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.