Individual Fellowship Application Guide - UCLA School of Nursing

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PHS SF424 (R&R) Individual Fellowship Application Guide2. Assurances and CertificationsEach application to the PHS requires that the following assurances and certifications be verified bychecking the “I agree” box on line 17 of the SF424 (R&R) Cover Component.Fellowship Applicant (PD/PI) and SO VerificationAfter the Fellowship Applicant (PD/PI) and SO successfully submit an application, they will receive anautomatically generated email requesting them to view and verify (or reject) the application on-line in theCommons. To do this, the PD/PI and SO need to:1. Make sure they can log onto the NIH eRA Commons. Before they receive the email, they should besure to know their Commons account names and passwords.2. Verify the electronic grant application via the NIH eRA Commons. Complete instructions on theverification process are in the Applicant Package.The assurances listed and explained below may or may not be applicable to your project, program, or typeof applicant organization. Applicants and grantees must comply with a number of additional public policyrequirements. Refer to the NIH Grants Policy Statement for additional information.2.1 Human Subjects Research(See also Part II: Supplemental Instructions for Preparing the Human Subjects Section of the ResearchTraining Plan.)The DHHS regulations for the protection of human subjects provide a systematic means, based onestablished, internationally recognized ethical principles, to safeguard the rights and welfare ofindividuals who participate as subjects in research activities supported or conducted by the DHHS. Theregulations stipulate that the awardee organization, whether domestic or foreign, bears responsibility forsafeguarding the rights and welfare of human subjects in DHHS-supported research activities. Theregulations require that all organizations engaged in non-exempt human subjects research supported orconducted by the DHHS hold a Federal-wide Assurance (FWA) with the Office for Human ResearchProtections (OHRP), and establish appropriate policies and procedures for the protection of humansubjects. These regulations, 45 CFR Part 46, Protection of Human Subjects, are available from the OHRP,Department of Health and Human Services, The Tower Building, 1101 Wootton Parkway, Suite 200,Rockville, MD 20852; telephone: 1-866-447-4777 (toll-free) or (240) 453-6900; email:ohrp@osophs.dhhs.gov. In general OHRP considers organizations that receive direct support from DHHSfor the conduct of nonexempt human subjects research to be engaged in human subjects research (formore information on whether an institution is engaged in human subjects research, refer tohttp://www.hhs.gov/ohrp/humansubjects/guidance/engage08.html). When a research project is conductedby multiple organizations each organization that is engaged in human subjects research must hold anFWA and comply with the regulations at 45 CFR 46.Non-exempt research involving human subjects may only be conducted under a DHHS award if theengaged organization(s) is operating in accord with an approved FWA and provides verification that anInstitutional Review Board (IRB) that is registered under the specific FWA has reviewed and approvedthe proposed activity in accordance with the DHHS regulations. No award to an individual will be madeunless that individual is affiliated with an assured organization that accepts responsibility for compliancewith the DHHS regulations. Foreign applicant organizations must also comply with the provisions of theregulations unless a determination of equivalent protections is made in accord with 45 CFR 46.101(h).Part III: Policies, Assurances, Definitions, and Other InformationIII-10
PHS SF424 (R&R) Individual Fellowship Application GuideUnder DHHS regulations to protect human subjects, certain research areas are exempt. (See ExemptionCategories). With the exception of research projects that meet the criteria for Exemption 4, studies thatare exempt from the human subjects regulatory requirements must still address the inclusion of women,minorities and children in the study design.Regulations 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.Research involving the use of coded private information or biological specimens may not constitutehuman subjects research. Refer to the OHRP Guidance on Research Involving Coded Private Informationor Biological Specimens to clarify when such research is or is not research involving human subjects(available at http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm). For additional helpdetermining whether research that involves the use of human data or biological specimens is humansubjects research, please refer to this web site: http://grants.nih.gov/grants/policy/hs/.Vulnerable PopulationsInvestigators who conduct research involving pregnant women, human fetuses and neonates, prisoners(including subjects who become prisoners after the research has started), or children, must follow theprovisions of the regulations in Subparts B, C, and D of 45 CFR Part 46, respectively. The subpartsdescribe the additional protections required for conducting research involving these populations. Relevantinformation may be obtained at the OHRP Web site (http://www.hhs.gov/ohrp/policy/index.html).REMINDER: DHHS regulations at 45 CFR Part 46, subpart C describe requirements for additionalprotections for research involving prisoners as subjects or individuals who become prisoners after theresearch has started. Refer to: http://www.hhs.gov/ohrp/humansubjects/guidance/prisoner.htm for completeinstructions.Exemptions 1-6 (see Exemptions under Human Subjects Research Definitions and Terms, Part III.3) donot apply to research involving prisoners or subjects who become prisoners (see Subpart C). AlthoughExemptions 1 and 3-6 apply to research involving children (see Subpart D), Exemption 2 can only beused for research involving educational testing or observations of public behavior when theinvestigator(s) do not participate in the activities being observed.Data and Safety MonitoringFor 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 the establishment of Data and Safety Monitoring Boards (DSMBs) formulti-site clinical trials involving interventions that entail potential risk to the participants, and generallyfor Phase III clinical trials. A DSMB also may be appropriate for clinical trials if the studies are blinded(masked), employ high-risk interventions, or involve vulnerable populations.Part III: Policies, Assurances, Definitions, and Other InformationIII-11
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Individual Fellowship Application Guide - UCLA School of Nursing

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