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

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

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.

Monitoring of Research Goal: To identify weaknesses in the system and develop tools to improve. Weijer,C et al CMAJ 1995, 152:  Strategies: 1. Continuing annual review 2. Monitoring of consent process 3. Monitoring of adherence to protocol 4. Monitoring of data integrity

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

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

Monitoring of Research Results

Monitoring of Research  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  92  100  96  99  98  95

Monitoring of Research For 19 studies with greater than minimal risk. Safety Committees – Formal47% – Informal53% Reported an SAE 6 Cases SAE’s at outside site 2 Cases SAE’s at local site 4 Cases – Reported to sponsor4 of 4 – Reported to local site3 of 4

Monitoring of Research  Recommendations: – Educational Measures – Change in Policy – Change in Process TOTAL Percent Number

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.

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