Issues affecting institutions and professional societies

Responsibilities and transparency

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Responsibilities of institutions and societies

Professional societies and health-related industries may establish mutually beneficial relationships. Societies may receive financial or other support from industry for publications, meetings, conferences and educational programs. Industry may, in turn, have the opportunity to showcase their products to a sophisticated and responsive audience. In addition to receiving money directly from industry, societies that allow companies to market products such as credit cards, insurance and stationery might receive royalties from any products sold. Societies might also be paid for the sale of their membership lists and may participate in the marketing of products related to medicine or healthcare. Council and committee members may have shareholdings in companies. All of these arrangements have the potential to create conflicts of interest.

The relationship between the professions and industry raises sensitive professional and public concerns because associations between societies and industry can compromise the societies’ objectives and damage their public standing. Indeed, the mere fact of a society’s association with industry may undermine its standing as an independent, disinterested contributor to debates about health and health policy.

Societies should, therefore, take care to ensure that their objectivity or public standing is not compromised by corporate or other sources of income. Dualities of interests should be disclosed in a transparent, timely and comprehensive manner, as described below.

The requirement of transparency

Detailed disclosure of interactions between individual practitioners and industry are becoming standard in Australia, New Zealand and in many other countries. Typically, responsibility is imposed on industry to provide publicly accessible data regarding direct and indirect payments, or other transfers of value to healthcare professionals. Industry also has a responsibility to provide data about direct and indirect payments to third parties made at the request of, or on behalf of, healthcare professionals. Payments to be reported include:

  • consulting fees

  • payments for other services, including those of an educational or teaching naturehonoraria, irrespective of whether these are received directly by the individual or are directed to a nominated trust fund, research fund or charity

  • provision of food and beverages

  • travel and accommodation

  • educational expenses

  • charitable contributions

  • royalties or licence fees

  • research and other grants

Professional associations should consider themselves subject to the same requirements of transparency as individual practitioners. That is, receipt of benefits or other transfers of value from industry – including government and non-government sources, by either a society or its individual members, should be fully disclosed and open to adequate public scrutiny.

To meet the requirement of transparency, organisations should establish mechanisms for the detection, management and public disclosure of relevant interests. In the case of individual practitioners, these mechanisms should include sufficient safeguards to ensure the accuracy of the data and the protection of the privacy of individual society members.

Conflicts of interest involving officers of a society

Officers of a society, including members of its council and committees and employees and volunteers, may have either pecuniary or non-pecuniary interests relevant to their roles within the society. These interests may take the form of shareholdings or paid consultancies, other commitments in the form of advisory positions, scientific collaborations, or any of the full range of pecuniary or non-pecuniary interests discussed in Interests, dualities of interest and conflicts of interest and Issues affecting health practitioners.

In these cases, the general rules for dualities and conflicts of interest should be applied, that is, that the dual interests should be declared, that an appropriate body should assess whether a conflict exists and, if the latter turns out to be the case, that appropriate action is taken.

If action is required, the nature of this will depend on the circumstances. Action may vary from the mere acknowledgment of the interest to withdrawal from participation in the body in question. Although those who participate in the activities of a society are entitled to privacy, this should be balanced against the need for the society members to be confident that their interests are being appropriately served.

As in other cases of disclosure, appropriate standards of transparency should be applied to ensure both the possibility of adequate scrutiny and protection of the privacy of the individuals involved.

Key points
  • Professional societies, including The Royal Australasian College of Physicians, should have in place processes for the declaration, management and public disclosure of relationships with industry, and of the competing interests of members and office holders.

  • These processes should apply to employees and office holders, as well as to the members of the professional societies.

Membership of disease-specific community health organisations

Many health professionals are involved with community-based organisations that deal with specific diseases such as cancer, asthma, diabetes or heart disease, or deal with specific sub-populations, such as Indigenous health organisations. Since many of these organisations are established by industry, work collaboratively with industry, support industry applications for registration and funding, and/or attract significant industry funds, their views and activities might be oriented towards, or influenced by, commercial imperatives.

Clinicians working with community health organisations should therefore be aware of the specific links that these organisations have with industry, clarify the organisation’s policies with respect to industry, encourage the organisation to develop guidelines and policies for involvement with industry and declare its involvement with industry, and ensure that they maintain their own independence when associating with community organisations. Clinicians should also ensure that any community-based educational programs with which they are involved are free of bias.

Membership by clinicians of community organisations may present interests that need to be disclosed in particular settings. The individuals concerned should be aware of this and, where relevant, disclose involvement and implied or incurred obligations.

Key points
  • Health professionals and medical organisations should be aware of the ties between community-based organisations and industry.

  • Health professionals who interact with these organisations should take steps to avoid inadvertently privileging commercial imperatives over patient welfare, and to ensure that educational programs with which they are involved are free of bias stemming from sponsorship relationships.

  • Appropriate firewalls should be maintained between professional societies and disease-specific community health organisations and industry sponsors to prevent conflicts of interest.

Meetings

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Where the professional association or organisation is organising and funding the meeting

At times, professional associations and clinical organisations (‘organisations’) might want to arrange research conferences or educational sessions, and are in a position to fund these meetings themselves without external financial support. In these situations, organisers should ensure that the scientific, political or other commitments of the organisation and its office holders do not inappropriately influence the content of the meetings. An organisation’s support of a meeting should be appropriately disclosed to meeting attendees.

Key points
  • Where the professional association or organisation is organising and funding the meeting:
    • The scientific, political or other commitments of organisations and office holders should not influence the content of educational or scientific presentations.
    • Organisational support for scientific/educational meetings should be disclosed to attendees.
    • Speakers at these meetings should disclose any relevant interests at the time of their presentations.

Where the professional association is seeking external commercial support for a meeting

Sources of commercial funding should not influence the scientific, educational or public policy decisions of societies. In situations where professional associations and healthcare organisations wish to seek external commercial funding to support their meetings, the association should convene an independent organising committee and adhere to the principles outlined in Issues affecting health practitioners.

In particular, commercial supporters should not be able to influence the planning, content, speaker selection or execution of any program of a society, and commercial sponsorships should not influence the subject matter of any meetings arranged under its auspices. It should be made clear that the display of commercial products or services at society meetings, and advertisements in a society’s journals or social event sponsorship, does not imply warranty, endorsement or approval of the products or services. It should also be made clear that such promotion is in no way an endorsement of effectiveness, quality or safety of the products or services.

Key points
  • Where the professional association is seeking external commercial support for a meeting:
    • Commercial supporters should not influence the planning, content, speaker selection or execution of a society’s program or the subject matter of presentations.
    • Support for organisational activities by commercial organisations should be treated with caution.

Where the organisation is convening meetings to develop policy

There are various special settings in which particularly complex issues of sponsorship may arise. These include conferences convened to discuss specific clinical or scientific issues and meetings of experts to develop clinical and public policy guidelines. These may be sponsored by professional societies or organisations or by external commercial industries.

Because policy and practice guidelines may, by definition, have greater impact on the design and delivery of healthcare than educational or scientific meetings, a greater degree of caution should be exercised regarding any possibility for commercial or political interests to influence these processes.

Nevertheless, the general rules described above apply. Outside funders of an event should have no influence over its content, over selection of speakers or participants, or over the content of reports or other documents, recommendations, guidelines or policies produced as a result. In general, individual societies should review, and accept responsibility for, any such documents.

Clear and rigorous rules for disclosure should be established for all such meetings, and should be publicised in relevant documentation. It is desirable for participants to include a majority with no pecuniary or non-pecuniary conflict of interest in the matter under study. Individuals with conflicts of interest may participate in such events as long as the appropriate public disclosures are made. The disclosures should also be appropriately managed by a planning committee that is independent of influence by commercial sponsors.

Key point

Where the organisation is convening meetings to develop policy or practice guidelines, external funders should have no influence over the content, selection of speakers or participants or the content of reports, recommendations or guidelines produced as a result.

Support for association members who wish to attend external meetings

It is appropriate that professional associations and healthcare organisations (rather than industry) provide funds for members, students, trainees and staff members to attend or present at educational or scientific conferences, provided that the selection of the recipients is equitable and transparent.

In cases where members of the organisation are offered commercial funding to attend meetings, they should disclose this, and obtain permission from, the organisation, which should have relevant policies and procedures in place. The principles outlined in Issues affecting health practitioners should be applied.

Key points
  • Professional associations and organisations should endeavour to fund healthcare professionals to attend meetings as part of their professional development and education.

  • Organisations should have processes in place to monitor situations in which members or employees are offered external funding to attend educational and scientific meetings.

Educational activities

Training programs

As with other activities sponsored by industry, in the case of educational programs – including continuing professional development (CPD) programs, sometimes also referred to in the medical context as ‘continuing medical education’ (CME) programs – there is convincing evidence that sponsorship alone often influences both the content of these programs and the effects they have on the behaviour of those who undertake them. Furthermore, because the conduct of educational activities is often a core responsibility of scientific and clinical societies, the independence of these programs is of profound importance both for the members of the societies and for the broader community.

Internationally, there has been a tendency for CPD to be delivered by for-profit companies that have strong links with the pharmaceutical industry. In Australia, it is increasingly common for meetings of purported educational intent to be organised by commercial entities for the achievement of profit, or for events of an obviously promotional kind to be referred to as an ‘educational’ activity. Industry funded CME that is designed for promotional purposes should not be disguised as education or science.

By its very nature, education cannot be subject to commercial or other sectional interests. Accordingly, in general, the use of the term ‘education’ should be restricted to contexts that are free of such interests. The activities of industry in providing information about their products, for example distributing materials that argue a specific case for a particular product with which they are associated, and conducting training programs in relation to the use of equipment supplied by them, should be distinguished from education and recognised as serving other purposes. It is important that adequate measures are taken to ensure that educational programs undertaken under the auspices of professional associations are free from the possibility of bias of any kind towards commercial sponsors and that the community can have full confidence that this is the case.

This means that for any such program:

  • the group responsible for organising it should include a majority of individuals who do not have relevant conflicts of interest

  • clear rules of management of dualities and conflicts of interest should be observed within the organising committee

  • high standards of transparency should be maintained, with public disclosure of relevant interests of the organising committee

  • the scientific, clinical and educational content should in no way be affected by the presence or nature of commercial sponsorship

  • speakers should be meticulous about declaring dualities and conflicts, and steps should be taken to ensure that their presentations are balanced

  • processes should be established to assess the outcomes of the programs, including provision for feedback regarding possible biases from course participants

Various mechanisms are available for ensuring that the above conditions are met. It is desirable that educational programs sponsored by a society do not involve industry support at all. However, if this is not possible, such support should be paid into a fund that is available to the society to conduct these and other activities. The process of negotiating with industry sponsors should be separated from that of designing the program. It is inappropriate for receipt of sponsorship support to be made contingent on conditions of any kind regarding choice of speakers or topics or inclusion of particular content.

The organising committee should adopt procedures to ensure that individuals with conflicts of interest may provide input into discussion, but should not participate in the actual decision-making process relevant to that issue. The committee should be able to provide a formal undertaking that the scientific, clinical and educational content are in no way affected by the presence or nature of commercial sponsorship. Alternatively, if this is not possible, the committee should provide a written statement of the way in which such sponsorship did affect the program content.

Clear guidelines and disclosure statements should be provided to prospective speakers and other teachers. When speakers have conflict of interests, their presentations may be subjected to review before delivery by a reviewer without such conflicts to ensure that it is balanced.

The policies and practices that have been adopted for a particular program should be open to public scrutiny. Independent observers, who can provide a disinterested assessment of the outcomes, should be identified.

It is the responsibility of the institution accrediting an educational activity to ensure that accreditation of a particular activity implies that the activity was free of inappropriate biases related to industry sponsorship or representation.

Key points
  • The institution accrediting an educational activity should be responsible for ensuring that the activity is free of biases related to industry sponsoring or presentation.

  • Clear guidelines, which include requirements for clear disclosure statements, should be provided to speakers.

  • The organising group should include a majority of individuals without conflicts of interest, and conflicts should be managed within the operation of the committee.

  • Measures should be adopted to ensure that the scientific, clinical and educational content is not affected by the presence or nature of commercial sponsorship.

  • Processes should be established to assess the outcome of the programs, including provision for feedback regarding possible biases from course participants.

Endorsements

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The concept of endorsement

The term ‘endorsement’ is used to refer to a statement of support or approbation from an individual or organisation for a product, recommendation or some other object or course of conduct by which the individual or organisation assumes a degree of responsibility for the ensuing outcomes.

This responsibility includes decisions by a society to approve or participate in a particular activity or to provide public support for a particular event, activity or product that has been planned or developed by an outside entity. These may include participation in consensus conferences to develop clinical guidelines and position statements, to endorse publications or educational activities not developed by the organisation, or to provide links in websites to such publications or educational activities.

The practice of endorsement raises a range of ethical issues, mainly relating to the processes according to which the original activities or products were generated, and how the various interests involved were managed at the time. Endorsement may involve material and other support, such as marketing assistance, and it may result in some benefit or advantage to the society in return for the assistance provided.

Endorsement of statements or communiqués generated by conferences

Such conferences (previously referred to as ‘consensus events’) include ‘state of the science’ conferences, ‘expert opinion’ conferences and ‘best practices’ conferences.

When endorsing the outcomes of such conferences, societies should consider whether they are satisfied that the processes according to which the conferences were organised and managed conform with the principles outlined in these Guidelines, in particular, whether outside funders have had any influence over the content or conduct of the event, the selection of speakers and participants, or the content of reports or other documents they produced. In addition, societies should consider whether such events have followed the appropriate procedures for disclosure and management of interests relating to each of the issues and topics discussed. These procedures should be fully documented in the body of relevant reports.

Endorsement of clinical guidelines

A role of professional organisations is to inform and educate the public and government about specific issues concerning medicine, science and clinical practice. From time to time, this may require taking positions in relation to the nature and consequences of particular health problems and treatments. This could include support for specific therapeutic agents or endorsement of clinical guidelines that support particular therapies.

The development of statements of endorsement of guidelines or treatments should be undertaken with great care to avoid compromising the objectivity and credibility of the organisation in the eyes of the broader community. Rigorous policies are needed concerning the processes according to which such statements are generated and reviewed. These policies and processes should ensure that in each case statements are based on relevant evidence, the conditions under which they were prepared included appropriate management of dualities, and any contributions from industry in support of their preparation are provided through arrangements that ensure the processes remain free of influence and are fully disclosed. Conditions should be satisfied where endorsement of statements or policies developed by other societies is considered similar.

Endorsement of clinical guidelines may be appropriate if the following conditions are satisfied:

  • the evidence on which the various statements in the guidelines are based was gathered and assessed using methods such as those of the Cochrane Collaboration or an equivalent body

  • the guidelines will be reviewed and updated according to a defined schedule

  • appropriate processes for disclosure and management of interests will be employed in the production of the guidelines

  • in particular, there has been no influence from pharmaceutical or other for-profit industry representatives

Endorsement of other publications or materials produced by outside organisations

The principles described above also apply to materials derived from other sources, including other professional societies, government bodies and community groups.

In all these cases, care needs to be taken to ensure that both pecuniary and non-pecuniary interests have been appropriately managed. Materials generated by religious or political bodies, or community groups advocating for particular issues or points of view, are especially susceptible to biases. Care should be exercised when considering whether to offer support to such organisations.

In general, it is desirable that such materials are produced by committees or groups in which the majority of participants do not have a relevant interest at a level that is likely to compromise their judgments or decisions. Procedures should also be adopted to ensure adequate disclosure and management of interests, and that outcomes are appropriately documented and annotated to advise how this was achieved.

Key point

Policies and processes should be in place to ensure that the preparation of statements of endorsement involves examination of the relevant evidence, appropriate management of dualities and conflicts of interest, and scrutiny of the statements, to exclude inappropriate industry influence.

Involvement of organisations in overseas activities

Responsibilities

As discussed in Health professionals and international health practice, individuals and organisations may be involved in overseas activities in relation to clinical practice, education, research and business or other activities. Educational institutions may have their own interests in relation to international activities, which may provide important sources of revenue. They have a responsibility both to trainees and students and to employees to ensure that their own commercial interests do not adversely or inappropriately impact on educational values.

Organisations working overseas need to be mindful of specific legal, cultural, religious and political issues that might arise. These may be of particular importance where the work involves engagement with vulnerable communities. Care must be taken to ensure that activities are undertaken with proper respect for local standards and traditions and that the professionals who engage in them have adequate cultural training. In some cases it may be appropriate to establish special processes for consulting with local communities and for reviewing decisions and practices that might raise cultural or legal issues.

Issues involving cross-border research are discussed above, and in national codes and regulatory documents. The principles that guide research in Australia and New Zealand apply equally for Australian and New Zealand researchers conducting their work in other settings, subject to the need to abide by local cultural and other requirements.

Key point

Institutions involved in overseas work should develop policies to ensure adequate attention is given to the protection of both the communities with which they are working and their own members who are offering services or conducting research.

Publications

Journals

Professional societies often contribute to the development of the understanding of medicine and other aspects of healthcare by financing the publication of scientific journals or other newsletters. In these settings, like the others discussed above, it is possible that both pecuniary and non-pecuniary conflicts of interest may arise. These include circumstances where editors, reviewers or others involved in the publication process have a personal interest in the content of an article submitted for publication, for example when a reviewer working in a similar area could benefit from delaying the publication of the article in question, or when editors could benefit from promoting their own work. Because journals often obtain significant earnings from advertising and from reprints bought by companies for distribution to health practitioners, the possibility also arises of such payments influencing editorial decision-making.

Journal editors should adhere to the principles of the International Committee of Medical Journal Editors or to other standards on which their editorial boards have agreed. Authors’ disclosures should be required in all cases and published together with the corresponding articles. Reviewers, editors and committee members associated with publications should be asked to declare dualities of interest. Persons with significant conflicts of interest should be excluded from consideration of the manuscripts involved. Journal editors should also recuse themselves from reviewing work in which a conflict of interest exists and transfer this responsibility to other appropriate parties.

In general, the sale of display advertising space is a legitimate source of revenue for professional journals. Advertising should not in any way influence decisions on editorial content. Decisions on the positioning of advertisements should be made independently of decisions made in the editorial departments on the content of a specific issue. Readers should be able to distinguish between advertising and editorial content. Submitted advertisements should be subject to approval by a medical panel, the members of which are cognisant of relevant standards. Advertisers are responsible for ensuring that advertisements comply with relevant laws.

Key points
  • Journals should establish clear policies that conform to international standards for author disclosures, review processes and advertising and other sources of support.

  • Income from the sale of reprints should be disclosed to readers.

Issues arising in relation to societies and institutions

Conclusions

The independence of professional and scientific societies may be affected in a number of ways by relations with industry. These relations may involve individual members, employees or the society itself. In all cases, care should be taken to ensure that appropriate mechanisms are available to deal with the particular issues.

Dualities and conflicts of interest in the conduct of the business of such societies should be approached in a systematic manner, which should, at the very least, include the following steps:

  • Establishment of a defined process for identifying dualities and assessing their potential to constitute conflicts and, if necessary, developing strategies in response.

  • Disclosure of financial and other interests in an appropriate manner.

  • Assessment of which interests are potentially relevant and examination of potential for conflict.

  • In the case of conflict, development of strategies to avoid compromising either the individual involved or the work of the society/institution/college.

  • Public communication of the outcomes of the process in appropriate ways.

Societies and institutions should establish mechanisms to ensure transparency in their relationships with industry, which will normally include provision of information in a publicly accessible form. Additionally, societies and institutions may wish to consider the principles highlighted in these Guidelines to develop their own policies and procedures.


Feedback invited

Suggestions and critical comments from all members of the community are welcome at any time. Email us at ethics@racp.edu.au


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