Individual Fellowship Application Guide - UCLA School of Nursing

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PHS SF424 (R&R) Individual Fellowship Application GuideField NameInstructionsavailable in a free, online format may include URLs or PMCID numbers along withthe full reference (note that copies of these publications are not accepted asappendix material, see F. Appendix below).Note for applications using the Adobe B (not B-1) package only: If submitting aresubmission of a renewal, this upload will not be available. Instead, the ProgressReport Publication List (Item 5) should be saved as an individual pdf file titled“Progress_Report_Publication_List.pdf” and attached in Item 12 (OtherAttachments) of the SF424 (R&R) Other Project Information component.HumanSubjects6. HumanSubjectsInvolvementIndefinite?Prefilled from the Research and Related Other Project Information form. If activitiesinvolving human subjects are not planned at any time during the proposed project atany performance site, skip the remainder of the block and continue to OtherResearch Training Plan Sections. If you have indicated “Yes” for Human Subjectsinvolvement, consult with your Sponsor and Administrative Officials at theSponsoring Institution before completing this section, and refer to Part IISupplemental Instructions for Preparing the Human Subjects Section of theResearch Training Plan. Human subjects requirements may apply even if you areobtaining specimens/data from collaborators or if you are subcontracting the humanresearch to another organization. For all research involving human subjects, a partof the peer review process will include careful consideration of protections fromresearch risks, as well as the appropriate inclusion of women, minorities, andchildren. The Scientific Review Group (SRG) will assess the adequacy ofsafeguards of the rights and welfare of research participants, and the appropriateinclusion of women, minorities, and children, based on the information in theapplication. The evaluation of the inclusion plans will be factored into the overallscore that the SRGs award for scientific and technical merit of the application.Much of the information on the protection of human subjects that you are requiredto provide in the Fellowship application is identical to information that you will berequired to provide for IRB review at your own institution.Do not use the protection of human subjects section to circumvent the page limits ofthe Research Strategy.Check “Yes” if at the time of application plans to involve human subjects areunknown. If an award is made, the fellow may not participate in human subjectsresearch until an updated research training plan is submitted and approved by theawarding component. Such a plan must be developed in consultation with thesponsor. Certification of the date of IRB approval must also be submitted before thefellow can participate in human subjects research.7. Clinical Trial Check the “Yes” or “No” box to indicate whether the project is a clinical trial. TheNIH defines a clinical trial as a prospective biomedical or behavioral research studyof human subjects that is designed to answer specific questions about biomedical orbehavioral interventions (drugs, treatments, devices, or new ways of using knowndrugs, treatments, or devices).Part I: Instructions for Preparing and Submitting an Application I-88
PHS SF424 (R&R) Individual Fellowship Application GuideField Name8. Agency-Defined PhaseIII ClinicalTrial?9. Protection ofHumanSubjects10. Inclusion ofWomen andMinorities11. Targeted/PlannedEnrollment(ClinicalResearch Only)InstructionsCheck the “Yes” or “No” box to indicate whether the project is an NIH-definedPhase III clinical trial. An NIH-defined Phase III clinical trial is a broadly basedprospective Phase III clinical investigation, usually involving several hundred ormore human subjects, for the purpose of either evaluating an experimentalintervention in comparison with a standard or control intervention or of comparingtwo or more existing treatments. Often the aim of such investigation is to provideevidence leading to a scientific basis for consideration of a change in health policyor standard of care. The definition includes pharmacologic, non-pharmacologic, andbehavioral interventions given for disease prevention, prophylaxis, diagnosis, ortherapy. Community trials and other population-based intervention trials are alsoincluded.Refer to Part II, Supplemental Instructions for Preparing the Human SubjectsSection of the Research Training Plan.This section is required for applicants answering “yes” to the question “Are humansubjects involved?” on the R&R Other Project Information form. If the answer is“No” to the question but the proposed research involves human specimens and/ordata from subjects applicants must provide a justification in this section for theclaim that no human subjects are involved.Do not use the protection of human subjects section to circumvent the page limits ofthe Research Strategy.Save this information in a single file in a location you remember. Click AddAttachment, browse to where you saved the file, select the file, and then clickOpen.Refer to Part II, Supplemental Instructions for Preparing the Human SubjectsSection of the Research Plan. This section is required for applicants answering “yes”to the question “Are human subjects involved?” on the R&R Other ProjectInformation form and the research does not fall under Exemption 4.Save this information in a single file in a location you remember. Click AddAttachment, browse to where you saved the file, select the file, and then clickOpen.If this application involves the Inclusion of Women and Minorities, complete theTargeted/Planned Enrollment Table for each protocol; see Part II, SupplementalInstructions for Preparing the Human Subjects Section of the Research Plan, Section4.3. For applicants answering “Yes” to the question “Are human subjects involved?”on the R&R Other Project Information Form and the research does not fall underExemption 4, complete the Targeted/Planned Enrollment Table for each protocol.Save this information in a single file in a location you remember. Click AddAttachment, browse to where you saved the file, select the file, and then clickOpen.Part I: Instructions for Preparing and Submitting an Application I-89
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Individual Fellowship Application Guide - UCLA School of Nursing

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