Here’s a short version of the criteria for approval
Criteria cover eight key points
Title 45, part 46.111 of the U.S. Department of Health and Human Services’ Protection of Human Subjects, revised in 2009, contains a very short, but important list of criteria for IRB approval of research.
The following are included in the criteria:
• Minimize risks to subjects by using sound research design that does not unnecessarily expose subjects to risk.
• Evaluate risks and benefits to see that risks to subjects are reasonable in relation to anticipated benefits.
• Select subjects equitably and be particularly cognizant of research issues related to involving vulnerable populations.
• Seek informed consent from each prospective subject or the subject’s legally authorized representative.
• Document informed consent.
• Monitor the data collected, as appropriate, to ensure subjects’ safety.
• Protect the privacy of subjects and maintain data confidentiality, when appropriate.
• Provide additional safeguards when some or all of the subjects are likely to be vulnerable to coercion or undue influence.
Title 45, part 46.111 of the U.S. Department of Health and Human Services’ Protection of Human Subjects, revised in 2009, contains a very short, but important list of criteria for IRB approval of research.
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