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National Information: Switzerland
- In 1970, it issued directives on experimental research in humans. These directives were revised and supplemented in 1981. Point 7 directive instructs that projects be examined by an ethics committee. The legal value of these directives has long been debated. First, they are not binding on physicians. Second, they emanate from a private entity, and as such are not part of the Swiss law. However, some cantons have made reference to them in their legislation as part of the code of practice and hence standards to meet in the area of research on human subjects. Furthermore, according to case law, to the extent that they reflect the rules recognised and applied by the medical corps, the directives could serve as a reference point enabling a judge to determine whether the requirements of legal practice had been met in a specific instance.
- In 1989, SAMS issued guidelines for the organisation and activities of medical ethics committees in charge of reviewing experimental research projects in humans. These guidelines supplement those of 1970/1981 so as to improve the functioning and efficiency of ethics committees.
- In 1996, SAMS merged the 1970/1981 and 1989 directives into one document: the 1997 guidelines for research in humans.
- In 1979, on the basis of the 1970 guidelines for research in humans and the World Medical Association’s Declaration of Helsinki of 1975, the Central Ethics Committee (ZEK) was established within SAMS. Its purpose was to act as an advisory body on medical ethics. They can be consulted both by the SAMS Senate and the Confederation. In theory, they also act as the focal point for the various cantonal ethics committees to provide a certain degree of coordination. However, this is not a role it has ever played, as this role has been assigned to another SAMS Committee.
- In 1992, the SAMS established a supraregional ethics committee for clinical research (UREK). Its purpose was to conduct ethical evaluations for multi-centre projects and projects implemented in cantons that did not have their own committees. This committee was dissolved at the end of 2001 on account of the small number of cases it examined and the entry into force of the Federal Law on Medicinal Products and Medical Devices ( Law on Therapeutic Products - LPT), which made it redundant.
- In 1900, the cantons created the Intercantonal Union for the Control of Medicines (UICM) under the control of the Intercantonal Office for the Control of Medicines (OICM), to formulate harmonised regulation of the manufacture and marketing of drugs in Switzerland.
- In 1993, the UICM adopted a regulation on drugs at the stage of clinical trials, which came into force in 1995. It requires that all clinical drug trial be declared to the OICM after the approval of a competent research ethics committee has been obtained. This rule includes the internationally recognised Good Clinical Practice (GCP) by making explicit reference to ICH-GCP.
- In 2002, the LPT came into force. This law includes specific clauses on clinical trials for therapeutic products (art. 53-57) which are supplemented by the Ordinance on Clinical Trials of Therapeutic Products (OClin). In particular, this ordinance requires the submission of all clinical trials of therapeutic products to a competent Research Ethics Committees (art. 9 OClin) as well as the duties of the RECs (art. 10 OClin).
I. Introduction and Historical Overview
As a Federal State, Switzerland is in some ways unique. Article 3 (general principles) and Chapter 2 of the Federal Constitution are key to the distribution of powers between the central government (Confédération/Bund) and the federal states (Cantons/Kantonen). In principle, the Confederation enjoys no powers beyond those expressly conferred by the Federal Constitution, as the cantons retain residual powers in the other areas. Article 118 of the Constitution vests the Confederation with powers in the area of health protection. However, there is no specific provision regarding research involving human beings or Research Ethics Committees.
Currently, legislation governing Research Ethics Committees (REC) is contained in different regulations at federal and cantonal levels. This configuration is the result of the continuous evolution of this regulation, which is gradually being harmonised on a broader scale.
Before the coming into effect of the new Federal Constitution on January 1, 2000 and of the Federal Law on Therapeutic Products on January 1, 2002, the control of therapeutic products fell to the cantons. Accordingly, norms governing clinical trials of drugs and Research Ethics Committees were initially governed by cantonal laws, resulting in disparities between cantons. Today, the regulation of RECs is based on federal regulation of pharmaceutical research, while the cantons still retain powers in regard to other kinds of research.
It is worth emphasising the continued importance of professional and ethical rules governing the development of national regulations, the effect of which is to harmonise practice. The Swiss Academy of Medical Sciences (SAMS, www.samw.ch) has played a key role in this regard, in particular through its directives and the various commissions it has established.
Simultaneously, the regulation of research has undergone increased "institutional" development.
Following the adoption of the Federal Law on Therapeutic Products (LPT), which abolished the UICM, the development of regulations continued at federal level.
Lastly, the Federal law of 18 December 1998 on Medically Assisted Procreation (LPMA), provides for the creation of a national ethics committee (art. 28). To meet this requirement, the Federal Council established a National Ethics Committee for human medicine (CNE) on July 3rd, 2001, through the Ordinance of 4 December 2000 on the National Commission on Ethics in the Field of Human Medicine (OCNE). This committee, however, has no specific powers with regard to the evaluation of research projects.
- The CNE is a special case in the sense that it does not issue opinions on research projects, but has an advisory role. It takes an ethical stand on social, scientific and legal issues relating to scientific developments and their application to human health and disease. It is an independent extra-parliamentary committee.
- CECs are purely institutional committees. They are directly attached to institutions such as hospitals, with the purpose of helping physicians and health care providers to take real-life decisions in connection with medical practice and the care of patients.
- The REC can be established by an act of government (ordinance, decision). The State Council appoints the members and regulates the organisation.
- The REC can be established independently, but is recognised by cantonal authorities. In the Geneva, Vaud and Zurich cantons, RECs were established by university hospitals. In the Valais, it was established by the central institute for Valais hospital, which is a foundation (an institution under private law), but which operates under legislative delegation on the basis of a service agreement issued by the State Council.
- The Swiss Agency for Therapeutic Products (Swissmedic - www.swissmedic.ch), which was established by the LPT and regulates clinical trials for therapeutic products.
- The Federal Office of Public Health (FOPH - www.bag.admin.ch/index.html?lang=en), which is responsible for carrying out scientific and ethical evaluations, particularly as regards projects involving embryonic stem cells and xenotransplantation.
II. The system of Research Ethics Committees: institutional affiliation
In Switzerland, the system of Research Ethics Committees is moving towards harmonisation and standardisation, especially procedures. Following the VanTx affaire, private ethics committees are no longer recognised as competent committees. Regarding the types of ethics committees and their duties, see the July 4 2002 judgment of the Federal Court 2A.450/2002.
Research Ethics Committees must be distinguished from other kinds of ethics committees, particularly the national ethics committees (CNE) and Clinical Ethics committees (CEC):
The ethical evaluation of research projects occurs at two levels: at the cantonal level through the REC, and at the federal level through The Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health (FOPH).
At the cantonal level, RECs can be organized under one of two models:
Between the early 1990s and 2007, the number of RECs fell progressively from over a hundred to about fourteen. All cantons do not necessarily have their own REC. There are several intercantonal agreements for the mutual recognition of Committees. This is the case for Bâle-Ville and Bâle-Campagne; Jura, Neuchâtel and Fribourg; Lucerne, Nidwald, Obwald, Schwyz, Uri and Zoug; and Zurich, Glaris and Schaffhouse. These agreements came into being because the number of research projects is relatively low in some cantons. In order to reduce administrative costs, the cantons in question recognise the REC of a canton which has greater research activities. Schaffhouse, for example, expects on average 15 clinical research projects per year to be submitted to the Research Ethics Committee of Zurich, whereas there are more than 500 in the Zurich canton.
The organisation of RECs remains a prerogative of cantons under art. 29 of OClin. Nonetheless, regardless of the type of affiliation of the Committee, it must conduct an ethical, scientific and technical examination of the protocol submitted and if needed, call on outside expert opinion if it does not possess the necessary in-house expertise.
There is a second assessment of clinical trials at federal level:
The competent body depends on the type of trial. Swissmedic is competent in areas within the purview of the LPT and OClin (therapeutic products, medical devices) and areas in which the legislation refers to the LPT (somatic gene therapy, radiopharmaceutical products). FOPH is responsible for research on stem cells and on the transplantation of organs, tissues or cells of human origin.
Thus, studies reviewed by cantonal RECs must still be notified to Swissmedic or to the FOPH, which must satisfy themselves that the legal provisions have been complied with and that the studies have obtained the approval from the competent REC. In some cases, the federal authorities may conduct their own review. If Swissmedic or the FOPH make no comment or give their approval, then the research can begin.
One of the major issues raised by the current system of Research Ethics Committees is their large number (14 in all) and the different opinions that they may issue on a single protocol. This is especially the case when the research is conducted in several cantons (multi-centre studies). It must then be submitted to each of the cantonal RECs for approval, with the possibility that some RECs might approve the study and others might not.
At present, the RECs operate according to a “militia” system, each member of the Committee works as a volunteer. With the increase in workload due to the increase in the number of protocols being submitted, and the increase in the duties of the RECs, this mode of operation is displaying its limitations and this might cause difficulties.
- The norms are found mainly in the Federal Law of 15 December 2000 on Medicinal Products and Medicinal Devices (Law on Therapeutic Products, LPT) as well as implementing instruments, in particular the Ordinance of 17 October 2001 on Clinical Trials of Therapeutic Products (OClin).
- For research on stem cells, the Federal Law of 19 December 2003 on Research on Embryonal Stem Cells (Law on Stem Cell Research, LRCS) refers to the provisions of LPT in regard to the competent Research Ethics Committees (art. 11). In this instance, the competent authority at the federal level is the Federal Office of Public Health (art.13).
- Concerning radioprotection, in the case of clinical trials of pharmaceutical products, the Ordinance of 22 June 1994 on Radiation Protection (ORaP) makes reference to the OClin provisions (art. 29). Moreover, the clinical trial must be notified to Swissmedic, which in turn notifies to the FOPH.
- Until June 30 2007, clinical trials involving transplants were regulated by the June 26 1996 Ordinance on the Control of Transplants (art. 23a): clinical trials had to comply with the ICH-GCP of 1st May 1996, which is the same reference as OClin. These trials had to be notified to the FOPH accompanied by the approval of the competent Research Ethics Committee. The Federal Law of 8 October 2004 on the transplantation of organs, tissues, and cells (Law on transplantation) came into force on July 1st, 2007. Article 36 of the law concerns clinical trials on the transplantation of organs, tissues and cells of human origin. This provision follows the LPT process: clinical trials have to receive the approval of the competent REC before being notified to the competent federal agency, in this case the FOPH. Nonetheless, in certain cases, the FOPH not only has to be notified, but also has to issue an authorisation. In particular, this is the case of tissue or cell grafts derived from a human embryo or foetus for use in humans (art. 38). For other types of grafts, the law on transplantation refers to the provisions of the LPT (art. 36 al. 5).
- The Federal Law of 18 December 1998 on Medically Assisted Procreation (LPMA) restrictively regulates research through the prohibition of any artificial insemination that is not conducted for the purpose of allowing a couple to have a child. This prohibition, supported by provisions of the Swiss Criminal Code (art. 29-38), is equally applicable to the practice of artificial insemination for research purposes.
- For human genetic analysis, the Federal Law of 8 October 2004 on Genetic Investigations in Humans (LAGH), which came into force on 1st of April 2007, does not apply to research in this area except with respect to the secondary use of biological material (art. 20). To carry out genetic analysis on such material for research purposes, it must have been made anonymous beforehand, and consent of the individual or his representative must have been obtained. Otherwise, the law refers to special provisions governing research in Switzerland.
- As regards epidemiological research, article 321bis of the Swiss Criminal Code provides the possibility of waiving confidentiality for research purposes on the following conditions: that the subject concerned does not refuse outright; approval from a committee of experts, after having verified the anonymity of the relevant data; the consent of the subject is difficult or impossible to obtain; and that the interests of science are preponderant. In other cases, the disclosure of information protected by professional confidentiality is considered an offence and can be prosecuted if a complaint is lodged. This issue has to be examined by the REC when evaluating a research protocol.
- All cantons are planning to establish Research Ethics Committees either through legislation or by administrative agreement when it is necessary to recognise and accept the opinion of the REC of another canton. Since the LPT came into force, cantons have been required to appoint a competent REC for studies within the ambit of the law (art. 57). However, OClin (art. 29 al. 1) allows cantons to declare the Research Ethics Committee of another canton competent.
- In most of the cantons, with the exception of Uri and Nidwald, legislation covers biomedical research involving human subjects in general, and not only a particular type of research. Nevertheless, in their legislation the majority of cantons (17 out of 26) refer to the system put in place by the LPT and the OClin, thus widening the scope of these provisions. The cantonal legislation does not provide fundamentally different solutions from those enshrined in the federal law; it only has a wider scope of application. However, some cantons have legislated more specifically in certain areas of research: for example, Bâle-Ville has passed a law on human reproductive medicine (Law of 18 October 1990 on Human Reproductive Medicine); Argovie, Berne, Fribourg and Valais have issued provisions governing the collection of organs or tissues from dead bodies. A minority of cantons (Appenzell Rhodes-Extérieures, Glaris, Grisons, Lucerne, Obwald, St-Gall, Tessin, and Zurich) refers to SAMS directives, but five of them also refer to the LPT.
- The table at the appendix shows cantonal legislation on research involving human subjects. It will be observed that there are no fundamental differences
from the federal legislation, although some cantons control some particular aspect such as the informed consent of research participants. Also, the body of
cantonal legislation is limited. This can be understood because it refers to the provisions of federal norms. At this level, we only find provisions dealing
with aspects left to the discretion of cantons.
The OClin does not regulate the organisation of RECs entirely, but defines the minimum standards to be met (art. 29-34). Thus, the REC has to be composed of at least three physicians with broad experience in the evaluation of the efficacy and safety of therapeutic products or in the area of clinical trials, as well as three non-medical professionals with experience in ethics, social work or law. At least one member of the ethics committee must be competent in biometrics, while one other member must be independent of the institution carrying out the clinical trial. Many cantons have not fixed a strict number of members and even exceed the minimum of six set by the OClin. - Cantons therefore enjoy some discretion in the composition, choice of members, duties, organisation, funding, training and retraining of REC members. REC composition is usually guided by the legislation as well as the field of competence of the REC. Its organisation is governed by committee regulations, which are drawn up by the committee itself or by the cantonal authority under which it operates.
- The 2001/20/EC Directive underscores the difference between minors (art. 4) and incompetent adults (art. 5) as research subjects. In particular, it establishes stricter conditions for conducting research on incompetent adults than for research involving minors: the former can only become research subjects where the direct benefit is greater than the risk for the person concerned, without regard to the benefit for the population from which the subject comes as a whole (art. 5 lit. i). In Switzerland, research on minors or incompetent adults is prohibited in principle if it is not of direct benefit to the person concerned (art. 55 al. 1 LPT), except in cases where the research is expected to result in the acquisition of important new knowledge on the state of the research subjects, their illness or their suffering, and thus offer long-term benefits for the person concerned or persons within the same population group, and the risks are minimal (art. 55 al. 2 LPT). Swiss law does not differentiate between minors and incompetent adults.
- RECs may give their opinion on clinical trials undertaken in Switzerland. The committee must issue a favourable opinion before the trial can be conducted (art. 54 al. 1 lit. c LPT). Pursuant to art. 10 al. 3 OClin, for multi-centre trials, the various committees involved in the proposal are able to give their opinion according to a simplified procedure, since the principal researcher will already have obtained the favourable opinion of the relevant REC. This is a legal requirement which is not exactly consistent with the directive 2001/20/CE. In fact, according to art. 7 al. 1 of the Directive, a single opinion is adopted for each Member State in which the multi-centre clinical trials are conducted regardless of the number of research sites.
- Lastly, while RECs have a time-limit of 60 days to give their opinion under the directive (art. 6 al. 5), under the OClin, the time-limit is only 30 days (art. 11).
III. Legal framework
The Swiss legal order is a direct result of the structure of the federal state that it is characterized by legislative involvement at three levels: federal, cantonal and communal. The powers are distributed according to the subject-area of legislation. The health sector in general and biomedical research in particular, also follows this rule.
Hence, even though there is centralisation of provisions in the federal legislative system, the norms to be applied in this area are found in many different provisions, both at federal and cantonal levels. To an outside observer, the legislative landscape appears at first glance to be complex.
At the federal level:
Other norms also apply depending on the area of research:
At the cantonal level (see appendix 1):
While there is no single piece of regulation that applies to research generally in Switzerland, this does not mean that there is a legal vacuum. On the one hand, the basic principles of the Federal State provide that cantons must comply with Federal regulations. This principle not only applies in the drafting of legislation, but also when there is no specific legislation. On the other hand, even where specific regulation does not exist, it should be borne in mind that law remains a complete system. Accordingly, in the absence of a specific law, general principles of law and general norms (Federal Constitution, Civil Code, Criminal Code, etc.) remain applicable. When cantons, in regulating research involving human subjects, refer to federal provisions and particularly to the LPT/OClin system, this also includes referrals made by the latter. The LPT (art. 53) requires that clinical trials of therapeutic products on human subjects comply with the principles of good practice for clinical trials. The OClin (art. 4) sets out these principles. For example, it refers to ICH-GCP and hence to the Declaration of Helsinki, on which it is based.
Beside legal constraints, there are other factors which make the ethical evaluation of protocols effectively mandatory for researchers. Researchers wishing to publish research findings, must abide by the requirement of nearly all scientific journals that ethics review of the project was obtained. Even if the immediate intent of research is not to publish but rather for marketing purposes for example, regulations on the patenting of the tested invention will apply: the Federal Law on Patents for Inventions provides that "inventions the implementation of which would be contrary to public order or morality shall not be patentable" (art. 2 al. 1). Thus, the approval by a REC can be important evidence of conformity with moral values and public order. Lastly, if the research has to be funded by an organisation, it may make its funding conditional upon the prior submission of the research proposal for review by an ethics committee. This is the case for the SNSF (Swiss National Science Foundation - www.snf.ch/e/seiten/default.aspx) whose form for research involving human subjects (division III) states: "In Switzerland, every scientific project involving research on humans has to be approved by an official ethics commission".
In practice, it is not only RECs that review the ethical aspect of protocols. The LPT has instituted a new regulatory organisation as the national authority for the control of therapeutic products: the Swiss Agency for Therapeutic Products or Swissmedic. Swissmedic’s prior approval is required for the commencement of clinical trials of therapeutic products. In practice, the proposal and the opinion of the cantonal REC are submitted to Swissmedic, which conducts the final review. This usually involves an ethical examination although less rigorous than that conducted by the REC.
For the RECs, there are two review procedures: a standard procedure, and a simplified procedure (art. 10 OClin). The simplified procedure is used for multi-centre trials: when the proposal has already been favourably reviewed by a cantonal REC following the standard procedure, the RECs of the other cantons in which the research will be carried out may review the proposal according to a simplified procedure.
Implementation of the 2001/20/EC Directive
As Switzerland is not a member of the European Union, the implementation of a European directive in Switzerland is partly a moot issue. To the extent that there is no reference to the directive in the Swiss legislation, it cannot be applied. At most, one can consider the extent to which Swiss legislation is compatible with European community law.
The 2001/20/EC directive is based on established principles of research ethics, especially those inspired by the Declaration of Helsinki (point 2 of the preamble). Moreover, this directive is equally based on texts predating its adoption, especially the guidelines of ICH-GCP. The ICH-GCP aims to "provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions". In Switzerland, OClin (art. 4) also refers to ICH-GCP and through this, reference is indirectly made to the Declaration of Helsinki. The recognized ethical bases for research are thus the same. This similarity is reflected for example in the check-list of points the RECs must examine during their reviews. This is not surprising however, because these are minimum requirements as demonstrated the directive (art. 6 al. 3: "In preparing its opinion, the Ethics Committee shall consider, in particular:" and the OClin (art. 10 al. 2: "[the Ethics Committee] shall satisfy itself, in particular:").
However the Euro-compatibility of Swiss legislation concerning ethics is not complete. There are certain differences, including the following:
- Cantons with Research Ethics Committees: Aarau; Appenzell R.-Ext.; Berne; Geneva; Grisons; Lucerne; St.-Gall; Thurgovie; Tessin; Valais; Vaud; Zurich.
- Cantons with a common Research Ethics Committee: Bâle-Ville, Bâle-Campagne (Ethikkommission beider Basel); Fribourg, Jura, Neuchâtel (Comité intercantonal d'éthique des cantons de Fribourg, Jura et Neuchâtel).
- Cantons not having Research Ethics Committees (protocols being submitted to the RECs of other cantons): Nidwald, Obwald, Schwyz, Uri, Zoug (they submit clinical research on therapeutic products to the REC of Lucerne); Appenzell R.-Int. (projects are submitted to the REC of St.-Gall); Glaris, Schaffhouse (projects are submitted to the REC of Zurich); Soleure (projects are submitted to the REC of Aarau).
- It should be noted that the ethics committee of Zurich is also competent for Liechtenstein.
IV. Number and composition of RECs / Association of RECs
There are currently 14 Research Ethics Committees in Switzerland distributed between cantons as follows:
Two types of affiliations exist for REC. They can either be part of the cantonal administration or be affiliated with a public institution such as a university or hospital.
Some of the committees are divided into sub-committees. This is the case of Geneva (4 sub-committees for research carried out in the public sector and 1 for research carried out by physicians in private practice). Vaud also has 3 sub-committees (called Sub-committees I, II, and III). Finally, Zurich has 10 specialized sub-committees. This may be explained partly by the fact that these 3 cantons have some the most active hospitals in Switzerland in terms of research and that their RECs are affiliated with these institutions. Nevertheless, it should be noted that the cantons of Berne or Bâle-ville, which also have university hospitals, have a single cantonal REC, which reviews all protocols.
The composition of these committees is not strictly defined by law. Hence, once the minimum standards prescribed by the OClin are met, cantons have some room of manoeuvre in defining their structure. Often, the concrete structure is determined on a case-by-case basis. Cantonal law sets the maximum number of members of a REC and their status (physicians, legal practitioners, biometricians, ethicists, with an education in social science, etc). The by-laws of the REC sets the instances where the REC meets in plenary, who the voting members are, the weight of each vote, etc.
In principle, members of a REC are appointed either by the cantonal government or by health authorities. The OClin (art. 30 al. 4) provides that the committee can call on external experts and is expected to do so when it does not have sufficient expertise to review a research proposal. However, such experts cannot vote.
The organization and operating procedures of RECs vary between committees as these are set by their respective by-laws.
- Improving cooperation: during their quarterly meeting of April 27 2005, Swiss clinical research ethics committees decided to form an Association of Research Ethics Committees (AREC).
- Natural reduction in the number of RECs: there has never been any intention of eliminating RECs from the research environment. Firstly, this is prohibited by law. Secondly, it runs counter to the fundamental principles of the State, the protection of research subjects and the purpose of scientific research. Nevertheless, a more efficient management of Research Ethics Committees would lead to the elimination of some RECs for two reasons. First, the unequal distribution of research among the different cantons means that some REC have little work and can thus continue to operate on the “militia” principle. This may seem counterproductive: those conducting ethical evaluations of projects may face the inconvenience of extra work and be required to obtain specific training yet the practical usefulness of this extra work may not be justified given the number of projects to be assessed. Second, in cantons where a lot of research is conducted, generally university cantons, there has been a professionalization of the secretariats of the RECs as well as financial investment by cantons. This leads to an increasingly efficient management of cases, and a better balance of the responsibilities and workload of REC members.
- Multi-centre research: when research is conducted at various sites, which Research Ethics Committees are competent? In other words, who has to submit a research protocol, and to which committee? This question already arises at national level when research is carried out in several cantons. At present, the protocol must be submitted to the RECs of all the cantons involved. Obviously, they can ask for modifications and thus delay the commencement of research in their own cantons. While a simpler procedure is provided for in OClin (art. 10 al. 3), this option is seldom exercised in practice. One of the duties of the AREC is to improve this practice.
- Insurance coverage: heads of research projects have to make provisions for possible harm to research participants. To this end, they can take out insurance in order to cover the costs resulting from a damage. In the past, however, some insurance policies did not cover damages resulting from clinical research. In order to avoid a recurrence of this situation, agreements are being negotiated between insurance companies and stakeholders in research to ensure that damages resulting from clinical research are covered.
- North-South research partnerships: here, the problem encountered is to some extent similar to that of multi-centre research. When research initiated in a country in the North is to be carried out in a country of the South, or with subjects originating from Southern countries, how should ethical review be carried out to ensure that the research is acceptable? It seems impossible to exclude double evaluation in such cases. Both national and international legislation tend to favour the principle of double review. This seems best suited to the need for better protection for research subjects.
V. Current issues
The motion submitted on March 17 2004 by national councillor Jean-Henri Dunant, under the title “Promoting Medical Research”, opened a debate by questioning the present status of RECs. The Federal Council was requested to establish the general conditions necessary for coordination at the national level or for merging different ethics committees for the purpose of strengthening medical research in Switzerland. The federal draft law on human subjects’ research (LRH) rendered this motion redundant, because it dealt with the same issue. Furthermore, the two systems proposed, that is, either having committees only in the university cantons or a national committee, were taken up by the LRH. During the consultation procedure, a clear majority was in favour of the current solution, that is, cantonal RECs.
The issue of reforming RECs has also merged into the general debate in Europe on whether it is appropriate for RECs to evaluate research which is not financed by industry. This is the result of the new awareness of the law among public sector researchers.
The general tendency is not towards reforming the system, but rather towards its reinforcement in the following areas:
Taken together, these two factors encourage naturally cantons with fewer research projects to refer them to the RECs of cantons with more projects.
Among the RECs, there are still 3 main issues that need to be discussed:
At a legislative level, the federal bill on research on human subjects was submitted to consultation in 2006. The purpose of this law is to gather into
one legal instrument all issues concerning health research involving human subjects, which was previously contained in several instruments. The only
exception to this is the law governing research on supernumerary embryos and embryonic stem cells. Since this only recently came into force, it will remain a
separate instrument so that its implementation can be assessed more effectively.
While the project is ambitious, it has been subject to some criticism. It tends to regulate in a uniform way sometimes widely disparate areas of research.
Those against the project consider it is inconceivable to adopt the same solutions to different problems. Moreover, as practice has already shown the
limitations of this approach in some cases. In any event, the LRH is only expected to come into force some time between 2010 - 2012. The situation will
therefore not change in the next few years, and even after it comes into force, it is not certain that the present system will in practice be fundamentally
modified. As noted earlier, a great majority of cantons have already introduced a system governing all research involving human subjects. It is to be hoped
that the future federal law will take into account all efforts made in the best interests of the protection of research participants.
- Federal administration website: www.admin.ch
- Research Ethics Committee website: www.swissethics.ch
- Swissmedic website: www.swissmedic.ch
- Swiss Academy of Medical Sciences website: www.samw.ch
- Federal Office of Public Health website: www.bag.admin.ch/index.html?lang=en
- Swiss Society for Biomedical Ethics website: www.bioethics.ch (FR-I-D)
- European network of Research Ethics Committees: www.eurecnet.org
- Research in Africa: www.trree.org