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Ethics in Biomedical Research

Section edited by Beatrice Godard and Anita Ho

This section will include manuscripts that consider ethical aspects of research in biological and medical sciences, as well as ethical implications of new technologies, -omics research, and human  enhancement. Manuscripts addressing researcher behavior are also welcome in this section.

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  1. Content type: Research article

    The rapid expansion of research on Brain-Computer Interfaces (BCIs) is not only due to the promising solutions offered for persons with physical impairments. There is also a heightened need for understanding B...

    Authors: Johannes Kögel, Jennifer R. Schmid, Ralf J. Jox and Orsolya Friedrich

    Citation: BMC Medical Ethics 2019 20:18

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  2. Content type: Debate

    Even after several decades of human drug development, there remains an absence of published, substantial, comprehensive data to validate the use of animals in preclinical drug testing, and to point to their pr...

    Authors: Jarrod Bailey and Michael Balls

    Citation: BMC Medical Ethics 2019 20:16

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  3. Content type: Research article

    The consent and community engagement process for research with Indigenous communities is rarely evaluated. Research protocols are not always collaborative, inclusive or culturally respectful. If participants d...

    Authors: Emily FM Fitzpatrick, Gaynor Macdonald, Alexandra LC Martiniuk, June Oscar, Heather D’Antoine, Maureen Carter, Tom Lawford and Elizabeth J Elliott

    Citation: BMC Medical Ethics 2019 20:12

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  6. Content type: Research article

    Consent processes for clinical trials involving HIV prevention research have generated considerable debate globally over the past three decades. HIV cure/eradication research is scientifically more complex and...

    Authors: Keymanthri Moodley, Ciara Staunton, Theresa Rossouw, Malcolm de Roubaix, Zoe Duby and Donald Skinner

    Citation: BMC Medical Ethics 2019 20:9

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  7. Content type: Correspondence

    In 2017 Ploug and Holm argued that anonymizing individuals in the Danish circumcision registry was insufficient to protect these individuals from what they regard as the potential harms of being in the registr...

    Authors: Robert S. Van Howe, Morten Frisch, Peter W. Adler and J. Steven Svoboda

    Citation: BMC Medical Ethics 2019 20:6

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    The original article was published in BMC Medical Ethics 2017 18:53

  8. Content type: Research article

    Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in hig...

    Authors: Daniel Mbuthia, Sassy Molyneux, Maureen Njue, Salim Mwalukore and Vicki Marsh

    Citation: BMC Medical Ethics 2019 20:3

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  9. Content type: Research article

    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 participa...

    Authors: Gerardo González-Saldivar, René Rodríguez-Gutiérrez, Jose Luis Viramontes-Madrid, Alejandro Salcido-Montenegro, Neri Alejandro Álvarez-Villalobos, Victoria González-Nava and José Gerardo González-González

    Citation: BMC Medical Ethics 2019 20:2

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  10. Content type: Debate

    Thus far, little work in bioethics has specifically focused on global health research priority-setting. Yet features of global health research priority-setting raise ethical considerations and concerns related...

    Authors: Bridget Pratt, Mark Sheehan, Nicola Barsdorf and Adnan A. Hyder

    Citation: BMC Medical Ethics 2018 19:94

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  12. Content type: Study protocol

    Randomized controlled trial (RCT) trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized b...

    Authors: Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson and Monica Taljaard

    Citation: BMC Medical Ethics 2018 19:90

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  13. Content type: Research article

    A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consid...

    Authors: Jeremy Furyk, Kris McBain-Rigg, Bronia Renison, Kerrianne Watt, Richard Franklin, Theophilus I. Emeto, Robin A. Ray, Franz E. Babl and Stuart Dalziel

    Citation: BMC Medical Ethics 2018 19:89

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  14. Content type: Research article

    Rapid Ethical Assessment (REA) is an approach used to design context tailored consent process for voluntary participation of participants in research including human subjects. There is, however, limited eviden...

    Authors: Alem Gebremariam, Alemayehu Worku Yalew, Selamawit Hirpa, Abigiya Wondimagegnehu, Mirgissa Kaba, Mathewos Assefa, Israel Mitiku, Eva Johanna Kantelhardt, Ahmedin Jemal and Adamu Addissie

    Citation: BMC Medical Ethics 2018 19:87

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  15. Content type: Research article

    Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible ...

    Authors: Phaik Yeong Cheah, Nattapat Jatupornpimol, Borimas Hanboonkunupakarn, Napat Khirikoekkong, Podjanee Jittamala, Sasithon Pukrittayakamee, Nicholas P. J. Day, Michael Parker and Susan Bull

    Citation: BMC Medical Ethics 2018 19:86

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  16. Content type: Debate

    The U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PL...

    Authors: Karine Dubé, Sara Gianella, Susan Concha-Garcia, Susan J Little, Andy Kaytes, Jeff Taylor, Kushagra Mathur, Sogol Javadi, Anshula Nathan, Hursch Patel, Stuart Luter, Sean Philpott-Jones, Brandon Brown and Davey Smith

    Citation: BMC Medical Ethics 2018 19:83

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  17. Content type: Research article

    The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent ...

    Authors: Juntra Karbwang, Nut Koonrungsesomboon, Cristina E. Torres, Edlyn B. Jimenez, Gurpreet Kaur, Roli Mathur, Eti N. Sholikhah, Chandanie Wanigatunge, Chih-Shung Wong, Kwanchanok Yimtae, Murnilina Abdul Malek, Liyana Ahamad Fouzi, Aisyah Ali, Beng Z. Chan, Madawa Chandratilake, Shoen C. Chiew…

    Citation: BMC Medical Ethics 2018 19:79

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  18. Content type: Research article

    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...

    Authors: 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 and Ezra Susser

    Citation: BMC Medical Ethics 2018 19:72

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  20. Content type: Research article

    Deep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) has generated big expectations. Our aim is to discuss the ethical justification of this research ...

    Authors: Merlin Bittlinger and Sabine Müller

    Citation: BMC Medical Ethics 2018 19:41

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  21. Content type: Research article

    Since 2010, the European Journal of Anaesthesiology has required the reporting of five items concerning ethical approval in articles describing human research: ethics committee’s name and address, chairperson’...

    Authors: Davide Zoccatelli, Martin R. Tramèr and Nadia Elia

    Citation: BMC Medical Ethics 2018 19:57

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  23. Content type: Research article

    Mozambique has seen remarkable growth in biomedical research over the last decade. To meet a growing need, the National Committee for Bioethics in Health of Mozambique (CNBS) encouraged the development of ethi...

    Authors: Jahit Sacarlal, Vasco Muchanga, Carlos Mabutana, Matilde Mabui, Arlete Mariamo, Assa Júlio Cuamba, Leida Artur Fumo, Jacinta Silveira, Elizabeth Heitman and Troy D. Moon

    Citation: BMC Medical Ethics 2018 19:37

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  24. Content type: Research article

    With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics ...

    Authors: Sinyoung Park, Chung Mo Nam, Sejung Park, Yang Hee Noh, Cho Rong Ahn, Wan Sun Yu, Bo Kyung Kim, Seung Min Kim, Jin Seok Kim and Sun Young Rha

    Citation: BMC Medical Ethics 2018 19:30

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  25. Content type: Research article

    Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of dispa...

    Authors: George Rugare Chingarande and Keymanthri Moodley

    Citation: BMC Medical Ethics 2018 19:8

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  26. Content type: Debate

    The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy...

    Authors: Gert J. van der Wilt, Janneke P. C. Grutters, Angela H. E. M. Maas and Herbert J. A. Rolden

    Citation: BMC Medical Ethics 2018 19:5

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  27. Content type: Debate

    Fake news and alternative facts have become commonplace in these so-called “post-factual times.” What about medical research - are scientific facts fake as well? Many recent disclosures have fueled the claim t...

    Authors: Bjørn Hofmann

    Citation: BMC Medical Ethics 2018 19:4

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  29. Content type: Research article

    For valid informed consent, it is crucial that patients or research participants fully understand all that their consent entails. Testing and revising informed consent documents with the assistance of their ad...

    Authors: Sabine Bossert, Hannes Kahrass, Ulrike Heinemeyer, Jana Prokein and Daniel Strech

    Citation: BMC Medical Ethics 2017 18:78

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  30. Content type: Research article

    Community engagement (CE) models have provided much needed guidance for researchers to conceptualise and design engagement strategies for research projects. Most of the published strategies, however, still sho...

    Authors: Rosemary Musesengwa and Moses J. Chimbari

    Citation: BMC Medical Ethics 2017 18:76

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  31. Content type: Debate

    The use of tissue collected at a forensic post-mortem for forensic genetics research purposes remains of ethical concern as the process involves obtaining informed consent from grieving family members. Two for...

    Authors: Laura J. Heathfield, Sairita Maistry, Lorna J. Martin, Raj Ramesar and Jantina de Vries

    Citation: BMC Medical Ethics 2017 18:66

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  32. Content type: Research article

    As part of the preparations to establish a population-based biobank in a large Israeli health organization, we aimed to investigate through focus groups the knowledge, perceptions and attitudes of insured Isra...

    Authors: Gideon Koren, Daniella Beller, Daphna Laifenfeld, Iris Grossman and Varda Shalev

    Citation: BMC Medical Ethics 2017 18:63

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  33. Content type: Research article

    Brain-Computer Interface (BCI) is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, suc...

    Authors: Sasha Burwell, Matthew Sample and Eric Racine

    Citation: BMC Medical Ethics 2017 18:60

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  34. Content type: Research article

    Protecting human subjects from being exploited is one of the main ethical challenges for clinical research. However, there is also a responsibility to protect and respect the communities who are hosting the re...

    Authors: Sanna-Maria Nurmi, Arja Halkoaho, Mari Kangasniemi and Anna-Maija Pietilä

    Citation: BMC Medical Ethics 2017 18:57

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  35. Content type: Debate

    Research into personal health data holds great potential not only for improved treatment but also for economic growth. In these years many countries are developing policies aimed at facilitating such research ...

    Authors: Thomas Ploug and Søren Holm

    Citation: BMC Medical Ethics 2017 18:53

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    The Correspondence to this article has been published in BMC Medical Ethics 2019 20:6

  36. Content type: Research article

    The increased use of information technology in every day health care creates vast amounts of stored health data that can be used for research. The secondary research use of routinely collected data raises ques...

    Authors: Thomas Ploug and Søren Holm

    Citation: BMC Medical Ethics 2017 18:51

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  37. Content type: Research article

    The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate inf...

    Authors: Pornpimon Adams, Sukanya Prakobtham, Chanthima Limpattaracharoen, Sumeth Suebtrakul, Pitchapa Vutikes, Srisin Khusmith, Polrat Wilairatana, Paul Adams and Jaranit Kaewkungwal

    Citation: BMC Medical Ethics 2017 18:50

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  38. Content type: Research article

    The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, ...

    Authors: Catherine M. Tansey, James Anderson, Renaud F. Boulanger, Lisa Eckenwiler, John Pringle, Lisa Schwartz and Matthew Hunt

    Citation: BMC Medical Ethics 2017 18:44

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  39. Content type: Debate

    Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organizatio...

    Authors: Emilie Alirol, Annette C. Kuesel, Maria Magdalena Guraiib, Vânia de la Fuente-Núñez, Abha Saxena and Melba F. Gomes

    Citation: BMC Medical Ethics 2017 18:43

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    The Erratum to this article has been published in BMC Medical Ethics 2017 18:45

  40. Content type: Debate

    Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Commi...

    Authors: Reidar K. Lie, Francis K.L. Chan, Christine Grady, Vincent H. Ng and David Wendler

    Citation: BMC Medical Ethics 2017 18:42

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  42. Content type: Research article

    Fecal microbiota transplantation (FMT) is reportedly the most effective therapy for relapsing Clostridium Difficile infection (CDI) and a potential therapeutic option for many diseases. It also poses important et...

    Authors: Yonghui Ma, Jinqiu Yang, Bota Cui, Hongzhi Xu, Chuanxing Xiao and Faming Zhang

    Citation: BMC Medical Ethics 2017 18:39

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  44. Content type: Research Article

    Obtaining prospective written consent from women to participate in trials when they are experiencing an obstetric emergency is challenging. Alternative consent pathways, such as gaining verbal consent at enrol...

    Authors: J. Lawton, N. Hallowell, C. Snowdon, J. E. Norman, K. Carruthers and F. C. Denison

    Citation: BMC Medical Ethics 2017 18:36

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  45. Content type: Research article

    There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper...

    Authors: Indira S. E. van der Zande, Rieke van der Graaf, Martijn A. Oudijk and Johannes J. M. van Delden

    Citation: BMC Medical Ethics 2017 18:35

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  46. Content type: Research article

    Researchers are required to seek consent from Indigenous communities prior to conducting research but there is inadequate information about how Indigenous people understand and become fully engaged with this c...

    Authors: E.F.M. Fitzpatrick, G. Macdonald, A.L.C. Martiniuk, H. D’Antoine, J. Oscar, M. Carter, T. Lawford and E.J. Elliott

    Citation: BMC Medical Ethics 2017 18:34

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  47. Content type: Research article

    Biobanks and biospecimen collections are becoming a primary means of delivering personalized diagnostics and tailoring individualized therapeutics. This shift towards precision medicine (PM) requires interacti...

    Authors: Leena Merdad, Lama Aldakhil, Rawan Gadi, Mourad Assidi, Salina Y. Saddick, Adel Abuzenadah, Jim Vaught, Abdelbaset Buhmeida and Mohammed H. Al-Qahtani

    Citation: BMC Medical Ethics 2017 18:32

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  48. Content type: Debate

    Despite the growing recognition for the need to improve the health of prisoners in Canada and the need for health research, there has been little discussion of the ethical issues with regards to health researc...

    Authors: Diego S. Silva, Flora I. Matheson and James V. Lavery

    Citation: BMC Medical Ethics 2017 18:31

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  49. Content type: Research article

    Robust technology infrastructure is needed to enable learning health care systems to improve quality, access, and cost. Such infrastructure relies on the trust and confidence of individuals to share their heal...

    Authors: Katherine K. Kim, Pamela Sankar, Machelle D. Wilson and Sarah C. Haynes

    Citation: BMC Medical Ethics 2017 18:25

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  50. Content type: Research article

    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...

    Authors: Eline M. Bunnik, Lisa van Bodegom, Wim Pinxten, Inez D. de Beaufort and Meike W. Vernooij

    Citation: BMC Medical Ethics 2017 18:10

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