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Ethical Codes of Conduct
Introduction and purpose
The International Menopause Society (IMS) 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 behavior.
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 behavior. They also include educational features indicating to members what would be the collective expectations of individual behavior. Also included will be regulatory features indicating and supporting the appropriate roles of behavior and issuing sanctions on occasion for violations.
Statements and recommendations from the IMS should be unbiased and free of any conflict of interest.
The core principles
The IMS has endorsed the following principles:
The aim of the IMS is to promote knowledge, study and research on all aspects of aging in men and women; to organize, prepare, hold and participate in international meetings and congresses on menopause and climacteric; and to encourage the interchange of research plans and experience between individual members.
Any external support or fund-raising activities should be solely restricted to achieve this mission and be unrestricted. Full disclosure of financial support or conflict of interest is indicated in relation to any meetings, educational material and official statements made by the Society.
The Scientific Committees of the IMS must ensure maintenance of independence in determining scientific content of meetings (including selection of sessions and speakers). Sources of commercial funding should not influence the scientific, educational or policy decisions of the Society.
The IMS Officers and staff must adhere to its values and ethical codes and should act to promote professionalism and trust in the Society. All members of the IMS Board are required to declare any conflict of interest, sign a declaration of affiliation and make a disclosure of financial interest to the Society’s Ethics Committee upon election to the Board.
The Ethics Committee of the IMS (which is elected by the IMS Board) is charged with the maintenance of ethical standards within the Society and will review specific instances in which commercial funding or relationships have the potential to influence the actual or perceived independence and credibility of the Society, its members or its activities.
The IMS has the mission to offer guidelines and educational programs to its affiliated National and Regional Menopause Societies. These purely educational activities may be supported by independent unrestricted grants, but such grants must be declared and must not influence scientific content or presentation.
The IMS has a written Conflicts of Interest Policy. Any conflicts of interest should be listed by all presenters at IMS Congresses, Workshops and other educational events as well as in documents meant for advisory or educational purposes. All educational documents issued by the IMS should be independent and free of conflict of interest.
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’s principal function is to disseminate knowledge about the science and practice of aging in men and women. It must ensure that meetings, publications and courses given the Society’s approval remain of the highest quality.
The Society has a responsibility to uphold professional ethics and to respond to ethical dilemmas, as they become apparent.
The responsibilities of the members include respect for colleagues, including their work and their reputations, the honest performance and reporting of research and the honoring 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
The IMS shall discharge its responsibilities to support menopause and healthy aging 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. All Scientific Meetings and other educational activities of the Society shall be conducted so as to provide the highest quality of objective information.
The Society shall not allow its objectivity to be influenced by corporate or other sources of income. Dualities of interest shall be disclosed to the Society Ethics Committee in a timely and comprehensive manner.
The Society shall provide prudent management of funds, verified by periodic auditing. The audit report shall be made available to members.
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.
Member privacy and confidentiality shall be maintained.
The Society shall conduct fair and democratic elections and ensure democratic decision-making among its Committees.
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.
The Society shall provide timely responses, as appropriate, to concerns and issues brought forth during public discussion regarding research and practice related to menopause.
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.
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.
The Society shall organize its activities to recognize the diverse professional needs of its members.
(B) 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, and strict enforcement of the guidelines should be conducted on a regular basis.
The IMS maintains a Corporate Board to allow members of that Board from the pharmaceutical industry and members from other government and non-government organizations to hold regular information exchange meetings with IMS office holders. Corporate members and ordinary members employed by the pharmaceutical or allied industries are not eligible to stand for election to the Board of the IMS and Corporate members do not participate in any policy decisions of the Society.
Sources of commercial funding should not influence the scientific, educational, or public policy decisions of the Society.
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.
The display of commercial products or services in exhibit hall areas at Society meetings, symposia 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 triennial Congress.
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.
The Society will instruct program directors, speakers and commercial sponsors about these policies prior to every presentation.
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. Chairs and speakers should disclose any conflict of interest.
Sponsored symposia may be held in conjunction with IMS Scientific Congresses. The sponsor may select topics and speakers for such symposia which must be submitted to the IMS Board for approval. Such Symposia must be identified as and stand separate from the official Congress Scientific Program and may not attract CME points.
Unrestricted educational grants in support of IMS Consensus Workshops may be permitted. However, neither sponsors nor their employees may attend or influence any final discussions or conclusions reached at such Workshops.
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.
The IMS may accept fees from industry for advertising of products in its journal, Climacteric, and for commercial exhibits at IMS meetings. However, such advertisements and displays do not imply the Society’s warranty, endorsement or approval of these products or services nor their effectiveness, safety or quality.
The IMS Board reviews and approves for publication all commercial advertisements submitted for publication in Society materials, including its journal Climacteric.
The Society will not endorse or market any product or service of a third-party company.
The Society shall not participate in the marketing of health-related products with the exception of its own journals, educational materials and programs.
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 benefit to the Society members is fully disclosed in advance and does not breach ethical standards.
Progress in understanding the pathophysiology of aging will benefit health and welfare. Such progress depends on integrity in the conduct of scientific research and truthful representation of the findings. The Society, through its publications, will ensure the highest standards of scientific integrity.
All authors submitting manuscripts or abstracts to any Society publication are expected to abide by its publication guidelines.
Authorship should include a substantial contribution to both the intellectual content and the writing of the manuscript and contributions from professional writers, particularly those employed by pharma, should be minimal and avoided wherever possible. When professional writing support is used, the writer should be acknowledged within the manuscript (not necessarily as an author) and any source of funding for this service declared.
Thus, honorary authorship is inconsistent with the definition of authorship. The primary burden for ensuring appropriate authorship belongs to the research institution, university or employing authority rather than the Journal or the Society.
The Editorial Board of Climacteric establishes publication guidelines that generally conform to the guidelines of the International Committee of Medical Journal Editors.
Publications with results obtained from the use of human subjects shall have identified approval from the institutional review board or equivalent.
Publications with results obtained from the use of animal subjects shall have identified approval from the institutional animal use committee or equivalent.
Peer review is an essential step in the publication process to ensure that published articles describe well-designed and executed research that provides a significant addition to the scientific literature.
Objective review of the scientific rigor of manuscripts is essential, and peer reviewers are necessarily experts knowledgeable in the field under review. As volunteers, reviewers provide important services to medicine, the authors, and the Editors, and they contribute to maintenance of high standards.
The Society has the mandate to select Editors for its journals and support the editorial process. The Editors have the fiduciary responsibility for managing the journals prudently, ensuring the quality of publications and maintaining the confidentiality and integrity of the review process.
Editors are responsible for acceptance or rejection of a manuscript.
Editors must strive to ensure that all manuscripts are evaluated in a fair and impartial manner. Editors should endeavor to select reviewers with appropriate expertise and sound judgment.
Reviewers should declare any conflict of interest and those with significant conflicts of interest should be rejected.
Journal Editors shall excuse themselves from reviewing work in which a potential or actual conflict of interest exists and transfer responsibility to an alternative Editor.
The Editors shall treat unpublished material in a confidential manner, avoiding disclosure of information about a manuscript under consideration to anyone other than those from whom professional advice is sought or as part of the normal editorial process.
The Editors must provide an organized and timely editorial process that includes written feedback and reviewer comments to the author.
The Editors are responsible for correction of publication errors.
Editors should inform reviewers in writing at the time of receipt of manuscripts of their responsibility to identify and report suspected duplicative publication, fraud, or plagiarism.
Editors may be obligated to conduct an initial inquiry into apparent or alleged misconduct involving manuscripts under consideration, in press, or published in Society journals. However, Editors generally do not have the mandate or authority for substantive investigations and should generally refer the question to the institution(s) of the contending parties. Care should be taken to respect the scientific reputations of all parties and to maintain confidentiality in this process.
Editors may seek confidential advice from the Ethics Committee in cases of ethical concern.
The International Menopause Society affirms that scientific misconduct in any form, including plagiarism, fabrication, or falsification of data, jeopardizes the research endeavor.
On occasion, the professional behavior of a member might be such as to warrant a sanction by the Society. Such decisions require an unequivocal demonstration of professional behavior that is unethical or illegal. Such decisions also require the administration of a due process procedure by the Society.
II. Responsibilities of the International Menopause Society members
(A) RESPONSIBILITY TO COLLEAGUES
Members shall treat their colleagues with respect and promote collegiality.
Members shall promote the educational and professional growth of their colleagues and trainees.
Members shall give proper attribution to the accomplishments and works of colleagues, including junior physicians, trainees and medical students.
Clinically related commercial ventures with colleagues shall maintain patient welfare as the top priority, not financial gain or academic promotion.
Members shall report to their appropriate local authorities the conduct of colleagues that threatens research integrity, the integrity of the medical profession or patient welfare. Any dispute involving IMS members following local intervention may be referred to the IMS Ethics Committee for further adjudication.
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 International Menopause Society are expected to conduct themselves according to the highest standards of professional behavior 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.
(C) RESPONSIBILITY TO REVIEW
Members have a responsibility to review articles submitted to scientific journals as well as research grant applications.
Reviewers should demonstrate respect for scientific inquiry, knowledge of the discipline and willingness to provide judgment of publications in a fair and impartial manner.
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 excuse themselves from the review, preferably without reading the submission.
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.
Studies should follow guidelines for human research subject protection as well as Institutional Review Board (IRB) or ethical committees requirements as to obtain approval for a given research protocol. These guidelines include informed consent, respect of confidentiality, clinical trials guidelines and safety reporting requirements.
(F) ETHICS OF CLINICAL PRACTICE
Those who pursue clinical practice have the responsibility to treat their patients with respect and within their scope of expertise, including obtaining informed consent where appropriate.
They should seek to avoid and, when that is not possible, disclose conflicts of interest and maintain patient privacy and confidentiality in the clinical setting and follow their respective national guidelines for Good Clinical patient management.
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. Gifts are very controversial and, in general, should not be accepted.
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.
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.
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.
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.
These Ethical Codes of Conduct have been developed by the Board of The International Menopause Society from templates developed by similar professional societies including The Endocrine Society, The American College of Obstetricians & Gynecologists, The Australasian Menopause Society and the Royal Australasian College of Physicians, whose assistance we gratefully acknowledge. This Code is seen as a living document to be revised and amended as ethical issues and health-care practices evolve.
The International Menopause Society
March 12, 2010