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.

Feedback of Individual Genetic Results to Research Participants: Is It Feasible in Europe?

BACKGROUND: There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges. MATERIALS AND METHODS: A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach. RESULTS: Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process. CONCLUSIONS: Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants.

Is there a duty to recontact in light of new genetic technologies? A systematic review of the literature.

PURPOSE: With rapid advances in genetic technologies, new genetic information becomes available much faster today than just a few years ago. This has raised questions about whether clinicians have a duty to recontact eligible patients when new genetic information becomes available and, if such duties exist, how they might be implemented in practice. METHODS: We report the results of a systematic literature search on the ethical, legal, social (including psychological), and practical issues involved in recontacting former patients who received genetic services. We identified 1,428 articles, of which 61 are covered in this review. RESULTS: The empirical evidence available indicates that most but not all patients value being recontacted. A minority of (older) articles conclude that recontacting should be a legal duty. Most authors consider recontacting to be ethically desirable but practically unfeasible. Various solutions to overcome these practical barriers have been proposed, involving efforts of laboratories, clinicians, and patients. CONCLUSION: To advance the discussion on implementing recontacting in clinical genetics, we suggest focusing on the question of in what situations recontacting might be regarded as good standard of care. To this end, reaching a professional consensus, obtaining more extensive empirical evidence, and developing professional guidelines are important.

The duty of GPs to follow up patients.

A recent Supreme Court of Victoria judgement examined the legal obligations of a general practitioner to recall a patient who does not undergo a test that has been recommended by the GP or to return for a consultation, despite being asked to do so.

[How to manage a claim for medical and technical error]. / Conduite à tenir pratique devant une plainte pour faute médicotechnique.

PURPOSE: The fast modifications in French medical legislation, the increasing number of litigations and the professional consequences for the practitioner warrant the necessity to recall the "how to manage" a claim for medical error. PATIENTS AND METHODS: Four cases of legal action against oncologists are presented. RESULTS AND DISCUSSION: The importance of quality and traceability of the given information, the essential pieces of the medical file, the description of the different process steps and of the contradictory meeting are presented and discussed. CONCLUSION: Beyond the control of medical and technical risks, the practitioners in general and the radiation oncologist in particular should learn on the daily management of the risk related to medical claim.

The return of individual research findings in paediatric genetic research.

The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant's autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher's primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project.

Reminder or recall?

The practice manager contacted the general practitioner's medical defence organization for advice. The practice manager was told that, from a legal point of view, there was no obligation on the practice to utilize any reminder system for routine investigations, although the practice may consider that the use of a reminder system was a useful service to offer their patients and part of good quality care. In this case, the adviser informed the practice manager that there was no legal duty to take any further action to 'remind' the patient that her Pap test was now due. Indeed, all Australian states and territories have cervical screening registers that can provide reminders to patients about Pap tests.

The duty to follow up.

Case histories are based on actual medical negligence claims, however certain facts have been omitted or changed by the author to ensure the anonymity of the parties involved. Many general practitioners are concerned that the law places all of the responsibility for follow up on to the GP and ask: 'What is the patient's responsibility'? This article explores the duty of GPs and patients to follow up tests and results.

Misusing informed consent: a critique of limitations on research subjects' access to genetic research results.

Express denials of access to genetic research results are being drafted into consent instruments. Some commentators suggest that the principle of beneficence can justify such a denial of access. This paper provides an ethical and legal critique of the use of consent instruments to disclaim responsibility for on-going disclosure by genetic researchers. Currently, the law of torts provides only weak protection for on-going disclosure for research subjects. The most substantive rights are to be found in the law of fiduciary obligations. The author concludes that, notwithstanding arguments to the contrary, there should be a presumption of disclosure in genetic research, unless the research subject elects otherwise. The author outlines one possible exception to this general presumption.