Individual Fellowship Application Guide - UCLA School of Nursing

PHS SF424 (R&R) Individual Fellowship Application GuideRegulations of the Food and Drug Administration (21 CFR 50, 21 CFR 56) generally apply to biomedicalresearch involving an unapproved drug, device or biologic and may apply to certain studies of approvedproducts. Additional information on FDA regulations is available athttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm. If work falls under FDA'sregulatory requirements, the grantee must follow both DHHS and FDA human subject protectionregulations.The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIHGuidelines) apply to all projects (NIH-funded and non NIH-funded) involving recombinant DNAmolecules that are conducted at or sponsored by an institution that receives NIH support for recombinantDNA research. See Part III, 2.9. Research Involving Recombinant DNA, including Human Gene TransferResearch.Federal requirements to protect human subjects apply to most research on human specimens (such ascells, blood, and urine), residual diagnostic specimens, and medical information. Research involvingexisting data, documents, records, pathological specimens, diagnostic specimens, or tissues that areindividually identifiable is considered “research involving human subjects.” The NIH Office ofExtramural Research Human Subjects Web site contains additional information and Frequently AskedQuestions to help investigators understand how these federal requirements apply to their research. Seehttp://grants.nih.gov/grants/policy/hs/index.htm.The DHHS regulations require the NIH to evaluate all applications and proposals involving humansubjects (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.120). This independentevaluation is conducted at the NIH through the peer review system and NIH staff review, and, as required,will take into consideration the risks to the subjects, the adequacy of protection against these risks, thepotential benefits of the research to the subjects and others, and the importance of the knowledge gainedor to be gained. On the basis of this evaluation, the NIH may approve or disapprove the application orproposal, or enter into negotiations to develop an approvable one.5.2 Vulnerable PopulationsInvestigators who conduct research involving pregnant women, human fetuses and neonates, prisoners (orsubjects who become prisoners after the research has started) or children, must follow the provisions ofthe regulations in Subparts B, C, and D of 45 CFR Part 46, respectively. The subparts describe theadditional protections required for conducting research involving these populations. Relevant informationmay be obtained at the OHRP Web site (http://www.hhs.gov/ohrp/policy/index.html).Exemptions 1-6 do not apply to research involving prisoners or subjects who become prisoners (seeSubpart C). Although Exemptions 1 and 3-6 apply to research involving children (see Subpart D),Exemption 2 can only be used for research involving educational testing or observations of publicbehavior when the investigator(s) do not participate in the activities being observed.5.3 Data and Safety Monitoring Plans for Clinical TrialsFor each proposed clinical trial, NIH requires a data and safety monitoring plan that describes oversightand monitoring to ensure the safety of participants and the validity and integrity of the data. The level ofmonitoring should be commensurate with the risks and the size and complexity of the clinical trial. Priorto the accrual of human subjects, a detailed data and safety monitoring plan must be submitted to theapplicant’s IRB and to the funding entity for approval. Adverse Events must be reported to the IRB, theNIH funding Institute or Center, and other appropriate offices or agencies. This policy requirement is inaddition to any monitoring requirements imposed by 45 CFR Part 46. NIH policy specifically requires theestablishment of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involvingPart II: Human SubjectsII-18