1. IRB SUBMISSION PROCESS FOR SHB STUDIES Version 9/18/2013

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3. 3 Questions? Contact the IRB staff at (404) 712-0720 or irb@emory.edu Not “Research” with “Human Subjects” 1. PI can make this determination without the IRB. 2. PI is encouraged to consult IRB in making this decision (email request to irb@emory.edu). 3. PI can submit study proposal in eIRB to get an official letter.  Is it “research”? Term of art defined at 45 CFR Section 46.102(d): a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.  Does it involve “human subjects”? Term of art defined at 45 CFR Section 46.102(f): a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information Exempt  PI must submit study proposal via eIRB for this determination  Informed Consent usually must be obtained; HIPAA may still apply  Many surveys and interviews of adults, educational program evaluations and secondary analysis of de-identified pre-existing data or samples  The IRB is the only unit authorized to make this determination  Exempt determination is valid indefinitely unless changes in project affect the analysis. PI must request clarification from IRB (submit an “amendment” in eIRB) Expedited Only if IRB determines that study poses no more than minimal risk AND all study procedures fit one or more categories in a special list published in the Federal Register  E.g., surveys, questionnaires, focus groups, noninvasive biological samples Full Board All other studies must be reviewed at a convened meeting of the IRB where quorum is present Emory University IRB Guidance for Investigators Proposing Sociobehavioral Research

4. Research or Not? Not Research as defined by 45 CFR 46: Some education activities Some Oral History Projects Quality Improvement, Assurance, Assessment Studies Case Reports or Case Series Some Ethnographic Studies Public Health Practice 4 Research (45 CFR Section 46.102(d)): a systematic investigation designed to develop or contribute to generalizable knowledge.

5. Human Subjects or Not? 45 CFR Section 46.102(F): a living individual about whom an investigator conducting research obtains data through intervention or interaction with individuals or obtains identifiable private information About a living person Intervention/interaction – in person, phone, internet Identifiers Private vs Public 5

6. Submitting Your Study Obtain an eIRB accounteIRB account Get CITI certificationCITI certification Create your eIRB submission application Get all accompanying documents needed for uploadingdocuments PI submits study for FA/Dept approval Get FA/Dept Approval and Submit to IRB Office 6

7. eIRB Study Application Online Submission Application (Smart Form) Upload Accompanying Documents Funding Documents – grant or contract (including budget) Lay summary Protocol Questionnaires, Interview Scripts, Surveys, Recruitment Materials: Advertisements, Flyers, Scripts Inform Consent Forms (and/or Assent Forms, Oral Consent Scripts) Miscellaneous Documents (Site or Database Permission Letters, Local IRB or Cultural Context Letters, Privacy Policy from contract workers…) 7

8. Who’s the PI?/ Required Reviews Undergraduate Students 8 -The Faculty Advisor/Research Mentor = Principal Investigator (PI). -The Student = Co-Investigator on the study -PI’s Department will have to approve the study before it can come to our office Graduate Students -The Student = Principal Investigator (PI) -The Faculty Advisor(s) = Co-Investigator (Co-I) and will have to approve the study before it can come to our office

9. For Further Submission Guidance, Assistance, Examples… Faculty Advisor IRB website at http://www.emory.edu/IRB/http://www.emory.edu/IRB/ eIRB Videos online Friday Office Hours 11AM-1PM Call or email the IRB OfficeIRB Office 9