Conflict of Interest Policy
National Office Research Ethics Committee Members & National Office Staff
Introduction
Research Ethics Committee Members (hereinafter collectively ‘Committee’ or individually a ‘Member’) supported by the National Office for Research Ethics Committees (hereinafter ‘National Office’) are appointed by the Minister for Health to act in the public interest by conducting research ethics review in prescribed areas of health research.
The National Office operationally supports Members across the lifecycle of review of a research ethics application. Members are participating on the Committees to bring their professional and personal expertise and knowledge to bear when reviewing ethics applications.
Given the nature of this expertise, it is probable that, from time to time, it may be the case that individual Members could have a conflict of interest, be that a real or perceived material interest, in the outcome of Committee business. The purpose of this document is to mitigate any of those potential conflicts, and to ensure that the decision-making process of the national ethics review system engenders the trust of the research community and wider public.
This policy is aligned with the principles of management of a material interest(s), as set out in SI 260/2021 Schedule 5, SI 41/2022 Schedule 5 and SI 257/2022, Schedule 5 and has applicability for all Members that are appointed to any Committee supported by the National Office.
A conflict of interest can occur when any personal or business material interest may have or may be perceived to have, an undue influence in a person’s judgement about the matter concerned.
1. A Member is regarded as having a material interest if they, their connected relative , or a nominee of either of them:
- is a member of a company or any other body that has a beneficial interest in, or material to, any matter to be considered;
- is in partnership with or is in the employment of a person who has a beneficial interest in, or material to, any such matter;
- is a party to any arrangement or agreement (whether or not enforceable) concerning land to which any such matter relates; or
- has a beneficial interest in, or material to, any such matter.
2. An interest that is so remote or insignificant that it cannot reasonably be regarded as likely to influence the member in considering or discussing, or in voting on, any question in respect of the matter or in performing any function in relation to the matter, will not be regarded as material.
3. A perceived conflict of interest is one that a reasonable person would consider likely to compromise a Member’s objectivity.
4. A Member will not have conflicts of interest and will be independent of the study sponsor, the investigators involved, and of persons financing the study and will have no other undue influence.
Procedure
1. Where a Member has a material interest in any matter that falls to be considered by the Committee, they shall:
- disclose to the Chairperson the nature of the interest in advance of any matter under consideration; and
- neither influence nor seek to influence a decision relating to the matter; and
- withdraw from a meeting or that part of a meeting at which the matter is being discussed or considered; and
- take no part in any deliberation or decision relating to the matter.
2. Where a material interest is disclosed, the following shall apply:
- the disclosure shall be recorded in the minutes of the meeting concerned ; and
- the disclosure shall be for as long as the matter of the disclosure is being discussed; and
- the Member by whom the disclosure is made, shall not be counted in the quorum for the meeting.
3. Any failure to comply with the conditions set out in procedure point 1 of this policy by a Member having disclosed a material interest, shall then result in the Chairperson determining the final decision in relation to the matter being discussed. In this scenario, the particulars of the decision-making process will be recorded in the minutes. Should the Chairperson disclose a material interest, then the other members of the Committee shall designate another member to determine the final decision in relation to the matter being discussed.
4. Any failure to comply with the conditions set out in procedure point 1 of this policy by a Member who has disclosed a material interest, may be removed by the Minister of Health and disqualified from being a Member.
5. If a Member thinks they may have a perceived conflict of interest, or if a perceived conflict of interest is raised by another person about a Member, the matter shall be discussed by the relevant Committee in advance of any discussion of the matter to which the conflict of interest relates. The Committee as a collective will decide whether a declaration of interest is warranted. In instances where there are divergent views, the Chairperson shall make the final decision. If it is decided that a perceived conflict of interest exists, then procedure point 2 of this policy, will apply.
6. In line with best practice for committees acting in the public interest, in order to guarantee independence and transparency, Members and National Office staff shall make an annual declaration of their financial interests.
7. These principles shall also apply to the National Office staff administering ethics applications, if such material interest arises during the course of their operations.
8. It is the responsibility of the Members and National Office staff and any person acting on its behalf to be aware of the policy in relation to disclosure and conflict of interest, and to abide by it.