The debate on the ‘right to know’ has simmered on for over 30 years. New examples where a right to be informed is contrasted to a right to be kept in ignorance occasionally surface and spark disagreement on the extent to which patients and research subjects have a right to be self-determining concerning the health related information they receive. Up until now, however, this debate has been unsatisfactory with regard to the question what type of rights—if any—are in play here (...) and to what extent they can provide a normative basis for informed consent. This paper provides an analysis of informed consent in the context of ‘epistemic interventions’: interventions which involve the communication of information. First, I offer an analysis of the concept of a ‘right not to know’ in the context of consent to epistemic interventions. I argue that the scope of the consent is determined by the extent to which this intervention can be seen as an infringement of the private sphere. After that I show how this analysis affects the scope and standards of informed consent. (shrink)

While ethical and empirical interest in so-called secondary variants and incidental findings in clinical genetics contexts is growing, critical reflection on the ethical foundations of the various recommendations proposed is thus far largely lacking. We examine and critique the ethical justifications of the three most prominent disclosure positions: briefly, the clinical geneticist decides, a joint decision, and the patient decides. Subsequently, instead of immediately developing a new disclosure option, we explore relevant foundational ethical values and norms, drawing on the normative (...) and empirical ethical literature. Four ethical signposts are thereby developed to help guide disclosure discussions. These are: respectful sharing of the clinician’s expertise; transparent communication; epistemic modesty; and respect for the embedded nature of the patient. We conclude by considering the most common current disclosure positions in the light of the four ethical signposts. (shrink)

BackgroundReturning neuroimaging incidental findings may create a challenge to research participants’ health literacy skills as they must interpret and make appropriate healthcare decisions based on complex radiology jargon. Disclosing IF can therefore present difficulties for participants, research institutions and the healthcare system. The purpose of this study was to identify the extent of the health literacy challenges encountered when returning neuroimaging IF. We report on findings from a retrospective survey and focus group sessions with major stakeholders involved in disclosing IF.MethodsWe (...) surveyed participants who had received a radiology report from a research study and conducted focus groups with participants, parents of child participants, Institutional Review Board members, investigators and physicians. Qualitative thematic analyses were conducted using standard group-coding procedures and descriptive summaries of health literacy scores and radiology report outcomes are examined.ResultsAlthough participants reported high health literacy skills, 67 % did not seek medical care when recommended to do so; and many participants in the focus groups disclosed they could not understand the findings described in their report. Despite their lack of understanding, participants desire to have information about their radiology results, and the investigators feel ethically inclined to return findings.ConclusionsThe language in clinically useful radiology reports can create a challenge for participants’ health literacy skills and has the potential to negatively impact the healthcare system and investigators conducting imaging research. Radiology reports need accompanying resources that explain findings in lay language, which can help reduce the challenge caused by the need to communicate incidental findings. (shrink)

Researchers have used drones to track wildlife populations, monitor forest fires, map glaciers, and measure air pollution but have only begun to consider how to use these unmanned aerial vehicles to study human beings. The potential use of drones to study public gatherings or other human activities raises novel issues of privacy, confidentiality, and consent, which this article explores in depth. It argues that drone research could fall into several different categories: non-human subjects research, exempt HSR, or non-exempt HSR. In (...) the case of non-exempt HSR, it will be difficult for institutional review boards to approve studies unless they are designed so that informed consent can be waived. Whether drone research is non-HSR, exempt HSR, or non-exempt HSR, it is important for investigators to consult communities which could be affected by the research. (shrink)

Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

Research involving minors has been the subject of much ethical debate. The growing number of longitudinal, pediatric studies that involve genetic research present even more complex challenges to ensure appropriate protection of children and families as research participants. Long-term studies with a genetic component involve collection, retention and use of biological samples and personal information over many years. Cohort studies may be established to study specific conditions (e.g. autism, asthma) or may have a broad aim to research a range of (...) factors that influence the health and development of children. Studies are increasingly intended to serve as research platforms by providing access to data and biological samples to researchers over many years. (shrink)

As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such pathways should look like. Building on an interview study of researchers’ practices and perspectives, we identified key considerations for the set-up of pathways for the detection, management and communication of (...) incidental findings in imaging research. We conducted an interview study with a purposive sample of researchers at research facilities across the Netherlands. Based on a qualitative analysis of these interviews and on existing guidelines found in the literature, we developed a prototype ethical framework, which was critically assessed and fine-tuned during a two-day international expert meeting with bioethicists and representatives from large population-based imaging studies from the United Kingdom, Germany, Sweden and Belgium. Practices and policies for the handling of incidental findings vary strongly across the Netherlands, ranging from no review of research scans and limited feedback to research participants, to routine review of scans and the arrangement of clinical follow-up. Respondents felt that researchers do not have a duty to actively look for incidental findings, but they do have a duty to act on findings, when detected. The principle of reciprocity featured prominently in our interviews and expert meeting. We present an ethical framework that may guide researchers and research ethics committees in the design and/or evaluation of appropriate pathways for the handling of incidental findings in imaging studies. The framework consists of seven steps: anticipation of findings, information provision and informed consent, scan acquisition, review of scans, consultation on detected abnormalities, communication of the finding, and further clinical management and follow-up of the research participant. Each of these steps represents a key decision to be made by researchers, which should be justified not only with reference to costs and/or logistical considerations, but also with reference to researchers’ moral obligations and the principle of reciprocity. (shrink)

It has become evident that neuroimaging raises new normative questions that cannot be addressed adequately within the (in this regard unspecific) frameworks of existing research ethics. Questions that are especially troubling are, among others, provoked by incidental findings. Two questions are particularly intricate in view of incidental findings: (1) How can the research subject’s right not to know be guaranteed? And (2) should a diagnostic check of scans by a neuroradiologist become an obligatory part of neuroscientific research protocols? The present (...) paper examines these question against the background of two recent recommendations. The differentiation between difference position and similarity position serves as an analytic tool to further investigate the issue and to develop a distinct proposal for answering the questions. (shrink)

Mit der Vielzahl von Daten aus genetischen Untersuchungsverfahren wächst das Problem von „Zufallsbefunden“, d. h. von zufällig erhobenen Nebenbefunden, die mit der ursprünglichen Fragestellung nicht in Verbindung stehen und dennoch eine Bedeutung für Gesundheit und Reproduktionsverhalten der untersuchten Person selbst oder ihrer Anverwandten haben. In Ermangelung nationaler oder internationaler Richtlinien greifen die Autoren die aktuelle Diskussion um den Umgang mit genetischen Zufallsbefunden in Behandlungs- und Forschungskontext auf. Dabei nehmen sie auf die für Deutschland relevanten rechtlichen und ethischen Rahmenbedingungen Bezug. Nach (...) Gendiagnostikgesetz (GenDG) muss in Deutschland im Rahmen eines Behandlungsvertrages auf die Möglichkeit von Zufallsbefunden hingewiesen werden. Es ist Bestandteil der Aufklärung und Einwilligung, inwieweit Zufallsbefunde mitgeteilt werden, wobei das Recht auf Nichtwissen und der Schutz nicht-einwilligungsfähiger Personen berücksichtigt werden müssen. Im Forschungskontext greift das GenDG nicht, aber auch hier sollte über mögliche Zufallsbefunde aufgeklärt werden, wenngleich eine Rückmeldung nicht zwingend, aber bei Befunden mit hohem klinischen Nutzen ethisch geboten sein kann. Folgende Aspekte sind im Umgang mit Zufallsbefunden zu berücksichtigen: 1) Art und Umfang der Aufklärung und Einwilligung bei einer unüberschaubaren Zahl von möglichen Befunden. 2) Einordnung der klinischen Bedeutung einer genetischen Veränderung im Sinne von gesichertem, wahrscheinlichem, möglichem oder fraglichem/unbekanntem klinischen Nutzen. 3) Prozessierung des Informationsrückflusses für Gegenwart und Zukunft. 4) Ressourcenplanung im Hinblick auf die klinische Validierung, die Erläuterung von Befunden und den Transfer in die klinische Praxis. Im Umgang mit genetischen Zufallsbefunden besteht erheblicher empirisch-ethischer Forschungs- und politischer Regelungsbedarf. Zeitgleich ist es unabdingbar, die Wahrnehmung und das Verständnis der untersuchten Personen sowie die Grundhaltung gegenüber Zufallsbefunden im Rahmen von Studien zu beleuchten und entsprechende Bildungs- und Kommunikationswerkzeuge zu entwickeln. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral findings,? (...) or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (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)

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. (shrink)

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)

Inappropriate authorship is a common problem in biomedical research and may be becoming one in bioethics, due to the increase in multiple authorship. This paper investigates the authorship policies of bioethics journals to determine whether they provide adequate guidance for researchers who submit articles for publication, which can help deter inappropriate authorship. It was found that 63.3% of bioethics journals provide no guidance on authorship; 36.7% provide guidance on which contributions merit authorship, 23.3% provide guidance on which contributions do not (...) merit authorship, 23.3% require authors to take responsibility for their contributions or for the article as a whole, 20% provide guidance on which contributions merit an acknowledgement but not authorship, 6.7% require authors to describe their contributions, and only 3.3% distinguish between authorship in empirical and conceptual research. To provide authors with effective guidance and promote integrity in bioethics research, bioethics journals should adopt authorship policies that address several important topics, such as the qualifications for authorship, describing authorship contributions, taking responsibility for the research and the difference between authorship in empirical and conceptual research. (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)

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)

The increasing complexity of human subjects research and its oversight has prompted researchers, as well as institutional review boards, to have a forum in which to discuss challenging or novel ethical issues not fully addressed by regulations. Research ethics consultation services provide such a forum. In this article, we rely on the experiences of a national Research Ethics Consultation Collaborative that collected more than 350 research ethics consultations in a repository and published 18 challenging cases with accompanying ethical commentaries to (...) highlight four contexts in which REC can be a valuable resource. REC assists: 1) investigators before and after the regulatory review; 2) investigators, IRBs, and other research administrators facing challenging and novel ethical issues; 3) IRBs and investigators with the increasing challenges of informed consent and risk/benefit analysis; and 4) in providing flexible and collaborative assistance to overcome study hurdles, mediate conflicts within a team, or directly engage with research participants. Institutions that have established, or plan to establish, REC services should work to raise the visibility of their service and engage in open communication with existing clinical ethics consult services as well as the IRB. While the IRB system remains the foundation for the ethical review of research, REC can be a valuable service for investigators, regulators, and research participants aligned with the goal of supporting ethical research. (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)

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)

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)

The American Journal of Bioethics, Volume 11, Issue 10, Page 30-32, October 2011.

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)

The American Journal of Bioethics, Volume 11, Issue 10, Page 32-33, October 2011.

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)

Neuroscientists are increasingly put into situations which demand critical reflection about the ethical and appropriate use of research tools and scientific knowledge. Students or trainees also have to know how to navigate the ethical domains of this context. At a time when neuroscience is expected to advance policy and practice outcomes, in the face of academic pressures and complex environments, the importance of scientific integrity comes into focus and with it the need for training at the graduate level in the (...) responsible conduct of research . I describe my experience teaching RCR in a graduate neuroscience program and identify three personal reflections where further dialogue could be warranted: mobilizing a common set of competencies and virtues standing for professionalism in the neurosciences; tailoring RCR for the neurosciences and empowering students through the active engagement of mentors; soliciting shared responsibility for RCR training between disciplines, institutions and governmental or funding agencies. (shrink)

Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.

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)

The “best-medical-interests” standard for reporting findings does not go far enough. Research subjects have a right to know about any comprehensible piece of information about them that is generated by research in which they are participating. An even broader standard may sometimes be appropriate: if subjects agree to accept information that they may not understand, then all information may be disclosed.

The use of magnetic resonance imaging to investigate brain structure and function has become increasingly common among neuroscientists, psychologists, and even economists in recent years. Yet, despite this increase in use, relatively little attention has been paid to the issue of incidental fndings. The current paper discusses these issues, and anticipates the future of incidental fndings in the context of other neuroimaging tools currently being used to investigate the living brain.

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)