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Do I need IRB, IEC or REB approval?

You must obtain approval of your research plan and protocol from each Institutional Review Board ( IRB ), Institutional Ethics Committee (IEC) or Research Ethics Board (REB), at which the research will be conducted, before any subjects can be enrolled in the study.  (The term IRB will be used to describe these committees in this tutorial.)  The purpose of the review is to:

  • Ensure that human subjects will be protected in your study.
  • Evaluate risks versus benefits.
  • Ensure equitable subject selection.
  • Ensure proper administration of informed consent process.
  • Ensure protection of privacy and confidentiality.
  • Ensure protection of subjects from coercion.

You must contact your institution to determine which documents to submit for review.  Most IRBs require that you submit the protocol, consent forms and any forms of advertisement or patient education.  You may be asked to send data collection forms, surveys or questionnaires and institution-specific paperwork, as well.  The board or committee will meet to discuss your research and may approve your research plan, may require modifications or disapprove the research.

Once your protocol (which includes your data monitoring plan) and consent forms are approved by your IRB, copies must be sent to your Program Official (PO) for review. 

If you are planning to use a clinical trial website to advertise for or enroll participants, you may need to obtain IRB approval for this also.  For details, read Guidance on Institutional Review Board Review of Clinical Trial Websites from OHRP .

Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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