Ethics Committees In Science Research Paper

It is generally accepted that the above mentioned Declaration of Helsinki had a most important influence on constitution and function of ethics committees, although it has nowhere reached the degree of a formal law. Nevertheless, it has been introduced in a very different way into the system of regulations of the states. In contrast to this, the declaration is obviously not observed in the USA.

Promoted by the declaration, ethics committees have been established by a broad variety of organizations, for example, university hospitals, general hospitals, medical associations, or pharmaceutical companies. This development very often preceded activities of parliaments or administrations. Introducing legal regulations, parliaments, and administrations, for their part, tried to respect and to overtake, as far as possible, with respect to constitution and internal right, the experience achieved by the already existing committees.

The first legal basis for ethics committees, in most cases, have been the drug laws. These specialized prescriptions have been expanded in an analogous way on all the other kinds of medical research on man, including medicinal products. Consequently, in some countries, the parliament has covered the whole of research on man by laws, decrees, or similar kinds of legitimation.

The protection of persons participating in biomedical research is generally considered being the principal obligation of ethics committees. The term ‘protection’ is understood as a prevention of physical damage as well as the protection of fundamental rights of the person concerned. The main point under this view of protection is to assure that the person participating in a research project gives his or her free, informed consent. This consent has to be given for a special project and has to be documented. Other points of consideration are data-protection and an adequate assurance of persons undergoing the research. In several countries the committees also have the duty to prevent the researcher himself or herself to be too audacious in undertaking a scientific project. Ethics committees have to prove the scientific quality and the ethic acceptance of research projects. There are a lot of points for such an examination, namely, minimization of risk by using methods with known risks whenever possible; acceptable relation between risk and potential direct benefit for the person concerned; and for the improvement of knowledge with the leading idea ‘the lower the expected direct potential benefit, the lower the acceptable risk and burden,’ a careful recruitment of participating persons with respect to the special problems of vulnerable persons. So far persons who are not able to consent, shall be included in the project, the informed consent has to be given by the legal representative in accordance with the national legislation. This representative has to receive all the information that is given to a person able to consent. Other points of examination are documentation of the results; use of collected data following the research protocol with guarantee for the privacy of the person; and protection of all persons (especially vulnerable persons) against force or undue influence on this decision.

In some countries the ethics committees have to prove the quality of the responsible researcher, the adequate equipment of the research institution, the foreseen benefit for the person concerned, as well as for the society and any kind of remuneration for researchers and persons participating in a project. In a number of countries, and this will be one of the most important tasks for the future, ethics committees have to monitor the research and to receive periodical reports of the ongoing project. Upcoming results or serious adverse events my lead an ethics committee to change its former vote.

The committees should intensify the discourse on ethical questions including statements of so-called national ethics committees. The unreflected acceptance of ethical guidelines, promoted by national ethic bodies, is neither wanted nor expected.

In decision-making the ethics committee has to respect national or federal laws regulating drugs, medicinal products, or the system of assurances. If there are special laws regulating medical research, like the ‘Loi Huriet’ in France, the Medical Research Council Act in the Republic of South Africa, or the Federal Common Rule in the USA, these regulations have to be observed as well. Administration, legislation or ‘guidelines for ethics committees’ formulated by a competent body, may oblige ethics committees to fulfil the requirements of The Declaration of Helsinki.

In the Republic of South Africa, the ethics committee of the Medical Research Council instituted by law, is responsible for regulating and the control of research, as far as it is undertaken for, or with support of, the Medical Research Council. This council has the right to publish guidelines for the function of ethics committees. In the case of a conflict between these guidelines and the regulation of a local ethic committee the prescriptions of the Medical Research Council have priority. In New Zealand, the ethics committee, instituted by the Health Research Council, itself founded by law in 1990, has the right to elaborate ethical guidelines for the Research Council itself and to elaborate standards for other ethics committees. The principal task of this ethics committee is the examination and admission of local ethics committees, which have to be accredited in a formal way and must follow the so-called national standard.

Membership and composition of ethics committees vary in such a wide range, that a special consideration is not given with one exception: the composition has to be ‘multi-disciplinary,’ laymen should be included, both sexes have to be represented in an adequate manner.

Ethics committees need some kind of administration and financing. This is done by preference, for the national ethics bodies by Ministers of Social Affairs, of Health, or of Research. Local ethics committees are mostly supported by the instituting organization, for example, university hospitals. In some countries, for example, the Federal Republic of Germany, the states’ laws prescribe that ethics committees have to be instituted by the medical associations and by faculties of medicine.

Generally, ethics committees are responsible for all research undertaken in the institution, by which they have been instituted. There may be some exceptions. In the Republic of South Africa only research projects that are supported by the Medical Research Council, have to be presented to such a committee. In Israel, the Director General of the Minister of Health has the right to reserve examination and approval of special kinds of research to the national ethics committee. In these cases, the decision of this committee is binding for local ethics committees. In some countries, the institution of ethics committees is restricted to states or community hospitals. Private hospitals are independent in their decision to introduce, or not introduce, such bodies.

The duty to seek the decision or the advice of an ethics committee is regulated in a different, but simple and understandable way. There are legal prescriptions, there is the legally based code of deontology, like in the Federal Rebublic of Germany or, in most cases, it is the administration, which requires such a step. In this field, considerations like approval by the responsible administration or financing play a major role. The conclusion is justified that the award of a grant depends on a favorable vote of an ethics committee.

In contrast, it is very difficult to define the legal or binding character of such a vote. Votes are considered as expertise, as anticipating expertise, as advice, as help and orientation, or as an approval. The character of advising is reflected by the official name of the national French ethics committee as ‘Comite consultatif.’ Positive or favorable votes are considered in all countries as a basic condition for undertaking a research project. Also, in the case of a negative vote the researcher, at least theoretically, has the right to decide on the undertaking of his project. This situation is, again in theory, given, for example, in the Federal Republic of Germany. In reality, it is the ethics committee that decides by its vote whether a research project is done or not. During a research project, in some countries ethics committees have the right to intervene. They can, with respect to, for example, serious adverse events, change their decision or, in the worst case, withdraw a positive vote.

There is a growing interest on whether there is some kind of hierarchy of the ethics committee within a country. As already mentioned, some national ethics committees, for example, in Israel, in New Zealand, or in the Republic of South Africa, have the right to prescribe guidelines for local ethics committees, or to accept general points of view for special fields of research to be followed by local ethics committees.

In some countries, higher authorities may intervene or correct the decision of local ethics committees. A researcher who does not agree with the decision of the local ethics committee can call the national ethics committee in Denmark. The national Committee may come to another decision that will be binding. In France, a negative vote has to be presented to the Minister of Health, who has the right to suspend it. The Minister of Health in Spain has independent of the vote of the relevant ethics committee, the possibility to stop a research project or to introduce a change with respect to national laws.

There is only little knowledge on formation or continued education of members of ethics committees or of methods of control of an ethics committee as a decision-making body. As an implemented system there is only the monitoring of IRBs by the ‘Department of Health and Human Services’ or by the ‘Center for Drug Evaluation and Research’ of the Food and Drug Administration in the USA.

Since 1997 the World Medical Association has tried to introduce a fundamental revision of its ‘Declaration of Helsinki.’ The 52 general assembly of the WMA adopted a revised version in October 2000. It is an open question whether this new version will gain the same outstanding importance as the former one. Beside this, there is a growing tendency in many states to introduce legal regulations of all kind of research by so-called ‘research laws.’ Such a law, based on a national legislation or on international conventions, for example, guidelines of the European Union or the ‘Convention on Human Rights and Biomedicine’ of The Council of Europe would bind all researchers, whereas the Declaration of Helsinki and prescriptions linked to it, are only compulsory for medical doctors. Ethics committees may exist in other fields of science other than medicine. Published details of such bodies are not known.

Bibliography:

1. Deutsch E, Taupitz J (eds.) 2000 Freedom and Control of Biomedical Research. Springer, Berlin
2. Le Bris S 1992 National Ethics Bodies. Council of Europe, Strasbourg, Austria
3. World Medical Association 1996 Declaration of Helsinki— Recommendations Guiding Physicians in Biomedical Research involving Human Subjects. Ferney-Voltaire Cedex, France, no. 17