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What are IRB procedures?

To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

Which of the following does not require IRB approval?

If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.

Which 3 main areas does the IRB verify?

IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review: Exempt, Expedited, and Full.

Who should be listed on an IRB protocol?

Study personnel, if any, are required to be listed in the IRB application on any research protocol that involves human subjects. The study personnel that are involved in the informed consent process should also be distinguished on the IRB study personnel list.

What are IRB ethical guidelines?

When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection - respect for persons, beneficence, and justice.

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