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The Office for Human Research Protections (OHRP) tells us, “The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117.

Resources
Institutional Review Board Guidebook
(https://www.hhs.gov/ohrp/archive/irb/irb_chapter4.htm)
Health and Human Services – Office of Human Research Protections
(https://www.hhs.gov/ohrp/)
Information Sheet Guidance for Institutional Review Boards (IRBs)
(https://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm)
The Hastings Center
(https://www.thehastingscenter.org/Default.aspx)
Video: OHRP: Research Involving Vulnerable Populations
(https://www.youtube.com/watch?v=SqRw6FevuXg&feature=player_embedded)
Instructions
The Office for Human Research Protections (OHRP) tells us, “The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117.
Respond to the following questions:
Discuss the basic elements of informed consent.
Review the Video listed in the resource section.
Identify at least 2 vulnerable populations and state why they are treated differently in regard to informed consent.

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