Federa Promotes a sound research environment COREON Promotes a sound regulatory environment Aangesloten, contribuerende instituten COREON Amsterdam

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net Rotterdam, 2015 - June 15, Dear WMA workgroup, Aangesloten, contribuerende instituten COREON The Federa welcomes the opportunity to comment on the draft ethical considerations regarding health

1 Chairman Federa - Prof. dr. L.H.J. Looijenga COREON Promotes a sound regulatory environment Chairman COREON Prof. dr. A. Burdorf World Medical Association WMA workgroup on the ethical considerations regarding health databases and biobanks. hdbb@wma.net Rotterdam, June 15, Dear WMA workgroup, Aangesloten, contribuerende instituten COREON The Federa welcomes the opportunity to comment on the draft ethical considerations regarding health databases and biobanks. Please find our comments attached. Amsterdam AMC - Divisie JK NKI - AVL - Afd. Psychosociaal Onderzoek en Epidemiologie Parelsnoer Instituut About the FEDERA and COREON The Federa (Foundation Federation of Dutch Medical Scientific Societies) represents scientific biomedical societies by promoting interdisciplinary collaboration and communication, amongst others, through an annual thematic conference, and by self-regulation. Proportional regulation has become a major activity of the COREON Committee, e.g. by means of developing Codes of Conduct, together with patient organizations. These Codes of Conduct have been widely accepted by medical research organizations. This is a necessity in an era of abundant and overlapping regulations or quasi regulations, such as by non-directly binding recommendations, of biomedical science. The Federa bundles 30 scientific biomedical societies with all together 10,000 members and coordinates about 20 organizations in COREON. On behalf of the Federa and COREON, Best regards, VU medisch centrum Bilthoven RIVM - Afd. Preventie en Zorgonderzoek - Centrum voor Voeding Gezondheid - Centrum Infectieziektebestrijding Den Haag SKION - Stichting Kinderoncologie Groningen UMCG - Afd. Epidemiologie UMCG - Medische Biobank Noord Nederland (LifeLines) Leiden BBMRI LUMC - Afd. Klinische Epidemiologie STG Sanquin bloedvoorziening TNO - Kwaliteit Leven Maastricht Universiteit Maastricht - Capaciteitsgroep Epidemiologie Nijmegen Radboudumc Rotterdam Erasmus MC - Afd. Epidemiologie en Biostatistiek - Afd. Maatschappelijke Gezondheidszorg - Afd. Pathologie Vereniging voor Epidemiologie (VvE) Prof. dr. L.H.J. Looijenga, Chairman Federa Prof. dr. A. Burdorf, Chairman COREON Utrecht Integraal Kankercentrum Nederland (IKNL) Nederlandse Vereniging voor Pathologie (NVVP ) Nivel Palga Pharmo Institute UMC Utrecht - Julius Centrum Universiteit Utrecht - Departement Farmaceutische Wetenschappen - Faculteit Diergeneeskunde (IRAS) Wageningen Universiteit Wageningen - Afd. Humane Voeding en Epidemiologie Dagelijks Bestuur Prof. dr. Lex Burdorf, voorzitter Dr. Marjanka K. Schmidt, secretaris Ernst J. de Graag MSc, penningmeester Dr. Michiel Paardekooper, public relations Prof. dr. A. van der Heide, regelgeving Federa: Stichting Federatie van Medisch Wetenschappelijke Verenigingen Commissies: Regelgeving in Onderzoek (COREON) - FederaDag

2 Comments of the FEDERA and COREON on the WMA Draft Declaration on Ethical Considerations regarding Health Databases and Biobanks 1. Introduction We welcome the open invitation to comment on the Draft Declaration. Being recognisant of the long standing tradition and accomplishments of the WMA to further human rights in the field of medicine, health care and research, a Declaration which takes into account the changing landscape of observational research could in principle be a welcome addition to the body of documents existing already. However, we wonder whether the present draft would be such an addition. Our main points are: The draft ignores the contribution of Health Databases to a learning health care system in solidarity-based health care systems. It makes a sharp distinction between patient care and research while these boundaries have become much more fluid in the context of observational research, where the patient is still treated according the best available standard of care as it stands at the moment. The emphasis on privacy, as that is understand in the draft declaration, and self-determination is one sided and does not take modern developments in ethics sufficiently into account. We will elaborate on this in the following. Sections 2-4 will address Health Databases, section 5 Biobanks. We conclude with some comments on specific provisions. 2. Health databases exist in various forms and serve various purposes Health Databases as understood in the draft Declaration contain information derived from patient records. The advent of electronic health care records (EHR s) makes retrieving such information and sending it in a secure way to the database much more easily possible than was the case about a decade ago. This EHR retrieval also allows for masking the identity of the patient to the database. Which does not mean that the database will contain anonymous data, see the following sections of this comment. Many such databases usually serve various purposes. One of them is to enable feedback to physicians about their performance according to the present standard of care, for example by showing funnel plots on certain indicators, where the specific health care provider is compared to the other anonymized health care providers. It has been shown that such benchmarking leads to considerable improvement in health care delivery for those at the lower end of the chart. The Databases which make this must feed-back possible must be sufficiently nuanced, for example to allow case-mix control, and must be used in a rigorous scientific way to allow outcomes which are valid and can be accepted by health care providers. Another possible purpose is the development of new clinical guidelines which takes into account their present application and consequences, as shown by the Health Databases, and other evidence such as from clinical trials. In other words: they further a learning health care system. Though point 6 seems to recognize the various applications, we wonder whether by mentioning understanding of diseases first, this point does not reverse what Health Databases are about, unless by understanding would be meant measuring incidence and prevalence, which many Health Databases do as well. Cancer registries are the prime example. On the other hand, if understanding disease is meant as to unravel the underlying omics processes which create disease in the human body, this is not what Health Databases are primarily about. The Declaration would gain in clarity if it would distinguish between Health Databases and Biobanks as they address different issues and different stages of research in our present health care arrangements. COREON Promotes a sound regulatory environment 1

3 3. Health databases as a necessary condition for public health and a learning health care system Various conceptions of public health exist and here we take a broad view, namely a health care system which enables optimal health care to all and timely recognizes threats to health which arise in- or outside health care. The WMA is possibly aware of the discussion about a learning health care system which started in the USA. In many countries of Europe clinical registries which are Health Databases according to the WMA definition have a long tradition of giving important contributions to the improvement of the performance of health care providers and the standard of care. In those countries the learning health care system existed already, though it did not use that appealing catch phrase. Other countries are now adopting this idea of a learning health care system. Aggregated data about what is happening in various sectors of health care are indispensable for such public health and a learning health care system. Health Databases are not the exception to the rule that patient data should only be used in the context of treatment and any other use would compromise confidentiality. Health Databases are increasingly becoming an integral part of appropriate health care delivery. They allow for timely feed-back to the health care system about what goes wrong and what might be improved. They allow further personalized medicine and translational research. The data in the Health Databases should be comprehensive and not biased, either through doctors bias or patient bias. Obviously, when making this claim two other claims are being made: a. There is a solidarity based health care system which attempts to offer optimal health care to all; b. Consent leads to bias Ad a: Our starting point is the Western European solidarity based health care systems. Though there can always be discussion whether the balance is optimal, in such systems everyone contributes to the health care system in an equitable way and profits from advances in health care if these meet certain criteria of scientific validity and equity for the system as a whole. Ad b: There is sufficient evidence for this claim. We may only remind you of the seminal article of Inglefinger about the death of German cancer registries when informed consent was introduced. We may point at the challenges of the present German system for cancer registries which aims to process only pseudomised-anonymous data (see section 6, second dot) which as has been argued, does not provide valid results¹. ¹ Rye Andersen M, Storm HH, Cancer registration, public health and the reform of the European data protection framework: Abandoning or improving European public Health research?, Eur. J. Cancer, 2015,51, (9): COREON Promotes a sound regulatory environment 2

4 Hence in many modern health care systems monitoring and following research of doctors, medical devices, pharmaceuticals, and system performance takes place through Health Databases without consent. Some health databases are even statutory obligatory, such as those held by the national statistical agencies. There should be transparency about this monitoring and often there is (informed) opt-out. The data are processed in a secure way without direct-identifiers attached. Additionally the juxtaposition of doctors versus others and doctors as the keepers of patient confidentiality is somewhat naïve and even old-fashioned. Modern health care is teamwork and so is patient confidentiality. ICT developers work on modern ways to make relevant data readily available to the treatment team and patients alike and on safe ways to release such data for a learning health care system. Information security officers monitor the safety standards of the EHR s and Health Databases. Just to mention two disciplines which influence present procedures of dealing with patient data and without whom doctors would be at loss in a modern complex health care environment. 4. The ethical basis of the draft Declaration We completely acknowledge that informed consent, or more nuanced shared decision making, is the basis of all medical treatment and that confidentiality of the patient-physician relationship is essential to equal access to health care. However, we submit that both principles 13 and 14 are too broad and to an extent even flawed on the ethics. In addition to the principles mentioned in the draft, other principles are paramount to an equitable health care system as well, just as they should be in our everyday relations, such as justice, solidarity and equity. Care ethics would also add compassion. We missed the mention of these other principles and an attempt to find a balance. We challenge that confidentiality in the patient-doctor relationship is eroded when patient data are further processed in secure way for a learning health care system. This is a system which can be (and usually is) very well explained to patients and most patients acknowledge that treatments can only be improved if they are monitored. If not for themselves, then for patients after them. We will be happy to submit references on this issue. 5. Possible criticism to the first two comments The above does not place the interests of society above that of individuals as might be thought. It places the interests of patients above all. Patients are undertreated or over treated because of lack of knowledge, patients might be insufficiently treated even if the knowledge is there because the team lacks the necessary skills, drugs will have unknown side effects, drugs have known sideeffects which could be prevented if drug administration would be more individualized, medical devices may fail, etc., etc. Health databases are there to redress these failures of the present system. Along this line of thought we challenge that such use of Health Databases could lead to discrimination or other detrimental effects to patients. The fundamental flaw in this reasoning is that it presents the status quo, our present arrangements, as the best possible balance. That is obviously not the case, as shown above. Additionally, possible major new ideas about different care arrangements or social arrangements in general which might follow analyzing Health Databases are never directly implemented. A scientific and general discussion will follow; possible new legislation needs democratic COREON Promotes a sound regulatory environment 3

5 legitimation and ultimately can be challenged in courts for (none) adherence to human rights. The latter also applies to decisions of (health) insurers, health care providers and others. Admittedly, again we take as the starting point our Western European democracies with the rule of law or Rechtsstaat as enshrined in various treaties. 6. Biobanks Biobanks exists in various forms. We are happy that in no. 18 the WMA seems to accept broad consent for biobanks which collect tissue from volunteers, whether healthy or patients. Yet, the term all principle information in article 18 is ambiguous and we wonder what all principle information means in this respect. In a restrictive view of in principle, there cannot be broad consent to very general biobanks such as the UK Biobank. We propose to change all principle information into sufficient information. We also wonder how no. 18 relates to no. 21 which seems to leave room for a more restrictive view The use of residual tissue of patients for research is a different matter. In such cases, future use is by definition unknown at the outset. Various European countries have instituted an informed opt out system for 'further use' of residual tissue for research. Research shows that this system may even be preferred by most patients over a system of informed consent². These opt out systems haven even been considered ethically preferable to consent if certain conditions are met. ³ 7. More detailed comments - Article 5 suffers from an individualistic framing of obligations involved and assumes those contributing data and/or tissue to Health Databases and Biobanks are always patients. We would suggest a wider scope for this article. - Article 6 suggests that improvements of health and disease can be significantly accelerated. We consider this to be a misleading understatement. Many improvements would simply not have been possible and still are impossible without Health Databases and Biobanks. For instance, reliable figures on incidence and prevalence of disease can only be gathered through Health Databases. We suggest a different wording fully acknowledging this crucial role of health Databases and Biobanks. - No s 8 and 9 contain terms which should be reconsidered. No. 8 mentions fully anonymized and non identifiable data. It is generally assumed that fully anonymized data are nonidentifiable. If both concepts mean something different, then that should be explained. The pseudo-anonymous in no. 9 is new to the privacy discourse, especially in opposition to identifiable data. Perhaps with the latter directly identifiable data is meant and with the former pseudonymized data (where either the pseudonym is reversible or the data under the pseudonym are indirectly identifiable). - Article 14 again suffers from an individualistic framing of the obligations involved and assumes those contributing data and/or tissue to Health Databases and Biobanks are always patients. We would suggest a wider scope, acknowledging the present day teamwork as referred to earlier. ² Vermeulen E, Schmidt MK, Aaronson NK, et al. Opt-out plus, the patients choice: preferences of cancer patients concerning information and consent regimen for future research with biological samples archived in the context of treatment. J Clin Pathol. 2009;62(3): doi: /jcp ; Hoeyer KL. Donors Perceptions of Consent to and Feedback from Biobank Research: Time to Acknowledge Diversity? Public Health Genomics. 2010;13(6): doi: / ³ Giesbertz NAA, Bredenoord AL, Delden JJM van. A Thick Opt-Out Is Often Sufficient. The American Journal of Bioethics. 2013;13(4): doi: / COREON Promotes a sound regulatory environment 4

6 - Articles 15 and 17 leave no room for opt-out systems. We urge a wording which leaves open the possibility of informed opt-out mechanisms, subject to oversight by an ethics committee. - The wording of article 16 suggests obligations for providing and correcting individually tailored information for all Health Databases and Biobanks. This would amount a huge administrative, logistic and financial burden in many cases, particularly those cases where data is collected, stored and used in a distributed fashion. Additionally it is often not technically feasible when the data or tissue have been pseudonymized. In order to respond to the request the keeper of the Database or Biobank must re-identify the data. But that is exactly what this keeper is not supposed to do (and usually cannot do either). And as such data will never be used on an individual level but are meant to be used on an aggregate level to find statistically relevant correlations; principle no. 16 serves no purpose. It is an entirely different matter that as part of the governance there should be broad transparency about the research projects for which the data or tissue are used, main results should be published on the website and that there should in principle be an option to opt-out at any stage usually through, because of the pseudonymisation, the health care providers which submitted the data or tissue. - We recommend to reconsider no. 19 completely as this principle is not compatible with the WHO International Health Regulations and national public health regulations concerning communicable (either animal to man or man to man) diseases. Quite rightfully the threshold for notifiable reporting is lower there and decided by different bodies than as proposed in no. 19. Apart from the lists of notifiable diseases in statutory provisions, upscaling of reporting and public health measures are decided by outbreak teams, often internationally composed, which usually work under considerable time pressure but in the end are always subject to democratic control. A suggestion might be that you state the Declaration does not apply to notifiable diseases according to national legislation following the WHO International Health Regulations. - The actual use of data or tissue is often decided by other bodies than ethics committees as proposed in no. 21, such as privacy committee. Additionally we assume that such a committee can approve certain standard releases without needing to review each case again. It would be helpful if the Declaration would be nuanced in this way. - We fully subscribe to the need to pay heed to principles and arrangements of governance in the context of this Declaration and generally agree with the articles on this theme. Our reservations with respect to these are more minor. - We have some reservation about no. 25. Generally, ensuring compliance is teamwork. Instead of appointing a physician, the article could perhaps better stress that a governance arrangement for ensuring compliance should be put in place. - With respect to article 26, we may point at the fact that principles have evolved further in a number of areas. In our view, the Declaration should be expanded to reflect the current principles and practice of governance by Biobanks better, particularly in areas of transparency, accountability and public and patient engagement, as well as with respect to policies for reporting back particularly acute, clinically relevant incidental findings (i.e. the rule of rescue )⁴. Such governance by Biobanks and Health Databases should be matched by proportionate governance of research using data and tissue. ⁵ ⁴ E.g. Chalmers D, Burgess M, Edwards K, Kaye J, Meslin EM, Nicol D. Marking Shifts in Human Research Ethics in the Development of Biobanking. Public Health Ethics. 2015;8(1): doi: /phe/phu023. ⁵ Sethi N, Laurie GT, Delivering proportionate governance in the era of ehealth: Making linkage and privacy work together, Medical Law International, 2013, 13 (2-3): DOI: / COREON Promotes a sound regulatory environment 5

Interconnecting health data - ethical, legal and social challenges: the OMEGA Linkage Use Case

Interconnecting health data - ethical, legal and social challenges: the OMEGA Linkage Use Case Dr Sandra van den Belt (NKI-PALGA) Coordinator OMEGA-Study & Mr dr J.A. Bovenberg (Lawyer) Use of pseudonymized