Function Of Ethics Committees Research Articles

Ethics Expertise between Imagined Publics and Imagined Scientists

The notion of value-neutral or at least independent scientific expertise is mainly based on the distinction between statements of facts and value judgement. The functioning of ethics committees, in particular bioethics committees, demonstrates that this separation is doomed to fail. These committees are supposed to regulate the production of new scientific knowledge through appeal to extra-scientific, non-epistemic values. In making regulatory judgments, the committees find themselves on the edge of a tension between `cognitive democracy' and epistemic inequality. Сommittees have a duty to represent the interests of the public, protecting its dignity and freedoms from possible abuse from researchers. At the same time, the committees, by conducting an “internal” judgment on the ethical permissibility of research projects, remain part of scientific groups and institutions. However, members of ethics committees often imagine academic colleagues as having an incomplete, deficient view of the public good. The committees find themselves in a field of conflict between the epistemic deficits of the imagined public and the ethical deficits of imagined scientists. However, counteracting this double deficit logic can take the form of an ethical abstinence that shuts down the possibilities of value-laden imagination. Moreover, such withdrawal itself is ideologically engaged. The program of `critique of forms of life' can be seen as setting the overall perspective of combining representation with the possibilities of normative judgment. This combination is particularly relevant in light of the ongoing debates about moral enhancement and human genome editing, since both areas of biomedical inquiry involve biotechnological and social transformation of human forms of life.

International Research and Philanthropy

International Research and Philanthropy

Challenges for ethics committees in biomedical research governance: illustrations from China and Australia.

In this paper, the evolution of the ethics committees for health research, their history, membership, and function in China and Australia is described. Investigators in each country compared the history and governance of their ethical systems based on the published evidence rather than personal opinions. Similarly, examples of challenges were selected from the literature. In both countries, the aim was to maximize the social benefits of research and minimize the risk imposed on the participants. Common challenges include maintaining independence, funding and delivering timely ethical reviews of the research projects. These challenges can be difficult where research ethics committees rely on voluntary contributions and lack a strong resource base. They must adapt to the increasingly rapid pace of research as well as the technological sophistication. Population health research can challenge the conventional views of consent and privacy. The principles of the sound ethical review are common in both countries; governance arrangements and operational procedures, however, can differ, reflecting the cultural values and norms of their host countries and in respect of legal environments. By studying the evolution and function of ethics committees in the two countries, we established the differences in the governance and health systems, while similar ethical objectives helped sustain collaborative research.

Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency.

As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications’ review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it)

Festina lente

The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19.Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally.

Scenarios in Medical Ethics-1: Composition and Functioning of Ethics Committees

Scenarios in Medical Ethics-1: Composition and Functioning of Ethics Committees

The structure of ethics review: expert ethics committees and the challenge of voluntary research euthanasia

In 2002, I wrote an editorial in this Journal arguing that it was time to review the structure and function of ethics committees in the USA, Australia and the UK.1...

The impact of the EU Regulation 536/2014 on the tasks and functioning of ethics committees in Germany

The EU Clinical Trial Regulation 536/2014 (CTR) and its implementation in Germany led to substantial changes of the established, well-accepted and effective system of reviewing clinical trial applications by ethics committees (ECs), which impair their independence. For the first time, the German federal legislator specified in detail the composition, functioning, tasks and responsibilities of ECs. ECs have to be registered with the federal drug authority BfArM and if an EC does not perform properly the registration can be withdrawn. In addition, the drug authorities may override the negative opinion expressed by an EC. The ECs will also lose their financial autonomy as the fees will be fixed by the federal government. The tasks and responsibilities of the ECs remain almost entirely unchanged, however. The ECs remain involved in the assessment of both parts of the application dossier. PartI is assessed together with the drug authorities, the drug authorities having the lead. The assessment of partII remains the sole responsibility of the EC. As the deadlines for the assessment became rather short, in particular for multinational trials, and the communication with the sponsor will be in writing only, the established procedures of ECs have to be modified. Up to now it was common to verbally discuss problematic issues with the sponsor. The CTR is focused on written communication with the sponsor via the EU portal. ECs, their office staff and chairpersons will need considerable professionalism and respective training. The future workflow requires substantial IT support. The ECs and the Association of Medical Ethics Committees in Germany will do their utmost to protect efficiently the research subjects and to promote Germany as amajor destination for clinical research.

Are trial participants adequately safeguarded by the ethics committees-the Indian scenario?

Are trial participants adequately safeguarded by the ethics committees-the Indian scenario?

A study to assess completeness of project application forms submitted to Institutional Ethics Committees (IEC) of a tertiary care hospital

Objectives:To review Ethics Committee (EC) application forms and to find out similarities and differences in content of five ECs forms in India.Materials and Methods:The completeness of EC application forms was assessed on the following themes: title, study team, sponsor responsibility, scientific aspects, patient safety, regulatory permissions, Informed consent process from 2008-2009. Application forms (available online) of 5 ECs were studied and compared.Results:A total of 445 application forms were analyzed, 382 were academic, 63 were sponsored. The common deficiencies in academic studies were inappropriate titles (25.13%), lack of budget details (90%). More than 95% studies had not mentioned the method of recruitment. The issue of vulnerability was not marked in more than 50% of studies. Compensation for participation/injury was poorly stated in academic (99%) studies. Among industry sponsored studies, 98% were compliant with regulatory permissions and 41% were CTRI registered. The information pertaining to Informed Consent was mentioned in all forms. Comparative analysis of application forms of 5 ECs showed that the requirements for submission were similar except 1-2 ECs asked for additional information like percentage of time allotted by investigator for studies, GCP training of study team, certification by investigator regarding accuracy of local versions of Informed consent.Conclusion:Our study recommends that increased awareness and vigilance by investigators of academic studies regarding submission of applications to EC will increase efficiency and speed of review process. A common application form for all ECs across India would be an important step to achieve uniformity in functioning of ethics committees.

Éthique en expérimentation animale

In the 1970s, under pressure from certain sections of society and thanks to initiatives by several scientific research teams, committees charged with improving the conditions of laboratory animals started to be created, first in the United States and subsequently in Europe. This led to the development of an ethical approach to animal experimentation, taking into account new scientific advances. In addition to the legislation designed to provide a legal framework for animal experimentation and to avoid abuses, this ethical approach, based on the concept that animals are sentient beings, encourages greater respect of laboratory animals and the implementation of measures designed to reduce their suffering. Now, all animal experiments must first receive ethical approval--from in-house committees in the private sector and from regional committees for public institutions. Very recently, under the impetus of the French ministries of research and agriculture, the National committee for ethical animal experimentation published a national ethical charter on animal experimentation, setting the basis for responsible use of animals for scientific research and providing guidelines for the composition and functioning of ethics committees. Inspired by the scientific community itself this ethical standardization should help to assuage--but not eliminate--the reticence and hostility expressed by several sections of society.

A Five Year Follow-Up National Study of Ethics Committees in Medical Organizations in Japan

Compared to institutional and area-based ethics committees, little is known about the structure and activities performed by ethics committees at national medical organizations and societies. This five year follow-up study aimed to determine (1) the creation and function of ethics committees at medical organizations in Japan, and (2) their general strategies to deal with ethical problems. The study sample included the member societies of the Japanese Association of Medical Sciences (n=92 in 1998, n=96 in 2003). Instruments consisted of two sections: (1) the structure, function and activities of ethics committees, and (2) the strategies for dealing with ethical problems. Response rates were 84.4% in 1998 and 64.4% in 2003. Findings showed a significant increase of ethics committees at medical organizations between 1998 (25.6%) and 2003 (50.0%). Members were mostly male, medical doctors in clinical or basic medicine, and members of the organization. The major functions of ethics committees were ethical reviews of research protocols, policy making and ethical reviews of manuscripts submitted for journal publication. Among organizations that did not have an ethics committee, a significant decrease was found in organizations that replied that they had never experienced an ethical problem which needed further investigation (p<0.01). Findings suggested an overall rise in awareness of the importance of ethical issues and also highlighted an increase in recognition of responsibility regarding ethical problems.

Ethics of studies involving human volunteers. II. Relevance and practical implementation for cosmetic scientists

The importance to the personal products industry of testing novel products in healthy human volunteers and the need to ensure the trials were both safe and ethical were addressed in Part I. The historical development of ethical standards for human testing was also summarized. The present paper highlights the ethical principles to be considered when testing novel non-medicinal products on human volunteers, and it describes how they can be implemented in a pragmatic manner to avoid delay to the sponsor's research program. The structure and function of ethics committees is discussed.

Ethics Committees in Croatia in the Healthcare Institutions: The First Study about their Structure and Functions, and some Reflections on the Major Issues and Problems

In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees. Croatia six years after the implementation of the Law on the Health Protection. Structure and function of ethic committees in the healthcare institutions. 46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work. Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.

Ethics Committees in Human Service Organisations for People with Learning Disabilities in the Netherlands

This paper describes the aims, roles and functions of ethics committees in Dutch service organisations for people with learning disabilities. The significance of ethical advice for professional practice depends not only on the role of an ethics committee, but also, and primarily, on the theoretical frameworks used. Ethics committees can be important partners for professionals in their search for responsible practice and a well‐considered moral response. Such a partnership has the potential to inspire new ways of showing respect to service users.

Ethical approval for health research in central and eastern Europe: an international survey

Research ethics committees in central and eastern Europe are increasing in importance as institutions in this region host a growing and more diverse range and volume of health-related research, with funding from an increasingly wide variety of sources.Aim: To describe the arrangements for ethical supervision of research in eleven countries of central and eastern Europe, so as to identify examples of good practice and areas of weakness.Methods: A questionnaire was sent to key informants known to be active in health-related research in Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Lithuania, Poland, Romania, Russia, and Ukraine in October 2000. It sought information on the composition and functioning of ethics committees, their training and any public concerns about the ethics of health-related research.Results: All countries except Ukraine confirmed that decision-making committee structures operate to oversee the ethics of research on human subjects. In all countries except Albania committees are comprised of medical and non-medical members. Members received specific training in bioethics in Estonia, Hungary, and Lithuania. Countries had made different degrees of progress in implementing arrangements for coordinating multi-site research and for monitoring research once it had commenced. Public concern about ethical issues arising from health-related research was rare.Conclusion: The development of ethical supervision of health-related research in central and eastern Europe varies considerably. In some countries there are significant weaknesses that should be addressed. Other countries could serve as examples of good practice in the region. A major challenge is how the public can be involved in this process.

Experiences with committees dealing with the issues of ethics

Ethics committees have been active in Germany for 15 years now. Since 1983, such committees, which were established under public law with medical schools, medical associations and representatives of the Federal Health Office among their members, have established a working group with a growing membership of currently some 45 committees. The group's functions include the exchange of experience, the discussion of relevant ethical issues as well as the harmonization and standardization of their internal procedures. In addition, it serves as a point of contact for members of Parliament, Government and journalists. Since 1990, the group has published four yearbooks under the title of ‘Medizin-Ethik’ [1]. Germany's ethics committees are bodies serving no other purpose than that of biomedical research on human beings (scientific experiments, diagnostic and therapeutic methods, clinical trials involving drugs). They are intended to protect test persons and patients against acts which must not be permitted for ethical and/or legal reasons. Ethics committees fulfil the task of counselling the medically responsible researcher and of examining in advance whether relevant scientific, legal, medical and ethical standards will be met by the biomedical project envisaging scientific research on human beings and whether such a project will not violate accepted values. The ethical and legal standards to be adhered to in this connection have been laid down in the declaration issued by the World Medical Association in Helsinki/Tokyo/Venice/Hong Kong, they have been codified in human rights declarations and in a great number of national legal provisions and have been included in scientific standards. Under paragraph 4 of section 1 of their professional regulations, German physicians are liable ‘to obtain advice… from an ethics committee set up with the regional office of their professional association or with a medical school before conducting biomedical experiments on human beings…’ The function of ethics committees is to provide advice. The committee's conclusions are summarized to make a recommendation which reflects the committee's opinion. Ethical ideals and standards cannot be established or modified by an ethics-committee. The committees are not allowed to decide on the validity or non-validity of such standards by a majority of votes, as some critics suspect, nor can they establish truth by putting it to the vote. What they do establish in a normal procedure permitted by law is the result of careful consideration: the committee makes a judgement on whether or not any scientific, legal, medical or ethical objections have to be raised against the project in question, after it has taken into account the respective prerequisites and conditions of the project submitted for evaluation. The accusation that ethics committees relieve physicians and researchers of their responsibility is as serious as it is unjustified. By their very nature, ethics committees can never replace a doctor's conscience. The moral and legal responsibility is bound to remain with the physician and scientist concerned, who is left with the decision whether or not to go ahead with the project in question. The experience we have acquired over a period of 15 years will enable us to answer questions concerning substantive and procedural problems involved in carrying out ethics consultation.

Ethics committees in Japanese medical schools.

The present features and functions of ethics committees in 80 Japanese medical schools were surveyed by employing questionnaires. Seventy-nine schools had already established committees on each campus (however, the ethics committee at Kitasato Medical University was formally established after the completion of this survey). The major role of Japanese ethics committees may be said roughly to correspond to that of Institutional Review Boards (IRB) in the U.S., although ethics committees have other functions as well. Among the ethics committees' many problems, two significant weaknesses should be underscored. The first is the inappropriate composition of the membership of the committees: more non-campus members, younger professionals, and women should be invited to participate. The second concern is the committees' essentially closed review process: this process has not been adequately open to the public even in cases in which the issue of the patient's confidentiality does not arise. However, several schools are now preparing to open their meetings to non-members and this policy should improve the present situation. It is fortunate, however, that the ethics committees in Japan's medical schools were established by members from each campus and not as a response to national directives or legislation.

Ethics Committees in Nursing Homes: Applying the Hospital Experience

Ethics Committees in Nursing Homes: Applying the Hospital Experience The need to develop effective methods for addressing ethical issues in clinical care is even greater in nursing homes than acute care hospitals. Institutionalization in itself raises a basic concern about the privacy and self-determination of long-term care patients. This is heightened by the fact that although 50-70 percent of these residents suffer some impairment of their decisional capacity, many lack legal guardians or involved family members to serve as surrogate decisionmakers. [1] Lack of clarity about the role of aggressive treatment, the comparative frequency with which decisions about the use of potentially life-sustaining treatment must be made, and the minimal presence of physicians in daily care in nursing homes increase the need to create institutional means to respond to the ethical dimensions of patient care in these facilities. Ethics committees, although still rare, are being formed with growing frequency in nursing homes. [2] Discussion of the role and composition of these committees in the literature is based largely on experience in the acute care setting. Ethics committees in hospitals recommend institutional policies, educate participants in the decisionmaking process, consult about ethical dilemmas in individual cases, and provide emotional support for professionals who confront ethical dilemmas in patient care. While both hospitals and long-term care facilities benefit from the policy development function of ethics committees, the relative importance of the remaining functions of ethics committees differs for each. The unique ethical issues that arise in long-term care suggest that a cautious approach should be taken to applying the lessons of the hospital experience to the nursing home when developing ethics committees. There should be a more limited need for ethics committees to review individual cases in nursing homes, since the trajectories of illness there tend to follow a more predictable course and can be more readily foreseen and planned for by residents and staff. Efforts to identify patient preferences can be initiated on admission or in the early months of placement before a crisis erupts. When patients are cognitively impaired at the time of placement, appropriate policies for identifying surrogate decisionmakers can also minimize the need for crisis-based committee review. The high rate of staff turnover in long-term care facilities, in contrast with the greater stability of primary caregivers in the acute care setting, dictates the need for continual emphasis on education in clinical ethics in nursing homes. The educational role of ethics committees, consequently, seems even more important in nursing homes than in hospitals. The function of providing emotional support to professionals also takes on greater significance in the nursing home context. The close relationships that can develop between nursing staff and patients make the emotional impact of ethical conflict even greater in this setting. Further, the frequency with which questions about life-extending care are faced by nursing staff, and the greater involvement of staff in the reactions of families to difficult decisions, make the need to provide emotional support especially pressing in long-term care. The composition of ethics committees in nursing homes should also be somewhat different from that in hospitals. The former should have a substantial number of nursing staff, as well as patients or their representatives. The need for greater nursing representation on committees in long-term care facilities stems from three factors: (1) the more central role of nursing staff in directing patient care; (2) the greater knowledge nurses develop about patients, especially about the values and treatment preferences expressed earlier by patients who have become cognitively impaired; and (3) the greater burden of responsibility nursing staff often bear in meeting facility policies about end-of-life care decisions. …

Guidelines for ethics committees in health care institutions. Judicial Council

THESE guidelines have been developed to aid in the establishment and functioning of ethics committees in hospitals and other health care institutions that may choose to form such committees, recognizing that the functions may vary depending on the type of institution. Ethics committees in health care institutions should be voluntary, educational, and advisory in purpose so as not to interfere with the primary responsibility and relationship between physicians and their patients. Generally, the function of the ethics committee is to consider and assist in resolving unusual, complicated ethical problems involving issues that affect the care and treatment of patients within the health care institution and concern those persons who are responsible for their care and treatment. Typical are issues involving quality of life, terminal illness, and utilization of scarce, limited health resources. The size of the ethics committee should be consistent with the needs of the institution but not so