Ethical issues in human genomics research in developing countries

Background  

Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS is taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.     

The ethics of relationality in implementation and evaluation research in global health: reflections from the Dream-A-World program in Kingston,Jamaica

Background

Despite recent developments aimed at creating international guidelines for ethical global health research, critical disconnections remain between how global health research is conducted in the field and the institutional ethics frameworks intended to guide research practice.

Discussion

In this paper we attempt to map out the ethical tensions likely to arise in global health fieldwork as researchers negotiate the challenges of balancing ethics committees’ rules and bureaucracies with actual fieldwork processes in local contexts. Drawing from our research experiences with an implementation and evaluation project in Jamaica, we argue that ethical research is produced through negotiated spaces and reflexivity practices that are centred on relationships between researchers and study participants and which critically examine issues of positionality and power that emerge at multiple levels. In doing so, we position ethical research practice in global health as a dialectical movement between the spoken and unspoken, or, more generally, between operationalized rules and the embodied relational understanding of persons.

Summary

Global health research ethics should be premised not upon passive accordance with existing guidelines on ethical conduct, but on tactile modes of knowing that rely upon being engaged with, and responsive to, research participants. Rather than focusing on the operationalization of ethical practice through forms and procedures, it is crucial that researchers recognize that each ethical dilemma encountered during fieldwork is unique and rooted in social contexts, interpersonal relationships, and personal narratives.

     

Adapting ethical guidelines for adolescent health research to street-connected children and youth in low- and middle-income countries: a case study from western Kenya

Background

Street-connected children and youth (SCCY) in low- and middle-income countries (LMIC) have multiple vulnerabilities in relation to participation in research. These require additional considerations that are responsive to their needs and the social, cultural, and economic context, while upholding core ethical principles of respect for persons, beneficence, and justice. The objective of this paper is to describe processes and outcomes of adapting ethical guidelines for SCCY’s specific vulnerabilities in LMIC.

Methods

As part of three interrelated research projects in western Kenya, we created procedures to address SCCY’s vulnerabilities related to research participation within the local context. These consisted of identifying ethical considerations and solutions in relation to community engagement, equitable recruitment, informed consent, vulnerability to coercion, and responsibility to report.

Results

Substantial community engagement provided input on SCCY’s participation in research, recruitment, and consent processes. We designed an assent process to support SCCY to make an informed decision regarding their participation in the research that respected their autonomy and their right to dissent, while safeguarding them in situations where their capacity to make an informed decision was diminished. To address issues related to coercion and access to care, we worked to reduce the unequal power dynamic through street outreach, and provided access to care regardless of research participation.

Conclusions

Although a vulnerable population, the specific vulnerabilities of SCCY can to some extent be managed using innovative procedures. Engaging SCCY in ethical research is a matter of justice and will assist in reducing inequities and advancing their health and human dignity.

     

Harnessing Social Networks along with Consumer-Driven Electronic Communication Technologies to Identify and Engage Members of 'Hard-to-Reach' Populations: A Methodological Case Report

Background  

Sampling in the absence of accurate or comprehensive information routinely poses logistical, ethical, and resource allocation challenges in social science, clinical, epidemiological, health service and population health research. These challenges are compounded if few members of a target population know each other or regularly interact. This paper reports on the sampling methods adopted in ethnographic case study research with a 'hard-to-reach' population.     

An inclusive approach to raising standards in general practice: working with a 'community of practice' in Western Australia

Background  

In this study we explored the challenges to establishing a community of practice (CoP) to address standards in general practice. We focused on the issue of improving referral letters which are the main form of communication between general practitioners (GPs) and specialists. There is evidence to suggest that the information relayed to specialists at the time of referral could be improved.     

Developing a Dementia Research Registry: a descriptive case study from North Thames DeNDRoN and the EVIDEM programme

Aim  

To describe the development of a dementia research registry, outlining the conceptual, practical and ethical challenges, and to report initial experiences of recruiting people with dementia to it from primary and secondary care.     

Ethical challenges in connection with the use of coercion: a focus group study of health care personnel in mental health care

Background

In recent years, the attention on the use of coercion in mental health care has increased. The use of coercion is common and controversial, and involves many complex ethical challenges. The research question in this study was: What kind of ethical challenges related to the use of coercion do health care practitioners face in their daily clinical work?

Methods

We conducted seven focus group interviews in three mental health care institutions involving 65 multidisciplinary participants from different clinical fields. The interviews were recorded and transcribed verbatim. We analysed the material applying a ‘bricolage’ approach. Basic ethical principles for research ethics were followed. We received permission from the hospitals’ administrations and all health care professionals who participated in the focus group interviews.

Results

Health care practitioners describe ethical dilemmas they face concerning formal, informal and perceived coercion. They provide a complex picture. They have to handle various ethical challenges, not seldom concerning questions of life and death. In every situation, the dignity of the patient is at stake when coercion is considered as morally right, as well as when coercion is not the preferred intervention. The work of the mental health professional is a complicated “moral enterprise”.The ethical challenges deserve to be identified and handled in a systematic way. This is important for developing the quality of health care, and it is relevant to the current focus on reducing the use of coercion and increasing patient participation. Precise knowledge about ethical challenges is necessary for those who want to develop ethics support in mental health care. Better communication skills among health care professionals and improved therapeutic relationships seem to be vital.

Conclusions

A systematic focus on ethical challenges when dealing with coercion is an important step forward in order to improve health care in the mental health field.

     

Ethical challenges in surgery as narrated by practicing surgeons

Background  

The aim of this study was to explore the ethical challenges in surgery from the surgeons' point of view and their experience of being in ethically difficult situations.     

End of life care in sub-Saharan Africa: a systematic review of the qualitative literature

Background  

End of life (EoL) care in sub-Saharan Africa still lacks the sound evidence-base needed for the development of effective, appropriate service provision. It is essential to make evidence from all types of research available alongside clinical and health service data, to ensure that EoL care is ethical and culturally appropriate. This article aims to synthesize qualitative research on EoL care in sub-Saharan Africa to inform policy, practice and further research. It seeks to identify areas of existing research; describe findings specifically relevant to the African context; and, identify areas lacking evidence.     

The anthropological approach challenges the conventional approach to bioethical dilemmas: a Kenyan Maasai perspective

Background

The cultural background, religion and societal norms have a huge influence on the decision making process for physicians, patients and their families, when faced with medical ethical dilemmas. While the medical professionals, through their training, can rely on the principles of autonomy, justice, beneficence and non-maleficence to guide them, the patients can only draw from their personal and cultural experiences.

Objective

To explore some of the challenges that face physicians when presented with ethical dilemmas.

Methods

A review of the literature on the principles of medical ethics and the cultural practices of the Maasai tribe, as well as, interview, interaction and observation of the patients and family during patient. management.

Results

In the Maasai community in Kenya, where family is the center of all attention and decision-making, the listed ethical principles and rules have a very different understanding of the self-determination, and autonomy becomes collective rather than individualistic. Medical practitioners when faced with ethical medical dilemmas are neither comfortable in adopting the conventional bioethical guidelines, nor in offering a health care purely based on cultural and historical practice.

Conclusion

In our set up, developing culturally relevant principles of bioethics appears to be the most effective solution in addressing medical ethical dilemmas.     

Recruiting Terminally Ill Patients into Non-Therapeutic Oncology Studies: views of Health Professionals

Background

Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study.

Methods

The study used a rapid assessment incorporating multiple qualitative methods including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information.

Results

MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research. Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation.

Conclusions

It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections. Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important.     

Prospective associations between intervention components and website engagement in a publicly available physical activity website: the case of 10,000 Steps Australia

Background

Effectiveness of and engagement with website-delivered physical activity interventions is moderate at best. Increased exposure to Internet interventions is reported to increase their effectiveness; however, there is a lack of knowledge about which specific intervention elements are able to maintain website engagement.

Objective

To prospectively study the associations of website engagement and exposure to intervention components for a publicly available physical activity website (10,000 Steps Australia).

Methods

Between June and July 2006 a total of 348 members of 10,000 Steps completed a Web-based survey to collect demographic characteristics. Website engagement was subsequently assessed over a 2-year period and included engagement data on website components; individual challenges, team challenges, and virtual walking buddies; and indicators of website engagement (average steps logged, days logging steps, and active users).

Results

On average participants logged steps on 169 (SD 228.25) days. Over a 2-year period this equated to an average of 1.6 logons per week. Binary logistic regression showed that individuals who participated in individual challenges were more likely to achieve an average of 10,000 steps per day (odds ratio [OR] = 2.80, 95% confidence interval [CI] 1.45–5.40), log steps on a higher than average number of days (OR = 6.81, 95% CI 2.87–13.31), and remain an active user (OR = 4.36, 95% CI 2.17–8.71). Additionally, those using virtual walking buddies (OR = 5.83, 95% CI 1.27–26.80) and of older age logged steps on a higher than average number of days. No significant associations were found for team challenges.

Conclusions

Overall engagement with the 10,000 Steps website was high, and the results demonstrate the relative effectiveness of interactive components to enhance website engagement. However, only exposure to the interactive individual challenge feature was positively associated with all website engagement indicators. More research is needed to examine the influence of intervention components on website engagement, as well as the relationship between website engagement and physical activity change.     

Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial

Background

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.

Findings

In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.

Conclusion

The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.     

Ethical issues relating to the banking of umbilical cord blood in Mexico

Background  

Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico.     

Ethics,economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

Background  

Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures.     

Action ethical dilemmas in surgery: an interview study of practicing surgeons

Background  

The aim of this study was to describe the kinds of ethical dilemmas surgeons face during practice.     

“Snake-oil,” “quack medicine,” and “industrially cultured organisms:” biovalue and the commercialization of human microbiome research

Background

Continued advances in human microbiome research and technologies raise a number of ethical, legal, and social challenges. These challenges are associated not only with the conduct of the research, but also with broader implications, such as the production and distribution of commercial products promising maintenance or restoration of good physical health and disease prevention. In this article, we document several ethical, legal, and social challenges associated with the commercialization of human microbiome research, focusing particularly on how this research is mobilized within economic markets for new public health uses.

Methods

We conducted in-depth, semi-structured interviews (2009–2010) with 63 scientists, researchers, and National Institutes of Health project leaders (“investigators”) involved with human microbiome research. Interviews explored a range of ethical, legal, and social dimensions of human microbiome research, including investigators’ perspectives on commercialization. Using thematic content analysis, we identified and analyzed emergent themes and patterns.

Results

Investigators discussed the commercialization of human microbiome research in terms of (1) commercialization, probiotics, and issues of safety, (2) public awareness of the benefits and risks of dietary supplements, and (3) regulation.

Conclusion

The prevailing theme of ethical, legal, social concern focused on the need to find a balance between the marketplace, scientific research, and the public’s health. The themes we identified are intended to serve as points for discussions about the relationship between scientific research and the manufacture and distribution of over-the-counter dietary supplements in the United States.     

Is informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA study

Background  

There is a permanent need to evaluate and develop the ethical quality of scientific research and to widen knowledge about the effects of ethical issues. Therefore we evaluated whether informed consent is related to implementation and success in a lifestyle intervention study with older research participants. There is little empirical research into this topic.     

Seeking consent for research with indigenous communities: a systematic review

Background

When conducting research with Indigenous populations consent should be sought from both individual participants and the local community. We aimed to search and summarise the literature about methods for seeking consent for research with Indigenous populations.

Methods

A systematic literature search was conducted for articles that describe or evaluate the process of seeking informed consent for research with Indigenous participants. Guidelines for ethical research and for seeking consent with Indigenous people are also included in our review.

Results

Of 1447 articles found 1391 were excluded (duplicates, irrelevant, not in English); 56 were relevant and included. Articles were categorised into original research that evaluated the consent process (n?=?5) or publications detailing the process of seeking consent (n?=?13) and guidelines for ethical research (n?=?38). Guidelines were categorised into international (n?=?8); national (n?=?20) and state/regional/local guidelines (n?=?10). In five studies based in Australia, Canada and The United States of America the consent process with Indigenous people was objectively evaluated. In 13 other studies interpreters, voice recording, videos, pictures, flipcharts and “plain language” forms were used to assist in seeking consent but these processes were not evaluated. Some Indigenous organisations provide examples of community-designed resources for seeking consent and describe methods of community engagement, but none are evaluated. International, national and local ethical guidelines stress the importance of upholding Indigenous values but fail to specify methods for engaging communities or obtaining individual consent. In the ‘Grey literature’ concerns about the consent process are identified but no solutions are offered.

Conclusion

Consultation with Indigenous communities is needed to determine how consent should be sought from the community and the individual, and how to evaluate this process.