Independence is a critical issue for Therapeutic Guidelines Limited as its reputation is staked on the integrity of its publications. Independence is relevant to Therapeutic Guidelines both at an organisational level and in the development of therapeutic information.
Therapeutic Guidelines’ independence as an organisation is founded on being financially self-sufficient, through publication and sale of its products. Therapeutic Guidelines receives no direct funding from commercial organisations, including the pharmaceutical industry, in the production of Therapeutic Guidelines and Australian Prescriber. Comprehensive declaration and management of conflicts of interest is crucial to the publication of independent therapeutic advice.
Therapeutic Guidelines requires all those involved in the Company to adhere to this Conflict of Interest Policy and provide an interest statement before appointment.
Interest Statements
Interest statements comprise declarations of any interests relevant to an individual might have relating to the role they are undertaking for Therapeutic Guidelines.
Interests may be academic, professional, commercial or personal, and may be financial or non-financial. Associations may be with government or any company that stands to gain from the inclusion of any product (or its competitor) in the guidelines. This includes any relationships or connections you have with other boards, committees or organisations that could affect the integrity and reputation of Therapeutic Guidelines. Therapeutic Guidelines provides individuals with an interest statement form to assist in providing a comprehensive declaration.
Planned and current interests, as well as interests within the past five years, are to be declared if relevant.
Therapeutic Guidelines does not seek or collect sensitive information as defined by the Australian Privacy Principles. Sensitive information includes health information and is generally afforded a higher level of privacy protection than other personal information. If a declaration is made that includes sensitive information, it will be managed in accordance with Therapeutic Guidelines’ Privacy Policy and will not be published.
Company
Directors, Members of the Company and staff are appointed on the basis of their expertise and interest in the core activities of Therapeutic Guidelines, in particular the promotion of quality use of medicines through the publication of independent therapeutic information.
Directors
Before appointment, Directors must provide the Chair of the Board or the Company Secretary with a written interest statement (see Interest Statements section above). It is the individual’s responsibility to identify and disclose any relevant changes in interests they might have relating to the role they are undertaking for Therapeutic Guidelines.
If a Director, including the Chair, has an interest with regard to any issue for consideration by the Board at a meeting, a statement to this effect must be provided by the relevant Director before any discussion takes place on that issue. If, in the opinion of the Chair, a conflict of interest exists that imperils the independence of the decision-making progress, the Chair may request that the Director leaves the meeting when discussing a decision related to the specific area or issue. If the Director concerned is the Chair, the remaining Directors may request that the Chair leaves the meeting during the discussion.
Directors must provide the Chair of the Board or Company Secretary with an updated written interest statement whenever changes occur.
The register of Directors’ declared interests is reviewed on a quarterly basis and published on Therapeutic Guidelines’ website <www.tg.org.au>
Members
Before appointment, Members of the Company must provide the Chief Executive Officer with a written interest statement (see Interest Statements section above). It is the individual’s responsibility to identify and disclose any relevant changes in interests they might have relating to the role they are undertaking for Therapeutic Guidelines.
Staff
Before appointment, staff must provide a written interest statement (see Interest Statements section above). This includes permanent and contracted employees, those under secondment, temporary arrangements, volunteers, contractors and consultants. It is the individual’s responsibility to identify and disclose any relevant changes in interests they might have relating to the role they are undertaking for Therapeutic Guidelines.
Therapeutic Guidelines
Expert group members
Expert group members are appointed on the basis of their:
- clinical or academic expertise in the therapeutic area under review,
- interest in the quality use of medicines, and
- integrity in providing independent and objective advice.
When composing expert groups, Therapeutic Guidelines aims to incorporate a diversity of expertise, perspective and opinion in the therapeutic area under review. Before appointment to an expert group, individuals must provide a written interest statement (see Interests Statement section above).
At the first expert group meeting, each member is asked to discuss their declared interests and consider how they could influence the guideline recommendations. Members must inform the expert group if there are changes to their declared interests throughout the duration of the project and these changes will be recorded in the register. Before each expert group meeting, the updated register of declared interests is circulated to members. At the start of each expert group meeting, the expert group and the Chair determine whether members have relevant conflicts of interest, and, if so, how these should be managed.
When an expert group member has an interest that is perceived to be a conflict, the member may be asked by the Chair to:
- not be involved in the writing or approval of recommendations associated with the conflict
- not take part in discussion or decision making related to the specific area or issue
- leave the expert group meeting when discussing a decision or recommendation related to the specific area or issue.
The process used to manage a conflict of interest is documented in the register of declared interests.
The member’s exclusion and the deliberations of the expert group are recorded in the minutes. If a group member is concerned that a conflict of interest has been inappropriately managed at an expert group meeting, this can be referred to the Therapeutic Guidelines Board through a confidential communication to the Chief Executive Officer.
The register of declared interests for the expert group is published on Therapeutic Guidelines’ website <www.tg.org.au>
External reviewers
The process for declaration and management of interests for external reviewers is similar to that for expert group members. If the expert group agrees that external review is required for a particular topic, then the external reviewer must submit a declaration of interests before participating in review.
Australian Prescriber
Editorial Advisory Committee
Members of the Editorial Advisory Committee are appointed on the basis of their expertise and interest in the core activities of Australian Prescriber. Before appointment, Members of the Editorial Advisory Committee must provide a written interest statement (see Interests Statements section above).
If a committee member, including the Chair, has an interest with regard to any issue for consideration the committee and the Chair determine whether members have relevant conflicts of interest, and, if so, how these should be managed. If, in the opinion of the Chair, a conflict of interest exists that imperils the independence of the decision-making progress, the Chair may request that the Committee Member leaves the meeting when discussing a decision related to the specific area or issue. If the Committee Member concerned is the Chair, the remaining Committee Members may request that the Chair leaves the meeting during the discussion.
If a committee member, including the Chair, has an interest with regard to any issue for consideration the committee and the Chair determine whether members have relevant conflicts of interest, and, if so, how these should be managed. If, in the opinion of the Chair, a conflict of interest exists that imperils the independence of the decision-making progress, the Chair may request that the Committee Member leaves the meeting when discussing a decision related to the specific area or issue. If the Committee Member concerned is the Chair, the remaining Committee Members may request that the Chair leaves the meeting during the discussion.
The interests of Committee Members are reviewed at each Editorial Advisory Committee meeting and the register of declared interests is published on Therapeutic Guidelines’ website <www.tg.org.au>
Authors
Authors are commissioned to write articles because of their:
- clinical or academic expertise in the therapeutic area under review,
- interest in the quality use of medicines, and
- integrity in providing balanced advice.
Authors of articles for Australian Prescriber are asked to provide details on their interests related to the article when the article is commissioned (see Interest Statement section above). Declaring relationships and activities that might represent conflicts of interest helps the Editorial Advisory Committee in the decision-making process, with readers’ interests in mind.
The Editorial Advisory Committee will decide if any declared interests should be published in articles and mentioned in podcasts based on a consideration of whether they are real, perceived, or potential conflicts of interest. The Committee reserves the right not to publish a paper if there is a concern that conflicts of interest may prevent readers from considering a paper to be truly objective.
Peer reviewers
Peer reviewers are engaged to provide feedback on articles commissioned for Australian Prescriber relevant to their area of expertise and interest. This feedback is important to improve content quality, provide a diversity of perspectives and balance any declared interests by an author.
Peer reviewers are asked to provide details on their interests related to the article they are reviewing to help the Editorial Advisory Committee in the decision-making process, with readers’ interests in mind (see Interests Statement section above).