Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and (...) even the entire head; computed tomography colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions. (shrink)

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

China has become a global player in the field of biosamples research and analysis of genetic data. The Beijing Genomics Institute is a genetics factory where enormous amounts of biosamples/data from all over the world are being analyzed. Most of the global bioethics discussions focused on research conducted by scientists from industrialized countries with subjects from poorer countries. Today, however, samples from industrialized nations are being analyzed in China on an unprecedented scale. This means that one should not just focus (...) on bioethics developments in western countries, but also should pay attention to the situation in China. Under this era of rapid advancement in genomics, reassessing the conventionally accepted bioethical principles is strongly needed. (shrink)

This paper addresses the question of how incidental findings in clinical research should be managed by researchers, focusing in detail on IFs discovered in neuroimaging research. It begins by engaging the larger research ethics issue of whether researchers have any obligations of clinical care to participants, and assesses the content and merits of one particular framework for answering this question, Richardson and Belsky's ancillary care model. From here the paper develops an organizational structure for integrating the ancillary care model with (...) existing research ethics standards, with the aim of better understanding their respective domains. It makes a distinction between incidental findings that are anticipated by informed consent documents, and those that are unanticipated, arguing that this distinction is critical for evaluating researcher obligations. Finally, it takes on the issue of incidental findings in neuroimaging research, translating the standards discussed into recommendations for both unanticipated and anticipated findings. (shrink)

The Inforare project aims to set up a system for the sharing of clinical and familial data, in order to study how genes are related to the severity of sickle cell disease. While the computerisation of clinical records represents a valuable research goal, an ethical framework is necessary to guarantee patients' protection and their rights in this developing field. Issues relating to patient information during the Inforare study were analysed by the steering committee. Several major concerns were discussed by the (...) committee and formalised in the patients' information letter: educating patients to aid the recruitment of family members, rules of confidentiality and the disclosure of aggregate, individual and unexpected research results. This paper presents the main issues addressed. (shrink)

This paper presents results found through searching publicly available U.S. data sources for information about how to handle incidental fndings (IF) in human subjects research, especially in genetics and genomics research, neuroimaging research, and CT colonography research. We searched the Web sites of 14 federal agencies, 22 professional societies, and 100 universities, as well as used the search engine Google for actual consent forms that had been posted on the Internet. Our analysis of these documents showed that there is very (...) little public guidance available for researchers as to how to deal with incidental fndings. Moreover, the guidance available is not consistent. (shrink)

The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental fndings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental fndings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of (...) this professional obligation to respond to incidental fndings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship. (shrink)

Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged (...) when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems. (shrink)

BackgroundA fundamental ethical challenge in conducting genomics research is the question of what and how individual level genetic findings and aggregate genomic results should be conveyed to research participants and communities. This is within the context of minimal guidance, policies, and experiences, particularly in Africa. The aim of this study was to explore the perspectives of key stakeholders' on returning genomics research results to participants in Kenya.MethodsThis qualitative study involved focus group discussions (FGDs) and in-depth interviews (IDIs) with 69 stakeholders. (...) The purposively selected participants, included research ethics committee (REC) members (8), community members (44), community resource persons (8), and researchers (9). A semi-structured interview guide was used to facilitate discussions. Six FGDs and twenty-five (IDIs) were conducted among the different stakeholders. The issues explored in the interviews included: (1) views on returning results, (2) kind of results to be returned, (3) value of returning results to participants, and (4) challenges anticipated in returning results to participants and communities. The interviews were audio-recorded, transcribed verbatim, and coded in Nvivo 12 pro. Thematic and content analysis was conducted.ResultsParticipants agreed on the importance of returning genomic results either as individual or aggregate results. The most cited reasons for returning of genomic results included recognizing participants' contribution to research, encouraging participation in future research, and increasing the awareness of scientific progress. Other aspects on how genomic research results should be shared included sharing easy to understand results in the shortest time possible and maintaining confidentiality when sharing sensitive results.ConclusionsThis study identified key stakeholders’ perspectives on returning genomic results at the individual and community levels in two urban informal settlements of Nairobi. The majority of the participants expect to receive feedback about their genomic results, and it is an obligation for researchers to see how to best fulfil it. (shrink)

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could potentially face. (...) Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place. (shrink)

BackgroundClinical genomic professionals are increasingly facing decisions about returning incidental findings (IFs) from genetic research. Although previous studies have shown that research participants are interested in receiving IFs, yet there has been an argument about the extent of researcher obligation to return IFs. We aimed in this study to explore the perspectives of clinical genomics professionals toward returning incidental findings from genomic research.MethodsWe conducted a national survey of a sample (n = 113) of clinical genomic professionals using a convenient sampling. (...) A self-administered questionnaire was used to explore their attitudes toward disclosure of IFs, their perception of the duties to return IFs and identifying the barriers for disclosure of IFs. A descriptive analysis was employed to describe participants' responses.ResultsSixty-five (57.5%) respondents had faced IFs in their practice and 31 (27.4%) were not comfortable in discussing IFs with their research subjects. Less than one-third of the respondents reported the availability of guidelines governing IFs. The majority 84 (80%) and 69 (62.7%) of the study participants indicated they would return the IFs if the risk of disease threat ≥ 50% and 6–49%, respectively and 36 (31.9%) reported they have no obligation to return IFs.ConclusionClinical genomics professionals have positive attitudes and perceptions toward the returning IFs from genomic research, yet some revealed no duty to do so. Detailed guidelines must be established to provide insights into how genomics professionals should be handled IFs. (shrink)

Rapid growth in structural and functional brain research has led to increasing ethical discussion of what to do about incidental findings within the brains of healthy neuroimaging research participants that have potential health importance, but which are beyond the original aims of the study. This dilemma has been widely debated with respect to general neuroimaging research but has attracted little attention in the context of neuromarketing studies. In this paper, I argue that neuromarketing researchers owe participants the same ethical obligations (...) as other neuroimaging researchers. The financial resources available to neuromarketing firms and the social value of neuromarketing studies should command greater attention to the elucidation and management of incidental findings. However, this needs to be balanced against finite resources available within most public health systems. (shrink)

Agitation is one of the most common behavioural and psychological symptoms in people living with dementia. This behaviour can cause tremendous stress and anxiety on family caregivers and healthcare providers. Direct observation of PLwD is the traditional way to measure episodes of agitation. However, this method is subjective, bias-prone and timeconsuming. Importantly, it does not predict the onset of the agitation. Therefore, there is a need to develop a continuous monitoring system that can detect and/or predict the onset of agitation. (...) In this study, a multi-modal sensor platform with video cameras, motion and door sensors, wristbands and pressure mats were set up in a hospital-based dementia behavioural care unit to develop a predictive system to identify the onset of agitation. The research team faced several barriers in the development and initiation of the study, namely addressing concerns about the study ethics, logistics and costs of study activities, device design for PLwD and limitations of its use in the hospital. In this paper, the strategies and methodologies that were implemented to address these challenges are discussed for consideration by future researchers who will conduct similar studies in a hospital setting. (shrink)

Much new global genetic research employs whole genome sequencing, which provides researchers with large amounts of data. The quantity of data has led to the generation and discovery of more incidental or secondary findings and to vigorous theoretical discussions about the ethical obligations that follow from these incidental findings. After a decade of debate in the genetic research community, there is a growing consensus that researchers should, at the very least, offer to return incidental findings that provide high‐impact, medically relevant (...) information, when it is not unduly burdensome to the research enterprise to do so. Much as genetic research has been limited to U.S. and European settings, the incidental findings debate has primarily focused on research conducted in high‐income countries. In a 2015 paper, Alberto Ortiz‐Osorno, Linda Ehler, and Judith Brooks note salient differences between the circumstances of research participants in low‐ and high‐resource settings that alter the analysis of when and why incidental findings should be offered to research participants. In this article, we expand on their analysis and present a framework for thinking about how investigators’ obligations to return genomic data might change in low‐resource settings, particularly in settings where participants do not have access to the medical care needed to treat, assess, or monitor incidental findings that are actionable in settings with plentiful resources. (shrink)

Functional magnetic resonance imaging is a powerful tool used in cognitive neuroscientific research. fMRI is noninvasive, safe, and relatively accessible, making it an ideal method to draw inferences about the brain–behavior relationship. When conducting fMRI research, scientists must consider risks associated with brain imaging. In particular, the risk of potentially identifying an abnormal brain finding in an fMRI research scan poses a complex problem that researchers should be prepared to address. This article illustrates how a social constructivism decision-making model can (...) be used as a framework to guide researchers as they develop protocols to address this issue. (shrink)

Personalized medicine with its promise of developing interventions tailored to an individual's health need and genetically related response to treatment might seem a promising antidote to the documented underutilization of standard depression treatments by African Americans. In addition, understanding depression not merely in biochemical terms but also in genetic terms might seem to counter cultural beliefs and stigma that attach to depression when conceived as a mood or behavioral problem under an individual's control. After all, if there is one thing (...) for which a person is not responsible and cannot be blamed, it is her genes. Nevertheless, for multiple reasons, a personalized medical approach to depression treatment, and its attendant conceptualization of depression and treatment response as genetically influenced, present the risk of exacerbating well-documented disparities in access to, and utilization of, treatment for depression among African-American and Caucasian elderly adults. (shrink)

Innovative therapy is the name we give to novel medical interventions, radically different from the standard of care, provided in order to benefit a patient, rather than to acquire new knowledge. They are paradigmshifting, not incremental, responses to serious patient problems that standard medical care inadequately addresses. Innovative therapies are often devised by clinicians, not basic science researchers; they do not follow the linear model of basic research, to translation, to clinical research, to application. Instead, they come from thinking backwards (...) from the patient’s circumstances, and forward from deep knowledge of how the body functions, to challenge the limits of current mechanisms for effecting cures. (shrink)

This paper explores the convergence of two recent and growing streams of bioethical work and concern. Each has originated independently, but each arises from the fact that the Common Rule that has shaped medical research ethics, as institutionalized in the United States and also abroad, is largely silent about what needs to be done in response to researchers’ positive obligations. One stream concerns what to do about the sometimes vast range of findings that may arise incidentally to performing research procedures. (...) The other asks whether medical researchers owe their study participants any “ancillary care” — that is, medical care that their study participants need but that goes beyond what is required to do the science safely. (shrink)

Recent scientific and technological developments have promoted the emergence of biobanks on a population scale. Although the storage of human biological material has taken place for a long time, it is only recently that biobanks have acquired a broader scientific significance, especially for genomic research. The increase in biobanks creates many ethical dilemmas, such as the protection of privacy, and creates the need for a new regulatory framework, which must enable the sustainable development of biobanks while also protecting the rights (...) of research subjects and biobank participants. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

Multiple authorship is becoming increasingly common in bioethics research. There are well-established criteria for authorship in empirical bioethics research but not for conceptual research. It is important to develop criteria for authorship in conceptual publications to prevent undeserved authorship and uphold standards of fairness and accountability. This article explores the issue of multiple authorship in bioethics and develops criteria for determining who should be an author on a conceptual publication in bioethics. Authorship in conceptual research should be based on contributing (...) substantially to: (1) identifying a topic, problem, or issue to study; (2) reviewing and interpreting the relevant literature; (3) formulating, analyzing, and evaluating arguments that support one or more theses; (4) responding to objections and counterarguments; and (5) drafting the manuscript and approving the final version. Authors of conceptual publications should participate substantially in at least two of areas (1)?(5). (shrink)

Recent work on incidental fndings, concentrating on the difcult problems posed by the ambiguous results often generated by high-tech medicine, has proceeded largely independently from recent work on medical researchers' ancillary-care obligations, the obligations that researchers have to deal with diseases or conditions besides the one(s) under study. This paper contends that the two topics are morally linked, and specifcally that a sound understanding of ancillary-care obligations will center them on incidental fndings. The paper sets out and defends an understanding (...) of ancillary-care obligations, which is based on the idea that when participants signed up for a study they may — independently of their beliefs and expectations and of those of the researchers — be taken to have partially entrusted certain aspects of their health into the researchers' hands. This partial-entrustment model of ancillary-care obligations, in turn, has substantive implications for how to deal ethically with incidental fndings; for instance, it suggests that researchers have no moral obligation to hunt for incidental fndings. (shrink)

Should innovative therapy occur only within a research paradigm and under institutional review board oversight? The health risks from current human embryonic stem cell clinical applications have raised again a fundamental question addressed first in papers submitted to inform the writing of the Belmont Report. Revisiting the thinking underlying the Belmont Report, together with examining changed circumstances since then, leads to a new model for overseeing innovative therapy based on its unique risks and context, important changes since the Belmont Report, (...) and new opportunities for addressing risks through safety and quality systems in health care. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature (...) of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

The establishment of MyCohort in 2005 showed that there is a growing interest on the part of the Malaysian government in the creation of biobanks in the country. This project can be considered as the biggest and most comprehensive cohort study in Malaysia, where hundreds of thousands of human samples are stored for epidemiological and biomedical research. However, little is known about the current issues or the situation related to biobank research in Malaysia. There are pressing issues that need answers (...) such as the governance of the national biobank as well as other privately owned biobanks in the nation, the public perspectives and perceptions regarding biobanks, and other matters such as the ethical, legal, and social issues related to biobank research. This article will highlight the status and issues related to biobank research in Malaysia and provide suggestions on future research practices that we feel need to be seriously considered. These suggestions are designed to advance and enlighten researchers’ knowledge, as well as provide the public with information on issues associated to biobanking. Good governance increases public knowledge and trust, and religious acceptance of biobank research and accountability can lead to increased participation in biobank research. The direct implications of the discussion about the ethical, legal, and social issues of biobanks are pertinent for the foundation of knowledge relating to biobanks, as well as the forward gestures for future medicine for mankind. (shrink)

Genomic research can reveal ‘unsolicited’ or ‘incidental’ findings that are of potential health or reproductive significance to participants. It is widely thought that researchers have a moral obligation, grounded in the duty of easy rescue, to return certain kinds of unsolicited findings to research participants. It is less widely thought that researchers have a moral obligation to actively look for health-related findings. This paper examines whether there is a moral obligation, grounded in the duty of easy rescue, to actively hunt (...) for genomic secondary findings. We begin by showing how the duty to disclose individual research findings can be grounded in the duty of easy rescue. Next, we describe a parallel moral duty, also grounded in the duty of easy rescue, to actively hunt for such information. We then consider six possible objections to our argument, each of which we find unsuccessful. Some of these objections provide reason to limit the scope of the duty to look for secondary findings, but none provide reason to reject this duty outright. We argue that under a certain range of circumstances, researchers are morally required to hunt for these kinds of secondary findings. Although these circumstances may not currently obtain, genomic researchers will likely acquire an obligation to hunt for secondary findings as the field of genomics continues to evolve. (shrink)

Background: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands’ biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband’s results to family members, including after the proband’s death? Methods: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and nonbiological family members. (...) Hypothetical scenarios based on actual research findings from the two cancer research resources were presented; participants were asked return of results preferences and justifications. Interview transcripts were coded and analyzed; survey data were analyzed descriptively. Results: Fifty-one individuals (17 probands, 21 biological relatives, 13 spouses/partners) were interviewed. Subsequently, a mailed survey was returned by 464 probands, 1,040 biological family members, and 399 spouses/partners. This analysis highlights the interviews, augmented by survey findings. Probands and family members attribute great predictive power and lifesaving potential to genomic information. A majority hold that a proband’s genomic results relevant to family members’ health ought to be offered. While informants endorse each individual’s choice whether to learn results, most express a strong moral responsibility to know and to share, particularly with the younger generation. Most have few concerns about sharing genetic information within the family; rather, their concerns focus on the health consequences of not sharing. Conclusions: Although additional studies in diverse populations are needed, policies governing return of genomic results should consider how families understand genomic data, how they value confidentiality within the family, and whether they endorse an ethics of sharing. A focus on respect for individual privacy—without attention to how the broad social and cultural context shapes preferences within families—cannot be the sole foundation of policy. (shrink)

Background: Increasing use of genetic technologies in clinical and research settings increases the potential for misattributed paternity to be identified. Yet existing guidance from the President's Commission for the Study of Ethical Problems in Biomedical and Behavioral Research and the Institute of Medicine (among others) offers contradictory advice. Genetic health professionals are thus likely to vary in their practice when misattributed paternity is identified, and empirical investigation into the disclosure of misattributed paternity is scarce. Given the relevance of this ethical (...) dilemma and its significance to users of genetic services, this study aimed to investigate the attitudes of lay people with regard to the disclosure of misattributed paternity. Methods: An online questionnaire was hosted and advertised through Amazon's Mechanical Turk to 200 United States residents aged 18 years or older. Respondents were asked to rate (via a Likert scale) the ethical permissibility of possible actions a clinician may carry out when misattributed paternity is identified. Data analysis consisted of preliminary descriptive analysis, chi-squared analysis, and Wilcoxon signed-rank tests. Results: There was no clear majority support for many of the options surveyed across different contexts, with only six out of ten scenarios displaying some general consensus. Men were more likely to support scenarios where the father is informed of paternity. Importantly, participants' views varied according to whether the desires of the father were previously expressed, suggesting that perceptions of the permissibility of a clinician's action will depend on the interests of all parties affected. Conclusions: This sample of the general public showed attitudes that were, at least to some degree, at variance with some professional guidelines. We give arguments for why at least some of these attitudes might be justified. We argue that case-specific judgments should be made and outline some of the relevant ethical considerations. While general guidelines ought to be considered, context-specific moral judgments cannot be avoided. (shrink)

Five years ago, an article co-written by some of us presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results. Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic (...) research. Because these techniques produce a vast amount of interpretable and non-interpretable data about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results. (shrink)

This paper reports from an ongoing multidisciplinary, ethnographic study that is exploring the views, values and practices (the ethical frameworks) drawn on by professional staff in assisted conception units and stem cell laboratories in relation to embryo donation for research purposes, particularly human embryonic stem cell (hESC) research, in the UK. We focus here on the connection between possible incidental findings and the circumstances in which embryos are donated for hESC research, and report some of the uncertainties and dilemmas of (...) our staff participants. We explore the views of our study participants in relation to two themes: (1) rights to information and anticipating how donors might be informed about future research findings and (2) occupational work goals and trust. (shrink)

This article examines the complex and contemporary issue of the return of research results in biobanks. After suggesting the exclusion of some adjacent issues usually flanking the debate, this article reviews the current practices of biobanks on the disclosure of research results to participants. It then focuses more specifically on the debate in the literature before turning to a review of the typology of recent reforms being put forward.

Incidental fndings of potential medical signifcance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography colonography studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defned plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical signifcance will be detected and reported in CTC research studies.

Both Morain and Largent (2023) and Garland, Morain, and Sugarman (2023) recognize the ethical challenges inherent in clinician participation in embedded research. Focusing on the question of integr...

Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES (...) FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher. (shrink)

Over the past decade, there has been an extensive debate about whether researchers have an obligation to disclose genetic research findings, including primary and secondary findings. There appears to be an emerging (but disputed) view that researchers have some obligation to disclose some genetic findings to some research participants. The contours of this obligation, however, remain unclear. -/- As this paper will explore, much of this confusion is definitional or conceptual in nature. The extent of a researcher’s obligation to return (...) secondary and other research findings is often limited by reference to terms and concepts like “incidental,” “analytic validity,” “clinical validity,” “clinical relevance,” “clinical utility,” “clinical significance,” “actionability,” and “desirability.” These terms are used in different ways by different writers to describe obligations in different sorts of cases. -/- Underneath this definitional confusion is a general notion, supported by much of the literature, that findings only need to be disclosed when they surpass certain presumably objective or measureable thresholds, such as medical importance or scientific reproducibility. The problem is that there is significant variability in the way that these terms and concepts are used in the literature and, as such, in defining the scope of an obligation to return findings that surpasses the relevant thresholds. -/- The goal of this paper is to analyze the definitional muddle underlying the debate about returning genetic research findings, with the hope of answering a few questions. First, what is the range of definitions being used in this debate? Based on an extensive literature review, Part 1 will lay out a range of articulated definitions for each relevant term, with the goal of categorizing them into a handful of distinct types. Part 2 explains the definitional redundancy and confusion in the current literature, and, drawing from the terminological patterns identified in Part 1, outlines more cohesive building blocks to inform the development of future disclosure frameworks.Our minimum goal in articulating these conceptual building blocks is to promote clearer articulations of, and distinctions between, future disclosure frameworks. More ambitiously, we suggest which definitions and conceptualizations we consider most appropriate to use in future disclosure frameworks. Here, we seek to balance benefits to participants through the disclosure of important information with the minimization of undue burdens on individual researchers and the research enterprise more generally. -/- Our analysis builds upon the central philosophical distinction between concepts and conceptions. The basic idea is that the “concept” of X refers to the general (and relatively uncontroversial) structure/shape of X, while various “conceptions” of X are more particular, filled out, and controversial elaborations of the concept. In other words, “concepts” of X will be formal representations of X, while “conceptions” of X will be substantive interpretations of the key elements and relationships operating within that formal framework. (Implicit in this distinction is an important point about the nature of disagreement – namely, that in order for two or more parties to “disagree” about X as opposed to simply talk past one another, there must be at least enough shared agreement about X to know that the parties are referring to the same thing. A concept of X provides this point of common agreement, while competing conceptions of X mark the areas where disagreement arises.) In this paper, we will employ this distinction in a fundamental way to clarify exactly where the primary disagreements arise in the debate over disclosing genetic research findings. -/- We propose that, underlying all the seeming confusion and disagreement, there are three central and widely agreed upon concepts at work in this debate—validity, value, and volition. The first two concepts concern the nature of the information itself. An obligation to disclose only exists when findings are valid and have value but there are competing conceptions of how to determine or define validity and valuableness. The third concept—volition—pertains not to the information but rather to the person to whom it will be disclosed. Does that person want or not want the information, and what is the best way of determining this? Here, too, competing conceptions arise. Our key point, though, is that almost all of the ethical disagreement arises because of competing conceptions of these three concepts. Understanding and appreciating this key point can help to refocus the substantive debate by providing some common ground to start from in determining how best to interpret these shared concepts. This refocusing can, ideally, produce more productive debate and facilitate some progress in resolving it. (shrink)

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

Magnetic resonance imaging is a noninvasive imaging tool that utilizes a strong magnetic field and radio frequency waves to visualize in great detail organs, soft tissue, and bone. Unlike conventional x-rays, there is no exposure to ionizing radiation and at most field strengths the procedure is considered safe for nearly every age group. Because it is non-invasive and possesses excellent spatial resolution, the use of MRI as a research tool has increased exponentially over the past decade. Uses have ranged from (...) add-ons to a clinical study to studies of brain development in typically developing children. In addition, a major effort has been made in recent years to use MRI to study brain function. Because the clinical utility of fMRI has not yet been realized, fMRI is still considered highly exploratory, and we cannot yet identify incidental findings of a functional nature. (shrink)

The possibility of generating incidental findings — in both research and clinical contexts — has long been regarded as a risk of these enterprises. Should incidental findings in research also be regarded as potential benefits? At first glance, it would seem they ought to be. After all, in particular circumstances or given a particular set of values, any piece of information can be beneficial. Therefore, it may seem incoherent or unduly paternalistic to regard IFs only as risks. Moreover, developments in (...) science and technology increasingly transform what was once of uncertain meaning and dubious value into information that is likely to have clear meaning and potential personal value, if not obvious clinical utility. For these reasons, it would seem that in the future, IFs should be treated as potential benefits in the design and regulation of research. (shrink)

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...) data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that (...) can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research. (shrink)

The rapid growth of next-generation genetic sequencing has prompted debate about the responsibilities of researchers toward genetic incidental findings. Assuming there is a duty to disclose significant incidental findings, might there be an obligation for researchers to actively look for these findings? We present an ethical framework for analyzing whether there is a positive duty to look for genetic incidental findings. Using the ancillary care framework as a guide, we identify three main criteria that must be present to give rise (...) to an obligation to look: high benefit to participants, lack of alternative access for participants, and reasonable burden on researchers. Our analysis indicates that there is no obligation to look for incidental findings today, but during the ongoing translation of genomic analysis from research to clinical care, this obligation may arise. (shrink)