Public Board of Directors papers 27.01.22
In December 2021, The Trust received a final version of the “Rapid Review” team’s report with confirmation that no serious matters had been identified and that no regulatory interventions or actions were required. In January 2022, The Regional Director wrote to the Trust with The Regional Office’s assessment of the report and provided the appended conclusions, also set out in the introduction to this report. Summary of Findings Terms of Reference 1 - How the Trust responded to the review conducted by Wendy Fisher which highlighted issues in management and culture within the R+I division in 2018 Summary of findings: The review confirms that in 2018 the R+I Division commissioned an operational review to assist in improving clinical trial set up times with the action plan being monitored through the divisional board and recommendations on wider issues being addressed in the draft research strategy. Terms of Reference 2 - How the Trust handled the review into concerns about the R+I division in 2020, including whether the people that raised concerns suffered detriment as a result of speaking up Summary of findings: The review confirms that The Trust’s arrangements for FTSU generally reflect good practice but also highlights areas in which the review team suggests that the response to the concerns raised in 2020 (corresponding to the peak of the first wave of the COVID pandemic) could have been improved. Terms of Reference 3 - How the Trust handled allegations concerning the sharing of patient data with Roche through the Foundation Medicine (FM) programme and Flatiron in and around 2018-date. Including whether people that raised concerns suffered detriment as a result. Summary of findings: The “Rapid Review” report confirms that work taking place to evaluate a potential major commercial partnership was still at the exploratory pilot stage when it was paused due to concerns raised to the Executive Team by clinicians - no business case had been approved, and no contract had been signed. The report makes no reference to the question about detriment. In response to the concerns The Trust commissioned a review and audit by Professor Andrew Hughes to learn any lessons from this experience and has reflected on and built these into policies for future programmes. Terms of Reference 4 - Whether there was a failure at the Trust to engage with clinicians in relation to commercial partnerships to ensure that: The scope and benefits were clear; The decision-making including procurement was transparent; The risks had been identified and mitigated before any agreements were signed Summary of findings: The “Rapid Review” report confirms the earlier findings by Andrew Hughes that there was extensive involvement and engagement of clinicians in the work to evaluate the potential major commercial partnership with Roche and that, furthermore, it was escalation of concerns by clinicians to the Executive Team that led the project to be paused. Terms of Reference 5 - The appropriateness of recruitment decisions within the R+I Division during this period Summary of findings: The “Rapid Review” team report confirms that although there were necessary pragmatic responses to the COVID pandemic emergency there were no evidence of inappropriate HR practices within the R+I Division. The pragmatic responses included redeployment of R+I staff to support the bio security arrangements for the site and acting up arrangements to ensure continuity of leadership. Terms of Reference 6 - In the Context of These Issues Consider What learning the Trust Should Consider and Make Recommendations in that Respect
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