Palmetto Health Research IRB Auditing ProcessesMarch 14, 2013

Melanie GriswoldBachelor of Science in NursingClinical Trials/ Research since 2003Research Compliance at Palmetto Health since August 2011

Introduction

To understand the Palmetto Health Research Division IRB auditing processes.

Objective

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

• 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

• Snooping• Punishment• Monitoring• Micro Managing

What an audit IS NOT

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

Research Audits PGR

http://www.palmettohealth.org/ResearchCompliance

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

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

IRB AUDIT• Typically audit the IRB first then the Investigator

INVESTIGATOR AUDIT• At Investigator site for an average of 3 days

Audit Plan

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

• 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

• 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

• CITI up to date for study staff and IRB• Document any lapses in training

Human Research Subject Protections Training

Read meeting minutesConcernsResolutionsIRB concerns matched auditor concernsAnswers to IRB members’ questions/ Investigator responses

IRB Meeting Review

Is protocol consistent with IRB application answers?Were application answers correct?

Protocol

Financial disclosure formsAdvertisementsRegulatory documentsDatesOther Submissions / approvals

other

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

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

Informed Consent Forms

• 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

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

http://www.youtube.com/user/USGOVHHS/

• OHRP videos• Informed Consent

Department of Health & Human Services YouTube Channel

http://www.palmettohealth.org/IRBPalmetto Health IRB Policies

Guidance for IndustryE6 Good Clinical Practice: Consolidated Guidance

http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf

International Conference of Harmonisation (ICH)

Contact Information

Melanie Griswold, RN, CCRC

Palmetto Health Research Compliance Monitor

Palmetto Health Research Compliance

(803) 434-4314

melanie.griswold@palmettohealth.org