The Joint Research Office (JRO) is engaging with the Deans, Vice Provost and UCL Enterprise to develop a policy that leaves UCL better situated to make the most of the new opportunities available through industry partnerships in clinical trials, and to respond to the challenges that these partnerships can lead to.
This new policy will specifically set out the considerations for negotiations with commercial partners. It applies to:
- UCL sponsored studies, where the Chief Investigator is an employee of the University and where there is funding, equipment, or intellectual input for the study, obtained (through UCL) from a commercial company,
- Studies which fall within Health and Social Care and are subject to the Research Governance Framework and/or Clinical Trial Regulations,
- UCL sponsored studies, where the contribution made by the commercial entities is considered significant as to warrant consideration of shared IP and/or data access.
As regulatory sponsor, UCL has adopted the position to own all data, results, samples, and intellectual property arising from a research study led by UCL.
With the research environment changing, there are increasing partnerships between industry (commercial partners) and Universities. These commercial partners have provided supplies, equipment, or financial support and input to design of protocol to UCL sponsored studies; increasingly requesting access to study-related data, results, and intellectual property as part of the agreement to supply support.
Data could be shared only when it is considered in the best interests of the project. In such case there has to be clarity as to where the data shall be used.
The default position in relation to data ownership, should be that it is not to be shared for risk of contamination of IP, potential infringement of confidentiality and data protection.
In cases where agreement (following the above principles) cannot be reached, the final decision as to whether UCL will agreed shared IP and/or data access with a commercial entity is to reside with the Dean of the relevant faculty (where the Chief Investigator is based) who will make a decision based on a risk/benefit assessment.