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Avera Institutional Review Board

Federal regulations require an Institutional Review Board (IRB) to review research on human subjects if the research involves federal funding.  Avera has determined that all research undertaken by this organization, or by those persons affiliated with this organization, must undergo the same level of review as research that falls under federal regulations. Avera has obtained a Federalwide Assurance (FWA), with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) affirming that Avera is in compliance with 45 CFR 46. This FWA also assures that all Avera facilities’ activities related to human subject research regardless of the funding source, will be guided by the ethical principles of the Belmont Report.

The Avera IRB is responsible for reviewing, approving, modifying, rejecting and monitoring research involving human subjects. The purpose of the IRB is to assure, both in advance and by periodic review, that appropriate steps are taken to protect rights and welfare of humans participating as research subjects. To accomplish this purpose, the Avera IRB uses a group process to review research protocols and related materials.

Avera IRB services include:

  • Coordination and administration of the Institutional Review Board
  • Guidance and support to investigators who plan to conduct clinical research projects
  • Coordination of Institutional Review Board meetings
  • Interpretation of regulatory requirements
  • Development of policies and procedures to assure compliance with institutional and governmental regulations
  • Ongoing education on human subject research issues through workshops, seminars and conferences