Further Procedural Guidance: Additional steps required in specific circumstances
Appendix B
General Rule
1. As explained in paragraph 19 the general rule is that disclosure should be made at the time the conflict first arises, or it is recognised that a conflict might be perceived, in writing to the Head of Department (or equivalent). If the Head of Department (or equivalent) has an interest in the matter to be discussed, the disclosure shall be made to the person at the next higher level of authority. In most cases this will be to the Head of Division. For University Senior Officers, the line of approval is to the Vice- Chancellor or the Registrar, as appropriate. However, in some circumstances, the procedure is slightly different. These are set out below.
Research
2. Where any researcher has a conflict of interest, they must follow the procedures described in Section D. A researcher must also comply with the following:
2.1 Clarification by principal investigators of any personal interests: to assist the assessment of situations which could lead to a real or perceived conflict of interest at the stage of applying for a research grant, or negotiating a contract the University requires all principal investigators to clarify whether they have any personal interest (shareholding, consultancy, directorship, etc.) in relation to the proposed sponsor. This is done on the X5 costing when submitting applications for external research funding to Research Services;
2.2 Ethics: researchers must also comply with specific declaration requirements as laid down by the appropriate Ethics Committee. Researchers should contact the Secretary of the relevant Ethics Committee if they have questions about those requirements;
2.3 Requirements of funding bodies: some funding agencies set requirements relating to conflict of interest. They may, for example, require direct notification of certain interests to them; reserve the right to review the proposed plan for managing the conflict of interest; and/or prohibit grant holders from undertaking certain activities. Researchers need to be aware of and comply with those specific requirements. Researchers should contact Research Services if they wish to seek advice on any aspect of funding terms and conditions;
2.4 Financial interest in a company involved in a biomedical or clinical research project: this is an area that attracts particular attention given the often very significant financial consequences of research outcomes and the potential harm to members of the public engaged in clinical trials or under treatment. The circumstances determine whether there is a conflict of interest, not the outcome.1 Staff or students who have a financial interest in a company that may reasonably appear to be affected by the results of a proposed biomedical or clinical research must disclose that interest and put to both the Head of Department and Head of Division for review/approval a conflict of interest plan/approach designed to protect the integrity of the research and the reputation of the academic(s), their research group(s) and the University;
2.5 Student receiving support from a company in which his or her supervisor has a financial interest, or where the outcomes of the research are related to the activities of such a company: to preserve the integrity of the research the student and academic must disclose the conflict to both the Head of Department and the Chair of the Conflict of Interest Committee for review/approval of a conflict of interest plan/approach.
1 Kassirer, J.P., and Angel, M., editorial, N. Eng. J. Med. 1993; 329:570-1.
Spin-outs and licensees of University IP
3. Staff or students may have a financial interest or other personal interest in a spin-out or in an organisation to which the University has licensed or is seeking to license University IP or may have personal IP with which they are intending to create a start up company.
4. In such cases:
4.1 they should normally play no executive role in any decisions made between the University or its subsidiaries and such spin-outs or IP licensees. If it is believed that there are exceptional circumstances to argue for such involvement, prior permission must be sought from the Head of Department and then from the Pro-Vice-Chancellor (Research). The proposed conflict of interest plan/approach to be put to the Head and then the Pro-Vice-Chancellor (Research) must aim to protect the reputation of the academic(s), their research group(s) and the University and ensure compliance with company law; and
4.2 if they wish to undertake a consultancy for that spin-out, they must seek prior permission from the Head of Department, and in turn from the Pro-Vice-Chancellor (Research). The proposed conflict of interest plan/approach to be put to the Head and then the Pro-Vice-Chancellor (Research) must aim to protect the reputation of the academic(s), their research group(s) and the University and ensure compliance with company law.
5. Staff (other than researchers who are subject to Council Regulations 7 of 2002 for the Administration of the University's Intellectual Property Policy) wishing to buy or subscribe for shares in a spin-out at any stage prior to the listing of the shares in the company on a recognised Stock Exchange must seek permission in advance from the Head of Department and then from the Registrar.
Sale, supply or purchase of goods or services
6. Staff must ensure the probity of all financial transactions. The sale or supply of goods by the University or the purchase of goods or services by the University must be carried out in accordance with the University's Financial Regulations. Staff should not normally be involved in supply or purchase decisions in relation to any external organisation in which they or any members of their family or any person with whom they have a close personal relationship have a financial interest or in any way have the capacity for personal gain. If there are exceptional circumstances that prima facie require such involvement, the following process should be followed:
6.1 the person should disclose, in writing to their Head of Department, the nature of the transaction, the potential conflict and the method proposed to manage the conflict;
6.2 they and their Head must formulate a proposed plan/approach that protects the University and ensures compliance with the law and the integrity of the transaction(s) and the individuals involved; and
6.3 the Head must then seek approval of that plan from the Director of Finance.
| ISSUE | |||
|---|---|---|---|
| Research Students | |||
| If a student were to receive support from a company in which the proposed academic supervisor has a financial interest, or where the results arising from, or IP generated in the course of, the research project are related to the activities of a company in which the proposed supervisor has a financial interest | Head of Department | Chair, Conflict of Interest Committee | Para. 2, Appendix B |
| Biomedical/Clinical Research | |||
| Staff or students who have a financial interest in a company that may reasonably appear to be affected by the results of their biomedical or clinical research | Head of Department | Pro-Vice-Chancellor (Research) | Para. 2, Appendix B |
| Spin-out and licensees | |||
| Staff or student who has a financial interest or other personal interest in a spin-out or in an organisation to which the University has licensed or is seeking to license University IP, wishing to: (i) be involved in the negotiation of any contract between the University or its subsidiaries and such spin-outs or IP licensees; or (ii) undertake a consultancy for that spin-out or organisation. |
Head of Department | Pro-Vice-Chancellor (Research) | Paras. 3 and 4, Appendix B |
| Sale, supply or purchase of goods/services | |||
| Staff seeking approval to be involved in University supply or purchase decisions in relation to any external organisation in which they have a financial interest or in any way have the capacity for personal gain | Head of Department | Director of Finance | Para. 5, Appendix B |