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IRB Frequently Asked Questions

I am just reviewing medical records; do I need IRB approval?
Yes, if the project meets the criteria for research with human subjects (your IRB office can help you determine this).

I’m just administering surveys/questionnaires; do I need IRB approval? Even if I am only interviewing a few people?
Yes. Any activity conducted by an individual who is affiliated with NEBH that involves research on human subjects must be prospectively reviewed by the IRB.

What adverse events need to be reported to the IRB?

  • Adverse events that are also unanticipated problems must be reported to the IRB. Unanticipated problems are any incident, experience, or outcome that meets all of the following criteria. The IRB office can give a more detailed definition.
  • Unexpected (in terms of nature, severity, or frequency)
  • Related or possibly related to participation in the research
  • Suggests that the research places subjects or others at greater risk of harm than was previously known or recognized

What changes require approval by the IRB after the protocol is approved?
Any proposed change to the protocol procedures (including subject selection, consent process), personnel, documents (including recruitment ads, study instruments) must be submitted to the IRB for review and approval prior to implementation.  Any other changes that may affect a participant’s willingness to participate in the study must also be submitted for prospective IRB review.

Do I need to let the IRB know when I have completed a study?
Yes, an investigator needs to inform the IRB that a study is being terminated or closed and complete a termination report. A study should not be terminated until all subjects have completed the study and research-related activity has ceased, including subject follow-up, data collection, and/or data analysis.