Ethics committee

Ethics committees are commissions set up by universities, professional associations or countries to advise, control and supervise scientists on ethical and legal issues, and to plan research on living and deceased people, including clinical studies . Especially in medicine , but also in psychology and other disciplines, examinations and approvals of such research projects are increasingly becoming standard. In this way, they are intended to protect the rights and safety of the subjects in accordance with the Declaration of Helsinki . Some commissions also assess animal experiments .

Legal basis and situation in Germany

For clinical trials of medicinal products (Sections 40, 42 AMG) and medical devices (Sections 20, 22 MPG), the relevant licensing authorities are registered ethics committees formed under state law. Your consent is also required for experiments with ionizing radiation (§§ 31 Paragraph 4 No. 5, 36 and §§ 33 Paragraph 3 No. 2, 36 Radiation Protection Act ).

Doctors and other organized professions (psychotherapists, dentists, pharmacists) are obliged by the professional regulations applicable in their chamber district to seek advice from the relevant commission formed according to state law. The sample standard for professional codes of state medical boards is § 15 MBO of the German Medical Association . Internal university regulations usually also stipulate this for researchers who are not covered by a statutory or sub-statutory obligation to provide advice (e.g. professional code).

The composition is regulated in state law (e.g. § 10 Chamber Act for the Health Professions (HKG)), in the special laws (AMG, MPG) and additionally in the statutes and rules of procedure. Members are usually medical professionals, scientists, lawyers, philosophers or theologians, as well as lay people. However, this varies greatly in the individual commissions. The Central Ethics Commission at the German Medical Association (as of 2016) consists of eight doctors and natural scientists as well as eight members from other faculties.

The ethics committees provide advice on professional ethics and professional law and issue a written vote.

In Germany, the legal basis for ethics committees is Section 40 (1) of the Medicines Act (AMG) and Section 20 (1) of the Medical Devices Act (MPG). The Stem Cell Act (StZG) also provides for the import of embryonic stem cells to be checked and assessed by a specially formed ethics committee ( § 8 , § 9 StZG). The specific formation of the commissions is based on the respective law of the federal state, as is their procedure. They are mostly made up of doctors, plus theologians, lawyers and humanities scholars. Some ethics committees also list students or health care professionals as members.

In terms of professional ethics, ethics committees are to be set up in accordance with § 15 of the model professional regulations for doctors at the state medical associations and the medical faculties or universities. The state laws typically leave the individual regulation to the medical associations and universities through statute law . So it is Saxon for example according to § 17 para. 1 no. 15 Healers Chamber Act objective of the Medical Association , in a professional code of advising the members ... before the research with vital human gametes and embryos ... to settle in professional ethics and professional ethics. The professional code of conduct of the Saxon State Medical Association then obliges doctors in Section 15 to contact the responsible ethics committee before undertaking research.

Outside of research, i.e. in medical treatment, the involvement of ethics committees in the area of genetic engineering in humans is not legal, but only professional, for example through the guidelines of the German Medical Association (see "Guidelines on gene transfer in human body cells") and the professional regulations of the State medical associations regulated. They oblige the doctor to seek advice from the respective ethics committee before using certain treatment methods.

Specially formed ethics committees must also provide expert opinions in accordance with the Transplantation Act ( Section 8 TPG) if an organ donation takes place among living people.

As far as binding decisions or administrative acts are concerned, administrative legal recourse is possible against statements of the ethics committees . For example, the supervisory authority can be called on; declaratory or avoidance actions are also possible. However, these means are only effective in the event of significant legal and procedural errors or in the case of gross material errors and arbitrariness, as the commissions are granted a large amount of freedom to make decisions.

In 1983 the "Working Group of Medical Ethics Commissions in the Federal Republic of Germany eV" was founded. It currently has 53 ethics committees formed under state law as members. The working group harmonises the activities of the ethics committees, especially in decision-making and procedural issues. It offers training on the work of ethics committees and promotes the exchange of opinions and experiences nationally and internationally. He takes a position on issues of ethics committees in public discourse.

Ethics committees for animal experiments

To safeguard animal welfare in animal experiments, there are ethics committees that support the licensing authorities in deciding whether to authorize animal experiments ( Animal Welfare Act , see Section 15 (1) TierSchG). One third of these commissions are made up of lists of proposals from animal welfare organizations and two thirds are made up of expert veterinarians, doctors and scientists.

Other ethics committees

Insofar as research takes place outside the medical field or the areas of application outlined above (e.g. green genetic engineering ), the involvement of ethics committees is neither required by law nor by professional ethics. Nonetheless, some companies have set up ethics committees that are purely advisory, on the one hand renewed self-regulation of research, but on the other hand are also primarily intended to serve the public image. There are also private ethics committees that are not organized under public law and that offer their services. The Central Ethics Committee at the German Medical Association also has a purely advisory role .

Outside the area of research, the establishment of ethics committees has recently also been discussed in the context of administrative ethics .

The Ethics Committee for Secure Energy Supply was set up during the Fukushima nuclear disaster to discuss risks and “social” assessments of nuclear energy and other forms of energy within three months.

The 'Ethics Commission for Automated and Networked Driving' was set up by the BMVI in 2017 and consists of 14 experts from the judiciary, industry and the church. In June of that year it presented a report and a recommendation of 20 'ethical rules', which should serve as the basis for decisions on the control systems of autonomous vehicles .

Criticism of the composition of ethics committees

Humanist associations and representatives of atheism have long criticized the fact that representatives of Catholics and Protestants very often appear in state ethics committees, but non-Christians not to the same extent, although non-denominational people now make up 1/3 of the population. In Switzerland, too, there was a comparable criticism of the National Ethics Commission in the field of human medicine (NEK), where allegations were made regarding the occupation by denominational ethicists, particularly in connection with the National Fund project "End of Life NRP 67".

Based on theological arguments, ethical decisions would be made that differ from decisions based on the values of the Enlightenment. In order to give expression to the separation of state and religion , there is a demand that state ethics committees dispense entirely with representatives of religions and only be staffed with scientists. Religion would thus remain a private matter and the believer could voluntarily dispense with pre-implantation diagnostics based on his religion, for example.

Ethics committees for psychology

In the field of psychology , ethical guidelines address both professional psychological activity and ethical principles for psychological research. The long-term goal is an ethical assessment of all psychological research projects on humans by appropriate ethics committees, the necessary structures have been established in many places. They can be set up specifically for psychology or centrally at the university. The ethical assessment is above all a weighing of values between gaining knowledge and encroaching on freedom / personal responsibility or possible negative consequences for health or well-being. The ethical evaluation of research includes three aspects:

Ethical responsibility of science in society (contribution to the progress of knowledge and social benefit)
Ethical treatment of participants in empirical studies (checking the implementation of ethical guidelines in such studies and checking for safety as the main subject of the ethics committee's work)
Ethical production, publication and exploitation of research results (no overinterpretation, manipulation, invention or theft)

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

In Germany , the national ethics committee is part of the German Society for Psychology , which draws up the "Ethical Guidelines of the German Society for Psychology and the Professional Association of German Psychologists" and monitors compliance with them. Guidelines for local ethics committees in psychology were also drawn up. Most psychological institutes already have their own ethics committees.

In Switzerland , the ethics committee of the Swiss Society for Psychology develops ethical guidelines and checklists for the ethical assessment of psychological research projects and supports the establishment of appropriate ethics committees at Swiss universities. The Federation of Swiss Psychologists has a professional ethics committee (BEK) which is responsible for professional ethical questions. All psychology training institutes also have their own ethics committee.

In Austria there is an ethical guideline for clinical psychologists and health psychologists as a guideline of the Federal Ministry of Health on the basis of an opinion by the advisory board of psychologists.

literature

Introduction and content control of ethical guidelines by Alexander Willemsen (diss.).

Christoph Jenni: Research control by ethics committees from an administrative law perspective: history, tasks, procedure (diss) , DIKE Verlag Zurich / St. Gallen 2010, ISBN 978-3-03751-283-8 .

Michael Keilpflug: Democracy Principle and Ethics Commissions in Medical Research (Writings on Health Law, edited by Helge Sodan , Volume 26) , Duncker & Humblot, Berlin 2012, ISBN 978-3-428-13740-4 .

Web links

German translation of the Declaration of Helsinki (PDF 158 kB) ( Memento from September 8, 2013 in the Internet Archive )

Germany

Working group of medical ethics commissions in the Federal Republic of Germany

Switzerland

Austria

Individual evidence

↑ Sample professional regulations at the German Medical Association (as of 2006) ( Memento from September 2, 2011 in the Internet Archive )

↑ C von Dewitz, FC Luft, C Pestalozza: Ethics commissions in medical research. Expert opinion on behalf of the Federal Republic of Germany for the Enquête Commission "Ethics and Law of Modern Medicine" of the German Bundestag , 2004 (PDF)

^ Erwin Deutsch, Andreas Spickhoff: Medical law : Medical law, pharmaceutical law, medical device law and transfusion law . Springer-Verlag, April 7, 2014, ISBN 978-3-642-38149-2 , pp. 921-2.