Consent – WMA – The World Medical Association

Adopted by the 53^rd WMA General Assembly, Washington, DC, USA, October 2002
and revised by the 67^th WMA General Assembly, Taipei, Taiwan, October 2016

PREAMBLE

1. The Declaration of Helsinki lays down ethical principles for medical research involving human subjects, including the importance of protecting the dignity, autonomy, privacy and confidentiality of research subjects, and obtaining informed consent for using identifiable human biological material and data.

2. In health care provision, health information is gathered by physicians or other members of the medical team to record health care events and to aid physicians in the on-going care of their patient.

3. This Declaration is intended to cover the collection, storage and use of identifiable data and biological material beyond the individual care of patients. In concordance with the Declaration of Helsinki, it provides additional ethical principles for their use in Health Databases and Biobanks.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

4. A Health Database is a system for collecting, organizing and storing health information. A Biobank is a collection of biological material and associated data. Biological material refers to a sample obtained from an individual human being, living or deceased, which can provide biological information, including genetic information, about that individual. Health Databases and Biobanks are both collections on individuals and population, and both give rise to the similar concerns about dignity, autonomy, privacy, confidentiality and discrimination.

5. Research using Health Databases and Biobanks can often significantly accelerate the improvement in the understanding of health, diseases, and the effectiveness, efficiency, safety and quality of preventive, diagnostic and therapeutic interventions. Health research represents a common good that is in the interest of individual patients, as well as the population and the society.

6. Physicians must consider the ethical, legal and regulatory norms and standards for Health Database and Biobanks in their own countries 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 individuals and population set forth in this Declaration.

When authorized by a national law adopted through a democratic process in respect of human rights, other procedures could be adopted to protect the dignity, autonomy and privacy of the individuals. Such procedures are only acceptable when strict rules on data protection are implemented.

7. Consistent with the mandate of WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in using data or biological material in Health Databases and Biobanks to adopt these principles.

ETHICAL PRINCIPLES

8. Research and other Health Databases and Biobanks related activities should contribute to the benefit of society, in particular public health objectives.

9. Respecting the dignity, autonomy, privacy and confidentiality of individuals, physicians have specific obligations, both ethical and legal, as stewards protecting information provided by their patients. The rights to autonomy, privacy and confidentiality also entitle individuals to exercise control over the use of their personal data and biological material.

10. Confidentiality is essential for maintaining trust and integrity in Health Databases and Biobanks. Knowing that their privacy will be respected gives patients and donors the confidence to share sensitive personal data. Their privacy is protected by the duty of confidentiality of all who are involved in handling data and biological material.

11. The collection, storage and use of data and biological material from individuals capable of giving consent must be voluntary. If the data and biological material are collected for a given research project, the specific, free and informed consent of the participants must be obtained in accordance with the Declaration of Helsinki.

12. If the data or biological material are collected and stored in a Health Database or a Biobank for multiple and indefinite uses, consent is only valid if the concerned individuals have been adequately informed about:

The purpose of the Health Database or Biobank;
The risks and burdens associated with collection, storage and use of data and material;
The nature of the data or material to be collected;
The procedures for return of results including incidental findings;
The rules of access to the Health Database or Biobank;
How privacy is protected;
The governance arrangements as stipulated in paragraph 21;
That in case the data and material are made non-identifiable the individual may not be able to know what is done with their data/material and that they will not have the option of withdrawing their consent;
Their fundamental rights and safeguards established in this Declaration; and
When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to other institutions or third countries.

13. In addition to the requirements set forth in the Declaration of Helsinki, when persons who were not able to consent, whose data and biological materials have been stored for future research, attain or regain the capacity to consent, reasonable efforts should be made to seek the consent of those persons for continued storage and research use of their data and biological materials.

14. Individuals have the right to request for and be provided with information about their data and its use as well as to request corrections of mistakes or omissions. Health Databases and Biobanks should adopt adequate measures to inform the concerned individuals about their activities.

15. Individuals have the right, at any time and without reprisal, to alter their consent or to ask for their identifiable data to be withdrawn from the Health Database and their biological material to be withdrawn from a Biobank. This applies to future use of the data and biological materials.

16. In the event of a clearly identified, serious and immediate threat where anonymous data will not suffice, the requirements for consent may be waived to protect the health of the population. An independent ethics committee should confirm that each exceptional case is justifiable.

17. The interests and rights of the communities concerned, in particular when vulnerable, must be protected, especially in terms of benefit sharing.

18. Special considerations should be given to the possible exploitation of intellectual property. Protections for ownership of materials, rights and privileges must be considered and contractually defined before collecting and sharing the material. Intellectual property issues should be addressed in a policy, which covers the rights of all stakeholders and communicated in a transparent manner.

19. An independent ethics committee must approve the establishment of Health Databases and Biobanks used for research and other purposes. In addition the ethics committee must approve use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have to be taken to protect the donor. The committee must have the right to monitor on-going activities. Other ethical review mechanisms that are in accordance to par 6 can be established.

GOVERNANCE

20. In order to foster trustworthiness, Health Databases and Biobanks must be governed by internal and external mechanisms based on the following principles:

Protection of individuals: Governance should be designed so the rights of individuals prevail over the interests of other stakeholders and science;
Transparency: any relevant information on Health Databases and Biobanks must be made available to the public;
Participation and inclusion: Custodians of Health Databases and Biobanks must consult and engage with individuals and their communities.
Accountability: Custodians of Health Databases and Biobanks must be accessible and responsive to all stakeholders.

21. Governance arrangements must include the following elements:

The purpose of the Health Database or Biobank;
The nature of health data and biological material that will be contained in the Health Database or Biobank;
Arrangements for the length of time for which the data or material will be stored;
Arrangements for regulations of the disposal and destruction of data or material;
Arrangement for how the data and material will be documented and traceable in accordance with the consent of the concerned persons;
Arrangement for how the data and material will be dealt with in the event of change of ownership or closure;
Arrangement for obtaining appropriate consent or other legal basis for data or material collection;
Arrangements for protecting dignity, autonomy, privacy and preventing discrimination;
Criteria and procedures concerning the access to and the sharing of the health data or biological material including the systematic use of Material Transfer Agreement (MTA) when necessary;
The person or persons who are responsible for the governance;
The security measures to prevent unauthorized access or inappropriate sharing;
The procedures for re-contacting participants where relevant;
The procedures for receiving and addressing enquiries and complaints.

22. Those professionals contributing to or working with Health Databases and Biobanks must comply with the appropriate governance arrangements.

23. Health Databases and Biobanks must be operated under the responsibility of an appropriately qualified professional assuring compliance with this Declaration.

24. The WMA urges relevant authorities to formulate policies and law that protect health data and biological material on the basis of the principles set forth in this document.

Adopted by the 65^th World Medical Assembly, Durban, South Africa, Otober 2014

Preamble

Aesthetic treatments have become increasingly common in recent years as society appears to have become more preoccupied with physical appearance. These treatments are performed by practitioners with widely differing clinical and educational backgrounds.

For the purpose of this statement, aesthetic treatment is defined as an intervention that is performed not to treat an injury, a disease or a deformity, but for non-therapeutic reasons, with the sole purpose of enhancing or changing the physical appearance of the individual concerned. In this statement, the individual undergoing treatment is referred to as the patient. The treatments available include a great variety of interventions, ranging from surgical procedures to injections and different kinds of skin treatments. This statement focuses on interventions that are methodologically similar to those performed in conventional health care. Tattooing, scarring and similar interventions are therefore not considered in this statement.

Body image affects a person’s self-esteem and mental health and is an integral part of a person’s overall health and well-being. However, media images of “perfect bodies” have become the norm, causing some people, to develop unrealistic and unhealthy body images.

Many aesthetic treatments involve risks and may potentially harm the health of the patient. Minors[1] are particularly vulnerable, as their bodies are often not fully developed. In order to protect persons considering or undergoing aesthetic treatment the WMA has developed the following basic principles regarding aesthetic treatments.

Reaffirming the medical ethics principles laid out in the WMA Declaration of Geneva, the WMA Declaration of Lisbon on the Rights of the Patient and the WMA International Code of Medical Ethics, and consistent with the mandate of the WMA, this statement is addressed primarily to physicians. However, the WMA encourages other practitioners performing aesthetic treatments to adopt these principles.

PRINCIPLES

1. The patient´s dignity, integrity and confidentiality must always be respected.

2. Physicians have a role in helping to identify unhealthy body images and to address and treat disorders when these exist.

3. Aesthetic treatments must only be performed by practitioners with sufficient knowledge, skills and experience of the interventions performed.

4. All practitioners providing aesthetic treatments must be registered with and/or licensed by the appropriate regulatory authority. Ideally, the practitioner should also be authorized by this authority to provide these specific aesthetic treatments.

5. All aesthetic treatments must be preceded by a thorough examination of the patient. The practitioner should consider all circumstances, physical and psychological, that may cause an increased risk of harm for the individual patient and should refuse to perform the treatment if the risk is unacceptable. This is especially true in the case of minors. Practitioners should always choose the most appropriate treatment option, rather than the most lucrative one.

6. Minors may need or benefit from plastic medical treatments but pure aesthetic procedures should not be performed on minors. If, in exceptional cases, aesthetic treatment is performed on a minors, it should only be done with special care and consideration and only if the aim of the treatment is to avoid negative attention rather than gain positive attention. All relevant medical factors, such as whether the minor is still growing or whether the treatment will need to be repeated at a later date, must be considered.

7. The patient must consent explicitly to any aesthetic treatment, preferably in writing. Before seeking consent the practitioner should inform the patient of all relevant aspects of the treatment, including how the procedure is performed, possible risks and the fact that many of these treatments may be irreversible. The patient should be given sufficient time to consider the information before the treatment starts. Where the patient requesting the treatment is a minor, the informed consent of his or her parents or legally authorized representative should be obtained.

8. All aesthetic treatments performed should be carefully documented by the practitioner. The documentation should include a detailed description of the treatment performed, information on medications used, if any, and all other relevant aspects of the treatment.

9. Aesthetic treatments must only be performed under strictly hygienic and medically safe conditions on premises that are adequately staffed and equipped. This must include equipment for treating life-threatening allergic reactions and other potential complications.

10. Advertising and marketing of aesthetic treatments should be responsible and should not foster unrealistic expectations of treatment results. Unrealistic or altered photographs showing patients before and after treatments must not be used in advertising.

11. Advertising and marketing of aesthetic treatments should never be targeted to minors.

12. Practitioners should never offer or promote financial loans as a means of paying for aesthetic treatment.

[1] For the purpose of this statement minor is defined as a person who, according to applicable national legislation, is not an adult.

Adopted by the 63^rd WMA General Assembly, Bangkok, Thailand, October 2012, and
revised by the 74^th WMA General Assembly, Kigali, Rwanda, October 2023

PREAMBLE

The United Nations states forced or coerced sterilisation is a violation of fundamental human rights, including the right to health, to information and privacy, and to be free from torture and other cruel, inhuman or degrading treatment or punishment. The United Nations also states specific populations are disproportionately affected by forced or coerced sterilisation, including women, women living with HIV, indigenous and ethnic minority girls and women, persons with disabilities, and transgender persons and intersex persons.

The WMA recognises that no person, regardless of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, culture, sexual orientation, social standing, or any other factor, should be subjected to forced or coerced sterilisation.

A full range of contraceptive services, including sterilisation, should be accessible and affordable to every individual. The state has a role to play in ensuring that such services are available, along with private, charitable and third sector organisations.

As with all other medical treatments, sterilisation should only be performed on a competent patient after an informed choice has been made and the free and valid consent of the individual has been obtained. Where a patient is incompetent, a valid decision about treatment must be made in accordance with the patient’s best interest as well as with relevant legal requirements and the ethical standards of the medical profession before the procedure is carried out.

The WMA condemns practices where a state or any other actor attempts to bypass ethical requirements necessary for obtaining free and valid consent for sterilization, which must be:

Free from material or social coercion;
Not a condition of other medical care (including safe abortion), social, insurance, institutional or other benefits and
Obtained when the person is not facing any stressor limiting their capacity of discernment, such as detention or a medical emergency (unless sterilization is the subject of the emergency).

RECOMMENDATIONS

Recalling the core ethical values of the medical profession enshrined in its International Code of Medical Ethics and the Declaration of Geneva: The Physician’s Pledge, and its long-standing commitment against torture and other cruel, inhuman or degrading treatment, the WMA condemns forced or coerced sterilisation and calls on:

Its Constituent Members

1. To advocate against such practices contrary to human dignity;

2. To support the provision of safe and ethical sterilization services or interventions, with due respect for the physical and mental integrity of the persons, including by guaranteeing their autonomous reproductive choices;

Physicians

3. To be alert to situations and settings where there is a risk of forced or coerced sterilisation, particularly for vulnerable and disproportionately affected persons, to ensure consent is valid and freely given and to oppose any form of involvement in forced or coerced sterilisation.

Adopted by the 60^th WMA General Assembly, New Delhi, India, October 2009
and revised by the 73^rd WMA General Assembly, Berlin, Germany, October 2022

PREAMBLE

Digital health is a broad term that refers to “the use of information and communication technologies in medicine and other health professions to manage illnesses and health risks and to promote wellness.” Digital health encompasses electronic health (eHealth) and developing areas such as the use of advanced computer sciences (including ‘big data’, bioinformatics and artificial intelligence). The term also includes telehealth, telemedicine, and mobile health (mHealth).
The term “digital health” may be used interchangeably with “eHealth.” These terms also include within them: Telehealth” or “Telemedicine,” which both utilize information and communications technology to deliver healthcare services and information at a distance (large or small). They are used for remote clinical services, including real-time patient monitoring such as in critical care settings. Also, they serve for patient-physician consultation where access is limited due to physicians’/patients’ schedules or preferences, or patient limitations such as physical disability. Alternatively, they can be used for consultation between two or more physicians. The difference between the two terms is that “Telehealth” refers also to remote clinical and non-clinical services: preventive health support, research, training, and continuing medical education for health professionals.
Technological developments and the increasing availability and affordability of mobile devices have led to an exponential increase in the number and variety of digital health services in use in both developed and developing countries. Simultaneously, this relatively new and rapidly evolving sector remains largely unregulated, which could have potential patient safety and ethical implications.
The driving force behind digital health should be improving quality of care, patient safety and equity of access to services otherwise unavailable.
Digital health differs from conventional health care in the medium used, its accessibility, and its effect on the patient-physician relationship, as well as on the traditional principles of patient care.
The development and application of digital health has expanded access to health care and health education in both regular and emergency situations. At the same time, its effect on the patient-physician relationship, accountability, patient safety, multistakeholder interactions, privacy and data confidentiality, fair access, and other social and ethical principles should be taken into consideration. However, the scope and application of digital health, telemedicine or telehealth are context-dependent. Factors such as human resources for health, size of service area and level of healthcare facilities should also be taken into consideration.
Physicians should be involved in the development and implementation of digital health solutions to be used in health care, in order to ensure they meet the needs of patients and health professionals.
Consistent with the mandate of the WMA, this statement is addressed primarily to physicians and their role in the health care setting. The WMA encourages others who are involved in healthcare to develop and adhere to similar principles, as appropriate to their role in the healthcare system.

Physician autonomy

Acceptable boundaries in the patient-physician relationship necessary for the provision of optimal care, should exist in digital as well as physical practice. The nearly continuous availability of digital health care has the potential to unduly interfere with a physician’s work-life balance due to theoretical 24/7 availability. The physician should inform patients about his or her availability and recommend services when he or she is not available.
Physicians should exercise their professional autonomy in deciding whether digital health consultation is appropriate. This autonomy should consider the type of visit scheduled, the physician’s comfort with the medium, and the physician’s assessment, together with the patient, of the patient’s comfort level with this type of care.

Patient-physician relationship

Face to face consultation should be the gold standard where a physical examination is required to establish a diagnosis, or where there is a wish on the part of the physician or patient to communicate in person as part of establishing a trusted physician-patient relationship. Face to face consultations may be preferable in some circumstances to take stock of non-verbal cues, and for consultations where there may be communication barriers or discussion of sensitive matters. Ideally, the patient-physician relationship in the context of digital health, should be based on a previously established relationship and sufficient knowledge of the patient’s medical history.
However, in emergency and critical situations, or in settings where access to doctors is not available other than via telemedicine, delivery of care via telemedicine should be prioritized even when a prior patient-physician relationship was not established. Telemedicine can be employed when a physician cannot be physically present within a safe and acceptable period. It can also be used to manage patients remotely including self-management and for chronic conditions or follow-up after initial treatment, where it has been proven to be safe and effective.
The physician providing telemedicine services should be familiar with the technology and/or should receive sufficient resources, training and orientation in effective digital communication. Additionally, the physician should strive to ensure that quality of communication during a digital health encounter is maximized. It is also important that the patient is comfortable using the technology employed. Any significant technical deficiencies should be noted in the documentation of the consultation and reported, if applicable.
The patient-physician relationship is based on mutual trust and respect. Therefore, the physician and the patient must identify each other reliably when telemedicine is employed. However, it must be recognized that sometimes third parties or ‘surrogates’ such as a family member should become involved in the case of minors, the frail, the elderly, or in an emergency situation.
The physician should give clear and explicit direction to the patient during the telemedicine encounter regarding who has ongoing responsibility for any required follow-up and ongoing health care.
In a digital consultation between two or more professionals, the primary physician remains responsible for the patient’s care and coordination. The primary physician remains responsible for protocols, conferencing, and medical record review in all settings and circumstances. Physicians providing consultation should be able to contact other health professionals and technicians, as well as patients, in a timely manner.

Informed consent

Proper informed consent requires that the patient be informed of, have capacity for, and provide consent specific to the type of digital health being used. All necessary information regarding the distinctive features of digital health, in general, and telemedicine, in particular, must be explained fully to patients including, but not limited to: how telemedicine works, how to schedule appointments, privacy concerns, the possibility of technological failure, including confidentiality breaches; possible secondary use of data; protocols for contact during virtual visits, prescribing policies and coordinating care with other health professionals. This information should be provided clearly and understandably without coercion or undue influence of the patient’s voluntary choices, while taking into account the patient’s perceived level of health literacy and other resource limitations specific to the type of digital health being used.

Quality of care

The physician must ensure the standard of care delivered via digital health is at least equivalent to any other type of care given to the patient, considering the specific context, location and timing, and relative availability of face to face care. If the standard of care cannot be satisfied via digital technology, the physician should inform the patient and suggest an alternative form of healthcare delivery.
The physician should have clear and transparent protocols for delivering digital health care such as clinical practice guidelines, whenever possible, to guide the delivery of care in the digital setting, recognizing that certain modifications may need to be made to accommodate specific circumstances. Changes to clinical practice guidelines for the digital setting should be approved by the appropriate governing and/or regulatory body or association. If the digital health solution is equipped with automated clinical practice support, this support must be strictly professionally based and not influenced by economic interests in any way.
The physician providing digital services should follow all regulatory requirements and relevant protocols and procedures related to informed consent (verbal, written, and recorded); privacy and confidentiality; documentation; ownership of patient records; and appropriate video/telephone behaviors.
The physician providing care by means of telehealth should keep a clear and detailed record of the advice delivered, the information on which the advice was based and the patient’s informed consent.
The physician should be aware of and respect the particular challenges and uncertainties that may arise when in contact with the patient through telecommunication. The physician must be prepared to recommend direct patient-physician contact whenever possible if he/she believes it is in the patient’s best interests or will improve compliance.
The possibilities and weaknesses of digital health in emergencies must be duly identified. If it is necessary to use telemedicine in an emergency, the advice and treatment suggestions will be influenced by the severity of the patient’s medical condition and the patient’s technological and health literacy. To ensure patient safety, entities that deliver telemedicine services should establish protocols for referrals in emergency situations.

Clinical Outcomes

Entities providing digital health programs should monitor and continuously strive to improve the quality of services to achieve the best possible outcomes.
Entities providing digital health programs should have a systematic protocol for collecting, evaluating, monitoring and reporting meaningful health care outcomes, safety data and clinical effectiveness. Quality indicators should be identified and utilized. Like all health care interventions, digital technology must be tested for its effectiveness, efficiency, safety, feasibility, and cost-effectiveness. Quality assurance and improvement data should be shared to improve its equitable use.
Entities implementing digital health are urged to report unintended consequences to help improve patient safety and further the overall development of the field. Countries are encouraged to implement these guiding principles in their own legislation and regulation.

Equity of care

Although digital health can provide greater access to distant and underserved populations, it may also exacerbate existing inequalities due to, among other things, age, race, socioeconomic status, cultural factors, or literacy issues. Physicians must be aware that certain digital technologies might be unavailable or unaffordable to patients, impeding access and further widening the health outcomes gaps.
Digital technologies should be implemented and monitored carefully to avoid inequity of access to these technologies. Where appropriate, social or healthcare services should facilitate access to technologies as part of basic benefit packages while taking all necessary precautions to guarantee data security and privacy. Access to vital technologies should not be denied to anyone based on financial status or a lack of technical expertise.

Confidentiality and data security

In order to ensure data confidentiality, officially recognized data protection measures must be used. Data obtained during a digital consultation must be secured to avoid unauthorized access and breaches of identifiable patient information through appropriate and up-to-date security and privacy measures. If data breaches do occur, the patient must be notified immediately in accordance with the law.
Digital health technologies generally involve the measurement or manual input of medical, physiological, lifestyle, activity, and environmental data to fulfill their primary purpose. The large amount of data generated also may be used for research or other purposes to improve healthcare and disease prevention. However, secondary uses of personal mHealth data can result in misuse and abuse.
Robust policies and safeguards to regulate and secure the collection, storage, protection, and processing of digital health users’ data, especially personal health data, must be implemented to assure valid informed consent and guarantee patients’ rights.
If patients believe that their privacy rights have been violated, they may file a complaint with the covered entity’s Privacy Officer or data protection authorities, in accordance with local regulations.

Legal principles

A clear legal framework must be drawn up to address potential liability arising from the use of digital technologies. Physicians should only practice telemedicine in countries/jurisdictions where they are licensed to practice and should adhere to the legal framework and regulations as defined by the country/jurisdiction where the physician originates care and the countries in which they practice. Physicians should ensure that their medical indemnity includes telemedicine and digital health coverage.
Reimbursement models must be set up in consultation with national medical associations and healthcare providers to ensure that physicians receive appropriate reimbursement for providing digital health services.

Specific principles of mHealth technology

Mobile health (mHealth) is a form of electronic health (eHealth) for which there is no fixed definition. It has been described as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other devices intended to be used in connection with mobile devices. It includes voice and short messaging services (SMS), applications (apps), and the use of the global positioning system (GPS).
A clear distinction must be made between mHealth technologies used for lifestyle purposes and those that require physicians’ medical expertise and meet the definition of medical devices. The latter must be appropriately regulated, and users must be able to verify the source of medical information provided, as these applications could potentially recommend non-scientific or non-evidence-based treatments. The information provided must be comprehensive, clear, reliable, non-technical, and easily understood by laypeople.
Concerted work must improve the interoperability, reliability, functionality, and safety of mHealth technologies, e.g., through the development of standards and certification schemes.
Comprehensive and independent evaluations must be carried out regularly by competent authorities with appropriate medical expertise to assess the functionality, limitations, data integrity, security, and privacy of mHealth technologies. This information must be made publicly available.
mHealth can only positively contribute to improvements in care if services are based on sound medical rationale. As evidence of clinical usefulness is developed, findings should be published in peer-reviewed journals and be reproducible.

RECOMMENDATIONS

The WMA recognizes the value of digital health to supplement traditional ways of managing health and delivering healthcare. The driving force behind digital health should be improving quality of care and equity of access to services otherwise unavailable.
The WMA emphasizes that the principles of medical ethics, as outlined in The Declaration of Geneva: The Physician’s Pledge and the International Code of Medical Ethics, must be respected in the practice of all forms of digital health.
The WMA recommends that the training of digital health literacy and skills be included in medical education and continuing professional development.
The WMA urges patients and physicians to be discerning in their use of digital health and to be mindful of potential risks and implications.
The WMA recommends further research in digital health to assess safety, efficacy, cost-effectiveness, feasibility of implementation, and patient outcomes.
The WMA recommends monitoring the risks of excessive or inappropriate use of digital health technologies and the potential psychological impact on patients and ensuring that the benefits of such technologies outweigh the risks.
The WMA recommends special attention be given to patients’ disabilities (audio-visual or physical) and patients who are minors, when using digital healthcare.
Where appropriate, National Medical Associations should encourage the development and update of ethical norms, practice guidelines, national legislation, and international agreements on digital health.
The WMA recommends that other regulatory bodies, professional societies, organizations, institutions, and private industry, monitor the proper use of digital health technologies and share these findings widely.

Adopted by the 56^th WMA General Assembly, Santiago, Chile, October 2005,
revised by the 60^th WMA General Assembly, New Delhi, India, October 2009
and by the 70^th WMA General Assembly, Tbilisi, Georgia, October 2019

PREAMBLE

Genetics contributes to the growing understanding of the causes, developments, classifications and treatments of diseases. The use of genetics is increasing, moving from the identification of monogenic diseases and use in cancer treatment towards predicting risks of multifactorial diseases and manipulation of individual genes. In these ways, the use of genetics does and increasingly will create great value at an individual as well as at a societal level. However, the use of genetic information about individuals also raises issues concerning confidentiality, privacy and the risk of psychological distress, stigmatization, and discrimination.

This declaration provides recommendations for the use of medical genetics that respects the ethical challenges that such use entails. It is primarily aimed at the use of genetics in the provision of health care. The collection, storage and use of genetic data beyond the individual care of patients should adhere to the principles put forward in the WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks. The use of genetics in medical research involving human subjects, including research on identifiable human material and data, should adhere to the principles put forward in the WMA Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects.

This Declaration should be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. The declaration should be updated in accordance with developments in the field of genetics.

Genetic information has characteristics that are ethically significant. Individually, these characteristics can also be found in other types of health care information. However, the combination of these characteristics makes genetic information particularly sensitive. This sensitivity – combined with the intense interest in genetic information from many different stakeholders – underscores the importance of respecting the fundamental principles of medical ethics, particularly the patient’s right to autonomy, confidentiality, privacy and benefit in relation to generating, storing, using or sharing genetic information.

Central among the ethically significant characteristics are:

Genetic information is identifying for an individual.
Genetic analysis can generate extensive and detailed information about an individual.
Genetic analysis may generate additional findings.
The full significance of the information generated by genetic analysis is not yet known.
Genetic information about an individual cannot be fully anonymized, and de-identified genetic information may be re-identified.
Genetic data contains information not only about the individual who has undergone testing, but also about individuals who are genetically related to the tested individual.
Genetic testing of one individual may entail that the physician asks for access to health care information about – or genetic testing of – genetically related persons (family members).

ETHICAL PRINCIPLES

Benefit

Genetic testing in the context of healthcare provision should primarily be done for the benefit of the patient being tested.

Relevance

Genetics test should not be wider in scope than what is relevant for the purpose of the test.

Informed consent

Genetic testing should only be done with the informed consent of the individual or his/her legal guardian. Genetic testing for predisposition to disease should be performed on children only if there are clear clinical indications and being aware of the test results would be in the best interests of the child.
The consent process must include providing the patient with understandable, accurate and adequate information about the following:
- The purpose, nature and benefits of the test.
- The risks, burdens and limitations of the test.
- The nature and significance of the information to be generated by the test.
- The procedures for return of results including additional findings and future discoveries.
- The options for responding to the results, including possible treatments.
- How, where, and for how long the test results, data and biological samples will be stored, and who can gain access to current and future results.
- The possible secondary uses of the information generated by the test
- The measures protecting confidentiality, privacy and autonomy, including data security measures
- The procedures for managing results that have implications for genetically related persons
- When applicable, commercial use and benefit sharing, intellectual property issues and the transfer of data or material to third parties.

Additional findings (secondary and incidental findings)

A genetic test may generate additional findings that are not related to the primary purpose of the test, also referred to as secondary or incidental findings. Procedures for handling such findings should be determined before the test, and information about these procedures should be communicated to the patient as part of the consent process.
The principles for managing additional findings must include consideration for:
- The patient’s preferences regarding the management of additional findings.
- The significance of the additional findings for the patient’s health and other interests.
- The significance of the findings for the health and other interests of persons who are genetically related to the patient.
- The scientific validity of the additional findings.
- The strengths of the evidence for the correlation between the additional findings and health related risks for the patient.
- The degree to which the additional findings are actionable, medically or otherwise.

Genetic counselling

Appropriate genetic counselling should always be offered when genetic tests or genetics-based treatments are offered or performed and for the interpretation of results. Counselling should enable the patient to make informed decisions according to their own values and interests. Counselling must not be biased by the personal values of the counsellor. The individual’s right not to be tested should be protected, and if the individual has been tested, there should be no obligation for the individual to act on the results of the test.
Medical students and physicians should receive education and training in genetic counselling, particularly counselling related to pre-symptomatic diagnosis of disease.

Confidentiality

Like all medical records, information from genetic testing or genetic therapy must be kept strictly confidential and must not be revealed to third parties in identifiable form without the consent of the individual tested. Third parties, to whom results may in certain circumstances be released, are identified in paragraph 15.

Informing third parties

In the case of a test result that may have implications for third parties such as close relatives, the individual tested should be encouraged to discuss the results of the test with such third parties. In cases where not disclosing the results involves an expected harm that is serious and unavoidable except by disclosure, and clearly greater than the harm likely to result from disclosure, the physician may reveal necessary information to such third parties without the consent of the patient but should usually discuss this with the patient first. If the physician has access to an ethics committee, it is preferable to consult such a committee prior to revealing information to third parties.

Data protection

The collection, storage and use of genetic data requires the highest level of data protection.

Discrimination

No individual or group must be discriminated against in any way based on genetic makeup, including the fields of human rights, employment and insurance. This protection should apply to those individuals who have undergone genetic testing or genetic therapy as well as those individuals about whom genetic information can be inferred. Particular care should be taken to protect vulnerable individuals and groups.

Cost of testing

The decision to include genetic analysis as part of medical care can introduce significant cost for the patient and the health care system. Therefore, such a decision should always be based on the expectation that the costs of the analysis are justified by the benefits for the patient.

Reliability and limitations

The identification of disease-related genes has led to an increase in the number of available genetic tests, analyses and treatments. As the number, types and complexity of these increase, great care must be taken to ensure their reliability, accuracy and quality and to inform patients about their limitations.
The benefit of a genetic test for an individual may depend on the availability of information about the relevant background population. Medical professionals should be aware of the scope and the limitations of genetic background data and health information stored in databases used in providing clinical genetic testing services.

Direct-to-consumer tests

If genetic tests are offered directly to consumers for medical purposes, they must meet the same technical, professional, legal and ethical standards as tests offered by certified laboratories and must be in accordance with the recommendations put forward in this statement. In particular, providers of direct-to-consumer tests must provide understandable, accurate and adequate information about the reliability and limitations of their services.

Clinical use of data from research

For research projects that involve genetic testing, and where the participant can be identified, the research participant must be informed about the possibility of findings that indicate a serious threat to the health of the participant. If there are such findings, the participant should be offered a referral to genetic counseling and appropriate medical intervention.

Gene therapy and editing

Gene therapy and editing represents a combination of techniques used to manipulate disease related genes. The use of these techniques should adhere to the following guidelines:

The use of gene therapy and somatic genome editing should conform to standards of medical ethics and professional responsibility.
Patient autonomy should be respected, and informed consent should always be obtained. This informed consent process should include disclosure of the risks of gene therapy and editing, including the fact that the patient may have to undergo multiple rounds of gene therapy, the risk of an immune response, the potential problems arising from the use of viral vectors and off-target genome effects.
Gene therapy and editing should only be undertaken after a careful analysis of the risks and benefits involved and an evaluation of the perceived effectiveness of the therapy, as compared to the risks, side effects, availability and effectiveness of other treatments.
Gene editing of germline cells has scientifically unresolved risks and should not be clinically applied. This does not preclude testing gene editing or other similar research.

Cloning

Cloning includes both therapeutic cloning, namely the cloning of individual stem cells to produce a healthy copy of a diseased tissue or organ for transplant, and reproductive cloning, namely the cloning of an existing human to produce a genetic duplicate of that human. The WMA opposes reproductive cloning of humans.

Adopted by the 52^nd WMA General Assembly, Edinburgh, Scotland, October 2000,
revised by the 57^th WMA General Assembly, Pilanesberg, South Africa, October 2006,
and rescinded at the 65^th WMA General Assembly, Durban, South Africa, October 2014

A. INTRODUCTION

Advances in medical sciences, especially surgical techniques, tissue typing and immuno-suppressive drugs, have made possible a significant increase in the rates of successful transplantation of organs. In the light of these developments, there is a need for renewed reflection on ethical issues concerning organ donation and transplantation and on principles relevant to the resolution of these issues. Therefore, the World Medical Association has undertaken a review of issues and principles concerning transplantation and has developed this policy to provide guidance to medical associations, physicians and other health care providers as well as to those who develop policy and protocols bearing on these issues.
This policy is based on principles of general and medical ethics. In matters of ethics, conflicts of values and principles are unavoidable; for example, there is a tension between a desire to procure organs for the purpose of providing important medical treatments on the one hand and the preservation of choice and personal liberty on the other. Applicable principles are referenced throughout this policy where they may help to clarify and make explicit the reasoning behind a given statement.

B. PROFESSIONAL OBLIGATIONS OF PHYSICIANS

The primary obligation of physicians is to their individual patients, whether they are potential donors or recipients of transplanted organs. In conjunction with this obligation physicians may also have responsibilities to the family members and close friends of their patients, for example, to seek and consider their views on organ retrieval from their deceased relative or friend. The obligation to the patient has primacy over any obligations that may exist in relationship to family members. Nevertheless, this obligation is not absolute; for example, the physician’s responsibility for the well-being of a patient who needs a transplant does not justify unethical or illegal procurement of organs.
Physicians have responsibilities to society, which include promoting the fair use of resources, preventing harm and promoting health benefit for all; this may include promoting donation of organs.
Transplant surgeons should attempt to ensure that the organs they transplant have been obtained in accordance with the provisions of this policy and shall refrain from transplanting organs that they know or suspect have not been procured in a legal and ethical manner.

C. ORGAN PROCUREMENT: SOCIAL ASPECTS

The WMA encourages its members to support the development of comprehensive, coordinated national strategies concerning organ procurement in consultation and cooperation with all relevant stakeholders. In developing strategy, due consideration should be given to human rights, ethical principles and medical ethics. Ethical, cultural and societal issues arising in connection with such a strategy, and with the subject of donation and transplantation in general, should be resolved, wherever possible, in an open process involving public dialogue and debate informed by sound evidence.
Some types of organ transplantation have become established and important health care services. To the extent that the lack of organs is a barrier to the provision of needed treatment, the medical profession has an obligation to promote policies and protocols to procure organs for needed treatment consistent with societal values.
It is important that individuals become aware of the option of donation and have the opportunity to choose whether or not to donate (e.g. facilitated choice). Awareness and choice should be facilitated in a coordinated multi-faceted approach by a variety of stakeholders and means, including media awareness and public campaigns. Physicians should provide their patients with the opportunity to make a choice with respect to organ donation, ideally in the context of an ongoing relationship with the patient and in advance of any crisis giving urgency to the choice.
The WMA supports informed donor choice. National Medical Associations in countries that have adopted or are considering a policy of “presumed consent”, whereby there is a presumption that consent has been given unless there is evidence to the contrary, or “mandated choice”, whereby all persons would be required to declare whether they wish to donate, should make every effort to ensure that these policies do not diminish informed donor choice, including the patient’s right to refuse to donate.
Consideration should be given to the establishment of national donor registries to collect and maintain a list of country citizens who have chosen either to donate or not to donate their organs. Any such registry must protect individual privacy and the individual’s ability to control the collection, use, disclosure of and access to his or her health information for purposes other than registration. Provisions must be in place to ensure that the decision is adequately informed and that registrants can withdraw from the registry without penalty.

D. ORGAN PROCUREMENT AT THE INSTITUTIONAL AND INDIVIDUAL LEVELS

Organ donation can be enhanced by local policies and protocols. The WMA recommends that organ procurement programmes, hospitals and other institutions in which procurement occurs should:
1. Develop policies and protocols encouraging the procurement of organs consistent with the statements in this policy. Such policies should be consistent with physicians’ professional obligations and societal values, including free and informed decision making, privacy, and equitable access to needed medical care.
2. Make these policies and protocols known to transplant coordinators, physicians and other health care providers in the institution.
3. Ensure that adequate resources are available to support proper implementation of the policies and protocols.

E. DONATION AFTER DEATH

Physicians have an obligation to ensure that interactions at the bedside, including those discussions related to organ donation, are sensitive and consistent with ethical principles and with their fiduciary obligations to their patients. This is particularly so given that conditions at the bedside of dying patients are not ideal for the process of free and informed decision making. Protocols should specify that whoever approaches the patient, family members or other designated decision maker about the donation of organs should possess the appropriate combination of knowledge, skill and sensitivity for engaging in such discussions. Medical students and practising physicians should seek the necessary training for this task, and the appropriate authorities should provide the resources necessary to secure that training. It is mandatory that the person who approaches the patient or family about the donation decision not be a member of the transplant team.

F. FREE AND INFORMED DECISION MAKING ABOUT ORGAN DONATION

The WMA considers that the potential donor’s wishes are paramount. In the event that the potential donor’s wishes about donation are unknown and the potential donor has died without expressing a clear wish about donation, the family or a specified other person may serve as a substitute decision-maker and may be entitled to give or refuse permission for donation unless there are previously expressed wishes to the contrary.
Evidence of the free and informed decision of the potential donor, or, where legally relevant, of the appropriate substitute decision-maker, must be ascertained before organ procurement can begin. In countries where presumed consent is the legal norm, the organ procurement process should include reasonable steps to discover whether the potential donor has opted out of donation.
Success in procuring organs for transplant should not be construed as a criterion for measuring the quality of the process of free and informed decision-making. The quality of this process depends on whether the choice was adequately informed and free of coercion and not on whether the outcome is a decision to donate.
Free and informed decision making is a process requiring the exchange and understanding of information and the absence of coercion. Because prisoners and other individuals in custody are not in a position to give consent freely and can be subject to coercion, their organs must not be used for transplantation except for members of their immediate family.
In order for the choice to donate organs to be duly informed, prospective donors or their substitute decision makers should, if they desire, be provided with meaningful and relevant information. Normally, this will include information about:
1. in the case of living donors, the benefits and risks of transplantation,
2. in the case of deceased donors, procedures and definitions involved in the determination of death,
3. testing of organs to determine their suitability for transplantation, which may reveal unsuspected health risks in the prospective donors and their families,
4. in the case of deceased donors measures that may be required to preserve organ function until death is determined and transplantation can occur,
5. in the case of deceased donors what will happen to the body once death has been declared,
6. what organs they are agreeing to donate,
7. the protocol that will be followed concerning the family in the event that the family objects to donation, and
8. in the case of living donors, the implications of living without the donated organ.
Prospective donors should be informed that families sometimes object to donation; donors should be encouraged to discuss their choice with their family to prevent conflict.
Prospective donors or their substitute decision makers should be given the opportunity to ask questions about donation and should have their questions answered sensitively and intelligibly.
Where the wishes of the patient are known and there is no reason to believe that the choice to donate has been coerced, has not been adequately informed, or has changed, these wishes should be carried out. This should be clarified in law, policy and protocols. Under these circumstances, families should be encouraged to respect the patient’s clearly expressed wishes.
Where the wishes of the patient are unknown or there is uncertainty about the patient’s wishes, national law should prevail.
Protocols for free and informed decision making should also be followed in the case of recipients of organs. Normally, this should include information about:
1. the risks of the procedure,
2. the likely short, medium and long-term survival, morbidity, and quality-of-life prospects,
3. alternatives to transplantation, and
4. how organs are obtained.
In the case of living donors, special efforts should be made to ensure that the choice about donation is free of coercion. Financial incentives for providing or obtaining organs for transplantation can be coercive and should be prohibited. Individuals who are incapable of making informed decisions, for example minors or mentally incompetent persons, should not be considered as potential living donors except in extraordinary circumstances and in accordance with ethics committee review or established protocols. In order to avoid a conflict of interest, the physician who obtains informed consent from the living donor should not be part of the transplant team for the recipient.

G. DETERMINATION OF DEATH

The WMA considers that the determination of death is a clinical matter that should be made according to widely accepted guidelines established by expert medical groups, and as outlined in The World Medical Association’s Declaration of Sydney on the Determination of Death and the Recovery of Organs.
Protocols and procedures should be developed to educate patients and families about procedures for diagnosing death and the opportunities for donation after death.
In order to avoid a conflict of interest, the physician who determines and/or certifies the death of a potential organ donor should not be involved in the organ removal or in subsequent transplantation procedures or responsible for the care of potential recipients of these organs.

H. JUSTICE IN ACCESS TO ORGANS

The WMA considers there should be explicit policies open to public scrutiny governing all aspects of organ donation and transplantation, including the management of waiting lists for organs to ensure fair and appropriate access.
Policies governing the management of waiting lists should ensure efficiency and fairness. Criteria that should be considered in allocating organs include severity of medical need, length of time on the waiting list, and medical probability of success measured by such factors as type of disease, other complications, and histocompatibility. There should be no discrimination based on social status, lifestyle or behaviour.
Special appeals for organs for a specific recipient require further study and ethical examination to evaluate the potential impact on the fairness of allocation.
Payment for organs for donation and transplantation must be prohibited. A financial incentive compromises the voluntariness of the choice and the altruistic basis for organ donation. Furthermore, access to needed medical treatment based on ability to pay is inconsistent with the principles of justice. Organs suspected to have been obtained through commercial transaction must not be accepted for transplantation. In addition, the advertisement of organs in exchange for money should be prohibited. However, reasonable reimbursement of expenses such as those incurred in procurement, transport, processing, preservation, and implantation is permissible.
Physicians who are asked to transplant an organ that has been obtained through a commercial transaction should refuse to do so and should explain to the patient why such a medical act would be unethical: because the person who provided the organ risked his or her future health for financial rather than altruistic motives, and because such transactions are contrary to the principle of justice in the allocation of organs for transplantation.

I. EXPERIMENTAL AND NEWLY DEVELOPING TRANSPLANTATION PROCEDURES

The WMA considers that, although many transplantation procedures have become standard medical care for a range of medical conditions, others are experimental and/or morally controversial and require further research, safeguards, guidelines, and public debate.
Experimental procedures require protocols, including ethics review, that are different and more rigorous than those for standard medical procedures.
Xenotransplantation raises special issues, particularly in light of the risk of unwitting cross-species transmission of viruses and other pathogens. There is an urgent need for extensive public debate about xenotransplantation to ensure that developments in this field are consistent with societal values. International guidelines to govern these practices should be developed.
Transplantation of organs developed using cell nuclear replacement technologies requires scientific review, public debate and appropriate guidelines before becoming accepted.