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IRB Processes

Human subjects research and secondary analysis using data from human subjects requires ethical review and approval. Data should not be collected or accessed before ethical approval is granted or waived.

Everyone should have completed an ethics training upon joining the group and should be familiar with activities that count as human subjects research. Review Training & Reference Materials if you need an ethics training refresher. We expect that team members should complete ethics training before working with study data.

Review Committees

If you are starting a new project, be aware that there are two committees that may grant research ethics approval for UNIGE-based research, depending on the nature of the study. Note that any given project using health data that are not public will be required to get approval from only one of these committees. If you are joining an ongoing project, you may need to be added to an existing IRB protocol. Consult with the project lead about which ethical approvals are required or whether you need to be added to an existing protocol. [ASA - Not 100% sure we add people to CUREG or CCER. Waiting for follow-up response from them to clarify.]

Consider ethical review from the following:

  • Geneva canton CCER: Required if we are doing primary health data collection in Switzerland and often needed for trials etc abroad.
  • UNIGE CUREG: Required for all other studies.
  • Research conducted with multiple partners may require ethical review from each partner institution involved. Consult with the project lead to understand the process.

Initial submission

  • Required documents: Protocol, information sheets, consent forms, data management plan, and translations.
  • Expect review and approval to take several months.
  • Store submitted and approved documents and correspondence with the IRB in shared project drives.

After approval

Be aware of the following requirements for reporting:

  • Amendments and protocol deviations
  • Annual reports, renewals, and end-of-study notification
  • Adverse event and safety reporting