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IRB
IRB
In-House Document Review
UserWise’s Institutional Review Board (IRB) is a group registered with the U.S. Department of Health and Human Services (HHS) that is formally designated to review and monitor biomedical research involving human subjects.
In accordance with FDA regulations, the UserWise IRB has the authority to approve, require modifications (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects for the purposes of ensuring the ethical treatment of study subjects.
By having an in-house IRB, we are able to streamline the review and approval process of study materials and documentation.
Contact us to get started on your document review today!
IRB Responsibilities
Identify Risk
- Identify risks for vulnerable populations
- Analyze sources of risk
- Establish measures to minimize risk
- Determine that risks are reasonable in relation to potential benefits to participants and to society
Establish Procedures
- Evaluate the equitable selection of participants
- Establish procedures for review and oversight of research at multiple sites
- Establish procedures for suspension or termination of previously approved research if warranted by findings
Review and Maintain Documentation
- Oversee creation of consent documentation with a focus on participant understanding and voluntary decision making
- Review consent process and documentation
- Maintain documentation of all activities
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