Describe some of the regulatory issues that you encounter in your position that are unique to the university sector.

Some of the work I do encompasses professional ethics in connection with research opportunities. Internally, where the research extends to, or involves, human or animal subjects, the university has specific bodies that meet regularly and issue guidance on ethical issues. There are also strict ethical issues and compliance requirements with respect to clinical studies with which the university is involved.

Through its Research Ethics Board, Western University provides the approval process for the hospitals in the city which are conducting clinical trials. The University also oversees the activities and clinical studies of the Robarts Research Institute, which is now part of the university.

Federal legislation, together with guidelines under the Canadian Institute of Health Research programme, Canadian Council on Animal Care, and Health Canada are applicable to studies, trials and research initiatives. A paramount consideration is the safety of those affected. However, these rules also cover privacy, anonymity and security of data and results. Protocols established by Western and the institutes supplement these legal obligations

Because we are a public institution, we obviously don't have shareholders - but we are accountable in other ways. For example, the university is subject to statutory freedom of information laws for the Province of Ontario, known as the Freedom of Information and Protection of Privacy Act. The city's hospitals are governed by separate privacy legislation.

With respect to the university, the provisions of the freedom of information laws allow anyone with a legitimate interest in learning about what the university does to seek information about its activities. Some topics are "off limits" for reasons of privacy and data protection - and there are some specific research exemptions - but we are generally obliged to answer most enquiries.

Some of the questions we are asked can be awkward to answer, because they drill down into the details of what researchers at the university are doing. When we answer these questions - which we generally do - we inevitably risk revealing information that would otherwise be protected by statute. We have established a specialist committee, headed by a privacy officer, to process these requests for information. Where the university believes the information is felt to be too sensitive to disclose, it is prepared to seek a court's permission to refuse to do so.

As a research institution, we deal with a significant amount of hazardous materials. We recently conducted a compliance training programme on what our employees should do in case of leakages or escapes from a laboratory, or an explosion. In order to satisfy compliance with provincial guidelines, the health and safety area within the university organised several seminars, and followed them up with a mandatory online training programme for each of our 3,500 employees. Employees were required to pass this programme as part of their annual performance appraisal - a primary goal was the creation of awareness of risks and compliance.

One of your main roles is to establish spin-off companies that emerge from the university`s research. Can you explain how this process works in practice?

Initially, we decide on which jurisdiction of incorporation the new company should be subject to, which can either be provincial or federal. We then establish the company's internal by-laws, and licence the spin-off technology to the company. It makes sense to licence, rather than assign, the technology to the spin-off company, because the university is more financially secure. That way, the university automatically retains the residual right to exploit the technology in the future, if the spin-off business ultimately fails.
 
Perhaps the most important part of the spin-off process is to engage professional managers as quickly as possible. In most situations, the academics or inventors who created the idea that forms the basis of the new company aren't put in charge of it. Instead, they are more likely to become the company's chief scientific officer. This arrangement allows them to continue to pursue research, while still maintaining their own laboratory at the university.
 
In order to incentivise their performance for the company, the inventors are normally given equity in the new company. However, to overcome any potential conflicts of interest between their work for the university and their work for the private company, the university has created a policy on this issue. The policy, which applies to all of the university's faculty members, is based on policies set by Canada's federal funding agencies.
 
As an institution, the university faces also faces a slight conflict of interest during the spin-off process. Once a decision is made to spin off an idea or product into a separate company, the university wants to be extracted from any liability issues as quickly as possible - we have to ensure the company is legally distinct from the university. On the other hand, the university, in conjunction with the inventor, will want to try to ensure that the company maximises the application of the technology. We will typically achieve this objective by way of board of director representation in the new company.
 
In most situations, the university will maintain an interest in any company it spins off - typically between 10 and 40 per cent of the company's equity. The university may only have a minority stake in the companies it spins off, but it wants its voice to be heard. Previously, the university would only seek observer status at the company's board meeting. Today, the university will normally seek its own full board member status - with unqualified voting powers. This university representation will be in addition to any board member status granted to the new product's inventor.