Autonomy Of Participants Research Articles

Guidelines for return of research results from pediatric genomic studies: deliberations of the Boston Children’s Hospital Gene Partnership Informed Cohort Oversight Board

Approaches to return individual results to participants in genomic research variably focus on actionability, duty to share, or participants' preferences. Our group at Boston Children's Hospital has prioritized participants' preferences by implementing the Gene Partnership, a genomic research repository, based on the "Informed Cohort" model that offers return of results in accordance with participant preferences. Recognizing that ethical oversight is essential, the Gene Partnership Informed Cohort Oversight Board was convened in 2009. Over 3 years, the Informed Cohort Oversight Board developed guidelines for the return of individual genomic research results. The Informed Cohort Oversight Board defined its guiding principles as follows: to respect the developing autonomy of pediatric participants and parental decision-making authority by returning results consistent with participants' preferences and to protect participants from harm. Potential harms and strategies to eliminate harm were identified. Guidelines were developed for participant preferences that consider the child's development and family dynamics. The Informed Cohort Oversight Board agreed that to prevent harm, including harms related to interfering with a child's future autonomy, there will be results that should not be returned regardless of participant preferences. The Informed Cohort Oversight Board developed guidelines for the return of results that respect the preferences of parents, children, and adult participants while seeking to protect against harm.

Efficient adaptive QoS-based service selection

Distributed service-based systems are becoming increasingly common, with a vast range of resources and functionalities being exposed as services over open networks (e.g. the web and Grid systems). Due to the distribution, participant autonomy and lack of local control, such systems operate in highly dynamic and uncertain environments, in which services can be added, removed or change their characteristics, at any time. Thus, adaptation to change during service composition is essential to meet user needs. Yet, even when service changes occur at an early stage (e.g. at selection time), current adaptive composition approaches delay their detection until after the quality violating or unavailable service is invoked, resulting in a costly recovery during execution and, in some cases, permanently unachievable goals. In response, this paper presents a novel reactive selection algorithm, which adapts to service changes efficiently while performing the selection, ensuring an executable, satisfactory and optimal solution prior to execution. The effectiveness of the algorithm is demonstrated analytically and empirically through a case study evaluation applied in the framework of learning object composition.

How do researchers manage genetic results in practice? The experience of the multinational Colon Cancer Family Registry

There is consensus internationally that research participants should be offered the opportunity to receive clinically relevant genetic information identified through research, but there is little empirical peer-reviewed work documenting this process. We report the experience of conducting genetic research with nearly 35,000 participants in the Colon Cancer Family Registry, based in the USA, Canada, Australia, and New Zealand. Investigators from six multinational sites provided information about disclosure protocols, implementation, and uptake of genetic results and made suggestions to inform practice. Across 5 of the 6 registry sites, 1,634 participants in families with mismatch repair or MutYH gene mutations have been offered results. Participant uptake ranged from 56 to 86%. Researchers faced significant challenges in the effort to return results. We offer suggestions in five key areas: (1) planning for the disclosure process, (2) participant information, (3) autonomy of participants, (4) monitoring scientific progress, and (5) involvement of stakeholders. Despite increasing discussion of the importance of returning incidental findings from genetic research, this paper highlights the considerable diversity, challenges, and costs faced in practice when returning expected findings with established utility and validity. We argue that more work is needed to ensure that genetic results in research are optimally managed.

The Human Genome Organisation: towards next-generation ethics

Ten years after the completion of the human genome [1], looking back over the policy statements of the Human Genome Organisation's (HUGO) Ethics Committee (EC) and of its Intellectual Property Committee (IPC) is more than just a trip down memory lane; it is the revelation of a seismic shift in the values underlying genomic research (Table ​(Table1).1). Founded in 1992 at the inception of the Human Genome Project, HUGO not only provided prospective scientific leadership on approaches to intellectual property, but also on ethical, legal and social issues. Indeed, the Statements constitute a harbinger of policy debates that persist today. Table 1 List of HUGO Statements In the past two decades, genetic research ethics has expanded rapidly from a domain seemingly 'ungoverned by any explicitly ethical or legal norms', to a rich and sophisticated field [2]. Initially, the concerns of the EC and IPC were to ensure participant autonomy through informed consent, respect for participant privacy and confidentiality in light of the sensitive nature of genetic information, and an equitable distribution of the burdens and benefits of genetic research. These concerns are prevalent throughout the HUGO Statements, even as the focus of genetic ethics has shifted from the protection of individuals, families and communities, to considering the broader interests of society, and international harmonization.

Restoring Balance: A Consensus Statement on the Protection of Vulnerable Research Participants

A diverse panel convened in June 2011 to explore a dilemma in human research: some traits may make individuals or communities particularly vulnerable to a variety of harms in research; however, well-intended efforts to protect these vulnerable individuals and communities from harm may actually generate a series of new harms. We have presented a consensus statement forged by the panel through discussion during a 2-day meeting and the article-writing process. We have identified practical problems that sometimes arise in connection with providing additional safeguards for groups labeled as vulnerable and offered recommendations on how we might better balance concerns for protection with concerns for justice and participant autonomy.

Using archived qualitative data for teaching: practical and ethical considerations

This paper will examine the practicalities and the ethics of using archived qualitative data for teaching. Practicalities focus on the basic infrastructure and resources: where data can be obtained, what supporting contextual materials exist, and the provision of customised teaching resources ready for classroom use. The remainder of the paper addresses the ethics of reusing data, first with an overview and then with a closer look at ethical challenges in reusing data for teaching. A symmetry in the roles of researchers and teachers frames this discussion. Researchers collect data from participants for deposit to an archive; teachers access data from an archive on behalf of their students. Both researchers and teachers are acting on behalf of others in their relationships with the archive, and this mediation has ethical consequences. The reuse debate has largely focused on risks to participants, notably possible violations of their privacy, but reusing data for teaching foregrounds new issues: the potential benefit for data to enhance learning, equitable access to data and autonomy of both research participants and students, thus enriching the ethical debate about archiving data.

Addressing Ethical and Methodological Challenges in Research with Refugee-background Young People: Reflections from the Field

Ethical complexities associated with research involving vulnerable and marginalized population groups are well recognized, while practical solutions to these challenges are somewhat less well described. In this article we focus on strategies for addressing interrelated practical, methodological and ethical issues which may arise during research with refugee-background participants considered vulnerable. The article draws on a study exploring the impact of social networks and support on the resettlement experiences of newly-arrived migrant youth of refugee background in Australia. Three key sets of issues are discussed: developing research processes that maximize the benefits of involvement for participants while reducing potential harms; enhancing capacities for participants to give informed consent; and adapting research methods to heighten their relevance to the circumstances of participants’ lives and enhance their engagement in the research. We argue that promoting ethical practice and methodological validity are mutually reinforcing objectives and illustrate how processes of ethical reflexivity were applied to resolve methodological challenges, promote autonomy and capacity of research participants and enhance the potential for outcomes to be rigorous and useful.

RESPECTING AUTONOMY WITHOUT DISCLOSING INFORMATION

There is widespread agreement that it would be both morally and legally wrong to treat a competent patient, or to carry out research with a competent participant, without the voluntary consent of that patient or research participant. Furthermore, in medical ethics it is generally taken that that consent must be informed. The most widely given reason for this has been that informed consent is needed to respect the patient's or research participant's autonomy. In this article I set out to challenge this claim by considering in detail each of the three most prominent ways in which 'autonomy' has been conceptualized in the medical ethics literature. I will argue that whilst these accounts support the claim that consent is needed if the treatment of competent patients, or research on competent individuals, is to respect their autonomy, they do not support the claim that informed consent is needed for this purpose.

Revisión ética de proyectos. Experiencia de un comité de ética de la investigación

Introduction and objectivesSince the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects. MethodsA descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010. ResultsAbout two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information. ConclusionsThe largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research.Full English text available from:www.revespcardiol.org

Ethical Review of Research Protocols: Experience of a Research Ethics Committee

Introduction and objectivesSince the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects. MethodsA descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010. ResultsAbout two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information. ConclusionsThe largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research.

A review of ethical frameworks for the disclosure of individual research results in population-based genetic and genomic research

Individual research results from population-based genetic and genomic research are traditionally not disclosed to research participants. Current practices of non-disclosure are, however, being challenged by an increasing number of scientists, ethicists and policy-makers who make arguments in favour of disclosing at least individual results of potential health or lifestyle significance to research participants. Simultaneously, research participants are expressing greater interest in accessing their results. This article first provides an overview of main arguments for and against the disclosure of individual research results to research participants. Next, it discusses the need for a move from the current ethical framework under which researchers operate, which is rather protective of research participants and does not encourage disclosure, to a new ethical framework that would better cope with current developments within the field. Comparative analysis of existing and potential ethical frameworks favours implementation of an ethical framework aimed at enhancing the autonomy of research participants through the disclosure of individual research results. Finally, this article explores practical models of disclosure that could be used under such a new framework. A model of disclosure that takes into account the two key criteria of communicability of research results and the research participant’s preferences to determine which results to disclose is found to comply best with the selected ethical framework.

Autonomy and interdependence: quandaries in research ethics

The autonomy of research participants is crucial in research ethics without which it will be difficult to carry out research. Central to the concept of autonomy is the debate on whether the cultural norms of individuals (particularly women) should be given priority in settings where these norms require that researchers should go through male heads such as husbands and traditional leaders. This paper examines issues relating to the autonomy of women in research ethics. It highlights the far-reaching implications of autonomy for women participating in research using Islam as a religion and Africa as case studies. The paper takes a look at what obtains in Ghana and Nigeria as African countries with diverse religious sects highlighting at the same time the extent to which women are autonomous in some Islamic parts of India and Pakistan. The paper stresses that in spite of certain factors limiting the autonomy of women in Africa and Islam, there is need for a more robust account of autonomy. It takes a relational approach to autonomy concluding at the same time that the best way to do bioethics is to be culture-sensitive.

In Defense of Broad Consent

Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

Adaptive socio-technical systems: a requirements-based approach

A socio-technical system (STS) consists of an interplay of humans, organizations, and technical systems. STSs are heterogeneous, dynamic, unpredictable, and weakly controllable. Their operational environment changes unexpectedly, actors join and leave the system at will, actors fail to meet their objectives and under-perform, and dependencies on other actors are violated. To deal with such situations, we propose an architecture for STSs that makes an STS self-reconfigurable, i.e., capable of switching autonomously from one configuration to a better one. Our architecture performs a Monitor-Diagnose-Reconcile-Compensate cycle: it monitors actor behaviors and context changes, diagnoses failures and under-performance by checking whether monitored behavior is compliant with actors goals, finds a possible way to address the problem, and enacts compensation actions to reconcile actual and desired behavior. Compensation actions take into account the autonomy of participants in an STS, which cannot be controlled. Our architecture is requirements driven: we use extended Tropos goal models to diagnose failures as well as to identify alternative strategies to meet requirements. After presenting our conceptual architecture and the algorithms, it is founded upon; we describe a prototype implementation applied to a case study concerning smart-homes. We also provide experimental results that suggest that our architecture scales well as the size of the STS grows.

Trade-Secret Model: Legal Limitations—Response

Trade-Secret Model: Legal Limitations—Response

DELIBERATION'S LEGITIMATION CRISIS: REPLY TO GLEASON

ABSTRACT Laurel Gleason contends that deliberative polling constrains the autonomy of participants and substitutes the ideas and agendas of “experts” for those of the deliberators. However, the format and informational constraints faced by participants in deliberative forums are no worse, and are in many ways better, than those faced by ordinary citizens. The real problem with deliberative polls is that if they were to become popular, it would be tempting for interest groups and partisan elites to create polls in which the constraints and briefing materials subtly tilted the participants in a desired direction. Public criticism of biased deliberative polls would, in turn, invite biased criticism of unbiased polls. In short, “policing” the quality of deliberative polls could recreate the very pathologies of real-world democratic discourse that the polls are designed to rectify. However, this problem is not insurmountable, because the participants themselves can police the proceedings by questioning the veracity and balance of the briefing materials.

The Solomon Islands mathematics: Pedagogy in transition?

This article examines the transition of the Solomon Islands School of Education’s primary and secondary mathematics education programme from a focus on content knowledge and teacher transmission, to a more activity-based, problem-solving, learner-centred approach. The ways the development team co-constructed that change so that it incorporated current mathematics education pedagogy, the Solomon Islands’ Mathematics Curriculum document, and elements of Solomon Islands mathematics are described. How the team attempted to manage the dilemma between local educational imperatives and the globalisation of mathematics education is considered. Central to this are comparisons with international research on mathematics education pedagogy, while giving recognition to the situating of these within localised contexts. The article describes the ways the transition evolved, and how issues related to the change process, such as trust, culture, pedagogy and power, were engaged with, both proactively and incidentally. It will also consider lecturer/student reflection on the programme and the ways the changes may have influenced teaching. This article contends that change that is co-constructed and hinged to respectful partner relationships, will lead to greater participant autonomy and enhance the sustainability of the change. Finally, it poses questions that require subsequent examination for the transition to be sustainable.

Component-Elements' Contents of Business Clusters: Systemic Representation

Definition problems of component-elements' contents of business clusters are reviewed in the article. It is proposed to define cluster components with the use of main cluster function and internal processes which supply its realization, to define cluster elements – based on principle of isolation and autonomy of participants of cluster systems.

Do Research Intermediaries Reduce Perceived Coercion to Enter Research Trials Among Criminally Involved Substance Abusers?

We examined the efficacy of including a research intermediary (RI) during the consent process in reducing participants' perceptions of coercion to enroll in a research study. Eighty-four drug court clients being recruited into an ongoing study were randomized to receive a standard informed consent process alone (standard condition) or with an RI (intermediary condition). Before obtaining consent, RIs met with clients individually to discuss remaining concerns. Findings provided preliminary evidence that RIs reduced client perceptions that their participation might influence how clinical and judicial staff view them. This suggests that using RIs may improve participant autonomy in clinical studies.

Can Contracts Enhance Participant Autonomy in Clinical Trials?

In “Assessing the Remedy: The Case for Contracts in Clinical Trials,” Sarah Edwards (2011) gives a compelling argument for reconfiguring the researcher–subject relationship from a fiduciary arrange...