Institutional review board

Ethics committees are mainly due to the revised Declaration of Helsinki of the World Medical Association in 1975. Overarching objective is the evaluation of research projects to be carried out on living things, from an ethical, legal and social point of view as well as the protection of the individual from the consequences of ( clinical ) research on beings.

Members are usually physicians, scientists, jurists and theologians. In 2006 was made up the Central Ethics Commission at the Federal Medical Council of 12 doctors and scientists as well as six members of other faculties. Create the ethics committees a written vote for or against the proposed research project. This procedure is in Germany (which must be performed for the authorization of medicinal products ), for example, for each clinical trial required by law ( see below).

• 8.1 Germany
• 8.2 Switzerland

Medical ethics committees

Legal framework

A) Statutory basis of ethics committees in Germany, the § 40 para 1 German Drug Law (AMG) and § 20 para 1 German Medical Devices Act (MPG). The Stem Cell Act ( StZG ) provides for the import of embryonic stem cells is also an examination and evaluation by a specially formed for Ethics Commission ( § 8, § 9 StZG ). The actual formation of the committees is governed by the respective laws of the state, as well as their method. They are mostly occupied mostly with physicians, added theologians, jurists and scholars. Some ethics committees also registered students or members of the health professions as members.

B ) are able legally to establish ethics committees according to § 15 of the Professional Code patterns for physicians at the regional medical associations and medical schools and universities. The state laws leave the single control typically the medical associations and universities by statute law. So it is Saxon for example, in accordance with § 17 Section 1 No. 15 Healers Chamber Act objective of the Medical Council ... to govern themselves in a professional code of the advice to members ... before the research with vital human gametes and embryos in professional ethics and professional ethics. The professional code of the Saxon State Chamber of Physicians committed then in § 15 the doctors to turn in front of relevant research projects to the relevant ethics committee.

C) Outside research, so in the medical treatment, the involvement of ethics committees in the field of genetic engineering on humans is not law, but only law regulating the profession, for example, by means of directives of the German Medical Association (see "Guidelines for gene transfer into human somatic cells " ) and by the professional codes of state Chambers of Physicians regulated. They undertake the doctor to seek advice before applying certain methods of treatment by the respective ethics committee.

Must take d) position by experts specially formed ethics committees after the Transplantation Law ( TPG § 8 ), if an organ is taking survivors.

There are those who think that ethics committees are contrary to the freedom of research, since the decision on ethical issues against the ban state " Wissenschaftsrichtertums " would run. The is argued, however, that ethics committees are within science, one an ethics commission is a less drastic remedy than a prohibition or control of research by an authority and they would only perceive a legal discretion, which exists, for example, when testing decisions.

Decisions

Whether the votes or recommendations of the ethics committees Verwaltungsaktqualität have (this is important for the question whether against decisions of an Ethics Committee of the administrative procedural law is given ) is in the affirmative, as far as a vote in favor of an ethics committee in accordance with § 40 Section 1 Sentence 2 AMG to results in a clinical trial at the Federal Institute for Drugs and Medical Devices ( BfArM) display, but not only is subject to approval. An ethics approval has to be modest ( negative vote ) to the Declaration of Helsinki approval ( positive vote ) or a non- consent. An ethics approval can not be open-ended, as it is the prerequisite for further decisions ( funding support, student insurance, student registration, publication ) clearly binary (agreement: yes / no ) is drawn up. As a prerequisite for further decisions an ethics approval has indirectly - in fact external effect. A negative ethics approval is an indirectly - factual violation of the fundamental right to freedom of research (Art. 5 § 3 of the Basic Law ), as a prerequisite for a positive ethics vote a negative ethics approval for non-fulfillment of a condition and thus to reject the above Decisions leads. Without positive ethics approval for example, funding for the financing of research can not be raised. Without positive ethics approval as research results can not be published and thus not recognized. The jurisprudence of the Federal Administrative Court acknowledged that from a plain - sovereign state action outgoing mere actual and indirect concern a fundamental right carrier means an interference with fundamental rights and such indirectly - constructive impairment of fundamental rights can be averted if it is very serious. A non- fulfillment of a requirement is a blockade. A blockade of freedom of research is more than just a nuisance and thus per se severe, so that a negative ethics approval outside AMG and MPG is vulnerable - and on an application to correct performance (power suit ) according to § 42 paragraph 2 Code of Administrative Procedure. This quality assurance on the constitutional guarantee of freedom of research is reached, as well as international research standards of Good Clinical Practice calls. The internationally standardized research Regulation Good Clinical Practice calls for quality assurance that a negative ethics approval to the courts is to call in order to take action against it can. Legal and scientific standard are thus congruent and after the equal treatment principle invariant with respect to location (national / international ) and research direction ( AMG, MPG, Radiation Protection Ordinance / RöV etc.).

Efficiency

It is said that to ensure the ethics committees of their task, the protection of the ( individual ) people in the research, overall responsibilities, with due with EU regulations, their influence is suppressed. But they also serve to protect the researcher from themselves, before blind ambition and self-indulgence. Skepticism in terms of performance, however, is appropriate where art and science of controlling them are required. Because there are far more legal and ethical aspects that characterize their work. Controversial research and medicine, especially their societal impact could be so easily covered with a cover of " ethically sound ". Under no circumstances it can be assumed that socially controversial research could be supplied by ethics committees a consensus. In science, it is required that the term is "independence" concretized and elaborated; the voluntariness of the Commission's work also brings disadvantages.

Ethics committees for animal experiments

In order to safeguard animal welfare in animal studies, there are ethics committees to consider when deciding on the approval of animal experiments support the licensing authorities (Animal Protection Act, see § 15 Section 1 of the Animal Welfare Act ). These commissions are to occupy one third proposal lists of animal welfare organizations, two-thirds with expert veterinarians, physicians and scientists.

Ethics committees of Psychology

In the field of psychology ethical guidelines thematize both occupational psychological activity as well as ethical principles of psychological research. The long term goal is an ethical evaluation of all psychological research on humans by appropriate ethics committees, the necessary structures are, however, many places yet established. The ethical assessment is primarily a trade-off between gaining knowledge and values ​​encroachment on the freedom / personal responsibility and possible negative consequences for health or well-being.

Europe: For the field of psychology, there are ethical guidelines of the EFPA for European psychologists associations that are implemented in national ethics guidelines.

In Germany, the national ethics committee at the German subsidiary is based on psychology that developed "Ethical Guidelines of the German Society for Psychology and the Professional Association of German Psychologists " and related to the research guidelines and monitors compliance. Also, guidelines for local ethics committees of psychology were developed.

In Switzerland, developed the National Ethics Committee of the Swiss Society of Psychology ethical guidelines and checklists for the ethical assessment of psychological research projects and supports the establishment of appropriate ethical committees at Swiss universities. The Federation of Swiss Psychologists is responsible with a professional ethics committee ( BEK ) for occupational ethics.

In Austria, a code of ethics for clinical psychologists and clinical psychologists as well as for health psychologists and health psychologists as a guideline of the Ministry of Health, upon advice of the psychologist Advisory Board exists.

Other ethics committees

As far as research outside the medical sector or the above -mentioned application areas takes place (for example, genetically engineered crops ), the involvement of ethics committees is neither law nor civil law necessary. Nevertheless, companies have partly purely advisory ethics committees set up and have to a renewed self- control research, but also involve primarily are intended for external representation. There are also private, not public law organized, ethics committees, offer their services. Purely advisory activity also has the Central Ethics Commission at the German Medical Association.

Outside the area of ​​research, the establishment of ethics committees in the context of administrative ethics is discussed recently.

The Ethics Committee for secure energy supply was used during the Fukushima nuclear disaster to advise you within three months of the risks and " social " Reviews of nuclear energy and other energy forms.

Criticism of the composition of ethics committees

Humanist organizations and representatives of atheism criticize have long known that very often representatives of Catholics and Protestants occur in state ethics committees, non-Christians, but not to the same extent, although non-denominational now represent nearly 40 % of the population. Because of theological arguments therefore ethical decisions would be made that differ from decisions based on the values ​​of the Enlightenment. To the separation of state and religion to express, is therefore requested that state ethics committees dispense entirely with representatives of religions and are only staffed by scientists. Religion would remain a private matter and so the believer can about the example on the basis of his religion on one Präimplationsdiagnostik voluntarily refrain.