• A 14-day limit for bioethics: the debate over human embryo research

      Giulia Cavaliere (BioMed Central, 2017-05-01)
      Abstract Background This article explores the reasons in favour of revising and extending the current 14-day statutory limit to maintaining human embryos in culture. This limit is enshrined in law in over a dozen countries, including the United Kingdom. In two recently published studies (2016), scientists have shown that embryos can be sustained in vitro for about 13 days after fertilisation. Positive reactions to these results have gone hand in hand with calls for revising the 14-day rule, which only allows embryo research until the 14th day after fertilisation. Main text The article explores the most prominent arguments in favour of and against the extension of the 14-day limit for conducting research on human embryos. It situates these arguments within the history of the 14-day limit. I start by discussing the history of the 14-day limit in the United Kingdom and the reasons behind the decision to opt for a compromise between competing moral views. I then analyse the arguments that those who are generally in favour of embryo research put forward in support of extending the 14-day rule, namely (a) the argument of the beneficence of research and (b) the argument of technical feasibility (further explained in the article). I then show how these two arguments played a role in the recent approval of two novel techniques for the replacement of faulty mitochondrial DNA in the United Kingdom. Despite the popularity and widespread use of these arguments, I argue that they are ultimately problematic and should not be straightforwardly accepted (i.e. accepted without further scrutiny). I end by making a case for respecting value pluralism in the context of embryo research, and I present two reasons in favour of respecting value pluralism: the argument of public trust and the argument of democracy. Conclusion I argue that 14-day limit for embryo research is not a valuable tool despite being a solution of compromise, but rather because of it. The importance of respecting value pluralism (and of respecting different views on embryo research) needs to be considered in any evaluation concerning a potential change to the 14-day rule.
    • A biobank management model applicable to biomedical research

      Patenaude Johane; Auray-Blais Christiane (BioMed Central, 2006)
      <p>Abstract</p> <p>Background</p> <p>The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information.</p> <p>Methods</p> <p>We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants.</p> <p>Results</p> <p>The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.</p> <p>Conclusion</p> <p>Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.</p>
    • A biobank management model applicable to biomedical research

      Patenaude Johane; Auray-Blais Christiane (BioMed Central, 2006-04-01)
      &lt;p&gt;Abstract&lt;/p&gt; &lt;p&gt;Background&lt;/p&gt; &lt;p&gt;The work of Research Ethics Boards (REBs), especially when involving genetics research and biobanks, has become more challenging with the growth of biotechnology and biomedical research. Some REBs have even rejected research projects where the use of a biobank with coded samples was an integral part of the study, the greatest fear being the lack of participant protection and uncontrolled use of biological samples or related genetic data. The risks of discrimination and stigmatization are a recurrent issue. In light of the increasing interest in biomedical research and the resulting benefits to the health of participants, it is imperative that practical solutions be found to the problems associated with the management of biobanks: namely, protecting the integrity of the research participants, as well as guaranteeing the security and confidentiality of the participant's information.&lt;/p&gt; &lt;p&gt;Methods&lt;/p&gt; &lt;p&gt;We aimed to devise a practical and efficient model for the management of biobanks in biomedical research where a medical archivist plays the pivotal role as a data-protection officer. The model had to reduce the burden placed on REBs responsible for the evaluation of genetics projects and, at the same time, maximize the protection of research participants.&lt;/p&gt; &lt;p&gt;Results&lt;/p&gt; &lt;p&gt;The proposed model includes the following: 1) a means of protecting the information in biobanks, 2) offers ways to provide follow-up information requested about the participants, 3) protects the participant's confidentiality and 4) adequately deals with the ethical issues at stake in biobanking.&lt;/p&gt; &lt;p&gt;Conclusion&lt;/p&gt; &lt;p&gt;Until a governmental governance body is established in Quebec to guarantee the protection of research participants and establish harmonized guidelines for the management of biobanks in medical research, it is definitely up to REBs to find solutions that the present lack of guidelines poses. The model presented in this article offers a practical solution on a day-to-day basis for REBs, as well as researchers by promoting an archivist to a pivotal role in the process. It assures protection of all participants who altruistically donate their samples to generate and improve knowledge for better diagnosis and medical treatment.&lt;/p&gt;
    • A bioethical framework to guide the decision-making process in the care of seriously ill patients

      Daniel Neves Forte; Fernando Kawai; Cláudio Cohen (BioMed Central, 2018-08-01)
      Abstract Background One of the biggest challenges of practicing medicine in the age of informational technology is how to conciliate the overwhelming amount of medical-scientific information with the multiple patients’ values of modern pluralistic societies. To organize and optimize the the Decision-Making Process (DMP) of seriously ill patient care, we present a framework to be used by Healthcare Providers. The objective is to align Bioethics, Evidence-based Practice and Person-centered Care. Main body The framework divides the DMP into four steps, each with a different but complementary focus, goal and ethical principle. Step 1 focuses exclusively on the disease, having accuracy is its ethical principle. It aims at an accurate and probabilistic estimation of prognosis, absolute risk reduction, relative risk reduction and treatments’ burdens. Step 2 focuses on the person, using empathic communication to learn about patient values and what suffering means for the patient. Emphasis is given to learning and active listening, not taking action. Thus, instead beneficence, we trust comprehension and understanding with the suffering of others and respect for others as autonomous moral agents as the ethical principles of Step 2. Step 3 focuses on the healthcare team, having the ethics of situational awareness guiding this step. The goal is, through effective teamwork, to contextualize and link rates and probabilities related to the disease to the learned patient’s values, presenting a summary of which treatments the team considers as acceptable, recommended, potentially inappropriate and futile. Finally, Step 4 focuses on provider-patient relationship, seeking shared Goals of Care (GOC), for the best and worst scenario. Through an ethics of deliberation, it aims for a consensus that could ensure that the patient’s values will be respected as well as a scientifically acceptable medical practice will be provided. In summary: accuracy, comprehension, understanding, situational awareness and deliberation would be the ethical principles guiding each step. Conclusion Hopefully, by highlighting and naming the different perspectives of knowledge needed in clinical practice, this framework will be valuable as a practical and educational tool, guiding modern medical professionals through the many challenges of providing high quality person-centered care that is both ethical and evidence based.
    • A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research

      Jeremy Furyk; Kris McBain-Rigg; Bronia Renison; Kerrianne Watt; Richard Franklin; Theophilus I. Emeto; Robin A. Ray; Franz E. Babl; Stuart Dalziel (BMC, 2018-11-01)
      Abstract Background 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 consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. Methods We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Results Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Conclusion Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps.
    • A critique of the regulation of data science in healthcare research in the European Union

      John M. M. Rumbold; Barbara K. Pierscionek (BioMed Central, 2017-04-01)
      Abstract The EU offers a suitable milieu for the comparison and harmonisation of healthcare across different languages, cultures, and jurisdictions (albeit with a supranational legal framework), which could provide improvements in healthcare standards across the bloc. There are specific ethico-legal issues with the use of data in healthcare research that mandate a different approach from other forms of research. The use of healthcare data over a long period of time is similar to the use of tissue in biobanks. There is a low risk to subjects but it is impossible to gain specific informed consent given the future possibilities for research. Large amounts of data on a subject present a finite risk of re-identification. Consequently, there is a balancing act between this risk and retaining sufficient utility of the data. Anonymising methods need to take into account the circumstances of data sharing to enable an appropriate balance in all cases. There are ethical and policy advantages to exceeding the legal requirements and thereby securing the social licence for research. This process would require the examination and comparison of data protection laws across the trading bloc to produce an ethico-legal framework compatible with the requirements of all member states. Seven EU jurisdictions are given consideration in this critique.
    • A developing country response to Lavery &lt;it&gt;et al&lt;/it&gt;. "In global health research, is it legitimate to stop clinical trials early on account of their opportunity costs?"

      Wassenaar Douglas R; Ramjee Gita (BioMed Central, 2009-09-01)
      &lt;p&gt;Abstract&lt;/p&gt; &lt;p&gt;Background&lt;/p&gt; &lt;p&gt;A recent paper presents an argument and mechanism for the possible stopping of clinical trials early based on opportunity costs.&lt;/p&gt; &lt;p&gt;Discussion&lt;/p&gt; &lt;p&gt;Although we agree that the costs and opportunity costs of clinical trials need to be reduced wherever possible, we raise concerns about the motivation and mechanism for stopping clinical trials early raised by Lavery &lt;it&gt;et al&lt;/it&gt;.&lt;/p&gt; &lt;p&gt;Summary&lt;/p&gt; &lt;p&gt;We argue that there are already enough acceptable criteria and actors in the clinical trials arena to justify early stoppage of clinical trials, and argue that factors other than efficacy need to be carefully considered, especially in developing country contexts.&lt;/p&gt;
    • A framework for the ethical assessment of chimeric animal research involving human neural tissue

      Sebastian Porsdam Mann; Rosa Sun; Göran Hermerén (BMC, 2019-01-01)
      Abstract Background Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, rendering them chimeric. Since technical and ethical limitations make neurological disorders difficult to study in humans, chimeric models with human neural tissue could help advance our understanding of neuropathophysiology. Main body In this article, we examine whether the introduction of human neural tissue and any consequent cognitive change is relevant to the way we ought to treat chimeras. We argue that changes in cognitive abilities are morally relevant to the extent that they increase the capacities that affect the moral status of any entity, including awareness, autonomy, and sociability. We posit that no being, regardless of species, should be treated in a way that is incommensurate with its moral status. Finally, we propose a framework that can be used to guide ethical assessment of research involving chimeras with advanced cognitive capacities. Conclusion We advance this framework as a useful tool for bringing relevant considerations to the forefront for those considering the ethical merit of proposed chimeric research. In doing so, we examine concepts relevant to the question of how any entity may be treated, including moral status, dignity, and capacities.
    • A palliative care approach in psychiatry: clinical implications

      Mattias Strand; Manne Sjöstrand; Anna Lindblad (BMC, 2020-04-01)
      Abstract Background Traditionally, palliative care has focused on patients suffering from life-threatening somatic diseases such as cancer or progressive neurological disorders. In contrast, despite the often chronic, severely disabling, and potentially life-threatening nature of psychiatric disorders, there are neither palliative care units nor clinical guidelines on palliative measures for patients in psychiatry. Main text This paper contributes to the growing literature on a palliative approach in psychiatry and is based on the assumption that a change of perspective from a curative to a palliative approach could help promote patient-centeredness and increase quality of life for severely ill patients in psychiatry as well as in somatic medicine. To exemplify this, we offer three different clinical scenarios: severe and enduring anorexia nervosa, treatment-refractory schizophrenia, and chronic suicidality and persistent self-injury in borderline personality disorder. Conclusion We emphasize that many typical interventions for treatment-refractory psychiatric disorders may indeed be of a palliative nature. Furthermore, introducing traditional features of palliative care, e.g. so-called goals of care conversations, could aid even further in ensuring that caregivers, patients, and families agree on which treatment goals are to be prioritized in order to optimize quality of life in spite of severe, persistent mental disorder.
    • A practical approach to the ethical use of memory modulating technologies

      Shawn Zheng Kai Tan; Lee Wei Lim (BMC, 2020-09-01)
      Abstract Background Recent advancements in neuroscientific techniques have allowed us to make huge progress in our understanding of memories, and in turn has paved the way for new memory modification technologies (MMTs) that can modulate memories with a degree of precision, which was not previously possible. With advancements in such techniques, new and critical ethical questions have emerged. Understanding and framing these ethical questions within the current philosophical theories is crucial in order to systematically examine them as we translate these techniques to the clinic. Main body In this paper, we discuss the ethical implications of modern neuroscience techniques that aim to disrupt or enhance memories. We attempt to frame the MMTs in the context of existing ethical philosophical theories to provide a cohesive analysis of the myriad of ethical quagmires that might emerge from such technologies. We argue the application of Aristotle’s Golden Mean and multiple accounts of authenticity are useful in approaching the ethical questions surrounding MMTs. We then propose a framework in which ethical considerations can be systematically examined. Lastly, we provide caveats and considerations for the use of this framework. Overall, we provide a practical approach for the ethical use of MMTs depending on the situation. Conclusion While at face value, our model appears to put severe limitations on the application of MMTs, we are not completely opposed to their use, but rather our framework guides the agent to consider the implications before making any decisions. Most importantly, we argue that the use of MMTs does not reduce the responsibility of the initial decision, and the agent must accept the post-MMT self as the new “true self” regardless of the outcome. As the developmental trajectory of MMTs suggests we are getting closer to practical clinical applications, ethical concerns across a wide range of disciplines need to be addressed to develop best strategies and policies when dealing with MMTs. If this can be achieved, we believe the ethical use of MMTs is not only possible but would also be of tremendous benefit to many people suffering from memory-related mental disorders.
    • A principled ethical approach to intersex paediatric surgeries

      Kevin G. Behrens (BMC, 2020-10-01)
      Abstract Background Surgery for intersex infants should be delayed until individuals are able to decide for themselves, except where it is a medical necessity. In an ideal world, this single principle would suffice and such surgeries could be totally prohibited. Unfortunately, the world is not perfect, and, in some places, intersex neonates are at risk of being abandoned, mutilated or even killed. As long as intersex persons are at such high risk in some places, any ethical guidelines for intersex surgeries will need to take these extreme risks of harm into account. Main text I therefore argue for five basic principles that ought to inform ethics guidelines for surgical interventions in intersex children, specifically in contexts in which such children are at risk of significant harm. What I set out to come up with is a set of principles that do not completely prohibit surgery, but only allow it where a strong case can be made for its necessity, in the best interests of the child, and where there is some kind of oversight to prevent misuse. The first principle is that interventions as drastic as these surgeries should only be performed when there is strong evidence that they are beneficial and not harmful. The second principle is that in surgeries should normally only be performed in cases of true medical necessity. Principle three is that surgeries should normally be delayed until such time as the intersex person is mature enough to assent to treatment or decide against it. Principle four is that the conventional ethical requirements regarding truth telling apply equally to intersex children as to anyone else. The final principle is that where physicians or parents think that surgery is in the best interests of the child, the burden of proof lies with them. Conclusion It is hoped that these principles might help medical teams and parents make better decisions about intersex surgeries on children, and they would make such surgeries very rare indeed, if they happen at all.
    • A Q methodology study on divergent perspectives on CRISPR-Cas9 in the Netherlands

      Mirjam Schuijff; Menno D. T. De Jong; Anne M. Dijkstra (BMC, 2021-04-01)
      Abstract Background CRISPR-Cas9, a technology enabling modification of the human genome, is developing rapidly. There have been calls for public debate to discuss its ethics, societal implications, and governance. So far, however, little is known about public attitudes on CRISPR-Cas9. This study contributes to a better understanding of public perspectives by exploring the various holistic perspectives Dutch citizens have on CRISPR-Cas9. Methods This study used Q methodology to identify different perspectives of Dutch citizens (N = 30) on the use of CRISPR-Cas9. The Q-sort method aims at segmenting audiences based on the structural characteristics of their perspectives. Participants individually ranked 32 statements about CRISPR-Cas9 and discussed their rankings in small groups. By-person factor analysis was performed using PQMethod. Participants’ contributions to the discussions were used to further make sense of the audience segments identified. Results Five perspectives on CRISPR-Cas9 were identified: (1) pragmatic optimism (2) concerned scepticism; (3) normative optimism; (4) enthusiastic support; and (5) benevolent generalism. Each perspective represents a unique position motivated by different ranking rationales. Sorting rationales included improving health, preventing negative impacts on society, and fear of a slippery slope. Overall, there is broad, but not universal support for medical uses of CRISPR-Cas9. Conclusions Research on CRISPR-Cas9 should prioritise the broadly supported applications of the technology. Research and public debates on CRISPR-Cas9, its uses, its broader implications, and the governance of CRISPR-Cas9 are recommended. A discourse that includes all perspectives can contribute to the embedding of future uses of CRISPR-Cas9 in society. This study shows that Q methodology followed by group discussions enables citizens to contribute meaningfully to discourses about research.
    • A qualitative study exploring stakeholder perspectives on the use of biological samples for future unspecified research in Malawi

      Limbanazo Matandika; Ruby Tionenji Ngóngóla; Khama Mita; Lucinda Manda-Taylor; Kate Gooding; Daniel Mwale; Francis Masiye; Joseph Mfutso-Bengo (BMC, 2020-07-01)
      Abstract Background There is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research. Methods This study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed. Results On the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted. Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns. Conclusions Study findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants.
    • A qualitative study of big data and the opioid epidemic: recommendations for data governance

      Elizabeth A. Evans; Elizabeth Delorme; Karl Cyr; Daniel M. Goldstein (BMC, 2020-10-01)
      Abstract Background The opioid epidemic has enabled rapid and unsurpassed use of big data on people with opioid use disorder to design initiatives to battle the public health crisis, generally without adequate input from impacted communities. Efforts informed by big data are saving lives, yielding significant benefits. Uses of big data may also undermine public trust in government and cause other unintended harms. Objectives We aimed to identify concerns and recommendations regarding how to use big data on opioid use in ethical ways. Methods We conducted focus groups and interviews in 2019 with 39 big data stakeholders (gatekeepers, researchers, patient advocates) who had interest in or knowledge of the Public Health Data Warehouse maintained by the Massachusetts Department of Public Health. Results Concerns regarding big data on opioid use are rooted in potential privacy infringements due to linkage of previously distinct data systems, increased profiling and surveillance capabilities, limitless lifespan, and lack of explicit informed consent. Also problematic is the inability of affected groups to control how big data are used, the potential of big data to increase stigmatization and discrimination of those affected despite data anonymization, and uses that ignore or perpetuate biases. Participants support big data processes that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions. Recommendations for ethical big data governance offer ways to narrow the big data divide (e.g., prioritize health equity, set off-limits topics/methods, recognize blind spots), enact shared data governance (e.g., establish community advisory boards), cultivate public trust and earn social license for big data uses (e.g., institute safeguards and other stewardship responsibilities, engage the public, communicate the greater good), and refocus ethical approaches. Conclusions Using big data to address the opioid epidemic poses ethical concerns which, if unaddressed, may undermine its benefits. Findings can inform guidelines on how to conduct ethical big data governance and in ways that protect and respect patients and society, ensure justice, and foster patient and public trust in public institutions.
    • A qualitative study on acceptable levels of risk for pregnant women in clinical research

      Indira S. E. van der Zande; Rieke van der Graaf; Martijn A. Oudijk; Johannes J. M. van Delden (BioMed Central, 2017-05-01)
      Abstract Background 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 was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. Methods We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Results Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals’ individual perception of risk may influence recruitment. Conclusions Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.
    • A qualitative study on aspects of consent for genomic research in communities with low literacy

      Daima Bukini; Columba Mbekenga; Siana Nkya; Lisa Purvis; Sheryl McCurdy; Michael Parker; Julie Makani (BMC, 2020-06-01)
      Abstract Background Low literacy of study participants in Sub - Saharan Africa has been associated with poor comprehension during the consenting process in research participation. The concerns in comprehension are far greater when consenting to participate in genomic studies due to the complexity of the science involved. While efforts are made to explore possibilities of applying genomic technologies in diseases prevalent in Sub Saharan Africa, we ought to develop methods to improve participants’ comprehension for genomic studies. The purpose of this study was to understand different approaches that can be used to seek consent from individuals with low literacy in Sub-Saharan African countries in genomic research to improve comprehension. Methods Using qualitative study design, we conducted focus-group discussions, in-depth interviews and participant observations as data collection methods. This study was embedded in a hospital based genomic study on Sickle Cell Disease at Muhimbili National Hospital in Tanzania. Thematic content analysis was used to analyse the transcripts and field notes. Results Findings from this study show that literacy level has little influence on understanding the research details. According to the participants of this study, the methods used to provide information, the language, and time spent with the study participants were the key factors influencing understanding. The availability of group sessions held before individual consent to allow for a detailed questions and answers format was agreed to be the best method to facilitate the comprehension. Conclusion The quality of the consenting process of participants will be influence by a number of factors. The type of research consented for, where the research will be implemented and who are the potential study participants are amongst the factors that need to be assessed during the consenting. Measures to improve participants’ comprehension need to be developed when consenting participants with low literacy level in genomic studies.
    • A qualitative study on existential suffering and assisted suicide in Switzerland

      Marie-Estelle Gaignard; Samia Hurst (BMC, 2019-05-01)
      Abstract Background In Switzerland, people can be granted access to assisted suicide (AS) on condition that the person whose wish is to die performs the fatal act, that he has his decisional capacity and that the assisting person’s conduct is not selfishly motivated. No restrictions relating to the ground of suffering are mentioned in the act. Existential suffering as a reason for wanting to die, however, gives raise to controversial issues. Moreover, existential suffering lacks definition and no consensus exists on how to evaluate and manage it. This study explores the perspectives of care professionals and volunteers from a “right-to-die organization” on existential suffering as a motive for assisted suicide requests. Methods A qualitative study based on face-to-face interviews was conducted with twenty-six participants: palliative care and primary care providers as well as EXIT right-to-die organization volunteers. Elements from the grounded theory approach were used. Results The twenty-six participants described existential suffering in a multiplicity of individual ways. In total, sixty-three stories were recounted. Their representations were grouped into eight categories: physical decline and its consequences, loneliness, fear of the future, life is over, loss of social significance, loss of hope for a better future, being a financial burden and loss of pleasurable activities. According to all participants, suffering coming from the loss of self-identity was always linked to physical decline, as if one’s image completely defined someone’s identity. Society’s perception of old people and vulnerable people were also often questioned. Another interesting point was that only four stories referring to a “pure” existential suffering were found. This suffering was related to a feeling that life has come to an end, without identification of any other related restriction or suffering. Conclusions Existential suffering is multifaceted. Legislators and right-to-die organisations have to address the question of what make a AS acceptable. The plurality of existential suffering implies the need of a very personalized care. A better understanding of what it is made of could provide a “toolbox” to people concerned by these requests, helping them to explore it in order to offer suffering people a wider range of alternatives.
    • A qualitative study on the voluntariness of counselling and testing for HIV amongst antenatal clinic attendees: do women have a choice?

      Tausi S. Haruna; Evelyne Assenga; Judith Shayo (BMC, 2018-11-01)
      Abstract Background Mother-to-child transmission (MTCT) of the Human Immunodeficiency –Virus (HIV) is a serious public health problem, contributing up to 90% of childhood HIV infections. In Tanzania, the prevention-of-mother-to-child-transmission (PMTCT) feature of the HIV programme was rolled out in 2000. The components of PMTCT include counselling and HIV testing directed at antenatal clinic attendees. It is through the process of Provider Initiated Counseling and Testing (PITC) that counselling is offered participant confidentiality and voluntariness are upheld and valid consent obtained. The objective of the study was to explore antenatal clinic attendees’ experiences of the concept of voluntariness vis- a- vis the implementation of prior counseling and subsequent testing for HIV under the PITC as part of their antenatal care. Methods In-depth interviews were conducted with17 antenatal clinic attendees and 6 nursing officers working at the Muhimbili National Hospital (MNH) antenatal clinic. The study data were analyzed using qualitative content analysis. Results Antenatal clinic attendees’ accounts suggested that counselling and testing for HIV during pregnancy was voluntary, and that knowledge of their HIV status led them to access appropriate treatment for both mother and her newborn baby. They reported feeling no pressure from nursing officers, and gave verbal consent to undergo the HIV test. However, some antenatal clinic attendees reported pressure from their partners to test for HIV. Healthcare providers were thus faced with a dilemma of disclosure/ nondisclosure when dealing with discordant couples. Conclusion Antenatal clinic attendees at MNH undertook the PITC for HIV voluntarily. This was enhanced by their prior knowledge of HIV, the need to prevent mother- to- child transmission of HIV, and the effectiveness of the voluntary policy implemented by nursing officers.
    • A qualitative study using traditional community assemblies to investigate community perspectives on informed consent and research participation in western Kenya

      Vreeman Rachel; Kamaara Eunice; Kamanda Allan; Ayuku David; Nyandiko Winstone; Atwoli Lukoye; Ayaya Samuel; Gisore Peter; Scanlon Michael; Braitstein Paula (BioMed Central, 2012-09-01)
      &lt;p&gt;Abstract&lt;/p&gt; &lt;p&gt;Background&lt;/p&gt; &lt;p&gt;International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings.&lt;/p&gt; &lt;p&gt;Methods&lt;/p&gt; &lt;p&gt;We sought to use &lt;it&gt;mabaraza&lt;/it&gt;, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from &lt;it&gt;mabaraza&lt;/it&gt; to identify emerging central concepts.&lt;/p&gt; &lt;p&gt;Results&lt;/p&gt; &lt;p&gt;Our findings from two &lt;it&gt;mabaraza&lt;/it&gt; with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent.&lt;/p&gt; &lt;p&gt;Conclusions&lt;/p&gt; &lt;p&gt;Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as &lt;it&gt;mabaraza&lt;/it&gt; in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.&lt;/p&gt;
    • A reflection on ethical and methodological challenges of using separate interviews with adolescent-older carer dyads in rural South Africa

      Dumile Gumede; Nothando B. Ngwenya; Stella Namukwaya; Sarah Bernays; Janet Seeley (BMC, 2019-07-01)
      Abstract Background 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 an ethnographic study exploring care relationships between adolescents and their older carers in the context of a large-donor funded HIV programme. We use these reflections to discuss some of the challenges and present possible management strategies that may be adopted in conducting dyadic health research in resource-poor settings. Methods Drawing from the relational agency, three rounds of separate interviews and participant observation were undertaken with dyads of adolescents aged between 13 and 19 and their older carers aged 50+ from October 2017 to September 2018. A reflexive journal was kept to record the interviewer's experiences of the whole research process. We identified methodological and ethical challenges from these data during the thematic analysis. Results A total of 36 separate interviews were conducted with six pairs of adolescent-older carer dyads (n = 12 participants). Five themes emerged: recruitment of dyads, consenting dyads, confidentiality, conducting separate interviews with adolescents and older carers, and interviewer-dyad interaction. We also illustrated how we dealt with these challenges. Conclusions Results from this study can guide the recruitment, consenting and collecting data for health studies that employ a similar form of enquiry in LMICs. However, ethical and methodological challenges should be recognised as features of the relationships between cross-generation dyads rather than weaknesses of the method.