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Existing attempts to explain why secondary researchers might have any obligation to return findings to the contributors of genetic samples falter because of the lack of any direct interaction between the secondary researchers and the contributors. The partial-entrustment account of these obligations defended here circumvents this problem by explaining how a chain of special responsibilities can be forged even in the absence of any direct interaction.Genet Med 2012:14(4):467-472.

Managers of genomic biobanks constantly face ethical and legal challenges ranging from issues associated with the informed consent process to procedural concerns related to access by researchers. Yet, with the availability of next-generation sequencing technologies, one topic is emerging as the focus of ongoing debate: the return of individual research results and incidental findings to participants. This article examines this topic from an international perspective, where policies and guidelines discussing the matter in the context of genomic biobanks and genomic research are analyzed and commented. This approach aims to highlight the shortcomings of these international norms, mainly the danger arising from both the therapeutic misconception and the conflation of research results with incidental findings. This article suggests some elements to consider in order to complement available guidance at the international level.

The author offers personal reflections on the implications of the article "Managing Incidental Findings & Research Results in Genomic Research Involving Biobanks & Archived Datasets" in terms of how the article addresses serious knowledge disparities and differing expectations between participants and researchers.Genet Med 2012:14(4):458-460.

Published guidelines suggest that research results and incidental findings should be offered to study participants under some circumstances. Although some have argued against the return of results in research, many cite an emerging consensus that there is an ethical obligation to return at least some results; the debate quickly turns to issues of mechanics (e.g., which results? who discloses? for how long does the obligation exist?). Although commentators are careful to distinguish this as an ethical rather than legal obligation, we worry that return of results may unjustifiably become standard of care based on this growing "consensus," which could quickly lead to a legal (negligence-based) duty to offer and return individualized genetic research results. We caution against this and argue in this essay that the debate to date has failed to give adequate weight to a number of fundamental ethical and policy issues that should undergird policy on return of research results in the first instance, many of which go to the fundamental differences between research and clinical care. We confine our comments to research using data from large biobanks, the topic of the guidelines proposed in this symposium issue.

Most discussions of researchers' duties to return incidental findings or research results to research participants or repository contributors fail to provide an adequate theoretical grounding for such duties. Returning findings is a positive duty, a duty to help somebody. Typically, such duties are specified narrowly such that helping is only a duty when it poses little or no risk or burden to the helper and does not interfere with her legitimate aims. Under current budgetary and personnel constraints, and with currently available information technology, routine return of individual findings from research using repository materials would constitute a substantial burden on the scientific enterprise and would seriously frustrate the aims of both scientists and specimen/data contributors. In most cases, researchers' limited duties to help repository contributors probably can be fulfilled by some action less demanding than returning individual findings. Furthermore, the duty-to-return issue should be analyzed as a conflict between (possibly) helping some contributors now and (possibly) helping a greater number of people who would benefit in the future from the knowledge produced by research.

Purpose: The debate surrounding the return of results from high-throughput genomic interrogation encompasses many important issues including ethics, law, economics, and social policy. As well, the debate is also informed by the molecular, genetic, and clinical foundations of the emerging field of clinical genomics, which is based on this new technology. This article outlines the main biomedical considerations of sequencing technologies and demonstrates some of the early clinical experiences with the technology to enable the debate to stay focused on real-world practicalities., Methods: These experiences are based on early data from the ClinSeq project, which is a project to pilot the use of massively parallel sequencing in a clinical research context with a major aim to develop modes of returning results to individual subjects., Results: The study has enrolled >900 subjects and generated exome sequence data on 572 subjects. These data are beginning to be interpreted and returned to the subjects, which provides examples of the potential usefulness and pitfalls of clinical genomics., Conclusion: There are numerous genetic results that can be readily derived from a genome including rare, high-penetrance traits, and carrier states. However, much work needs to be done to develop the tools and resources for genomic interpretation. The main lesson learned is that a genome sequence may be better considered as a health-care resource, rather than a test, one that can be interpreted and used over the lifetime of the patient.

Whether or not to give research results back to individuals whose specimens are used for biomedical research is a subject of considerable controversy. Much of the debate has been focused around the ethical and legal concerns with some consideration of broader social issues such as whether or not people will be affected by such information for employment or health care. Much less attention has been paid to biobanks that collect the specimens used to generate the research findings and the issues and operational requirements for implementing return of individual research results. In this article, we give the biobanks' perspective and highlight that given the diversity among the types of biobanks, it may be difficult to design and implement a blanket policy in this complex area. We discuss the variability in the types of biobanks and some important issues that should be considered in determining whether or not research results should be provided to individuals whose specimens are used in biomedical research. We also discuss challenges that should be considered in implementing any approaches to the return of research results.

Although issues involved in offering individual results to participants in genomic research have received considerable attention, communication of aggregate results has been the subject of relatively little ethical analysis. Offering participants aggregate results is typically assumed to be a good thing, and studies have found that a significant majority of biobank research participants, when asked about their interest in aggregate results, say that access to such information would be important. Even so, return of aggregate results remains a relatively uncommon practice. In this article, we explore the opportunities involved in communicating aggregate results to participants in genomic research, including affirming the value of research participation, informing participants about research being conducted based on broad consent for future unspecified research, educating participants and the public about the research process, and building trust in the research enterprise. We also explore some of the challenges, including the complex intersection between individual and aggregate results, as well as practical hurdles. We conclude by offering our preliminary recommendations concerning the provision of aggregate results and an agenda for much-needed future research.

Objective: Sharing qualitative research findings with participants, namely member-check, is perceived as a procedure designed to enhance study credibility and participant involvement. It is rarely used, however, and its methodological usefulness and ethical problems have been questioned. This article explores benefits and risks in applying member-check when studying healthcare topics, questioning the way it should be performed., Methods: We discuss researchers' experiences in applying member-check, using four examples from three different studies: healthcare-providers' experiences of working with sexual-abuse survivors; adolescents' exposure to domestic-violence, and delivering and receiving bad news., Results: Methodological and ethical difficulties can arise when performing member-check, challenging the day-to-day researcher-participant experience, and potentially, the physician-patient relationship., Conclusion: Applying member-check in healthcare settings is complex. Although this strategy has good intentions, it is not necessarily the best method for achieving credibility. Harm can be caused to participants, researchers and the doctor-patient relationship, risking researchers' commitment to ethical principles., Practice Implications: Because participants' experience regarding member-check is difficult to predict, such a procedure should be undertaken cautiously. Prior to initiating member-check, researchers should ask themselves whether such a procedure is potentially risky for participants; and if anonymity cannot be guaranteed, use alternative procedures when needed., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)

Conflict of interest refers to a set of conditions in which professional judgment concerning the validity of research might be influenced by a secondary competing interest. The competing interest that has received most attention in the literature addressing the prevalence and effects of such conflicts on the practice of empirical research has been that of financial relationships between investigators and research sponsors. The potential for conflicts of interest to arise in the evaluation of drug prevention programs was raised by Moskowitz in this journal in 1993, but to date there has been no attempt made to estimate the scope of this problem. The present study addressed this issue using a sample of "model" school-based drug and violence prevention interventions by first, identifying the types or relationships that exist between program developers and program distributors, and, second, by assessing how many of the evaluations of these programs published in peer-reviewed journals had been conducted by the developers of the programs compared to independent evaluation teams. The data presented indicate that there are relatively few published evaluations that do not involve program developers and that there are few instances in which there is complete separation between the program developer and program distributor. Using the open systems model of the Institute of Medicine Committee on Research Integrity as a framework, it is argued that the culture and norms of the program developer and those of the program evaluator are fundamentally distinct and therefore failure to separate these roles produces high potential for conflict of interest to arise.

As canons for trustworthiness developed explicitly in the discourse of qualitative inquiry, the emphasis was on procedural matters rather than fundamentally relational ones. A nod was made to the relational in such strategies as "member checks" but the issues of how the evaluator actually relates to participants and to the larger communities of practice and discourse--matters subsumed under moral principles and ethical standards--were often marginalized. This chapter posits that the first consideration in designing and conducting rigorous evaluation inquiry, and in critiquing the results of any research, should be the study's trustworthiness. Judging a study's trustworthiness, however, should focus on much more than procedural matters; it should also rely on moral principles and ethical standards which specifically address how we relate to an evaluation's participants. Central to these considerations are cross-cultural sensibilities about the nuanced meanings associated with any principles and standards. The chapter provides a theoretical framework for this position and offers two illustrative examples in the form of dialogues.

Ethical problems encountered by foundation officers in their evaluation-related work were identified via an email survey of a sample of Council on Foundations member organizations. Of the respondents who had worked with evaluators, one-third indicated that they had faced ethical challenges. Most challenges fell into one of four categories: Evaluation Findings, Internal Functioning of the Foundation, Authorship/Ownership/Dissemination of the Evaluation, and Evaluator-Focused Issues. Conflicts of interest involving a variety of stakeholders were reported. The potential for foundation officers to define "ethical problems" differently from evaluators is raised, and the role that attributional processes can play in descriptions of the sources of ethical conflicts is addressed. The study's findings underscore the practical importance of developing an in-depth understanding of the views of ethical problems held by both foundation officers and evaluators.

The nurse-midwife and scientist share similar ethos (fundamental attitudes that guide action); yet, in their respective professional roles, ethos can translate into actions that appear discordant. Discord can lead to resolution, when examined through the primary principles of ethical conduct: autonomy, beneficence, nonmalfeasance, and justice.