ETHICAL CONSIDERATIONS IN CONTEMPORARY CLINICAL PRACTICE – THE WMA PERSPECTIVE Prof. John R. Williams, Ph.D. Director of Ethics World Medical Association
Jan 09, 2016
ETHICAL CONSIDERATIONS IN CONTEMPORARY
CLINICAL PRACTICE – THE WMA PERSPECTIVE
Prof. John R. Williams, Ph.D.Director of Ethics
World Medical Association
OUTLINE OF PRESENTATION
• Introduction to the World Medical Association
• The WMA and Medical Ethics• Confidentiality• Human Rights• Clinical Research• Commercial Enterprises• Conclusion
WMA’S MISSION
The purpose of the WMA is to serve
humanity by endeavoring to achieve the
highest possible standards of medical
care, ethics, science, education, and
health-related human rights for all
people.
The World Medical Association
• Established after WW2, mainly in reaction to atrocities involving physicians
• Global representative body for physicians
• 84 National Medical Associations, approximately 7 million physicians
WMA’S UNIQUENESS
The WMA is the only international organization that speaks on behalf of all the world’s physicians, regardless of location, specialty or practice setting.
WMA’S ACTIVITIES
•Policy development and review• Medical ethics• Human rights• Health issues• Medical education
•Advocacy• WHO on tobacco control and other issues
affecting physicians and/or public health• Observer status for Taiwan at WHO
WMA’S ACTIVITIES
• Projects– Implementation of Istanbul Protocol on the
Effective Investigation and Documentation of Torture and other Cruel or Inhuman Treatment or Punishment
– Medical Ethics Manual– MDR TB Training Course
• Clearinghouse of Information– Medical ethics– Public health (liaison between WHO and national
medical associations)
WMA’S ACTIVITIES
• Networking
– face-to-face at the twice-annual meetings of representatives of
NMAs
– virtually through the website (www.wma.net) and email
• Publications– World Medical Journal
WMA ETHICS UNIT
• Coordinates policy development and review• Liaises with other international ethics
groups (e.g., WHO, UNESCO)• Facilitates exchange of information at
conferences and via the WMA website (www.wma.net/e/ethicsunit/index.htm)
• Develops new ethics products (e.g., the medical ethics manual)
POLICY DEVELOPMENT AND REVIEW
• Approx. 60 current policy statements and resolutions on ethical issues
• Review of oldest policies underway – Telemedicine– HIV/AIDS– Terminal Illness– Medical Education
• Ethical policies require 75% majority vote at the Assembly for adoption or amendment
WMA MEDICAL ETHICS MANUAL
• Published January 2005
• For medical students and practising physicians
• Available on WMA website: www.wma.net
• Chinese translation planned
ETHICS - MEDICAL ETHICS
• Ethics identifies values and principles for decision-making and behaviour and resolves conflicts over ethical issues.
• An ethical issue: a situation where it is not clear what is the right thing to do.
• Medical ethics deals with issues that involve physicians.
THE WMA AND MEDICAL ETHICS
• Long history of medical ethics
• Current ethical expertise and experience
• Includes human rights and medical professionalism
• Widespread consultation
• Search for consensus (75% approval)
MEDICAL ETHICS
• Clinical ethics
• Professional ethics
• Research ethics
• Public policy ethics
CONFIDENTIALITY
• Hippocrates – “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself holding such things shameful to be spoken about.”
• WMA Declaration of Geneva – “I will respect the secrets that are confided in me, even after the patient has died.”
CHALLENGES TO CONFIDENTIALITY
• Complexity of medical care
• Infomatics/computerization
• Databases for administrative, planning, research or commercial purposes
• Permissive or no legislation/regulation
• Failure to implement data protection policies
PROTECTING CONFIDENTIALITY
WMA Declaration on Ethical Considerations Regarding Health Databases:
• Patient ‘owns’ personal health information.
• Patient discloses personal health information for therapeutic purposes.
• Other uses generally require patient’s consent.
PROTECTING CONFIDENTIALITY
• Person who receives personal health information (usually the treating physician) has primary responsibility for protecting confidentiality.
• Physicians can release information to third parties for legitimate reasons.
• Patient information should be anonymised wherever possible.
HUMAN RIGHTS• The foundation of international medical ethics
• Principal human rights for health:
Right to life
Right to freedom from discrimination, torture, and cruel, inhuman or degrading treatment
Right to freedom of opinion and expression
Right to equal access to public services in one’s own country
Right to medical care.
PHYSICIANS AND HUMAN RIGHTS
• Often the first to encounter victims of human rights abuses
• Responsibility to patient can conflict with demands of prison officials, police or military
PHYSICIANS AND HUMAN RIGHTS
• Medical ethics (e.g., WMA Declaration of Tokyo) clearly states that physicians should not participate in torture or other cruel, inhuman or degrading treatment.
• Resources: On-line course for prison physicians
(http://www.wma.net/e/webcourse_2004.htm) Physicians for Human Rights (http://www.phrusa.org/) International Rehabilitation Council for Torture Victims
(http://www.irct.org/usr/irct/home.nsf)
PHYSICIANS AND CLINICAL RESEARCH
• Physician roles: Investigator Sponsor/funder employee Ethics committee member Government official Treating physician
PHYSICIANS AND CLINICAL RESEARCH
WMA Declaration of Helsinki:
“It is the duty of the physician to protect the life, health, privacy, and dignity of the human subject.”
PHYSICIANS AND CLINICAL RESEARCH
Before agreeing to participate in a clinical trial, a physician should:
1. Ensure that the trial protocol has been approved by an reputable, independent ethics review committee.
2. Review the protocol to determine whether it is appropriate for the physician’s patient population.
3. Ensure that participation will not involve a conflict of roles or of interests.
PHYSICIANS AND CLINICAL RESEARCH
Before asking a patient to participate in a clinical trial, a physician should:
1. Ensure that the patient fulfils all the criteria for enrolment in the study;
2. Be assured that the patient will not be harmed by giving up the current treatment in favour of the experimental treatment or a placebo.
PHYSICIANS AND CLINICAL RESEARCH
When asking a patient to participate in a clinical trial, a physician should:
1. Explain clearly the purpose and nature of the trial, the risks and benefits of participation, and the alternatives to participation;
2. Invite the patient to ask for clarification or further information about participation.
3. Ensure that the patient’s decision whether or not to participate is informed and voluntary.
PHYSICIANS AND CLINICAL RESEARCH
After enrolling a patient in a clinical trial, a physician should:
1. Monitor the patient carefully to ensure that no harm is occurring as a result of the trial regime;
2. Record and report patient data accurately;3. Communicate to the patient the results of
the trial when they become available.
PHYSICIANS AND CLINICAL RESEARCH
An additional role?
Declaration of Helsinki, para. 30:“At the conclusion of the study, every patient
entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.”
PHYSICIANS AND COMMERCIAL ENTERPRISES• Professional, research, public policy and clinical
ethics• Industry needs physicians to develop and to
prescribe their products• Patients trust physicians to give them optimal
treatment (sometimes no medication or surgery)• Governments and health insurers rely on
physicians to keep costs as low as possible
PHYSICIANS AND COMMERCIAL ENTERPRISES• Many potential conflict-of-interest situations• WMA and some national medical associations
have guidelines for physicians (WMA Statement Concerning the Relationship of Physicians and Commercial Enterprises)
• Basic ethical principle: the physician must give priority to the patient in any conflict of interests
PHYSICIANS AND COMMERCIAL ENTERPRISES
• Maintain professional and clinical independence: do not rely on industry representatives or
advertisements for product information; be cautious about accepting gifts from
commercial enterprises, including sponsorship to attend conferences;
do not participate in industry-sponsored research unless you are assured that your patients will be protected.
CONCLUSION
• The WMA’s experience is that there are many common ethical issues facing physicians all over the world.
• In particular, both individual patients and society in general are increasingly questioning physician behaviour and decision-making.
• Although the issues are similar, the solutions often vary because of national and cultural differences. However, the globalization of medicine will likely reduce these differences.
CONCLUSION
• General ethical guidance on these issues is available from the WMA and more specific guidance from national medical associations.
• But it is the responsibility of each physician to learn and to practise the ethical standards of the medical profession, for their own good, that of their patients, of the profession and of society.
Thank You !!
Contact Information
John R. Williams, Ph.D.
Director of Ethics
World Medical Association
Website: www.wma.net