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Appendix 4.

Conflict of Interest Management

It is recognised that during the process of any guideline development, considerations other than the evidence itself can influence decision-making, have the potential to bias recommendations in sometimes unexpected ways, and thereby erode the impartiality, integrity and reputation of the guideline.

These biases might, for example, disproportionately favour one treatment or medical product over another, or one treatment modality over another, or even ultimately lead to overdiagnosis or treatment. It is therefore well-established as important to anticipate, recognise and manage any potential source of bias that might be introduced into the process of guideline development, and allow scrutiny and management of any declared interests which have the potential to introduce such biases.

Scrutiny assists in the elimination of any potential bias or the introduction of any improper motivations and allows transparency of potential conscious or unconscious influences in decision-making.

For this guideline a Conflict of Interest (COI) was defined as an interest of a member of the GDG that conflicts with or has the potential to conflict with the duties and responsibilities of membership and the process of guideline development. This includes any outside interest which could be perceived to introduce any bias into the decision-making of committee members.

Potential members were asked to declare any financial interests or personal relationships over the three years preceding the formation of the group and any arising during guideline development. COIs that were scrutinised included renumeration, academic, personal or political relationships, employment, consultancies or honoraria, grants, gifts, gratuities or any other form of remuneration, and financial connections, whether that be to funders or stock ownership.

Each potential member was asked to report all financial interests when any benefits or losses either in money or in kind have occurred or may occur, and other relationships when a strong position, prejudice, familial connection or other relationship held by a person could reasonably (or be perceived to) affect a person’s judgement in relation to fair decisions about evidence, and their participation in group decision making. Individuals were asked to declare any such relationships or interests whether or not they thought they might provoke a conflict. Potential participants were informed that such disclosures would be viewed by others to ensure that the process of guideline development was a transparent and prudent process.

These conflicts or potential conflicts were managed by a Conflict of Interest Management Group, which consisted of the two Guideline Chairs and an independent observer, ethicist Professor Lynn Gillam, who did not otherwise participate in the guideline development process. This group operated within the AADPA policy for the Identification and Management of Potential Conflict of Interests, which was developed to align with standard A6 of the NHMRC Procedures and requirements for meeting the 2011 NHMRC standard for clinical practice guideline (Appendix document). The conflicts of interests of the Chairs were scrutinised by the independent ethics expert of the COI Management Group and the President of AADPA.

The COI Management Group scrutinised the written disclosures made by all potential GDG members and determined whether there were any conflicts or potential conflicts of interest and whether the nature or financial elements of these constituted a low, medium or high COI or potential COI. Any disclosure that could be perceived to affect the person’s judgement, decision-making about evidence, affect the person’s participation in group decision-making or erode the integrity of the group decision was classed as a conflict or potential COI.

Where a COI or potential COI was identified, the Conflict of Interest Management Group considered whether it could be managed, for example, by exclusion from certain discussions or decisions, divestment of financial interests, resignation from other entities likely to be affected by any recommendations, peer review or public consultation, or by any other measure.  On the basis of the declaration of interests made, appointments to the GDG were either not approved, approved unconditionally, or approved with constraints, such as the formulation of a management plan to mitigate the conflict or potential conflict.  A register of disclosures and management plans was maintained throughout the life of the committee.

At the first and all subsequent meetings, members of the committee were reminded about the need to provide updates to COI disclosures and were given the opportunity to raise any concerns about the interests of other committee members.

The Conflict of Interest process is further detailed in Appendix 1 of the Administrative Report. The Conflict of Interest declarations for the GDG is available via request: