November 2005 - Ethics Committees

In recent years there has been a significant shift in bioethical decision making from the individual to the group. Physicians, hospital administrators and political authorities who used to make important clinical and policy decisions by themselves, perhaps with some advice from trusted associates, are now often expected to consult with committees about proposed courses of action and may even have to obtain the approval of the committee before acting.

In the area of health and health care, there are four major types of committees:

1. Research ethics committees review and approve, or reject, proposed research studies. The first mention of such committees in the Declaration of Helsinki was in the 1975 version. Approval by a research ethics committee is now a standard requirement everywhere for most biomedical research studies involving human subjects. Parallel committees are required in many countries for research involving animals.
   
   
2. Clinical ethics committees, usually based in hospitals, have several roles: to provide advice to health care professionals on dealing with difficult clinical cases; to draft or comment on institutional policies on ethical issues (e.g., withholding and withdrawing of life-sustaining treatments); and to offer educational programs on ethics to the staff of the institution and sometimes to the patient population. There are many such committees in Canada and the U.S.A. but relatively few in other countries.
   
   
3. Ethics committees of health professional associations develop policies on ethical issues for the members of the association and educate the members about these policies and other matters involving ethics. The Medical Ethics Committee of the World Medical Association reviews all proposed new and amended ethics policies before deciding whether to recommend their adoption by the Council and the General Assembly. Many National Medical Associations have similar committees, as do some international medical specialist organizations and some national associations of other health professionals.
   
   
4. National and international ethics committees provide advice for dealing with public policy issues of an ethical nature (e.g. research on embryonic stem cells, the legalization of euthanasia, etc.). The international committees include the UNESCO International Bioethics Committee, the Council of Europe Steering Committee on Bioethics, and the European Group on Ethics in Science and New Technologies.

The following documents provide useful advice for establishing and operating one or more of these types of ethics committees:

UNESCO: Establishing Ethics Committees (2005)

UNESCO: Bioethics Committees at Work: Procedures and Policies (2005)

WHO: Operational guidelines for ethics committees that review biomedical research (2000)

WHO: Surveying and evaluating ethical review practices (2002)

European Commission: Facing the Future Together: Conference on Research Ethics Committees in Europe, Brussels 27-28 January 2005.

A list of national bioethics committees and their contact information can be viewed on the WHO website: http://www.who.int/ethics/committees/en/index.html.

The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) is a network of regional fora for research ethics committees and other interested parties.

September 2005 - Privacy of Personal Health Information

Protecting patient privacy and the confidentiality of personal health information is an ongoing challenge for medical associations and individual physicians. Governments, health care institutions, researchers and commercial enterprises have seemingly insatiable appetites for patient data, and laws and policies designed to protect privacy are often either too lax or not properly enforced. Physicians must consider demands for information about their patients in the light of the Hippocratic Oath requirement that "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." Moreover, the WMA's International Code of Medical Ethics requires that "A physician shall preserve absolute confidentiality on all he knows about his patient even after the patient has died." Although it is difficult, if not impossible, to maintain such absolute patient confidentiality, the intimate nature of the patient-physician relationship does require that confidentiality be protected to the greatest degree possible.

Several medical association have developed programs to inform their members about the need and the ways to maintain confidentiality, including the following:

• American Medical Association, HIPPA Resources
• Australian Medical Association, AMA Privacy Kit
• British Medical Association, Confidentiality as Part of a Bigger Picture
• Canadian Medical Association, A Plain Language Guide for Physicians to the CMA Health Information Privacy Code
  

These materials deal specifically with the privacy protection laws in the respective countries.

The European Union has been a leader in the protection of personal data, including health information, since the adoption of its Data Protection Directive in 1995. The Directive required all European Union states to incorporate its provision in national law. Recently the European Commission funded two research projects to evaluate the application of the Directive and to recommend any needed changes or additional actions:

• The PRIVIREAL (Privacy in Research Ethics and Law) project focussed on the application of the Directive to medical research, especially the role of research review by independent ethics committees in the member states, as regards data protection. The project, which ended in June 2005, resulted in a series of recommendations to the European Commission and five published volumes of background material.
• The EuroSOCAP (European Standards on Confidentiality and Privacy in Healthcare among Vulnerable Patient Populations) project is developing standards and guidelines to inform policy makers and health care professionals about how to protect the privacy and confidentiality of patients, especially those who are most vulnerable. A workshop to discuss the draft standards and guidelines was held in Brussels on 8 September 2005 and a final document is expected by the end of 2005.