TriHealth IRB
IRB Forms can be found in the Clinical Research Toolbox
Initial IRB Review
TriHealth is committed to quality research. In an effort to SERVE research participants, future patients, and the research community, all research is evaluated and reviewed before it starts at TriHealth. The pathways for new research review at TriHealth are explained here. Please follow instructions here to submit your study.
The Board meets the first and third Tuesday of each month. IRB meeting dates and times can be found at the above IRB Dates/Times link.
IRB Forms can be found in the Clinical Research Toolbox
Continuing IRB Review/Re-Approval/Final Closure
- Complete the Continuing Review/Re-Approval/Final Closure Form.
- Use the Continuing Review/Re-Approval/Final Closure Checklist to provide documents, as applicable.
- Once completed, submit all documents to irb_hrpp@trihealth.com. If your submission is incomplete, this will delay processing.
IRB Forms can be found in the Clinical Research Toolbox
Research Modifications/Staff Changes
- Complete the Modification Form or the Staff Change Form, or both, if applicable.
- Once completed, submit all documents to irb_hrpp@trihealth.com. If your submission is incomplete, this will delay processing.
IRB Forms can be found in the Clinical Research Toolbox
UPIRTSO/Safety Reporting
Complete the below form(s), as applicable. Once completed, submit all documents to irb_hrpp@trihealth.com.
- The Unanticipated Problem Submission Form should be used to report events that are Unanticipated/Unexpected, Related and Serious within 5 business days of occurrence or within 24 hours in the event of death. The IRB will acknowledge receipt and let you know if any further response is required.
- Investigators may submit serious adverse events and/or external events that do NOT meet the criteria of a UPIRTSO for IRB review and acknowledgment. An investigator may submit these to the IRB using the IND/IDE Safety Submission Form. If applicable, a serious adverse event report (e.g. Medwatch, SUSARS) should be included in the submission. These submissions may be required by sponsors and/or preferred by investigators. The IRB will acknowledge receipt and let you know if further information is required.
- The Protocol Deviation/Non-Compliance Form should be used to report MAJOR protocol deviations and non-compliance issues that have an adverse effect on the safety and welfare of subjects and/or data collected and/or are related to a breach of confidentiality within 10 business days of becoming aware of the issue. The IRB will acknowledge receipt and let you know if any further response is required.
- The Protocol Deviation Log should be used to report MINOR protocol deviations only and should be submitted with your Continuing Review/Re-Approval/Final Closure Form.
- The Safety Submission Form should be used to report changes to Investigator Brochures, Package Inserts, and Device manuals and to submit DSMB reports (as received), Annual Device Status reports, etc. If the revisions require changes to the Protocol or Informed Consent, you must also submit a Modification Form.
IRB Forms can be found in the Clinical Research Toolbox
If you have any questions about IRB submission requirements, please contact Tiffany Miller, IRB Coordinator at (513) 865-5248 or irb_hrpp@trihealth.com.