1. ETHICAL CONSIDERATIONS IN CONTEMPORARY CLINICAL PRACTICE – THE WMA PERSPECTIVE Prof. John R. Williams, Ph.D. Director of Ethics World Medical Association

2. OUTLINE OF PRESENTATION
Introduction to the World Medical Association
The WMA and Medical Ethics
Confidentiality
Human Rights
Clinical Research
Commercial Enterprises
Conclusion

3. 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.

4. 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

5. 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.

6. WMA’S ACTIVITIES Policy development and review Advocacy 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
Documentary history. Also many national documents, e.g., U.S. President’s Commission (Belmont Report).

7. WMA’S ACTIVITIES Projects Clearinghouse of Information
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)
Particular attention to research in developing countries (cf. DoH 2000).

8. WMA’S ACTIVITIES Networking
– face-to-face at the twice-annual meetings of representatives of NMAs
– virtually through the website ( and
Publications
World Medical Journal

9. 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 (
Develops new ethics products (e.g., the medical ethics manual)
Criteria for publication, also applicable to undertaking research projects. New doesn’t exclude replicating studies until they are confirmed. Important vs. trivial.

10. 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

11. WMA MEDICAL ETHICS MANUAL
Published January 2005
For medical students and practising physicians
Available on WMA website:
Chinese translation planned

12. 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.

13. 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)

14. MEDICAL ETHICS Clinical ethics Professional ethics Research ethics
Public policy ethics

15. 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.”

16. 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

17. 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.

18. 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.

19. 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.

20. 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

21. 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 (
Physicians for Human Rights (
International Rehabilitation Council for Torture Victims (

22. PHYSICIANS AND CLINICAL RESEARCH
Physician roles:
Investigator
Sponsor/funder employee
Ethics committee member
Government official
Treating physician

23. 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.”

24. PHYSICIANS AND CLINICAL RESEARCH
Before agreeing to participate in a clinical trial, a physician should:
Ensure that the trial protocol has been approved by an reputable, independent ethics review committee.
Review the protocol to determine whether it is appropriate for the physician’s patient population.
Ensure that participation will not involve a conflict of roles or of interests.

25. PHYSICIANS AND CLINICAL RESEARCH
Before asking a patient to participate in a clinical trial, a physician should:
Ensure that the patient fulfils all the criteria for enrolment in the study;
Be assured that the patient will not be harmed by giving up the current treatment in favour of the experimental treatment or a placebo.

26. PHYSICIANS AND CLINICAL RESEARCH
When asking a patient to participate in a clinical trial, a physician should:
Explain clearly the purpose and nature of the trial, the risks and benefits of participation, and the alternatives to participation;
Invite the patient to ask for clarification or further information about participation.
Ensure that the patient’s decision whether or not to participate is informed and voluntary.

27. PHYSICIANS AND CLINICAL RESEARCH
After enrolling a patient in a clinical trial, a physician should:
Monitor the patient carefully to ensure that no harm is occurring as a result of the trial regime;
Record and report patient data accurately;
Communicate to the patient the results of the trial when they become available.

28. 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.”

29. 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

30. 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

31. 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.

32. 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.

33. 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.

34. Thank You !!

35. Contact Information
John R. Williams, Ph.D.
Director of Ethics
World Medical Association
Website: