Criteria for Approval in Research: Key Requirements and Safeguards
Learn about the essential criteria for research approval, including minimizing risks, equitable selection of subjects, obtaining informed consent, data monitoring, privacy protection, and additional safeguards for vulnerable subjects. Explore the importance of risk assessment, equitable subject selection, informed consent documentation, and more in research ethics and IRB processes.
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Presentation Transcript
Revisiting 45 CFR 46.111 Criteria for approval Social Behavioral Board, 4.12. 2024
45CFR46.111 Criteria for Approval 45CFR46.111 Criteria for Approval To approve research, the following requirements must be satisfied 1. 2. Risks to subjects are minimized Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of knowledge that may reasonably be expected to result Selection of subjects is equitable Informed consent will be obtained and documented (unless waived) accordingly There are adequate provisions for data monitoring to ensure safety of subjects if appropriate There are adequate provisions to protect the privacy of subjects and to maintain confidentiality of the data if appropriate (section 26iStar) There are additional safeguards to protect the rights and welfare of subjects likely to be vulnerable to coercion or undue influence (section 22 - special subjects) 3. 4. 5. 6. 7.
All IRB Members follow criteria for approval All IRB Members follow criteria for approval At USC IRB members are the analysts/staff that are doing expedited and full board reviews. All full board members (all of you )! And while not regulatory, we follow these criteria for exempt studies too!
Risk to Subjects Risks can be both time and situation specific Risks can be subjective and relevant to specific populations, or even individuals Possible type of harm Social, physical, economic, legal, dignity and respect
Selection of Subjects is Equitable Selection of Subjects is Equitable Are investigators being inclusive in recruitment activities Consider the appropriate use of exclusion criteria
Informed Consent Each participants will sign ICF or the participants Legally Authorized Representative (LAR) Will be appropriately documented OR will be waived
