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Cooperative IRB Review Arrangements for Multicenter Research: Central IRB Perspective

Agenda. Overview of CRRI IRB Challenges in reviewing pediatric research Potential solutions Questions. 2. . . . . Types of IRBs. Academic Medical Centers Community Hospital Government Agency Associations/Advocacy Groups Independent Central". 3. . . . . Regulations Go

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Cooperative IRB Review Arrangements for Multicenter Research: Central IRB Perspective

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    1. Cooperative IRB Review Arrangements for Multicenter Research: Central IRB Perspective 1

    2. Agenda Overview of CRRI IRB Challenges in reviewing pediatric research Potential solutions Questions 2

    3. 3

    4. 4

    8. Reporting Responsibilities 8

    9. 9

    10. 10

    11. Challenges for CRRI IRB in Reviewing Pediatric Research Poor protocol design Determination of “risk” category Therapeutic Misconception Poor site selection/Training Variable execution and implementation/SOP Investigator/Institutional Over-delegation Lack of Institutional “will” Confusion regarding “who’s in charge” Poor patient/public understanding of research 11

    12. Ethical Concerns Conflicts of interests (interest of subject vs. interest of PI/institution) Autonomy (e.g., assent and age of majority) Coercion (e.g., subject recruitment/payment) Privacy/confidentiality (e.g. genetics research) 12

    13. 13

    14. 14

    15. How CRRI Addresses Issues Escalating Review Process Non-binding review Staff review at intake Regulatory review as necessary Designee review (may be binding) Full-board review (multiple options) Executive/IO Action Staff/IRB training and corrective actions Policy Review/Modification Ongoing QA/AC Activity 15

    16. How CRRI Addresses Issues AAHRPP Accreditation Standardized/Documented Approach Implementation of new technology “smart form” Assume collaborative responsibility/authority Workflow processes for institutional partners “shared responsibilities for HRP” 16

    17. The Partnership for Human Subject Protection 17

    18. 18

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