Individual Fellowship Application Guide - UCLA School of Nursing

PHS SF424 (R&R) Individual Fellowship Application GuideInstructions and Required InformationIf proposed studies using human data or biological specimens do not involve human subjects as describedin the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens(http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm), provide an explanation of why theproposed studies do not constitute research involving human subjects. Save this explanation as a .pdf fileentitled “Human Subjects Research.pdf” and attach in Item 9 of the PHS Fellowship Supplemental Form– Research Training Plan.The explanation could include: a description of the source of the data/biological specimens, and whetherthere is any intervention or interaction with the subjects in order to obtain the specimens and data; whatidentifiers will be associated; the role(s) of providers of the data/biological specimens in the proposedresearch; and the manner by which the privacy of research participants and confidentiality of data will beprotected.Research that does not involve intervention or interaction with living individuals, or identifiable privateinformation, is not human subjects research (see Definitions in Part III.3). Research involving the use ofcoded private information or biological specimens may not constitute human subjects research if theconditions of the OHRP Guidance on Research Involving Coded Private Information or BiologicalSpecimens have been met (http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm).Research that only proposes the use of cadaver specimens is not human subjects research because humansubjects are defined as “living individuals.” The use of cadaver specimens is not regulated by 45 CFRPart 46, but may be governed by other Federal, State or local laws.Scenario B. Non-Exempt Human Subjects ResearchCriteriaHuman Subjects ResearchExemption ClaimedClinical TrialNIH-Defined Phase III Clinical TrialYesNoNoNoInstructions and Required InformationAlthough no specific page limitation applies to this section of the application, be succinct.In the application narrative, provide the required information for each of the following topics below as aseparate file. Save each of the four files as a .pdf file and attach in Items 9-12 of the PHS FellowshipSupplemental Form – Research Training Plan.Protections for Human Subjects - Section 4.1 - 4.1.4Inclusion of Women and Minorities - Section 4.2Targeted/Planned Enrollment Table(s) - Section 4.3Inclusion of Children - Section 4.4If the research involves collaborating sites, provide the information identified above for each participatingsite.Part II: Human SubjectsII-4