1	Harry Shulman, Esq. Davis Wright Tremaine LLP IRBs IN THE COMMUNITY HOSPITAL SETTING Hospital Council of Northern & Central California Educational Program June 5, 2007
2	COMMON IRB DEFICIENCIES As Found in OHRP and FDA Audits Failure of IRB Leadership Failure to Conduct or Document Substantive or Meaningful Reviews Failure to Obtain Sufficient Information/Data regarding Risks to Subjects Inadequate or Inappropriate IRB Participation Inadequate Training - IRB, Staff and Researchers - Lack of Detailed Understanding of Regulations Inappropriate Use of Expedited Procedures Inadequate Quorum and Membership Inadequate or Insufficient Resources/Support
3	COMMON IRB DEFICIENCIES Inadequate/Non-existent Consent Form Reviews Failure to Assure IND/IDE submissions Inadequate Adverse Event Reporting or System Inappropriate Implementation of Substantial Study Changes without IRB Approval Issuance of Approval Letters Prior to Receiving or Confirming Revisions Inadequate Consideration of Conflicts of Interest Failure to Assure Privacy & Confidentiality
4	Other Areas of Concern 2007 OIG Work Plan includes disclosures of researchers’ financial interests and other conflicts of interest as focus areas for audits. Areas of Potential Liability to Research Subjects: Non-Compliance with Laws Intended to Protect Them Inadequate consent Conflicts of Interest involving IRB members, the institution itself, and physician investigators. “Dignitary” Claims
5	COMMUNITY HOSPITAL ISSUES Perceptions Should Be More Deferential to Researchers, Sponsors and IRBs at Large Institutions Lack of Responsiveness Site Issues IRB as Hospital Committee vs. Medical Staff Committee Facility Resources Facility Suitability/Equipment/Staffing
6	COMMUNITY HOSPITAL ISSUES Site Issues Continued . . . Physician Competency/Privileges Hospital Administrative Involvement Contractual Terms & Agreements Financial Arrangements and Accounting Practices Tax Exempt Status Issues
7	SOLUTIONS TO SOME COMMON IRB ISSUES Standardized Materials Investigator Packet IRB Initial Review Instructions and Procedures for Protocol Submission and Review Meeting Attendance; Copies; Deadlines Required Documents Protocol; Informed Consent; Investigator Brochure; Approval Request Form; Advertisements; Statement of Assurances
8	SOLUTIONS TO SOME COMMON IRB ISSUES Standardized Materials Continued . . . IRB Forms Consent Form Guidance with Model Language Request for Approval Statement of Assurances Request for Continuation Adverse Event Report Notification of Change (Protocol/Consent Form) Final Report
9	SOLUTIONS TO SOME COMMON IRB ISSUES IRB Review Fees Preliminary IRB Review Routine Distribution of Educational Materials Cooperative and Delegated Review Memorandum of Understanding Consolidation of IRBs
10	SOLUTIONS TO SOME COMMON IRB ISSUES Comprehensive IRB Procedural Manual IRB Jurisdiction Define Nature & Scope of Research Eligible for Review Define “Research” Specify Exemptions from IRB Approval Requirements
11	SOLUTIONS TO SOME COMMON IRB PROBLEMS IRB Procedural Manual Continued . . . IRB Procedures Submission of Proposed Study Material to be Submitted Medical Device Studies - Special Requirements Humanitarian Use Devices (HUDs) Discretion of IRB Chair to Require Preliminary Review by Other Committees or Institutional Officials
12	SOLUTIONS TO SOME COMMON IRB PROBLEMS IRB Procedural Manual Continued . . . IRB Manner of Conducting Business Quorum Expedited Review Cooperative Review Communications with Researchers and Sponsors Reporting as specified in Regulations and Institutional Policy
13	SOLUTIONS TO SOME COMMON IRB PROBLEMS IRB Procedural Manual Continued . . . IRB Records Types of Records Retention of Records Inspection of Records Confidentiality Criteria For Approval Basic Criteria Additional Safeguards for Vulnerable Subject Groups Grounds for Disapproval
14	SOLUTIONS TO SOME COMMON IRB PROBLEMS IRB Procedural Manual Continued . . . Informed Consent Requirements Procedures for Obtaining Informed Consent Basic Elements (Federal and State Law) Additional Elements Monitoring of Research Unanticipated and Serious Adverse Events Complaints
15	SOLUTIONS TO SOME COMMON IRB PROBLEMS IRB Procedural Manual Continued . . . Routine Periodic Review and Re-Approval Investigation of Suspected Research Misconduct Suspension or Withdrawal of IRB Approval; Basic Fair Procedure