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  1. Consideration and Disclosure of Group Risks in Genomics and Other Data-Centric Research: Does the Common Rule Need Revision?Carolyn Riley Chapman, Gwendolyn P. Quinn, Heini M. Natri, Courtney Berrios, Patrick Dwyer, Kellie Owens, Síofra Heraty & Arthur L. Caplan - forthcoming - American Journal of Bioethics:1-14.
    Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...)
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  • Participant views on practical considerations for feedback of individual genetic research results: a case study from Botswana.Dimpho Ralefala, Mary Kasule, Olivia P. Matshabane, Ambroise Wonkam, Mogomotsi Matshaba & Jantina de Vries - 2023 - Global Bioethics 34 (1):1-14.
    Key to discussions around feedback of individual results from genomics research are practical questions on how such results should be fed back, by who and when. However, there has been virtually no work investigating these practical considerations for feedback of individual genetic results in the context of low-and middle-income countries (LMICs), especially in Africa. Consequently, we conducted deliberative focus group discussions with 6 groups of adolescents (n = 44) who previously participated in a genomics study in Botswana as well as (...)
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  • Managing community engagement in research in Uganda: insights from practices in HIV/aids research.Nancy E. Kass & John Barugahare - 2022 - BMC Medical Ethics 23 (1):1-12.
    BackgroundCommunity engagement in research is valuable for instrumental and intrinsic reasons. Despite existing guidance on how to ensure meaningful CE, much of what it takes to achieve this goal differs across settings. Considering the emerging trend towards mandating CE in many research studies, this study aimed at documenting how CE is conceptualized and implemented, and then providing context-specific guidance on how researchers and research regulators in Uganda could think about and manage CE in research.MethodsWe conducted qualitative interviews and focus group (...)
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  • Preventing ethics dumping: the challenges for Kenyan research ethics committees.Kate Chatfield, Doris Schroeder, Anastasia Guantai, Kirana Bhatt, Elizabeth Bukusi, Joyce Adhiambo Odhiambo, Julie Cook & Joshua Kimani - 2021 - Research Ethics 17 (1):23-44.
    Ethics dumping is the practice of undertaking research in a low- or middle-income setting which would not be permitted, or would be severely restricted, in a high-income setting. Whilst Kenya operates a sophisticated research governance system, resource constraints and the relatively low number of accredited research ethics committees limit the capacity for ensuring ethical compliance. As a result, Kenya has been experiencing cases of ethics dumping. This article presents 11 challenges in the context of preventing ethics dumping in Kenya, namely (...)
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  • Community Engagement in Precision Medicine Research: Organizational Practices and Their Impacts for Equity.Janet K. Shim, Nicole Foti, Emily Vasquez, Stephanie M. Fullerton, Michael Bentz, Melanie Jeske & Sandra Soo-Jin Lee - 2023 - AJOB Empirical Bioethics 14 (4):185-196.
    Background In the wake of mandates for biomedical research to increase participation by members of historically underrepresented populations, community engagement (CE) has emerged as a key intervention to help achieve this goal.Methods Using interviews, observations, and document analysis, we examine how stakeholders in precision medicine research understand and seek to put into practice ideas about who to engage, how engagement should be conducted, and what engagement is for.Results We find that ad hoc, opportunistic, and instrumental approaches to CE exacted significant (...)
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  • Biosafety, biosecurity, and bioethics.David B. Resnik - 2024 - Monash Bioethics Review 42 (1):137-167.
    The COVID-19 pandemic has highlighted the importance of biosafety in the biomedical sciences. While it is often assumed that biosafety is a purely technical matter that has little to do with philosophy or the humanities, biosafety raises important ethical issues that have not been adequately examined in the scientific or bioethics literature. This article reviews some pivotal events in the history of biosafety and biosecurity and explores three different biosafety topics that generate significant ethical concerns, i.e., risk assessment, risk management, (...)
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  • (1 other version)What constitutes good ethical practice in genomic research in Africa? Perspectives of participants in a genomic research study in Uganda.Rwamahe Rutakumwa, Jantina de Vries, Michael Parker, Paulina Tindana, Oliver Mweemba & Janet Seeley - 2020 - Global Bioethics 31 (1):169-183.
    ABSTRACT Previous research has consistently highlighted the importance of stakeholder engagement in identifying and developing solutions to ethical challenges in genomic research, especially in Africa where such research is relatively new. In this paper, we examine what constitutes good ethical practice in research, from the perspectives of genomic research participants in Uganda. Our study was part of a multi-site qualitative study exploring these issues in Uganda, Ghana and Zambia. We purposively sampled various stakeholders including genomic research participants, researchers, research ethics (...)
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  • Rules of engagement: perspectives on stakeholder engagement for genomic biobanking research in South Africa.Ciara Staunton, Paulina Tindana, Melany Hendricks & Keymanthri Moodley - 2018 - BMC Medical Ethics 19 (1):13.
    Genomic biobanking research is undergoing exponential growth in Africa raising a host of legal, ethical and social issues. Given the scientific complexity associated with genomics, there is a growing recognition globally of the importance of science translation and community engagement for this type of research, as it creates the potential to build relationships, increase trust, improve consent processes and empower local communities. Despite this level of recognition, there is a lack of empirical evidence of the practise and processes for effective (...)
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  • Community engagement in genetics and genomics research: a qualitative study of the perspectives of genetics and genomics researchers in Uganda.Harriet Nankya, Edward Wamala, Vincent Pius Alibu & John Barugahare - 2024 - BMC Medical Ethics 25 (1):1-13.
    Background Generally, there is unanimity about the value of community engagement in health-related research. There is also a growing tendency to view genetics and genomics research (GGR) as a special category of research, the conduct of which including community engagement (CE) as needing additional caution. One of the motivations of this study was to establish how differently if at all, we should think about CE in GGR. Aim To assess the perspectives of genetics and genomics researchers in Uganda on CE (...)
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  • Perspectives on returning individual and aggregate genomic research results to study participants and communities in Kenya: a qualitative study.Gershim Asiki, Michele Ramsay, Anita Ghansah, Paulina Tindana, Catherine Kyobutungi, Shukri F. Mohamed & Isaac Kisiangani - 2022 - BMC Medical Ethics 23 (1):1-11.
    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. (...)
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  • Lay persons’ perception of the requirements for research in emergency obstetric and newborn care.Dan Kabonge Kaye - 2021 - BMC Medical Ethics 22 (1):1-13.
    Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The (...)
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  • Community involvement in biomedical research conducted in the global health context; what can be done to make it really matter?Federica Fregonese - 2018 - BMC Medical Ethics 19 (S1).
    Background Community involvement in research has been advocated by researchers, communities, regulatory agencies, and funders with the aim of reinforcing subjects’ protection and improving research efficiency. Community involvement also has the potential to improve dissemination, uptake, and implementation of research findings. The fields of community based participatory research conducted with indigenous populations and of participatory action research offer a large base of experience in community involvement in research. Rules on involving the population affected when conducting research have been established in (...)
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  • The challenge of community engagement and informed consent in rural Zambia: an example from a pilot study.Joseph Mumba Zulu, Ingvild Fossgard Sandøy, Karen Marie Moland, Patrick Musonda, Ecloss Munsaka & Astrid Blystad - 2019 - BMC Medical Ethics 20 (1):45.
    There is a need for empirically based research on social and ethical challenges related to informed consent processes, particularly in studies focusing on adolescent sexual and reproductive health. In a pilot study of a school-based pregnancy prevention intervention in rural Zambia, the majority of the guardians who were asked to consent to their daughters’ participation, refused. In this paper we explore the reasons behind the low participation in the pilot with particular attention to challenges related to the community engagement and (...)
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  • Forming and implementing community advisory boards in low- and middle-income countries: a scoping review.Yang Zhao, Thomas Fitzpatrick, Bin Wan, Suzanne Day, Allison Mathews & Joseph D. Tucker - 2019 - BMC Medical Ethics 20 (1):1-11.
    Background Community advisory boards have expanded beyond high-income countries and play an increasing role in low- and middle-income country research. Much research has examined CABs in HICs, but less is known about CABs in LMICs. The purposes of this scoping review are to examine the creation and implementation of CABs in LMICs, including identifying frequently reported challenges, and to discuss implications for research ethics. Methods We searched five databases for publications describing or evaluating CABs in LMICs. Two researchers independently reviewed (...)
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  • Engaging research ethics committees to develop an ethics and governance framework for best practices in genomic research and biobanking in Africa: the H3Africa model.Paulina Tindana, Aminu Yakubu, Ciara Staunton, Alice Matimba, Katherine Littler, Ebony Madden, Nchangwi Syntia Munung & Jantina de Vries - 2019 - BMC Medical Ethics 20 (1):1-7.
    In the past decade, there has been an increase in genomic research and biobanking activities in Africa. Research initiatives such as the Human Heredity and Health in Africa Consortium are contributing to the development of scientific capacity and infrastructure to support these studies on the continent. Despite this growth, genomic research and biobanking have raised important ethical challenges for key research stakeholders, including members of research ethics committees. One of these is the limited ethical and regulatory frameworks to guide the (...)
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  • Can biosampling really be “non-invasive”? An examination of the socially invasive nature of physically non-invasive biosampling in urban and rural Malawi.Myness Kasanda Ndambo, Christopher Bunn, Martyn Pickersgill, Robert C. Stewart, Amelia C. Crampin, Maisha Nyasulu, Beatson Kanyenda, Wisdom Mnthali, Eric Umar, Rebecca M. Reynolds & Lucinda Manda-Taylor - 2024 - Global Bioethics 35 (1).
    Glucocorticoids are understood to represent useful biomarkers of stress and can be measured in saliva, hair, and breastmilk. The collection of such biosamples is increasingly included in biobank and cohort studies. While collection is considered “non-invasive” by biomedical researchers (compared to sampling blood), community perspectives may differ. This cross-sectional, qualitative study utilising eight focus groups aimed to determine the feasibility and acceptability of collecting ostensibly “non-invasive” biological samples in Malawi. Breastfeeding women, couples, field workers, and healthcare providers were purposively sampled. (...)
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  • Researchers’ perspectives on return of individual genetics results to research participants: a qualitative study.Erisa Sabakaki Mwaka, Deborah Ekusai Sebatta, Joseph Ochieng, Ian Guyton Munabi, Godfrey Bagenda, Deborah Ainembabazi & David Kaawa-Mafigiri - 2021 - Global Bioethics 32 (1):15-33.
    Genetic results are usually not returned to research participants in Uganda despite their increased demand. We report on researchers’ perceptions and experiences of return of individual genetic research results. The study involved 15 in-depth interviews of investigators involved in genetics and/or genomic research. A thematic approach was used to interpret the results. The four themes that emerged from the data were the need for return of individual results including incidental findings, community engagement and the consenting process, implications and challenges to (...)
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  • Evaluating community engagement in global health research: the need for metrics.Kathleen M. MacQueen, Anant Bhan, Janet Frohlich, Jessica Holzer & Jeremy Sugarman - 2015 - BMC Medical Ethics 16 (1):1-9.
    BackgroundCommunity engagement in research has gained momentum as an approach to improving research, to helping ensure that community concerns are taken into account, and to informing ethical decision-making when research is conducted in contexts of vulnerability. However, guidelines and scholarship regarding community engagement are arguably unsettled, making it difficult to implement and evaluate.DiscussionWe describe normative guidelines on community engagement that have been offered by national and international bodies in the context of HIV-related research, which set the stage for similar work (...)
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