TABLE 2

Criteria for IRB Approval of Research

  1. Risks to subjects are minimized. Are procedures consistent with sound research design used? Do procedures not unnecessarily expose subjects to risk? Whenever possible, are procedures already being performed for diagnostic or treatment purposes? Note: consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that participants would receive even if not participating in the research).

  2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and to the importance of the knowledge that may reasonably be expected to result. Consider only those risks and benefits that may result from the research and not possible long-range effects of the knowledge gained.

  3. Selection of subjects is equitable. Consider the purposes and setting of the research, paying special attention to any vulnerable populations.

  4. Informed consent will be prospectively obtained and documented (unless the IRB approves a waiver of this requirement).

  5. Adequate provisions exist to monitor the data and ensure subject safety.

  6. Adequate provisions exist to protect the privacy of subjects and maintain confidentiality of data.

  7. The influence of payments on equitable selection and amount, method, and timing of compensation is not coercive or do not present undue influence to potential subjects. Also, consider whether completion bonuses are reasonable and do not unduly induce subjects to remain in the study when they otherwise would withdraw.

  8. If some or all subjects are likely to be vulnerable to coercion or undue influence, additional safeguards exist to protect their rights and welfare.