ethics committees

Ethics Committees

Caterina Moniz Vaz

(Bio)ethic ComitteePossible 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 UnionAn 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 CommitteesAustralia Ireland RomaniaAustria Israel RussiaBelgium Italy SingaporeCanada Japan Slovenia

Czech Republic Korea SpainDenmark Lithuania SwedenEstonia Luxembourg SwitzerlandFinland Malta TaiwanFrance Mexico The Nederlands

Germany New Zealand United KingdomGreece Norway United States of

Hungary Nordic Countries AmericaIceland Poland

India Portugal

Council of EuropeCommittee 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.

UNESCOInternational 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);

UNESCOIntergovernmental 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).

UNESCOAssisting 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)



• 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);



-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).



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.



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 AntónioHospital Joaquim UrbanoMaternidade 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 CruzHospital São Francisco XavierHospital de Egas Moniz

Centro Hospitalar de Lisboa Norte, EPE:Hospital Santa Maria Hospital Pulido Valente

Centro Hospitalar de Lisboa Central, EPEHospital São JoséHospital Santo António dos CapuchosHospital Santa MartaHospital Dona EstefâniaHospital Curry CabralMaternidade 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

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