Ethics and biomedical research

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.     

Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.     

The Role of a Hospital Ethics Consultation Service in Decision-Making for Unrepresented Patients

Despite increased calls for hospital ethics committees to serve as default decision-makers about life-sustaining treatment (LST) for unrepresented patients who lack decision-making capacity or a surrogate decision-maker and whose wishes regarding medical care are not known, little is known about how committees currently function in these cases. This was a retrospective cohort study of all ethics committee consultations involving decision-making about LST for unrepresented patients at a large academic hospital from 2007 to 2013. There were 310 ethics committee consultations, twenty-five (8.1 per cent) of which involved unrepresented patients. In thirteen (52.0 per cent) cases, the ethics consultants evaluated a possible substitute decision-maker identified by social workers and/or case managers. In the remaining cases, the ethics consultants worked with the medical team to contact previous healthcare professionals to provide substituted judgement, found prior advance care planning documents, or identified the patient’s best interest as the decision-making standard. In the majority of cases, the final decision was to limit or withdraw LST (72 per cent) or to change code status to Do Not Resuscitate/Do Not Intubate (12 per cent). Substitute decision-makers who had been evaluated through the ethics consultation process and who made the final decision alone were more likely to continue LST than cases in which physicians made the final decision (50 per cent vs 6.3 per cent, p = 0.04). In our centre, the primary role of ethics consultants in decision-making for unrepresented patients is to identify appropriate decision-making standards. In the absence of other data suggesting that ethics committees, as currently constituted, are ready to serve as substitute decision-makers for unrepresented patients, caution is necessary before designating these committees as default decision-makers.     

Assessment of the ethical review process in Sudan

The ethical review process is an important component of contemporary health research worldwide. Sudan started an ethical review process rather late in comparison with other countries. In this study, we evaluate the structure and functions of existing ethics review committees. We also explore the knowledge and attitudes of Sudanese researchers toward the ethical review process and their experience with existing ethics review committees. There are four ethics review committees in the country; these committees have no institutional regulations to govern their functions. Furthermore, Sudan also lacks national guidelines. Ethical reviews are carried out primarily for studies seeking international funding and are almost always governed by the funding agencies' requirements. Nearly half of respondents (46.3%) knew about the existence of research ethics committees in Sudan. Researchers reported a variety of experiences with the ethical review process; most of them were unable to define 'ethics committee'.     

Ethical review issues in collaborative research between us and low-middle income country partners: a case example

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct of human behavior research and research capacity building in the host country.     

Human Research Ethics Committees: Examining their Roles and Practices

considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.     

The roles and functions of hospital-based ethics committees.

Ethics committees ar becoming much more visible on the Canadian health care scene. They range from research-ethics committees that decide whether research projects are ethically sound to case-oriented committees that look at particular issues and give advice. Eike-Henner Kluge says that ethics committees are useful tools, but only when they are appropriately constituted and function in a professional manner. Otherwise, he warns, they become either useless or a liability.     

Research ethics: the case with the tule (kuna), Urabbá, Colombia

An ethical analysis was performed during the development of a research project titled "Culture, nourishment and malaria in the Kuna aboriginals of Urabá, Colombia." This project had 2 objectives; (1) to investigate the prevalence of malaria and its relationship with hypovitaminosis A and nutritional status, and (2) to understand the community's conceptions and practices towards malaria. The current paper summarizes reflections concerning the application of ethical principles and moral values during the course of the malaria research project. Two intercultural relationships were clearly defined: the culture of the Tule (Kuna) Indians, with a traditional medical system, and the culture of the research group, focused on the biomedical model. The rationale and the discussion proposed during the writing of the project proposal was presented as well as the dilemmas that developed during the project within the communities. These problems required rapid decision-making in situations for which the scientists had not been adequately prepared. A need was indicated for application of ethical principles to permeate the analysis throughout the research process in a horizontal manner, such that the human dignity of the participants and the ethnicity of the community are preserved above the purposes of the project. In the research process, mediation between the ethics of conviction and the ethics of consequences must take precedence, with both outcomes tied to an informed consent in place during the process. The establishment of national and local research ethics committees was indicated as necessary to preserve the lifestyle and culture of the ethnic groups. These values were seen as endangered given the trading pressures and health policies in a globalized world.     

Ethics in a bicultural context -- a report from New Zealand

The distinctiveness of Bioethics in New Zealand stems in part from a renewal of emphasis on Maori rights, based on the Treaty of Waitangi, the foundation document of the New Zealand state. Increasingly, committees dealing with health research ethics and with the ethics of assisted reproductive technology have to incorporate Maori values and perspectives.     

Diversity in the practice of district ethics committees.

A survey of ethics committees in district health authorities was carried out to find out the size and make up of committees and what information and guidance they offered to scientists who apply to do research. A sample (n = 28) of committees in England (n = 190), half from teaching districts and half from non-teaching districts, was contacted by post requesting this information. A high degree of diversity was found, not only in the methods that committees used but also in the ethical criteria each considered to be pertinent for research. It was also shown that published guidelines have made little impact. It is suggested that issuing more guidelines will be of limited use. Rather, the following are needed: information about why guidelines have been widely ignored, better communication between committees, some form of education for committee members, and a formal register of committees compiled.     

Beneficial effects on employment and preventive health care: the concept and results of counselling processes from a German project

Since December 1998 a project of working time counselling named "Design of Modern Working Times" is supported by the federal state of North Rhine-Westphalia in Germany and the European Union; AWiS-consult is entrusted to carry out this project. The service offered to all companies, institutions, work committees, and employees interested covers information, assessment of existing working time schedules, development of alternative or new working time schedules, and accompanying implementation processes. Up to June 2001 nearly 300 inquiries were worked on, most of them from industry, service companies, and from the field of care and hospitals. Working time design in this project aims not only at work safety and health care but also at beneficial effects on employment. In a special campaign from May 2000 to May 2001, 61 companies were supported by AWiS-consult, with the result of more than 400 new employees and 16 companies with employment secured, so the combination of preventive health care and beneficial effects on employment by working time design can be assessed as successful.     

生命伦理学委员会

生命伦理学委员会是从伦理学角度审查人体试验研究,保护受试者权益的决策咨询组织。该委员会一般由来自法学、伦理学、医学、药学等领域的专家学者组成,其审查遵循的重要依据是世界医学会制订的《赫尔基辛宣言》。近年来,伦理委员会快速发展,但各伦理委员会审查质量参差不齐。因此,相关部门尚需加强对伦理委员会成员的培训,并加强对伦理委员会的监管,方能促进我国伦理委员会的良性发展。     

European Ethical Review Committee: the experience of an international ethics committee reviewing protocols for drug trials.

An international ethics review committee, founded seven years ago, has several unusual features: it selects its own members, who are independent of the drug industry; it includes members with no medical or paramedical background, such as lay people and lawyers; and it reviews protocols together with the study''s sponsor. Membership of 31 from nine European countries enables frequent meetings and there is a full meeting of the committee every year to review progress and consider policy. Of the first 294 protocols for phase I, II, or III trials reviewed, 37 were admitted outright, 243 were amended (usually during the discussion of the protocol), and 14 were rejected. It is suggested that, to overcome the problem of ethics review in smaller institutions, regional health authorities in Britain might consider establishing similar committees.     

The new system of review by multicentre research ethics committees: prospective study

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested.ConclusionsThe new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.     

Informed Consent in Health Research: Challenges and Barriers in Low‐and Middle‐Income Countries with Specific Reference to Nepal

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low‐and middle‐income countries (LMICs) in recent years, only limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent.     

A critical analysis of Australian clinical ethics committees and the functions they serve

The predominant function of Australian clinical ethics committees (CECs) is policy formation. Some committees have an educational role. Few committees play any direct role in advising on ethics in the management of individual patients and this occurs only in exceptional circumstances. There is a tendency to exaggerate both the number and function of committees. It is suggested that studies of ethics committees, based on questionnaire surveys, should be interpreted cautiously. An examination of ethical issues indicates that there is a role for a critical analysis of power relations in Australian hospitals that is not fulfilled by CECs.     

Ethics,evolution and culture

Recent work in the fields of evolutionary ethics and moral psychology appears to be converging on a single empirically- and evolutionary-based science of morality or ethics. To date, however, these fields have failed to provide an adequate conceptualisation of how culture affects the content and distribution of moral norms. This is particularly important for a large class of moral norms relating to rapidly changing technological or social environments, such as norms regarding the acceptability of genetically modified organisms. Here we suggest that a science of morality/ethics can benefit from adopting a cultural evolution or gene-culture coevolution approach, which treats culture as a second, separate evolutionary system that acts in parallel to biological/genetic evolution. This cultural evolution approach brings with it a set of established theoretical concepts (e.g. different cultural transmission mechanisms) and empirical methods (e.g. evolutionary game theory) that can significantly improve our understanding of human morality.

Addressing the challenge for expedient ethical review of research in disasters and disease outbreaks

Guideline 20 of the updated International Ethics Guidelines for Health‐related Research Involving Humans (2016) by the Council for International Organizations of Medical Sciences (CIOMS) provides guidance on research in disasters and disease outbreaks against the background of the need to generate knowledge quickly, overcome practical impediments to implementing such research, and the need to maintain public trust. The guideline recommends that research ethics committees could pre‐screen study protocols to expedite ethical reviews in a situation of crisis, that pre‐arrangements be made regarding data sharing and biomedical sample sharing, and that sponsors and research ethics committees seek to minimize risk to researchers conducting research during a disaster. This paper critiques these recommendations against the background of the findings of a survey of public health officials and chairs of research ethics committees in the Caribbean during 2016, which sought to determine the best template for the expeditious ethical review of research proposals in emergency and epidemic situations in the Caribbean, and whose findings can serve as a model for other low‐ and middle‐income countries.     

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.