Palmetto Health Research IRB Auditing Processes

1. Palmetto Health Research IRB Auditing Processes March 14, 2013

2. Introduction Melanie Griswold Bachelor of Science in Nursing Clinical Trials/ Research since 2003 Research Compliance at Palmetto Health since August 2011

3. Objective To understand the Palmetto Health Research Division IRB auditing processes.

5. Audit A systematic and independent examination and verification of trial-related activities, documents, and processes to determine compliance with applicable standards; the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and/ or regulatory requirement(s). Palmetto Health Research Audits PGR

6. Purpose of Auditing Protect the rights and well being of the human subjects Ensure that the reported research data are accurate, complete and verifiable from source documents Verify that the conduct of the study is in compliance with the approved protocol and with applicable regulatory requirements Opportunity for training, education, support Prevent occurrences of non-compliance

7. What an audit IS NOT Snooping Punishment Monitoring Micro Managing

9. Research Audits PGR The Palmetto Health Research Compliance Department is responsible for conducting audits of a) any research conducted at Palmetto Health and b) the Palmetto Health Institutional Review Board (IRB).

10. Research Audits PGR http://www.palmettohealth.org/ResearchCompliance

11. Types of Audits For Cause Audits: The For Cause Audit is performed when a question of noncompliance, research integrity or misconduct exists. Targeted Reviews: Targeted reviews use auditing techniques, yet due to their specific nature, are abbreviated auditing assessments used to: Assess the need for a full audit Confirm compliance in specific areas of a given research study Gather data in order to render an opinion on specific study practices Random Audits: All active Palmetto Health IRB-approved clinical research projects have an equal chance of being selected to undergo an audit.

12. How are studies chosen for an audit? Audits are chosen in multiple ways: Active Investigator Randomly chosen from a list generated from eIRB New Investigator Allegation/ Complaint

13. Audit Plan IRB AUDIT Typically audit the IRB first then the Investigator INVESTIGATOR AUDIT At Investigator site for an average of 3 days

14. Regulations/ Standards • PH IRB Federal Wide Assurance- engaged in human subjects research (not exempt) • “Common Rule” - Department of Health and Human Services regulations 45 CFR part 46, subpart A • Palmetto Health and Palmetto Health Institutional Review Board (IRB) Policies • IRB policy commits clinical trials to International Conference of Harmonisation (ICH) Good Clinical Practice (GCP) - E6 • Site’s Standard Operating Procedures • Protocol • Other regulations and/ or standards listed in protocol

15. IRB Application/ eIRB Complete review of eIRB and/ or paper applications IRB Application answers answer the questions are complete consistent clear, concise ideas Review all study details Read eIRB comments – issues, if/ how they were resolved

16. Red Flags in IRB Applications Multiple typos Drop off sentences Nonsensical statements Blanks Statements that do not fully answer the question Opinions (unless medically oriented) Fragmented, incomplete answers Jargon, slang terms Use of unknown abbreviations (ex. Sponsor specific)

17. Human Research Subject Protections Training CITI up to date for study staff and IRB Document any lapses in training

18. IRB Meeting Review Read meeting minutes Concerns Resolutions IRB concerns matched auditor concerns Answers to IRB members’ questions/ Investigator responses

19. Protocol Is protocol consistent with IRB application answers? Were application answers correct?

20. other Financial disclosure forms Advertisements Regulatory documents Dates Other Submissions / approvals

21. Informed Consent Forms From IRB Standpoint: “Common Rule” - Department of Health and Human Services regulations 45 CFR part 46, subpart A Essential / required elements -Makes sense addressing the element Compare to protocol (study activities, etc) Reading level/ understandability

22. Informed Consent Forms Risks minimized Risk/ Benefit Ratio Subject Selection Equitable Informed consent obtained & documented Data Monitored Privacy & confidentiality Vulnerable populations: safeguards

23. Risk of Research Non-Compliance Loss of federal funding Civil Penalties- fines Criminal Penalties- fines, jail time Revocation of Federal Wide Assurance (FWA) Suspension of research activities by IRB and / or government agencies Debarment/ disqualification from participating in research Government investigations of research compliance Inability to publish the data

24. Common Rule http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html Code of Federal Regulations TITLE 45PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 46PROTECTION OF HUMAN SUBJECTS

25. Department of Health & Human Services YouTube Channel http://www.youtube.com/user/USGOVHHS/ OHRP videos Informed Consent

26. Palmetto Health IRB Policies http://www.palmettohealth.org/IRB

27. International Conference of Harmonisation (ICH) Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf

28. Contact Information Melanie Griswold, RN, CCRC Palmetto Health Research Compliance Monitor Palmetto Health Research Compliance (803) 434-4314 melanie.griswold@palmettohealth.org