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.