Ethics
Committees
Caterina Moniz Vaz
(Bio)ethic Comittee
Possible definitions:
• an interdisciplinary group of people, constituted by health professionals and other
professionals, as well as representatives of the community, with the goal to help
reflecting moral dilemmas arised by the patients, to provide consulting, teach,
research and suggest institutional rules in ethical matters (Tealdi and Mainetti)
• multidisciplinary group of health professionals in a health institution with the
function of managing ethical dilemmas that take place inside the institution
(Cranford and Dundera)
• multidisciplinary group that meets to improve the ethical quality of the medical
decisions and to assess the morality of everything that relates to a possible
intervention on human life (Maria Júlia Bertomeu)
The three possible conventional blocks/kinds
of Ethics Committee:
• Research E. C.- which aim to watch over the quality of the investigation on human
subjects and their protection, (also known as Institutional Review Boards in the USA);
legislation: Nuremberg Code, Declaration of Helsinki, (National Research Act, USA,
“Good Clinical Practice”).
• Hospital E. C.- which seek to solve the ethic conflicts in hospital assistance and
elaborate care protocols.
• National E. C.- permanent or not, some are worldwide references with important
publications: The President’s Commission for the Study of Ethical Problems in Medicine,
Biomedical and Behavioral Research, USA 1980-1983; Comité Consultatif National
d’Étique pour les Sciences de la Vie et de la Santé, Fr. 1983; Law Reform Commission of
Canada, 1971; Council of Europe’s several committees report.
In the European Union
An Ethics Committee as a committee dedicated to the rights and well-being of research
subjects, (also known as an I. R. B.), may also refer to the E.C. for all research conducted in
the E.U.
• The E.C., according to the Directive 2001/20/EC (4th April), is an independent body in a
member state of the E.U., consisting of healthcare professionals and non-medical
members, whose responsibility it is to protect the rights, safety and well-being of
human subjects involved in a clinical trial and to provide public assurance of that
protection by expressing an opinion on the clinical trial protocol, the suitability of the
investigators involved in the trial, and the adequacy of facilities, and on the methods
and documents to be used to inform trial subjects and abstain their informed consent.
• With the clinical trials directive, the E.U. envisioned a harmonization of Research E.C.
across Europe, including the time taken to assesse a trial proposal and the kinds of
issue a committee should take into account.
Hospital E.C.’s “Story”
Its origin is better perceived looking at USA since the 1960’s:
• 1962- Seattle, the excess of chronic renal patients and the lack of equipment to do the
dialysis made that committees where established to set the criteria of the use of the
equipment.
• 1968- Senator Walter Mondale proposed to the American Congress the creation of a
Health Science and Society Committee. And an article about brain death criteria, from
the Ad Hoc Committee, Harvard Medical School, is published which leads to the
formation of E. C.’s on the hospitals to decide about when is the patient clinically dead
to consider whether to unplug or not the life supporting machines.
• 1971- forms an E.C. at the Hennepin County Medical Center, Minneapolis, named
“Thanatology Committee”, to decide about ethical, medical and legal problems
concerning terminal patients.
• 1973- the first suggestion to create E. C. in the hospitals was made by Dr. Karen Teel, a
pediatrician, that had a major influence on the case of Karen Ann Quinlan.
Hospital E.C.’s “Story”
• 1976- Massachusetts General Hospital created a subcommittee from the Clinical Care
Committee with the goal to review 15 cases of patients with cancer without apparent
possibility of healing. They published the results with great impact on the medical field.
• 1983- the President’s Commission for the Study of Ethical Problems in Medicine and
Biomedical and Behavioral Research publishes “Deciding to Forego, Life-Sustaining
Treatment” encouraging the creation of Hospitals E.C.
• 1984- because of the Baby Doe case (1982) the U.S. Government formally
recommended the creation of pediatric care review committees.
• 1987- a law in the state of Maryland requires the creation of advisory committees on
the hospitals with the goal to assess the decision making process in life-threatening
diseases.
• 1994- the American Hospitals Association proposed that each hospital created an E.C.
National Ethics Committees
Australia
Austria
Belgium
Canada
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
India
Ireland
Israel
Italy
Japan
Korea
Lithuania
Luxembourg
Malta
Mexico
New Zealand
Norway
Nordic Countries
Poland
Portugal
Romania
Russia
Singapore
Slovenia
Spain
Sweden
Switzerland
Taiwan
The Nederlands
United Kingdom
United States of
America
Council of Europe
Committee on Bioethics
• On the January 1st 2012, following the reorganization of
intergovernmental bodies at the Council of Europe, the
Committee on Bioethics has taken over the responsibilities of
the Steering Committee on Bioethics (CDBI), for the tasks
assigned by the Conventions on Human Rights and
Biomedicine as well as for the intergovernmental works on
the protection of human rights in the field of biomedicine.
World Health Organization
Ethics is concerned with moral principles, values and standards of conduct.
The fields of health and healthcare raises numerous ethical concerns, related
to, e.g., health care delivery, professional integrity, data handling, use of
human subjects in research, and the application of new techniques such as
gene manipulation.
The WHO launched in 2002 its Ethics and Health Iniciative.
World Health Organization
• The Ethics and Health Team started developing a database: ONEC database
(Opinion submitted by the several National E.C.)
• Partnerships: Ethics and Health collaborates with many organizations and
institutions, from governmental and intergovernmental to academic and professional
and provides the permanent secretariat for the Global Summit of National Bioethics
Advisory Bodies.
U.N. Organizations: – U.N. Inter-Agency Committee on Bioethics; UNESCO;
F.A.O.; ILO; O.H.C.H.R; W.I.P.O
International Initiatives –S.I.D.C.E.R.; G.F.B.R.
Regional Organizations: Council of Europe (Bioethics); E.G.E.S.N.T; European
Commission.
UNESCO
International Bioethics Committee (IBC):
• created in 1993;
• body of 36 experts;
• follows progress in the life sciences and its applications in order to ensure respect for
human dignity and freedom;
• Tasks: promote reflection on ethical and legal issues; encourage exchange of ideas/info,
and action of awareness; co-operate with international organizations and with national
and regional bioethical committees; dissemination of principles of UNESCO;
•
gathers at least once a year, produces advice and recommendations adopted by
consensus (then transmitted to the Members States);
UNESCO
Intergovernmental Bioethics Committee (IGBC):
• created in 1998, under artº 11, statutes of IBC;
• 36 Member States;
• Meets at least every 2 years to examine the advice and recommendation of the IBC;
• State Members: Portugal, Brazil, Canada, (among others).
UNESCO
Assisting Bioethics Committees (ABC):
• The Universal Declaration on Bioethics and Human Rights advocates establishment of
independent, multidisciplinary and pluralist E.C., national, regional and locally, or
institutionally;
• Believes E.C: will be important intermediaries for the implementation of the normative
instruments adopted by Member States;
• The ABC-project is a program to support the establishment and operations of E.C. (with
special focus on National E.C.).
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
Context:
• Because the national decision-makers need to be advised by studies and opinions that
are exempt and qualified about the ethical procedures aspects, positions statements or
legislative projects, the creation of National E. C. has become somewhat general.
• In Portugal the need was felt in 1986 due to a legislative project about assisted
reproduction.
• And because of the complexity and the novelty of the issues, in 1987 a legislative
project for a National Board was submitted.
• Therefore the Law nr. 14/90, 9th June created the CNECV, which was then altered by the
Law nr. 24/2009, 29th May. (CNECV was of the Cabinet Councils sphere and now it’s the
Parlaments)
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
• It has already produced 57 Opinions (“Pareceres”), organized 10 Public Seminars, and,
now on a regular basis, also the “Luso-Brazilien Bioethics Encounter”.
• All the documents it has produced were published and/or compilated.
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
Characterization:
• Nature: CNECV is an independent advisory body of national scope (artº 267/3, CPR).
• Its Mission: to analyse the ethical issues raised by the scientifical progress of biology,
medicine or health in general, and sciences of life.
It aims to be a permanent forum of study and transdisciplinary discussion about ethical
challenges, (art. 2º).
• Powers/duties: (art. 3º) to follow systematically the evolution of the ethical issues
raised by the scientific progress of the domains referred, (a) to g) ):
-to provide opinions about those issues, by its own or when solicited (e.g..: the
President of the Republic, Republic Assembly, Government, certain Institutions);
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
-to provide an annual report, to the R. Assembly, about the state of the application of
new technologies to human life, it’s implications, and give advice about it, if so;
-to promote training and awareness to the generic public, namely through
conferences, and public presentations of the ethical issues;
-to assure the national representation in international meetings of its own kind
institutions;
-to publicize its activities, opinions and publication, for which it as its own editorial
capacity;
-to elaborate a report about its activity at the end of each civil year, (then sent to the
sovereign bodies).
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
Composition: 19 members, all with recognized merit, from the domains of human/social science,
medicine biology or life sciences, (art. 4º) ;
Their designation is made by 10 different entities:
• 6 people that ensure special qualification on sciences of life- R. Assembly;
• 8 people that ensure special qualification on bioethics- Medical/Nurse/Biologist/Bar Association,
Academy of Sciences, Council of Deans, and the Coroner of the National Forensic Institute;
• 3 people with recognized merit qualification on the fields of biology, medicine, health, ang 2
people with recognized merit on the fields of the law, sociology/philosophy- Cabinet Council.
• Each term elects its President and Vice-president;
• Among its members a Coordinating Committee is elected: 2 persons of each electable group,
meant to do administrative and financial management, and other tasks that the CNECV delegates,
(art. 5º);
• Also the CNECV can create other internal specialized committees to analyze specific issues.
National Board of Ethics for the Life Sciences
(Comissão Nacional de Ética para as Ciências da
Vida_CNECV)
Dynamic:
• The CNECV meets once a month or more if necessary;
• The voting’s are done with simple majority;
• The CNECV participates in several events, such as of the Council of Europe, Unesco, Nec
Forum;
• The CNECV has its own documentation center to use and provide;
• The CNECV provides itself with financial allocations from the R. Assembly;
• Besides the Law nr. 24/2009, it has its own (internal) rules
• The members have a confidentiality duty about the content of the debates and
deliberations;
• Uses a transdisciplinary methodology.
CNECV actual board
Hospitals E.C.
• E.C. as a multidisciplinary hospital body composed of a broad spectrum of personnel,
physicians, nurses, social workers, priests, (it normally includes a board member of the
institutions, a lay person and an administrator, a clergy and an ethicist), which
addresses the moral and ethical issues within the hospital.
• Most E.C. work in an advisory capacity. They can help patients and families reach
informed decisions and work with health care providers in order to make complex and
difficult decisions.
• The E.C. often reviews hospital policies and procedures for potential problems and may
also reduce the potential for litigation against the institution.
Hospitals E.C.
Portuguese e.g.
Centro Hospitalar do Porto:
Hospital Santo António
Hospital Joaquim Urbano
Maternidade Júlio Dinis
• E.C. as a multidisciplinary body to support the Board of Directors;
• Designed to cover the essential aspects of the ethical problems of a hospital with
charitable activity, university teaching and research;
• Legislation: DL nr. 97/95, 10th May and Law nr. 46/2002, (regarding the
composition, constitution, mandate, direction and competence).
Hospitals E.C.
Portuguese e.g.
Centro Hospitalar de Lisboa Ocidental, EPE:
Hospital de Santa Cruz
Hospital São Francisco Xavier
Hospital de Egas Moniz
Centro Hospitalar de Lisboa Norte, EPE:
Hospital Santa Maria
Hospital Pulido Valente
Centro Hospitalar de Lisboa Central, EPE
Hospital São José
Hospital Santo António dos Capuchos
Hospital Santa Marta
Hospital Dona Estefânia
Hospital Curry Cabral
Maternidade Alfredo da Costa
Hospitals E.C.
Portuguese e.g.
Characterization
• Constituted by the board of directors;
• Works as a supporting but technically independent body;
• Contribute for the compliance of ethical standards protecting the human
dignity and integrity;
• Elaborates opinions about the hospital´s ethical conducts;
• Everyone can “ask” for its opinion, directly or indirectly;
• Legislation: DL 97/95, 10th May, changed by Law 46/2004, 19th August (from
the Directive 2001/20/CE), CIOMS, Declaration of Helsinki.
Thank You for Your attention