Criteria for Institutional Review Board Approval
Criteria 1: Risks to subjects are minimized.
Criteria 2: Risks to subjects are reasonable in relation to anticipated benefits, if any.
Criteria 3: Selection of subjects is equitable.
Criteria 4: Informed consent will be sought.
Criteria 5: Informed consent will be appropriately documented or appropriately waived.
Criteria 6: There are adequate provisions for monitoring the data collected to ensure the safety of subjects.
Criteria 7: There are adequate provisions to protect the privacy of subjects and to maintain confidentiality of data.
Vulnerable Populations
Additional safeguards are included in the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence, when applicable.