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Informed Consent Requirements for Obtaining Informed Consent

Informed Consent Requirements for Obtaining Informed Consent

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This video guidance represents OHRP's current thinking on this topic at the time of production and should be viewed as recommendations, unless specific regulatory requirements are cited. The use of the word "must" in OHRP guidance means that something is required under HHS regulations at 45 CFR Part 46. The use of the word "should" in OHRP guidance means that something is recommended or suggested but not required. An institution may use an alternative approach if the approach satisfies the requirements of the HHS regulations at 45 CFR Part 46.

Hi, Dr. Mitchell. Thank you so much for taking the time to meet with me… is this still a good time for us to talk?

Absolutely!

Thank you. I just had a few questions that I wanted to go over with you about this protocol that I am about to submit to the IRB for review. 

Sure, no problem. And by the way thank you very much for dropping it off yesterday so that I had a chance to go ove

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