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Policies, Forms & Guidance Documents

Institutional Review Board Policies

Learn more about Avera Institutional Review Board's (IRB) policies.

Application Submission

Avera Institutional Review Board has an online system for submission and review of initial, renewal and revisions of IRB applications. Please contact the Department of Human Subjects Protection/IRB for a username and password if you are submitting new documents at irb@avera.org or 605-322-4755.

Please contact the Department of Human Subjects Protection at 605-322-4755 with any questions.

Guidance Documents

These documents are not to be submitted, rather they are intended to be used for your own submission guidance purposes.

Ethical Codes

Institutional Review Boards (IRBs) are guided by the ethical principles applied to all research involving humans as subjects :

Other helpful links

Clinicaltrials.gov, sponsored by the NIH, is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

Public Responsibility in Medicine and Research (PRIM&R) provides professional development opportunities concerning research administration and regulatory compliance, and has formalized professional standards and credentials that document the expertise necessary for effective and appropriate research ethics support.

The National Institutes of Health (NIH) is the nation’s medical research agency, supporting scientific studies that turn discovery into health.

U.S. Food and Drug Administration (FDA) provides information about medical product safety and the approval process.

FDA Information Sheets

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