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.

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)

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)

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 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)

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 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)

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)

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.

Controlled Human Infection Studies (CHIS) involving the deliberate exposure of healthy individuals to infectious agents, are emerging as a valuable tool for medical research. This systematic survey explores the perceptions of ethics committee members from various Indian medical research institutions after participating in a sensitization workshop on CHIS. This cross-sectional study was conducted on the workshop participants through an online survey. The workshop was held in a hybrid mode and around 60 participants from four tertiary care institutions (...) and research institutes had participated. A structured questionnaire was used to assess their evolving perspectives, challenges, and recommendations related to CHIS and the effectiveness of the workshop. Both Likert scale and open-ended items were included in the survey. Responses are presented as percentage and views supported through the quotes from responses. Around 43 participants responded to the survey (72%). Participants acknowledged the potential benefits of CHIS but were concerned about the psychological harm and other risks. Challenges were identified in conducting and reviewing CHIS, including regulatory approvals, risk assessment, and robust informed consent. The need for development of regulatory guidelines, specialized training, risk mitigation strategies, community engagement, and compensation mechanisms were highlighted. The sensitization workshop was considered valuable in enhancing participants' understanding of CHIS, although participants expressed a need for continued training and experience to effectively review such studies. With the Indian Council of Medical Research (ICMR) releasing a policy statement on ethical conduct of CHIS in India, this study provides a foundation for future capacity-building initiatives among ethics committee members. The findings emphasize the significance of ongoing dialogue to standardize the ethical review process for CHIS, thus facilitating their acceptance and realization in India's medical research landscape. (shrink)

I am in the process of trying to organize an ethics committee at a large community mental health center in Central Massachusetts and am seeking advice from anyone with experience in this or a similar milieu. The agency is a large (almost 700 employees), nonprofit, community-based program that operates under the auspices of a broad, academically affiliated, behavioral health system. An independent board of trustees, responsible to the parent organization governs the agency. The agency primarily provides outpatient care and (...) treatment to adults and children with mental health, substance abuse, developmental disabilities, and homelessness issues. It does not provide any psychiatric emergency or acute in-patient mental health services but does operate an inpatient detoxification unit for substance abuse treatment and DUI program. Additionally, the agency has a vast network of residential programs and transitional facilities for individuals with a history of chronic mental illness and substance abuse problems. Outpatient medical care is also provided to homeless clients who reside in area shelters (including a shelter for men and women) and a large number of clients who have HIV/AIDS and/or who have been dually diagnosed (substance abuse and mental illness), and are part of a scattered-site supportive housing program. (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)

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)

Over the past 15 years or so, Clinical Ethics Committees (CECs) have been established in many healthcare settings in the UK. How do they work, who sits on them, and what do they discuss? How formal should they be? Should their decisions be binding on clinicians, or purely advisory? Should they offer their services to patients and their families too? Are they valuable additions to clinical support, or simply intellectual talking-shops for their members? Should other countries set up (...) CECs as part of their own approach to Clinical Ethics? (shrink)

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

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)

This paper describes the medical ethics scene in Britain. After giving a brief account of the structure of British medical ethics and of the roles of the different groups involved it mentions some of the important medico-moral events and issues of the fairly recent past, and describes in greater detail four important examples of professional, legal, governmental and media concerns with medical ethics, themselves illustrating the wide variety of interests wishing to influence the British (...) medical profession's ethics. The examples offered are the development of research ethics committees, the Sidaway case concerning informed consent, the Warnock Committee's Report on in vitro fertilisation and associated issues, and the 1980 Reith Lectures on Unmasking Medicine. In the final section a fairly new methodological development in British medical ethics is described in which the medical profession is increasingly recognising the need to add to traditional medical ethics education, with its longstanding history of the inculation and enforcement of ethical norms, an element of philosophical or critical medical ethics, at the heart of which is justification of substantive medico-moral claims in the light of counterarguments. (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)

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)

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 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)

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)

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)

A referral was made to our Cardiac Transplant Program for a patient who was in the New Jersey Prison System. The Medical Director of the New Jersey Department of Corrections called regarding a 39-year-old inmate who was being treated in a New Jersey hospital that has a unit for prisoners from a nearby cor- rectional facility. The referring physician described the patient to our Medical Director of heart transplantation as a “murderer” who had been incarcerated since 1987 and (...) sentenced to prison for 30 years without eligibility for parole before completion of his 30-year sentence. The patient was being treated in the CCU of the facility and according to preliminary studies, was suffering from a possible dilated cardiomyopathy. There was evidence of a prior cerebrovascular accident (etiology unknown) with a dense hemiplegia of the left side. The patient was alert but unable to care for himself. There were a number of specific tests necessary to evaluate the patient's candidacy for heart transplantation before actually placing him-on a waiting list. However, the transplant director was uncertain about having the patient brought to our facility for further testing and called some members of the Transplant Selection Committee team to discuss the case. (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)

Clinical ethics committees (CECs) are well established in North America where they are known as hospital or health care ethics committees. Similar groups and other kinds of clinical ethics support are now developing in Europe. This supplement to the Journal of Medical Ethics provides an overview of the issues arising from the provision of clinical ethics support services, and clinical ethics committees in particular. Its primary focus is the UK but (...) contributors from North America and continental Europe provide an international perspective. Clinical ethics committees are an emerging feature of UK health care. This supplement's first paper provides an overview of the current provision of clinical ethics support in the UK and an assessment of the way in which CECs are developing. Personal perspectives from five UK CECs provide insight into some of the issues that those considering setting up a committee in their …. (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)

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)

A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called “revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the (...) medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then “sovereign acts” or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee’s vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult. (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)

Ethics committees have a bad reputation for impeding, rather than facilitating research. Here, I argue that many committees actually improve the quality of the research proposal to such an extent that they deserve credit as authors in any resulting publications, or at least an acknowledgement of the contribution made.

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)

For some time, clinical ethics committees (CECs) have been a prominent feature of hospitals in North America. Such committees are less common in the United Kingdom and Europe. Focusing on the UK, this paper evaluates why CECs have taken so long to evolve and assesses the roles that they should play in health care policy and clinical decision making. Substantive and procedural moral issues in medicine are differentiated, the former concerning ethicolegal principles and their paradigmatic application to (...) clinical practice and the latter dealing with how such application should be negotiated in the face of disagreement and/or uncertainty. It will be argued that the role of CECs is both substantive and procedural. Provided that they do not overstep their appropriate moral and professional boundaries, CECs will be shown to have an important and positive function in improving hospital care within the UK and elsewhere. (shrink)

Increasing European co-operation must take place in many areas, including medical ethics. Against the background of common cultural norms and pluralistic variation within political traditions, religion and lifestyles, Europe will have to converge towards unity within the field of medical ethics. This article examines how such convergence might develop with respect to four major areas: European research ethics committees, democratic health systems, the human genome project and rules for stopping futile treatments.

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since (...) most research proposal are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (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)

To incorporate medical ethics into clinical practice, it must first be understood and valued by health care professionals. The recognition of this principle led to an expanding and continuing educational effort by the ethics committee of the Vancouver General Hospital. This paper reviews this venture, including some pitfalls and failures, as well as successes. Although we began with consultants, it quickly became apparent that education in medical ethics must reach all health care professionals—and medical (...) students as well. Our greatest successes came in the formative years of a medical career (ie, in medical school and residency training programmes), but other efforts were not wasted, particularly among nurses and other health care professionals.Although this is a personal review of the experience in one institution, the lessons learnt in Vancouver are applicable to the further development of medical ethics in the UK. (shrink)

IOS Prexs, 2002 Introduction This book is the final project report of the BIOMED II project Ethical Function in Hospital Ethics Committees Commission,-2001 ...

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)

The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great (...) strides have been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research. (shrink)