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HHS Policy for Protection of Human Research Subjects<br />
Code of Federal Regulations<br />
DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46 Revised January 15, 2009<br />
• In order to approve research covered by this policy the<br />
IRB shall determine that all of the following<br />
requirements are satisfied:<br />
• Risks to subjects are minimized<br />
• Risks to subjects are reasonable in relation to<br />
anticipated benefits, if any, to subjects, and the<br />
importance of the knowledge that may reasonably be<br />
expected to result.<br />
• Selection of subjects is equitable.<br />
• Informed consent will be sought from each prospective<br />
subject or the subject's legally authorized representative,<br />
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.111
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