Standard Indemnity and Compensation Agreement (sICA)
After consultation with many local Pharma companies, CROs, DHBs and Universities, a standard Indemnity and Compensation Agreement (sICA) was created and released in November 2009. Following feedback from industry the sICA has been modified slightly and has now been released as Version 2 (dated July 2010).
While there were a number of new issues raised post-release the most common issue was that of a reference to third parties in Clause 3a. This has been removed and revised wording inserted. It is hoped that this makes Version 2 more palatable to a wider range of organisations.
Also note that the Guidance Document has been updated as well. There has been wide consultation across DHBs regarding this modification and therefore it is envisaged that all DHBs (and some other research providers) will prefer to use this sICA without modification. However, the use of the sICA is not compulsory rather it provides an opportunity to streamline indemnity requirements in the start-up of sponsored clinical trials.
Our thanks must go to the people who have been involved in this process over the past 18 months. Special thanks to the writing group for addressing the issues raised and completing the task.
Mary Casey – Snr Legal Counsel – Waitemata DHB
Bruce Northey – Snr Legal Counsel – ADHB
Stuart Ryan – General Manager – CCRep