The Danish Research Ethics Committee System, Overview and Critical Assessment (Research Involving Human Participants V2)
The Danish Research Ethics Committee System1
Overview and Critical Assessment
SÖ 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