plan (or Item 9 of the PHS Fellowship Supplemental form for Fellowship applicants), you must provide sufficient information for reviewers to determine that the proposed research meets:

1) the requirements of the DHHS regulations to protect human subjects from research risks (45 CFR part 46);

2) NIH policy requirements for Data and Safety Monitoring for Clinical Trials;

3) the ClinicalTrials.gov requirements if applicable;

4) the requirements of NIH policies on inclusion of women, minorities, and children;

5) the requirements of NIH policy on reporting race and ethnicity data for subjects in NIH-defined clinical research; and

6) additional requirements for NIH-defined Phase III clinical trials.

See instructions for Scenario F.


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