COMPLIANCE ISSUES: Observed in ORO Reviews 200304 OFFICE OF RESEARCH OVERSIGHT ORO DEPT' OF VETERANS

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COMPLIANCE ISSUESObserved in ORO Reviews
2003-04OFFICE OF RESEARCH OVERSIGHT (ORO)
DEPT. OF VETERANS AFFAIRS David A. Weber,
Ph.D., FACNPChief OfficerFriday, November 12,
2004
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ORO ON-SITE REVIEWS

• Types of Reviews
• For-Cause
• Routine

• Reviews Focus on Regulatory Compliance
• Identify deficiencies

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For Cause On-Site Reviews

• Investigate reported or alleged instances of
  noncompliance with the laws, regulations,
  policies, and/or procedures governing research
• Teams of 2-5 members, 2-4 days
• Site visit report
• Facility develops action plan
• Continuous follow-up until actions complete
• Restrictions, suspensions, etc.

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Core Regulations and Policies

• 38 CFR 16 Protection of Human Subjects
• 21 CFR 50 Protection of Human Subjects
• 21 CFR 56 Institutional Review Boards
• 21 CFR 312 Investigational New Drug
  Application
• 21 CFR 812 Investigational Device Exemptions

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Core Regulations and Policies

• Handbook 1200.5, Requirements for the Protection
  of Human Subjects in Research (July 15, 2003)
• What to Report to ORO (November 11, 2003)
• Manual M-3, Part I
• Chapter 2 Organizational Structure
• Chapter 3 Functions of the Research and
  Development Committee

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WHAT TO REPORT TO OROMEMORANDOM

• Identifies issues VHA facilities must report to
  ORO as required by various Federal regulations
  and VHA policies.
• http//www.va.gov/oro/
• November 12, 2003

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COMPLIANCE REVIEW FINDINGS2003-2004
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COMPLIANCE FINDINGS 2003-04

• -Failure to obtain written informed consent
• 38CFR16.116 and 117a VHA 1200.5, App. C CFG31,
  32
• -Failure to follow IRB approved protocol
• 38CFR16.103.b.4.iii VHA 1200.5, 7.c.1 CFG23

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COMPLIANCE FINDINGS 2003-04

• Failure to obtain RD Committee approval prior to
  conducting research
• M-3, P-1, Ch 3.01.e VHA HB 1200.5, 7.b
• Resources and staff not adequate to support HRPP
  program. Inadequate protocol/records tracking
  system
• 38CFR16.103.b.2 CFG 52

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COMPLIANCE FINDINGS 2003-04

• Failure to maintain records for at least 3 years
  after completion of study
• 3 yrs in 38CFR115(b), 5 yrs in VHA HB 1200.5.8.j
• Inconsistent documentation in IRB minutes and IRB
  files
• 38CFR16.115.a.1,3,4,7, and 116d
• Reviews of SAE by RD and IRB not documented
• 21CFR56.101(a), 21CFR.108, and 21CFR56.111.

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OTHER FINDINGS 2003-04

• Terms/duration of IRB and RD Committee members
  not compliant with M-3,P-1, Ch 2.02b(2) and 3.01e
• Major delays in completing minutes. To be
  completed within 3 weeks VHA HB 1200.5(7)(i)(2)
• more

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OHRP Compliance Activitieshttp//ohrp.osophs.dhhs
.gov/compovr.htm

• Common Findings and Guidance
• (77 items)
• Initial and Continuing Review (16)
• Expedited Review Procedures (5)
• Reporting Unanticipated Problems IRB Review of
  Protocol Changes (4)
• Applications of Exemptions (5)
• Informed Consent (15)
• IRB Membership, Expertise, Staff, Support and
  Workload (9)
• Documentation of IRB Activities, Findings, and
  Procedures (18)
• Miscellaneous OHRP guidance (5)

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THE END