OHRP: General Informed Consent Requirements

Note: This video was created before the 2018 revisions of the Common Rule and may include information that is not up to date.

In this Office for Human Research Protections (OHRP) video, all of the characters are fictional. This presentation takes part in two scenes. In the first scene an investigator meets with an expert to go over some issues for obtaining legally effective informed consent from potential subjects with schizophrenia before submitting her protocol to the IRB. These issues include determining capacity to consent, using a legally authorized representative, and meeting the regulatory requirements for the process of informed consent. In the second scene, Dr. Presley obtains appropriate informed consent from a potential subject, Mr. Smith, who has the capacity to consent.

OHRP Educational Videos-Additional Information

OHRP educational videos were developed by the OHRP Division of Education and Development and are intended to provide information regarding the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46. The videos represent OHRP's current thinking on these topics 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. OHRP is available to discuss alternative approaches at 240-453-6900 or 866-447-4777.

More more information, please visit: http://www.hhs.gov/ohrp

From the U.S. Department of Health and Human Services (HHS) http://www.hhs.gov

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