The scientific = ethical committees =96 yesterday, today and tomorrow

The=20 scientific ethical committees =96 yesterday, today and=20 tomorrow

-A=20 publication to mark the 20th anniversary of the scientific ethical = committee=20 system

Foreword

The=20 scientific ethical committee system in Denmark turned 20 in the year=20 2000.

The=20 Danish Central Scientific Ethical Committee chose to celebrate this = anniversary=20 on 10 November 2000 at a conference held in the historic parliamentary = hall of=20 the Landsting at Christiansborg Palace, seat of the Danish Parliament.=20

At=20 that conference we focused on the development of the committee system up = to the=20 present day and the challenges it faces in the = future.

We=20 had asked a number of people=97both inside and outside the committee = system=97to=20 shed some light on the work of the committee system in the past, present = and=20 future.

I=20 myself thoroughly enjoyed hearing the visions of future challenges = presented by=20 our users. It gave food for thought. We intend to use these visions and=20 suggestions in our future work to improve the committee system=97in = particular, to=20 improve the protection of trial subjects.

We=20 must never forget that good research is only good research if it is also = ethically acceptable. The principal task of the scientific ethical = committees is=20 to ensure that we conduct only research projects which are ethically = defensible=20 in Denmark. Thus it was yesterday, so it is today and so too it will be = in the=20 future, when we shall find ourselves facing such great challenges as = trials=20 involving xenotransplantation, fetal stem cell cloning and the increased = internationalization of research.

In=20 order to convey to a wider audience the interesting papers delivered at = the=20 conference, we have asked the individual speakers to resume the views = they put=20 forward in a short article. I should like to thank the individual = speakers for=20 having risen to this challenge.

By=20 the Chairman of the Danish Central Scientific Ethical Committee, = Kamma=20 Bertelsen, MD,=20 Medical Director

Contents

Foreword=20

By=20 the Chairman of the Danish Central Scientific Ethical Committee, = Kamma=20 Bertelsen, MD,=20 Medical Director

New = guidelines for=20 trials =20 7

By=20 Birte=20 Weiss,=20 Danish Minister for Information Technology and = Research

Introduction and=20 development of the committee system =20 12

By=20 Professor Povl=20 Riis,=20 MD

The = scientific=20 ethical committee system in the year 2000 =20 16

By=20 Chairman Kamma=20 Bertelsen, MD,=20 Medical Director

The = ethical dilemma=20 of the end that justifies the means =20 21

By=20 the Chairman of the Danish Council of Ethics, Erling=20 Tiedemann

Many = patients do=20 not wish to take part in trials =20 25

By=20 S=F8ren=20 Madsen,=20 MB, PhD, Clinical Assistant

Society=92s=20 requirements and expectations =20 28

By=20 Poul=20 Nyrup Rasmussen,=20 Prime Minister of Denmark

The = patient and the=20 scientific ethical committee =20 35

By=20 Karen=20 Ellen Spannow,=20 Ethnographer

The = researcher and=20 the scientific ethical system =20 37

By=20 Professor Jens=20 Christian Djurhuus,=20 MD

The=20 scientific ethical committee system and the danish medicines agency=97an = example=20 of fine cooperation =20 41

By=20 Jan=20 Renneberg,=20 MD, Head of Division

Expectations=20 and requirements of the danish association of the pharmaceutical = industry =20 43

By=20 Thim=20 Engel,=20 Medical Director of Glaxo Wellcome A/S, member of the Danish Association = of the=20 Pharmaceutical Industry (LIF)

What=20 requirements and expectations do the regional scientific ethical = committees=20 believe they need to meet? =20 45

By=20 Henning=20 Kvist Poulsen,=20 MD, Medical Director, Chairman of the regional committee for the = counties of=20 Ringkj=F8bing,

Ribe=20 and South Jutland

What=20 challenges does the committee system face in the future=97nationally and = internationally? =20 47

By=20 Jens=20 William Grav,=20 MSc. (Pol.Sci.), Head of Section, member of the Danish Central = Scientific=20 Ethical Committee

Appendices =20 53

New=20 guidelines for trials

By=20 Birte Weiss,

Danish=20 Minister for Information Technology and = Research

The=20 scientific ethical committee system in Denmark started in 1980 on a = voluntary=20 basis as an initiative among biomedical researchers. The basis was the = Nuremberg=20 Code and the Declarations of Helsinki. Today it is gratifying to see a=20 functional ethics committee system, which has grown from the bottom = up=97from the=20 grass roots, the biomedical researchers=97and has now reached adulthood. = The=20 frameworks and main components for the committees=92 work are now in=20 place.

We can be proud of = the Danish=20 scientific ethical committee system, which is unique. Denmark is the = only=20 country to have a coherent, nationwide committee system with common = guidelines=20 and statutes. Other countries=97including the other Nordic = lands=97chiefly have=20 institutional committees with very low representation of lay people. The = make-up=20 of the scientific ethical committees is a splendid example of democratic = dialogue and cooperation between experts and the rest of=20 society.

Regulations and=20 legislation

Along=20 the way, the committee system has become more rule based. For many years = the=20 recommendations of the Central Scientific Ethical Committee formed the = basis for=20 the committees=92 work, and in 1992 the scientific ethical committee = system was=20 regulated by law.

The Danish Act on = the=20 Scientific Ethical Committee System lays down the legal framework for = the=20 scientific ethical assessment of research projects in overall terms. The = requirement of informed consent is entirely fundamental to the rules = governing=20 the scientific ethical assessment of research projects and to the = committee=20 system.

Informed=20 consent must meet specific criteria:

=95=20 The trial subjects=92 participation must be absolutely=20 voluntary

=95=20 Informed consent must be given in writing.

=95=20 Trial subjects=92 consent must be explicit.

Inter=20 alia, trial subjects must be informed:

=95=20 ‑of the aim of the trial. Is it a meaningful project at all? Is = quality up to=20 standard?

=95=20 of all possible side-effects,

=95=20 of all known risks associated with the trial,

=95=20 of drawbacks and inconveniences,

=95=20 that participation is voluntary,

=95=20 that they can always withdraw from the trial = again.

The=20 informed consent requirements were placed on a statutory footing with = the Danish=20 Committees Act of 1992. Down through the nineties, however, there turned = out to=20 be a need to intensify the informed consent requirement and lend more = specific=20 shape to it. In November 2000, therefore, we=97the committees and = I=97collectively=20 sent out an executive order and a guideline on information and consent = in the=20 case of biomedical trials.

The executive order = is=20 directed at researchers, trial subjects and the committees alike. On the = skeleton of the executive order and the guideline we have fleshed out = all phases=20 of a biomedical research project, from introductory planning to = follow-up=20 control of project handling; and we have attained a national legal = commitment in=20 accordance with international rules.

The guideline is = addressed=20 primarily at researchers and offers a broader description and = explanation of the=20 rules about information, consent and risk evaluation. In addition, there = is a=20 series of instructions about registration and approval of projects as = well as=20 follow-up control for the same.

The guideline is = supplemented=20 by a folder describing the basic conditions surrounding biomedical = trials and=20 the rights of the trial subjects. The folder targets future trial = subjects and=20 is a fine example of the way in which the task of dialoguing with trial = subjects=20 is being taken up by the scientific ethical = committees.

The=20 committee system=92s basic dilemma

The=20 Act, the executive order and the guideline have provided us with a set = of new=20 and unified rules governing medical trials. It is an area that can be = sensitive=20 and difficult to handle. I hope that the new rules will cast light on = the area=20 for researchers, committees and trial subjects.

The=20 rules illustrate the twofold task of the committee = system:

=95=20 The most important thing is to protect trial = subjects.

=95=20 ‑In parallel with this, the committees must put in place sensible = terms for=20 high-quality biomedical research.

The=20 two overriding tasks of the committee system are rooted in the basic = dilemma=20 faced by biomedical research and the committees: on the one hand, to = promote=20 research for the benefit of the common good; and on the other hand, to = protect=20 the integrity and dignity of the individual trial subject. No one must = be=20 disadvantaged as a result of taking part in biomedical trials, yet it = must be=20 possible to have e.g. new medicine or a new form of therapy tested. It = is a=20 difficult balancing act.

Regard for the individual = always=20 precedes regard for the advancement of scientific knowledge. That is and = must=20 always be the point of departure. In such cases the end cannot justify = the=20 means=97there are basic rights that apply to the individual, even in his = or her=20 capacity of trial subject. Society wants research=97but not at any=20 price.

Protection=20 of trial subjects and regard for research are not necessarily = incongruous. The=20 ability to find trial subjects who are willing to take part in a trial = is=20 altogether central to the possibility of biomedical research and to = biomedical=20 trials. And this is possible only if society can have properly founded=20 confidence in research projects complying with society=92s ethical = standards. The=20 committees vouch for that compliance.

I think that the = new rules on=20 information and consent that we have just sent out hit the mark in the=20 fundamental balancing of trial subjects=92 interests against the = interests of=20 research.

Regulating=20 trials in progress

Another=20 aspect of the committees=92 work is the follow-up control on research = projects.=20 The new executive order and guideline on biomedical trials cover all = phases of=20 biomedical research, including regulation of those projects=20 approved.

Researchers are = basically=20 self-regulating, in ethical terms, providing a guarantee for much of the = way in=20 the sphere of ethics. Formalized control by the committees will have an=20 additionally reassuring and preventive effect.

Overall, the = scientific=20 ethical committees are in the cross-field between research and ethics,=20 overseeing consideration of the regard for the individual vis-=E0-vis = the=20 interests of science. Patients have an understandable interest in having = their=20 illness cured, while the researcher often has an interest in his or her=20 project.

To a great extent, = the two=20 interests coincide=97but there can be conflict. The committees are = guarantors that=20 the process will not go off the rails and that regard for the individual = always=20 weighs more heavily than regard for science. We have now been given = rules that=20 cover the entire spectrum, from planning to implementing and completing = a=20 project. It remains to be seen how the new rules are going to work in = the=20 future.

The=20 committees=92 role as guarantors

The=20 scientific ethical committee system is a guarantor in the field of = ethics=97a=20 guarantor for trial subjects and a guarantor for researchers that the = ethical=20 dimension is sound and will not bar the way for new biomedical projects = in the=20 future. I trust that the new executive order, guideline and folder on=20 information and consent will elucidate the area and be of assistance to=20 researchers, trial subjects and committees alike.

It is my impression = that the=20 committees contribute important input with regard to protecting trial = subjects=20 and guaranteeing scope for new biomedical knowledge. I should like to = offer my=20 congratulations on the occasion of the anniversary and anticipate that, = having=20 now attained adulthood and gained the support of law based controls and = other=20 regulations, the committees will continue to make a valuable = contribution to=20 upholding the ethical principles governing biomedical=20 trials.

Introduction=20 and development of the committee system

As=20 well as safeguarding trial subjects, the Danish scientific ethical = committee=20 system has boosted the quality of biomedical trial = plans.

By = professor=20 Povl Riis, md

The=20 history of the scientific ethical system has long-reaching roots, even = in that=20 part of the events familiar to me from personal experience. In = accordance with=20 the concept of the duality of scientific ethics, science and ethics, the = committee system also has two parallel roots. One is clinical science, = i.e. the=20 emergence of patient-centred science in the 20th century. The other is = the=20 rediscovered visibility of non-tangible values after the Second World = War=92s=20 violation of fundamental human rights.

Methodology=20 and systematic approach

In=20 its systematic form, clinical science is no more than about 100 years = old. The=20 Dane Johannes Fibiger introduced it in 1898. With the First World = War=92s blockade=20 on international scientific links, however, the innovation was virtually = forgotten for 50 years, even in Denmark. In 1948 the Englishman Austin=20 Bradford-Hill rediscovered clinical science and created contemporary = clinical=20 research methodology, i.e. the doctrine of scientific trial planning,=20 implementation, interpretation and publication.

Today we can = ascribe the=20 innovation of the methodological umbrella term to two basic principles: = one that=20 all evaluation is based on comparisons, the other that the pattern of=20 pathological and life processes constantly varies.

In order to take = the two=20 principles on board, new tools were taken into the service of medical = science.=20 Notions like control groups, drawing lots, blinding of both trial = patients and=20 investigators, and the use of placebo preparations were introduced.=20

The new methodology = necessitated some break with the traditional patient/doctor = relationship,=20 wherein dwelt the illusion of a tailor-made investigation and treatment = regime=20 for the individual patient.

These new = realizations and=20 their derived tools made their impact in Denmark at the beginning of the = 1960s.

The=20 century of the declarations

The=20 second root from recent history was an acknowledgement of the necessary = validity=20 of fundamental, non-tangible values=97for the patient-doctor = relationship, too,=20 particularly in trial situations. This turned into a show-down with = paternalism,=20 placing the emphasis on the right of self-determination instead. The = requirement=20 for truth imposed on information increased at the same time as issue was = taken=20 with the medical atrocities of the concentration camps. All this led to = both the=20 1948 Geneva Declaration and the 1st Declaration of Helsinki from=20 1964.

But for a young = generation of=20 clinicians interested in research, these initiatives were not = sufficient, as=20 judged from the level of hands-on science. The enthusiasm of young = doctors led=20 to a revivalist-style initiative, which in turn led to the World Medical = Association asking myself and two of my Nordic colleagues, Erik Enger = from=20 Norway and Clarence Blomquist from Sweden, to write a new 2nd = Declaration of=20 Helsinki.

In the new version = we=20 stressed the need for ethical evaluations to be undertaken by = independent=20 committees, and thus the way was paved for a Danish=20 system.

Tentative=20 beginnings

The=20 World Medical Association adopted the 2nd Declaration of Helsinki in = 1975.=20 Immediately afterwards Denmark took the first step towards creating = independent=20 committees. Bolstered by the Danish Research Administration under head = of=20 section Lis Attrup, a series of meetings was arranged with all parties=20 concerned: the Ministry for the Interior as representative of national = hospital=20 management, the Association of County Councils in Denmark, the = universities, the=20 scientific health research societies, the professional organizations for = inter=20 alia dentists, pharmacists, doctors and many more. The result was a = consensus to=20 create an official Danish, though initially non-law based scientific = ethical=20 committee system.

An official report = from 28=20 March 1977 described the committee system. This was followed up with = statutes=20 and rules of internal procedure for the regional committees and the = Danish=20 Central Scientific Ethical Committee in November = 1977.

Far=97reaching=20 danish model

Being=20 the first country in the world to decide to establish a nationwide, = independent=20 committee system, Denmark had a free hand when it came to choosing its=20 structure, professional range and membership etc.=97an opportunity of = which it=20 took full advantage.

Firstly, it was = decided that=20 those disciplines that come into research-related contact with the = Danish=20 population within the framework of the health service and similar = educational=20 and research institutions should all be covered by one set of rules and = one=20 corresponding committee system. Consequently, not only pharmacists, = dentists and=20 doctors were covered; also nurses, physiotherapists, occupational = therapists,=20 psychologists, midwives, biochemists, civil engineers and others who = might=20 become participants in health-professional research would be=20 included.

Considering that = there was no=20 legal provision for demanding=20 such=20 endorsement of the new system, it was impressive to experience the = support=20 accorded to the plans for a scientific system.

The next decision = concerned=20 the question of whether the Danish committees were to be institutional,=20 i.e. linked to universities and major hospitals, say, or regional,=20 i.e. responsible for all biomedical research involving human subjects = within a=20 geopolitical area.

The choice fell on = the=20 latter, in order to thereby involve the part of research that takes = place in=20 general medical and dental practice in the pharmaceutical industry and = in=20 governmental research institutes.

The=20 danish model

The=20 third question was the representation of lay people in the Danish = committee=20 system. The earmarking model was familiar from abroad, i.e. a formalized = requirement for "one legal adviser" and/or "one theologian" on the panel = of=20 members, or "one lay person" (usually a woman) as representative of the = human=20 and social considerations for trial patients and healthy trial subjects. = In=20 Denmark an equal apportionment between scientific and non-scientific = members was=20 chosen. This was based on the fundamental outlook that when it comes to = ethics,=20 lay people are just as much experts as researchers and even have the = advantage=20 of being independent of research ambitions and = interests.

The construct = aroused=20 international astonishment but has since been fully accepted as "The = Danish=20 Model". We subsequently went even further in Denmark by creating a lay = majority=20 on all committees through the 1992 Act on a Scientific Ethical Committee = System.

It was decided to = recruit the=20 lay people from the existing representative democracy, i.e. from county = councils=20 and equivalent bodies, not from the patients=92=20 organizations.

One=20 central and eight regional committees

Another=20 major decision had to be taken. Should the Danish system be one or two = pronged?=20 Resort was had here to a Danish tradition from the judicial system and = other=20 institutions whose decisions have a radical effect on citizens=92 lives, = to wit=20 the establishment of an appeals body. It thus became a system with = seven=97later=20 eight=97regional committees, based on one or more counties (with the = traditional=20 special arrangement for the City of Copenhagen and the Municipality of=20 Frederiksberg) as well as a central committee with two members from each = regional committee, one lay and one scientific, and a ministerially = appointed=20 chairmanship.

Many=20 things besides trial protocols

During=20 its 20 years in existence, the committee system has met with a large but = also=20 significant workload, assessing up to 3,000 trial protocols annually. = With=20 decreasing frequency it has been possible to view the system as a=20 bureaucratically dilatory element of the researchers=92 community, but = it has also=20 meant a boost in quality for biomedical trial plans, in addition to = fulfilling=20 its prime objective: obtaining optimal security and respect for Danish = patients=20 and healthy trial subjects.

The Danish = experience amassed=20 from 20 years of committee work and long preparations has led to Denmark = having=20 expert status within the EU in the assessment of scientific ethics = projects, on=20 the Council of Europe during the formulation of the 1997 Bioethics = Convention=20 and in the continuing work on a so-called protocol that includes only = biomedical=20 projects whose object is human, as well as international work on ethics=20 involving the use of biobanks and, finally, on the Nuffield Foundation = in London=20 to articulate a much needed set of rules for the developed countries=92 = research=20 cooperation with the developing countries in order to prevent=20 exploitation.

The=20 scientific ethical committee system in the year=20 2000

The=20 mounting demands on the scientific ethical committees will be hard to = satisfy=20 unless more resources are earmarked to deal with the great number of=20 protocols.

By = Chairman=20 Kamma Bertelsen, MD, Medical Director

There=20 are currently eight regional committees. In those areas where the large=20 university hospitals are located, the committee includes only one = county, e.g.=20 Copenhagen County and Aarhus County. In areas with less research = activity,=20 several counties have been merged into one committee. For the City of = Copenhagen=20 and the Municipality of Frederiksberg, there are so many cases that it = has been=20 necessary to set up two committees.

Structure=20 of the committees

The=20 committees usually have seven members, i.e. four lay persons and three=20 specialists. The committees=92 term of office follows the county council = elections. Members are appointed by the county council. The lay members = are=20 generally county council politicians, whose appointment is based on = political=20 considerations. The appointment of specialists is also done definitively = by the=20 county council, but subject to prior approval by the three research fora = for the=20 universities in Copenhagen, Aarhus and Odense. This is intended to = ensure that=20 specialists have insight into research, e.g. by being active = researchers.=20

The committee = elects its own=20 officers. Most committees have a specialist as chairman, but there are = also=20 committees chaired by a lay person. This is the case on the Vejle, Funen = and=20 North Jutland committees. If the chairman is a doctor, the vice-chairman = must be=20 a lay person and vice versa.

The Danish Central = Scientific=20 Ethical Committee has 20 members, 16 of whom are designated by the = regional=20 committees, gen-erally the chairman and vice-chairman; two are = appointed by=20 the Minister for Research and two by the Minister for Health. Of the = four=20 ministerially appointed members, there is only one specialist. This = means that=20 both the regional committee and the Danish Central Scientific Ethical = Committee=20 have a predominance of lay people.

The=20 committees=92 task

Under=20 Danish law, it is the task of the regional committee to approve trials, = monitor=20 approved trials and contribute to the ethical debate in the=20 region.

The bulk of the = committee=92s=20 efforts consists of approving trials. Only to a very moderate extent has = it been=20 engaged in inspecting trials already set in motion. Wherever possible, = the=20 committees have attempted to take part in the ethical debate at regional = level.

When approving = trials, the=20 committees evaluate protection of the trial subjects above all. In = addition, the=20 law also requires the emphasis to be placed on scientific standards, as = the=20 committee must evaluate whether the trial meets proper scientific = standards in=20 terms of purpose and method, and whether there is an adequate basis for=20 implementing it.

This evaluation = needs to be=20 made because it is unethical to include people in trials that are not of = a=20 sufficiently high scientific standard. The background to the trial must = be=20 clarified by reviewing the literature, and its design and method = evaluated. In=20 addition, consideration must be given to whether it is expected to = include a=20 sufficiently large number of people to achieve statistical=20 significance.

The committees = often have to=20 rely on the researchers themselves having scoured the literature in = sufficient=20 detail and having undertaken the necessary calculations. In some = instances the=20 committee does not possess the professional/specialist insight to = evaluate these=20 things and therefore has to request assistance from external=20 consultants.

Lay=20 people paint a more subtle picture

The=20 structure of the Danish committee system has many advantages. The large=20 representation of lay people makes the system open and transparent, as = well as=20 ensuring that the patient information leaflets are comprehensible. There = is good=20 communication with the public and with political = circles.

The disadvantages = of the=20 committee system are the small number of specialists. Sometimes the = committee=20 lacks the requisite specialist insight to perform a qualified = professional=20 evaluation. Given the dearth of medical specialists that exists, it is = also=20 becoming very difficult to recruit research experts to the=20 committees.

The lack of = specialist=20 expertise is a problem that must be resolved if there is still to be = respect for=20 the committees=92 work. I am therefore proposing to discuss whether the=20 introduction of exemption from service or the payment of fees might make = it more=20 attractive to sit on the committees. However, it must be stressed that = the fee=20 can never be allowed to reach such proportions that sitting on a = scientific=20 ethical committee can become a livelihood.

A panel of expert = consultants=20 should be formed whom the committees can consult when they themselves do = not=20 command the requisite specialist expertise. If deemed appropriate, such = a group=20 of specialist consultants can be remunerated on a par with members of = the Danish=20 Patients=92 Board of Complaints.

Problems=20 needing to be resolved

The=20 scientific ethical committee system in Denmark functions smoothly today = in many=20 ways. The large representation of lay people has proved a good=20 idea.

However, if the = committee=20 system is to continue operating smoothly and to be equipped to face the = demands=20 of the future, there are a number of problems that need to be resolved, = e.g.=20 shared databases, consolidation of the committees=92 specialist = expertise and the=20 introduction of controls on approved trials. The initiative has already = been=20 taken to implement a large number of improvements in 2001, giving us an = even=20 better committee system in the future.

1,200=20 cases in one year

The=20 committee system dealt with 1,200 new cases in 1999. The number of cases = was=20 previously given as 3,000=97a figure arrived at by including multicentre = cases on=20 several committees and supplementary protocols.

The=20 table shows the number of cases in 1999 broken down by regional = scientific=20 ethical committee:

The=20 Scientific Ethical Committee for Copenhagen County =96 = 169

The=20 Scientific Ethical Committees for the City of Copenhagen and the = Municipality of=20 Frederiksborg =96 422

The=20 Scientific Ethical Committee for the counties of Bornholm, = Frederiksberg,=20 Roskilde, Storstr=F8m and West Zealand =96 86

The=20 Scientific Ethical Committee for the counties of Vejle and Funen =96=20 140

The=20 Scientific Ethical Committee for the counties of Ribe, Ringkj=F8bing and = South=20 Jutland =96 60

The=20 Scientific Ethical Committee for Aarhus County =96 = 258

The=20 Scientific Ethical Committee for the counties of Viborg and North = Jutland =96=20 67

The=20 ethical dilemma of the end that justifies the = means

A=20 legitimate end does not legitimize using any means=20 whatsoever.

By = the chairman=20 of the danish council of ethics, Erling Tiedemann

The=20 statement about the end justifying the means is normally used to express = criticism of a course of action taken by others, but rendered in = value-free=20 terms and modern English it might run like this: The=20 end legitimizes the means.

Phrased in this = way, it is an=20 expression that need not be correct, though nor need it be=20 wrong.

When=20 the end legitimizes the means

It=20 is not allowed to just blow up other people=92s houses, for example, but = when=20 Copenhagen was burning in 1728, the conflagration was finally arrested = by=20 blowing up a house to create a gap in the row of houses as a=20 fire-break.

The end was to stop = the fire;=20 the means was to blow up a house.

So was it OK? Did = the end=20 legitimize the means? Most people will probably reply in the=20 affirmative.

Among the sailors = of Holmen=20 (the Royal Dockyard in Copenhagen) called in to fight the fire, however, = some=20 were aware that there was a sizable stock of wine in the cellar of the = house, so=20 they crept down into the cellar and got stuck into drinking the=20 wine.

The demolition = squad knew=20 nothing of what was happening=97and so the sailors of Holmen went the = same way as=20 the house and the wine, i.e. up in smoke.

It was an accident, = of=20 course. But for the sake of argument, let us imagine that they knew = perfectly=20 well that there were people in the house. Would we still say now that = the=20 explosion was ethically acceptable?

Faced with such an = explosion,=20 some of us might find ourselves in two minds even about the wine=85 but = the=20 majority will surely feel that the limit to what is permissible=97and = hence the=20 limit to the truth value of the statement about the=20 end justifying the means=97ran=20 not between the house and the wine, but between the material values and = the=20 sailors, or in other words: between the objects and the=20 people.

The=20 difficult borderline

So=20 a legitimate end does not legitimize using any means whatsoever, and the = criterion here must be of an ontological nature=97i.e. pertain to the = nature of=20 the situation, the essence of things, the distinctive character of that = which=20 exists, or however one wishes to try=97perhaps with a touch of hesitant=20 humility=97to express the fact that not everything is an object, but may = be a=20 person, for instance. And people=97incidentally=97are not just anything = either, e.g.=20 not animals, plants or insects.

With reference to = the=20 expression that the end justifies the means, therefore, we might = conclude that=20 there are things which should not normally be done but which may be = ethically=20 acceptable under special circumstances because the purpose can justify = the=20 action, but that=97conversely=97we can also reach a boundary where we = have to say=20 that, no matter how good the intention, we are now verging on something = that we=20 cannot do because in the process we would end up overstepping an ethical = limit=20 that must not be overstepped.

In society, = however, we have=20 a terrifically hard time getting round to taking a stance on such=20 limits.

Standard=20 replies and slippery slope arguments

One=20 of the tasks of ethics is to rationalize our moral choices and our = stance on=20 ends and means alike, and on what can justify what, but what of these=20 rationales?

We are often forced = to admit=20 that in the ethical debate such rationales are frequently rather = shallow,=20 building on certain automaton-like replies, certain boilerplate=20 arguments.

Let me mention one = or two of=20 them.

"Well, we=92re = already doing=20 trials on embryos for up to a fortnight," they say, for example. "So = what=92s to=20 stop them being used to clone stem cells?" That is the typical slippery = slope=20 argument that implicitly presupposes that what we have been doing until = now is=20 ethically acceptable, simply because we have=20 been=20 doing it. But that is by no means a given. In reality we ought to have = _the=20 courage to subject the decisions of the past to ethical revision more = often,=20 instead of just blindly continuing to build on them. "If it=92s legal to = perform a=20 termination up to the 12th week, what=92s to prevent the aborted fetuses = being=20 used and making medical products from them?", the argument goes. The = question=20 contains an implicit but erroneous assumption that whatever is legal is=20 therefore also ethically acceptable by default. But who on earth says = so? There=20 is plenty of unethical legislation in this world.

Another example: = "Performing=20 therapeutic human cloning," they say, "is not quite as bad as performing = reproductive cloning would be." That is possible; we need to discuss it. = But one=20 thing does not necessarily become ethically acceptable just because it = is=20 possible to mention something else that is worse.

One last example: = "They=92re=20 already doing it abroad after all!" That may well be true=97but so what? = Is a=20 practice in foreign parts per se a determinant of what is=20 ethical?

I think you can = recognize all=20 these examples of arguments from the ethical debate, and perhaps we need = to=20 venture to contemplate whether the standard replies that are second = nature to=20 us, as it were, are actually correct.

Should=20 we invariably treat?

It=20 is a common ethical assumption, as you know, that if it is possible to = treat=20 disease and relieve human suffering, then it must be = done.

There is little = disagreement=20 on that score. But perhaps there is little reflection on it=20 too.

We have many = renally impaired=20 people in Denmark, for example, who are waiting for a transplant. Why = not just=20 buy them kidneys in India?

We don=92t do that, = because we=20 recognize that we would be crossing an ethical boundary that ought to be = regarded as sacred. We don=92t exploit people=92s distress and poverty = that way;=20 and, what is more, we even have the basic ethical tenet that human = organs must=20 not become a commodity=97a thing.

So now, at any = rate, we have=20 put an initial question mark against the standard answer we always=20 give.

The end does not = justify the=20 means if the means is not alright. A legitimate end cannot legitimize = the use of=20 any means whatsoever. We sometimes come to a boundary where we have to = say that,=20 no matter how good the end and no matter how urgent the objective = appears to us,=20 we are now verging on something that we are not allowed to do, because = we know=20 that to use such means would be to overstep an ethical boundary that = must not be=20 overstepped=97one which, moreover, must never be overstepped, no matter = how good=20 the intention we may have.

Often we talk of = the=20 "slippery slope". The problem in many cases is not whether, formally = speaking,=20 we could later say no to B if we have said yes to A. The problem with = the=20 slippery slope is that by saying yes to A, in the same process we often = say yes=20 to B, though we may delude ourselves and others into thinking we would = never do=20 it. For if the ethical rationale we accept for saying yes to A is = simultaneously=20 an equally tenable rationale for B, then in the same process we have = actually=20 said yes to B. On subsequently arriving at B, then, we encounter = precisely the=20 standard argument mentioned: "We have already said yes to A, what is to = prevent=20 B?"

The slippery slope = is where=20 we end up the first time we vouch for something limited with reasoning = that may=20 as well justify something more far-reaching. The slippery slope is where = we end=20 up if the end is allowed to justify a means that is=20 reprehensible.

One=20 and all

But=20 what, then, can act as a guiding principle if an ethical evaluation is = to=20 crystallize in a decision about where to draw the line in each specific = instance=20 between the means the end can justify and the means it cannot legitimize = because=20 it would entail a blatant disregard for more fundamental ethical=20 values?

In our culture, = more=20 fundamental values of this kind have a hard time asserting themselves = against=20 the prevalent philosophy of utilitarianism and rights. They are not = based on=20 consideration of "what harm can it do?"=97well, at least not on the face = of it=97but=20 on far more long-term considerations along the lines of: "What will = happen to=20 ourselves as people if we embark on this path?"

An important = consideration in=20 this regard is that violating the dignity of one human being may, in a = way, mean=20 violating not only that person=92s dignity but the dignity of humankind = as such.=20 Everyone is wronged when the dignity of the person is wronged. Equally,=20 therefore, everyone is duty-bound to respond when the dignity of the = person is=20 violated in relation to the individual.

Many=20 patients do not wish to take part in trials

The=20 patient=92s experience of being a trial subject is partly dependent on = the number=20 of doctors the patient meets along the way during the trial period. Too = many=20 doctors make for a negative experience, questionnaire studies=20 show.

By = S=F8ren Madsen,=20 MB, PhD, Clinical Assistant

Recent=20 years have seen an additional decline in patient participation in = medical trials=20 from a level that was already low. The problem is global and presumably=20 universally valid, but has been most visible and debated within = therapeutic=20 trials connected with severe cancer.

Serious=20 consequences

The=20 trend has serious consequences because the anticipated improvements in=20 treatments and investigative methods are being postponed or, at worst,=20 prevented.

In addition, the = validity of=20 future results is being compromised. These, after all, were achieved in = a small=20 and declining random sample of the total volume of patients, where the = selection=20 factors are completely unknown for the main part. In other words, it is=20 extremely uncertain whether those patients taking part in trials differ = in=20 relevant ways from those opting not to take part in trials. This = selection of=20 patients for trials is crucially important, as the results are usually = just=20 transferred for use in the entire population.

As a further = corollary, there=20 will be a growing need to enlarge the number of research centres = required to=20 take part, both nationally and internationally, with increasing demands = on=20 finances as a result. There is also the risk that only financially = strong=20 companies will have the requisite finances to sponsor trials in the = future.=20 There is thus the fear that problem issues of no commercial interest = will be=20 explored to a decreasing extent.

Why=20 do patients opt out?

The=20 negatively charged media debate on trials has presumably been an = instrumental=20 factor in patients increasingly opting out of participation in trials. = There is=20 currently very little knowledge about patients=92 reasons for agreeing = or=20 declining to take part in medical-science trials and how trial subjects = evaluate=20 the information they receive. Our knowledge about patients=92 motivation = for=20 taking part in trials is even smaller.

In an attempt to = clear up=20 some of the unanswered questions, we carried out a series of = questionnaire=20 studies in the period 1995-99, based out of the Copenhagen University = Hospital=20 at Herlev.

The study included = both=20 healthy and sick people. Their replies have given us new knowledge about = people=92s attitudes towards different aspects of medical trials. The = study also=20 answers essential questions about the factors that determine whether = people say=20 yes or no to taking part in trials=97and how the patient perceives being = a trial=20 subject.

The study had an = ascending=20 severity gradient built in, from healthy persons in the normal = population to=20 patients in relatively severely stressful therapeutic trials connected = with=20 cancer.

Questionnaires were = issued to=20 a total of 877 individuals, 622 of whom we received replies from (see = box for=20 further details concerning the trial groups).

The=20 necessary trials

Attitudes=20 to medical trials were positive in all groups=97including patients who = had=20 declined to take part in trials. A majority in all groups found = scientific=20 trialling necessary prior to the introduction of anything new. The study = indicates that patients faced with the possibility of taking part in a = relevant=20 trial are generally more clear on their attitude to trials than = individuals=20 whose participation in trials is more hypothetical. The closer = respondents were=20 to relevant trials, the more positive their basic outlook on trials and = their=20 attitude to both their own participation and that of=20 others.

The potential trial = participants in the healthy background population had a more positive = approach=20 to other people=92s participation in trials than to their own = participation=97a=20 tendency also visible in cancer patients opting out of trial = participation.=20 Patients currently taking part in trials, as compared with patients = opting not=20 to take part in trials, were more positive towards both their own = participation=20 and that of "others".

Both egoistic and = altruistic=20 motives for trial participation were graded high in all groups. Patients = thus=20 took part in trials not merely because they hoped to be cured, but = largely also=20 to contribute towards improvements in the treatment of future=20 patients.

A hotly discussed = topic in=20 connection with trial participation has been the "drawing-lots=20 principle".

Of those in the = population=20 questioned, at outpatient clinics and among patients taking part in = trials, only=20 half had a positive view of the "drawing-lots principle" = (randomization).=20 Attitudes were more negative on the part of people who did not wish to = take part=20 in trials, where the actual drawing-lots principle and fear of "the = unknown"=20 were the primary reasons for declining to take part in=20 trials.

One=20 doctor better than several doctors

In=20 our study, the trial participants not suffering from cancer were = generally more=20 satisfied with the information provided than both those suffering from = cancer=20 and the people who had opted not to take part in = trials.

Trial participants = suffering=20 from cancer did not feel they had been given comprehensive information = in the=20 course of the trial. They had a higher degree of unanswered questions = and had=20 experienced the trial as being more time consuming than=20 expected.

The most important = single=20 reason for the positive trial experience among participants not = suffering from=20 cancer was the fact that they had been monitored by only one doctor = throughout=20 the whole trial cycle. Trial subjects who had been diagnosed with cancer = were=20 typically treated by 5-8 doctors, which was the prime cause of their = negative=20 trial experiences.

The presence of the = scientific ethical committee system was important for the trial = subjects=92=20 decision to take part in trials, just as virtually all potential trial = subjects=20 considered the committee system important for their attitude to=20 trials.

Patients who refuse = to take=20 part in trials have no moral scruples on that account. Only a minority = of the=20 patients felt that declining to take part in trials would create a moral = problem; equally, only a third of potential trial participants in the = population=20 and among outpatients accepted trial participation as a moral=20 obligation.

Ample=20 time for information

In=20 order to ensure that patients are willing to take part in future trials, = the=20 requisite resources need to be set aside=97in terms of both time and=20 finance=97possibly also through funding from the drug companies=20 involved.

The key concept is = still=20 trust between doctor and patient. In order to preserve=97and = expand=97this, the=20 patient should see only a limited number of doctors during the trial.=20 Familiarity with the trial protocol on the part of the doctors involved = is=20 crucial to the relationship of trust. Plenty of time must be set aside = for=20 providing information, and the written information (preferably detailed) = must=97of=20 course=97be worded in understandable Danish without the use of = unnecessary jargon.=20 Finally, time must be reserved to allow patients to reconsider before = making=20 their final decision.

Parts=20 of the questionnaire study have been published in the following = journals:=20 Journal of Internal Medicine 1999; 245: 571-9, Ugeskrift for L=E6ger = 1999; 161:=20 2661-6. Bulletin of Medical Ethics 2000; 159: 13-18. Journal of Internal = Medicine 2000; 248: 461-73. Additional information about the study is = available=20 on application to S=F8ren Madsen at the Copenhagen University Hospital = at Herlev,=20 Medical Ward C, tel. (+45) 4488 4488; pager 381; e-mail:=20 smadsen@dadlnet.dk

S=F8ren=20 Madsen has studied attitudes towards medical trials among potential and = current=20 trial participants. The study also included patients who had opted not = to take=20 part in trials.

The questionnaires = were=20 answered by 622 people, divided between the following groups: 325 people = from=20 the healthy background population, 128 outpatient patients not suffering = from=20 cancer, 79 non-cancer patients currently taking part in trials, 41 = cancer=20 patients taking part in trials and finally 49 cancer patients opting out = of=20 trials.

Open-ended = questions were=20 answered in a multiple choice-like design which gave the additional = option of=20 adding free text. In the part of the project covering clinical trials, = patients=20 answered questionnaires three times during the trial (at the start, = during the=20 trial procedure and following completion of trial participation), = whereas only a=20 single questionnaire was answered by the remaining=20 respondents.

The studies were = conducted in=20 collaboration between the Department of Medical Gastroenterology C at = the=20 Copenhagen University Hospital at Herlev and the oncological departments = at the=20 Herlev hospital and the University Hospital in=20 Odense.

Society=92s=20 requirements and expectations

By = Poul Nyrup=20 Rasmussen, prime minister of denmark

Thank=20 you for your invitation to the 20th anniversary of the scientific = ethical=20 committee system and congratulations on the = anniversary.

The scientific = ethical=20 committee system is unique and, as far as I know, exists nowhere else in = the=20 form familiar to us here in Denmark. The actual combination of = specialist=20 expertise and the popular element is unique. And I am convinced that it = is=20 fundamentally right.

Research per se is = becoming=20 more and more extensive, and the exigencies of taking an ethical = position=20 greater and greater. In other words, there will be no less of a = requirement for=20 the scientific ethical committee system=97on the contrary. We now need = even more=20 to discuss principles, ethics, attitudes=97morals, if you like=97and = constructively,=20 not pointing an accusatory finger, but in a spirit of dialogue. We have = no less=20 of a need to discuss values=97on the contrary: in the fragmented world = in which we=20 now find ourselves, in the centrifugal world that globalization also = entails,=20 there is a need for sheet anchors; a need for some sense of security, in = the=20 best sense of the word, and clarity on matters of = ethics.

Where=20 is the borderline?

Research=20 in the field of medicine is possibly the most dynamic research area of = all, and=20 certainly the one in which there is greatest all-round interest in=20 progress.

After all, it is = about our=20 health, our quality of life, and in the final analysis our life and = death. There=20 is no doubt, therefore, that technological development and the vistas = opened up=20 by e.g. genetic engineering will put research under pressure, in future=20 too.

Research=20 faces great challenges:

-=20 ‑on the one hand, = the challenge of=20 being able to offer more and more effective = treatments

-=20 ‑on the other hand, = the challenge=20 of practising ethically defensible research.

Anyone=20 researching into people encounters the question of the relationship = between=20 scientifically good research and ethically defensible research. In a = broader=20 perspective, however, the question concerns us all. Research not = conducted on an=20 ethically defensible premiss deprives us of our belief in scientific = methods and=20 results, and at the end of the day means a lack of support for such=20 research.

It is exceedingly = important,=20 therefore, that research be done in an ethically defensible manner. But = what=20 is=20 ethically=20 defensible research? Where do we draw the line? How far are we to go in=20 exploring future life? How far are we to go in prolonging life that is = already=20 alive?

There is=20 no=20 fixed limit. The limit is swayed by developments in society, new = research, moral=20 boundaries, ethical principles and the legislative goalposts we=20 erect.

Here, too, it is = important to=20 take on board the international dimension. We are not adherents of = "dumping",=20 i.e. relegating research and trials to the countries with the lowest = ethical=20 standards, so it is necessary for us to collaborate internationally on = ethical=20 standards.

Finally, like all = other=20 research, medical research has to do with expanding our knowledge, = finding new=20 solutions; and it is often difficult to evaluate the precise gains and = possible=20 costs, if any, of new research.

This complex = electric field=20 is precisely where the scientific ethical committees make an important=20 democratic contribution to society=92s control over biomedical=20 research.

The = delicate=20 balance

Present=20 regulation of biomedical trials began in the post-war period. The = relationship=20 between research and ethics came into focus in the light of the dreadful = medical=20 trials in the German concentration camps.

That is the = backdrop behind=20 our basic principles of clinical research on humans, = i.e.:

=95=20 that trial subjects take = part on a=20 voluntary basis

=95=20 ‑that they are = correctly informed=20 about the trial and its

=20 implications

=95=20 ‑that their consent = is based on=20 having understood the

=20 information

=95 and that they are at = liberty to=20 withdraw from the trial at

any time.=20

These=20 principles are also at the foundation of the Danish Act on the = Scientific=20 Ethical Committee System=97a system unique in its kind and something of = which we=20 can be proud. Denmark is the only country that has a coherent, = nationwide=20 committee system with common guidelines and statutes. Other = countries=97including=20 the other Nordic lands=97have mainly institutional committees with very = low=20 representation of lay people.

The scientific = ethical=20 committees are a meeting point for researchers and lay people. The aim = is to=20 meld professional standards and plain common sense in a fruitful = dialogue that=20 will produce frameworks and boundaries for biomedical research in such = important=20 areas as:

=95 research involving trials = on=20 humans

=95 research on human germ=20 lines

=95 research on fertilized = eggs,=20 tissues and cells

=95 and research on deceased=20 subjects.

Biomedical=20 research and controls over it are an important area for society and for = all of=20 us. We need research into biomedicine=97but we do not want research at = just any=20 price.

The basic dilemma = is=20 society=92s interest in acquiring new biomedical knowledge=97new drugs, = new forms of=20 treatment=97vis-=E0-vis the consideration of protecting trial=20 subjects.

In a trial = situation,=20 consideration for the individual must be carefully weighed up in = relation to the=20 scientific interest in advancing our knowledge for the benefit of a = larger group=20 of people. It is a weighing of ends and means. And it will always be = pivotal to=20 the dialogue between researchers and society.

Society=92s=20 requirements and expectations

What=20 requirements and expectations does Danish society have, then, of = researchers on=20 the one hand and the scientific ethical committees on the=20 other?

First,=20 the researchers.=20 Well, there are many, such as:

=95 new knowledge about = people=92s=20 diseases

=95 better medicine with = fewer=20 side-effects

=95 improved methods of=20 treatment

=95 more reliable=20 diagnoses

=95 mapping human genes with = a view to=20 better treatment

of=20 disease.

In=20 a nutshell: improved health and a better basis for preventing=20 disease.

Then, the = scientific=20 ethical committees:

Society=20 needs ethical control over research projects. Society requires = frameworks for=20 such research=97frameworks born of the fruit of dialogue between = researchers and=20 lay people. Society invariably needs the ethical dimensions to be taken = on board=20 in research projects, e.g.:

=95 ‑what is the = purpose of the=20 project? Is it even meaningful? Is quality up to = standard?

=95 what inconveniences are = being=20 imposed on trial subjects?

=95 what risks lie in store = for the=20 trial subjects?

=95 ‑are risks and = inconveniences in=20 reasonable proportion to the anticipated result of the=20 project?

The=20 scientific ethical committees are society=92s guarantor of two = overriding=20 considerations:

=95 to protect trial = subjects=92=20 integrity

=95 to create sensible = conditions for=20 high-quality

biomedical=20 research.

And=20 therein lies the basic dilemma for the committees: The trial subjects = often have=20 an interest in alleviating their illness, whereas the researcher has an = interest=20 in promoting his or her research project.

However, the = committees=92 two=20 overriding considerations are not necessarily at variance. Science and=20 researchers fundamentally have an interest in making sure that research = results=20 are achieved within the frameworks that secure society=92s respect for = both the=20 research process and the research results.

In the longer term, = the=20 committees=92 ethical approval of research projects ensures that the = population=20 feels comfortable about taking part in research projects. Without the = work of=20 the committees the population is left without an ethical guarantee=97and = the=20 result could be a lack of trial subjects.

Luckily, the fact = of the=20 matter is that, at bottom, researchers are highly sensitive to the = ethical=20 dimensions.

The=20 main problem is generally: where is the = borderline?

In=20 all research, the researcher=92s self-regulation is key to the ethical = design of=20 scientific trials. To a great extent that self-regulation is sufficient = for=20 society=97and the scientific ethical committees=97not to object to the = trials and to=20 be able to sanction them.

But=20 self-regulation cannot stand in isolation, of course. The committees=92 = approval=20 procedures are important to the individual project; similarly, they have = a=20 preventive effect, which reinforces the researchers=92 self-regulation = of research=20 projects.

Now=20 the committees will also have to set about ensuring follow-up control to = ensure=20 that research projects are executed in accordance with the approved = plan,=20 affording us as citizens yet another guarantee that the ethical = principles=20 underlying approval are being complied with. And seen from the = researchers=92=20 point of view, that means enhanced respect for scientific trials on=20 people.

In=20 the process we also ensure that there is trust among the population in=20 biomedical trials. The scientific ethical committees thereby play a = central role=20 in terms of increasing research that will benefit = society.

The=20 next 20 years

I=20 shall round off simply by pointing out that the numbers of elderly will = be=20 constantly increasing and that, needless to say, the elderly segment of = the=20 population will be making greater demands=97and rightly so=97of = treatment and care.=20 Technological possibilities are also enabling us to accommodate a = greater=20 proportion of the elderly population=92s wish for a greater quality of = life in=20 their latter days. Medical research will therefore remain one of the = most=20 dynamic areas of research in the future, perhaps even growing in = stature. It may=20 even become necessary for society to motivate and be instrumental in = funding=20 it.

The field of = biotechnology is=20 one of the positions of strength which the Danish government has elected = to=20 commit itself to strategically, also in terms of the business community = and=20 research efforts. Here the integration in the =D8resund Region, as also = in other=20 parts of the country, will clearly contribute to bringing Denmark into a = leading=20 position in this watershed field. That means an even greater focus on = the=20 ethical regulation of biomedical research=97and even more focus on the = interaction=20 between the general public and research.

I am happy, = therefore, to=20 note that the area is well-regulated, or well-founded, on the occasion = of this=20 20th anniversary.

You on the = committee system=20 are a mutually inspiring but also a democratic regulatory body, which = must not=20 become a millstone around the necks of researchers, but on the contrary = a source=20 of security for them, and for society and citizenry at one and the same = time.=20 The researchers avoid having aspersions cast, while the general public = can be=20 confident that security and ethical principles are in order. And surely, = when it=20 comes down to it, that is no bad thing?

So, once again, = hearty=20 congratulations=97and the best of luck with the next 20=20 years.

The=20 patient and the scientific ethical = committee

The=20 real world and the thoughts of the patient are poles apart from the = researcher=92s=20 interest in carrying out medical trials. Being transformed into a = patient is a=20 violent shock to anyone=92s system.

By = Karen Ellen=20 Spannow, ethnographer

The=20 moment when the healthy person is transformed into a patient is scarcely = characterized by notions of scientific ethics and committees. When = confronted=20 with the risk of death and chronic disease, an eddy of thoughts whirl = around in=20 completely different directions. Close affiliations with family, friends = and=20 colleagues play intrusively on the mind, while the endeavours of = macro-society=20 to provide uniform and qualified treatment for all sick people are, at = most,=20 faint background noise.

"In=20 loco patientis"

The=20 role of patient is enacted in many different ways. Any claim to = represent the=20 patient=92s link with the work done to ensure that research and = treatment of=20 disease take place in an ethically defensible manner is risky. It = presupposes a=20 belief that disease does the same to all people. But representing = patient=20 interests is not without its problems. Belonging to the probably-healthy = and the=20 here-and-now-survivors invites humility, because it is not possible to = fully=20 comprehend what thoughts passed through the head of those who were less=20 fortunate, and to know with any certainty what expectations of ethical = practice=20 they would have emphasized as being the most essential. One might ask = whether=20 lumping the hordes of people who daily allow their bodies to be = subjected to=20 ethical practice together into the term "the patient" is even ethically=20 acceptable.

Bearing these = reservations in=20 mind, I can imagine many patients=97in as far as they even think of the = Scientific=20 Ethical Committee=97thinking of it primarily as an initiative designed = to=20 safeguard the quality of treatment, the accuracy of information and, in=20 addition, to foster the patient=92s integrity and dignity, particularly = in=20 connection with clinical trials.

Ethics=20 in practice

I=20 can become slightly apprehensive at the idea of ethics in the treatment = of=20 disease having been delegated to a committee and thus being potentially = regarded=20 as separate from daily practice. The question is whether, in serving a = just=20 cause and fine-tuning the welfare society, the responsibility and the = right to=20 define various problems will end up being farmed out to a veritable = Babylon of=20 boards and bodies that will then have to battle to coordinate and = implement all=20 the good advice and intentions. The more responsibility is conferred = upon=20 structures=97in the form of laws and rules=97the easier it is for = individuals to=20 procrastinate indefinitely. Mistakes and foul-ups can be put down to = loopholes=20 and gaps in the body of rules, and lead not infrequently to the = formation of new=20 committees. The general absence of authority creates forests of = uncertainty that=20 constantly have to be cleared aside.

Quest=20 for the best treatment

A=20 recurring patient-related problem which the committee system is often = drawn into=20 is the question of participation in clinical studies. An increasing = number of=20 patients are refusing to take part in clinical trials for fear of not = receiving=20 the best treatment. Many are confident that the absolutely right = treatment=20 already exists, but the fact of the matter is that if it were known what = were=20 the best treatment, there would be no reason to have trials. There is = therefore=20 an inherent paradox in refusing to take part in trials, only to then = demand the=20 best possible treatment. Furthermore, we forget that we are never one = hundred=20 percent identical to another person and that, in principle, every = treatment can=20 be classed as an experiment or a trial.

Disorders=20 perceived as personal

On=20 the other hand, the paradox fits in well with the fact that old = communalities=20 are under pressure. Whereas it was once perfectly alright to have a = disease akin=20 to the neighbour=92s, new types of identity-creating processes in which = each=20 individual has to create their own identity or image mean that people = nowadays=20 tend to view their disease more as an individual affair. The mindset of = personal=20 disease with altogether distinctive attributes is at the root of much=20 alternative therapy and is profoundly at odds with the ambition of = established=20 medicine, to compile a series of standard therapies covering as many as=20 possible, as best possible.

Same=20 species=97same=20 treatment

I=20 am deeply concerned about the development of notions that each = individual must=20 receive personalized treatment for disease. While I do recognize that we = are=20 each individually quite unique, I wish to maintain that, since we belong = to the=20 same biological species, we also have much in common. It is perilous to = abandon=20 the ambition of evolving the best possible standard therapies, as it = will be=20 utterly impossible to summarize individual treatments in such a way as = to=20 determine what is to best avail=97just as perilous as it is to assume = that the=20 ethical rules should be bent to accommodate individual=20 whims.

The=20 researcher and the scientific ethical = system

Increased=20 need for specialist expertise and more control calls for innovative = thinking and=20 close cooperation.

By=20 professor Jens Christian Djurhuus, md

Over=20 the past two decades the scientific ethical committee system (VEK) has = become a=20 natural part of the clinical research process. The system has become=20 fundamentally important to patient and volunteer based studies. Not only = those=20 who consent to take part in human studies but largely also those who = decline the=20 offer can rest assured that their interests are taken into consideration = when=20 the studies are being planned and later implemented. VEK does a huge = amount of=20 work to ensure that the research community is assured of a worthy = sparring=20 partner so that studies involving trial subjects are implemented in an = ethically=20 satisfactory fashion. These considerations are in focus and are also = reflected=20 in the way the ethical committees are made up. Despite no satisfaction = studies=20 having been undertaken, it is my clear opinion that the researcher = community has=20 respect for the work being done by the ethics = committees.

Regulatory=20 function

A=20 regulatory function within the terms of reference of the ethics = committees has=20 been debated. The committees have made proposals to set up central = registers of=20 research projects and trial participants, to create an "itinerant police = force"=20 to travel the country, examining whether projects applied for are = actually being=20 implemented and how. Finally, it has been suggested setting up a = regulatory body=20 to investigate the actual recruitment procedure surrounding trial=20 participants.

In its comments on = these=20 proposals, the Danish Medical Research Council (DMRC) has stressed that = VEK in=20 itself is well provided for in terms of regulatory facilities. In = respect of=20 drug testing, any expertise not found in VEK is available from companies = and/or=20 in good clinical practice units. Additional expertise can be sourced at = the=20 faculties of health sciences or from DMRC.

Demand=20 for greater expertise

The=20 scientific ethical committee system faces other, much greater tasks than = exercising control, however.

With the HUGO = project, we=20 expect an exponential increase in the use of molecular biology and = genetics=20 within patient based research.

The biobank problem = is=20 currently raising its head in a big way, too, producing a great need for = knowledge about the creation of biobanks, the preconditions for using = biobanks,=20 establishing projects on the basis of problematic new issues in existing = biobanks, and so on. It is important to prepare an international set of = rules in=20 the field, or at least a collective Nordic one, aimed at preventing = technology=20 transfer dumping between the Nordic countries.

In order to cater = for these=20 increased needs, the committee system must be changed so as to achieve a = stronger link with the university based domains and possibly more firmly = anchored preliminary processing by panels of university experts. One = solution=20 may be to reduce the number of scientific ethical committees while = concurrently=20 forging a link to the three great university = domains.

Taking=20 the strain

As=20 for the committee system, the greater complexity of future clinical = research=20 will be redressed by changing the area which the committee system has=20 traditionally had as its chief occupation, i.e. conventional trialling = of=20 medicinal products.

The new rules, = incorporating=20 the compulsory application of "good clinical practice" in connection = with that=20 type of study, mean that highly effective quality control will be made = available=20 under other auspices. VEK can thus be relieved of its regulatory=20 function.

When the = conversation turns=20 to VEK and other authorities, it is important to stress the need for = efficient=20 interaction between ethics and the prerequisites for drug approval. The = USA is=20 having a debate on placebo, with the ethicists wanting to get rid of the = placebo-controlled study and the approving authorities simultaneously = continuing=20 to require this type of study as a condition for approval. The = researcher=20 community will make a vocal appeal for close coordination so that the = researcher=20 is not caught up between the various interests of the=20 authorities.

The=20 scientific ethical committee system and the danish medicines=20 agency

=97an=20 example of fine cooperation

The cost of future requirements of ethics in biomedical = research will=20 be more resources and a new division of labour.

By=20 Jan Renneberg, md, head of division

During=20 its first 20 years, the scientific ethical committee system has = celebrated great=20 triumphs and has been a trendsetter both nationally and internationally. = In=20 those 20 years developments have moved very rapidly=97both within and = around the=20 system.

Together with the=20 incontrovertible success, new challenges await just around the corner. = The=20 system must now prove its worth and its place in the European = cooperation=97is the=20 system ready for that?

The answer is not = certain.=20 The European scientific ethical universe is undergoing whirlwind = development in=20 current years, with the focus on increased cooperation with the = authorities, at=20 national and international level, between = countries.

Turning twenty is = not easy,=20 and by no means so in an age when every day makes new demands. This is = the=20 situation facing the scientific ethical system. A new directive in the = field of=20 clinical trials may be adopted even this year.

Tall=20 order for a non-homogeneous group

Viewed=20 from the Danish Medicines Agency=92s standpoint, we have a scientific = ethical=20 system which is based on the voluntary performance of work; the = individual=20 committees have more lay members than specialists; the committees meet = once a=20 month: communications between the committees are not always perfect and = are=20 occasionally the cause of prolonged case-work flows; in multicentre = studies the=20 individual committees differ on their stance; the same trial can be = accepted on=20 one committee but not on another; replies to the investigator are not=20 necessarily coordinated when several committees are involved; some = committees=20 have hobbyhorses that complicate the approval procedure; the Danish = Central=20 Scientific Ethical Committee is an avenue of appeal against the ruling = of a=20 local committee. Finally, none of the committees have sufficient = resources to=20 handle side-effects reports on an ongoing basis.

It should be = stressed that=20 the scientific ethical committees do a formidable job with the = facilities they=20 have.

Resource-intensive=20 directive

Based=20 on the above views of the scientific ethical committee system, I want to = highlight certain aspects of the upcoming directive for the field of = clinical=20 trials which is expected to be adopted this year or early next=20 year:

=95 ‑The scientific = ethical system will=20 be the approving authority in future.

=95 ‑The individual = committee will be=20 able to assess whether the preclinical basis is adequate for initiating = a trial=20 on human beings.

=95 ‑Specific = professional expertise=20 must be present on the committee. This refers, for example, to specific=20 paediatric and psychiatric expertise.

=95 ‑One committee must = be the overall=20 representative of Danish committees in multinational=20 studies.

=95 Inspection of trials=97at = the trial=20 site.

=95 ‑The casework = procedure must have=20 been completed within 60 days in the majority of = trials.

The=20 new directive requires the committee system to be resourced in the form = of paid=20 man-hours and an up-to-date IT structure capable of ensuring direct and=20 continuous contact between individual local committees, the Central = Scientific=20 Ethical Committee and selected authorities, e.g. the Danish Medicines=20 Agency.

Finally, work = should be=20 shared between the Medicines Agency and the scientific ethical system = along the=20 lines of the division we have today, in which the Medicines Agency does = not=20 approve a trial that has not also gained the approval of the scientific = ethical=20 system=97with the case flow simply reversed in future. That way, part of = the=20 pressure on committee approval can be moved from the committee to the=20 authority.

Future=20 challenges

Several=20 other great challenges await the scientific ethical system and the = Danish=20 Medicines Agency:

=95 Trials on genetically = modified=20 organisms

=95 Gene testing. Increased = development=20 of in=20 vitro diagnostics.

=95 Gene = therapy.

=95 = Biobanks

=95 EU database of clinical = trials on=20 drugs.

These=20 few topics, selected at random, will help direct the focus on trials = with drugs=20 in future. Derived discussions concerning the increased number of = patients in=20 Phases I and II, and resultantly fewer patients in Phases III and IV, = are a=20 development and a challenge which the Danish Medicines Agency is looking = forward=20 to taking on together with the scientific ethical committee=20 system.

Expectations=20 and requirements of the danish association of the =

pharmaceutical=20 industry

Harmonizing=20 rules and directives in EU countries will facilitate approval of trial=20 protocols.

By = Thim Engel,=20 medical director of glaxo wellcome a/s, member of the danish association = of the=20 pharmaceutical industry (lif)

The=20 ethical dimension in connection with drug research is important=97for = the=20 pharmaceutical industry too. The Danish Association of the = Pharmaceutical=20 Industry (LIF) has therefore been working in close liaison with CVK and = the=20 regional committees, and we have had a constructive dialogue=97a contact = that has=20 been important and must continue.

Future=20 cooperation

LIF=20 respects the work of introducing a countrywide database with public = access that=20 will contain an overview of all projects approved. In this connection = LIF=20 anticipates a close dialogue on the subject of "information". We feel = that our=20 member companies should have the right to set out very summary = information, e.g.=20 an agent against disease X, compared with placebo. There may be cases in = which=20 intellectual property law or patent interests require the non-disclosure = of=20 confidential details for a fixed duration. This, of course, does not = prevent the=20 ethical evaluation from being both thorough and comprehensive. However, = there=20 must be some channel allowing the interested party to approach the = company for=20 additional information.

We still expect to = be=20 consulted in conjunction with legislative amendments and new information = initiatives.

We have noted that = the Danish=20 Central Scientific Ethical Committee intends to hold 2-3 public = consultations a=20 year. LIF is happy to volunteer its services, both as co-organizer and = speaker,=20 especially if the topic of one of next year=92s meetings is going to be = "the=20 influence of the pharmaceutical industry on Danish=20 research".

Courses=20 and information material

During=20 recent years the pharmaceutical industry has taken the initiative to = arrange a=20 series of briefing sessions and conferences, which have fortunately been = given a=20 positive reception by the members of the scientific ethical committees = and=20 others. The most recent meeting has just been held on the topic of = "Genetic=20 Engineering Techniques and Clinical Trials".

In 1993 the first = edition of=20 "From Molecule to Patient Treatment" was published, and updated versions = have=20 since appeared, tracing quarter of a century in the development of new = drugs and=20 describing the principles governing research.

Future=20 ethical questions

Fast-paced=20 developments in genetic engineering are giving rise to a number of = scientific=20 ethical questions. This is true of genetic diagnostics, which is = increasingly=20 enabling us to identify hereditary diseases=97sadly, often without = having any=20 effective method of cure. This raises the question of the right not to = be=20 advised versus society=92s wish to pinpoint and prevent hereditary=20 diseases.

The same issue = presents=20 itself in pharmacogenetics, i.e. the correlation between the genes and = the=20 outcome of medical treatment, impact and = side-effects.

In the field of = gene therapy,=20 our uncertainty is even greater=97if that were possible=97but the need = for therapy=20 is extensive. Cystic fibrosis is one example of a relatively frequent = genetic=20 disorder with striking excessive mortality which may possibly become = treatable=20 in a foreseeable number of years by supplying the missing gene. For = those=20 afflicted by the disorder, it will be a revolution=97if successful. = Research is=20 already taking place in the USA and the UK, amongst other=20 countries.

EU=20 directive on clinical trials

Since=20 January 1997 the harmonized guidelines for good clinical practice (GCP) = have=20 been part of clinical practice in the EU. The guidelines are not = binding,=20 however, and the member states have introduced different national laws = and/or=20 administrative rules. In many countries these rules have led to delays = in=20 approving new trial protocols.

LIF therefore has = great=20 expectations of the committee system=92s handling of the new EU = directive on=20 clinical trials with drugs. The proposal aims to streamline the = documentation=20 and administrative procedures for implementing clinical trials while at = the same=20 time guaranteeing patients the same protection in all EU=20 countries.

We presume that the = spirit=20 and letter of this directive will be respected, although we know full = well that=20 not all scientific ethicists consider that it provides enough time for = dealing=20 with cases. We therefore support the endeavours by the chairperson of = the Danish=20 Central Scientific Ethical Committee to raise more funds for operating = the=20 system. By conducting a close dialogue with the scientific ethical = committee=20 system, we believe we can be instrumental in finding new and effective=20 procedures for exchanging the requisite documents so that cases can be = processed=20 to the satisfaction of all parties.

What=20 requirements and expectations do the regional scientific ethical = committees=20 believe they need to meet?

When=20 approving trial protocols, the regional committees seek to ensure a = lawful=20 research environment while simultaneously safeguarding the rights of the = trial=20 subjects.

By = Henning Kvist=20 Poulsen, MD, Medical Director, Chairman of the regional committee for = the=20 counties of Ringkj=F8bing, Ribe and South = Jutland

In=20 general terms, the regional scientific ethical committee is mandated to = ensure=20 that the biomedical research that takes place within the purview of the=20 committee is in accordance with the Danish Act on the Scientific Ethical = Committee System and the Handling of Biomedical Research Projects. Inter = alia,=20 this Act describes a number of specific tasks for the committee system, = which it=20 is not possible to include or comment on in this concise=20 account.

Too=20 many shortcomings

The=20 secretariat sees to it that the protocol contains the necessary = appendices. In=20 this regard, checks are particularly carried out to see whether there is = a=20 layman=92s resum=E9, patient information, declaration of consent, = project-related=20 scientific ethical considerations and an account of the project finances = in=20 accordance with current recommendations.

Despite the = guidelines=20 available on compiling a project description etc., shortcomings and the = need for=20 revision occur in far too many applications. More often than not, the = point of=20 contention is the quality of the patient information/declaration of = consent,=20 layman=92s resum=E9 and the ethical deliberations.

The patient = information must=20 be worded in correct and readily understandable Danish and must contain = the=20 necessary information. For the sake of the committee=92s lay members, = the layman=92s=20 resum=E9 must also be written in easy-to-understand Danish without the = use of=20 specialist terminology or words and phrases of foreign origin. As = regards the=20 ethical deliberations, it is not sufficient merely to state that the Act = and/or=20 the Declaration of Helsinki will be complied with.

Processing=20 cases takes time

The=20 case-handling procedure is not altogether identical on the various = committees=20 but varies according to number of cases and geographical area. On the = committees=20 for the counties of Ringkj=F8bing, Ribe and South Jutland, the = case-handling=20 procedure is as follows:

All protocols for = assessment=20 are sent out to the members of the committee, who then have about two = weeks to=20 forward a written assessment of the project to the chairperson. Assuming = that no=20 observations on the project have been received, the chairperson drafts a = letter=20 of approval. However, if observations on the project are forthcoming = from=20 committee members, these are coordinated by the chairperson, who then = obtains=20 supplementary corrections and particulars from the=20 researcher(s).

If the revised = protocol=20 accommodates the objections put forward, the research project can be = approved=20 immediately.

If just one member = of the=20 committee or even the researcher him/herself wishes to have the project = assessed=20 at a committee meeting, this will be done at the first available = meeting,=20 usually within 1-2 months. Irrespective of any prior approval of a = project, all=20 projects will be examined at the following committee=20 meeting.

In cases where the = project is=20 a multicentre one on which _our committee is the primary committee, the=20 project=97once approved=97will be forwarded to the other regional = committees=20 affected for consultation; they then have four weeks to produce any = objection to=20 the ruling made by our committee. In these cases the project must not be = commenced before the expiry of the four-week time = limit.

General=20 considerations

By=20 optimizing communications and adopting uniform guidelines/criteria for = the=20 assessment of biomedical research projects, the regional committees = strive to=20 ensure as uniform a practice for project approval as humanly=20 possible.

Similarly, by = performing a=20 consultative and facilitatory function that is active, educational and=20 constructive, the regional committees endeavour to help disseminate = knowledge of=20 the ethical problems that may be associated with planning and executing=20 biomedical research.

Fruitful and = constructive=20 cooperation on the regional scientific ethical committees, in dealings = between=20 committees and researchers, and between the regional committees = mutually, should=20 be the scientific ethical committee system=92s chief contribution to = ensuring a=20 secure, open and confidence-inspiring research environment in Denmark = for trial=20 subjects and researchers alike.

What=20 challenges does the committee system face in the =

future=96nationally=20 and internationally?

Close=20 cooperation between the countries=92 scientific ethical committees = safeguards=20 trial subjects and research alike.

By = Jens William=20 Grav, msc. (pol.sci.), head of section, member of the danish central = scientific=20 ethical committee

Recent=20 years have seen the committee system evolve into a more public-law-style = approval system, subject to greater legislative regulation, with a remit = to=20 approve biomedical trials. This development will be reinforced in years = to come,=20 not only because of the requirements and expectations made of the = committee=20 system by the outside world but also because of the desire for renewal = and=20 modernization within the committee system internally. Furthermore, = technological=20 developments in the field of biomedicine are also making greater demands = on the=20 committee system.

Future=20 challenges

Individual=20 citizens, politicians and the press will expect great openness and = transparency=20 to continue being a feature of biomedical trials. They also want = assurances that=20 the approving committees will make the "correct" decisions and that = approved=20 guidelines for the trial will be complied with. Conversely, however, = they do not=20 want the committees to prevent socially beneficial research=20 either.

Trial subjects = normally=20 attach importance to receiving good, suitably ample and comprehensible=20 information. They wish to be sure they are not being exposed to = unnecessary=20 risks by taking part in the trial. When it comes to obtaining their = informed=20 consent, it is also important that the trial subjects do not feel = pressurized=20 into taking part in trials.

For the researcher = who has=20 submitted a trial for approval, receiving a quick and unequivocal reply = is=20 crucially important. It is also important that there are no appreciable = regional=20 differences between the rulings of the individual scientific ethical = committees.=20 The same goes for the pharmaceutical industry, which often collaborates = with the=20 researcher.

All these = requirements and=20 wishes need to be placed in an international perspective as well, where = there=20 will often be a tendency for research to gravitate towards those = countries which=20 have the infrastructure needed for the individual trial and = simultaneously place=20 fewest obstacles in the path of the trial in = question.

Readily=20 accessible information

In=20 a modern society, the greatest openness possible is the prerequisite for = getting=20 the population to support and rally around the necessary research. There = must=20 therefore be great openness and transparency surrounding research. The = creation=20 of a database containing all relevant information about trials must be=20 instrumental in giving the population access to information about = research=20 projects completed and in progress. It is therefore important that the = Danish=20 Central Scientific Ethical Committee=92s homepage on the Internet should = be=20 considerably expanded.

Information about = new=20 projects approved must be continually provided by means including a = newsletter,=20 to appear at least four times a year. The newsletter must also contain = general=20 articles about new initiatives in the field.

In order to further = involve=20 the public in the debate, several public consultations a year must be = held on=20 sensitive research topics.

Access=20 to greater expertise

In=20 recent decades, biomedical research has become more and more = specialized. Many=20 times, that makes it difficult to make the right rulings because the = individual=20 committees lack specialist expertise in a number of fields. In order to = ensure=20 that the decision-making basis is improved, the body of specialist = expertise on=20 the committees needs to be expanded. One way of ensuring this is to have = active=20 researchers as specialist committee members. Channels for obtaining = expert=20 statements should be simplified, moreover, e.g. by setting up a panel of = experts.

In order to ensure = the proper=20 treatment of trials involving biomedical equipment etc., in particular, = a=20 technical unit should be established to assist the committees on these = cases, as=20 does the Danish Medicines Agency in the case of pharmaceutical=20 testing.

Controls=20 are necessary

In=20 order to prevent non-compliance with the guidelines for approved trials, = it is=20 important to subject trials to annual checks by the scientific ethical=20 committees. These controls must not only include inspection visits to = the=20 researcher and the trial subjects; it is also important to record the = trial=20 subjects=92 experience of taking part in trials. This can be done, for = example, by=20 including relevant questions to this effect in the patient satisfaction = studies=20 already being conducted.

The requirements = for=20 comprehensible information made by trial subjects are best met by = ensuring that=20 the persons responsible for the information have undergone training in=20 communications skills.

Moreover, trial = subjects=92=20 requirements are safeguarded by having clear rules as to how verbal = information=20 should be submitted and how written information to trial subjects should = be=20 formulated. The new executive order and the guideline on biomedical = trials=20 constitute an attempt to create such a set of rules for the first time.=20 Inspection visits will also be instrumental in enhancing trial = subjects=92 sense=20 of security.

Biobanks

This=20 must not be allowed to lull us into complacency, however. On the = contrary, in=20 the years ahead the committee system must follow up the rules so that a = good=20 foundation can be made better, both for the researchers and especially = for the=20 trial subjects, whose protection is the committee system=92s supreme = task. Amongst=20 other things, the committee system should satisfy itself that new rules = are=20 forthcoming in novel areas such as research into = biobanks.

In the biobank = field, a=20 minimum safeguard should ensure that policies contain provisions on the = use of=20 non-project-specific collections and "old" clinical collections, on who = has=20 right of ownership and on who has access to the = biobank.

International=20 consensus

Biomedical=20 research is international. In order to protect all trial subjects and = avoid=20 research dumping and "treaty shopping"=97i.e. researchers playing off = the=20 individual countries=92 different regulatory bases against one = another=97it is=20 therefore important to create fixed minimum rules. When these rules are = being=20 negotiated, it is crucial that the relevant scientific ethical committee = system=20 should be represented. It must be the present, not the past, that shapes = the=20 future.

It is also = important to=20 establish closer collaboration across national borders between the = organizations=20 that deal with questions of scientific ethics. In order to secure the = best=20 possible treatment for trial subjects in all countries, a tighter = network should=20 therefore be established between scientific ethical committees in the = European=20 countries. In particular, a close-knit network needs to be established = with=20 those committees that come from our neighbouring countries. The = collaboration=20 with the Norwegian scientific ethical committees and the regional = cooperation=20 between Copenhagen and Scania in Sweden are good examples of the way in = which=20 such cooperation can be effected.

Appendices

The=20 Danish Central Scientific Ethical Committee=97in addition to taking a = position on=20 medical trial protocols=97has been involved in the following=20 initiatives:

-=20 Setting up the Danish Council of Ethics in = 1987

-=20 The Danish Committee on Scientific Dishonesty in=20 1992

-=20 Danish Act No. 503 of 24 June 1992 on a Scientific Ethical Committee = System and=20 the Handling of Biomedical Research Projects with the amendments issuing = from=20 Section 8 of Act No. 1133 of 21 December 1994, Act No. 499 of 12 June = 1996,=20 Section 4 of Act No. 1228 of 27 December 1996 and Section 31 of Act No. = 460 of=20 10 June 1997.

-=20 The committee also acts as an adviser to the Nordic countries in = connection with=20 the creation of scientific ethical committees. Given that Denmark was = the first=20 country to form a scientific ethical committee, the Danish Central = Scientific=20 Ethical Committee has been an essential know-how resource whose members = have=20 acted as pioneers in setting up similar committees in the USA and=20 Europe.

The=20 scientific ethical committees=97yesterday, today and=20 tomorrow

Conference=20 to mark the 20th anniversary of the scientific ethical committee system = on 10=20 November 2000 at the parliamentary hall of the Landsting at = _Christiansborg=20 Palace

9.15 &nbs= p; =20 Welcome and presentation of program, by the Chairman of the = Danish=20 Central Scientific Ethical Committee, MD Kamma Bertelsen, Medical = Director

9.30 &nbs= p; =20 New guidelines for trials, by the Danish Minister for Research, = Birte=20 Weiss

9.45 &nbs= p; =20 Introduction and development of the Danish scientific ethical = committee=20 system, by Professor Povl Riis

10.15=20 &nbs= p; =20 The scientific ethical committee system in the year 2000, by = Kamma=20 Bertelsen

10.30=20 &nbs= p; =20 Discussion

10.45=20 &nbs= p; =20 Break

11.00 &nbs= p; =20 The ethical dilemma of the end that justifies the means, by the = Chairman=20 of the Danish Council of Ethics, Erling Tiedemann

11.30=20 &nbs= p; =20 ‑Attitudes towards medical trials among potential and = current trial=20 participants and among patients who have opted not to take part in = trials, _by=20 S=F8ren Madsen, MB, PhD, Herlev

12.00 &nbs= p; =20 Discussion

12.30=20 &nbs= p; =20 Lunch

13.45-15.45=20 =20 What expectations and requirements does the outside world have of = the=20 scientific ethical committee system? Co-chairman, Arne Skibsted=20 Jacobsen

13.45=20 &nbs= p; =20 Society=92s requirements and expectations, by the Danish Prime = Minister,=20 Poul Nyrup Rasmussen

14.15=20 &nbs= p; =20 The patient, by ethnographer Karen Ellen = Spannow

14.30=20 &nbs= p; =20 The researcher, by the vice-chairman of the Danish Medical = Research=20 Council, Professor Jens Christian Djurhuus

14.45=20 &nbs= p; =20 The Danish Medicines Agency, by Jan Renneberg, MD, head of=20 division

15.00 &nbs= p; =20 The Danish Association of the Pharmaceutical Industry (LIF), by = Thim=20 Engel, Medical Director of Glaxo Wellcome A/S, member of=20 LIF

15.15=20 &nbs= p; =20 ‑What requirements and expectations do the regional = scientific ethical=20 committees believe they need to meet?, by Henning Kvist Poulsen, MD, = Medical=20 Director, Chairman of the regional committee for the counties of = Ringkj=F8bing,=20 Ribe and South Jutland

15.30=20 &nbs= p; =20 Discussion

16.00 &nbs= p; =20 Coffee break

16.30=20 &nbs= p; =20 ‑What challenges does the committee system face in the = future=97nationally=20 and internationally?, by Jens William Grav, member of the Danish = _Central=20 Scientific Ethical Committee

CVK=20 Secretariat

Danish Research Agency

Randersgade 60

DK-2100 Copenhagen =D8

Tel.: (+45) 3544 6200

E-mail: forsk@forsk.dk

www.forsk.dk/cvk/index.htm

Kamma=20 Bertelsen

Chairman of the Danish Central Scientific Ethical = Committee

MD, Medical Director, Department of Onvology

University Hospital at Odense

DK-5000 Odense C

Tel.: (+45) 6541 1851

E-mail: Kamma.bertelsen@ouh.fyns-amt.dk

Erling=20 Tiedemann

Chairman of the Danish Council of Ethics

Vesterbrogade 28

DK-1620 Copenhagen V

Tel.: (+45) 3325 9340 (priv.)

Fax (+45) 3325 9341

E-mail: erling@tiedemann.dk

www.etiskraad.dk

Thim=20 Engel

Medical=20 Director

Glaxo=20 Wellcome a/s, member of the Danish Association of the Pharmaceutical=20 Industry.

Nyk=E6r=20 68

DK-2605=20 Br=F8ndby

E-mail:=20 skj@glaxowellcome.dk

Tel.=20 (LIF) (+45) 3927 6060. Glaxo Wellcome: (+45) 3635 = 9110

Karen Ellen=20 Spannow

Ethnographer

Centre=20 for Alcohol and Drug Research at the University of = Aarhus.

Jens=20 Baggesens Vej 43-45

DK-8200=20 Aarhus N

Tel.=20 (+45) 8610 8555

Fax=20 (+45) 8610 8558

E-mail:=20 canfkesp@au.dk

Povl=20 Riis

Professor,=20 MD, h.c., FRCP (London)

Nerievej=20 7

DK-2900=20 Hellerup

Tel.:=20 (+45) 3962 9688 (priv.)

Fax.=20 (+45) 3962 9588

S=F8ren=20 Madsen

MB,=20 PhD, Clinical Assistant

Copenhagen=20 University Hospital at Herlev,

University=20 of Copenhagen,

Department=20 of Medical Gastroenterology C

Ringvej=20 75

DK-2730=20 Herlev

Tel.:=20 (+45) 4488 4488. Pager: 381

E-mail:=20 smadsen@dadlnet.dk

Jan=20 Renneberg

MD,=20 Head of Division

The=20 Danish Medicines Agency.

Frederikssundsvej=20 378

DK-2700=20 Br=F8nsh=F8j

Tel.:=20 (+45) 4488 9111

E-mail:=20 jre@dkma.dk

Jens=20 Christian Djurhuus

MD, professor, Institute of Experimental Clinical = Research,

University of Aarhus.

Vice-chairman of the Danish Medical Research Council

Tel. (+45) 8949 5500

Fax: (+45) 8949 6011

E-mail: bb@iekf.au.dk

Henning=20 Kvist Poulsen

MD, Medical Director,

Department of Obstetrics and Gynaecology,

Central Hospital Esbjerg-Varde.

Chairman of the regional committee for the counties of = Ringkj=F8bing,=20 Ribe and South Jutland.

=D8stergade 80

DK-6700 Esbjerg

Tel. (+45) 7918 2009

E-mail: hkp@ribeamt.dk

Jens=20 William Grav

MSc. (Pol.Sci.), Head of Section, member of the Danish = Central

Scientific Ethical Committee.

Kastrupvej 80, 3 th.

DK-2300 Copenhagen S

Tel. (+45) 3392 3392

E-mail: jwg@mail.dk