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Conflicts of interest in relation to research

• External/Third Party Policies
• NIH Financial Conflict of Interest
• The questions on the outside grant (OG) form
• Actions required at other points in the research lifecycle
• Sources of advice and assistance

External/Third Party Policies

All those to whom the University's policy applies, need also to be aware of, and comply with, the requirements of external/third party requirements affecting their activities. For example,

• Authors submitting a manuscript will be asked by the publisher to (or should in any event) disclose any 'significant financial interest' or other relationship with the manufacturers of any commercial products or providers of commercial services discussed in the manuscript and any financial supporters of the research.
• Those acting in peer review or advisory roles (e.g. related to grant proposals, journal manuscripts, research policy) will be asked (or should in any event) disclose any conflicts of interest
• Some research funding agencies may require direct notification to them of certain interests, and/or reserve the right to review approve a proposed plan for managing a conflict of interest; and/or prohibit grant holders from undertaking certain activities.

Staff and students need to be aware of and comply with these types of requirements.

NIH Financial Conflict of Interest

The US Department of Health and Human Services has revised the regulations on disclosing and reporting conflicts of interest for researchers funded via its Public Health Service (which includes the NIH) available at http://grants.nih.gov/grants/policy/coi/fcoi_final_rule.pdf.
The new regulations (which took effect on 24 August 2012) make some significant changes to the previous framework for disclosing, managing and reporting conflicts of interest.

In particular, the new regulations:

• Require investigators to complete training related to the regulations and their institution’s financial conflict of interest policy.
• Require investigators to disclose to their institutions annually all of their significant financial interests (SFIs) related to their institutional responsibilities. Please note that SFIs include (but are not limited to) consultancy payments, honoraria, paid authorship, equity interests (including any stock, stock option, or other ownership interest) and reimbursed travel. Institutional responsibilities are defined as teaching/education, research, outreach, clinical service, training and University and public service, on behalf of their institution and directly related to those credentials, expertise and achievements upon which the Investigator’s institution position is based
• Lower the threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
• Require institutions to report to the NIH additional information on identified financial conflicts of interest and how they are being managed.
• Require institutions to make certain information accessible to the public concerning identified financial conflicts of interest held by senior/key personnel.

Frequently Asked Questions (FAQs) about the new regulations are available at http://grants.nih.gov/grants/policy/coi/coi_faqs.htm

Oxford researchers are asked to note the following:

• The regulations apply to all Investigators funded by the NIH (or via a sub-contract with a University, where the research in question is funded by the NIH). The regulations define an 'Investigator’ as project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.
• A Significant Financial Interest need not necessarily represent a Financial Conflict of Interest, but must be disclosed by the Investigator to the relevant Head of Department or Faculty to determine whether this presents any possible conflict of interest which needs to be reported to the NIH.
• There is no requirement to make a 'nil return’ if an Investigator does not hold any Significant Financial Interests.
• Each Investigator must complete training in the regulations (prior to engaging in research related to any NIH-funded grant or contract and at least every four years). To satisfy this requirement, an online training module is available to complete at http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm. As part of this training requirement, NIH-funded Investigators are also required to familiarise themselves with their own University’s Policy on Conflict of Interest.
• The procedure at Oxford for making a declaration internally is set out in this Flow Diagram (25kb). In summary, a declaration of a 'Significant Financial Interest’ should be made initially to the researcher’s Head of Department or Faculty (or in the case of a Head of Department or Faculty, to the Head of Division) via the Annual Declaration of Significant Financial Interests form (39kb).
  If, in the view of the Head of Department or Faculty (or Division), this could present a Financial Conflict of Interest, this should then be submitted to the Secretary of the University’s Committee on Conflict of Interest (coisec@admin.ox.ac.uk) together with a plan for how the conflict can be reduced, eliminated or managed. The Secretary of the University’s Committee on Conflict of Interest will then liaise with Research Services who will submit the plan to the NIH via their electronic Research Administration (eRA) Commons Financial Conflicts of Interest module.The Investigator is required to produce annual updates on how the conflict is being managed.
• Significant Financial Interests do not include (1) payments made by the University (salary, royalties, honoraria, expense reimbursement or any other remuneration) or (2) income from seminars, lectures, or teaching engagements sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical centre, or a research institute that is affiliated with an Institution of higher education or (3) an investment by a mutual fund, pension fund or other investment fund over which the investigator or his/her immediate family member does not exercise management of fund investment.



The questions on the outside grant (OG) form

The revised policy approved by Council on 13 July 2009 continues a long-established requirement for researchers to formally indicate any actual or perceived conflict of interest or any circumstances that could lead to any actual or perceived conflict of interest at the research grant application or contract negotiation stage.

The outside grant (OG) form produced in Resolve includes the following two questions on page F1:

3a) "Do you or any of your co-investigators have:

• employment or consulting arrangements with;
• financial interests in (e.g. an equity holding in); or
• fiduciary responsibilities towards (e.g. a board appointment with)

the proposed sponsor?"

3b) "Will the acceptance of the proposed grant or contract lead to potential or real conflict of interest?"

All Principal Investigators must complete this section of the OG form.

Research Services staff will scrutinise the OG forms received for grant and contract applications in the usual way, and any positive responses to the above questions will be referred to the PI's Head of Department.

The Head of Department will be asked to consider the issues raised in the OG, in accordance with the University Policy on Conflict of Interest, and to advise Research Services in writing that the appropriate action has been taken prior to acceptance by the University of the proposed research grant or contract.

As required under the Policy, any unresolved matter shall be referred to the Conflict of Interest Committee for advice.

Actions required at other points in the research lifecycle

Situations related to conflict of interest may develop at any time during the 'research lifecycle.' These may arise from or relate to the research activities of University staff, students, academic visitors and collaborators, changing personal circumstances, research supervision, publications, funding, consultancy, invitations to take part in external activity, external research funding or involvement in potential or actual technology transfer initiatives (e.g. the licensing or sale of IP or creating spin-out companies).

The University's Conflict of Interest policy places the onus on the individual involved to recognise and disclose activities that might give rise to conflicts of interest or the perception of conflicts and to ensure that such conflicts are seen to be properly managed or avoided.

The general rule, with the exception of committee business 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).

As described in the Policy, many situations will require nothing more than a declaration and a brief written record of that declaration, which must be held in the department's or college's records.

Some instances will however need to be dealt with by agreeing how the conflict can be actively managed.

There are however some particular instances where the general procedure is varied and further specific steps are required such that approval is obtained not only from the Head of Department (or equivalent) but also from a designated University official, as set out in the table at Further procedural guidance of the Policy. For example, 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.

Sources of advice and assistance

Staff and students are encouraged to discuss issues related to conflict of interest with colleagues, mentors, supervisors, Senior Tutors, Directors of Graduate Studies, Heads of Department, College Heads, Heads of Divisions or others as appropriate.

If an individual is uncertain about how the University Policy on Conflict of Interest might affect his or her activities or has any questions about its application, he or she can contact the appropriate person (as set out in paragraph 19) or the Secretary of the Committee on Conflict of Interest.

If the situation relates to a research proposal or research project, the terms of conditions of external funding, or any related activities, you are welcome to contact Research Services, in particular Kathryn Dally or Glenn Swafford in the first instance.

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