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.

Recontacting Pediatric Research Participants for Consent When They Reach the Age of Majority.

Because children are presumed to have insufficient cognitive ability to consent to participate in research, pediatric research raises particular ethical and legal issues. For children who have not reached the age of consent stipulated by law or policy, parents (or legal guardians) must authorize their participation. This paper explores the issue of whether, to satisfy the ethical and legal norms of consent for research, participants in pediatric studies who attain the age of majority after their parents or guardians enrolled them in a study should be "recontacted" to obtain their consent to remain in the study. Using three different contexts (longitudinal studies, clinical trials, and newborn screening), we argue that distinctions should be made between the risks and benefits involved in recontacting for consent before determining the potential duties of researchers. An obligation to recontact should always be balanced with the feasibility and cost of such efforts in each particular research context and with consideration for the existence or lack of an ongoing relationship with the participant.

Attitudes of the general public towards the disclosure of individual research results and incidental findings from biobank genomic research in Australia.

BACKGROUND: Over the past decade, managing the disclosure of findings of genomic research has been the subject of extensive scientific, ethical and legal commentary and is a major challenge for biobanks. AIMS: To examine views of the general Australian public about the disclosure of individual research results (IRR) and incidental findings (IF) from biobank genomic research. METHODS: A national computer assisted telephone interview was conducted amongst a representative sample of (n = 800) adult residents across each Australian State and Territory. RESULTS: The majority of the Australian general public would be interested in receiving IRR and IF if they allowed their blood/tissue to be used in research; 94.4% (n = 800) reported that they would like to receive 'specific information obtained from your sample that may be important to your health or treatment', and 83.4% their 'potential genetic risk of an inherited disease'. Although fewer desired to receive 'any IF that were not directly related to your (potential) diagnosed condition' (70.0%), most would still like to receive IF. A latent class analysis on the desire to receive (or not) all types of results revealed differences in preferences in the information they wished to receive. CONCLUSION: The majority of Australians desire to receive most information arising from research involving their tissue, including IRR and IF. Differences in the extent and type of information they desire to receive are noted. Biobanks must establish strategies to identify information needs of donors, assess research data and communicate with donors and donor families. Processes need to take account of differences in donor preferences and in the clinical or research context(s).

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.

An update to returning genetic research results to individuals: perspectives of the industry pharmacogenomics working group.

The ease with which genotyping technologies generate tremendous amounts of data on research participants has been well chronicled, a feat that continues to become both faster and cheaper to perform. In parallel to these advances come additional ethical considerations and debates, one of which centers on providing individual research results and incidental findings back to research participants taking part in genetic research efforts. In 2006 the Industry Pharmacogenomics Working Group (I-PWG) offered some 'Points-to-Consider' on this topic within the context of the drug development process from those who are affiliated to pharmaceutical companies. Today many of these points remain applicable to the discussion but will be expanded upon in this updated viewpoint from the I-PWG. The exploratory nature of pharmacogenomic work in the pharmaceutical industry is discussed to provide context for why these results typically are not best suited for return. Operational challenges unique to this industry which cause barriers to returning this information are also explained.

An implementation framework for the feedback of individual research results and incidental findings in research.

BACKGROUND: This article outlines procedures for the feedback of individual research data to participants. This feedback framework was developed in the context of a personalized medicine research project in Canada. Researchers in this domain have an ethical obligation to return individual research results and/or material incidental findings that are clinically significant, valid and actionable to participants. Communication of individual research data must proceed in an ethical and efficient manner. Feedback involves three procedural steps: assessing the health relevance of a finding, re-identifying the affected participant, and communicating the finding. Re-identification requires researchers to break the code in place to protect participant identities. Coding systems replace personal identifiers with a numerical code. Double coding systems provide added privacy protection by separating research data from personal identifying data with a third "linkage" database. A trusted and independent intermediary, the "keyholder", controls access to this linkage database. DISCUSSION: Procedural guidelines for the return of individual research results and incidental findings are lacking. This article outlines a procedural framework for the three steps of feedback: assessment, re-identification, and communication. This framework clarifies the roles of the researcher, Research Ethics Board, and keyholder in the process. The framework also addresses challenges posed by coding systems. Breaking the code involves privacy risks and should only be carried out in clearly defined circumstances. Where a double coding system is used, the keyholder plays an important role in balancing the benefits of individual feedback with the privacy risks of re-identification. Feedback policies should explicitly outline procedures for the assessment of findings, and the re-identification and contact of participants. The responsibilities of researchers, the Research Ethics Board, and the keyholder must be clearly defined. We provide general guidelines for keyholders involved in feedback. We also recommend that Research Ethics Boards should not be directly involved in the assessment of individual findings. Hospitals should instead establish formal, interdisciplinary clinical advisory committees to help researchers determine whether or not an uncertain finding should be returned.

Consenting for current genetic research: is Canadian practice adequate?

BACKGROUND: In order to ensure an adequate and ongoing protection of individuals participating in scientific research, the impacts of new biomedical technologies, such as Next Generation Sequencing (NGS), need to be assessed. In this light, a necessary reexamination of the ethical and legal structures framing research could lead to requisite changes in informed consent modalities. This would have implications for Institutional Review Boards (IRBs), who bear the responsibility of guaranteeing that participants are verifiably informed, and in sufficient detail, to understand the reality of genetic research as it is practiced now. Current literature allowed the identification of key emergent themes related to the consent process when NGS was used in a research setting. METHODS: We examined the subjects of secondary use, sharing of materials and data, and recontacting participants as outlined in the Canadian Informed Consent templates and the accompanying IRB instructions for the conduct of genetic research. The research ethics policy applied by the three Canadian research agencies (Tri-Council Policy Statement, 2nd Edition) was used to frame our content analysis. We also obtained IRB-approved consent forms for genetic research projects on brain and mental health disorders as an example of a setting where participants might present higher-than-average vulnerability. RESULTS: Eighty percent of documents addressed different modalities for the secondary use of material and/or data, although the message was not conveyed in a systematic way. Information on the sharing of genetic sequencing data in a manner completely independent of the material from which it originated was absent. Grounds for recontacting participants were limited, and mainly mentioned to obtain consent for secondary use. A feature of the IRB-approved consent documents for genetic studies on brain and mental health disorders using NGS technologies, offered a complete explanation on sharing material and data and the use of databases. CONCLUSIONS: The results of our work show that in Canada, many NGS research needs are already dealt with. Our analysis led us to propose the addition of well-defined categories for future use, adding options on the sharing of genetic data, and widening the grounds on which research participants could consent to be recontacted.

Should genetic findings from genome research be reported back to the participants?

BACKGROUND: Today, new and powerful sequencing technology is being used in biomedical research. In parallel, an intense ethical debate has arisen regarding the handling of the information which is generated through such comprehensive analyses. The conflict concerns whether any findings made during research, intended or incidental, should be reported back to the individual research participant. KNOWLEDGE BASIS: We reviewed international academic literature that has addressed the issue of feedback from genetic studies. The arguments in favour and against providing individual information from genome research to research participants were reviewed. Key arguments in this debate are presented and commented on. RESULTS: A growing number of voices argue in favour of return of research-generated genetic information with reference to key values such as autonomy, respect, charity, mutuality and reciprocity. The counter-arguments are not as easily accessible, but concern the fundamental distinction between research and treatment, which indicates that researchers are not obliged to provide individual information to participants. Partly, the counter-arguments focus on the possible unfortunate consequences that such feedback may have for individuals, research and society as a whole. INTERPRETATION: We are standing at a crossroads with regard to assessing whether returning research-generated genetic risk information at the individual level is a moral imperative. Here, individually based research ethics run up against concerns of social medicine and research-based obligations. The right balance has probably not yet been found.

Applying bioethical principles to place-based communities and cultural group protections: the case of biomonitoring results communication.

In this article, an argument is made for extending bioethical principles to place-based community and cultural group protections when there are conflicting perspectives on reporting individual results of biomonitoring studies. Bioethical principles of beneficence, nonmaleficence, respect for autonomy, and justice can incorporate participatory decision-making and understandings of the group conditions of individual research participants, particularly for research studies with vulnerable groups. Arguments for and against biomonitoring communication to individual participants are reviewed here. Assessments of risks and benefits of biomonitoring communication can be improved by considering the contextual conditions of cultural groups and place-based communities. Providing participatory decision-making with all stakeholders about biomonitoring communication can provide more fair benefits than adopting a general, prescriptive clinical standard that favors only group report-backs when clinical utility is low and the scientific understandings of low dose exposures of chemical contaminants to humans are still uncertain.

[Counter-transference in eating disorder treatment:a systematic review]. / [Le contre-transfert dans le traitement des troubles alimentaires : recension systématique des écrits.]

OBJECTIVE: To identify counter-transference occurrences and causes in therapists treating patients with eating disorders, and to present suggested solutions to overcome counter-transference's negative aspects and to enhance treatment quality. METHOD: Using the major health science and psychology databases, we have identified studies dealing with counter-transference in eating disorder treatment. RESULTS: Many counter-transference occurrences are identified. It seems that therapists often feel negative affects while treating patients with eating disorders. Counter transference seems to be affected by factors related to both the disorder and to the patient and therapist. Further, negative counter-transference can lead to consequences interfering with proper conduct of treatment. The main solutions identified to deal with counter-transference are supervision, consulting with colleagues, and teamwork. CONCLUSIONS: Many factors involved in counter-transference seem hardly modifiable;hence it is important to implement efficient solutions allowing overcoming its negative aspects. Moreover, few empirical studies have focused on counter-transference in eating disorder treatment. That research field is highly pertinent but very rarely exploited, and it deserves the scientific community's attention.

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.

Research participants' perspectives on genotype-driven research recruitment.

Genotype-driven recruitment is a potentially powerful approach for studying human genetic variation but presents ethical challenges. We conducted in-depth interviews with research participants in six studies where such recruitment occurred. Nearly all responded favorably to the acceptability of recontact for research recruitment, and genotype-driven recruitment was viewed as a positive sign of scientific advancement. Reactions to questions about the disclosure of individual genetic research results varied. Common themes included explaining the purpose of recontact, informing decisions about further participation, reciprocity, "information is valuable," and the possibility of benefit, as well as concerns about undue distress and misunderstanding. Our findings suggest contact about additional research may be least concerning if it involves a known element (e.g., trusted researchers). Also, for genotype-driven recruitment, it may be appropriate to set a lower bar for disclosure of individual results than the clinical utility threshold recommended more generally.