IRB Inquiry Form

Emory IRB Policies and Procedures

Emory IRB contact info for study-specific questions

Conducting Research at CHOA?

1.  Does My Project Need IRB Review?

  • Emory IRB only reviews projects that meet the definition of “human subjects research”
    • study involving living persons or their identifiable data; “identifiable” = contains any element(s) considered to be identifiers (hyperlinked list refers to PHI identifiers, but for the purposes of what IRB considers "identifiable" data, these are relevant even when HIPAA does not apply), AND
    • findings have to be generalizable = i.e. relevant to a wider population beyond just the specific people/setting in the study
  • Non-Human Subjects Research Determination Form – complete this if not sure whether IRB submission is required; if project is NHSR, save form for reference/documentation
  • Levels of IRB review(Exempt, Expedited, full board)

2.  PI qualifications:
  • Student-led research:
    • Undergraduates and Laney Graduate School students are not allowed to serve as PI on IRB submissions. Select the faculty advisor as the PI on the study, and include the student in the local study team members list as a Co-investigator.
    • Rollins School of Public Health students can be PIs, and the IRB submission requires approval from the student’s faculty advisor.
  • SOMPI eligibility policy (SOM Residents and fellows are not allowed to be PI)
  • ECAS PI eligibility policy
  • EHC Nurses: BSN or higher degree with Doctoral nurse mentor, prior written approval of SON department chair, can be PI for minimal risk research;
    • If working on a study that meets the FDA definition of “clinical trial,” need written approval of Service Line Director and SON Dean’s Office and SON, SOM, or SPH faculty as Co-I.
  • EHC Pharmacy:
    • EHC Pharmacist with PharmD: may only serve as PI with written approval of Service Line Director of Hospital Chief Medical Officer and SOM Dean’s Office and Emory faculty as Co-I.
    • EHC-affiliated Pharmacy Residents: Can be PI if Emory faculty, or Collin Lee approved in writing and is listed as co-I; only minimal risk, non-interventional research, and not for any NIH- or FDA- definition clinical trial.

3. Study staff training guidance (especially CITI training!)
  • Refer to OCR guidance on clinical research training requirements for study staff
  • Group 1 Biomedical Focus (3 years) – most often required CITI training; for any general research involving or related to clinical procedures/patients/data
    • NOTE: Do NOT confuse with the "Biomedical Responsible Conduct of Research" course! RCR does not meet Emory requirements and is not accepted by the IRB.
  • Group 2 Social-Behavioral Focus (3 years) – required for staff conducting purely social-behavioral research (e.g. psychology, sociology, education, and similar) with no biomedical components
  • Group 5 Good Clinical Practice (3 years) – required for staff on clinical trials that are federally funded and/or FDA regulated regardless of funding source
  • Be sure to link your eIRB and CITI accounts by logging into CITI through the institution (Emory SSO) with your Emory NetID. Then use Step-by-Step Guidance for Selecting Required Courses and Obtaining a CITI Account (PDF)
  • If you have CITI training through another institution, please affiliate your account with Emory and take any remaining modules to achieve Emory certification. Emory does not accept outside CITI training. 
  • Emory IRB will not approve a study unless all research staff have current Emory CITI training

4. eIRB technical guidance - how to complete submissions in the eIRB system (“eIRB smartform”)
5.  Study submission guidance
  1. Protocol templates
  2. Consent form templates(signed, verbal/online, screening, assent of minor subjects)
  3. eIRB Page Level Help
  4. Retrospective medical records review: waiver of consent & waiver of HIPAA authorization
  5. Identifying prospective participants for recruitment via medical records search: partial HIPAA waiver
  6. Ancillary reviews – all studies require approval from PI’s Department; other ancillary reviews are study-dependent (find information on our eIRB guidance page)
  7. Ancillary committees’ reviews are separate from IRB review and some have their own submission processes
  8. Emory IRB will not approve a study unless all required ancillary reviews have been completed

6. Participant Recruitment

7. HIPAA in a nutshell:
  • HIPAA = federal law to protect privacy and security of patient records held by healthcare entities; invoked if research involves accessing medical records
  • Emory IRB reviews and approves release of data from healthcare records (PHI) for research: per HIPAA, Emory IRB serves as the Privacy Board for research done within any Covered Component (EHC, Grady, sometimes CHOA, etc.) of the Emory University Hybrid Covered Entity.
  • Completing eIRB smartform section “HIPAA Applicability and Waivers Requested”:
    • Start with #4 - HIPAA Applicability and Waivers Worksheet:
      • Pages 1-2: must be completed for all studies – follow all worksheet instructions carefully!
      • Pages 3-4: consent waivers – for waiver of consent (usually Option A, rarely Option B), or waiver of documentation of consent, i.e. verbal/online unsigned consent (Option C)
      • Pages 5-6: HIPAA waiver/alteration – DO NOT COMPLETE FOR PARTIAL HIPAA WAIVER! Only complete pgs. 5-6 for waiver of HIPAA authorization, or alteration of HIPAA if obtaining verbal consent with HIPAA authorization
    • After completing worksheet,return to eIRB smartform question #1 – select “Yes” only if all answers on 1 of worksheet are “Yes”(Unless VA- select “Yes” if this is a VA study); in all other cases, select “No” and proceed to #2
    • #2 – select “Yes” if accessing medical records for research
    • #3 – select applicable HIPAA waiver(s) requested for study (partial HIPAA waiver, complete waiver, etc.)

Still need assistance? Email us at irb@emory.edu!