Institutional Review Board reviews research proposals considering
Procedures planned to minimize risks to human subjects
Anticipated benefits
Equitable selection of subjects
Informed consent and its documentation
Privacy of subjects and confidentiality of data
Protections for vulnerable populations (children, prisoners, and pregnant women)
Possible conflicts of interest
The following video by HHS "explains the IRB review process and criteria, and why IRBs sometimes seek clarification and information from researchers" (source)
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, to subjects, and the importance of the knowledge that may reasonably be expected to result.
Selection of subjects is equitable.
Informed consent will be sought from each prospective subject or the subject's legally authorized representative.
Informed consent will be appropriately documented.
Adequate provision for monitoring the data ensure the safety of subjects.
Adequate provisions protect the privacy of subjects and to maintain the confidentiality of data.
For purposes of conducting the limited IRB review, the IRB shall make the following determinations: (i) broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained (ii) broad consent is appropriately documented or waiver of documentation is appropriate.
Additional safeguards have been included to protect subjects vulnerable to coercion or undue influence.
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