ABSTRACT Introduction: Informed consent has been recognized as an important component of research protocols and procedures of disclosure and consent in collaborative research have been criticized, as they may not be in keeping with cultural norms of developing countries. This study, which is part of a larger project funded by the United States National Bioethics Advisory Commission, explores the opinions of developing country researchers regarding informed consent in collaborative research. Methods: A survey of developing country researchers, involved in human subject (...) research, was conducted by distributing a questionnaire with 169 questions, which included questions relating to informed consent. In addition, six focus group discussions, eight in‐depth interviews and 78 responses to open‐ended questions in the questionnaire provided qualitative data. Results: 203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers in their most recent studies. A large proportion of respondents recommended that human subject regulations should allow more flexibility in ways of documenting informed consent. 84% of researchers agreed that a mechanism to measure understanding should be incorporated in research studies as part of the process of informed consent. Discussion: This paper is an empirical step in highlighting the ethical issues concerning disclosure. Health researchers in developing countries are well aware of the importance of consent in health research, and equally value the significance of educating human subjects regarding study protocols and associated risks and benefits. However, respondents emphasize the need for modifying ethical regulations in collaborative research. (shrink)

On the 20th anniversary of its publication, this classic manifesto is updated with an important new preface by the author. Freire reflects on the impact his book has had, and on many of the issues it raises for readers in the 1990s. These include the fundamental question of liberation and inclusive language as it relates to Freire's own insights and approaches.

This article explores the concept of internationally acceptable codes of ethics within the context of an Egyptian nurse’s PhD studies. Theoretical work, including gaining ethical approval for the project, took place in the UK, while the data collection phase of the study was done in Egypt. This highlighted areas where the Arab Muslim interpretation of some ethical principles, especially around the issue of gaining informed consent, differed from that currently accepted in British research ethics. The authors argue that it may (...) not be possible, or even desirable, to standardize codes of ethics globally in areas such as academic research. Ethical principles develop from a unique mix of culture and religion. It may be more important to develop cultural competence that includes the ability to understand and respect the way in which ethical principles are interpreted by various societies. (shrink)

Humans have always played a crucial role in the evolutionary dynamics of agricultural biodiversity and thus there is a strong relationship between these resources and human cultures. These agricultural resources have long been treated as a global public good, and constitute the livelihoods of millions of predominantly poor people. At the same time, agricultural biodiversity is under serious threat in many parts of the world despite extensive conservation efforts. Ethical considerations regarding the collecting, research, and use of agricultural biodiversity are (...) currently topics of great concern. For example, easy access to genetic resources for breeding purposes is important, but international agreements and legal frameworks are necessary to ensure adequate recognition of the contributions of local communities and traditional farmers in creating and nurturing these resources. Here, we assess ethical principles in the context of existing codes of conduct that are relevant for agro-biodiversity researchers. We aim to create awareness among scientists and policy makers who are concerned with agro-biodiversity research and its potential impact on local communities. We encourage a serious assessment of the ethical principles presented here and hope to facilitate an integration of these principles into the reader’s personal ethical framework. Key ethical principles considered here include the importance of obtaining prior informed consent, equity, and the inalienability of rights of local communities and farmers. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Ecological research and conservation practice frequently raise difficult and varied ethical questions for scientific investigators and managers, including duties to public welfare, nonhuman individuals (i.e., animals and plants), populations, and ecosystems. The field of environmental ethics has contributed much to the understanding of general duties and values to nature, but it has not developed the resources to address the diverse and often unique practical concerns of ecological researchers and managers in the field, lab, and conservation facility. The emerging field of (...) “ecological ethics” is a practical or scientific ethics that offers a superior approach to the ethical dilemmas of the ecologist and conservation manager. Even though ecological ethics necessarily draws from the principles and commitments of mainstream environmental ethics, it is normatively pluralistic, including as well the frameworks of animal, research, and professional ethics. It is also methodologically pragmatic, focused on the practical problems of researchers and managers and informed by these problems in turn. The ecological ethics model offers environmental scientists and practitioners a useful analytical tool for identifying, clarifying, and harmonizing values and positions in challenging ecological research and management situations. Just as bioethics provides a critical intellectual and problem-solving service to the biomedical community, ecological ethics can help inform and improve ethical decision making in the ecology and conservation communities. (shrink)

203 surveys were considered complete and were included in the analysis. Written consent was not used by nearly 40% of the researchers.

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96. 1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women (...) living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women's health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided. (shrink)

Professionals in environmental fields engage with complex problems that involve stakeholders with different values, different forms of knowledge, and contentious decisions. There is increasing recognition of the need to train graduate students in interdisciplinary environmental science programs in these issues, which we refer to as “social ethics.” A literature review revealed topics and skills that should be included in such training, as well as potential challenges and barriers. From this review, we developed an online survey, which we administered to faculty (...) from 81 United States colleges and universities offering IESPs. Respondents overwhelmingly agreed that IESPs should address values in applying science to policy and management decisions. They also agreed that programs should engage students with issues related to norms of scientific practice. Agreement was slightly less strong that IESPs should train students in skills related to managing value conflicts among different stakeholders. The primary challenges to incorporating social ethics into the curriculum were related to the lack of materials and expertise for delivery, though challenges such as ethics being marginalized in relation to environmental science content were also prominent. Challenges related to students’ interest in ethics were considered less problematic. Respondents believed that social ethics are most effectively delivered when incorporated into existing courses, and they preferred case studies or problem-based learning for delivery. Student competence is generally not assessed, and respondents recognized a need for both curricular materials and assessment tools. (shrink)

Professionals in environmental fields engage with complex problems that involve stakeholders with different values, different forms of knowledge, and contentious decisions. There is increasing recognition of the need to train graduate students in interdisciplinary environmental science programs in these issues, which we refer to as “social ethics.” A literature review revealed topics and skills that should be included in such training, as well as potential challenges and barriers. From this review, we developed an online survey, which we administered to faculty (...) from 81 United States colleges and universities offering IESPs. Respondents overwhelmingly agreed that IESPs should address values in applying science to policy and management decisions. They also agreed that programs should engage students with issues related to norms of scientific practice. Agreement was slightly less strong that IESPs should train students in skills related to managing value conflicts among different stakeholders. The primary challenges to incorporating social ethics into the curriculum were related to the lack of materials and expertise for delivery, though challenges such as ethics being marginalized in relation to environmental science content were also prominent. Challenges related to students’ interest in ethics were considered less problematic. Respondents believed that social ethics are most effectively delivered when incorporated into existing courses, and they preferred case studies or problem-based learning for delivery. Student competence is generally not assessed, and respondents recognized a need for both curricular materials and assessment tools. (shrink)

In medical research, the ethical principle of respect for persons is operationalized into the process of informed consent. The consent tools should be contextualized and adapted to the different socio-cultural environment, especially when research crosses the traditional boundaries and reaches poor communities. We look at the challenges experienced in the malaria Quinact trial, conducted in the Democratic Republic of Congo, and describe some lessons learned, related to the definition of acceptable representative, the role of independent witness and the impact of (...) socio-economic vulnerability. To ensure children's protection, consent is required by the parents or, in their absence, by a legally mandated representative. In our setting, children's responsibility is often entrusted permanently or temporarily to relatives or friends without a tribunal mandate. Hence, a notion of ‘culturally acceptable representative’ under supervision of the local Ethics Committee may be more suitable. To ensure protection of illiterate subjects, an independent witness is required to confirm that the consent was freely given. However, in low-literacy contexts, potential witnesses often don't have any previous relationship with patient and there may be power-unbalance in their relationship, rather than genuine dialogue. In poor communities, trial participation may be seen as an opportunity to secure access to healthcare. Poverty may also lead to ‘competition’ to access the research-related benefits, with a risk of disturbance at societal or household level. Adjusting consent procedures to sociocultural and socioeconomic realities is essential for fulfilling the underlying ethical principles. This requires a collaborative dialogue between researchers, regulators and ethics committees. (shrink)

Research ethics principles and regulations typically have been applied to the protection of individual human subjects. Yet, new paradigms of research that include the place-based community and cultural groups as partners or participants of environmental research interventions, in particular, require attention to place-based identities and geographical contexts. This paper argues the importance of respecting “place” within human subjects protections applied to communities and cultural groups as part of a critical need for research ethics and cultural competence training for graduate research (...) students. These protections and benefits are extensions of the Belmont Principles and have been included in recent recommendations from research regulatory committees. (shrink)

We argue that the ecological research community should develop a plan for improving the ethical consistency and moral robustness of the field. We propose a particular ethics strategy—specifically, an ongoing process of collective ethical reflection that the community of ecological researchers, with the cooperation of applied ethicists and philosophers of biology, can use to address the needs we identify. We suggest a particular set of conceptual and analytic tools that, we argue, collectively have the resources to provide an empirically grounded (...) and conceptually complete foundation for an ethics strategy for ecological research. We illustrate our argument with information gathered from a survey of ecologists conducted at the 2013 meeting of the Canadian Society of Ecology and Evolution. (shrink)

In this paper, we describe the potential role laypersons on ethics committees can play in ensuring community concerns are addressed in the design and implementation of genomic research. We draw inferences from the outcome of an empirical study of the impact of training of laypersons to address community engagement issues in ethics review of research protocol. While this paper does not advocate a particular solution, it describes the importance of community engagement in genomic research, the current limitations there are in (...) engaging communities in the design of these research projects and how communities can be indirectly engaged in the design and implementation of genomic research through the engagement of laypersons on ethics committees. However, to ensure that these laypersons can play this role, their capacity needs to be built to play this role appropriately. There is evidence to show that where resources are invested in building the capacity of laypersons to play their role as community ‘watchdogs’ in research, they play this role aptly. Community engagement is important in genomic research as genomic researchers will increasingly require community perspectives in critical ethics decision making. (shrink)

Background 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. Methods (...) We sought to use mabaraza , 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 mabaraza to identify emerging central concepts. Results Our findings from two mabaraza 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. Conclusions 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 mabaraza 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. (shrink)