VIEWS OF THE PROCESS AND CONTENT OF ETHICAL REVIEWS OF HIV VACCINE TRIALS AMONG MEMBERS OF US INSTITUTIONAL REVIEW BOARDS AND SOUTH AFRICAN RESEARCH ETHICS COMMITTEES

Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for ‘major changes’ in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were ‘self‐taught’ in ethics. This study, the first we know of to offer quantitative data comparing US vs. non‐US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy‐makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.     

CURRICULUM GUIDE FOR RESEARCH ETHICS WORKSHOPS FOR COUNTRIES IN THE MIDDLE EAST

To help ensure the ethical conduct of research, many have recommended educational efforts in research ethics to investigators and members of research ethics committees (RECs). One type of education activity involves multi‐day workshops in research ethics. To be effective, such workshops should contain the appropriate content and teaching techniques geared towards the learning styles of the targeted audiences. To ensure consistency in content and quality, we describe the development of a curriculum guide, core competencies and associated learning objectives and activities to help educators organize research ethics workshops in their respective institutions. The curriculum guide is divided into modular units to enable planners to develop workshops of different lengths and choose content materials that match the needs, abilities, and prior experiences of the target audiences. The content material in the curriculum guide is relevant for audiences in the Middle East, because individuals from the Middle East who participated in a Certificate Program in research ethics selected and developed the training materials (e.g., articles, powerpoint slides, case studies, protocols). Also, many of the activities incorporate active‐learning methods, consisting of group work activities analyzing case studies and reviewing protocols. The development of such a workshop training curriculum guide represents a sustainable educational resource to enhance research ethics capacity in the Middle East.     

Impact of Three Years Training on Operations Capacities of Research Ethics Committees in Nigeria

This paper describes a three‐year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross‐section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants’ knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically.     

Twenty years of human research ethics committees in the Baltic States

Two decades have passed since the first attempts were made to establish systematic ethical review of human research in the Baltic States. Legally and institutionally much has changed. In this paper we provide an historical and structural overview of ethical review of human research and identify some problems related to the role of ethical review in establishing quality research environment in these countries. Problems connected to (a) public availability of information, (b) management of conflicts of interest, (c) REC composition and motivation of REC members, and (d) differing levels of stringency of ethical review for different types of studies, are identified. Recommendations are made to strengthen cooperation among the Baltic RECs.     

A multicenter study of the awareness and attitudes of Egyptian faculty towards research ethics: a pilot study

The awareness and attitudes of faculty towards research ethics committees (RECs) and research ethics practices are largely unknown. Accordingly, we conducted a cross-sectional survey study involving various faculties (Medicine, Nursing, Pharmacy, and Dentistry) from four universities in Egypt. A large majority (> 85%) held positive attitudes towards RECs, but almost a third thought that RECs would delay research. More than half had not received prior training in research or medical ethics, but more than 90% thought that this subject matter should be taught to postgraduates. A large majority recognized the need for informed consent and confidentiality protections in research, but some held attitudes regarding certain research ethics practices that were questionable. We conclude that a curriculum in research ethics should be developed for university faculty and that further qualitative studies should explore the basis of several of the attitudes regarding practices in research ethics.     

CAPACITY BUILDING OF ETHICS REVIEW COMMITTEES ACROSS AFRICA BASED ON THE RESULTS OF A COMPREHENSIVE NEEDS ASSESSMENT SURVEY

A needs assessment survey of ethics review committees (ERCs) across Africa was conducted in order to establish their major needs and areas of weaknesses in terms of ethical review capacity. The response rate was 84% (31 of 37 targeted committees), and committees surveyed were located in 18 African countries. The majority of the responding committees (61%) have been in existence between 5 and 10 years; approximately 74% of the respondents were institutional committees, with the remainder being either national (6/31) or regional (2/31).
In terms of the ethical review process, nine of the 31 committees that responded did not have standard operating procedures (SOPs), and seven of the 22 that did have SOPs had never revised them after their initial development (an average period of three years). Of the 31 committees, 10 operated without any ethical guidelines. Many of the committees (13/30) met once per month, and the number of proposals reviewed annually varied, ranging from five to over 100. All respondents relied on paper-based data management and archiving systems.
Overall, the survey identified the major constraints on ERCs as lack of office equipment, outdated or lack of SOPs, lack of electronic data management systems, inadequate resources, lack of or insufficient expertise on the committees, and poor recognition of the importance of the role of the committees. Consequently, the authors are addressing the identified needs and weaknesses through the Bill and Melinda Gates Foundation-funded capacity building project. The impact of the intervention project will be assessed during and at the end of the four-year longitudinal project.     

EMPIRICAL ETHICS AS DIALOGICAL PRACTICE

In this article, we present a dialogical approach to empirical ethics, based upon hermeneutic ethics and responsive evaluation. Hermeneutic ethics regards experience as the concrete source of moral wisdom. In order to gain a good understanding of moral issues, concrete detailed experiences and perspectives need to be exchanged. Within hermeneutic ethics dialogue is seen as a vehicle for moral learning and developing normative conclusions. Dialogue stands for a specific view on moral epistemology and methodological criteria for moral inquiry. Responsive evaluation involves a structured way of setting up dialogical learning processes, by eliciting stories of participants, exchanging experiences in (homogeneous and heterogeneous) groups and drawing normative conclusions for practice. By combining these traditions we develop both a theoretical and a practical approach to empirical ethics, in which ethical issues are addressed and shaped together with stakeholders in practice. Stakeholders' experiences are not only used as a source for reflection by the ethicist; stakeholders are involved in the process of reflection and analysis, which takes place in a dialogue between participants in practice, facilitated by the ethicist. This dialogical approach to empirical ethics may give rise to questions such as: What contribution does the ethicist make? What role does ethical theory play? What is the relationship between empirical research and ethical theory in the dialogical process? In this article, these questions will be addressed by reflecting upon a project in empirical ethics that was set up in a dialogical way. The aim of this project was to develop and implement normative guidelines with and within practice, in order to improve the practice concerning coercion and compulsion in psychiatry.     

RESEARCH INTEGRITY IN CHINA: PROBLEMS AND PROSPECTS

In little more than 30 years, China has recovered from the intellectual stagnation brought about by the Cultural Revolution to become a global leader in science and technology. Like other leading countries in science and technology, China has encountered some ethical problems related to the conduct of research. China's leaders have taken some steps to respond to these problems, such as developing ethics policies and establishing oversight committees. To keep moving forward, China needs to continue to take effective action to promote research integrity. Some of the challenges China faces include additional policy development, promoting education in responsible conduct of research, protecting whistle‐blowers, and cultivating an ethical research environment.     

GOING FROM PRINCIPLES TO RULES IN RESEARCH ETHICS

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis‐à‐vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing in the validity of the rules. I conclude by arguing that this is not likely to be accomplished. The rules I call into question are the rules requiring:

• – that studies be designed in a scientifically valid way
• – that risks to subjects be minimized
• – that subjects be afforded post‐trial access to experimental interventions
• – that inducements paid to subjects not be counted as a benefit to them
• – that inducements paid to subjects not be ‘undue’
• – that subjects must remain free to withdraw from the study at any time for any reason without penalty

Both canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries.     

Research ethics training in Peru: a case study

With the rapidly increasing number of health care professionals seeking international research experience, comes an urgent need for enhanced capacity of host country institutional review boards (IRB) to review research proposals and ensure research activities are both ethical and relevant to the host country customs and needs. A successful combination of distance learning, interactive courses and expert course instructors has been applied in Peru since 2004 through collaborations between the U.S. Naval Medical Research Center Detachment, the University of Washington and the Department of Clinical Bioethics of the National Institutes of Health to provide training in ethical conduct of research to IRB members and researchers from Peru and other Latin American countries. All training activities were conducted under the auspices of the Peruvian National Institute of Health (INS), Ministry of Health. To date, 927 people from 12 different Latin American countries have participated in several of these training activities. In this article we describe our training model.     

Challenges faced by research ethics committees in El Salvador: results from a focus group study

Objective:  To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building.
Methods:  Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed.
Results:  Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight.
Conclusions:  Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.     

CURRENT FUNCTIONS OF ITALIAN ETHICS COMMITTEES: A CROSS‐SECTIONAL STUDY

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross‐sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion at a European level. Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond. Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations. Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision‐making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models.     

The ethically trained physician: myth or reality?

Through a questionnaire distributed to 300 physicians in the Toronto area, three aspects of their ethical awareness were examined: the formal codes, the need for consultation in making decisions and the need for training in medical ethics. Most of the physicians (81%) felt that they were facing ethical problems in their daily practice. A majority of these would try to solve the problems either themselves (30%) or through discussion with a colleague (43%). When they turned outside the profession it was sometimes to a lawyer (12%), which suggests concern with the legalities of some situations. Only a small proportion of the respondents were found to be familiar with two of the established codes of ethics, yet 13% would still turn to the code of the Canadian Medical Association for guidance. Finally, there was widespread recognition of the need for proper training in medical ethics and for the establishment of a specialty in this field.     

The role of ethics in experimental marine biology and ecology

Although most countries have ethical guidelines for research involving human subjects and other sentient animals, the ethical issues associated with field research have received little attention. Most experimental marine biologists and ecologists operate without ethical guidelines or scrutiny, despite intermittent community concern about their activities. We offer suggestions on how marine biologists and ecologists can protect the future of research involving the field collection and experimental manipulation of organisms by developing mechanisms to address community concerns that such research is ethically responsible. We urge experimental marine biologists and ecologists to take pre-emptive initiatives by encouraging: (1) institutional animal ethics committees to broaden their terms of reference to include environmental ethics; (2) scientific societies to develop codes of ethics to guide the environmental research conducted by their members; (3) editorial boards of journals to require the research they publish to conform to an appropriate code of ethics, and (4) management agencies that issue permits for field research to establish an ethics committee to advise them on the ethical issues raised by specific research proposals. We conclude that the resultant administrative burden on scientists would be low but that the penalties of operating without such protection can be high.     

Multidimensional training among Latin America's restoration professionals

The ambitious restoration commitments made by Latin American countries have increased the demand for professionals having multidimensional training in ecological restoration; however, little is known about the kind of training that professionals are currently receiving. Through an online survey, we explored whether restoration professionals in Latin America have been trained on the ecological, socioeconomic, and management dimensions of ecological restoration, and their perceptions of training constraints and curricula needs. Half of the 411 respondents simultaneously work in academia, governments, and nongovernmental organizations, lessening the typical division between the science and practice of restoration, and suggesting the need for stronger multidimensional training to adequately respond to different needs and expectations. Over 80% received formal academic training in fields relevant for restoration and most respondents also reported attending interdisciplinary courses. Training was more focused on the ecological dimension of restoration compared to socioeconomic or management dimensions. Respondents have similar education levels (i.e. most respondents have postgraduate degrees), independently from the organization type in which respondents work, and multidimensionality among organization types was slight. Professionals expressed a need for training opportunities not demanding full‐time dedication. Although increasing training opportunities in socioeconomic and management dimensions is needed, we highlight opportunities to reinforce multidimensional training on restoration through organizational and institutional training, and collaborations among organizations.     

Assessing formal teaching of ethics in physiology: an empirical survey, patterns, and recommendations

Ethics should be an important component of physiological education. In this report, we examined to what extent teaching of ethics is formally being incorporated into the physiology curriculum. We carried out an e-mail survey in which we asked the e-mail recipients whether their institution offered a course or lecture on ethics as part of the physiology teaching process at their institution, using the following query: "We are now doing an online survey in which we would like to know whether you offer a course or a lecture on ethics as part of your physiology teaching curriculum." The response rate was 53.3%: we received 104 responses of a total of 195 sent out. Our responses came from 45 countries. While all of our responders confirmed that there was a need for ethics during medical education and scientific training, the degree of inclusion of formal ethics in the physiology curriculum varied widely. Our survey showed that, in most cases (69%), including at our Medical University of Graz, ethics in physiology is not incorporated into the physiology curriculum. Given this result, we suggest specific topics related to ethics and ethical considerations that could be integrated into the physiology curriculum. We present here a template example of a lecture "Teaching Ethics in Physiology" (structure, content, examples, and references), which was based on guidelines and case reports provided by experts in this area (e.g., Benos DJ. Ethics revisited. Adv Physiol Educ 25: 189-190, 2001). This lecture, which we are presently using in Graz, could be used as a base that could lead to greater awareness of important ethical issues in students at an early point in the educational process.     

Composition and capacity of Institutional Review Boards,and challenges experienced by members in ethics review processes in Addis Ababa,Ethiopia: An exploratory qualitative study

Few studies in sub-Saharan Africa evaluate Institutional Review Boards (IRBs) capacity. The study aims to explore the composition of IRBs, training, and challenges experienced in the ethics review processes by members of research institutions and universities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs members were trained on research ethics and good clinical practice. However, majority perceived the trainings as basic. IRB members faced several challenges including: investigators wanting rapid review; time pressure; investigators not following checklists; limited expertise in reviewing clinical trials, studies on genetics, and traditional medicine; lack of IRB offices for administrative work; competing tasks; limited staffing and the lack of a standardized review system. There is need for advanced training on research ethics to meet the evolving research needs. In addition, investments in IRBs are needed in terms of funding, and physical and human resources in Addis Ababa and Ethiopia in general.     

GLOBAL HEALTH ETHICS FOR STUDENTS

As a result of increased interest in global health, more and more medical students and trainees from the 'developed world' are working and studying in the 'developing world'. However, while opportunities to do this important work increase, there has been insufficient development of ethical guidelines for students. It is often assumed that ethics training in developed world situations is applicable to health experiences globally. However, fundamental differences in both clinical and research settings necessitate an alternative paradigm of analysis. This article is intended for teachers who are responsible for preparing students prior to such experiences. A review of major ethical issues is presented, how they pertain to students, and a framework is outlined to help guide students in their work.     

A Role for Research Ethics Committees in Exchanges of Human Biospecimens Through Material Transfer Agreements

International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.