Individual Fellowship Application Guide - UCLA School of Nursing

More documents

Recommendations

Info

PHS SF424 (R&R) Individual Fellowship Application Guide3. Gender representation of specimens or existing datasets cannot be accurately determined (e.g.,pooled blood samples, stored specimens, or data-sets with incomplete gender documentation areused), and this does not compromise the scientific objectives of the research.B. Minority groups or subgroups:1. Some or all minority groups or subgroups are excluded from the study because:• inclusion of these individuals would be inappropriate with respect to their health;• the research question addressed is relevant to only one racial or ethnic group;• evidence from prior research strongly demonstrates no differences between racial or ethnicgroups on the outcome variables;• a single minority group study is proposed to fill a research gap; or• sufficient data already exists with regard to the outcome of comparable studies in theexcluded racial or ethnic groups and duplication is not needed in this study.2. Some minority groups or subgroups are excluded or poorly represented because the geographicallocation of the study has only limited numbers of these minority groups who would be eligible forthe study, and the investigator has satisfactorily addressed this issue in terms of:• the size of the study;• the relevant characteristics of the disease, disorder or condition; or• the feasibility of making a collaboration or consortium or other arrangements to includerepresentation.3. Some minority groups or subgroups are excluded or poorly represented because the purpose of theresearch constrains the applicant's selection of study subjects by race or ethnicity (e.g., uniquelyvaluable cohorts, stored specimens or existing datasets are of limited minority representation, verysmall numbers of subjects are involved, or overriding factors dictate selection of subjects, such asmatching of transplant recipients or availability of rare surgical specimens).4. Racial or ethnic origin of specimens or existing datasets cannot be accurately determined (e.g.,pooled blood samples, stored specimens or data sets with incomplete racial or ethnic documentationare used) and this does not compromise the scientific objectives of the research.4.2.1 Additional Instructions and Requirements When NIH-DefinedPhase III Clinical Trials Are ProposedIf the proposed research includes an NIH-Defined Phase III Clinical Trial, the section on Inclusion ofWomen and Minorities also must address whether clinically important sex/gender and/or race/ethnicitydifferences are expected from the intervention effect. The discussion may include supporting evidenceand/or data derived from animal studies, clinical observations, metabolic studies, genetic studies,pharmacology studies, and observational, natural history, epidemiology and other relevant studies. Thediscussion of expected sex/gender and/or race/ethnicity differences in intervention effect must includeselection and discussion of one of the following analysis plans:• Plans to conduct valid analyses to detect significant differences in intervention effect amongsex/gender and/or racial/ethnic subgroups when prior studies strongly support thesesignificant differences among subgroups, or• Plans to include and analyze sex/gender and/or racial/ethnic subgroups when prior studiesstrongly support no significant differences in intervention effect between subgroups.Part II: Human SubjectsII-13
PHS SF424 (R&R) Individual Fellowship Application Guide(Representation of sex/gender and racial/ethnic groups is not required as subject selectioncriteria, but inclusion is encouraged.), or• Plans to conduct valid analyses of the intervention effect in sex/gender and/or racial/ethnicsubgroups (without requiring high statistical power for each subgroup) when the prior studiesneither support nor negate significant differences in intervention effect among subgroups.4.3 Instructions for Completing the Targeted/PlannedEnrollment Tables for Reporting Race and Ethnicity Datafor Subjects in Clinical ResearchIf your application includes Targeted/Planned Enrollment tables, save all as a single PDF file and attachthem in Item 11. Targeted/Planned Enrollment of the PHS Fellowship Supplemental Form – ResearchTraining Plan.The NIH Policy on Reporting Race and Ethnicity Data for Subjects in Clinical Research is described andreferenced in Section 5.8.A. New ApplicationsAll new clinical research studies should collect and report information on participants with respect to twocategories of ethnicity and five categories of race. The Inclusion Enrollment Report(http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc) for reporting summary dataon participants to NIH includes two categories of ethnicity and five categories of race and is based on theOffice of Management and Budget (OMB) reporting standards for data on race and ethnicity.Investigators should review the instructions and Frequently Asked Questions about using the EnrollmentTable format at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.When reporting these data in the aggregate, investigators should report: (a) the number of researchparticipants in each ethnic category; (b) the number of research participants who selected only onecategory for each of the five racial categories; (c) the total number of research participants who selectedmultiple racial categories reported as the “number selecting more than one race,” and (d) the number ofresearch participants in each racial category who are Hispanic or Latino. Investigators may provide thedetailed distributions, including all possible combinations, of multiple responses to the racial designationsas additional information. However, more detailed data should be compiled in a way that they can bereported using the required categories.Instructions for Completing Targeted/Planned Enrollment Table(http://grants.nih.gov/grants/funding/424/SF424R-R_enrollment.doc)Attach the Targeted/Planned Enrollment Table as Item 11. Provide the study title.The “Total Planned Enrollment” means the number of subjects that are expected to be enrolled in thestudy, consistent with the definition in ClinicalTrials.gov.The “Total Planned Enrollment” will be reported in two ways in the table: by “Ethnic Category” and by“Racial Categories.”“Ethnic Category”: Provide the numeric distribution of the Total Planned Enrollment according toethnicity and sex/gender in the top part of the table.“Racial Categories”: Provide the numeric distribution of the Total Planned Enrollment, this time by racialcategories and sex/gender, in the bottom part of the table. Note that Hispanic is an ethnic, not a racial,category.Part II: Human SubjectsII-14
Page 1 and 2:
U.S. Department of Health and Human
Page 3:
PHS SF424 (R&R) Individual Fellowsh
Page 6 and 7:
PART IInstructions for Preparing an
Page 8 and 9:
Page 10 and 11:
Page 12 and 13:
Page 14 and 15:
Page 16 and 17:
Page 18 and 19:
Page 20 and 21:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77: PHS SF424 (R&R) Individual Fellowsh
Page 136 and 137: PART IIIPolicies, Assurances, Defin
Page 172: PHS SF424 (R&R) Individual Fellowsh
show all

Individual Fellowship Application Guide - UCLA School of Nursing

Create successful ePaper yourself

Delete template?

Save as template?