Research Ethics Committees, Data Protection and Medical Research in European Countries

D. Townend, D. Beyleveld, D. Beyleveld

• Publisher: Routledge
• Year: 2017
• ISBN:
  9781351903974
• Edition: 1
• Topic: Law
• Subtopic: Ethics & Professional Responsibility in Law
• Index: Law

The Data Protection and Medical Research in Europe: PRIVIREAL series represents the results of this EC-funded project examining the implementation of Directive 95/46/EC on data protection in relation to medical research and the role of ethics committees in European countries. The series consists of five separate volumes following the complete development of the PRIVIREAL project. This volume relates to the second stage of this project and is concerned with the setting up and role of research ethics committees. It assesses their legal responsibilities, especially with regard to data protection matters and contains reports from more than 20 European countries on these issues. Focusing on the theoretical role and practical operation of research ethics committees and the impact of relevant international and national instruments, this volume will be an essential resource for all those concerned with data protection issues in medical research.

Chapter 1

Introduction

Deryck Beyleveld, David Townend and Jessica Wright

This volume contains reports on the theoretical role and practical operation of research ethics committees (RECs) and in particular the impact of relevant international and national instruments on this area. The reports were prepared for the second workshop of the EC-funded 5^th Framework Programme concerted action project, ‘Privacy in Research Ethics and Law’ (PRIVIREAL) (PL QLRT-2001-00056), which took place at the University of Helsinki from 14–17 August 2003. This volume is a companion to another volume (also published by Ashgate Publishing Ltd). The companion volume contains keynote papers given at the second workshop and a review of the operation of RECs in the different states, looking at the relevant regulation on the area, with a particular focus on data protection. That report was compiled from papers contained in the present volume. Reports were received from all the participating countries (see below) except Cyprus.

In this publication, the term New Member States (NMS) is used to indicate the Czech Republic, Cyprus, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia. The ‘candidate countries’ are made up of Bulgaria and Romania, whilst, as in previous editions, ‘EU Member States’ refers to pre-2004 Member States.

Aims of PRIVIREAL

Protection of privacy of subjects in medical research depends as much on ethics review as on data protection law, but little is known about how this interacts with implementation of Directive 95/46/EC to protect privacy. PRIVIREAL brings together experts on relevant law and on ethics review of medical research from across all the EU Member States (except Luxembourg) and Norway (like Iceland and Liechtenstein, a member of the European Economic Area but not the EU, which has agreed to be bound by Directive 95/46/EC) as well as the NMS and candidate countries, to evaluate the interaction between implementation of the Directive and research ethics review in protecting Directive rights of research subjects, with a view to making recommendations to the Commission about how to optimize the protection provided by research ethics review (taking into account the background EU and domestic legal and ethical culture/s).

To carry out these aims, PRIVIREAL has three phases. In the first phase, which led to the first PRIVIREAL workshop (held at the University of Sheffield from 9–12 January 2003), what the partner countries have done, or plan to do, to implement Directive 95/46/EC in relation to medical research was ascertained, and the adequacy of this was evaluated in relation to the requirements of the Directive. In the second phase, which led to the second PRIVIREAL workshop (held at the University of Helsinki from 14–17 August 2003), the remit and practice of RECs in relation to legal requirements generally and those of data protection law in particular, were ascertained. This volume and its companion present the results of this phase. In the third phase, which was the concern of the final PRIVIREAL workshop (held at the University of Coimbra from 7–11 July 2004), the protection of privacy of medical research subjects resulting from the domestic implementation of Directive 95/46/EC, together with the remit and practice of RECs to protect data protection rights of medical research subjects, were evaluated in the context of domestic legal and ethical culture in relation to the objectives of Directive 95/46/EC. Recommendations will be made to the European Commission about what it might do to better protect privacy of medical research subjects where protection is judged to be inadequate. The results of the first phase have been published by Ashgate Publishing Ltd., as will be the results of the third phase.

Methodology of PRIVIREAL

The primary source of data is reports by experts in the partner countries. However, central to the project is a website (http://www.privireal.org). This contains relevant legislation and guidance on the topics of relevance to the project, with as much as possible being made available in translation to English as well as the original language. To assist with the second and third phases of the project, there was a questionnaire for RECs that could be completed on-line in English, French or German. There is also a public discussion forum in addition to sections that can only be accessed by the partners. The website is complementary to the published volumes, and readers of the volumes are invited to consult the website and use it actively.

The workshops have only been open to partners of PRIVIREAL. The purpose of the first two workshops was primarily to enable partners to discuss summaries and analyses of the material they submitted which form the basis of the reports prepared for the first two phases by the coordinating team. The purpose of the third workshop was to discuss and prepare recommendations for the European Commission. The first two workshops also provided for keynote papers given by invited partners or by persons from outside the project to comment on controversial, but crucially important, topics for the relevant phase of the project. These papers do not represent a consensus among the partnership; they are merely the views of their authors. Only in the recommendations, published in the third phase, will concerted statements and judgments (where possible) be made.

Chapter 2

Research Ethics Committees in Austria

Peter Rehak^*

Establishment of RECs in Austria

Development

The system for ethical review in Austria was initiated by three medical faculties (in Vienna, Graz and Innsbruck) in the early 1980s with the establishment of research ethics committees (RECs) to evaluate clinical research projects on a voluntary basis. The formalization process started in 1988 when the amended Hospital Act¹ first stated that ‘committees’ are to be established in hospitals for the evaluation of medical research on medicinal products. A further amendment to the Hospital Act in 1993 renamed these committees ‘ethics committees’ and extended their responsibility to research on medical devices and the application of new medical methods.

In 1993, a major amendment to the Drug Act foresaw implementation of Directive 91/507/EEC,² the EU-GCP,³ and the establishment of ethics committees by the federal states for the evaluation of research on medicinal products outside of hospitals. The Medical Devices Directive⁴ resulted in a novel law in 1996, the Medical Devices Act, which also implemented the Active Implantable Medical Devices Directive.⁵ Subsequently, an amendment implemented the In Vitro Diagnostic Medical Devices Directive.⁶

In 1997, an amendment to the Act on University Organization provided, for the first time, regulations for the ethics committees of medical faculties. This amendment established—among other things—the review of ‘applied medical research on human subjects’ as an additional responsibility.

Present Status

The ethical review system in Austria is well regulated. The review of medical research on medicinal products and on medical devices is covered by law for research in and outside of hospitals. In hospitals, the application of new medical methods is also subjected to review by ethics committees. Thus, the ethical review of the vast majority of research projects on human subjects is regulated by law. The review of other medical research involving human subjects⁷ is at present only covered by the Act on University Organization and therefore applies only to university hospitals.

In general, the system of review of medical research is separate from systems for clinical ethics advice. However, there may be some overlap regarding the persons involved.

Membership and Accountability

An REC has at least the following members: a medical doctor (neither the medical director of the hospital nor the investigator); a medical specialist in the field of the given project; a nurse; a lawyer; a pharmacist; a patient advocate; a representative of handicapped persons; a theologian or other person with pastoral or ethical competence; a technical security officer/biomedical engineer (only in the case of research on medical devices); and a statistician or biometrician (in some federal states and in university RECs).

University RECs tend to have more medical doctors of different specialities as members. RECs may also consult external experts. Hospital RECs are accountable to the bodies responsible for the hospital, university RECs to the respective medical university, and RECs for trials outside of a hospital to the government of the respective federal state.

General Powers of RECs

Powers

In the legal sense, RECs have only advisory powers.⁸ Though the researchers or sponsors are obliged to seek the advice of the responsible REC, explicit approval is at present only necessary in special cases, for example, for trials on medicinal products involving patients who are not capable of giving informed consent.

Notification of trials must be given in advance to the competent authority and, if appropriate, to the medical director of the hospital. In practice, the competent authority and/or the medical director will not approve the research if the opinion of the REC is unfavourable.

Non-compliance

If researchers do not submit their research for review in advance or do not comply with the requirements of the review and this comes to the attention of the REC, it may notify the medical director of the hospital and/or the medical faculty, if appropriate. This may result in disciplinary actions taken by the hospital or the university (medical faculty).

If failures are brought to the public’s attention, the Medical Association, the Federal Government, and/or the regulatory authorities may also take action.

General Legal Responsibility of RECs

Cognizance of Law

That RECs must be cognizant of the law is at least implicitly indicated by the mandatory inclusion of a lawyer. Clearly, RECs may not approve unlawful research.

On the basis of the elements of review, for example the qualification and experience of the researcher, the suitability of the site, the study protocol (its scientific merit and benefit/risk ratio), the information provided to the trial subjects, the modalities of recruitment and obtaining informed consent, amongst others, RECs may reject research that is in principle lawful.

Guidance

RECs take into account, among other guidance, the Declaration of Helsinki,⁹ the EC-GCP-Guideline,¹⁰ and the International Conference on Harmonization Harmonized Tripartite Guideline on Good Clinical Practice.¹¹

The Impact of the Directive 2001/20/EC

Since Directive 2001/20/EC is effective only for studies on medicinal products, it covers only a part of the work of the RECs, even though it is the largest part (in Austria nearly 70 per cent).

The Directive does provide for substantial changes: a favourable opinion of the REC will be necessary for the start of a trial (this will also have an impact on the legal status and the responsibilities of RECs); a unique opinion will have to be provided for multi-centre trials; only a single request for additional information will be possible; and, last but not least, the paperwork will be improved (for example, the application form).

There is already a time limit of 60 days for the decision in Austria, but the new limit of 35 days for the evaluation of amendments will be a challenge for RECs.

Compliance to Law in Practice

In general, RECs comply with the law and do not approve unlawful research projects. RECs have become increasingly aware of the data protection law. To disseminate information on data protection to applicants and RECs, the ‘Forum of the Austrian Ethics Committees’ posted a leaflet on data protection in clinical research projects on the website of the ‘Forum’ in 2002.¹² Furthermore, some relevant points on data protection have been added to the application form that may be used for applications to all Austrian RECs. Even so, there are still some differences from one REC to another. In special cases, RECs will also seek external advice, for example, from the Data Protection Commission.

Legal Actions Against RECs

There is no special law regarding actions against RECs. Legal actions are therefore only possible on the basis of non-specific law. To date, legal action has not been known to have been taken against an REC. At present, no le...