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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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  2. Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using second...

    Authors: G. Owen Schaefer, Graeme Laurie, Sumytra Menon, Alastair V. Campbell and Teck Chuan Voo

    Citation: BMC Medical Ethics 2020 21:23

    Content type: Debate

    Published on:

  5. The clinical introduction of non-invasive prenatal testing for fetal aneuploidies is currently transforming the landscape of prenatal screening in many countries. Since it is noninvasive, safe and allows the e...

    Authors: Hazar Haidar, Meredith Vanstone, Anne-Marie Laberge, Gilles Bibeau, Labib Ghulmiyyah and Vardit Ravitsky

    Citation: BMC Medical Ethics 2020 21:15

    Content type: Research article

    Published on:

  6. Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and et...

    Authors: Blessings M. Kapumba, Kondwani Jambo, Jamie Rylance, Markus Gmeiner, Rodrick Sambakunsi, Michael Parker, Stephen B. Gordon and Kate Gooding

    Citation: BMC Medical Ethics 2020 21:14

    Content type: Research article

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  7. Sharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant con...

    Authors: Phaik Yeong Cheah and Jan Piasecki

    Citation: BMC Medical Ethics 2020 21:12

    Content type: Debate

    Published on:

  9. As Next Generation Sequencing technologies are increasingly implemented in biomedical research and (translational) care, the number of study participants and patients who ask for release of their genomic raw d...

    Authors: Christoph Schickhardt, Henrike Fleischer and Eva C. Winkler

    Citation: BMC Medical Ethics 2020 21:7

    Content type: Research article

    Published on:

  10. Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid con...

    Authors: Jennifer Ilo Van Nuil, Thi Thanh Thuy Nguyen, Thanh Nhan Le Nguyen, Van Vinh Chau Nguyen, Mary Chambers, Thi Dieu Ngan Ta, Laura Merson, Thi Phuong Dung Nguyen, Minh Tu Van Hoang, Michael Parker, Susan Bull and Evelyne Kestelyn

    Citation: BMC Medical Ethics 2020 21:4

    Content type: Research article

    Published on:

  11. Digital Pills (DP) are an innovative drug-device technology that permits to combine traditional medications with a monitoring system that automatically records data about medication adherence as well as patien...

    Authors: Andrea Martani, Lester Darryl Geneviève, Christopher Poppe, Carlo Casonato and Tenzin Wangmo

    Citation: BMC Medical Ethics 2020 21:3

    Content type: Research article

    Published on:

  13. In their letter to the Editor in this issue, Kolstoe and Carpenter challenge a core aspect of our recently published case study of research approvals [BMC Medical Ethics 20:7] by arguing that we conflate resea...

    Authors: Mila Petrova and Stephen Barclay

    Citation: BMC Medical Ethics 2019 20:101

    Content type: Correspondence

    Published on:

    The original article was published in BMC Medical Ethics 2019 20:7

    The Correspondence to this article has been published in BMC Medical Ethics 2019 20:100

    The Correspondence to this article has been published in BMC Medical Ethics 2019 20:100

  14. One important ethical issue in randomised controlled trials (RCTs) is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of ra...

    Authors: Maureen Mupeta Kombe, Joseph Mumba Zulu, Charles Michelo and Ingvild F. Sandøy

    Citation: BMC Medical Ethics 2019 20:99

    Content type: Research article

    Published on:

  15. People with lived experience are individuals who have first-hand experience of the medical condition(s) being considered. The value of including the viewpoints of people with lived experience in health policy,...

    Authors: Katherine Rittenbach, Candice G. Horne, Terence O’Riordan, Allison Bichel, Nicholas Mitchell, Adriana M. Fernandez Parra and Frank P. MacMaster

    Citation: BMC Medical Ethics 2019 20:95

    Content type: Debate

    Published on:

  16. Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing j...

    Authors: Yanni Wu, Michelle Howarth, Chunlan Zhou, Mingyu Hu and Weilian Cong

    Citation: BMC Medical Ethics 2019 20:94

    Content type: Research article

    Published on:

  17. Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this res...

    Authors: Stephanie Armstrong, Adele Langlois, Niroshan Siriwardena and Tom Quinn

    Citation: BMC Medical Ethics 2019 20:88

    Content type: Research article

    Published on:

  18. Citizen science is increasingly prevalent in the biomedical sciences, including the field of human genomics. Genomic citizen science initiatives present new opportunities to engage individuals in scientific di...

    Authors: Christi J. Guerrini, Meaganne Lewellyn, Mary A. Majumder, Meredith Trejo, Isabel Canfield and Amy L. McGuire

    Citation: BMC Medical Ethics 2019 20:84

    Content type: Research article

    Published on:

  19. Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regul...

    Authors: Wongani Nyangulu, Randy Mungwira, Nginanche Nampota, Osward Nyirenda, Lufina Tsirizani, Edson Mwinjiwa and Titus Divala

    Citation: BMC Medical Ethics 2019 20:82

    Content type: Debate

    Published on:

  20. 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 (H3Africa) Consortium are contributi...

    Authors: Paulina Tindana, Aminu Yakubu, Ciara Staunton, Alice Matimba, Katherine Littler, Ebony Madden, Nchangwi Syntia Munung and Jantina de Vries

    Citation: BMC Medical Ethics 2019 20:69

    Content type: Commentary

    Published on:

  21. Community advisory boards (CABs) have expanded beyond high-income countries (HICs) and play an increasing role in low- and middle-income country (LMIC) research. Much research has examined CABs in HICs, but le...

    Authors: Yang Zhao, Thomas Fitzpatrick, Bin Wan, Suzanne Day, Allison Mathews and Joseph D. Tucker

    Citation: BMC Medical Ethics 2019 20:73

    Content type: Research article

    Published on:

  22. Structured training in research integrity, research ethics and responsible conduct of research is one strategy to reduce research misconduct and strengthen reliability of and trust in scientific evidence. Howe...

    Authors: Priya Satalkar and David Shaw

    Citation: BMC Medical Ethics 2019 20:72

    Content type: Research article

    Published on:

  23. As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has...

    Authors: Rasmus Bjerregaard Mikkelsen, Mickey Gjerris, Gunhild Waldemar and Peter Sandøe

    Citation: BMC Medical Ethics 2019 20:71

    Content type: Debate

    Published on:

  24. Research ethics is an integral part of research, especially that involving human subjects. However, concerns have been expressed that research ethics has come to be seen as a procedural concern focused on a fe...

    Authors: Angus Dawson, Sapfo Lignou, Chesmal Siriwardhana and Dónal P. O’Mathúna

    Citation: BMC Medical Ethics 2019 20:68

    Content type: Debate

    Published on:

  25. HIV molecular epidemiology is increasingly recognized as a vital source of information for understanding HIV transmission dynamics. Despite extensive use of these data-intensive techniques in both research and...

    Authors: Farirai Mutenherwa, Douglas R. Wassenaar and Tulio de Oliveira

    Citation: BMC Medical Ethics 2019 20:67

    Content type: Research article

    Published on:

  26. Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the ...

    Authors: Joeri K. Tijdink, Yvo M. Smulders, Lex M. Bouter and Christiaan H. Vinkers

    Citation: BMC Medical Ethics 2019 20:64

    Content type: Research article

    Published on:

  27. Novel precision oncology trial designs, such as basket and umbrella trials, are designed to test new anticancer agents in more effective and affordable ways. However, they present some ethical concerns referre...

    Authors: Karolina Strzebonska and Marcin Waligora

    Citation: BMC Medical Ethics 2019 20:58

    Content type: Debate

    Published on:

  28. Biobanking is a relatively new concept in Egypt. Building a good relationship with different stakeholders is essential for the social sustainability of biobanks. To establish this relationship, it is necessary...

    Authors: Ahmed S. Abdelhafiz, Eman A. Sultan, Hany H. Ziady, Ebtesam Ahmed, Walaa A. Khairy, Douaa M. Sayed, Rana Zaki, Merhan A. Fouda and Rania M. Labib

    Citation: BMC Medical Ethics 2019 20:57

    Content type: Research article

    Published on:

  29. Rare Disease research has seen tremendous advancements over the last decades, with the development of new technologies, various global collaborative efforts and improved data sharing. To maximize the impact of...

    Authors: Minh Thu Nguyen, Jack Goldblatt, Rosario Isasi, Marlene Jagut, Anneliene Hechtelt Jonker, Petra Kaufmann, Laetitia Ouillade, Fruszina Molnar-Gabor, Mahsa Shabani, Eric Sid, Anne Marie Tassé, Durhane Wong-Rieger and Bartha Maria Knoppers

    Citation: BMC Medical Ethics 2019 20:55

    Content type: Research article

    Published on:

  31. Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards (CABs) is one method of practicing community invo...

    Authors: Charmaine Khudzie Mlambo, Eva Vernooij, Roos Geut, Eliane Vrolings, Buyisile Shongwe, Saima Jiwan, Yvette Fleming and Gavin Khumalo

    Citation: BMC Medical Ethics 2019 20:50

    Content type: Research article

    Published on:

  32. This article discusses our reflections on ethical and methodological challenges when conducting separate interviews with individuals in dyads in the uMkhanyakude district, South Africa. Our work is embedded in...

    Authors: Dumile Gumede, Nothando B. Ngwenya, Stella Namukwaya, Sarah Bernays and Janet Seeley

    Citation: BMC Medical Ethics 2019 20:47

    Content type: Research article

    Published on:

  33. International research guidance has shifted towards an increasingly proactive inclusion of children and adolescents in health research in recognition of the need for more evidence-based treatment. Strong calls...

    Authors: Vicki Marsh, Nancy Mwangome, Irene Jao, Katharine Wright, Sassy Molyneux and Alun Davies

    Citation: BMC Medical Ethics 2019 20:41

    Content type: Research article

    Published on:

  34. Paediatric research in low-income countries is essential to tackle high childhood mortality. As with all research, consent is an essential part of ethical practice for paediatric studies. Ethics guidelines rec...

    Authors: Helen Mangochi, Kate Gooding, Aisleen Bennett, Michael Parker, Nicola Desmond and Susan Bull

    Citation: BMC Medical Ethics 2019 20:32

    Content type: Research article

    Published on:

  35. During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating Europe...

    Authors: Ascanio Tridente, Paul A. H. Holloway, Paula Hutton, Anthony C. Gordon, Gary H. Mills, Geraldine M. Clarke, Jean-Daniel Chiche, Frank Stuber, Christopher Garrard, Charles Hinds and Julian Bion

    Citation: BMC Medical Ethics 2019 20:30

    Content type: Research article

    Published on:

  36. Ensuring that countries have adequate research capacities is essential for an effective and efficient response to infectious disease outbreaks. The need for ethical principles and values embodied in internatio...

    Authors: Abha Saxena, Peter Horby, John Amuasi, Nic Aagaard, Johannes Köhler, Ehsan Shamsi Gooshki, Emmanuelle Denis, Andreas A. Reis and Raffaella Ravinetto

    Citation: BMC Medical Ethics 2019 20:29

    Content type: Debate

    Published on:

  37. There is unanimous agreement regarding the need to ethically conduct research for improving therapy for patients admitted to hospital with acute conditions, including in emergency obstetric care. We present a ...

    Authors: Dan K. Kaye, Gershom Chongwe and Nelson K. Sewankambo

    Citation: BMC Medical Ethics 2019 20:27

    Content type: Debate

    Published on:

  38. Large-scale linkage of international clinical datasets could lead to unique insights into disease aetiology and facilitate treatment evaluation and drug development. Hereto, multi-stakeholder consortia are cur...

    Authors: Shona Kalkman, Menno Mostert, Christoph Gerlinger, Johannes J. M. van Delden and Ghislaine J. M. W. van Thiel

    Citation: BMC Medical Ethics 2019 20:21

    Content type: Research article

    Published on:

  39. 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

    Content type: Research article

    Published on:

  40. 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

    Content type: Debate

    Published on:

  41. 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

    Content type: Research article

    Published on:

  43. The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the re...

    Authors: Mila Petrova and Stephen Barclay

    Citation: BMC Medical Ethics 2019 20:7

    Content type: Debate

    Published on:

    The Correspondence to this article has been published in BMC Medical Ethics 2019 20:100

    The Correspondence to this article has been published in BMC Medical Ethics 2019 20:101

  44. 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

    Content type: Research article

    Published on:

  45. 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

    Content type: Correspondence

    Published on:

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

  46. 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

    Content type: Research article

    Published on:

  47. 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

    Content type: Research article

    Published on:

  48. 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

    Content type: Debate

    Published on:

  49. In Switzerland, research with identifiable human tissue samples, and/or its accompanying data, must be approved by a research ethics committee (REC) before it can be allowed to take place. However, as the dema...

    Authors: Flora Colledge, Sophie De Massougnes and Bernice Elger

    Citation: BMC Medical Ethics 2018 19:93

    Content type: Research article

    Published on:

    The Correction to this article has been published in BMC Medical Ethics 2019 20:24

  50. 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

    Content type: Study protocol

    Published on:

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BMC Medical Ethics

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