This text provides a comprehensive and timely examination of the most pertinent factors affecting institutional ethics committees, for ethicists, trustees, administrators, physicians, clergy, nurses, social workers, attorneys and others with an interest in ethics committees.

This article gives an overview of the development, remit, structure and working of the British Medical Association's Medical Ethics Committee. It situates it within a brief history of the Association and gives examples of current work.

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

Medical ethics committees are increasingly called on to assist doctors, patients, and families in resolving difficult ethics issues. Although committees are becoming more sophisticated in the substance of medical ethics, little attention has been given to the processes these committees use to facilitate decision-making. In 1990, the National Institute for Dispute Resolution in Washington, D.C., provided a planning grant from its Innovation Fund to the Institute of Public Law of the University of (...) New Mexico School of Law to look at what ethics committees can learn from facilitation and mediation techniques. The study's thesis was that, if adapted for use by medical ethics committees, facilitation and mediation techniques can be helpful to those bodies in case review consultations and in other internal committee processes. This article reports on that project. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient (...) consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is widely (...) recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

Abstract Context: Established in 1997, Summa Health System’s Medical Ethics Committee (EC) serves as an educational, supportive, and consultative resource to patients/families and providers, and serves to analyze, clarify, and ameliorate dilemmas in clinical care. In 2009 the EC conducted its 100th consult. In 2002 a Palliative Care Consult Service (PCCS) was established to provide supportive services for patients/families facing advanced illness; enhance clinical decision-making during crisis; and improve pain/symptom management. How these services affect one another has thus (...) far been unclear. Objectives: This study describes EC consults: types, reasons, recommendations and utilization, and investigates the impact the PCCS may have on EC consult requests or recommendations. Methods: Retrospective reviews of 100 EC records explored trends and changes in types of consults, reasons for consults, and EC recommendations and utilization. Results: There were 50 EC consults each in the 6 years pre- and post-PCCS. Differences found include: (1) a decrease in number of reasons for consult requests (133–62); (2) changes in top two reasons for EC consult requests from ‘Family opposed to withdrawing life-sustaining treatment (LST)’ and ‘Patient capacity in question’ to ‘Futility’ and ‘Physician opposed to providing LST’; (3) changes in top two recommendations given by the EC from ‘Emotional Support for Patient/Family’ and ‘Initiate DNR Order’ to ‘Comfort Care’ and ‘Withdraw Treatment.’ Overall, 88% of recommendations were followed. Conclusion: PCCS availability and growth throughout the hospital may have influenced EC consult requests. EC consults regarding family opposition to withdrawing LST and EC recommendations for patient/family support declined. Content Type Journal Article Pages 1-16 DOI 10.1007/s10730-011-9170-9 Authors Jessica Richmond Moeller, Department of Psychiatry and Behavioral Sciences, Akron General Medical Center, 400 Wabash Ave, Akron, OH 44307, USA Teresa H. Albanese, Health Services Research and Education Institute, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Kimberly Garchar, Kent State University, 6000 Frank Ave., N.W, North Canton, OH 44720, USA Julie M. Aultman, Department of Family and Community Medicine, Northeast Ohio Medical University, P.O. Box 95, Rootstown, OH 44272, USA Steven Radwany, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Dean Frate, Internal Medicine, Palliative Care and Hospice Services, Summa Health System and Northeast Ohio Medical University, 55 Arch St., Suite 1A, Akron, OH 44304, USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737. (shrink)

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (...) (range: 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary. (shrink)

The return of individual research results and incidental findings from biobanking research is a much debated ethical issue globally but has extensive relevance in India where the burden of out of pocket health care expenses is high for the majority. The views of 21 ethics committee (EC) members and 22 researchers from Bengaluru, India, concerning the ethics of biobanking research were sought through in‐depth interviews using an unfolding case vignette with probes. A shared view among most was that (...) individual research results which are ‘actionable’ or have ‘clinical significance’ should be returned to the sample contributors through their treating physicians. This was seen as an ethical obligation and a moral duty on the side of the researcher to “give back” to the person who contributed to the research. The challenges foreseen were that of resources, both financial and personnel, for the time and counseling needed to accompany the disclosure of results. Perceptions of ‘ownership’ appear to influence the concept of benefit sharing. While benefit sharing in financial terms was considered ethically challenging, certain researchers and ethics committee members made a case for “two way altruism” where the researcher in return for the altruistic ‘valuable contribution’, shares with the contributor/ community, benefits of the research which could include research findings, improved patient care, and more affordable access to the new diagnostic tests or products arising from the research. This defines the emerging ethic of “giving back” which goes beyond individual rights and ensures reciprocity and distributive justice. (shrink)

Next SectionIn response to public outrage stemming from exposés of animal abuse in research laboratories, the US Congress in 1985 mandated Institutional Animal Care and Use Committees (IACUCs) to oversee animal use at institutions receiving federal grants. IACUCs were enjoined to respect public concern about the treatment of animals in research, but they were not specifically instructed whether or not to perform ethical cost-benefit analyses of animal research protocols that IACUCs have chosen, with approval contingent upon a balancing of (...) animal pain and suffering against a reasonable expectation of resultant human benefit. IACUCs have chosen not to make such ethical judgments but, rather, restrict themselves to an advisory role, often tweaking the details of animal-use protocols, but eventually approving all of them. This disinclination by IACUCs to take a broader ethical view of their authority and responsibilities may reflect a membership composition highly skewed towards animal researchers themselves (67%) and institutional veterinarians (15%), both with vested interests in continuing animal research. The resultant ethical monoculture may impair IACUC's ability to meet public concern for laboratory animal welfare. Psychological research has established that unconscious bias affects us all, that deliberations among the like-minded lead to adapting extremist positions, and that groupthink blinds organisations to alternatives that might be obvious to outsiders. Taken together, skewed IACUC membership composition and psychological research insights into unconscious bias and groupthink suggest that an infusion of ethical diversity by increasing the percentage of institutionally unaffiliated members on IACUCs would broaden their ethical perspectives and enable them to better address public concerns about laboratory animal welfare. (shrink)

The new class of anti-inflammatory drugs, the COX-2 inhibitors, have been commercially successful to the point of market dominance within a short time of their launch. They attract a price premium on the basis that they are associated with fewer adverse gastric events than traditional anti-inflammatory drugs. This marketing continues even though a pivotal safety study with one of the COX-2 inhibitors, rofecoxib, showed a significant increase in myocardial infarction with rofecoxib use compared with a traditional anti-inflammatory drug. This finding (...) has led to a series of publications containing pooled analyses of existing data that both support and refute the possibility of increased cardiovascular risk with COX-2 inhibitors.These medical journal publications have served to obfuscate rather than provide guidance for medical practitioners. Consideration of a research ethics committee approach to this issue suggests that it would deal with the controversy in a straightforward manner—namely, it would simply inform research participants of the trial results with rofecoxib. The certainty of this research ethics committee approach raises the issue of whether it should be applied in normal medical practice outside of the research environment. A consideration of the legal tests for disclosure of information suggests that therapeutic medical practice should mirror that within the research environment, in this case. (shrink)

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers’ experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands (...) of medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research. (shrink)

The first clinical ethics committees in Norway were established in 1996. This started as an initiative from hospital clinicians, the Norwegian Medical Association, and health authorities and politicians. Norwegian hospitals are, by and large, publicly funded through taxation, and all inpatient treatment is free of charge. Today, all the 23 hospital trusts have established at least one committee. Center for Medical Ethics , University of Oslo, receives an annual amount of US$335,000 from the Ministry of (...) Health and Care Services to coordinate the committees and to facilitate competency building for committee members. (shrink)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the (...) complex ethical issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)

ABSTRACT Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to ‘harmonise’ their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, and so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive (...) for complete consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this ‘the justice argument.’ The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the ‘moral pluralism argument.’ The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the ‘due process argument.’ While we fall short of establishing exactly how much variation and on what substantive issues would be ethically permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research. (shrink)

When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A (...) moral view which can be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals. (shrink)

Background Ethics committees and their system of research protocol peer-review are currently used worldwide. To ensure an international standard for research ethics and safety, however, data is needed on the quality and function of each nation's ethics committees. The purpose of this study was to describe the characteristics and developments of ethics committees established at medical schools and general hospitals in Japan. Methods This study consisted of four national surveys sent twice over (...) a period of eight years to two separate samples. The first target was the ethics committees of all 80 medical schools and the second target was all general hospitals with over 300 beds in Japan (n = 1457 in 1996 and n = 1491 in 2002). Instruments contained four sections: (1) committee structure, (2) frequency of annual meetings, (3) committee function, and (4) existence of a set of guidelines for the refusal of blood transfusion by Jehovah's Witnesses. Results Committee structure was overall interdisciplinary. Frequency of annual meetings increased significantly for both medical school and hospital ethics committees over the eight years. The primary activities for medical school and hospital ethics committees were research protocol reviews and policy making. Results also showed a significant increase in the use of ethical guidelines, particularly those related to the refusal of blood transfusion by Jehovah's Witnesses, among both medical school and hospital ethics committees. Conclusion Overall findings indicated a greater recognized degree of responsibilities and an increase in workload for Japanese ethics committees. (shrink)

Since Clinical Ethics Consultation has become important in the public health sector in the last decade in Germany, there are on-going questions about effectiveness. Targets have been established by the Ethics Committees, in regard to assisting patients, families and health care teams at times of ethical conflicts during the decision-making process in medical care. Of all the ethics consultations over the last eight years at Erlangen University Hospital the consultations carried out in the pediatric department (...) were chosen to be reviewed by a pediatrician and an ethicist. These were evaluated on the basis of team formation, interdisciplinary orientation, ethical criteria, completeness and methods of documentation. Results of the analysis of those records show a well-organized consultation team with regard to its personnel composition. Discrepancies with ethical questions posed in the literature are revealed, and also some partially incomplete documentation regarding medical facts and descriptions of the patients' or parents' opinion. (shrink)

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. (shrink)

Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment.Design: Cross-sectional national survey of general hospitals to identify all ethics committees and interview of ethics committee chairpersons.Setting: Israel five years after the passage of the Patients' Rights (...) Act.Main measurements: Patients' rights and informal ethics committee structure and function.Results: One-third of general hospitals have an ethics committee, with committees concentrated in larger facilities. Hospitals without committees tended to lack any structure to handle ethics issues. Committees tend to be interdisciplinary and gender-mixed but ethnic mix was poor. Confidentiality is the rule, however, legal liability is a concern. One-third of patients' rights ethics committees never convened and most committees had considered fewer than ten consults. Access to the consultation process and the consultation process itself varied substantially across committees. Some patients' rights ethics committees attempted to solve cases, others only rendered decisions. Informal committees often refused to consider cases within Patients' Rights Act jurisdiction.Conclusions: Despite statutory requirement, many Israeli patients and clinicians do not have access to ethics committees. The scant volume of cases shows serious discrepancies between practice and Patients' Rights Act regulations, suggesting the need for education or revision of the law. Heterogeneity in committee function demonstrates need for substantial improvement. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and (...) decision-making. The key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

With the recent Clinical Trials Directive, a degree of harmonisation into research ethics committees across Europe, including the time taken to assess a trial proposal and the kinds of issues a committee should take into account, has been introduced by the European Union . How four different member states—Hungary, Portugal, Sweden and the UK—have chosen to implement the directive is shown. Although this has resulted in four very different ways of structuring RECs, similar themes are present in all (...) four cases, such as centralisation of control over RECs within member states, harmonisation of REC procedures across the EU and increased role of political decision making with regard to such committees. (shrink)

Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research (...) team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause the (...) research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

Zemyarska MS. Is it ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it? J Med Ethics 2019;45:346–50. doi: 10.1136/medethics-2018-104983. The Acknowledgements section of ….

In this paper the authors argue that research ethics committees should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: competent individuals (...) are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the “normal” constraints on people taking risks with themselves; RECs do not judge individual competence ; individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, the moral and political authority of RECs has not been established in this respect. (shrink)

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs (...) attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures. (shrink)

Awareness of the morally significant distinction between research and innovative therapy reveals serious gaps in the legal provision for compensation in the UK for injured subjects of medical research. Major problems are limitations inherent in negligence actions and a culture that emphasises indemnifying researchers before compensating victims. Medical research morally requires compensation on a no-fault basis even where there is proper consent on the part of the research subject. In particular, for drug research, there is insufficient provision in (...) the current patient guidelines of the Association of the British Pharmaceutical Industry, since they make "no legal commitment" to paying compensation for injury to patient subjects. There is a need for the provision of both adequate insurance and contractual arrangements for making payments. The solution is for Local Research Ethics Committees (LRECs) to make use of their power to withhold approval of medical research where compensation is not legally enforceable. (shrink)

The role of Hospital Ethics Committees is to support patients and their relatives as well as medical staff in solving ethical issues that arise in relation to the implementation of medical care. In Poland there are no clearly formulated legal regulations concerning the establishment and functioning of hospital ethics committees. Hospitals applying for accreditation are obliged to present solutions defining the way of solving ethical issues in a given institution, some of them appoint HECs (...) for this purpose. The aim of this study was to analyze information concerning the functioning of hospital ethics committees in Poland on the basis of publicly available data published on the websites of accredited hospitals. Very few accredited hospitals make public information about functioning in their ethics consulting facilities through hospital ethics committees. In most cases, the information provided on the functioning of HECs is general, both in terms of the committees’ functioning, type of cases under consideration and the composition of personnel. (shrink)

Few ethics committees were in place when the New Jersey Supreme Court announced its ruling on the Quinlan case in 1976. Today, the vast majority of hospitals have formed ethics committees and their use in nursing homes and other healthcare facilities is growing. Given the increasing commitment to the use of ethics committees and their increasing influence on healthcare decision making, the careful evaluation of committee performance should be a high priority. Yet to date (...) ethics committees appear to have undergone relatively little scrutiny. While professional articles on ethics committees do appear and at least one journal sets aside a regular section for the discussion of “Ethics Committees at Work” articles to date have primarily been limited to essays, philosophical inquiries, reports, case studies, and, occasionally, surveys. The use of more structured research methodologies has been lacking. As a result, it is not yet clear, for example, what characteristics describe the best functioning ethics committee. Indeed, what constitutes best functioning lacks careful definition as well. Committee impact on medical decision making and patient outcomes, while discussed, has not been systematically measured and analyzed. (shrink)

Background: The bioethics literature contains speculation but little data about sociodemographic differences between patients for whom ethics committees (EC) are consulted for conflict about life-sustaining treatment (LST) and the broader hospital population that these committees serve. To provide an empirical context for this discussion, we examined differences in five sociodemographic factors between patients for whom an EC was consulted for conflict over LST and the general inpatient population, hypothesizing that nonwhite patients were most likely to be disproportionately (...) represented. Methods: This was a retrospective cohort study comparing self-reported race/ethnicity, household income, insurance status, primary language, and religious affiliation between patients involved in EC consultations for conflict over LST and the general adult inpatient population at a large academic hospital from January 1, 2007, through December 31, 2013. Results: There were 169 EC consultations involving conflict over LST and 243,197 adult inpatient admissions over the study period. On bivariate analysis, patients for whom the EC was consulted for conflict over LST were more likely to be nonwhite, low-income, and to speak a primary language other than English. They were not more likely to be underinsured or to report a religious affiliation. On multivariate analysis, patients for whom the EC was consulted for conflict over LST were more likely to be nonwhite (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.7–3.7; p <.001). They were also more likely to be low income (OR, 1.8; 95% CI, 1.1–3.0; p =.02). They were not more likely to speak a primary language other than English (OR, 1.4; 95% CI, 0.9–2.1; p =.17). None of the assessed variables were associated with conflict over LST requiring additional meetings beyond the first EC consultation. Conclusions: Nonwhite and low-income status patients are disproportionately represented in EC committee consultation for conflict over LST compared to the general inpatient population. (shrink)

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.

In lieu of an abstract, here is a brief excerpt of the content:Ethics Committees in HospitalsPat Milmoe McCarrick (bio)(Literature about hospital ethics committees has grown enormously since Scope Note 3 first appeared. This update provides new information about resources and documents now available while continuing to include important earlier sources.)Hospital ethics committees increasingly have taken hold in the United States since 1983, when the President's Commission for the Study of Ethical Problems in Medicine and (...) Biomedical and Behavioral Research encouraged their creation in its report, Deciding to Forego Life-Sustaining Treatment (III, 1983, p. 5).The President's Commission report (pp. 160-64) suggested the following roles for ethics committees: 1) review of treatment decisions made on behalf of incompetent, terminally ill patients; 2) review of medical decisions having ethical implications with the option, in cases of disagreement, to refer cases to a court with proper jurisdiction; 3) provision of social, psychological, spiritual, or other counseling for patients, family members, physicians, or other hospital staff; 4) establishing guidelines regarding treatment or other medical decisions; and 5) sponsoring or conducting educational programs to inform all concerned, including the public, about ethical problems in medicine.No exact count of these committees is available. According to estimates cited by Donald F. Phillips, managing editor of Hospital Ethics, about two-thirds to three-fourths of hospitals with more than 200 beds have ethics committees, as do about one-third of hospitals under 200 beds. He thinks that about half of the 6,000 hospitals in the United States now have working ethics committees.Several journal articles and a court decision in the late 1970s influenced their formation. A 1975 journal article by pediatrician Karen Teel (VII A) urged the use of hospital ethics committees to provide for dialogue in individual care situations as an appropriate sharing of responsibility. Another early article suggested that beyond parents and treating physicians, a "disinterested," mixed lay and medical committee could consider cases about defective newborns to improve the ethical decisionmaking process (VII A, Robertson and Fost, 1976). Three 1977 discussions in the Hastings Center Report highlighted this new concept (VII A, Levine; Shannon; Veatch).Produced at the National Reference Center for Bioethics Literature, Kennedy Institute of Ethics, Georgetown University, Washington, DC 20057. It is supported by funds provided under grant number LM04492 from the National Library of Medicine, National Institutes of Health. Literature available through June 1992 is represented in this Scope Note. [End Page 285]The court decision was the March 31, 1976 ruling by the New Jersey Supreme Court in the Karen Quinlan case. The parents of a young woman in a persistent vegetative state had requested that she be taken off a respirator. The court designated a "prognosis" role for the hospital ethics committee and stipulated that the committee must concur that the patient will never return to a "cognitive, sapient state" before the life-support system can be withdrawn (In the Matter of Karen Quinlan, 70 N.J. 10, 355 A.2d 647, cert. denied sub nom. Garger v. New Jersey, 429 U.S. 922 (1976)). Shortly after the Quinlan decision, Massachusetts General Hospital's Clinical Care Committee created an ad hoc subcommittee (a psychiatrist, a legal counsel, an ICU nurse, an oncologist/internist, a surgeon, and a lay person who had recovered from serious cancer disease) which looked at 15 cases. Based on the subcommittee's success, establishment of a permanent committee to review treatment of the terminally ill was recommended by the critical care committee (VII A, Clinical Care Committee 1976).In its 1984 Baby Doe rules, the federal government recommended establishment of infant care review committees, which promoted the growth of hospital ethics committees (VII C, Povar 1991). In July 1987 Maryland became the first state to require by law that hospitals establish patient care advisory committees to offer advice about choices available in the care of life-threatening illnesses; this requirement was extended to nursing homes in 1990 [codified as amended at Md. Health-Gen. Code Ann. Sections 19-370 to -374 (1990)] (VII C, Hollinger 1991).Recently the role for these committees has been noted in the Accreditation Manual for Hospitals, 1992 Supplement (p. 10, Patient Rights, Section RI. 1.1.6.1) of the Joint Commission... (shrink)

Background Clinical Ethics Committees are well established at healthcare institutions in resource-rich countries. However, there is limited information on established CECs in resource poor countries, especially in Africa. This study aimed to establish baseline data regarding existing formal CECs in Africa to raise awareness of and to encourage the establishment of CECs or Clinical Ethics Consultation Services on the continent. Methods A descriptive study was undertaken using an online questionnaire via SunSurveys to survey healthcare professionals and bioethicists (...) in Africa. Data were subjected to descriptive analysis and Fischer's exact test was applied to determine associations. Texts from the open-ended questions were thematically analysed. Results In total 109 participants from 37 African countries completed the survey in December 2019. A significant association was found between participants’ bioethics qualification or training and involvement in clinical ethics. All participants were familiar with Research Ethics Committees, and initially conflated RECs with CECs. When CECs were explained in detail, approximately 85.3% reported that they had no formal CECs in their institutions. The constraints to developing CECs included lack of training, limited resources, and lack of awareness of CECs. However, the majority of participants were interested in establishing CECs. Participants listed assistance required in establishing CECs including funding, resources, capacity building and collaboration with other known CECs. The results do not reflect CECs established since the onset of COVID-19 in Africa. Conclusions This study provides a first look into CECs in Africa and found very few formal CECs on the continent indicating an urgent need for the establishment of CECs or CESs in Africa. While the majority of healthcare professionals and bioethicists are aware of ethical dilemmas in healthcare, the concept of formal CECs is foreign. This study served to raise awareness of CECs. Research ethics and RECs overshadow CECs in Africa because international funders from the global north support capacity development in research ethics and establish RECs to approve the research they fund in Africa. Raising awareness via educational opportunities, research and conferences about CECs and their role in improving the quality of health care in Africa is sorely needed. (shrink)

Although ethics committees in Japan have been developing in major medical schools and in some hospitals, their members are usually medical professionals from the same institution. The lack of national legislation for setting up ethics committees permits only a voluntary code of standards for doing clinical research work in high tech medical applications. The author argues for the necessity of more open debate on bioethical issues and proposes the participation of the lay public (...) and bioethicists in Ethics Committees in Japan. Keywords: ethics committees, bioethics, Japan, patients' rights, high-tech medicine CiteULike Connotea Del.icio.us What's this? (shrink)

We have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years.

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics (...) committees and their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)

BackgroundThe last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries.MethodsSemi-structured interviews were conducted from (...) July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs.ResultsAcross the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding.ConclusionThe broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. (...) The role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. (...) The role of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)