case study ethics committee

Annual Review of Ethics Case Studies

What are research ethics cases.

For additional information, please visit Resources for Research Ethics Education

Research Ethics Cases are a tool for discussing scientific integrity. Cases are designed to confront the readers with a specific problem that does not lend itself to easy answers. By providing a focus for discussion, cases help staff involved in research to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for dealing with hard problems on their own.

Research Ethics Cases for Use by the NIH Community

• Theme 24 – Using AI in Research and Ethical Conduct of Clinical Trials (2024)
• Theme 23 – Authorship, Collaborations, and Mentoring (2023)
• Theme 22 – Use of Human Biospecimens and Informed Consent (2022)
• Theme 21 – Science Under Pressure (2021)
• Theme 20 – Data, Project and Lab Management, and Communication (2020)
• Theme 19 – Civility, Harassment and Inappropriate Conduct (2019)
• Theme 18 – Implicit and Explicit Biases in the Research Setting (2018)
• Theme 17 – Socially Responsible Science (2017)
• Theme 16 – Research Reproducibility (2016)
• Theme 15 – Authorship and Collaborative Science (2015)
• Theme 14 – Differentiating Between Honest Discourse and Research Misconduct and Introduction to Enhancing Reproducibility (2014)
• Theme 13 – Data Management, Whistleblowers, and Nepotism (2013)
• Theme 12 – Mentoring (2012)
• Theme 11 – Authorship (2011)
• Theme 10 – Science and Social Responsibility, continued (2010)
• Theme 9 – Science and Social Responsibility - Dual Use Research (2009)
• Theme 8 – Borrowing - Is It Plagiarism? (2008)
• Theme 7 – Data Management and Scientific Misconduct (2007)
• Theme 6 – Ethical Ambiguities (2006)
• Theme 5 – Data Management (2005)
• Theme 4 – Collaborative Science (2004)
• Theme 3 – Mentoring (2003)
• Theme 2 – Authorship (2002)
• Theme 1 – Scientific Misconduct (2001)

For Facilitators Leading Case Discussion

For the sake of time and clarity of purpose, it is essential that one individual have responsibility for leading the group discussion. As a minimum, this responsibility should include:

• Reading the case aloud.
• Defining, and re-defining as needed, the questions to be answered.
• Encouraging discussion that is “on topic”.
• Discouraging discussion that is “off topic”.
• Keeping the pace of discussion appropriate to the time available.
• Eliciting contributions from all members of the discussion group.
• Summarizing both majority and minority opinions at the end of the discussion.

How Should Cases be Analyzed?

Many of the skills necessary to analyze case studies can become tools for responding to real world problems. Cases, like the real world, contain uncertainties and ambiguities. Readers are encouraged to identify key issues, make assumptions as needed, and articulate options for resolution. In addition to the specific questions accompanying each case, readers should consider the following questions:

• Who are the affected parties (individuals, institutions, a field, society) in this situation?
• What interest(s) (material, financial, ethical, other) does each party have in the situation? Which interests are in conflict?
• Were the actions taken by each of the affected parties acceptable (ethical, legal, moral, or common sense)? If not, are there circumstances under which those actions would have been acceptable? Who should impose what sanction(s)?
• What other courses of action are open to each of the affected parties? What is the likely outcome of each course of action?
• For each party involved, what course of action would you take, and why?
• What actions could have been taken to avoid the conflict?

Is There a Right Answer?

Acceptable solutions.

Most problems will have several acceptable solutions or answers, but it will not always be the case that a perfect solution can be found. At times, even the best solution will still have some unsatisfactory consequences.

Unacceptable Solutions

While more than one acceptable solution may be possible, not all solutions are acceptable. For example, obvious violations of specific rules and regulations or of generally accepted standards of conduct would typically be unacceptable. However, it is also plausible that blind adherence to accepted rules or standards would sometimes be an unacceptable course of action.

Ethical Decision-Making

It should be noted that ethical decision-making is a process rather than a specific correct answer. In this sense, unethical behavior is defined by a failure to engage in the process of ethical decision-making. It is always unacceptable to have made no reasonable attempt to define a consistent and defensible basis for conduct.

This page was last updated on Friday, July 26, 2024

Case report

BMC Medical Ethics welcomes well-described reports of cases that include the following: • Unreported or unusual side effects or adverse interactions involving medications. • Unexpected or unusual presentations of a disease. • New associations or variations in disease processes. • Presentations, diagnoses and/or management of new and emerging diseases. • An unexpected association between diseases or symptoms. • An unexpected event in the course of observing or treating a patient. • Findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

Case reports submitted to BMC Medical Ethics should make a contribution to medical knowledge and must have educational value or highlight the need for a change in clinical practice or diagnostic/prognostic approaches. BMC Medical Ethics will not consider case reports describing preventive or therapeutic interventions, as these generally require stronger evidence. We will not consider reports on topics that have already been well characterised or where other, similar, cases have already been published. 

Authors should describe how the case report is rare or unusual as well as its educational and/or scientific merits in the covering letter that will accompany the submission of the manuscript. Case report submissions will be assessed by the Editors and will be sent for peer review if considered appropriate for the journal.

Case reports should include relevant positive and negative findings from history, examination and investigation, and can include clinical photographs, provided these are accompanied by a statement that written consent to publish was obtained from the patient(s). Case reports should include an up-to-date review of all previous cases in the field. Authors should follow the CARE guidelines and the CARE checklist should be provided as an additional file.

Authors should seek written and signed consent to publish the information from the patient(s) or their guardian(s) prior to submission. The submitted manuscript must include a statement that this consent was obtained in the consent to publish section as detailed in our editorial policies .

Professionally produced Visual Abstracts BMC Medical Ethics will consider visual abstracts. As an author submitting to the journal, you may wish to make use of services provided at Springer Nature for high quality and affordable visual abstracts where you are entitled to a 20% discount. Click here to find out more about the service, and your discount will be automatically be applied when using this link.

Preparing your manuscript

The information below details the section headings that you should include in your manuscript and what information should be within each section.

Please note that your manuscript must include a 'Declarations' section including all of the subheadings (please see below for more information).

Title page 

The title page should:

• "A versus B in the treatment of C: a randomized controlled trial", "X is a risk factor for Y: a case control study", "What is the impact of factor X on subject Y: A systematic review, A case report etc."
• or, for non-clinical or non-research studies: a description of what the article reports
• if a collaboration group should be listed as an author, please list the Group name as an author. If you would like the names of the individual members of the Group to be searchable through their individual PubMed records, please include this information in the “Acknowledgements” section in accordance with the instructions below
• Large Language Models (LLMs), such as ChatGPT , do not currently satisfy our authorship criteria . Notably an attribution of authorship carries with it accountability for the work, which cannot be effectively applied to LLMs. Use of an LLM should be properly documented in the Methods section (and if a Methods section is not available, in a suitable alternative part) of the manuscript
•  indicate the corresponding author

The Abstract should not exceed 350 words. Please minimize the use of abbreviations and do not cite references in the abstract. The abstract must include the following separate sections:

• Background: why the case should be reported and its novelty
• Case presentation: a brief description of the patient’s clinical and demographic details, the diagnosis, any interventions and the outcomes
• Conclusions: a brief summary of the clinical impact or potential implications of the case report

Keywords 

Three to ten keywords representing the main content of the article.

The Background section should explain the background to the case report or study, its aims, a summary of the existing literature.

Case presentation

This section should include a description of the patient’s relevant demographic details, medical history, symptoms and signs, treatment or intervention, outcomes and any other significant details.

Discussion and Conclusions

This should discuss the relevant existing literature and should state clearly the main conclusions, including an explanation of their relevance or importance to the field.

List of abbreviations

If abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations should be provided.

Declarations

All manuscripts must contain the following sections under the heading 'Declarations':

Ethics approval and consent to participate

Consent for publication, availability of data and materials, competing interests, authors' contributions, acknowledgements.

• Authors' information (optional)

Please see below for details on the information to be included in these sections.

If any of the sections are not relevant to your manuscript, please include the heading and write 'Not applicable' for that section. 

Manuscripts reporting studies involving human participants, human data or human tissue must:

• include a statement on ethics approval and consent (even where the need for approval was waived)
• include the name of the ethics committee that approved the study and the committee’s reference number if appropriate

Studies involving animals must include a statement on ethics approval and for experimental studies involving client-owned animals, authors must also include a statement on informed consent from the client or owner.

See our editorial policies for more information.

If your manuscript does not report on or involve the use of any animal or human data or tissue, please state “Not applicable” in this section.

If your manuscript contains any individual person’s data in any form (including any individual details, images or videos), consent for publication must be obtained from that person, or in the case of children, their parent or legal guardian. All presentations of case reports must have consent for publication.

You can use your institutional consent form or our consent form if you prefer. You should not send the form to us on submission, but we may request to see a copy at any stage (including after publication).

See our editorial policies for more information on consent for publication.

If your manuscript does not contain data from any individual person, please state “Not applicable” in this section.

All manuscripts must include an ‘Availability of data and materials’ statement. Data availability statements should include information on where data supporting the results reported in the article can be found including, where applicable, hyperlinks to publicly archived datasets analysed or generated during the study. By data we mean the minimal dataset that would be necessary to interpret, replicate and build upon the findings reported in the article. We recognise it is not always possible to share research data publicly, for instance when individual privacy could be compromised, and in such instances data availability should still be stated in the manuscript along with any conditions for access.

Authors are also encouraged to preserve search strings on searchRxiv https://searchrxiv.org/ , an archive to support researchers to report, store and share their searches consistently and to enable them to review and re-use existing searches. searchRxiv enables researchers to obtain a digital object identifier (DOI) for their search, allowing it to be cited. 

Data availability statements can take one of the following forms (or a combination of more than one if required for multiple datasets):

• The datasets generated and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]
• The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
• All data generated or analysed during this study are included in this published article [and its supplementary information files].
• The datasets generated and/or analysed during the current study are not publicly available due [REASON WHY DATA ARE NOT PUBLIC] but are available from the corresponding author on reasonable request.
• Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.
• The data that support the findings of this study are available from [third party name] but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the authors upon reasonable request and with permission of [third party name].
• Not applicable. If your manuscript does not contain any data, please state 'Not applicable' in this section.

More examples of template data availability statements, which include examples of openly available and restricted access datasets, are available here .

BioMed Central strongly encourages the citation of any publicly available data on which the conclusions of the paper rely in the manuscript. Data citations should include a persistent identifier (such as a DOI) and should ideally be included in the reference list. Citations of datasets, when they appear in the reference list, should include the minimum information recommended by DataCite and follow journal style. Dataset identifiers including DOIs should be expressed as full URLs. For example:

Hao Z, AghaKouchak A, Nakhjiri N, Farahmand A. Global integrated drought monitoring and prediction system (GIDMaPS) data sets. figshare. 2014. http://dx.doi.org/10.6084/m9.figshare.853801

With the corresponding text in the Availability of data and materials statement:

The datasets generated during and/or analysed during the current study are available in the [NAME] repository, [PERSISTENT WEB LINK TO DATASETS]. [Reference number]  

If you wish to co-submit a data note describing your data to be published in BMC Research Notes , you can do so by visiting our submission portal . Data notes support open data and help authors to comply with funder policies on data sharing. Co-published data notes will be linked to the research article the data support ( example ).

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See our editorial policies for a full explanation of competing interests. If you are unsure whether you or any of your co-authors have a competing interest please contact the editorial office.

Please use the authors initials to refer to each authors' competing interests in this section.

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All sources of funding for the research reported should be declared. If the funder has a specific role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript, this should be declared.

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You may choose to use this section to include any relevant information about the author(s) that may aid the reader's interpretation of the article, and understand the standpoint of the author(s). This may include details about the authors' qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

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Smith JJ. The world of science. Am J Sci. 1999;36:234-5.

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Saito Y, Hyuga H. Rate equation approaches to amplification of enantiomeric excess and chiral symmetry breaking. Top Curr Chem. 2007. doi:10.1007/128_2006_108.

Complete book, authored

Blenkinsopp A, Paxton P. Symptoms in the pharmacy: a guide to the management of common illness. 3rd ed. Oxford: Blackwell Science; 1998.

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Doe J. Title of subordinate document. In: The dictionary of substances and their effects. Royal Society of Chemistry. 1999. http://www.rsc.org/dose/title of subordinate document. Accessed 15 Jan 1999.

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Zheng L-Y, Guo X-S, He B, Sun L-J, Peng Y, Dong S-S, et al. Genome data from sweet and grain sorghum (Sorghum bicolor). GigaScience Database. 2011. http://dx.doi.org/10.5524/100012 .

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• J Med Ethics Hist Med

Hospital/clinical ethics committees' notion: an overview

Fatemeh hajibabaee.

1 PhD Candidate in Nursing, Faculty of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran;

Soodabeh Joolaee

2 Associate Professor, Center for Nursing Care Research, Iran University of Medical Sciences,Tehran, Iran; Iranian Academy of Medical Sciences, Tehran, Iran;

Mohammad Ali Cheraghi

3 Associate Professor, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran;

Pooneh Salari

4 Associate Professor, Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran, Iran;

Patricia Rodney

5 Associate Professor, School of Nursing, University of British Columbia, Vancouver, Canada.

Hospital ethics committees (HECs) help clinicians deal with the ethical challenges which have been raised during clinical practice. A comprehensive literature review was conducted to provide a historical background of the development of HECs internationally and describe their functions and practical challenges of their day to day work. This is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases. The keyword ethics committee, combined with hospital, clinic, and institution, was used without a time limitation. All original and discussion articles, as well as other scientific documents were included. Of all the articles and theses found using these keywords, only 56 were consistent with the objectives of the study. Based on the review goals, the findings were divided into three main categories; the inception of HECs in the world, the function of HECs, and the challenges of HECs. According to the results, the Americas Region and European Region countries have been the most prominent considering the establishment of HECs. However, the majority of the Eastern Mediterranean Region and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The results highlight the status and functions of HECs in different countries and may be used as a guide by health policymakers and managers who are at the inception of establishing these committees in their hospitals.

Introduction

Owing to the new knowledge obtained from medical studies and the diversity of not only lifestyles, but also moral and religious values in modern societies, medical involvement and decision-making processes associated with healthcare are becoming more and more complicated. Moreover, noticeable economic pressure is being experienced by healthcare systems throughout the world, as awareness of ethical implications in medicine has been raised through public political and medico-legal discussions about patient independence, euthanasia and assisted dying ( 1 ). Csikai has noted that as complicated ethical issues have drawn widespread public attention and fulfilled the need to have protected patients' rights in the health care setting, the need for formal ethics committees has been recognized by most institutions ( 2 ). Much significance has been acquired by ethics committees in the hospital setting due to the developments in medical technology ( 2 ) around the late 20 th century. Over the past 30 years, having hospital ethics committees (HECs) has been encouraged or assigned to hospitals in many countries ( 3 ), whereas such committees have not been extensively present in the healthcare settings of developing countries ( 4 ).

Support has been provided to clinicians by HECs when they have met ethical challenges in their clinical practice ( 5 , 6 ). These committees have made much progress in regards to doctors, nurses, and other health experts becoming acutely aware of the ethical decisions they have to make ( 4 ). A healthcare ethics committee or hospital ethics committee is characterized as a body of persons established by a hospital or health care institution and assigned to consider, debate, study, take action on, or report on ethical issues that arise in patient care ( 7 ). Over time, HECs have moved toward democratic processes of discussion by which ethical processes are advocated with the consideration of the benefit of patients, their families, and health care team members ( 6 ).

HECs have made considerable progress in many countries since the 1980s ( 8 ) and are now well established in many countries ( 9 , 10 ).

An ethics committee consult is periodically called by nurses, to help patients and to get assistance in solving ethical dilemma. Preparation before asking for an ethics consultation is critically taken into account ( 5 ).

Ethical issues must be taken into consideration even more in nursing ( 11 ) and nurses should be educated on ethical issues through ongoing education programs, in-service programs, patient care conferences, and academic courses ( 12 ). Moreover, those who serve on an ethics committee have a personally and professionally rewarding experience due to the service provided for staff, patients, and families ( 5 ). The title “hospital ethics committee” can be utilized interchangeably with “patient care advisory committee”, "healthcare ethics committee", "clinical ethics committee", "institutional ethics committee", and "hospital clinical ethics committee" ( 3 , 7 ). HECs are responsible for providing ethics consultations. They also evaluate the results of consultations when the consultant is an individual ethicist instead of a board of ethicists ( 13 ). Most published literature has reported policy review, education, and consultation as the leading roles of these committees ( 14 ). More and more, organizational ethical issues, such as the allocation of resources, are being addressed by the HECs ( 6 ).

Ethics committees consist of members from many various disciplines in the health care setting. A holistic examination of a patient’s or their family’s situation that might involve a complicated ethical dilemma is possible through an interdisciplinary view of the issue ( 2 ). The various perspectives of nurses, chaplains, physicians, social workers, lawyers, and others brings variety to the debate and serves the patient in the best way possible ( 7 ). Committee members should be diverse in terms of their culture and skills, experiences, and knowledge. Variety inspires debates to obtain new information and consider alternative ideas ( 15 ), which is regarded as a prerequisite to culturally safe and ethically sound discussions ( 6 ). In order to prevent parochialism, a number of health professional members should be recruited from outside the institution ( 4 ). The committee members "should be inclined to learn about clinical ethics, receptive to various ideas and viewpoints, able to deal with emotionally charged topics and interpersonal disagreements, and capable of tolerating vagueness” ( 16 ). In general, the success of any HEC is dependent on the commitment and devotion of its members. As a matter of fact, there is increasing attention to the competencies needed for individuals engaged in ethics committees, especially ethics consultants ( 17 ).

Numerous studies have applied different methods to examine the performance and various dimensions of HECs in different countries in recent years, and have revealed similarities and differences. HECs still do not exist or have not been appropriately established in some developing countries, and few studies have been performed in this regard in these countries. Thus, it appears necessary to conduct studies that can provide guidelines for the establishment and operation of HECs through presenting an integrated comprehensive image of the process of development and performance of such committees.

The three main goals of this review included to describe the history and development of HECs in the world [countries classified according to World Health Organization (WHO) Regional Offices], explain the function of HECs, and to discuss the challenges of their practice.

Initially, world literature was reviewed, and then, analyzed and compared to formulate an appropriate guideline to establish committees with favorable structure and performance in countries where the establishment of ethics committees in hospitals has been newly planned. Consequently, this is the first part of a comprehensive literature review conducted between February 2014 and August 2016 by searching through scientific databases such as PubMed, Ovid, Scopus, Web of Science, and Google Scholar. The keyword ethics committee was used in combination with hospital, clinic, and institution. All original and discussion articles, as well as other scientific documents were included without a time limitation.

In the present study, countries with published studies on the history and procedures related to HECs development in English were included. The countries were classified according to WHO Regional Offices. This study was derived from the first author’s PhD thesis performed in Iran where HECs have lately been developed.

Among all the articles and theses which were found with these keywords, only 56 were consistent with the objectives of this study. There were 5 theses, 18 quantitative studies, 3 qualitative studies, 21 discussion articles, 5 editorials, 1 commentary, 2 comparative studies, and 1 review study. Based on the ‎review goals, the findings were divided into three main categories; the history and development of HECs in the world, the function of HECs, and the challenges of HECs.

History and development of hospital ethics committees

Of the documented literatures published on the history of HECs in different countries, 22 belong to western countries and began around 1985 ( 5 , 7 , 9 , 13 , 14 , 18 - 33 ). The history and process of the development of HECs in western countries are provided in this section based on the year the committees were established.

The United States

Review committees were formed in the US following requests for the approval of all decisions about abortion in the 1960s ( 20 ). Due to the limited number of dialysis machines in the 1970s, a number of committees were developed to determine patients’ priority in access to hemodialysis ( 20 , 21 ). Since HECs (also known as heath care ethics committees) were developed in the 1980s in the US, most available data on these committees are obtained from the American literature ( 5 , 22 ). While only 1% of hospitals in the US had HECs in 1983, this rate increased to over 90% by 2001 ( 23 ). In 1984, the development of these committees was endorsed by the American Medical Association and the American Hospital Association. Their tasks were considered to be encompassing several areas and guiding hospital policy, but the key and most groundbreaking goal was to make recommendations in individual cases ( 34 ). There has been dynamic discussion over how valuable these committees truly are ( 35 ). Today, HECs are the primary mechanisms for managing ethical issues in clinical care in the USA ( 36 , 37 ).

Limited HECs existed in Canada before the 1980s ( 13 , 18 ). In 1986, the Guide to Accreditation of Health Care Facilities indicated the need for multidisciplinary ethics committees for the resolution of biomedical issues ( 38 ). Two national surveys of Canadian HECs in 1984 and 1989 reported that, respectively, 18% and 58% of the hospitals in the country had a HEC ( 18 , 39 ). Today, however, the exact conditions of HECs in Canada are not known ( 13 ). Moreover, a study in 2010 found that 85% of the surveyed Canadian hospitals had HECs ( 13 ).

European Region

Netherlands

In the Netherlands, HECs were established in the early 1970s. For almost 20 years, however, they were mostly mixed committees. They started as bottom-up enterprises and have maintained their nature ever since ( 24 ). It has also been reported that ethics advice on clinical issues can be provided by HECs in the Netherlands ( 40 ).

The growth of bioethics and ethics committees in France differs greatly from that in other countries ( 25 ). Two major movements in France led to the formation of ethics committees in the 1980s. The first was a political movement which resulted in the development of a permanent national ethics committee called “ Comité Consultatif National d’Ethique ” (CCNE). The second, a professional movement, facilitated the formation of local ethics committees. During 1983-93, the CCNE focused on three major topics including medically assisted procreation and the embryo, research on human beings, and genetics ( 25 ).

United Kingdom

Among the European countries, United Kingdom was one of the pioneers in this regard. A number of local reasons, including institutional response to particular problematic cases and clinicians’ concern about the ethical aspects of clinical practice, were involved in the development of the first clinical ethics committees in the UK ( 22 ). One of the first HECs was created at what is now called Barts and The London NHS Trust, incorporating the formerly independent St. Bartholomew's and The Royal London Hospitals, The London Chest Hospital, and the Queen Elizabeth Hospital for Children. This HEC, which began its work in 1995, is now an integral feature of professional life within the trust and is a sub-committee of the trust's Clinical Governance Committee, working closely with the Medical Director. The terms of reference of the HEC emphasize two important dimensions ( 41 ). First, the committee acts proactively in the development of coherent and practical ethico-legal policies and provision of recommendations for the traditional issues commonly faced in clinical settings and mentioned in the literature related to medical ethics and law. The HECs’ second function is reactive and involves the provision of relevant advices on particular ethico-legal issues discussed by clinical colleagues ( 42 ).

In Slovakia, in June 1992, the ‘‘Guidelines on Establishment and Work of Ethics Committees in Health Care Facilities and Biomedical Research Institutions’’ ( 43 ) were elaborated by the Central Ethics Committee, and published in the form of the Ministry of Health's recommendations. The guidelines provided detailed directions regarding the formation and responsibilities of local ethics committees ( 24 ).

A law passed in 1994 obliged all general and psychiatric hospitals in Belgium to develop a local ethics committee to handle the responsibilities of both Research Ethics Committees (RECs) and HECs. This seems to be the origin of ethics committees in charge of both research and clinical ethics ( 26 ). In 2000, however, the Belgian Court of Arbitration excluded ethics consultation from the HEC-related tasks. Since the Belgian HECs are controlled on a national scale, all hospitals have their own ethics committee responsible for a large number of committee tasks ( 43 ).

In 1996, a group of hospital clinicians, politicians, and health authorities, along with the Norwegian Medical Association launched an initiative in Norway which led to the development of the first HECs in the country. As a result, there is at least one ethics committee at any of the 23 hospital trusts providing 4.9 million Norwegians with specialized and hospital-based healthcare services ( 44 ).

The establishment of a HEC is mandatory in all hospitals registered in the Christian Association of Hospitals in Germany ( 22 ). According to a new study in Germany, the percentage of hospitals with HECs was found to be 86.4% ( 45 ).

Among European countries, Croatia achieved the legal requirements for the establishment of ethics committees around 1997. The 1997 "Law on the Health Protection" obliges all healthcare institutions in Croatia to create an ethics committee. Each committee should have 5 members including 2 individuals who are not involved in the field of medicine ( 28 ). In Croatia, a top-down approach was adopted for the development of ‘‘mixed’’ ethics committees, i.e., a combination of HECs and RECs, in healthcare institutions ( 24 ). Ethics committees were established in almost half (46%) of all healthcare institutions in the country (except drugstores and homecare provision centers) 6 years after the reinforcement of the Law on the Health Protection in Croatia (in 2006). Most of these committees (89%) consist of 3 medical professionals and 2 experts in other fields. Moreover, while 49% of the committees were mainly involved in the analysis of research protocols, a small percentage of them provided standing orders, professional guidelines, or other related documents ( 28 ).

In Lithuania, HECs, called medical ethics commissions, are established based on the Health Care System Law of the Republic of Lithuania and the Model Guidelines for Medical Ethics Commissions (released by the Ministry of Health in 1997). The Health Care System Law of the Republic of Lithuania was passed by the Parliament in the early 1990s and obliged all large healthcare institutions to create a specific HEC. The Lithuanian National Bioethics Committee was then established in response to the need for an organization to manage and support these HECs. The Model Guidelines for Medical Ethics Commissions provided details on the mission, functions, establishment, and composition of HECs ( 24 ).

Although ethics committees exist in university hospitals in Turkey, so far, these committees have had no advantages over pharmaceutical RECs. Due to the need for HECs to resolve the ethical issues faced by not only doctors, but also patients, the senate of Kocaeli University Medical Faculty in Turkey approved the establishment of a HEC on November 13, 2000 ( 46 ). Demir and Buken stated: "In Turkey, The introduction of HECs is relatively recent and the number of committees is limited" ( 10 ).

There were no documents of existing HECs in Polish hospitals until 2007 ( 43 ). We could not find any legal or ethical regulation concerning HECs. Medical ethics committees of medical councils or chambers of physicians and dentists, working at national and regional levels, are the only committees in Poland which handle issues related to medical ethics and have similar functions (but not exactly) to those of HECs. However, they have limited effects on the development of healthcare policies and clinical decision-making. In 1990, the first General Medical Assembly, the highest authority of the Polish Chamber of Physicians and Dentists (PCHPD), recommended the establishment of the Medical Ethics Committee of the Supreme Medical Council ( 43 ). Nevertheless, not many hospitals in Poland currently have HECs and the existing committees usually fail to provide the required structure, services, and workload ( 29 ).

Western Pacific Region

Despite their ongoing development in Australia, HECs and other ethics support services are generally not accessible by all institutions ( 47 ). The Committee at John Hunter has published their experience ( 48 ), but there are not many documents about Australian HECs. In New South Wales and other parts of Australia, public hospitals are supposed to focus on providing clinical ethics support as a priority ( 49 ).

Chinese Medical Association (CMA) set up the HEC as one of its branches in 1988. The Regulation of Hospital Ethical Committees in China was issued at the sixth conference of medical ethics in Chengdu in 1991, and then, revised by the CMA in 1995 ( 50 ). In 2007, the Ministry of Health of China published a review of methods used in biomedical research involving humans. Today, all medical institutions and hospitals in the country have an ethics committee whose main function is to ensure respect for principles of autonomy, beneficence, and justice ( 50 ).

In Japan, 20 (25.6%) medical organizations developed an ethics committee in 1998, and this rate increased to 29 (50.0%) in 2003 ( 50 ). A recent study on 4000 hospitals in Japan reported 51.1% of the surveyed hospitals to have an ethics committee. Moreover, 16.8% of the hospitals were working on developing their HECs ( 51 ).

When faced with ethical dilemmas in university hospitals, residents and physicians in Korea have very limited access to clinical ethicists or active hospital ethics committees to consult with ( 52 ). According to a study in Korea, only 3.4% of the surveyed residents had discussed their ethical issues with an attending faculty member or a hospital ethics committee. The participating residents tended to resolve their ethical conflicts on their own (15.1%) or by asking for advice from their colleagues or senior residents (44.9%) or the hospital’s ethics committee (0.7%) ( 52 ).

New Zealand

A total of 15 Health and Disability Ethics Committees have been established in New Zealand. These committees are currently working based on the national guidelines ( 53 ). These committees are accredited by the Health Research Council Ethics Committee for the ethical review and approval of research ( 4 ).

The Report of the Inquiry into National Women’s Hospital (1988) concluded that the ethical review of research proposals and other issues should be performed by independent ethics committees consisting of 50% lay people (not involved in health professions) and also chaired by a lay person ( 53 ).

Eastern Mediterranean Region

In the previous two decades, there have been remarkable movements in the field of bio-medical ethics in Iran, mainly in the educational, research, and policy-making aspects ( 54 ). The regulations and guidelines for the HECs were established by the Iranian Ministry of Health and Medical Sciences in 2000. Based on a national study for identifying the priorities of medical ethics in Iran, the constitution of HECs was one of 10 priorities ( 55 ); however, HECs are not yet working as strong as other hospital committees. The results of a study conducted in one of the major cities in Iran indicates that HECs are functioning as combined committees (85.7%) entitled ethics committee and religious principles. These committees are chaired by doctors (42.8%), hospital directors (2.5%), hospital managers (14.28%), and nurses (14.2%) in different educational hospitals ( 56 ).

In this review, very few documents were found regarding other countries in the Middle East Region. This might be because of the language limitation, since our search was conducted only in English documents. The review indicated that while HECs in most developed countries are well established and active, in some developing countries, even if they exist, there is a gap in their activating strategies. In some cases they are only a grand name on the list of different hospital committees and do not perform any specific tasks.

Functions of hospital ethics committees

Slowther et al. stated: "The healthcare ethics committees were born out of a grass-root process in American hospitals" ( 57 ). Three domains or functions must be covered by HECs in their ordinary work. First, the HEC needs to educate its members, hospital staff, and also patients about ethical issues. The second function of an HEC is to cooperate in the development and revision of various hospital policies and guidelines to facilitate service provision by hospital personnel. The third function of a HEC is the task of ethical case analysis ( 58 ).

The committees have a variety of responsibilities including the resolution of clinicians’ ethical issues, provision of ethical training to their members (at least one individual) and individuals from other institutions, and cooperation in the formulation of institutional policies related to clinical ethical issues. Although a committee may perform only one of the mentioned tasks, most existing committees are involved in all of them ( 4 ).

The function and constitution of these committees are different from RECs, the purpose of which is considered the ethical review of research on human subjects ( 4 ). One or more of the following three functions may ordinarily be performed by the HECs in the United States ( 59 ): ( 1 ) providing ethical consultations upon the requests from clinicians or sometimes patients and their families. The main goals of an ethics consultation in hospital ethics committees is presented in table 1 ; ( 2 ) Assisting in the formulation of hospital policies and guidelines by presenting the required ethical input; and ( 3 ) training the health personnel of the institution ( 22 ).

The main goals of ethical consultation in hospital ethics committees ( 9 )

In Norway, individual patient cases are normally debated in the HEC, not with ethics consultant teams or individual consultants, as is often the case in many other countries ( 27 ). The procedures for case discussions suggested in the HEC manual are defining the ethical problem(s), describing all facts, identifying the values and pertinent laws at risk, identifying and discussing probable solutions of the case, conclusion, and follow-up and evaluation. The manual puts more emphasis on the patient’s situation, values, and interests which are to be given a central place in the committee’s work ( 30 ). A study in Norway indicated that between 1 and 8 seminars for hospital employees during the last 2 years with, altogether, 4,400 participants had been arranged by 30 of the 31 HECs. To elaborate on the ethical guidelines, 26 of the HECs had become involved. The topics of the guidelines were end-of-life issues (including not attempting resuscitation and caring for the relatives), patient autonomy issues/involuntary treatment, prioritization issues, confidentiality, communication with patients on Facebook and cultural issues/language problems ( 30 ).

In Croatia, the implementation of ethical principles of the medical profession, approval of research activities (protocols) within the healthcare institution, supervision of drug and medical device trails, supervision of organ procurement from deceased persons, and resolution of other ethical issues in the health institution are undertaken by the ethics committees ( 28 ). Table 2 shows the suggested functions for hospital ethics committees.

Suggested functions for hospital ethics committees ( 60 )

The challenges of hospital ethics committees

Challenges of HECs can be divided into three main categories based on the reviewed literature.

Clarifying and maintaining their position inside the institution

Although HECs may have a multiplicity of goals and functions, one of the challenges that all HECs share is clarifying and maintaining their position inside their respective institution. HECs in Europe have to protect the interests of both individuals and the organization while maintaining a critical independence ( 8 ).

Convincing professionals of the necessity of engaging patients and their families in the decision making process

Persuading health professionals of the significance of engaging patients and their families in medical decision-making is also a challenge. In fact, when a discussion about the hospitals’ "do not resuscitate policy" was started, some committee members and other clinicians involved in the initial development of the policy disagreed with the disclosure of information and the engagement of patients and their families in "do not resuscitate" decisions. Finally, the committee agreed on a policy that ensured the patients’ right to be involved in making such decisions, unless exceptional conditions were present. Recent media publicity has supported the committee's point of view ( 31 ).

Educational challenges

In the educational setting, a major challenge was to convince the staff, especially the junior medical staff, of the equal significance of ethical issues and clinical teaching. In fact, medical students are more focused on acquiring factual clinical knowledge than on discussing the ethical issues they face ( 31 ).

According to a recent national survey in the US, 81% of the 519 surveyed hospitals and 100% of hospitals with over 400 beds provided ethics consultation services. Despite these noticeable rates, there is still ongoing debate about educating bioethicists, the objectives of ethics consultation, methods of evaluating consultation outcomes, and the best approach toward ethics consultation ( 9 ).

Developing more objective methods for the evaluation of effectiveness and providing the required ethical education for the members of such committees can be considered as the future challenges in this field. The relationships between these committees and the national structure and guidelines for ethics committees in some countries, such as New Zealand, need further attention. In fact, particular requirements for ethical approval of research projects may not be relevant when individual clinical situations are concerned ( 4 ).

A multiplicity of concerns has been raised about HECs. HECs can damage the doctor-patient relationship which is a delicate and vital component of health care, decrease doctors’ professional autonomy, and gradually undermine their responsibility and authority to act in the best interest of their patients ( 61 ).

They may either limit the patients’ freedom of choice or neglect (rather than protect) their interests by attracting attention to various competing interests, e.g., the interests of the hospital and its personnel.

By adding an extra layer to the overburdened administrative bureaucracy of hospitals, HECs may decrease the already insufficient time available for clinical care. They may also raise unnecessary moral and even political disputes ( 32 ). Finally, in an attempt to protect themselves, HECs may act (e.g., perform analyses and provide recommendations) with extreme caution ( 33 ).

Conclusions

According to the results, the Americas Region and European Region countries such as United States, Canada, and Netherlands have been the most prominent considering the establishment of HECs. Nevertheless, the majority of Eastern Mediterranean Region countries and South-East Asia Region countries are only beginning to establish these committees in their hospitals. The major functions of HECs were ethics consultation, education about ethical issues, and policy-making. Based on the reviewed literature, challenges of the HECs can be divided into the 3 main categories of elucidating and establishing their position within the institution, persuading professionals of the importance of participating patients and families in decision-making, and challenges related to providing education.

The authors of this study tried to present an integrated image of the development of HECs and their performance and challenges around the world. Since the inception of these committees was in Western countries, the findings of this study may be used as a guide by health policymakers and managers who are only beginning to establish these committees in their hospitals. Moreover, health service providers in countries, where there is still no report about activities of HECs or these committees do not act efficiently, do not have any information about the performance of such committees. Therefore, the results of this study help health service providers become familiar with the status of these committees in different countries and their main functions.

There is a need for further research addressing the real gaps and some of the institutional challenges of HECs and evaluating the functions of HECs.