Mission of HRPO
and the IRB

Our mission is to protect the rights and welfare of participants in “human research” as defined in 45 CFR 46.102(d) and (f) and “clinical investigations” as defined in 21 CFR 50.3(c).d

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Tip of the Week

What is a best practice for optional items in a consent form?

Do you have any optional items in your consent form? Perhaps you have a series of blanks that allows participants to opt in or out of an additional data or specimen collection process with their initials. If you have a consent form with additional space blanks where the participant marks YES or NO, there should be a spot for them to initial their choice. It is critical that the participant completes these sections if they exist. Any blank optional items in a consent form must be treated as a “No” or an “opt out” from the participant.

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Our office uses data collected from carefully defined performance metrics to measure results and ensure continuous quality improvement of our program. These metrics are also intended to provide a better understanding of the IRB process.

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