Health Services Research Human Subjects Protection K Lynn

Health Services Research & Human Subjects Protection K. Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE Office of Research & Development Department of Veterans Affairs February 23, 2007

Human Research Has Changed • New opportunities • • • Electronic age Larger, more complex studies Faster translation to clinical care • New risks • How can we meet your needs? 2

Health Services Research & Human Subjects Protection - Perceptions • What we hear from HSR&D investigators about IRBs • • • Reviews are inconsistent Too slow & inefficient – unnecessary delays Too demanding • • • Requirements are not realistic Demands compromise study design Over-estimate risks 3

Health Services Research & Human Subjects Protection - Perceptions • What we hear from IRBs about HSR&D investigators • • • Don’t understand when they need IRB approval or informed consent Protocols don’t provide adequate information to assess human subjects issues Under-estimate risk 4

Ultimate Goals • • • Teamwork (e. g. , PIs, ORD, ORO, ISOs, Privacy, Police/Security, unions, etc. ) Define the issues (not just perceptions) Develop informed guidance for investigators, IRBs and others responsible for protecting subjects 5

Meeting Challenges to HSR&D Investigators for Human Subjects Protection • VA Central IRB • Key issues • • • Defining risks (e. g. , to privacy – de-identification) When is it research vs. QI or program evaluation Dealing with large, complex studies Engagement - Which IRBs need to approve a multi -site study? Data security & confidentiality HSR&D investigator’s perspective 6

VA Central IRB Purpose • Improve human research protection in VA-funded multi-site studies by ensuring • • • Appropriate ethical & scientific review Local issues are addressed Enhance efficiency of reviews 7

VA Central IRB Examples of Research Projects • Health Services Research • Quality Improvement • Database Research • Nursing Research • Cooperative Studies • Genomics Research 8

VA Central IRB Roll-out • VA-funded research only • First - Multi-site VA Health Services Research & Cooperative Studies • Later - Will consider the possibility of serving as IRB of record for small research programs 9

VA Central IRB Logistics • No charge to VA facilities • Staffed by PRIDE in ORD • IRB members from all over the country • Monthly meetings • Evaluate performance 10

VA Central IRB Process • PI enlists sites • PI submits protocol to VA Central IRB including list of participating VA facilities • VA Central IRB performs review • Local VA facilities provide comments (e. g. , local issues, state & local language) • VA Central IRB is final arbiter • Local VA facilities opt in 11

VA Central IRB Advantages • More consistent expert ethical & scientific review • Earlier identification of trends in adverse events • Improved veterans’ access to multi-center trials • Improved efficiency • Transparent, consistent process • Model for local IRBs 12

Challenges for VA Central IRB Local Accountability • Concept of “IRB” vs. “Human Research Protection Program” (HRPP) • • Every facility that performs human research has ultimate responsibility for its HRPP, even if it uses another facility’s IRB or the VA Central IRB Medical Center Director must designate someone (e. g. , IRB, R&D Committee or an individual) to ensure accountability 13

Local Accountability Local Responsibilities • Providing local knowledge of • • Research culture Community culture & attitudes State & local laws Investigator oversight • Research misconduct/impropriety • Training & credentialing • Monitoring & auditing • Handling of adverse events 14

Memorandum of Understanding (MOU) Between Local Facility & VA Central IRB • “Crisp” agreements with clear delineation of respective • • • Roles Responsibilities Authorities 15

Challenges for VA Central IRB It Will Not Solve Everyone’s Problems • • Other approvals - R&D Committee, IACUC, biosafety, unions, OMB Many current delays are caused by investigators’ not promptly providing all information needed for IRB review 16

Preparing for the VA Central IRB • • • Site visits to NCI CIRB & independent IRBs National IRB workshops on alternatives to current IRBs Communications • • • NLB Health Systems Committee, ORO, Ethics, Nursing, Patient Care Services, Public Health, etc. Field focus group 4 regional Local Accountability meetings VA IRB Chairs meeting New staff: IRB Administrator & IRB Coordinator Identify & train IRB members 17

Contact Information lynn. cates@va. gov 18