Navigating eIRB and eIRB Submission Types Katie Daniels Amanda Goode IRB Coordinator IRB Coordinator Committee C Committees A & B 864-455-4984 864-455-4360 Kdaniels@ghs.org Agoode@ghs.org

Objectives Learn what is eIRB Understand how GHS uses eIRB Know the functions of eIRB Understand the different types of submissions Observe a demonstration of how to submit in the eIRB

eIRB Overview electronic Institutional Review Board HSSC- Health Sciences South Carolina Made up of 8 Institutions: GHS USC MUSC AnMed Health Palmetto Health Self-Regional Spartanburg Regional Clemson (only HSSC institution that does not use eIRB) IRB is committee established to protect the rights and welfare of human research subjects recruited to participate in research activities Application used to communicate, manage IRB review and documentation Note Clemson is different. They have access to eIRB and are included in HSSC agreements, but do not utilize eIRB at their site.

How to get started in eIRB? Who needs an eIRB account? Any person participating in research activities… Principal Investigators Co-Investigator(s) Study Coordinator(s) Other Study Team Member(s) Regulatory staff, project assistants, students, etc. Guest List Read-only access Studies collaborating with Clemson- add Clemson IRB as guest

How to get started in eIRB? (Cont.) eIRB user account HSSC affiliates visit: https://eirb.healthsciencessc.org Select affiliated institution Complete registration fields, click ‘Register’ 3-5 business days to activate account Affiliated- have institutional ID and password Outside HSSC affiliates email me for instructions to obtain GHS username & PW to register for eIRB

Uses for eIRB Submit research proposals for IRB approval Submit Continuing Reviews Submit study Amendments/Changes Submit Reportable Events

Submitting Studies- Research vs. Quality Improvement “Is this project a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge?” If Yes, Research! i.e., Intended to publish in journals, present results at conference; anything that leaves the institution If quality improvement- no IRB Oversight required

Submitting Studies- Human Subjects vs. Non-Human Subjects “Does this project involve the investigator obtaining data about living individuals through 1) intervention or interaction with the individual; or 2) identifiable information?” If Yes, Human Subjects Research! i.e., prospective studies, retrospective chart reviews (with access to PHI), studies involving collection of specimens, etc. If non-human subject research- no IRB oversight required

Submitting Studies- Full Board vs. Expedited vs. Exempt Full Board: Studies involving more than minimal risk Committee A: Non-Pediatric/Non-Oncology Committee B: Pediatrics, Adult Studies (not adult oncology) Committee C: Adult Oncology Expedited: Studies involving no more than minimal risk IRB Chairs review Exempt: IRB oversight not required Full Board: each committee meets once a month, all studies are reviewed by two reviewers, at the meeting the reviewer discussion any questions, finding, etc with committee, vote, deadlines for study submission is listed on the website. Expedited: Currently 7 Expedited Review Categories (Not as heavily regulated as exempt. Categories are listed as research that may be reviewed as expedited) Exempt: Currently 6 Exempt Categories (new common rule there are two new exempt categories applicable if institution is utilizing broad consent- GHS is not)

Submitting Studies- In Conclusion Submit Everything! Best to let IRB determine if oversight is required IRB notice of review is required for most publications and/or conference presentations, even if research is non-human subjects, exempt, etc Based on how you answer questions- QI, Non-human subjects research, and exempt research have a shorted eIRB application Only documentation required in application is a project protocol that explains the project thoroughly enough for the IRB to make the appropriate determination

Submitting Studies- What will I Need? New Study Submittal Checklist Investigator Signature Page Consent Forms Protocol Data collection forms, surveys, questionnaires, etc. CV of PI CITI Training For full list, visit eIRB website: https://hsc.ghs.org/eirb/forms/

eIRB Study Page Study Statuses Requiring Action: Changes Requested per IRB Staff Contingencies Pending Department Review Expired Pre Submission Study Statuses : Acknowledged Approved Assigned to IRB Meeting Awaiting Correspondence Changes Requested per IRB Staff Completed Contingencies Pending Department Review Disapproved Exempt Approval Expired External IRB Review In Review IRB Staff Review Not Human Subjects Research Pre Submission Suspended Withdrawn

Continuing Reviews

Continuing Reviews All studies require IRB review no less than once per year (i.e., 364 days or 6 months) Current Study Status Number of Subjects Subjects’ Demographic Information Interim Findings Redacted Last Signed Consent Form For pediatric studies: updated pediatric risk grading form Updated COI information

Continuing Reviews *this continuing review snapshot is before submission to the IRB

Amendments

Amendments Submit Amendments whenever there are changes to: Study Personnel Advertisements/Study Recruitment material Informed Consent Documents Protocol Documents Investigator’s Brochures Editorial/Administrative Changes Additional Sites for Treatment/Follow-up Modification in Subject Enrollment Goals Location of Program Activities Questionnaires & Assessment Tools Risk Change(s) Subject Confidentiality/Anonymity Subject Population HIPPA Authorization Study Funding Source/ Sponsorship Conflict of Interest (COI) Other Changes, etc.

Amendments are reviewed based on: Risk The initial study submission review type Amendment Requirements Risk change assessment Description of what is changing Update changes in SmartForm

…for the people in the back Amendments …for the people in the back Update the SmartForm!

Amendments *this amendment snapshot is post submission to IRB

Reportable Events

Reportable Events Unanticipated Problem Adverse Event Unexpected Related or possibly related Change in known or recognized risk Adverse Event undesirable/unintended , although typically not unexpected, result of therapy or intervention Protocol Deviations Other Reports/Events Not a bad thing to submit

Submitting Reportable Events Type of reportable event Multi-study reportable event Internal vs. External event If only local study, always Internal External AEs should only be reported to local IRB when event requires changes to study protocol, IB, or Informed Consent Specific event questions

Reportable Event

eIRB Demo http://eirb.healthsciencessc.org

Contact Us Office of Human Research Protection (OHRP) 701 Grove Road- Employee Services Center (ESC) Greenville, SC 29605 864-455-8997 Matt Hudson, PhD Chris Wright, MD OHRP Director OHRP Medical Director MHudson2@ghs.org CWright2@ghs.org Katie Daniels Amanda Goode IRB Coordinator IRB Coordinator Committee C Committees A & B 864-455-4984 864-455-4360 Kdaniels@ghs.org Agoode@ghs.org