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  1. Informed Decision-Making and Capabilities in Population-Based Cancer Screening.Ineke L. L. E. Bolt, Maartje H. N. Schermer, Hanna Bomhof-Roordink & Danielle R. M. Timmermans - forthcoming - Public Health Ethics.
    Informed decision-making is considered an important ethical and legal requirement for population-based screening. Governments offering such screening have a duty to enable invitees to make informed decisions regarding participation. Various views exist on how to define and measure IDM in different screening programmes. In this paper we first address the question which components should be part of IDM in the context of cancer screening. Departing from two diverging interpretations of the value of autonomy—as a right and as an ideal—we describe (...)
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  • A Mixed-Methods Study on Perceptions Towards Use of Rapid Ethical Assessment to Improve Informed Consent Processes for Health Research in a Low-Income Setting.Adamu Addissie, Gail Davey, Melanie J. Newport, Thomas Addissie, Hayley MacGregor, Yeweyenhareg Feleke & Bobbie Farsides - 2014 - BMC Medical Ethics 15 (1):35.
    Rapid Ethical Assessment (REA) is a form of rapid ethnographic assessment conducted at the beginning of research project to guide the consent process with the objective of reconciling universal ethical guidance with specific research contexts. The current study is conducted to assess the perceived relevance of introducing REA as a mainstream tool in Ethiopia.
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  • Predictors of Consent to Cell Line Creation and Immortalisation in a South African Schizophrenia Genomics Study.Megan M. Campbell, Jantina de Vries, Sibonile G. Mqulwana, Michael M. Mndini, Odwa A. Ntola, Deborah Jonker, Megan Malan, Adele Pretorius, Zukiswa Zingela, Stephanus Van Wyk, Dan J. Stein & Ezra Susser - 2018 - BMC Medical Ethics 19 (1):72.
    Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during (...)
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  • Cluster randomized trial assessing the effects of rapid ethical assessment on informed consent comprehension in a low-resource setting.Adamu Addissie, Serebe Abay, Yeweyenhareg Feleke, Melanie Newport, Bobbie Farsides & Gail Davey - 2016 - BMC Medical Ethics 17 (1):1.
    _BMC Medical Ethics_ is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies. _BMC __Medical Ethics _is part of the _BMC_ series which publishes subject-specific journals focused on the needs of individual research communities across all areas of biology and medicine. We do not make editorial decisions on the basis of the interest of a study or (...)
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  • Editorial – Ethical Practice and Genomic Research.Michael Parker & Janet Seeley - 2020 - Global Bioethics 31 (1):164-168.
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  • Digital Tools in the Informed Consent Process: A Systematic Review.Francesco Gesualdo, Margherita Daverio, Laura Palazzani, Dimitris Dimitriou, Javier Diez-Domingo, Jaime Fons-Martinez, Sally Jackson, Pascal Vignally, Caterina Rizzo & Alberto Eugenio Tozzi - 2021 - BMC Medical Ethics 22 (1):1-10.
    Background Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice. Understanding, satisfaction and participation were compared for digital tools versus the (...)
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  • The CORBEL Matrix on Informed Consent in Clinical Studies: A Multidisciplinary Approach of Research Infrastructures Building Enduring Life-Science Services.Paola Mosconi, Tamara Carapina, Irene Schluender, Victoria Chico, Sara Casati, Marialuisa Lavitrano, Mihaela Matei, Serena Battaglia, Christine Kubiak, Michaela Th Mayrhofer & Cinzia Colombo - 2021 - BMC Medical Ethics 22 (1):1-15.
    BackgroundInformed consent forms for clinical research are several and variable at international, national and local levels. According to the literature, they are often unclear and poorly understood by participants. Within the H2020 project CORBEL—Coordinated Research Infrastructures Building Enduring Life-science Services—clinical researchers, researchers in ethical, social, and legal issues, experts in planning and management of clinical studies, clinicians, researchers in citizen involvement and public engagement worked together to provide a minimum set of requirements for informed consent in clinical studies.MethodsThe template was (...)
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  • Informed Consent in Genomic Research and Biobanking: Taking Feedback of Findings Seriously.Paulina Tindana, Cornelius Depuur, Jantina de Vries, Janet Seeley & Michael Parker - 2020 - Global Bioethics 31 (1):200-215.
    Genomic research and biobanking present several ethical, social and cultural challenges, particularly when conducted in settings with limited scientific research capacity. One of these challenges is determining the model of consent that should support the sharing of human biological samples and data in the context of international collaborative research. In this paper, we report on the views of key research stakeholders in Ghana on what should count as good ethical practice when seeking consent for genomic research and biobanking in Africa. (...)
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  • Gurus and Griots: Revisiting the Research Informed Consent Process in Rural African Contexts.Richard Appiah - 2021 - BMC Medical Ethics 22 (1):1-11.
    BackgroundResearchers conducting community-based participatory action research in highly collectivistic and socioeconomically disadvantaged community settings in sub-Saharan Africa are confronted with the distinctive challenge of balancing universal ethical standards with local standards, where traditional customs or beliefs may conflict with regulatory requirements and ethical guidelines underlying the informed consent process. The unique ethnic, socioeconomic, and cultural diversities in these settings have important implications for the IC process, such as individual decisional autonomy, beneficence, confidentiality, and signing the IC document.Main textDrawing on insights (...)
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  • Why ‘Understanding’ of Research May Not Be Necessary for Ethical Emergency Research.Dan Kabonge Kaye - 2020 - Philosophy, Ethics, and Humanities in Medicine 15 (1):1-8.
    Background Randomized controlled trials are central to generating knowledge about effectiveness of interventions as well as risk, protective and prognostic factors related to diseases in emergency newborn care. Whether prospective participants understand the purpose of research, and what they perceive as the influence of the context on their understanding of the informed consent process for RCTs in emergency obstetric and newborn care are not well documented. Methods Conceptual review. Discussion Research is necessary to identify how the illnesses may be prevented, (...)
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  • Reframing Consent for Clinical Research: A Function-Based Approach.Scott Y. H. Kim, David Wendler, Kevin P. Weinfurt, Robert Silbergleit, Rebecca D. Pentz, Franklin G. Miller, Bernard Lo, Steven Joffe, Christine Grady, Sara F. Goldkind, Nir Eyal & Neal W. Dickert - 2017 - American Journal of Bioethics 17 (12):3-11.
    Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...)
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  • The Consent Continuum: A New Model of Consent, Assent, and Nondissent for Primary Care.Marc Tunzi, David J. Satin & Philip G. Day - 2021 - Hastings Center Report 51 (2):33-40.
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  • From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository.Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra Berry, Camille Nebeker & Dmitry Khodyakov - 2020 - Journal of Law, Medicine and Ethics 48 (1):172-182.
    The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing to elicit diverse research stakeholders' views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is (...)
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  • Consent in Clinical Research.Collin O'Neil - 2018 - In Andreas Müller & Peter Schaber (eds.), The Routledge Handbook of the Ethics of Consent. New York, USA: Routledge. pp. 297-310.
    This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent is (...)
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  • Informed Consent: What Must Be Disclosed and What Must Be Understood?Joseph Millum & Danielle Bromwich - 2021 - American Journal of Bioethics 21 (5):46-58.
    Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...)
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  • Informed Consent Procedure in a Double Blind Randomized Anthelminthic Trial on Pemba Island, Tanzania: Do Pamphlet and Information Session Increase Caregivers Knowledge?Marta S. Palmeirim, Amanda Ross, Brigit Obrist, Ulfat A. Mohammed, Shaali M. Ame, Said M. Ali & Jennifer Keiser - 2020 - BMC Medical Ethics 21 (1):1-9.
    BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial (...)
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  • “I Want to Do It, But I Want to Make Sure That I Do It Right.” Views of Patients with Parkinson’s Disease Regarding Early Stem Cell Clinical Trial Participation.Inmaculada de Melo-Martín, Michael Holtzman & Katrina S. Hacker - 2020 - AJOB Empirical Bioethics 11 (3):160-171.
  • Education Versus Screening: The Use of Capacity to Consent Tools in Psychiatric Genomics.Camillia Kong, Mehret Efrem & Megan Campbell - 2020 - Journal of Medical Ethics 46 (2):137-143.
    Informed consent procedures for participation in psychiatric genomics research among individuals with mental disorder and intellectual disability can often be unclear, particularly because the underlying ethos guiding consent tools reflects a core ethical tension between safeguarding and inclusion. This tension reflects important debates around the function of consent tools, as well as the contested legitimacy of decision-making capacity thresholds to screen potentially vulnerable participants. Drawing on human rights, person-centred psychiatry and supported decision-making, this paper problematises the use of consent procedures (...)
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  • Dissenting From Care.Data: An Analysis of Opt-Out Forms.Paraskevas Vezyridis & Stephen Timmons - 2016 - Journal of Medical Ethics 42 (12):792-796.
    BackgroundCare.data was a programme of work led by NHS England for the extraction of patient-identifiable and coded information from general practitioner records for secondary uses. This study analyses the forms which enabled patients to opt out.MethodsTheoretical sampling and summative content analysis were used to collect and analyse dissent forms used by patients to opt out from care.data. Domains included basic information about the programme, types of objections and personal details required for identification purposes.ResultsOne hundred opt-out forms were analysed. Fifty-four forms (...)
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  • Informed Consent to HIV Cure Research.Danielle Bromwich & Joseph R. Millum - 2017 - Journal of Medical Ethics 43 (2):108-113.
    Trials with highly unfavourable risk–benefit ratios for participants, like HIV cure trials, raise questions about the quality of the consent of research participants. Why, it may be asked, would a person with HIV who is doing well on antiretroviral therapy be willing to jeopardise his health by enrolling in such a trial? We distinguish three concerns: first, how information is communicated to potential participants; second, participants’ motivations for enrolling in potentially high risk research with no prospect of direct benefit; and (...)
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  • Can Informed Consent to Research Be Adapted to Risk?Danielle Bromwich & Annette Rid - 2015 - Journal of Medical Ethics 41 (7):521-528.
    The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for (...)
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  • Understanding, Interests and Informed Consent: A Reply to Sreenivasan.Danielle Bromwich - 2015 - Journal of Medical Ethics 41 (4):327-331.
    It is widely agreed that the view of informed consent found in the regulations and guidelines struggles to keep pace with the ever-advancing enterprise of human subjects research. Over the last 10 years, there have been serious attempts to rethink informed consent so that it conforms to our considered judgments about cases where we are confident valid consent has been given. These arguments are influenced by an argument from Gopal Sreenivasan, which apparently shows that a potential participant's consent to research (...)
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  • Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context.Joseph Millum, Christine Grady, Gerald Keusch & Barbara Sina - 2013 - Journal of Empirical Research on Human Research Ethics: An International Journal 8 (5):3-16.
    In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research (...)
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  • Cancer Clinical Trial Participants' Assessment of Risk and Benefit.Connie M. Ulrich, Sarah J. Ratcliffe, Gwenyth R. Wallen, Qiuping Zhou, Kathleen Knafl & Christine Grady - 2016 - Ajob Empirical Bioethics 7 (1):8-16.
  • Understandings of Genomic Research in Developing Countries: A Qualitative Study of the Views of MalariaGEN Participants in Mali.Karim Traore, Susan Bull, Alassane Niare, Salimata Konate, Mahamadou A. Thera, Dominic Kwiatkowski, Michael Parker & Ogobara K. Doumbo - 2015 - BMC Medical Ethics 16 (1):1-10.
    BackgroundObtaining informed consent for participation in genomic research in low-income settings presents specific ethical issues requiring attention. These include the challenges that arise when providing information about unfamiliar and technical research methods, the implications of complicated infrastructure and data sharing requirements, and the potential consequences of future research with samples and data. This study investigated researchers’ and participants’ parents’ experiences of a consent process and understandings of a genome-wide association study of malaria involving children aged five and under in Mali. (...)
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  • Participants’ Awareness of Ethical Compliance, Safety and Protection During Participation in Pharmaceutical Industry Clinical Trials: A Controlled Survey.Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava & José Gerardo González-González - 2019 - BMC Medical Ethics 20 (1):2.
    The rapid increase of industry-sponsored clinical research towards developing countries has led to potentially complex ethical issues to assess. There is scarce evidence about the perception of these participants about the ethical compliance, security, and protection. We sought to evaluate and contrast the awareness and perception of participants and non-participants of industry-sponsored research trials on ethical, safety, and protection topics. A Cases-control survey conducted at twelve research sites in México. Previous and current participants of ISRT as well as non-participants with (...)
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  • Multimedia Informed Consent Tool for a Low Literacy African Research Population: Development and Pilot-Testing.Muhammed Olanrewaju - 2014 - Journal of Clinical Research and Bioethics 5 (3).
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