Policy Tag: Patient Autonomy

Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964
and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)
55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)
59th WMA General Assembly, Seoul, Republic of Korea, October 2008
64th WMA General Assembly, Fortaleza, Brazil, October 2013
and by the 75th WMA General Assembly, Helsinki, Finland, October 2024

 

PREAMBLE

  1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human participants, including research using identifiable human material or data.

The Declaration is intended to be read as a whole, and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

  1. While the Declaration is adopted by physicians, the WMA holds that these principles should be upheld by all individuals, teams, and organizations involved in medical research, as these principles are fundamental to respect for and protection of all research participants, including both patients and healthy volunteers.

 

GENERAL PRINCIPLES

  1. The WMA Declaration of Geneva binds the physician with the words, “The health and well-being of my patient will be my first consideration,” and the WMA International Code of Medical Ethics declares “The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interest.”
  1. It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research. The physician’s knowledge and conscience are dedicated to the fulfilment of this duty.
  1. Medical progress is based on research that ultimately must include participants.

Even well-proven interventions should be evaluated continually through research for their safety, effectiveness, efficiency, accessibility, and quality.

  1. Medical research involving human participants is subject to ethical standards that promote and ensure respect for all participants and protect their health and rights.

Since medical research takes place in the context of various structural inequities, researchers should carefully consider how the benefits, risks, and burdens are distributed.

Meaningful engagement with potential and enrolled participants and their communities should occur before, during, and following medical research. Researchers should enable potential and enrolled participants and their communities to share their priorities and values; to participate in research design, implementation, and other relevant activities; and to engage in understanding and disseminating results.

  1. The primary purpose of medical research involving human participants is to generate knowledge to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions; and ultimately to advance individual and public health.

These purposes can never take precedence over the rights and interests of individual research participants.

  1. While new knowledge and interventions may be urgently needed during public health emergencies, it remains essential to uphold the ethical principles in this Declaration during such emergencies.
  1. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, autonomy, privacy, and confidentiality of personal information of research participants. The responsibility for the protection of research participants must always rest with physicians or other researchers and never with the research participants, even though they have given consent.
  1. Physicians and other researchers must consider the ethical, legal and regulatory norms and standards for research involving human participants in the country or countries in which the research originated and where it is to be performed, as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research participants set forth in this Declaration.
  1. Medical research should be designed and conducted in a manner that avoids or minimizes harm to the environment and strives for environmental sustainability.
  1. Medical research involving human participants must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications. Such research requires the supervision of a competent and appropriately qualified physician or other researcher.

Scientific integrity is essential in the conduct of medical research involving human participants. Involved individuals, teams, and organizations must never engage in research misconduct.

  1. Groups that are underrepresented in medical research should be provided appropriate access to participation in research.
  1. Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research will not adversely affect the health of the patients who serve as research participants.
  1. Appropriate compensation and treatment for participants who are harmed as a result of participating in research must be ensured.

Risks, Burdens, and Benefits

  1. In medical practice and in medical research, most interventions involve risks and burdens.

Medical research involving human participants may only be conducted if the importance of the objective outweighs the risks and burdens to the research participants.

  1. All medical research involving human participants must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Measures to minimize the risks and burdens must be implemented. The risks and burdens must be continuously monitored, assessed, and documented by the researcher.

  1. Physicians and other researchers may not engage in research involving human participants unless they are confident that the risks and burdens have been adequately assessed and can be satisfactorily managed.

When the risks and burdens are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians and other researchers must assess whether to continue, modify or immediately stop the research.

Individual, Group, and Community Vulnerability

  1. Some individuals, groups, and communities are in a situation of more vulnerability as research participants due to factors that may be fixed or contextual and dynamic, and thus are at greater risk of being wronged or incurring harm. When such individuals, groups, and communities have distinctive health needs, their exclusion from medical research can potentially perpetuate or exacerbate their disparities. Therefore, the harms of exclusion must be considered and weighed against the harms of inclusion. In order to be fairly and responsibly included in research, they should receive specifically considered support and protections.
  1. Medical research with individuals, groups, or communities in situations of particular vulnerability is only justified if it is responsive to their health needs and priorities and the individual, group, or community stands to benefit from the resulting knowledge, practices, or interventions. Researchers should only include those in situations of particular vulnerability when the research cannot be carried out in a less vulnerable group or community, or when excluding them would perpetuate or exacerbate their disparities.

Scientific Requirements and Research Protocols

  1. Medical research involving human participants must have a scientifically sound and rigorous design and execution that are likely to produce reliable, valid, and valuable knowledge and avoid research waste. The research must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

The welfare of animals used for research must be respected.

  1. The design and performance of all medical research involving human participants must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

In clinical trials, the protocol must also describe any post-trial provisions.

Research Ethics Committees

  1. The protocol must be submitted for consideration, comment, guidance, and approval to the concerned research ethics committee before the research begins. This committee must be transparent in its functioning and must have the independence and authority to resist undue influence from the researcher, the sponsor, or others. The committee must have sufficient resources to fulfill its duties, and its members and staff must collectively have adequate education, training, qualifications, and diversity to effectively evaluate each type of research it reviews.

The committee must have sufficient familiarity with local circumstances and context, and include at least one member of the general public.  It must take into consideration the ethical, legal, and regulatory norms and standards of the country or countries in which the research is to be performed as well as applicable international norms and standards, but these must not be allowed to reduce or eliminate any of the protections for research participants set forth in this Declaration.

When collaborative research is performed internationally, the research protocol must be approved by research ethics committees in both the sponsoring and host countries.

The committee must have the right to monitor, recommend changes to, withdraw approval for, and suspend ongoing research.  Where monitoring is required, the researcher must provide information to the committee and/or competent data and safety monitoring entity, especially about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the research, the researchers must submit a final report to the committee containing a summary of the findings and conclusions.

Privacy and Confidentiality

  1. Every precaution must be taken to protect the privacy of research participants and the confidentiality of their personal information.

Free and Informed Consent

  1. Free and informed consent is an essential component of respect for individual autonomy. Participation by individuals capable of giving informed consent in medical research must be voluntary. Although it may be appropriate to consult family members or community representatives, individuals capable of giving informed consent may not be enrolled in research unless they freely agree.
  1. In medical research involving human participants capable of giving informed consent, each potential participant must be adequately informed in plain language of the aims, methods, anticipated benefits and potential risks and burdens, qualifications of the researcher, sources of funding, any potential conflicts of interest, provisions to protect privacy and confidentiality, incentives for participants, provisions for treating and/or compensating participants who are harmed as a consequence of participation, and any other relevant aspects of the research.

The potential participant must be informed of the right to refuse to participate in the research or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information and communication needs of individual potential participants as well as to the methods used to deliver the information.

After ensuring that the potential participant has understood the information, the physician or another qualified individual must then seek the potential participant’s freely given informed consent, formally documented on paper or electronically.  If the consent cannot be expressed on paper or electronically, the non-written consent must be formally witnessed and documented.

All medical research participants should be given the option of being informed about the general outcome and results of the research.

  1. When seeking informed consent for participation in research the physician or other researcher must be particularly cautious if the potential participant is in a dependent relationship with them or may consent under duress. In such situations, the informed consent must be sought by an appropriately qualified individual who is independent of this relationship.
  1. In medical research involving human participants incapable of giving free and informed consent, the physician or other qualified individual must seek informed consent from the legally authorized representative, considering preferences and values expressed by the potential participant.

Those persons incapable of giving free and informed consent are in situations of particular vulnerability and are entitled to the corresponding safeguards. In addition to receiving the protections for the particularly vulnerable, those incapable of giving consent must only be included if the research is likely to either personally benefit them or if it entails only minimal risk and minimal burden.

  1. When a potential research participant who is incapable of giving free and informed consent is able to give assent to decisions about participation in research, the physician or other qualified individual must seek that assent in addition to the consent of the legally authorized representative, considering any preferences and values expressed by the potential participant. The potential participant’s dissent should be respected.
  1. Research involving participants who are physically or mentally incapable of giving consent (for example, unconscious patients) may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group. In such circumstances the physician or other qualified individual must seek informed consent from the legally authorized representative. If no such representative is available and if the research cannot be delayed, the research may proceed without informed consent provided that the specific reasons for involving participants with a condition that renders them unable to give informed consent have been stated in the research protocol and the research has been approved by a research ethics committee.

Free and informed consent to remain in the research must be obtained as soon as possible from a legally authorized representative or, if they regain capacity to give consent, from the participant.

  1. The physician or other researcher must fully inform potential participants which aspects of their care are related to the research. The refusal of a patient to participate in research or the patient’s decision to withdraw from research must never adversely affect the patient-physician relationship or provision of the standard of care.
  1. Physicians or other qualified individuals must obtain free and informed consent from research participants for the collection, processing, storage, and foreseeable secondary use of biological material and identifiable or re-identifiable data. Any collection and storage of data or biological material from research participants for multiple and indefinite uses should be consistent with requirements set forth in the WMA Declaration of Taipei, including the rights of individuals and the principles of governance. A research ethics committee must approve the establishment and monitor ongoing use of such databases and biobanks.

Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.

Use of Placebo

  1. The benefits, risks, burdens, and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:
  • If no proven intervention exists, the use of placebo, or no intervention, is acceptable; or
  • If for compelling and scientifically sound methodological reasons the use of any intervention other than the best proven one(s), the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention; and the participants who receive any intervention other than the best proven one(s), placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option.

Post-Trial Provisions

  1. In advance of a clinical trial, post-trial provisions must be arranged by sponsors and researchers to be provided by themselves, healthcare systems, or governments for all participants who still need an intervention identified as beneficial and reasonably safe in the trial. Exceptions to this requirement must be approved by a research ethics committee. Specific information about post-trial provisions must be disclosed to participants as part of informed consent.

Research Registration, Publication, and Dissemination of Results

  1. Medical research involving human participants must be registered in a publicly accessible database before recruitment of the first participant.
  1. Researchers, authors, sponsors, editors, and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human participants and are accountable for the timeliness, completeness, and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations, and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.

Unproven Interventions in Clinical Practice

  1. When an unproven intervention is utilized in an attempt to restore health or alleviate suffering for an individual patient because approved options are inadequate or ineffective and enrollment in a clinical trial is not possible, it should subsequently be made the object of research designed to evaluate safety and efficacy. Physicians participating in such interventions must first seek expert advice, weigh possible risks, burdens, and benefits, and obtain informed consent. They must also record and share data when appropriate and avoid compromising clinical trials. These interventions must never be undertaken to circumvent the protections for research participants set forth in this Declaration.

 

Disclaimer: ©2024 World Medical Association. All Rights Reserved. All intellectual property rights in the Declaration of Helsinki are vested in the World Medical Association. The WMA has granted JAMA exclusive rights to publish the English-language version of the Declaration through December 31, 2024.

Adopted by the 35th World Medical Assembly, Venice, Italy, October 1983
Revised by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
and by the 73rd WMA General Assembly, Berlin, Germany, October 2022

 

PREAMBLE

When a patient is seriously ill and the restoration of health may not be possible, the physician and the patient are often faced with a complex set of decisions regarding medical treatment.

The end of life must be recognized and respected as an important part of a person’s life.

Advances in medical science have improved the ability of physicians to address many issues associated with end-of-life care. While the priority of research to cure disease should not be compromised, more attention must be paid to developing palliative treatments and improving assessment and response to the physical, psychological, social and spiritual or existential components of terminal illnesses and other conditions at the end of life.

WMA remains firmly opposed to euthanasia and physician-assisted suicide, as set forth in the WMA Declaration on Euthanasia and Physician-Assisted Suicide.

Ethically-appropriate care at the end of life should routinely promote patient autonomy and shared decision-making, and be respectful of the values of the patient, his or her family or intimate associates, and surrogate(s). The WMA recognizes that attitudes and beliefs toward death and dying vary widely from culture to culture and among different religions, and palliative care resources are unevenly distributed. The approach to medical care at the end of life will be influenced significantly by these factors, and thus attempting to develop detailed universal guidelines on terminal care is neither practical nor wise. Therefore, the WMA articulates the following:

 

RECOMMENDATIONS

Pain and Symptom Management

  1. Palliative care at the end of life is part of good medical care. The objective of palliative care is to maintain patient dignity and freedom from distressing symptoms. Care plans should emphasize keeping a patient as comfortable as possible and the patient’s pain controlled while recognizing the importance of attention to the social, psychological and spiritual needs of the patient, and his or her family and intimate associates.
  2. The clinical management of pain in patients at the end of life is of paramount importance in terms of alleviating suffering. The WMA Resolution on Access to Adequate Pain Treatment (2020) makes recommendations for physicians and governments that optimize treatment of pain and other distressing symptoms. Physicians and National Medical Associations should promote the dissemination and sharing of information regarding pain management to ensure that all physicians involved in end-of-life care have access to best practice guidelines and the most current treatments and methods available. National Medical Associations should oppose laws or regulations that unduly inhibit physicians from providing intensive, clinically appropriate symptoms management for patients at the end of life in keeping with recognized best practices.
  3. When a patient at the end of life experiences severe pain or other distressing clinical symptoms that do not respond to intensive, symptom-specific palliation, it can be appropriate to offer sedation to unconsciousness as an intervention of last resort. Sedation to unconsciousness must never be used to intentionally cause a patient’s death and should be restricted to patients in the final stages of life. Thorough efforts should be made to obtain consent of the patient or the patient’s surrogate(s).
  4. Palliative care is often provided by multidisciplinary healthcare teams. When possible, the physician should be the leader of the team, being responsible, amongst other obligations, for diagnosis and medical treatment plans.  A carefully kept medical record is of the utmost importance. The rationale for all symptom management interventions, including medications for symptom relief, should be documented in the medical record, including the degree and length of sedation and specific expectations for continuing, withdrawing, or withholding future life-sustaining treatments.
  5. The health care team should promote collaborative care of the patient and offer bereavement support after the patient’s death. The needs of children and families or intimate associates may require special attention and competence, both when children are patients and when they are dependents of patients.

Education and Research

  1. Education of healthcare professionals should include the teaching of end-of-life medical care. Where it does not exist, the establishment of palliative medicine as a medical specialty should be considered. In countries where palliative medicine is not a recognized specialty, post-graduate training in palliative medicine can nevertheless improve the quality of palliative care provided.
  2. Physician education should help to develop the skills necessary to increase the prevalence and quality of meaningful patient advance care planning for patients with life-threatening illness and the right of patients to use written advance directives that describe their wishes and goals regarding care in the event that they are unable to communicate. Physicians should receive education to encourage their patients to formally document their goals, values and treatment preferences and to appoint a substitute health care decision maker with whom the patient can discuss in advance his or her values regarding health care and treatment.
  3. Governments and research institutions are encouraged to invest additional resources in developing treatments to improve end-of-life care. This includes, but is not limited to, supporting research on general medical care, specific treatments, psychological implications and organization to improve end-of-life care.
  4. When employing treatments, the physician must carefully consider the balance between the intended benefits to the patient and the potential harm. National Medical Associations should support the formulation of palliative treatment guidelines.
  5. The physician must also communicate to the patient a willingness to discuss at any time the natural course of the disease and what to expect during the dying process, while also providing guidance about treatments and alternatives that could ease the patient’s suffering, including palliative care or psychotherapy. If a patient indicates a desire to die or expresses suicidal thoughts, the physician has a duty to engage in open and confidential discussions with the patient to understand the motives and reasoning behind these thoughts.
  6. Physicians should assist the dying patient in maintaining an optimal quality of life by controlling symptoms and addressing psychosocial and spiritual needs, to enable the patient to die with dignity and in comfort. Physicians should inform patients of the availability, benefits and other aspects of palliative care. Discussions about patient preferences should be initiated early, routinely offered to all patients and should be revisited regularly to explore any changes patients may have in their wishes, especially as their clinical condition changes. Information and communication among the patient, his or her family or intimate associates, surrogates and members of the health care team are one of the fundamental pillars of quality care at the end of life.
  7. Physicians should endeavor to identify, understand and address the psychosocial and spiritual needs of their patients, especially as they relate to patients’ physical symptoms. Physicians should try to ensure that psychological, social and spiritual resources are available to patients, their families and intimate associates, to help them deal with the anxiety, fear and grief associated with the end of life.
  8. Physicians should encourage patients to designate a substitute decision-maker/surrogate to make decisions that are not expressed in an advance directive. In particular, physicians should discuss the patient’s wishes regarding the approach to life-sustaining interventions as well as palliative measures that might have the additional effect of accelerating death. Because documented advance directives are sometimes not available in emergency situations, physicians should emphasize to patients the importance of discussing treatment preferences with individuals who are likely to act as substitute health care decision-makers/surrogates. Whenever possible and consented to by the patient, the patient’s substitue decision-makers/surrogates should be included in these conversations.
  9. If a patient has decision-making capacity, his or her autonomous right to refuse any medical treatments or interventions must be respected even if the patient’s life may be shortened. Physicians should make sure that the patient is adequately treated for pain and discomfort before consent for end-of-life care is obtained in order to ensure that unnecessary physical and mental suffering do not interfere with decision making. Laws regarding the decision-making capacity of minor patients vary greatly, but discussions with the family, and child, if possible, are encouraged.
  10. Upon a patient’s death, physicians may apply such means as are necessary to keep organs viable for transplantation, provided that they act in accordance with the ethical guidelines established in the WMA Declaration of Sydney on the Determination of Death and the Recovery of Organs. In addition, any transplantation must be in accordance with the principles in the WMA Statement on Organ and Tissue Donation.

Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949
Revised by the 22nd World Medical Assembly, Sydney, Australia, August 1968,
the 35th World Medical Assembly, Venice, Italy, October 1983,
the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006
and by the 73rd WMA General Assembly, Berlin, Germany, October 2022

Preamble

The World Medical Association (WMA) has developed the International Code of Medical Ethics as a canon of ethical principles for the members of the medical profession worldwide. In concordance with the WMA Declaration of Geneva: The Physician’s Pledge and the WMA’s entire body of policies, it defines and elucidates the professional duties of physicians towards their patients, other physicians and health professionals, themselves, and society as a whole.

The physician must be aware of applicable national ethical, legal, and regulatory norms and standards, as well as relevant international norms and standards.

Such norms and standards must not reduce the physician’s commitment to the ethical principles set forth in this Code.

The International Code of Medical Ethics should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. Consistent with the mandate of the WMA, the Code is addressed to physicians. The WMA encourages others who are involved in healthcare to adopt these ethical principles.

 

General principles

1. The primary duty of the physician is to promote the health and well-being of individual patients by providing competent, timely, and compassionate care in accordance with good medical practice and professionalism.

The physician also has a responsibility to contribute to the health and well-being of the populations the physician serves and society as a whole, including future generations.

The physician must provide care with the utmost respect for human life and dignity, and for the autonomy and rights of the patient.

2. The physician must practise medicine fairly and justly and provide care based on the patient’s health needs without bias or engaging in discriminatory conduct on the basis of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, culture, sexual orientation, social standing, or any other factor.

3. The physician must strive to use health care resources in a way that optimally benefits the patient, in keeping with fair, just, and prudent stewardship of the shared resources with which the physician is entrusted.

4. The physician must practise with conscience, honesty, integrity, and accountability, while always exercising independent professional judgement and maintaining the highest standards of professional conduct.

5. Physicians must not allow their individual professional judgement to be influenced by the possibility of benefit to themselves or their institution. The physician must recognise and avoid real or potential conflicts of interest. Where such conflicts are unavoidable, they must be declared in advance and properly managed.

6. Physicians must take responsibility for their individual medical decisions and must not alter their sound professional medical judgements on the basis of instructions contrary to medical considerations.

7. When medically appropriate, the physician must collaborate with other physicians and health professionals who are involved in the care of the patient or who are qualified to assess or recommend care options. This communication must respect patient confidentiality and be confined to necessary information.

8. When providing professional certification, the physician must only certify what the physician has personally verified.

9. The physician should provide help in medical emergencies, while considering the physician’s own safety and competence, and the availability of other viable options for care.

10. The physician must never participate in or facilitate acts of torture, or other cruel, inhuman, or degrading practices and punishments.

11. The physician must engage in continuous learning throughout professional life in order to maintain and develop professional knowledge and skills.

12. The physician should strive to practise medicine in ways that are environmentally sustainable with a view to minimising environmental health risks to current and future generations.

Duties to the patient

13. In providing medical care, the physician must respect the dignity, autonomy, and rights of the patient. The physician must respect the patient’s right to freely accept or refuse care in keeping with the patient’s values and preferences.

14. The physician must commit to the primacy of patient health and well-being and must offer care in the patient’s best interests. In doing so, the physician must strive to prevent or minimise harm for the patient and seek a positive balance between the intended benefit to the patient and any potential harm.

15. The physician must respect the patient’s right to be informed in every phase of the care process. The physician must obtain the patient’s voluntary informed consent prior to any medical care provided, ensuring that the patient receives and understands the information needed to make an independent, informed decision about the proposed care. The physician must respect the patient’s decision to withhold or withdraw consent at any time and for any reason.

16. When a patient has substantially limited, underdeveloped, impaired, or fluctuating decision-making capacity, the physician must involve the patient as much as possible in medical decisions. In addition, the physician must work with the patient’s trusted representative, if available, to make decisions in keeping with the patient’s preferences, when those are known or can reasonably be inferred. When the patient’s preferences cannot be determined, the physician must make decisions in the patient’s best interests. All decisions must be made in keeping with the principles set forth in this Code.

17. In emergencies, where the patient is not able to participate in decision making and no representative is readily available, the physician may initiate an intervention without prior informed consent in the best interests of the patient and with respect for the patient’s preferences, where known.

18. If the patient regains decision-making capacity, the physician must obtain informed consent for further intervention.

19. The physician should be considerate of and communicate with others, where available, who are close to the patient, in keeping with the patient’s preferences and best interests and with due regard for patient confidentiality.

20. If any aspect of caring for the patient is beyond the capacity of a physician, the physician must consult with or refer the patient to another appropriately qualified physician or health professional who has the necessary capacity.

21. The physician must ensure accurate and timely medical documentation.

22. The physician must respect the patient’s privacy and confidentiality, even after the patient has died. A physician may disclose confidential information if the patient provides voluntary informed consent or, in exceptional cases, when disclosure is necessary to safeguard a significant and overriding ethical obligation to which all other possible solutions have been exhausted, even when the patient does not or cannot consent to it. This disclosure must be limited to the minimal necessary information, recipients, and duration.

23. If a physician is acting on behalf of or reporting to any third parties with respect to the care of a patient, the physician must inform the patient accordingly at the outset and, where appropriate, during the course of any interactions. The physician must disclose to the patient the nature and extent of those commitments and must obtain consent for the interaction.

24. The physician must refrain from intrusive or otherwise inappropriate advertising and marketing and ensure that all information used by the physician in advertising and marketing is factual and not misleading.

25. The physician must not allow commercial, financial, or other conflicting interests to affect the physician’s professional judgement.

26. When providing medical care remotely, the physician must ensure that this form of communication is medically justifiable and that the necessary medical care is provided. The physician must also inform the patient about the benefits and limitations of receiving medical care remotely, obtain the patient’s consent, and ensure that patient confidentiality is upheld. Wherever medically appropriate, the physician must aim to provide care to the patient through direct, personal contact.

27. The physician must maintain appropriate professional boundaries. The physician must never engage in abusive, exploitative, or other inappropriate relationships or behaviour with a patient and must not engage in a sexual relationship with a current patient.

28. In order to provide care of the highest standards, physicians must attend to their own health, well-being, and abilities. This includes seeking appropriate care to ensure that they are able to practise safely.

29. This Code represents the physician’s ethical duties. However, on some issues there are profound moral dilemmas concerning which physicians and patients may hold deeply considered but conflicting conscientious beliefs.

The physician has an ethical obligation to minimise disruption to patient care. Physician conscientious objection to provision of any lawful medical interventions may only be exercised if the individual patient is not harmed or discriminated against and if the patient’s health is not endangered.

The physician must immediately and respectfully inform the patient of this objection and of the patient’s right to consult another qualified physician and provide sufficient information to enable the patient to initiate such a consultation in a timely manner.

Duties to other physicians, health professionals, students, and other personnel

30. The physician must engage with other physicians, health professionals and other personnel in a respectful and collaborative manner without bias, harassment, or discriminatory conduct. The physician must also ensure that ethical principles are upheld when working in teams.

31. The physician should respect colleagues’ patient-physician relationships and not intervene unless requested by either party or needed to protect the patient from harm. This should not prevent the physician from recommending alternative courses of action considered to be in the patient’s best interests.

32. The physician should report to the appropriate authorities conditions or circumstances which impede the physician or other health professionals from providing care of the highest standards or from upholding the principles of this Code. This includes any form of abuse or violence against physicians and other health personnel, inappropriate working conditions, or other circumstances that produce excessive and sustained levels of stress.

33. The physician must accord due respect to teachers and students.

Duties to society

34. The physician must support fair and equitable provision of health care. This includes addressing inequities in health and care, the determinants of those inequities, as well as violations of the rights of both patients and health professionals.

35. Physicians play an important role in matters relating to health, health education, and health literacy. In fulfilling this responsibility, physicians must be prudent in discussing new discoveries, technologies, or treatments in non-professional, public settings, including social media, and should ensure that their own statements are scientifically accurate and understandable.

Physicians must indicate if their own opinions are contrary to evidence-based scientific information.

36. The physician must support sound medical scientific research in keeping with the WMA Declaration of Helsinki and the WMA Declaration of Taipei.

37. The physician should avoid acting in such a way as to weaken public trust in the medical profession. To maintain that trust, individual physicians must hold themselves and fellow physicians to the highest standards of professional conduct and be prepared to report behaviour that conflicts with the principles of this Code to the appropriate authorities.

38. The physician should share medical knowledge and expertise for the benefit of patients and the advancement of health care, as well as public and global health.

Duties as a member of the medical profession

39. The physician should follow, protect, and promote the ethical principles of this Code. The physician should help prevent national or international ethical, legal, organisational, or regulatory requirements that undermine any of the duties set forth in this Code.

40. The physician should support fellow physicians in upholding the responsibilities set out in this Code and take measures to protect them from undue influence, abuse, exploitation, violence, or oppression.

©2022 World Medical Association. All Rights Reserved. All intellectual property rights in the International Code of Medical Ethics are vested in the World Medical Association.

Croatian translation

Portuguese translation

Adopted by the 71st WMA General Assembly (online), Cordoba, Spain, October 2020

 

PREAMBLE

The patient-physician relationship is part of a human relationship model that dates back to the origins of medicine. It represents a privileged bond between a patient and a physician based on trust. It is a space of creativity where information, feelings, visions, help and support are exchanged.

The patient-physician relationship is a moral activity that arises from the obligation of the physician to alleviate suffering and respect the patient’s beliefs and autonomy. It is usually initiated by mutual consent – expressed or implied – to provide quality medical care.

The patient-physician relationship is the fundamental core of medical practice. It has a universal scope and aims at improving a person’s health and wellbeing. This is made possible by knowledge sharing, common decision making, patient and physician autonomy, help, comfort and companionship in an atmosphere of trust. Trust is an inherent component of the relationship that can be therapeutic in and of itself.

The patient-physician relationship is essential to patient-centred care. It requires both the physician and the patient to be active participants in the healing process. While the relationship encourages and supports collaboration in medical care, competent patients make decisions that direct their care. The relationship may be terminated by either party. The physician must then assist the patient in securing transfer of care and refer the patient to another physician with the necessary ability to continue the care.

The patient-physician relationship is a complex issue subject to myriad cultural, technological, political, social, economic or professional influences. It has evolved throughout history, according to culture and civilisation, in the pursuit of what is most appropriate based on scientific evidence for patients by improving their mental and physical health and well-being and alleviating pain. The relationship underwent deep changes as a result of momentous milestones such as the Universal Declaration of Human Rights (1948), the WMA declarations of Geneva (1948), Helsinki (1964), and the Lisbon (1981).The relationship has slowly progressed towards the empowerment of the patient.

Today, the patient-physician relationship is frequently under threat from influences both within and outside health care systems. In some countries and health care systems, these influences risk alienating physicians from their patients and potentially harming patients. Amongst those challenges likely to undermine the therapeutic efficacy of the relationship, we note a growing trend to:

  • A technologization of medicine, sometimes leading to a mechanistic view of health care, neglecting human considerations;
  • The dilution of trustworthy relationships between people in our societies, which negatively influences healthcare relationships;
  • A primary focus on economic aspects of medical care to the detriment of other factors, posing sometimes difficulties to establish genuine relationships of trust between the physician and the patient.

It is of the utmost importance that the patient-physician relationship addresses these factors of influence in such a way that the relationship is enriched, and that its specificity is warranted. The relationship should never be subject to undue administrative, economic, or political interferences.

 

RECOMMENDATIONS

Reiterating its Declaration of Geneva, the International Code of Medical Ethics and its Lisbon Declaration on Patient Rights and given the vital importance of the relationship between physician and patient in history and in the current and future context of medicine, the WMA and its Constituent Members:

  1. Reaffirm that professional autonomy and clinical independence are essential components of high-quality medical care and medical professionalism, protecting the right of the patients to receive the health care they need.
  2. Urge all actors involved in the regulation of the patient-physician relationship (governments and health authorities, medical associations, physicians, and patients) to defend, protect and strengthen the patient-physician relationship, based of high-quality care, as a scientific, health, cultural and social heritage.
  3. Call on Constituent Members and individual physicians to preserve this relationship as the fundamental core of any medical action centred on a person, to defend the medical profession and its ethical values, including compassion, competence, mutual respect, and professional autonomy, and to support patient-centred care.
  4. Reaffirm its opposition to interference from governments, other agents and institutional administrations in the practice of medicine and in the Patient-physician
  5. Reaffirm its dedication to providing competent medical service in full professional and moral independence, with compassion and respect for human dignity.
  6. Commit to address emerging factors which could pose a threat to the patient-physician relationship and to take action to mitigate against those factors.

Portuguese translation

Adopted by the 29th World Medical Assembly, Tokyo, Japan, October 1975
Editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005
and the 173rd WMA Council Session, Divonne-les-Bains, France, May 2006
and revised by the 67th WMA General Assembly, Taipei, Taiwan, October 2016

 

PREAMBLE

It is the privilege of the physician to practise medicine in the service of humanity, to preserve and restore bodily and mental health without distinction as to persons, and to comfort and to ease the suffering of his or her patients. The utmost respect for human life is to be maintained even under threat, and no use is to be made of any medical knowledge contrary to the laws of humanity.

For the purpose of this Declaration, torture is defined as the deliberate, systematic or wanton infliction of physical or mental suffering by one or more persons acting alone or on the orders of any authority, to force another person to yield information, to make a confession, or for any other reason.

 

DECLARATION

1. The physician shall not countenance, condone or participate in the practice of torture or other forms of cruel, inhuman or degrading procedures, whatever the offense of which the victim of such procedures is suspected, accused or guilty, and whatever the victim’s beliefs or motives, and in all situations, including armed conflict and civil strife.

2. The physician shall not provide any premises, instruments, substances or knowledge to facilitate the practice of torture or other forms of cruel, inhuman or degrading treatment or to diminish the ability of the victim to resist such treatment.

3. When providing medical assistance to detainees or prisoners who are, or who could later be, under interrogation, physicians should be particularly careful to ensure the confidentiality of all personal medical information. A breach of the Geneva Conventions shall in any case be reported by the physician to relevant authorities.

4. As stated in WMA Resolution on the Responsibility of Physicians in the Documentation and Denunciation of Acts of Torture or Cruel or Inhuman or Degrading Treatment and as an exception to professional confidentiality, physicians have the ethical obligation to report abuses, where possible with the subject’s consent, but in certain circumstances where the victim is unable to express him/herself freely, without explicit consent.

5. The physician shall not use nor allow to be used, as far as he or she can, medical knowledge or skills, or health information specific to individuals, to facilitate or otherwise aid any interrogation, legal or illegal, of those individuals.

6. The physician shall not be present during any procedure during which torture or any other forms of cruel, inhuman or degrading treatment is used or threatened.

7. A physician must have complete clinical independence in deciding upon the care of a person for whom he or she is medically responsible. The physician’s fundamental role is to alleviate the distress of his or her fellow human beings, and no motive, whether personal, collective or political, shall prevail against this higher purpose.

8. Where a prisoner refuses nourishment and is considered by the physician as capable of forming an unimpaired and rational judgment concerning the consequences of such a voluntary refusal of nourishment, he or she shall not be fed artificially, as stated in WMA Declaration of Malta on Hunger Strikers. The decision as to the capacity of the prisoner to form such a judgment should be confirmed by at least one other independent physician. The consequences of the refusal of nourishment shall be explained by the physician to the prisoner.

9. Recalling the Declaration of Hamburg concerning Support for Medical Doctors Refusing to Participate in, or to Condone, the Use of Torture or Other Forms of Cruel, Inhuman or Degrading Treatment, the World Medical Association supports, and encourages the international community, the National Medical Associations and fellow physicians to support, the physician and his or her family in the face of threats or reprisals resulting from a refusal to condone the use of torture or other forms of cruel, inhuman or degrading treatment.

10. The World Medical Association calls on National Medical Associations to encourage physicians to continue their professional development training and education in human rights.

Adopted by the 39th World Medical Assembly, Madrid, Spain, October 1987,
and reaffirmed by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005 and by the 200th WMA Council Session, Oslo, Norway, April 2015,
and rescinded and archived by the 70th WMA General Assembly, Tbilisi, October 2019
* This document has been replaced by the completely rewritten  “WMA Declaration on Euthanasia and Physician-Assisted Suicide” (2019)

 

Euthanasia, that is the act of deliberately ending the life of a patient, even at the patient’s own request or at the request of close relatives, is unethical. This does not prevent the physician from respecting the desire of a patient to allow the natural process of death to follow its course in the terminal phase of sickness.

Adopted by the 54th WMA General Assembly, Helsinki, Finland, September 2003
reaffirmed by the 194th WMA Council Session, Bali, Indonesia, April 2013 and
reaffirmed with minor revisions by the 224th WMA Council, Kigali, Rwanda, October 2023

 

PREAMBLE 

An advance directive is a written and signed document or a witnessed verbal statement whereby persons record their wishes regarding the medical care they wish to receive, or not receive, if they become unconscious or otherwise unable to express their will.

This type of document may have different names in different countries (e.g., “living will” or “biological wills”). The acceptability and legal status of such directives may differ from one country to another, depending on social, cultural, religious and other factors.

The majority of persons who draw up such directives are particularly concerned about excessive, ineffective or prolonged therapeutic interventions in the terminal phases of life, in situations where there is clear and irreversible physical or mental degeneration.

The WMA Declaration of Lisbon on the Rights of the Patient states that if the patient is unconscious and “if a legally entitled representative is not available, but a medical intervention is urgently needed, consent of the patient may be presumed unless it is obvious and beyond any doubt on the basis of the patient’s previous firm expression or conviction that he/she would refuse consent to the intervention in that situation.”

 

RECOMMENDATIONS

  1. A patient’s duly executed advance directive should be honoured unless there are reasonable grounds to suppose that it is not valid because it no longer represents the wishes of the patient or that the patient’s understanding was incomplete at the time the directive was prepared. If the advance directive is contrary to the physician’s convictions, provisions should be made to transfer the care of the patient to another consenting physician.
  2. If the physician is uncertain about the validity of an advance directive to terminate life-prolonging treatment, he/she should consult family members or legal guardians of the patient concerned and should seek advice from at least one other physician or the relevant ethics committee. The family members or legal guardians should be designated in the advance directive, be trustworthy and willing to testify as to the intention(s) expressed in the advance directive by the signatory. The physician should consider any relevant legislation concerning substitute decision making for incompetent patients.
  3. Patients and their family members should be educated on the possibility of having living wills and advised to review their advance directives periodically.
  4. In the absence of an advance directive or a legally designated substitute decision maker, physicians should render such treatment as they believe to be in the patient’s best interests.
  5. Constituent Members of countries that do not have adequately developed legal frameworks and hospital protocols for advance directives, are encouraged to work with relevant authorities to develop such frameworks, integrate these changes both in the medical curricula and public education, as well as promote awareness among practicing physicians through continuing professional development programs.