The Danish Research Ethics Committee System, Overview and Critical Assessment (Research Involving Human Participants V2)
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Author(s): Sören Holm, University of Manchester
Summary2
The Danish Research Ethics Committee (REC) system was legally established in 1992, but its history goes back to the late 1970s. In 1977 an agreement was made between the Danish Medical Association, the Association of Danish Counties (representing the hospital owners), the Danish Medical Research Council, and others to establish a REC system in accordance with the Helsinki II declaration of the World Medical Association (1975). The system began working in 1980 and was fully established in 1982. The overwhelming majority of Danish hospitals are publicly owned, and most doctors are salaried employees of the public health service. From its inception the system therefore included the major players on the Danish health care scene. The legislation passed in 1992 merely formalised the features of the earlier system with a few changes, and made it absolutely clear that what is important in deciding whether a research project should be assessed is not the profession of the researcher, but the nature of the project. According to the law, all biomedical research projects must be submitted for approval, and the official commentary on the law makes it clear that 'biomedical' should be read very broadly to include all research projects involving present and former patients. The law was revised in 1996, and some uncomplicated questionnaire and register based studies are now exempt from the requirement of REC approval.3 Already from the beginning the Danish REC system was characterised by four main features which set it apart from most systems elsewhere:
- RECs are regional and not institutional.
- RECs are relatively small, and there is a large proportion of lay members.
- There is a relatively easy mechanism for the approval of multi-centre trials.
- There is a central national REC above the regional RECs.
Denmark has eight regional RECs each covering one or more of the Danish counties. All biomedical research protocols within this geographic area must be submitted to the REC for approval. It is illegal and punishable by up to four months in prison to begin a biomedical research project without REC approval. A REC can make four different decisions about a project:
- approval,
- approval on the condition that certain changes are made (resubmission not necessary),
- approval denied, but changes proposed for a possible resubmission, and
- approval denied.
Total denial of approval is rare, but it is very common that researchers are asked to change parts of their projects, most often the patient information sheet. All decisions about approval of a research project must be unanimous in the regional committees, otherwise the project is referred to the Central Research Ethics Committee (CREC). A researcher who is not satisfied with the decision of the regional REC can appeal to the CREC. Decisions made by the CREC are final and cannot be appealed to any other administrative body.
A committee has between 7 and 15 members, with a majority of lay members of one (i.e., if there are 7 members, 4 are lay and 3 are professional). The professional members are appointed by the Danish Health Sciences Research Council, and the lay members are appointed by the County Councils. Although the lay members are politically appointed, they do not represent their respective political parties in the REC. The lay members are not usually lawyers, clergy or philosophers, but 'true' lay people. The members are appointed for four year periods, and can be reappointed once. Each REC has a secretariat, usually staffed by a lawyer, but there are no bioethics advisors attached to the RECs. One problem in the system is that few RECs have access to expertise within research methodology, and therefore they may have problems in assessing certain kinds of projects (e.g., projects involving very advanced statistical methods or qualitative research methods).
The number of research projects assessed by each REC varies between 120 and 500 per year, with the RECs covering university hospitals having the largest work load. Some RECs debate all submitted projects in a meeting of the full REC, whereas others only debate those projects that at least one member finds problematic.
The reason for having regionally and not institutionally based RECs is that this removes some of the pressures that an institutionally based REC may encounter. In an institution there may be pressure applied on the REC to approve or disapprove certain kinds of research, disregarding the ethical status of the research. A regional REC is far less likely to succumb to such pressures because the members are not all associated with one single institution.
The RECs have a legal right to control whether research projects are conducted in accordance with the permission given, and to have access to the final results of a trial. This right is very seldom used at present, because the RECs lack the manpower to perform active controls. Prior to the last revision of the legislation in 1996 the RECs and a number of commentators in the public debate advocated more funding for the RECs in order to enable them to take on an active controlling role, but this proposal did not find favour with the politicians.
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Multi-Centre Trials and the CREC
A major problem in the function of RECs in many countries is the approval of multi-centre trials, i.e., trials taking place in many centres and therefore under the jurisdiction of many different RECs. The Danish REC systems have developed a simple mechanism for handling the assessment and approval process of such trials. According to the Danish regulations the protocol for a multi-centre trial should be submitted to the committee in whose area the leading investigator works, along with information about which other hospitals/clinics are involved in Denmark. This REC will then distribute the protocol to the other RECs in whose area there are hospitals/clinics involved in the trial, and ask for their comments on the project within a timeframe of 30 days. The REC to which the multi-centre project is submitted is responsible for final approval of the project, on behalf of all the RECs involved, and will take care of coordinating the various comments that are submitted from the other RECs. In this way a multi-centre project can be approved within 60 days, almost as fast as a single-centre project. If one of the RECs involved does not think that the project should be approved, but the others think it is acceptable, the coordinating REC will try to negotiate a compromise, but if no compromise can be found the project will be referred to the CREC for final decision (this happens less than ten times per year).
The CREC consists of two members appointed by each REC (one professional and one lay member), two members appointed by the Minister of Health, and two members appointed by the Minister of Research. The CREC appoints its own chairman among the members. The CREC has five functions: 1) it acts as an appeal body for researchers who are dissatisfied with the decision of their local REC, 2) it makes decisions about multi-centre trials in cases where there are irresolvable disagreements among RECs, 3) it develops guidelines for specific areas of research ethics assessment (e.g., use of radioactive material, remuneration of research subject, trials performed by Danish researchers in third world countries), 4) it ensures uniformity of decisions in the local RECs, and 5) it publishes a yearly report highlighting some of the current problem areas in research ethics.
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Danish RECs are embedded in Danish society in general and in the Danish health care system in particular. This influences their structure and mode of operation, and some knowledge of this context is therefore necessary for a full understanding of the RECs.
Denmark is a small country in the northwest of Europe. It has a population of 5.2 million inhabitants, of whom approximately 300,000 are first and second generation non-Scandinavian immigrants (mainly from Turkey, Pakistan, the former Yugoslavia, Vietnam, Sri Lanka, and Somalia). The state religion is Lutheran Christianity, but Denmark is one of the most secularised countries in Europe. There has traditionally been a very strong labour movement and a strong social democratic political party, and concepts like 'equality' and 'solidarity' still play a large role in Danish political debate.4 Since the 1930s an extensive welfare state has developed with the provision of social security, unemployment benefits, pensions, education and health care being seen as the responsibility of the state. The development of the welfare state has been supported by almost all political parties after the Second World War.
A Short History of the Danish Health Care System
The health care system is a major component of the Danish welfare state. The first mention of health insurance can be found in 1403 when the guild of bakers in Copenhagen decided to pay illness benefits to its members. This was followed by similar systems in other guilds and most guilds had some form of health insurance at the end of the 18th century.5 When the guilds were abolished during the end of the 19th century many small cooperative health insurance funds emerged either as continuation of the funds set up by various guilds or as one branch of a cooperative movement which also included cooperative dairies, banks, shops, breweries, etc. These funds reimbursed general practitioners and practising specialists, although there was often a small co-payment on the part of the patient. These small local funds soon formed local negotiation consortiums negotiating fixed prices with the local physicians and excluding physicians not willing to restrict themselves to the negotiated fees. By the beginning of the 20th century each region in the country had what was in effect a one-payer systems for a large part of the population, with only a small upper-class still paying directly out of its own pocket. Later in the century after the Second World War many of the smaller funds merged and only a few large funds continued to operate. Payment to these funds was graded according to broad income bands, but there were also substantial state subsidies, and the state paid for those who could not afford membership themselves.
In the hospital sector the system of payment was different, because almost all hospitals in Denmark were established by municipal authorities or the state, the exception being a few hospitals established by religious orders. In this sector payment has therefore always been predominantly tax-based although extras like single rooms were traditionally available for those who could pay.
In the 1960s it was decided politically to move to a purely tax-based system with the counties (administrative units with 50,000 to 600,000 inhabitants) as the administrative units responsible for planning, running, and funding both primary and hospital care, and this decision was finally implemented in 1973. This decision created an integration of many previously separate parts of the health care system, but at the same time it upheld a division in 14 small geographical units.
The Present Structure of the Health Care System
The 1973 structure continues to operate although some changes have been made in recent years. In this structure the counties are responsible for planning, managing and running hospitals, general practice, practising specialists, community physiotherapy, and responsible for paying for the subsidies on subscription medicine.
The state has no direct responsibility for health care, but the Ministry of Health establishes general guidelines for the quality of the services to be offered. The Ministry of Health was established in 1987. Previously the health area had been managed by a department in the Ministry of the Interior, and the late establishment of a separate Ministry of Health can be seen as a reflection of the limited formal influence of the state in this area. All employees in hospitals are salaried. All groups, including junior doctors, work 37 hours a week.
Until 1989 Denmark did not have any real private hospitals,6 and the range of fee-for-service care available was therefore confined to the procedures which could be carried out in the surgery of individual doctors. In 1989 the first private hospital was established under the guise of catering primarily for foreigners or Danish nationals living abroad. This publicly announced target-group turned out to be small, and the hospital soon diverted its efforts towards elective orthopaedic surgery for Danes who wanted to jump the waiting lists. A number of similar small clinics and three larger hospitals have since been established, but the total number of available beds in the private sector is still below 150 compared to approximately 22,500 somatic beds in the public sector. Along the way all three of the large private hospitals have gone bankrupt (one of them with accumulated losses of 182 million Danish kroner). One of these hospitals was economically reconstructed, but this one remaining large private hospital has not returned any profit in six years of operation.7 Health insurance covering treatment in private hospitals is now available, but payments are not tax-deductible, and it is mainly bought by companies for their top executives. About 23,000 Danes have comprehensive hospital insurance.7 The number of insured is predicted to rise, especially in the form of so-called 'catastrophic illness insurance' which pays out a lump sum if the insured person gets a serious illness. This sum can be used for treatment at a private hospital, but can also be used for other purposes. A number of private firms have included this type of insurance in their benefit package.
Community Services/Primary Care
General practitioners, practising specialists, dentists, and community physiotherapists are all (at least in theory) private businesspeople. Reality is however somewhat different. Reimbursement to general practitioners and practising specialists is dependent on the practice being authorized by the county. Each county can unilaterally decide on the number of practising specialists it wants to authorize, whereas the number of general practitioners is regulated by a formula relating the size of the population to a minimum number of general practitioners.
Each patient has to register with a specific general practitioner. The doctor then receives a small yearly fee for each patient, but the main part of the income of general practitioners is based on fees received for specific services. There is no patient co-payment, and it is illegal to charge the patients extra fees. A general practitioner can only have a certain number of registered patients.
Patients can only see a practising specialist or a community physiotherapist within the public system if they are referred by their general practitioner. In that case treatment is free, but if the patients themselves seek a practising specialist directly they have to pay the full fee out-of-pocket.
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Danish Medical Research Before the Helsinki II Declaration
From the beginning of modern medicine in the 1800s Danish medicine developed a strong research culture. Like in most other countries research came to be seen as a natural extension of the physician's obligation to treat and cure patients, and no sharp distinction was made between therapeutic interventions and research interventions. The mechanism for the control of research was the conscientious doctor's careful consideration of the best interest of his or her patient, and this was supposed to be covered by the provision in the legislation on licensing of medical practitioners which contained an explicit duty to show care and conscientiousness in the performance of one's medical practice (Law no. 72, 1934). This view was prevalent until well into the 1960s. Immediately after the Second World War there was some discussion in Ugeskrift for LÊger (the Danish Medical Journal) about the Nazi experiments, but on a general level this discussion and interest soon petered out. The only interest which remained was in the fate of the Danish doctor Carl VÊrnet who had performed experiments on homosexual men in the Buchenwald concentration camp. He was arrested in Denmark immediately after the war, but was then allowed to go to Sweden for specialist treatment of a heart condition. He escaped from Sweden and eventually made his way to Argentina where he died in the late 1950s. The Nuremberg Code never had any major impact on Danish research practice or the legal regulation of research in Denmark.8 During the 1950s the randomised, controlled trial (RCT) began to be used by Danish medical researchers, and in the Danish Medical Journal from the mid and late fifties there are many reports of RCTs performed without the consent and knowledge of the patients in the trials. Some of these studies involved the new neu-roleptic drugs that were being developed at that time, and in some cases the researchers felt justified in not informing the nursing staff at the relevant units that some patients were receiving a new drug, whereas others were receiving placebo. It was feared that the results would be biased if the nurses had this knowledge.
The first Helsinki Declaration of the World Medical Association (WMA) in 1964 had no impact in Denmark,9 and the unveiling of research scandals in other countries was scarcely mentioned in the Danish medical press.
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The Helsinki II Declaration and the Establishment of Research Ethics Committees
The draft for the Helsinki II Declaration of the WMA was written by three Scandinavians, professor Erik Enger from Norway, docent Clarence Blomquist from Sweden, and professor Povl Riis from Denmark.10 It was passed by the WMA general assembly in October 1975 and adopted by the board of the Danish Medical Association (DMA) in December 1975. It thereby became binding on all members of the DMA (about 98 percent of all active Danish doctors).9 Article I.2 of the original Helsinki II declaration specifies that the research plan for a medical trial should be put to an independent committee for review and guidance. Immediately after the adoption of the declaration the DMA therefore initiated efforts towards establishing such independent committees. These efforts were primarily led by professor Povl Riis, who at that time was also editor of the Danish Medical Journal. A series of meetings were held between representatives of the DMA and the other main interested parties, the Danish counties as the hospital owners and employers of most doctors, the Danish universities, the Danish Medical Research Council, and a number of others. This led to a proposal in 1977 recommending the provisional establishment of a system of RECs for a trial period of unspecified duration.11 This proposal was adopted by the DMA, the Danish counties, the Danish universities, the medical scientific associations, the pharmaceutical industry, the Danish medical and health care journals, the Danish Dental Association, the Danish Association of Pharmacists, and the Ministry of the Interior.12 Although the proposal thus had the backing of the counties and the Ministry the system of RECs established was still of an extra-legal nature and researchers had no legally binding obligation to submit research protocols to the RECs.
The first RECs were established in 1980, and the whole country was covered by 1982.13 The system was based on regional RECs, each covering one or more counties and being responsible for all biomedical research in that area. The committees had between six and ten members. Half of these were professional members appointed by the Danish Medical Research Council after consultation with local representatives of the medical and other health care professions, and the other half were lay members appointed by the County Council(s). All members were appointed for four year terms, with the possibility of reappointment without limits the number of terms. The terms followed the election term of the County Councils. Although the lay members were politically appointed they were appointed in a personal capacity and not as representatives of their party. Each REC elected a chairman and a vice-chairman (one professional and one lay). All decisions to approve a research project in a REC had to be unanimous.
The system further contained a Central Research Ethics Committee covering the whole of Denmark. The CREC was constituted of the chairmen and vice-chairmen of the regional RECs14 and a number of members appointed by the Ministry. The CREC was first formed in 1981, and its first chairman was professor Povl Riis, who continued in this post until 1998.
The CREC had two functions. The first of these was to act as an appeal body in cases of disagreement in a REC or between RECs, or in cases where a researcher appealed a decision made by a REC. The second was to issue general recommendations to RECs concerning the evaluation of research projects. These recommendations indirectly became normative for the conduct of researchers and the planning of research projects, since it became clear that projects not respecting the recommendations would not be approved.
Given the extra-legal status of the committees no formal sanctions existed that could be applied to researchers who either did not submit their research projects or did not conduct their research projects in the form in which they had been approved. There were, however, a range of informal sanctions which seems to have been sufficient to ensure compliance. These included the threat that nonapproved research would not be published, and the belief that employers would view a breach of research ethics rules as a serious breach of the employment contract.
In the early period of the function of this system researchers were asked to submit a research protocol and a self-declaration concerning compliance with the Helsinki II Declaration. If researchers declared that the project was in full compliance with the declaration they could initiate the project before the REC had evaluated it (projects involving children and other incompetent patients could not be initiated without explicit approval). In these cases the REC did not often perform a substantial evaluation of the projects, but only of the patient information material. This gradually changed, and in the late 1980s all project were actively evaluated before approval.
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Putting Research Ethics Committees on a Legal Footing
During the 1980s there were a small number of public 'research scandals' in Denmark, and there was an at times heated public discussion about the effectiveness of the RECs which were claimed to be too medically dominated.15 This lead to a political debate about the status of the REC system, and to the appointment of a commission to consider a legal establishment of RECs and a revision of the system. The commission published a report in 1989 recommending that a law should be passed establishing a national REC system.16 After some further political discussion a law was passed in 1992 (Law no. 503, 1992, On a scientific ethical committee system and the consideration of biomedical research projects). Minor changes were made to this law in 1996 (Law no. 499, 1996). The REC system established by this law is to a very large extent identical to the previously existing extra-legal system. The regional RECs and the CREC, and the division of labour between the RECs and the CREC, are retained.
The composition of RECs is slightly changed to give more lay representation. According to the law a REC has between 7 and 15 members, with a majority of lay members of one (i.e., if there are 7 members, 4 are lay and 3 are professional). The professional members are appointed by the Danish Health Sciences Research Council, and the lay members are appointed by the County Councils. A practice has developed so that at least one of the professional members is a general practitioner. Although the lay members are still politically appointed, they do not represent their respective political parties in the REC. There are no specific requirements as to who the lay members should be. The lay members are not usually lawyers, clergy or philosophers, but 'true' lay people, although teachers and clergy are probably over-represented among the lay members.17 The members are appointed for four-year periods, and can be reappointed once. Each REC has a secretariat, usually staffed by a lawyer, but there are no bioethics or research methodology advisors attached to the RECs. All decisions about approval of projects have to be unanimous, otherwise the project must be referred to the CREC for decision.
The law opens a possibility to establish more than one REC in a given region if the number of research projects submitted becomes too great for one committee. This situation has arisen for the committee covering the Copenhagen and Frederiksberg municipalities, and thereby the University of Copenhagen and the National Hospital. In this region two RECs have been formed, and research projects are distributed between them on a consecutive basis, REC-1 getting the unevenly numbered and REC-2 the evenly numbered projects.
Members of the RECs are not paid for their work, except the chairman and vice-chairman (25,000 and 20,000 Danish kroner per year, respectively), but can get reimbursement for lost earnings while attending meetings (330 Danish kroner per meeting). RECs are directly funded by the counties, and research projects based in county institutions are handled free of charge. There is a charge of Danish kroner 2,500 per project for projects based in noncounty institutions (including projects initiated by the pharmaceutical industry). The RECs have tried to have the charge abolished because it creates a large administrative burden for very little financial gain, but have as yet not been successful.
The Constitution and Function of the Central Research Ethics Committee
According to the legislation the CREC consists of two members appointed by each REC (one professional and one lay member), two members appointed by the Minister of Health, and two members appointed by the Minister of Research. Three of the members appointed by the government should represent handicap groups or social interest groups, the remaining government appointee represents the research interests of the state. The CREC appoints its own chairman among the members. Members of the CREC are appointed for four-year terms and can be reappointed once. The CREC has five main functions:
- it acts as an appeal body for researchers who are dissatisfied with the decision of their local REC,18
- it makes decisions about multi-centre trials in cases where there is irresolvable disagreements among RECs,
- it develops recommendations for specific areas of research ethics assessment (e.g., use of radioactive material, remuneration of research subject, trials performed by Danish researchers in third world countries),
- it ensures uniformity of decisions in the local RECs, and
- it publishes a yearly report highlighting some of the current problem areas in research ethics.
The CREC further has an obligation to cooperate with the Danish Council of Ethics through common meetings and the publication of common reports.19 This cooperation has for some years been characterised by a state of 'armed neutrality,' with the CREC feeling that the Council of Ethics wanted to interfere with the CREC's handling of specific research projects, and the Council of Ethics feeling that the CREC was very reluctant to discuss major general problems in research ethics. Part of the problem seems to be that the two bodies have not fully understood the roles they each have. Despite this turf war one major report on health science information banks was published in 1996.20 In the CREC decisions can be made about a project by majority vote, but there has to be a majority of both the professional and the lay members. Decisions made by the CREC cannot be referred to any higher administrative authority, so the only recourse for a researcher who is dissatisfied with a CREC decision is to go to court claiming that the decision made was illegal and should therefore be made void. No such case has been before the Danish courts yet.
Besides the CREC an informal coordination mechanism between RECs has also emerged in form of the Secretariat Council ('SekretariatsrÂdet') where the administrators from the REC secretariats meet regularly to discuss common problems. It is also mainly through this informal body that information is exchanged with the RECs in the other Nordic Countries.21 The recommendations issued by the CREC are available in English translation, but this publication is unfortunately now very out-of-date.22 Work is under way to consolidate most of the recommendations into two guidance documents, one directed at researchers and one directed at RECs, but this work has not been finished at the present time, but should finish sometime in the summer or autumn of 2000.23 These guidance documents will be issued as common guidance from the CREC and the Minister for Research.
No Danish RECs Outside of Biomedicine
The Danish REC system only covers biomedical research (although the definition of biomedical is rather wide, see the section 'What projects should be submitted'). There is no REC system for research outside the health sector. In the mid-1990s it was discussed whether RECs were needed for the social sciences, the humanities, or other areas of research. A working group was established by the Danish Social Sciences and the Danish Humanities Research Council to consider this question, and it reached the conclusion that RECs were not necessary in these areas.24 Seen from a research ethics perspective the arguments presented seem more than a little dubious. In the working group there was clearly a worry that RECs would mean a requirement for informed consent, which would be difficult to obtain in some social science and psychology projects. It was further argued by some members of the group that (some kinds of) social science are very important for policy formation and administration in a modern society, and that they should therefore not be too constrained by ethical demands. Some also claimed that the potential for harming research participants in the social sciences is much lower than in the health sciences.
After the report from the working group the discussion about RECs outside the health area has died down in Denmark.
Punishment for Breaking the Law
A researcher who is in breach of the law, for instance by not submitting a project or by carrying out a project in an illegal manner, can be reported to the police, charged and if found guilty by the courts receive a punishment consisting of a fine or imprisonment up to 120 days. A number of researchers have recently been reported to the police, but none of the cases have yet been before the courts.
For a registered health professional (a physician, nurse, physiotherapist, etc.) the Danish Board of Health ('Sundhedsstyrelsen') can also initiate professional disciplinary procedures, since breach of the REC legislation is viewed as a breach of professional duty.
The RECs do not have any formal relationship with the institutions from which the researchers come, or with the public funding bodies for research. They cannot ask institutions to initiate disciplinary procedures, or funding bodies to withdraw funding, if they find evidence of breach of the law.
This does, however, not mean that institutions or funding bodies are uninterested in the decisions of RECs. The Danish Health Sciences Research Council requires REC approval as one of the necessary conditions for funding, and the same policy is followed by the major private funders in the health research area.
There are also a number of cases where researchers have resigned after REC critique of their research. In some of these cases it has been evident that the institution has leaned on the researcher.
What projects should be submitted?
Paragraph 6 in the law makes it clear that all biomedical research projects should be submitted for approval to the regional REC and that a project can only be initiated once approval has been obtained. This includes pilot-experiments. According to the official comments on the legislation 'biomedical' should be interpreted very broadly to include not only interventional or diagnostic studies involving some kind of bodily intrusion or the use of drugs, but also basic biological research on humans, health related epidemiology, health related sociology, and all projects were people are studied because they are patients or have been patients.
No distinctions are made with regard to the legal status of the institution where the research is taking place (i.e., public/private), with regard to the funding source (i.e., public/private), or with regard to the profession of the researcher. All projects must be submitted. What decides whether a project should be submitted is solely its content.25 A project carried out in a private institution, without any kind of public funding, and by a researcher who is not a health professional will thus require REC approval, if it falls within the legal definition of 'biomedical.' On the formal/legal level the REC system functions in exactly the same way as the system for issuing building permits, which also covers all kinds of buildings, no matter how they are funded or by whom they are built.
There are, however, still a number of grey areas with regard to the demarcation between research and quality assurance/development activities, between research and educational projects performed as part of the studies of medical and other students, and most significantly between research and 'experimental' use of new treatments. The last grey area concerns the established right of medical practitioners to try new and untested treatments in patients for whom this seems to be the best (or in some cases the last or only) option. There have been a number of cases where doctors have used this therapeutic privilege on substantial series of patients, and where the situation has looked more like research than last resort therapy when viewed from the outside. The Danish Board of Health has tried to clarify the situation by issuing official guidance to Danish doctors, but this has not totally resolved the unclarities.26 A REC can make four different decisions about a project:
- approval,
- approval on the condition that certain changes are made (resubmission not necessary),
- approval denied, but changes proposed for a possible resubmission, and
- approval denied.
Total denial of approval is rare, but it is very common that researchers are asked to change parts of their projects, most often the patient information sheets. Amendments to approved projects also have to be submitted for approval and cannot take effect before they have been approved.
A REC can also decide that a project falls outside the legal definition of a biomedical research project and that it therefore does not need REC approval. When such a decision is made researchers sometimes ask whether they cannot get approval anyway, because they feel that they need it, either for future publication of results, or in order to get access to patients (this last factor is most often important for nonmedical researchers), or in order to document approval to non-Danish research sponsors. RECs are, however, not able to approve projects outside their remit.
Certain kinds of projects need REC approval, but also need approval from other bodies before they can be initiated. Projects involving the use of pharmaceuticals for nonregistered indications need approval from the Danish Pharmaceuticals Authority ('LÊgemiddelstyrelsen') which is also responsible for official inspection of GCP-compliance in Denmark. Projects involving the establishment of a register or a bio-bank containing person identifiable information needs approval of the register and its data-protection provisions from the Registry Authority ('Registertilsynet').
Assessment of Multi-Centre Projects
A major problem in the function of RECs in many countries is the approval of multi-centre trials, i.e., trials taking place in many centres and therefore under the jurisdiction of many different RECs.27 Often researchers have to communicate with a large number of RECs, and they may be met with mutually contradictory demands for changes in the project design or patient information by different RECs. The researcher may in the end have to activate different versions of the protocol in different centres, in order to meet the irreconcilable demands of the different RECs.
The Danish REC system has developed a simple mechanism for handling the assessment and approval process of such trials. According to the Danish regulations the protocol for a multi-centre trial should be submitted to the committee in whose area the leading investigator works, along with information about which other hospitals/clinics are involved in Denmark. This REC will then distribute the protocol to the other RECs in whose area there are hospitals/clinics involved in the trial, and ask for their comments on the project within a timeframe of 30 days. The REC to which the multi-centre project is submitted is responsible for final approval of the project, on behalf of all the RECs involved, and will take care of coordinating the various comments that are submitted from the other RECs. In this way a multi-centre project can be approved within 60 days and almost as fast as a single-centre project. If one of the RECs involved does not think that the project should be approved, but the others think it is acceptable, the coordinating REC will try to negotiate a compromise, but if no compromise can be found the project will be referred to the CREC for final decision (this happens less than ten times a year).
The results of the Danish system for multi-centre trials are:
- that the researcher is only in correspondence with one REC,
- that demands for changes in design or patient information will be co-ordinated so that the researcher is never required to reconcile contradictory demands him- or herself, and
- that all Danish centres in a multi-centre project conduct the trial according to one approved protocol and not according to a number of regionally specific versions.
Consequences of Legalisation
The legalisation of the REC system has had a number of consequences. It has meant that biomedical research in Denmark is no longer controlled by the Helsinki II Declaration, or any other subsequent declarations that the WMA may pass. A REC can take the Helsinki II Declaration into account in areas where present Danish legislation is unclear or gives no specific guidance, but the declaration can never supersede Danish legislation. This has created problems for a number of researchers holding foreign grants (including NIH grants) since the Danish RECs are no longer able (or willing for that matter) to certify that the project is performed in accordance with the Helsinki II Declaration (see the standard letter from one of the RECs in Appendix A28).
Another consequence has been that Danish RECs are now subject to the same rules about public access to the administrative process as other parts of the public administration. This does in principle give public access to all research protocols, except those that contain commercially sensitive information (and even in such cases the public should have access to those sections of the protocol that are not commercially sensitive). The CREC has actively tried to obstruct public access, and has therefore been in protracted conflict with the parliamentary Ombudsman. The CREC has argued that it is necessary to protect the researchers intellectual property rights in new scientific ideas or methods and that public access must therefore be restricted (as the only way to restrict access by competitors), but this argument has been firmly rejected by the Ombudsman.29 The present situation is unclear. Technically the CREC and RECs have accepted the Ombudsman's ruling, but in practice some requests for access are apparently still being obstructed. Some RECs now ask researchers to specify in advance what parts of their protocols they consider commercially sensitive, and what parts can be open to immediate public access.
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The 1996 Revision of the Law
The 1996 revision of the 1992 law was initially aimed at clarifying which projects should be submitted to the RECs for approval (Law no. 499, 1996). Under the 1992 law every project with a biomedical component, or dealing with patients or previous patients should be submitted. This included a large number of research projects based on questionnaires, or on anonymised analysis of already existing health databases.30 Most of these projects contained no research ethical problems of any kind. The purpose of the revision of the law was thus to exclude such unproblematic projects in order to reduce the work load of RECs. During the parliamentary debate about this revision an initially unrelated media debate flared up concerning the amount of money researchers were paid by pharmaceutical firms, and especially about the problems caused by researchers receiving large per capita payments for each person included in a trial. This debate was initiated by a single television program concerning the payments received by oncological researchers in connection with trials of Taxol (Paclitaxel), but was quickly broadened by the printed press. This debate was picked up by some politicians and the government rapidly added a new clause to the bill before parliament stating that the patient information has to contain explicit information about the support received from firms and private and public foundations. This exemplifies a fairly common feature of the Danish political debate about research ethics and the regulation of research. 'Research scandals' are always met with a demand for tighter regulation, even in those cases where the researcher in question is breaching existing regulation, and where the response should therefore be punishment and perhaps increasing control of compliance with existing regulations.
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The Function of the System
How does the Danish REC system then work in practice? This is a difficult answer to answer in abstraction, and only a limited amount of research has up to now been done on the function of the system. In this section I will try to give an overview of what is known, as well as of the views held in the Danish biomedical research community.
Knowledge About the System in the Population and Among Researchers
The Danish population is in general positive towards medical research, and accepts that it is necessary, although negative views about medical researchers are also prevalent.31 The general knowledge about the existence of the REC system in the Danish population is poor. In a telephone survey of a random sample of the adult Danish population (N=1,137) it was found that only 30 percent were aware of the existence of an official body which controls medical research, and that only a very small minority was aware of the composition of RECs and that the lay members outnumber the professional members. Most believed the lay representation to be small.32 Other studies have, however, shown that the fact that a project has been approved by an independent REC is an important factor in determining the willingness to participate in the project, and that this holds for the public, for out-patients, and for actual trial participants.33 With regard to medical and other researchers we only have indirect evidence. The number of submitted research projects rose rapidly during the first ten years of the existence of the REC system, but now seems to have stabilised around 2,400 projects per year with only very little annual growth. This is probably an indication of a situation where those projects that should be submitted are submitted. Courses about research ethics is an obligatory part of medical undergraduate education, and of some doctoral programs.
A recent survey of Danish doctors' knowledge about the content of various national and international declarations and oaths showed that the Helsinki II Declaration was the declaration that was best known.34 The knowledge about the content of the Helsinki II Declaration was even better than the knowledge about the Danish Physician's Oath ('LÊgel¯ftet') which every Danish doctor solemnly swears at the graduation ceremony.
The Evaluation of Projects in RECs
Because of the large differences in number of projects submitted each year, each REC has slightly different procedures for evaluating projects. All RECs operate a system of designated pre-evaluators where a project is allocated to two members (one professional and one lay) for specific scrutiny after it has been checked for completeness and legality by the secretariat. Most RECs have 6 to 12 meetings per year, and in some RECs with the smallest number of projects every project submitted is discussed in a meeting where the pre-evaluators briefly outline the project and give an opinion. In other RECs with larger numbers of projects only certain kinds of projects are discussed in a meeting, this will include those projects where the pre-evaluators have identified problems, but also certain generic types of projects. In the two RECs for Copenhagen and Frederiksberg municipalities which handle 30 percent of all research projects in Denmark the types of projects that will always be discussed in a meeting includes projects involving: 1) inmates in prisons, 2) fetuses, embryos, or gametes, 3) radiation above a certain level, and 4) a desire expressed by the researcher for discussion in a meeting.35 Projects involving children and other incompetent persons are circulated to all members of the REC and only approved without discussion in a meeting if no member has any queries about the project. All in all five to ten percent of all projects are discussed in a meeting in these two RECs, whereas the rest are managed simply by consensus between the two pre-evaluators. This consensus may involve requirements for changes in the research design or patient information.
RECs do perform a rudimentary scientific review of the projects that are submitted, and projects that are clearly methodologically substandard will be rejected. The argument here is the obvious one that people should only participate in research which is methodologically sound and able to answer the research question asked. Because of the composition of the RECs and their secretariats it is, however, impossible to perform an in-depth scientific review (see the section below, 'Problems in the Constitution and Membership of RECs'). The Danish system does not contain any specific mechanism to ensure that such a scientific review does take place. Most research projects will be vetted in the institutions where they originate, but there is no guarantee that this happens, and no way of documenting it formally.
Chairman's action does not take place in the primary evaluation of a project, but can take place in cases where a research project is resubmitted with the requested changes, or in cases where a researcher submits minor amendments to an already approved project. The meetings of RECs are not public and the minutes are viewed as internal working papers and are therefore not open for public access.
The Effects of REC Evaluation
It has been shown that the research protocols submitted for REC approval contain very few ethical considerations, even in those cases where the project contains substantial ethical problems.36 Another study has shown that the patient information sheets that are submitted to Danish RECs are difficult to read, and that they often lack important information. The REC process rectifies some of these problems, but even after REC approval not all patient information is satisfactory.37 It is, however, the general impression that the 'ethical standard' of research protocols has gone up over the years.
One positive unintentional side-effect of having a REC system which requires submission of all research protocols is that the scientific quality of the protocols has improved considerably over the years. The mere fact that somebody else outside the research team is going to read the protocol diligently forces the researcher to state his or her considerations about design, number of patients, etc., very explicitly, and thereby forces the researcher to think in a more structured and explicit way.
Problems in the Constitution and Membership of RECs
The majority of lay members in Danish RECs, which seems to be a unique feature of the Danish system, causes no problems. Just like the professional members the lay members have problems in the beginning finding out 'what it is all about,' but they soon settle in and are able to make a constructive contribution. Lay members do not only contribute to the vetting of the readability and content of patient information but can and do make comments on all parts of the protocols. The fact that there is more than one lay member has two positive effects. It refutes the charge of tokenism, and it reduces the chance that the individual lay member can be silenced by the professional members. The way lay members are appointed also removes any possibility for research institutions to influence the process and recruit 'tame' lay members to the RECs. In general those who are appointed have an interest in the area prior to their appointment and are used to committee work from previous experiences on political committees of various sorts.
A greater problem is the potential lack of certain kinds of expertise in the RECs. Part of their remit is to ensure that the research projects submitted are scientifically/methodologically sound and worthwhile. This in many cases requires an expertise in research methodology and/or statistics that is not necessarily present in the RECs. The professional members may possess this expertise, but then again they may not. This has been exemplified by a number of research protocols using qualitative research methodologies that have been rejected initially, mainly because no one on the RECs in question possessed the necessary knowledge about this particular form of research. This problem could be solved either by enlarging the secretariats of the RECs by the establishment of a post for a research methodologist who could screen projects, by stating more specific requirements for members of RECs in this area, or by establishing some form of peer review.
Another potentially problematic lack of expertise among the members is in the area of research ethics/law and bioethics/biolaw in general. In the present system this expertise is mainly held by the secretariats, at least as far as the legal knowledge is concerned, but this potentially reduces the possibility for really in-depth ethical discussions of problematic projects.
The Control Function of RECs
According to Danish legislation the RECs have a legal duty and right to monitor that the approved projects are carried out in compliance with the approved research protocol (β 9, sect. 1 & 2). In discussions before the initial legislation in 1992 and before the revisions in 1996 it was pointed out by the RECs, the DMA, the Danish Council of Ethics, and many others that such a control and monitoring function could only work if the RECs were given additional resources. The members of RECs are, as mentioned above, not paid, and most of them feel that they are already devoting considerable time and energy to REC work, and the secretariats are not excessively well staffed. There is thus simply no available resource in the form of person hours to perform any active control. The politicians did, however, show themselves to be completely resistant to these arguments.
Most RECs now require researchers to submit a final short report when a project is finished or abandoned, but this only gives a very superficial picture of the actual conduct of the research in question. At present the only real control occurs in cases where the RECs are alerted to potential irregularities by research participants, relatives, or health professionals. In such cases RECs do perform site-visits or summon the researcher to explain him or herself.
Discussions about the control function are presently underway between the CREC and the Ministry of Research, but the outcome is uncertain. The plan involves site visits to 5 to 10 percent of all projects performed by two members of an especially established team of monitors. The present idea is that these monitors should be recruited among former REC members.
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Advantages and Problems in a Regional REC System
The main reason for having regionally and not institutionally based RECs is that this removes some of the pressures that an institutionally based REC may encounter. In an institution there may be pressure applied on the REC to approve or disapprove certain kinds of research, disregarding the ethical status of the research or its compliance with national rules or international declarations. A regional REC is far less likely to succumb to such pressures because the members are not all associated with one single institution. The experiences in the Danish REC system is that the professional members do not feel themselves to be representatives of their institution, just as the lay members do not feel themselves to be representatives of their party. In a given region there will usually be many more research active institutions than there are professional members of the REC, and since the professional members are appointed not based on advice from the institutions but from the professions, any idea of representing the institution and its interests is effectively suppressed. The downside is that the REC may sometimes lack knowledge of very specific, but important institutional factors influencing a given research project.
There is, however, a problem in applying the exact same structure across Denmark. Even though several counties may elect to have one joint REC the differences in research activity between different regions is so large that the work load and experience of RECs vary widely. If multi-centre projects are discounted some RECs see less than 50 new projects a year, whereas others see more than 400. With multi-centre projects included the discrepancy becomes less (100 versus 500) but it is still substantial. In general those RECs that cover universities and/or university hospitals get the largest load of projects.
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Four Simple Improvements to the Danish REC System
Following from the description above there are a number of simple improvements which could be implemented while maintaining the strengths of the system, which I take to be:
- The regional and not institutional RECs.
- The large number of lay members in RECs.
- The existence of the CREC with the role described above.
- That all projects have to be submitted, both public and private.
The first of these improvements would be to upgrade the secretariats of the RECs with expertise in research methodology and statistics, so that the methodological soundness of the submitted projects could be screened, prior to the RECs' consideration of the projects. A formal mechanism for peer review could be another option, but peer review is notoriously open to a range of biases. Above I have also identified the lack of bioethics/biolaw expertise as a problem, but I do not think that it is a problem of the same magnitude as the possible lack of methodological expertise.
The second improvement would be to require researchers to submit clear justification for the importance of their projects, preferably in the form of a structured review of the already available knowledge in the area. Due to the work of the Cochrane collaboration the methodology for performing structured reviews (and meta-analyses) is rapidly developing, and it is now clear that the traditional unstructured review which often forms the 'Background' section of a research protocol is inadequate.
The third improvement, which is discussed in more detail below, would be to develop the monitoring role of RECs so that they could really fulfil their mandate. This would, like the first improvement mentioned require increased funding.
The fourth and final improvement would be a change in REC culture, so that RECs are more actively engaged in public discussion about difficult research projects. There have been a few instances where the CREC, the researchers, and the affected patient groups have actively sought to create public debate and awareness, but this could be developed more. This would hopefully have the beneficial side-effect that the public become more aware of the existence and role of RECs.
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Areas of Possible Future Development
In the following section I will discuss two possible future developments of the Danish REC system. One of these is an extension or accentuation of its function as a democratic institution, and the other is an extension of its monitoring role with regard to already approved research.
RECs as Democratic Institutions
Biomedical research involving human subjects is a social practice which relies on social acceptance for its continuation and flourishing. This social acceptance has to encompass both the goals of the activity and the way the activity is conducted. In a very early paper on medical research ethics Hans Jonas pointed out that research and development is always an optional goal.38 It is not incoherent or irrational to think that no more medical research should be performed, as long as one is willing also to accept that no more medical progress will be made. But then it is not irrational not to wish for progress! The RECs probably have only a minor role to play in explaining the general goals of biomedical research to the public, but they do have potentially very important roles to play with regard to the social acceptance of the goals of specific projects and the conduct of research. We know that recruitment rates to biomedical research have been falling steadily over the last 10 to 20 years,39 and unless this trend is reversed it will lead to serious problems concerning both the pace of biomedical progress and the generalisability of those results that are generated.
Although the approval procedure could be analysed purely in terms of protection from problematic research, the presence of lay members on most RECs point to another possible function. What are the lay members there for? The most minimal interpretation of their role is that they are there simply to ensure that the information given to prospective research participants is understandable by 'ordinary people' and not too filled with medical jargon. On this minimal interpretation the role of the lay person would be purely as a 'linguistic sounding board.' However, some countries have a majority of lay members on their RECs, and in most countries lay members are not chosen on the basis of their ear for language, so it is not unreasonable to suggest that they also perform other roles. But what roles?
If we reconceptualise RECs not only as formal approval bodies, but as institutions within a democratic framework which at the same time regulates and legitimises biomedical research we may become clearer about the role of both the RECs themselves and their lay members. When a REC approves a project it is not a neutral administrative act, it is also an implicit endorsement of the project and its qualities; or that is at least the way it will seem to the outside observer. RECs carry the honorific 'ethics' in their name, and something that is approved by an ethics committee must in fact be ethical! RECs may not want their approval to have this implication of endorsement, but it is difficult to avoid, and it is worth considering whether it cannot be used constructively.
Can we imagine a situation where REC approval actually functions as a partial legitimisation of the specific research project?
The most common public worries about biomedical research are that research is only carried out to promote the career of the researchers or to promote the interests of the pharmaceutical industry. The researchers are not really interested in helping patients, or solving those health problems that are important seen from the point of view of society. Many research projects are therefore performed that are really unimportant, and where the participation of research subjects is therefore wasted (This is a simplified and thereby slightly caricaturised version of the public worries). How would a REC have to look like, and what would it have to do in order to be able to allay these public worries?
First, it would probably have to be (and be seen to be!) totally independent of research interests. This points towards that the members of RECs should not be appointed by the research institutions themselves, but through some independent mechanism. It further points towards a very substantial representation of non-researchers on the RECs. It is 'common knowledge' that doctors (and other researchers) are as thick as thieves, and this common knowledge will affect the perception of RECs, whether or not it is actually true! In this context it is not enough to argue that researchers are honourable persons who would never let their own interests or the interests of their colleagues influence their decisions on RECs, if the public is not fully convinced by the argument.
Second, the nonresearchers would have to be 'elected' to the REC by a mechanism that is transparent and accepted in the society where the REC is operating. The nonresearchers will have to be independent, to be beyond reproach, and to be people who are seen as truly representing the public interest. Different methods may suit different societies but just co-opting the 'great and the good,' or the local vicar does not add much democratic legitimation.
Third, RECs would have to be very open about their methods of working and the reasons for specific decisions. Only by aiming at complete transparency can the necessary confidence be developed in the public.
Fourth, many RECs would have to become tougher in their rejection of research protocols that are deemed to be methodologically poor, or to give only very limited benefit to society. People who are willing to become research subjects are a scarce resource, and just like other scarce resources it should be protected and used wisely and not squandered on projects without clear benefit. A potential research subject should not have to worry about whether or not the project he or she is being asked to participate in is of good scientific quality and likely to produce beneficial scientific results. The fact that is has been approved by a REC should be conclusive evidence of scientific quality and expected benefit.
Fifth, RECs would have to engage in public discussion and consultation concerning contentious research projects and contentious justifications for research projects. Whether a research project is socially acceptable in a certain society, and whether it will add or detract from the general acceptance of biomedical research is not always a question which can be answered by pure conceptual analysis, or by applying a set of rules and guidelines. Some societies may accept certain kinds of research which would be deemed unacceptable in other societies, and certain justifications for research may be acceptable in some societies but not in others (e.g., research with the primary aim of benefiting the national pharmaceutical industry). As democratic institutions RECs would have to consult those people on whose behalf the decisions are made, in order to be able successfully to claim that they represent these people.
These five requirements that RECs would have to fulfil before they could gain a stronger role in the democratic legitimation of research would in many instances necessitate radical changes in the structure and function of existing RECs, and it is therefore doubtful whether RECs will take on this role in the future.
Monitoring the Conduct of Research40
In many countries RECs have a right and an obligation to monitor how the approved research projects are actually conducted, but this monitoring role is in many cases much less developed. If monitoring is performed it is often based only on annual or final reports from the researchers themselves, or is only activated when there are complaints about specific projects. We are thus in most countries in a situation where it is ensured that the research protocols are ethically acceptable, but where it is never in reality controlled that the research is conducted according to the protocols and that there are no ethically problematic breaches of the protocols. The situation can in certain respects be compared to a situation where sensible speed limits are imposed, the quality of cars inspected, but the speed of motorists never measured and speeding tickets only issued in cases where an accident has occurred.
Other agencies than RECs may in some cases perform monitoring of biomedical research. This is for instance the case with all GCP-compliant research, where the sponsor (often the pharmaceutical industry) is required to ensure both adequate monitoring and auditing of the research. The aims of this monitoring are, however, not primarily to ensure an ethically acceptable conduct of the research, but to ensure the scientific validity. The GCP rules do contain provisions about ethics and ethics review, but their main raison d'etre is not the maintenance of ethical standards. There are also many biomedical research projects that are not subject to the GCP rules, since their purpose is unrelated to the development and registration of new pharmaceuticals.
How can the monitoring role of RECs be developed in the future?
There seem to be two possible ways to go. The first of these possible developments involves more and more detailed regulation of specific aspects of the research design, patient information, etc. When research 'scandals' are unveiled a standard response from politicians is 'We must have stricter regulation,' but it is doubtful whether this is actually a correct and useful response. Many of the 'scandals' concern research projects that have either never been approved by a REC or are conducted in breach of the approved protocol. It is, to say it mildly, unclear why and how stricter regulation can help in such cases. The more reasonable response seems to be to punish the transgressors (partly for reasons of future deterrence) and to ensure better control in the future, so that no unapproved research can be conducted, and breaches of the approved protocols can be detected and rectified. Stricter regulation without increased control may even in some circumstances be counterproductive because it can increase the incentive to try to circumvent the REC system, either by redescribing research as 'quality control' or 'routine data collection for statistical purposes,' by cutting corners in the actual conduct of research, or by carrying out the study in another country/jurisdiction with less constraining regulation.
What would be involved if RECs took the second route and began to monitor research projects?
Many models can be envisaged, but a comprehensive monitoring of research projects must involve at least three components:
- The researchers' self-assessment of compliance with the protocol.
- Site visits to control documentation and data-protection issues.
- Surveys of patients.
The first of these components would be the easiest to implement, but would give the least reliable data.
Researchers could simply be sent a standardised questionnaire at the end of their project, asking simple questions about consent and information procedures, etc. Although such a process will not generate absolutely reliable data because of problems of self-incrimination, it is not worthless. It becomes important because if researchers are asked about their consent procedures, their recruitment problems, their data protection measures, etc., they are given a chance to reflect upon their own practice and the practice of their co-workers, and this can, at least in some instances, lead to beneficial changes in practice. In the long run the mere fact that researchers know that they will be asked such questions may also lead them to proactively ensure that they comply better with the regulations than in situation where they know that no control is going to happen.
The second and third component are more difficult to implement and require a much greater investment of resources, but they are never the less important because they give a more accurate picture of the ethical conduct of research. By implementing direct control of a proportion of all research projects the REC will be able to detect if there are clear breaches of the rules and regulations governing research. The REC will furthermore be able to get a better feel for how the research is conducted within the different research active institutions in a given area, and this information may be valuable in the assessment of future research protocols.
It could be argued that the monitoring function should be separate from the RECs, and that it is a natural function of, for instance the bodies that authorise health care professionals. The conduct of unethical or unapproved research is a breach of professional duty, and should be controlled and sanctioned as any other kind of professional misconduct or malpractice (e.g., by official censure or removal of authorisation). This argument is not unreasonable but if a separation between the approval and monitoring functions was implemented in this way it would probably lead to an underutilisation of the information produced by the monitoring exercise. The authorising bodies are usually only interested in clear cases of professional misconduct, since it is only such cases that can form the basis for action against individual health care professionals. The RECs are (or should be) interested in a much broader range of information including the clear cases of misconduct, but also cases of exemplary or innovative research practice, and cases where the rules are not clearly broken but just bent in problematic ways. It is this broad range of information which will allow a REC to identify areas of research practice where intervention or guidance is necessary.
In order for RECs to fulfil such a monitoring role, and to utilise the information gained constructively, they must be given certain powers. The legislation or regulations governing RECs must clearly state that:
- RECs have a duty to monitor approved projects,
- RECs have a right to access and collect the information that is necessary to fulfil the duty, including a right to perform the necessary inspections at premises where research is taking place, and
- RECs are given authority to apply a range of sanctions to researchers who perform research that contravenes the regulations or the approval that has been given. RECs would also need more staff and more money, since good monitoring of research performance is very labour intensive.
If institutionally based RECs took on a more active monitoring role they might very easily come into conflict with some of the (perhaps more superficial?) interests of the institution. Regionally based RECs could more easily handle such conflicts of interest.
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Can the Danish REC System Be Transferred?
Although a number of problems in the current Danish REC system have been identified in this paper, the overall assessment is that the system functions satisfactorily, and that with a few modifications it could be brought to function really well. But can its structure be transferred elsewhere and the same level of functionality be expected?
One consideration to take into account is simply the matter of size. The system at the regional level is size-independent in the sense that a region can be subdivided, or more RECs established in a region if the number of research projects in the region grows too large. At the national level there is however size dependency. A CREC with representation of all regional RECs can only work if the number of RECs is reasonably small, otherwise the CREC will simply be too large. This problem can be handled as long as the increase in number of RECs is not large, for instance by only having one representative from each REC, but if there are 500 to 600 RECs there is no way to give all direct representation on a CREC. In such a situation it would seem reasonable to split the function of the CREC in two and establish two kinds of bodies. The first kind of body would deal with the appeal function of the CREC, and would be regional appeal-RECs each covering a number of RECs. On these A-RECs it would still be possible to have direct representation of the involved RECs. The second kind of body would be a national body issuing legally binding recommendations for the evaluation of research proposals in RECs.
The size problem also plays a role in considering the transferability of the Danish system for handling multi-centre trials, but here a further consideration also comes into play. Denmark is a fairly culturally homogeneous country, and although there are regional differences, it is still a viable assumption that a project that is acceptable in Copenhagen is also acceptable in the west of Jutland. Regional values are not so different that the approval of one REC cannot in most cases be extended to other RECs. This situation may not obtain in other countries where either regional differences are larger, or where certain sectors of the health care system are based on specific, for instance religious, value systems.
There is no reason to believe that the majority of lay members on Danish RECs could not be implemented successfully elsewhere, although the mode of appointment would probably have to be modified according to local political customs.
Similarly there seems to be no reason why regional RECs, with the advantages described earlier, could not be transferred to other contexts than the Danish. There may be some institutions that are so special, either because of their area of work, or because of the value system on which they are based, that they would require their own institutional RECs, but the number of such institutions must be fairly small. It is also important to note that even if the regional RECs in Denmark approve a research project this does not give the researcher any positive claim right against his or her institution to be allowed to perform the project at the institution. Under the current system REC approval only entails that the project fulfils a general societal set of ethical rules. If an institution wants to implement its own more stringent set of rules that option is still open.
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Acknowledgements
This paper builds on a number of my previous published papers in this area. Some of these have been published in collaboration with others, and I gratefully acknowledge the invaluable contributions of my co-authors S¯ren Madsen, Povl Riis, Peter Rossel, and Henrik R. Wulff.
I gratefully thank Rikard Vrogaard, Head of Secretariat, The Scientific-Ethical Committee for Copenhagen and Frederiksberg Municipalities, for many helpful comments to a draft of this paper.
Finally I thank my mother Edith Holm, current member of the Danish Central Scientific-Ethical Committee, for many informative and helpful discussions over the years.
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Footnotes
Cite this page:
"The Danish Research Ethics Committee System, Overview and Critical Assessment (Research Involving Human Participants V2)"
Online Ethics Center for Engineering
6/14/2006
National Academy of Engineering
Accessed: Monday, September 06, 2010
<www.onlineethics.org/Topics/RespResearch/ResResources/nbacindex/nbachindex/hholm.aspx>