COI Policy

Introduction

STANDING Collaboration is part of a NHMRC Program Grant, to be conducted by researchers at the University of South Australia. We are based in the Patient Safety Group (PSG) within the Centre for Population Health Research, led by Professor Bill Runciman. Our group provides support for the Australian Patient Safety Foundation (APSF), a not-for-profit organisation devoted to advancing the cause of patient safety. The PSG works closely with the Australian Institute of Health Innovation, based at Macquarie University, and with a number of consumer organisations and professional bodies, such as the Improvement Foundation.


Purpose

This project aims to provide for an open and transparent process for the purpose of identification, declaration and management of conflicts of interest (COI) during the STANDING Collaboration review of conditions and indicators. We acknowledge that it would be unrealistic to expect that clinicians will have no competing interests. This document clearly defines circumstances when conflicts emerge, and how they should be declared and managed. It is important to ensure confidence in the integrity of the review process and any publications resulting from this study.

According to the Procedures and requirements for meeting the 2011 NHMRC standard for clinical practice guidelines document (the 2011 NHMRC Standard): “guideline development committees are required to identify, document and manage potential competing interests. A competing interest declaration must be completed by each member of the group (requirement A6). Guideline developers currently identify, document and manage potential competing interests through compliance with their own institutional procedures relating to conflicts of interest”.

The STANDING Collaboration project will comply with these principles, outlined by the NHMRC:

  • transparency in the disclosure of any interests
  • managing interests in a manner consistent with the current NHMRC policy
  • providing balance and diversity of expertise and perspectives
  • alancing the benefit of having persons with expertise against the risks of their interests biasing a process
  • safeguarding that a focus on technical knowledge should not override or dominate all other considerations
  • ensuring the committee or working group is chaired by someone who has no conflicts of interest that could, or could be perceived to, erode the integrity of the recommendations
  • warranting the integrity of the guidelines.

All participants involved in any stage of the condition indicator reviews will be asked to complete the COI Declaration Form and agree to the terms of use (Appendix D1). Project staff, clinical champions, and reviewers (whose roles are defined in Section 4) should declare both financial and non-financial interests which could conceivably conflict, or appear to conflict, with their role as reviewers. Reviewers will complete the COI declaration during the wiki registration process; the Research Groupand Clinical Champions will use this document to declare any conflicts of interest.


What should be declared?

Financial

An interest must be declared as a potential conflict when benefits or losses either in money or in-kind have occurred, or may occur, at a level that might reasonably be perceived to affect a person’s judgement in relation to fair decisions (NHMRC 2012).

Non-financial

An interest must be declared as a potential conflict when a strong position or prejudice or 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 (NHMRC 2012).

NHMRC Examples

Financial – payments, gratuities, consultancies, honoraria, employment, grants, support for travel or accommodation, payment for meals and beverages or entertainment or educational event attendance (including registration fees) or gifts from an entity having commercial interest.

Relationships – board memberships, employment, stock ownership or consultancies with corporations whose products/services relate to the conditions under review.

Affiliations or associations with any organisations or activities which could reasonably be perceived to be an influence due to a competing interest either for or against the issue for which a guideline is being developed.

Institutional interests (that is, interests arising from an affiliation or association of an individual to an institution) – for example, when parties with an interest in the topic of the guideline have made gifts to the member’s institution to endow chairs or fund the construction of research facilities or donate equipment to support a project in which the member is involved; or when research conducted within an institution could affect the value of equity that the institution holds in a company or the value of a patent that the institution licenses to a company.

Receipt of research funding by the prospective member or immediate family members from any entity that has a commercial interest in the prospective guidelines.

Any other influences which might reasonably be considered likely to affect the expert judgement of the individual, or lead to the perception by others that the judgement of the individual is compromised.


Roles

Research Group (Chief Investigators, Associate Investigators, Technical staff)

Chief Investigators

The Chief Investigator (CI) has a dual role:

  • To ensure each appointed Clinical Champion does not have a conflict of interest related to the clinical condition for which they are responsible.
  • To review each conflict of interest and determine whether or not, on the basis of the declaration of interests, the expert reviewer’s appointment is allowable.
Associate Investigators

Associate Investigators may volunteer as Clinical Champions.

Technical staff (Project Manager, Program Manager, Research Fellow)

These staff are involved in reviewing the guidelines and collating the condition indicators. The Project Manager (wiki administrator) is responsible for the management of the wiki which includes: the collation of the declared conflicts (which are forwarded to the CI) and ensuring any conflicts which are deemed by the CI as allowable are highlighted for each condition prior to the review conducted by the Clinical Champion.

Clinical Champions

Clinical Champions are responsible for the final review of the collated expert reviewer responses for each condition. In the instance where an expert reviewer has a perceived or potential conflict of interest the Clinical Champion will use his or her expertise in determining if the indicator review has been unduly influenced by the declared conflict and will accept or reject elements of the review. It is essential that each Clinical Champion will be required to have no conflicts of interest that could, or could be perceived to, erode the integrity of a group decision.

Reviewers

Reviewers will nominate conditions for which they consider themselves experienced and/or experts. Their role is to edit (add, modify, or delete) and comment on the proposed clinical indicators. Reviewers should be aware that by agreeing to participate:

  • Their information will be provided to the Chief Investigators and possibly Clinical Champions for consideration.
  • They will update this information throughout their involvement with the development of these guidelines in the event that their circumstances change.
  • They will comply with the conflict interest management plan.
  • They allow any interests they have disclosed in this form, and any interests declared after they complete this form, to be taken into consideration when deciding to accept or reject their suggestions.

Management of conflicts

The following describes how declared conflicts will be managed:

  1. The Project Manager (wiki administrator) will forward information about potential conflicts to the CIs for review. The conflicts will be alerted by:
    1. Collating the returned COI (from the Research Group and Clinical Champions)
    2. A report generated by the wiki which will identify Reviewer conflicts.
  2. The CI will, using the guide below, determine whether or not a Reviewer’s comments are included or precluded based on the conflict of interest declared:
    1. Consider whether or not there are factors that could, or could be perceived to, affect a person’s expert judgement in relation to fair decisions about evidence and their participation in group decision-making;
    2. Consider whether there could exist real, perceived or potential competing interests that could influence a person’s expert judgement or erode the integrity of a group decision.
  3. CIs categorise a Reviewer’s comments in three ways:
    1. May proceed and participation can occur without any constraint; or
    2. May proceed and interests disclosed. A Reviewer with perceived or potential conflicts may continue participation in the review. However, their conflict will be disclosed to the condition Clinical Champion after the Expert Review’s review is complete, and before the Clinical Champion’s review; or
    3. Precluded.

References

The information contained in this document relies on the following sources:

  1. NHMRC Guideline development and conflict of interest: Identifying and managing conflicts of interest of prospective member and members of NHMRC committees and working groups developing guidelines 2012.

    www.nhmrc.gov.au

  2. NHMRC Form for disclosure of interests (Guideline development).

    www.nhmrc.gov.au

  3. National Institute for Health and Clinical Excellence (NICE), A code of practice for declaring and dealing with conflicts of interest 2007.

    www.nice.org.uk

  4. University of South Australia, Conflicts of Interest in Research. Available at:

    w3.unisa.edu.au