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Challenges: Monitoring of Research: The Options

Challenges: Monitoring of Research: The Options. Robert Bortolussi and Diann Nicholson IWK Health Centre, Dalhousie University, Halifax NS. Monitoring of Research. MRC Guideline 1987:

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Challenges: Monitoring of Research: The Options

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  1. Challenges:Monitoring of Research: The Options Robert Bortolussi and Diann Nicholson IWK Health Centre, Dalhousie University, Halifax NS

  2. Monitoring of Research • MRC Guideline 1987: “Research officers … may be required to maintain scrutiny by periodic review of research and the factors involved in ethics approval.” • Canadian survey in 1995: only 18% of REB’s had any review process and only 2% had a systematic regular audit. • Internationally poor compliance with similar guidelines

  3. Monitoring of Research Challenges & Issues: • Lack of clarity on goals, • Lack of standards, • Fear of negative effect on trust between REB and investigators, • Lack of funding to undertake a review.

  4. Monitoring of Research Goal: To identify weaknesses in the system and develop tools to improve. Weijer,C et al CMAJ 1995, 152:1973-1980 • Strategies: • Continuing annual review • Monitoring of consent process • Monitoring of adherence to protocol • Monitoring of data integrity

  5. Monitoring of Research Establishing standards: • Membership on Auditing Committee. • Selection of protocols. • Audit process. • Establish an atmosphere of trust • Two way dialogue, two way learning • Record keeping review • Consent for review • Adverse event review

  6. Monitoring of Research • Evaluation Criteria; • Evidence of good record keeping • Monitoring of integrity of data and adherence to protocol • Monitoring of consent • Monitoring of adverse events

  7. Monitoring of Research Results

  8. Record Keeping Original records (n = 32) Continuing records (25) Data Integrity Laboratory information (26) Validation of lab data (26) Adequate storage (13) Adherence to protocol (26) Consent Signature (174) Date (167) Consent taker (168) Consent unchanged (174) Percent 91 93 100 100 92 100 96 99 98 95 Monitoring of Research

  9. For 19 studies with greater than minimal risk. Safety Committees Formal 47% Informal 53% Reported an SAE 6 Cases SAE’s at outside site 2 Cases SAE’s at local site 4 Cases Reported to sponsor 4 of 4 Reported to local site 3 of 4 Monitoring of Research

  10. Recommendations: Educational Measures Change in Policy Change in Process TOTAL Percent Number 58 11 32 6 11 2 100 19 Monitoring of Research

  11. Monitoring of Research Opportunities: • Clarity on goals must be demonstrated, • Development of standards, • Promote trust between REB and investigators, • Funding to undertake a review • Total of 9 to 20 person-hours occupied for each protocol reviewed in clerical, administrative and REB member activities.

  12. Monitoring of Research Learn from the audit to develop educational, policy and process changes

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