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What is determination for exemption IRB?

Studies that receive an exemption determination from IRB are exempt from the specific regulations and requirements in Title 45, Part 46 of the Code of Federal Regulations. Please note, however, that they are still considered human subject research.

What is Hrpp IRB?

Institutional Review Boards (IRBs) As part of the HRPP, the primary goal of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Michigan.

What is the main responsibility of the IRB?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

What are some common activities of an Hrpp or IRB office?

To ensure that the IRB has all the information necessary to approve the research, many HRPP or IRB offices work closely with investigators and research teams to address any preliminary concerns and provide all necessary documentation and information prior to initial review.

What qualifies as human subjects research?

Human subjects research is any research that systematically collects data or information about living individuals through intervention, interaction, or the use of identifiable private information with the intent of developing or adding to generalizable knowledge.

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