Criteria of Approval

The IRB ensures the following specific criteria are met for approving research involving human subjects:

1. Minimization of Risks: Risks to subjects are minimized:
   1. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
   2. Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risk-Benefit Ratio: 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. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Equitable Selection of Subjects: The selection of subjects is equitable. In making this assessment, the IRB should consider the research's purposes and the setting in which it will be conducted. The IRB should be particularly cognizant of the special problems of research that involve a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed Consent: Each subject or their legally authorized representative must provide informed consent as required by 45 CFR 46.116. Consent should be appropriately documented or waived per 45 CFR 46.117.
5. Deception or Withholding of Information: If deception or withholding of information is necessary for adequate testing of the hypotheses and there is no practical alternative:
   1. Sufficient justification must be provided that the potential benefits to the subject or the importance of the knowledge to be gained outweigh any potential risks that may be present as a result of such deception.
   2. Assurances of acceptable debriefing must be provided, if appropriate. The PI must give each subject an explanation to questions ensuing from participation in the research project following its conclusion. It is strongly recommended that this occur immediately following participation for each subject, but if, in the judgment of the IRB, such information could adversely affect subsequent data collection in the same study, the full explanation may be delayed for a reasonable period. In cases where deception is unavoidable and may result in emotional stress, full debriefing is mandatory immediately following completed participation.
6. Adequacy of Facilities and Resources: The adequacy of facilities and other resources necessary for the completion of the study and the protection of subjects’ rights must be assessed.
7. Data Monitoring: Adequate provisions must ensure data monitoring to protect subject safety.
8. Privacy and Confidentiality: Measures to protect subject privacy and maintain data confidentiality must be in place.
9. Protection of Vulnerable Subjects: When some or all subjects are likely vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, economically or educationally disadvantaged persons), additional safeguards are integrated into the study to protect their rights and welfare.
10. Protocol Completeness: The protocol explicitly outlines the design and procedures from inception to completion.