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




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3. Instructions for Preparing the Section on Protection of Human Subjects

Scenario A. No Human Subjects Research Proposed

Criteria


Human Subjects Research No

Exemption Claimed No

Clinical Trial N/A

NIH-Defined Phase III Clinical Trial N/A

Instructions and Required Information


If proposed studies using human data or biological specimens do not involve human subjects, provide an explanation of why the proposed studies do not constitute research involving human subjects.

In the application narrative for paper PHS398 applications, create a heading labeled “Protection of Human Subjects” and include the following statement below the heading: “No Human Subjects Research is proposed in this application” For electronic SF424 (R&R) applications, save this explanation as a .pdf file entitled “Human Subjects Research.pdf” and attach in line 6 of the PHS 398 Research Plan (for K applicants, item 14 of the PHS 398 Career Development Award Supplemental Form; for F applicants, item 9 of the PHS Fellowship Supplemental Form – Research Training Plan).

The explanation could include: a description of the source of the data/biospecimens and whether there is any intervention or interaction with the subjects in order to obtain the specimens and data; what identifiers will be associated with the human specimens and data and who has access to subject identities; the role(s) of providers of the data/biological specimens in the proposed research; and the manner by which the privacy of research participants and confidentiality of data will be protected.

Research that does not involve intervention or interaction with living individuals, or identifiable private information, is not human subjects research (see Definitions in Part III.3). Research involving the use of coded private information or biological specimens may not constitute human subjects research if the conditions of the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens have been met (http://www.hhs.gov/ohrp/policy/cdebiol.html).

Research that only proposes the use of cadaver specimens is not human subjects research because human subjects are defined as “living individuals.” The use of cadaver specimens is not regulated by 45 CFR part 46, but may be governed by other Federal, State or local laws.

Scenario B. Non-Exempt Human Subjects Research

Criteria


Human Subjects Research Yes

Exemption Claimed No

Clinical Trial No

NIH-Defined Phase III Clinical Trial No

Instructions and Required Information


Although no specific page limitation applies to this section of the application, be succinct.

In the application narrative for paper PHS398 applications, create a section entitled “Protection of Human Subjects” and create a subheading for each of the following items. For electronic SF424 (R&R) applications, provide the required information as a separate file. Save each of the four files as a .pdf file and attach in lines 6-9 of the PHS 398 Research Plan (for K applicants, items 14-17 of the PHS 398 Career Development Award Supplemental Form; for F applicants, items 9-12 of the PHS Fellowship Supplemental Form – Research Training Plan).

Follow the instructions that are identified for each of the following topics and provide the required information:

Protection of Human Subjects - Section 4.1 - 4.1.4

Inclusion of Women and Minorities - Section 4.2

Targeted/Planned Enrollment Table(s) - Section 4.3

Inclusion of Children - Section 4.4

If the research involves collaborating sites or subprojects, provide the information identified above for each participating site.


Scenario C: Human Subjects Research Claiming Exemption 1, 2, 3, 4, 5, or 6

Criteria


Human Subjects Research Yes

Exemption Claimed 1, 2, 3, 4, 5, or 6

Clinical Trial Yes or No

NIH-Defined Phase III Clinical Trial No

Instructions and Required Information


Although no specific page limitation applies to this section of the application, be succinct. The exemptions appear in Part III under Human Subjects Research Definitions and Terms.

Although the research may be exempt from the DHHS regulatory requirements, it is still research involving human subjects and the application must follow the instructions that are identified for each of the following topics and provide the information that is requested.

In the application narrative for paper PHS398 applications, provide the required information for each of the following topics below. For electronic SF424 (R&R) applications, provide the required information for each of the following topics below as a separate files. Save each of the four files as a .pdf file and attach in lines 6-9 of the PHS 398 Research Plan (for K applicants, items 14-17 of the PHS 398 Career Development Award Supplemental Form; for F applicants, items 9-12 of the PHS Fellowship Supplemental Form - Research Training Plan).

Protection of Human Subjects - Include the following statement: “This Human Subjects Research falls under Exemption(s) … .” Clearly identify which exemption(s) (1, 2, 3, 4*, 5, or 6) you are claiming and justify why the research meets the criteria for the exemption(s) that you have claimed.

If the research will include a clinical trial, even if exempt, include a Data and Safety Monitoring Plan – Section 4.1.5, and address the ClinicalTrials.gov requirements if applicable – Section 4.1.6.

Inclusion of Women and Minorities - Section 4.2

Targeted/Planned Enrollment Table(s) - Section 4.3

Inclusion of Children - Section 4.4

*NOTE: If all of the proposed research meets the criteria for Exemption 4, then the requirements for inclusion of women and minorities, targeted/planned enrollment table, and inclusion of children, do not need to be addressed.

Scenario D: Delayed-Onset Human Subjects Research

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