Criteria for Approval
In order to approve research covered by these regulations the IRB shall determine that all of the following requirements are satisfied:
- Risks to subjects are minimized.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and to the importance of the knowledge that may be expected to result.
- The worthiness of the research and the rigor of the research design minimize potential harm to participants, including the harm resulting from wasting participants’ time.
- Informed consent is sought from each prospective subject or the subject’s legally authorized representative and consent is appropriately documented.
- The research plan makes adequate provision for monitoring the data collected to ensure the safety and confidentiality of subjects.
- The research plan gives particular consideration to participants belonging to vulnerable populations, such as children, prisoners, disabled persons, or economically or educationally disadvantaged persons. When subjects belonging to these populations are likely to be vulnerable to coercion or harm, additional safeguards are included in the study to protect the rights and welfare of these subjects.