Code of Ethics for the Australasian Menopause Society

Introduction

The Australasian Menopause Society is a professional organization whose members have the privileges and responsibilities ceded to professionals.

Professionals have specialized knowledge and skills which they are expected to exercise with competence and objectivity. Balancing these privileges are the responsibilities to adhere to the norms of professional behaviour.

Professional societies represent their members to the public and there are expectations by the public that these Societies will identify, disseminate and enforce the professional norms of their membership.

Codes of ethics have aspirational features identifying high standards of professional behaviour. They also include educational features indicating to members what would be the collective expectations of individual behaviour. Also included will be regulatory features indicating and supporting the appropriate roles of behaviour and issuing sanctions on occasion for violations.

This code of ethics has been developed by the board of the Australasian Menopause Society from templates developed for the Endocrine Society and the Royal Australasian College of Physicians (see Appendix 1). This code is seen as a living document to be revised and amended as ethical issues evolve.

Executive Summary of the Code of Ethics

The Code is divided into two sections, the Responsibilities of the Society and the Responsibilities of the Members.

The responsibilities of the Society are to conduct the affairs of the Society in an ethical and prudent manner. It should be careful to maintain its independence from industry support and to ensure that its educational presentations remain objective and complete. The Society should be careful in endorsing or marketing products and services not of its own design. The Society's principal function is to disseminate knowledge about menopause science and practice. It must ensure that meetings, publications and courses given the Society's imprimatur remain of the highest quality. The Society has a responsibility to teach professional ethics and to respond to ethical dilemmas, as they become apparent.

The responsibilities of the Australasian Menopause Society members include respect for colleagues, including their work and their reputations, the honest performance and reporting of research and the honouring of predecessors and collaborators. This also includes appropriate sharing of research tools. Responsibilities involve high standards of research on humans, including respect for research subjects, informed consent, maintenance of privacy and confidentiality, ethical approval of the research design, and honest reporting of adverse results. Research employing animals should include respect for animals as sentient creatures.

Those who pursue clinical practice have the responsibility to treat their patients with respect and within their scope of expertise, including obtaining informed consent when appropriate. They should avoid or disclose conflicts of interest and maintain patient privacy and confidentiality in the clinical setting. They must keep adequate records and inform patients of clinical developments. They must remain informed of developments in their field of expertise from objective and complete sources. Physicians should be cautious in accepting gifts from pharmaceutical and device companies because these gifts may be intended to influence opinion. Physicians are obliged to use their expertise to participate in decision-making regarding the distribution of resources in medicine for the benefit of patients, both as individuals and as groups.

I. Responsibilities of the Society as an organization

a. Responsibilities of the Society: General

The Australasian Menopause Society shall discharge its responsibilities to support menopause research, education, and clinical practice with excellence, openness and the highest integrity. The Society has a responsibility to promote high quality science and collegiality among its members and to protect member privacy. The Annual Scientific Meeting and other educational programs of the Society shall be conducted so as to provide the highest quality of objective information.

1. The Society shall not allow its objectivity to be influenced by corporate or other sources of income. Dualities of interest shall be disclosed in a timely and comprehensive manner.

2. The Society shall provide prudent management of funds, verified by periodic auditing. The audit report shall be made available to members.

3. The management of the Society shall be subject to regular performance review by Board.

4. Members shall be kept informed of the activities of the Society and the affairs of the Society shall be open to the members, including the activities of its Committees.

5. Member privacy and confidentiality shall be maintained in accordance with Australian privacy legislation.

6. The Society shall conduct fair and democratic elections and ensure democratic decision-making among its Committees.

7. The Society shall provide members with mechanisms for voicing their concerns. Timely and constructive responses to issues raised by members shall be an important Society function.

8. The Society shall provide timely responses, as appropriate, to concerns and issues brought forth during public discussion regarding research and practice related to menopause.

9. The Society shall strive to ensure that there are no barriers to any of its activities as a result of affiliation, sex, ethnicity or disability by encouraging diversity in all activities and all Committees.

10. Society participation is based on volunteer efforts. While time commitments may be expected, members shall not be expected to incur significant financial expenses in their service to the Society. Service to the Society should not be based on economic considerations.

11. The Society shall organize its activities to recognize the diverse professional needs of its members.

b. Responsibilities of the Society: Relations with Industry

Scientific societies and industry have a mutually beneficial relationship in which the Society receives substantial financial support for its scientific meetings. Conversely industry has an unparalleled opportunity to showcase its advances to a sophisticated and responsive audience. The Society needs to articulate and regularly update its policies related to funding from industry. This includes full disclosure and maintenance of independence in determining scientific content (including selection of sessions and speakers). Even with safeguards, the risk remains that meetings (and sessions) may appear to be influenced by commercial enterprises.

Meetings

Sources of commercial funding should not influence the scientific, educational, or public policy decisions of the Society.

a. Commercial supporters shall not control in any way the planning, content, speaker selection, or execution of any program of the Society, particularly those that are certified for continuing medical education credits.

b. The display of commercial products or services in exhibit hall areas at Society meetings, symposium or social event sponsorship do not imply warranty, endorsement or approval of these products or services, nor effectiveness, quality or safety. The display of misleading data shall not be countenanced. Neither shall commercial sponsorships influence the subject matter of the Annual Meeting.

c. Complete disclosure of commercial support is required for all Society-sponsored activities, as well as a balanced and objective presentation of data related to commercial products. Speakers are required to indicate at the time of their presentations any dualities of interest, including any relationship to the session sponsor.

d. The Society will instruct program directors, speakers and commercial sponsors about these policies prior to every presentation.

e. The appropriate Society Committee will develop a policy for nominating chairs for continuing education programs. Session chairs (or the Committee) will determine the content of the session and invite speakers with the approval of the Committee. Speakers will be asked explicitly to ensure balanced presentations related to controversial issues, including presentation of advantages and disadvantages of specific therapies.

c. Responsibilities of the Society: Endorsements

As a professional organization the Society may take positions intended to inform the public and/or educate legislators regarding specific issues related to menopause. Pivotal to this responsibility, the Society may act to promote the study, or increase awareness, of specific medical conditions.

In these cases, to the extent possible, the Society shall not support specific treatments in order to avoid compromising its objectivity and credibility. Further, such support should not be in return for a specific quid pro quo. Any such statements shall undergo formal internal review for their impact on the integrity of the Society.

d. Responsibilities of the Society: Marketing

1. The Society shall not participate in the marketing of health-related products with the exception of its own journals, educational materials and programs.

2. The Society may make available to its members specific goods or services as a benefit (as in discounts or group availability), that may raise money for the Society, provided that the rationale of the endorsement and the benefit to the Society members are fully disclosed in advance.

e. Responsibilities of the Society: Sanctions

On occasion, the professional behaviour of a member might be such as to warrant a sanction by the Society. Such decisions require an unequivocal demonstration of professional behaviour that is unethical or illegal. Such decisions also require the administration of a due process procedure by the Society.

II. Responsibilities of the Australasian Menopause Society members

A. Responsibility to Colleagues

1. Members shall treat their colleagues with respect and promote collegiality.

2. Members shall promote the educational and professional growth of their colleagues and trainees.

3. Members shall give proper attribution to the accomplishments and works of colleagues, including junior physicians, trainees and medical students.

4. Clinically related commercial ventures with colleagues shall maintain patient welfare as the top priority, not financial gain or academic promotion.

5. Members shall report to appropriate authorities the conduct of colleagues that threatens research integrity, the integrity of the medical profession or patient welfare.

6. Members who supervise trainees shall disclose to them their financial interests in projects directly involving the trainee's academic program. It is suggested that mentor-trainee relationships that involve these financial interests be delineated and approved by the institution's leadership.

B. Research (General)

Members of the Australasian Menopause Society are expected to conduct themselves according to the highest standards of professional behaviour in both research and clinical care. They should engage in responsible performance and reporting of research. They should behave in a collegial manner and share intellectual property appropriately.

1. Performance and reporting of research. Scientific studies must be carried out with rigor and honesty. Data should be reported fully and truthfully.

2. To the extent possible, experimental results and analyses should be submitted promptly for publication. However, there are cases in which competitive and/or patent issues based on a proprietary interest in a new finding may require some delay in submission; this delay should be minimized. Dissemination of the results of negative studies is also important. To this end members conducting research should register their research with The Cochrane Collaboration or other appropriate bodies so that a record of unpublished results may be maintained.

C. Responsibility to Review

Members have a responsibility to review articles submitted to scientific journals as well as research grant applications.

1. Reviewers should demonstrate respect for scientific inquiry, knowledge of the discipline and willingness to provide judgment of publications in a fair and impartial manner.

2. When the request for review is made, reviewers have an obligation to inform the editor or manager immediately of actual or perceived conflicts of interest and to recuse themselves from the review, preferably without reading the submission.

3. Reviewers are obliged to maintain the privacy and confidentiality of the communication.

D. Research Tools

Sharing of materials should be a goal of investigators, applied to the extent it is practical. It is desirable to encourage agreements and basic guidelines for the transfer of research tools and the Society encourages dissemination of research tools without legal agreements whenever possible.

E. Human Research: Investigator Responsibilities

Research involving humans includes direct interaction with individual persons, and the acquisition or use of personal data from participants. All research must be justifiable in terms of its potential contribution to new knowledge, must be based on a thorough study of the existing literature, and must incorporate clearly stated hypotheses, methods and assessment of risks and discomfort to participants. Studies should be properly statistically powered and include appropriate controls.

1. Members are responsible for ensuring that the welfare, rights, beliefs and customs of research participants are fully respected. They must give full informed consent to the proposed research.

2. Members have a responsibility to ensure that the risk of harm or discomfort to participants in research is minimized. This responsibility exceeds that of any commitment to the goals or potential benefits of knowledge.

3. Members should honour their commitment to obtain new knowledge and communicate it to other researchers and society. This commitment should prevail over other motivations for conducting research, including economic or academic benefit.

4. All research involving humans must be conducted or supervised by individuals with the appropriate skill and experience in the conduct of human research.

5. Adequate resources must be available for the proper conduct of the research, and provision must be made for adverse events.

6. Participants in research should be indemnified against costs associated with any injury related to the study and should be informed of the terms of this indemnity in their consent process.

7. Proper provision must be made for the secure storage of data obtained in the conduct of the work. Data should be safely stored for a specified period to allow verification of results and assessment of adverse events following administration of drugs.

8. While full reports of the research should be published, the confidentiality of individual participants must be maintained.

9. Where developing results suggest that the risks associated with a particular research project are significantly greater than originally anticipated, urgent IRB review should be requested, the participants notified and the research stopped.

F. Human Research: Informed Consent

Informed consent is a practical application of respect for a person. Consent should be directly obtained from subjects with decision-making capacity.

Before research involving human subjects is undertaken, the consent of each participant must be obtained. This involves the provision of sufficient information at a level, language and form appropriate to their knowledge, education and understanding. The purposes, methods, demands, risks (physical, psychosocial, economic and familial) and discomforts associated with the research should be disclosed in a context where a choice about whether to participate can be made free from coercion, pressure, or excessive inducements. The goal is the comprehension of the participants, not the teaching act of the investigators.

G. Human Research: Privacy and Confidentiality

The protection of confidentiality is an important, but not an absolute, value of medicine. Research involving human subjects should respect the privacy of the participants and the confidentiality of any data obtained in the course of the research in accordance with Australian privacy regulations.

H. Human Research: Clinical Trials

A clinical trial is a research study directed to the examination of a new therapy on persons. It may involve new drugs, devices or procedures for which limited efficacy and safety data are available. A trial may require the involvement of individuals with specific conditions that may make them especially vulnerable. The participants in clinical trials are usually committed individuals who are making sacrifices and taking risks in the interest of science. They must be treated with the utmost respect. Clinical trials provide potential for divergence among the interests of the investigator, the sponsor, and the patient. On the part of the clinician, conflicts of interest include career enhancement and financial gain versus adequate concern for the needs and rights of the patient.

Investigators should make their own decisions as to whether a clinical trial is well designed and ethical by understanding the literature and by ensuring adherence to the rules.

I. Ethics of Clinical Practice

1. Responsibilities to patients

(a) Patients should be treated with respect, regardless of their social, financial or medical status, life-styles or sexual preferences.

(b) Physicians must practise within their scope of expertise. Patients with conditions outside of this scope should, if possible, be referred to others with appropriate competence.

(d) Physicians must maintain (or offer alternative) avenues of communication and/or access for patients after normal business hours and during holidays or vacations.

(e) Conflicts of interest, that is, circumstances in which the physician has a financial interest in clinical or research ventures, must not be allowed to pose a threat to patient welfare, and shall be identified and disclosed.

(f) Sexual relationships with patients, employees and students are ethically improper.

(g) Privacy and confidentiality shall be maintained in patient relations. Conversations about specific patients should be held in private only with parties relevant to the care of the patient. Clinical records must also be held confidential and should not be released without the explicit or implicit permission of the patient, except when required by law.

(h) Confidentiality may be breached when required by law, such as reporting of certain infections (TB, syphilis) or the possibility of child, spousal or elder abuse.

2. Consent

(a) While the ordinary practices of medicine including history taking, physical examination and provision of advice and medications involve the implicit consent of the patient, invasive procedures require explicit written consent. There are other practices that may require explicit informed consent, for example, using medications in an off label manner, especially when the risks are significant.

(b) Obtaining consent is not always straightforward: for example, it may be limited by the nature of the illness, or by the ability of the patient to understand. Because of the close relationships that are often built up between doctors and their patients, great care must also be exercised to avoid undue influence.

3. Reporting

(a) Medical practitioners have an obligation to ensure that all diagnoses, opinions and results of studies are recorded and followed up appropriately. A medical practitioner is obliged to attempt to inform a patient of significant results of tests.

(b) Physicians have a responsibility to use existing, approved drugs in the most effective and appropriate way, to monitor their use, to report adverse reactions and to keep up to date with scientific developments.

4. Clinical decision-making

As far as possible, clinical decision should be based on evidence as well as experience. However, evidence can vary in quality and may itself be subject to ethical values, either in relation to its acquisition or its application. Physicians have the responsibility to assess critically the nature of evidence on which their decisions are based and to remain aware that ethics and evidence cannot be separated.

5. Gifts

Manufacturers may wish to offer physicians many gifts and members should be very sensitive to the potential influences these gifts may carry. Acceptable gifts include books, simple diagnostic kits or equipment etc.

6. Expenses/Honoraria

After careful consideration and if one's academic independence can be preserved and respected, it is appropriate to accept reasonable travel/accommodation and sustenance expenses together with an honorarium commensurate with lost income to participate in research or educational fora. Such support should be acknowledged openly at the fora. The presenter should not be involved in the promotion of the sponsor's product and the lecture or presentation should be appropriate and the same as if the topic was presented to any independent peer reviewed meeting.

7. Clinical Innovation

Recognizing that the boundary between clinical practice and research may be blurred, it is important that clinicians be committed to careful evaluation of new or potentially new treatments that are tried in the course of clinical practice. If clinical observation suggests that a new therapy may have promise, a more systematic evaluation of this therapy may be initiated. This systematic evaluation constitutes experimental therapy (or research). In this case, the clinician must ensure that appropriate procedures for ethical review and consent are followed.

8. New Technologies

Physicians must become sensitive to new approaches to organizing health care on patient management, privacy and confidentiality all of which present new ethical dilemmas. In light of the potential for electronic breaches, physicians need to remain protective of their patients' privacy.

9. Political role

Physicians play an important role in determining the distribution of health care resources. Doctors are always under an obligation to exercise restraint and responsibility in the use of society's resources. However, physicians are not simply agents required to carry out mandates regarding health care. For the benefit of their patients and of society they must use their knowledge and expertise to take initiatives to influence health care policy development and implementation.

Appendix 1

Stanley C Korenman, M.D. Chair
Ethics Advisory Committee Members: Mark Bach, MD, PhD; Katrina Bramstedt, MA; Paul Komesaroff, MD, PhD; Joan Lakoski, PhD; Katherine Moore, PhD; Robert Speth, PhD.

Australasian Menopause Society

Cointent Updated January 2008