Experts reflecting on the duty to recontact patients and research participants; why professionals should take the lead in developing guidelines.

Sequencing technology is increasing the scale of information that could benefit patients who have been tested in the past. This raises the question whether professionals have a duty to recontact such patients or their families. There is currently no clear basis for a legal duty to recontact, and professional guidelines are limited. We conducted interviews with 14 senior professionals from the Netherlands and UK to obtain a range of opinions on what obligations are estimated to be possible or desirable. There was (near) consensus that a lack of resources currently inhibits recontacting in clinical practice, that recontacting is less desirable in research, that information on recontacting should be part of informed consent, and that a legal duty should follow professional standards. There was a diversity of opinions on the desirability of a more systematic approach, potential obligations in hybrid clinical-research projects, and who should bear responsibility for seeking updates. Based on the literature, legal framework and these interviews, we conclude that a general duty to recontact is unlikely, but that in specific circumstances a limited duty may apply if the benefit to the individual is significant and the burden on professionals not too extensive. The variation in opinion demonstrates that further deliberations are desirable. The development of guidelines-a process the European Society of Human Genetics has begun-is important to ensure that the courts, in deciding a recontacting case, can take into account what professionals consider responsible standards in this field.

Parents who wish no further treatment for their child.

BACKGROUND: In the ethical and clinical literature, cases of parents who want treatment for their child to be withdrawn against the views of the medical team have not received much attention. Yet resolution of such conflicts demands much effort of both the medical team and parents. OBJECTIVE: To discuss who can best protect a child's interests, which often becomes a central issue, putting considerable pressure on mutual trust and partnership. METHODS: We describe the case of a 3-year-old boy with acquired brain damage due to autoimmune-mediated encephalitis whose parents wanted to stop treatment. By comparing this case with relevant literature, we systematically explored the pros and cons of sharing end-of-life decisions with parents in cases where treatment is considered futile by parents and not (yet) by physicians. CONCLUSIONS: Sharing end-of-life decisions with parents is a more important duty for physicians than protecting parents from guilt or doubt. Moreover, a request from parents on behalf of their child to discontinue treatment is, and should be, hard to over-rule in cases with significant prognostic uncertainty and/or in cases with divergent opinions within the medical team.

Surrogate decision-making for incompetent elderly patients: the role of informal representatives.

Informal or unofficial representation refers to the practice (more common in some European jurisdictions than in others), that persons not designed by a court or by the patient himself, make medical decisions on the patient's behalf in case of their incompetence. If the law provides for this, it is usually next of kin (spouse, children, brothers and sisters, etc.) who are allowed to act in such a capacity. Informal representation raises several questions. Are family members always familiar with what their relative would have wished, ready to take responsibility, and not too much reigned by their emotions? The basic legal concern is whether there are sufficient procedural and other safeguards to protect the incompetent patient from representatives who do not serve their best interests. In addressing these issues, after a brief survey of the law in the Netherlands as compared with that in Belgium, Germany and England/Wales, we will argue that informal representation as such is not at variance with international and European standards. However, an 'informal' approach to surrogate decision-making should always go together with sufficient protection of the incompetent patient, including procedural safeguards with regard to the decision that the patient is incompetent, limits to the decision-making power of informal representatives and effective forms of conflict resolution.

Researchers' opinions towards the communication of results of biobank research: a survey study.

Eighty Dutch investigators (response 41%) involved in biobank research responded to a web-based survey addressing communication of results of biobank research to individual participants. Questions addressed their opinion towards an obligation to communicate results and related issues such as ownership of blood samples, privacy, therapeutic relationship, costs and implications for participants. Most researchers (74%) indicated that participants only have to be informed when results have implications for treatment or prevention. Researchers were generally not inclined to provide more feedback to patients as compared with healthy participants, nor were they inclined to provide feedback in return for participants' contribution to the biobank. Our results demonstrate major and significant differences in opinion about the feedback of individual results within the community of biobank researchers.

Introduction of a national electronic patient record in The Netherlands: some legal issues.

The electronic patient record (EPR) is a major technological development within the healthcare sector. Many hospitals across Europe already use institution-based electronic patient records, which allow not only for electronic exchange of patient data within the hospital, but potentially also for sharing medical data with external healthcare providers, involved in the patient's care, such as general practitioners or pharmacists. In this article, we discuss the attempt made by the Dutch government to introduce a nationwide electronic patient record (n-EPR). Describing and analyzing the new legislation that is currently being developed to establish the infrastructure for the n-EPR and the related legal issues, we conclude that the introduction of a n-EPR give rise to some substantial concerns. These vary from technical and quality issues such as the reliability of patient data and sufficient standardization and interoperability of the systems used, to issues in the field of data security and confidentiality. For a successful introduction of the n-EPR within the healthcare sector, a condicio sine qua non is that the related legislation provides sufficient safeguards and clarity with respect to the responsibilities and liabilities of its main users: the healthcare professionals.

Regulating tissue research: do we need additional rules to protect research participants?

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.

Communication of biobanks' research results: what do (potential) participants want?

The aim of this study was to investigate (potential) research participants' (a) information preferences with regard to receiving biobanks' genetic research results, and (b) attitudes towards the duties of researchers to communicate research results. A total group of 1,678 was analyzed, consisting of a sample of the general Dutch population (N=1,163) and patients with asthma, rhinitis, and thrombosis (N=515) who completed a survey including six fictitious genetic research results each presented as aggregate and individual result, varied for treatability and kind of disease. Five questions assessed attitudes towards researchers' duties to communicate research results. Additionally, background characteristics were measured. A majority of the respondents wanted to receive aggregate results as well as individual results. A small majority (59%) held the view that researchers should communicate individual results with no health consequences. One third agreed with an information duty only when treatment is available. A preference for individual results and an attitude in favor of communicating results were both associated with belonging to the general Dutch population rather than being a patient, wanting to learn about own health as the reason for biobank-participation, a monitoring coping style, a general desire for health information, perceived meaningfulness of genetic information and no anticipated anxiousness. A sizable majority of respondents showed a high information preference for individual results, even when it is unclear that treatment is available. Fewer were of the opinion that researchers should make this possible. For their communication policy biobanks should take notice of (potential) participants' high information preferences and expectations.

The potential of legislation on organ donation to increase the supply of donor organs.

OBJECTIVES: The aim of this paper is to assess the possibilities to adapt the 1998 Dutch Organ Donation Act, taking account of fundamental principles such as the right to physical integrity, equitable access to and equal availability of care, and the non-commerciality principle, with a view to increasing the organ supply. METHODS: In 2008 the Dutch Taskforce on Organ Donation presented several proposals to amend the Act and to increase the supply of organs. This paper describes the proposals to amend the Act and evaluates them by assessing their intrinsic adherence to basic principles and the available evidence that these proposals will indeed increase the organ supply. RESULTS: Several proposals could constitute an infringement of fundamental principles of the Act. Moreover, evidence for their impact on the organ supply is lacking. Changing the consent system is possible, as this would not incur legal objections. There are diverging views regarding the impact of consent systems on the organ supply. CONCLUSIONS: The scope for changing the Act and its impact on organ procurement is at best limited. Relying on legislation alone will possibly not bring much relief, whereas additional policy measures may be more successful.

Donor education campaigns since the introduction of the Dutch organ donation act: increased cohesion between campaigns has paid off.

Governments utilize special policy measures to increase and maintain positive attitudes among their citizens towards consent registration and organ donation. Little has been published on these national strategies. Some studies report on the impact of single policy measures shortly after their implementation, whereas the assessment of the impact of a national strategy on organ donation over a long period of time has been lacking. The aim of this study is to assess the impact of the Dutch donor education strategy (1998-2008) on the availability of donor organs, by trying to disentangle the impact of education from other factors. In this study, we have devised a research strategy to assess the impact of policy measures at national level, while providing information about Dutch initiatives to increase registration and procurement rates, and demonstrating and explaining these increases. The increased resources and improved strategies employed to educate the public in relation to organ donation have paid off, but the impact decreases over time. The question remains whether the effects of these policy measures will further level off over time and what levels of increase in donor registration rates and efficiency of donor procurement are realistic targets to achieve.

Imagining the impact of different consent systems on organ donation: the decisions of next of kin.

Next of kin play an important role in organ donation. The aim of this study was to assess the extent to which explicitness of consent to organ donation by the deceased impacts the likelihood that next of kin will agree to organ donation of the deceased by using hypothetical cases. Results indicate that that people say they are more willing to agree to donate organs of those who explicitly consented to donate than those whose permission to donate is presumed. The degree of explicitness for the consent to donate by the deceased appears to influence the next of kin's decision about whether to agree to donation. This variation might explain the absence of differences in efficiency between various types of consent systems.

Biobank research: reporting results to individual participants.

Over the last years we conducted an extensive study on the question whether and, if so, how, any results to be derived from research with large scale biobanks shoud be communicated to individual research participants. More specifically, our research intended (1) to assess the attitudes and information preferences of major stakeholders (participants/researchers), and (2) to examine whether there are any legal obligations of researchers to provide feedback to individuals. Our aim was to elaborate a general normative framework that could provide (further) guidance in this matter and be taken into account in the establishment and operation of biobanks. In this article, we first summarize the results of the empirical study on attitudes and preferences; subsequently, address the legal aspects. The article ends with a section that discusses our main findings and provides the basis for the guiding principles we propose; the principles themselves are located in an Annex.

Health law in Europe: from the present to the future.

This article deals with the development of health law in Europe, and in particular with its future: what challenges are waiting us and are we able to cope with them? After identifying what makes health law different from other disciplines, the first part discusses how it has developed and where we stand now, both at the national and at the European level. The second part focuses on the future. After touching upon a number of societal developments and the increasing 'Europeanisation' and globalisation of health issues, it addresses the question how we should anticipate the challenges ahead.

The impact of donor policies in Europe: a steady increase, but not everywhere.

BACKGROUND: Transplantable organs are scarce everywhere. Therefore, countries have developed policies to support the efficient use of potential donors. Nevertheless, the shortage of organs remains. Were these policies in vain? The aim of this study is to assess the impact of donor policies on donor procurement in 10 Western European countries from 1995 to 2005. METHOD: To assess the impact of the donor policies we studied the conversion of potential donors into effectuated donors. 80% of the donors died from CVAs or a (traffic) accident. We considered these mortality rates to be a good proxy for potential donors. Here we call the conversion of potential donors into actual donors 'the donor efficiency rate by proxy'. RESULTS: The mortality rates for CVA and (traffic) accidents have decreased in the countries under study. At the same time, in most countries the donor efficiency rates have steadily increased. The variance in donor efficiency rates between countries has also increased from 1995 to 2005. Four countries introduced a new consent system or changed their existing system, without (visible) long-term effects. CONCLUSION: The overall increase in donor efficiency means that the efforts to improve donor policies have paid off. However, substantial differences between countries were found. The success of donor policies in terms of the number of absolute donors is blurred by the success of policies on traffic safety and CVA treatment. It remains unclear which specific policy measures are responsible for the increase in donor efficiency rates. This increase is not related to having a presumed consent system. Furthermore, an analysis of countries that introduced a new consent system or changed their system showed no effect on donor efficiency.

Poor agreement among expert witnesses in bile duct injury malpractice litigation: an expert panel survey.

OBJECTIVE: To determine the inter-rater agreement of expert witness testimonies in bile duct injury malpractice litigation. BACKGROUND DATA: Malpractice litigation is an increasing concern in modern surgical practice. As most of the lawyers are not educated in medicine, expert witnesses are asked to testify about negligence of care in most jurisdictions. Although expert witnesses greatly determine the outcome of a claim, the reliability of expert testimony may be arbitrary. METHODS: Surgical expert witnesses independently assessed whether negligence of care occurred by reviewing the complete medical history of closed litigation cases. All cases concerned iatrogenic bile duct injury, which occurred during laparoscopic cholecystectomy. The level of agreement was measured and case characteristics associated with negligence were determined. RESULTS: Thirteen independent experts reviewed 10 closed litigation cases. In 1 of the 10 cases, full agreement was observed. In 7 of the 10 cases, the highest percentage of agreeing experts was 53% or less. Chance-corrected levels of agreement were in the slight to fair range (Kendall W coefficient of concordance = 0.16-0.25). Disease-related mortality was associated with judgments on negligence (P = 0.02). Judgments on negligence of care were not associated with delay in diagnosis or the severity of injury. Experts with more years of clinical experience agreed more about negligence. Experts working in an academic setting agreed less than experts working in a teaching hospital. Finally, 8 of the 13 experts plead for the assignment of more than 1 expert witness to review and comment in a surgical litigation case. CONCLUSIONS: The reliability of expert witness testimonies in bile duct injury litigation is frail. Defendants, plaintiffs, experts, and lawyers should be aware of the drawbacks of expert witness testimonies. Raising consensus concerning the standards of surgical care may be required to improve agreement in judgments on negligence.

Cost issues in new disease-modifying treatments for advanced cancer: in-depth interviews with physicians.

BACKGROUND: The high costs of new disease-modifying, but non-curative, treatments in advanced cancer are increasingly regarded as problematic. Little is known about oncologists' beliefs regarding their ethical obligations for cost considerations about these types of treatments. PARTICIPANTS AND METHODS: This study used in-depth interviews to explore how physicians in The Netherlands view their role regarding the cost of potentially beneficial but expensive drugs, especially for new disease-modifying treatments in advanced cancer. Thirty-six physicians, 19 physicians caring for patients with advanced cancer and 17 physicians participating in four national oncology guideline committees, were interviewed. RESULTS: Physicians identified cost considerations on three levels: individual patient care, hospital policies and national guideline development. Generally, physicians were reluctant to consider costs in individual patient care, believing this compromised their ethical obligations. They did consider costs relevant at the level of hospital policies regarding coverage for drugs. They were divided regarding the role of cost considerations in national practice guideline development. CONCLUSIONS: The distinctive levels of decision-making were understood to be morally relevant as physicians separated their role as direct care provider from that of taking part in decisions about coverage. Because of the fundamental tension between the physician obligation to act in the best interest of the individual patient, the vulnerability of having a life-threatening illness and the inevitability of sharing resources in modern health care, cost considerations will always be problematic for physicians. The roles physicians play at different levels, especially at the levels of hospital policies and national practice guidelines, should further be developed and explicated.

Dementia and the law.

The care for patients with dementia raises many legal (and ethical) issues. This article explores some of the more important topics, i.e. (early) diagnosis of the disease, the availability and provision of care, treatment and non treatment decisions, and medical research with dementia patients.