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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!

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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
Jumpstart your study with IRB recruitment material review

About Us


Our consultants partner with medical device companies to fulfill any and all steps of the Usability Engineering Process.

UserWise offers a wide range of services spanning the product development cycle. Our consultants assist in performing user research, constructing the use-related risk analysis, conducting formative evaluations, executing summative usability validation testing, refining user manuals, compiling the Usability Engineering File and FDA Human Factors/Usability Engineering Submission Report, and so much more. 

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