Palmetto Health Research IRB Auditing Processes
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Transcript of Palmetto Health Research IRB Auditing Processes
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Palmetto Health Research IRB Auditing ProcessesMarch 14, 2013
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Melanie GriswoldBachelor of Science in NursingClinical Trials/ Research since 2003Research Compliance at Palmetto Health since August 2011
Introduction
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To understand the Palmetto Health Research Division IRB auditing processes.
Objective
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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).
Audit
Palmetto Health Research Audits PGR
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• 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
Purpose of Auditing
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• Snooping• Punishment• Monitoring• Micro Managing
What an audit IS NOT
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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).
Research Audits PGR
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Research Audits PGR
http://www.palmettohealth.org/ResearchCompliance
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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 practicesRandom Audits: All active Palmetto Health IRB-approved clinical research projects have an equal chance of being selected to undergo an audit.
Types of Audits
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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
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IRB AUDIT• Typically audit the IRB first then the Investigator
INVESTIGATOR AUDIT• At Investigator site for an average of 3 days
Audit Plan
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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
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• 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
IRB Application/ eIRB
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• 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)
Red Flags in IRB Applications
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• CITI up to date for study staff and IRB• Document any lapses in training
Human Research Subject Protections Training
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Read meeting minutesConcernsResolutionsIRB concerns matched auditor concernsAnswers to IRB members’ questions/ Investigator responses
IRB Meeting Review
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Is protocol consistent with IRB application answers?Were application answers correct?
Protocol
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Financial disclosure formsAdvertisementsRegulatory documentsDatesOther Submissions / approvals
other
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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
Informed Consent Forms
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• Risks minimized• Risk/ Benefit Ratio• Subject Selection Equitable• Informed consent obtained & documented• Data Monitored• Privacy & confidentiality• Vulnerable populations: safeguards
Informed Consent Forms
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• 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
Risk of Research Non-Compliance
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http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
Code of Federal RegulationsTITLE 45
PUBLIC WELFAREDEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 46PROTECTION OF HUMAN SUBJECTS
Common Rule
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http://www.youtube.com/user/USGOVHHS/
• OHRP videos• Informed Consent
Department of Health & Human Services YouTube Channel
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http://www.palmettohealth.org/IRBPalmetto Health IRB Policies
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Guidance for IndustryE6 Good Clinical Practice: Consolidated Guidance
http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf
International Conference of Harmonisation (ICH)
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Contact Information
Melanie Griswold, RN, CCRC
Palmetto Health Research Compliance Monitor
Palmetto Health Research Compliance
(803) 434-4314