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Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.
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Transplante de Coração , Transplante de Pulmão , Transplante Heterólogo , Transplante Heterólogo/ética , Humanos , Transplante de Pulmão/ética , Animais , Estados Unidos , Transplante de Coração/ética , National Heart, Lung, and Blood Institute (U.S.) , Pesquisa Biomédica/ética , Doadores de Tecidos/provisão & distribuição , Doadores de Tecidos/éticaRESUMO
BACKGROUND: To enhance the development of a curriculum in professionalism for medical students, the aim of this research was to evaluate medical students' responses regarding professionalism teaching and behaviors in their clinical experience at the Arabian Gulf University (AGU). METHODS: A retrospective cross-sectional, questionnaire-based study involving Year 5 medical students at the AGU. We used a "climate of professionalism" survey that consisted of two parts. The first part asked students to rate their perceptions of the frequency of professionalism practices of their peers (medical students), residents, and faculty. The response choices included: "mostly", "sometimes", and "rarely". The second part asked the students to assess their perceptions of the professionalism teaching and behaviors of the faculty. The response choices included: "mostly", "sometimes", and "rarely". We calculated an overall score for the responses in both parts of the questionnaire by assigning 3, 2, and 1 points to the response choices, respectively. We also calculated subscale scores reflecting different professionalism constructs. We used descriptive statistics and a one-way Analysis of Variance (ANOVA) followed by multiple testing comparisons with Bonferroni correction to examine pairwise comparisons. A p < 0.05 was considered statistically significant. RESULTS: The mean total scores of participants' ratings of professional behaviors of medical students, residents, and faculty for each academic year were approximately 60% of the total maximum score. The mean total scores of participants' rating of faculty's teaching and modeling behaviors concerning professionalism were approximately 58% of the maximum score. Compared with similar studies performed in the Arab Region, ratings regarding professional teaching and modeling of professionalism were lower. CONCLUSION: We recommend the further evaluation of professionalism teaching and behaviors at the AGU and further discussions regarding curriculum reform.
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Educação de Graduação em Medicina , Estudantes de Medicina , Estudos Transversais , Humanos , Percepção , Profissionalismo , Estudos Retrospectivos , UniversidadesRESUMO
BACKGROUND: Moral distress occurs when constraints prevent healthcare providers from acting in accordance with their core moral values to provide good patient care. The experience of moral distress in nurses might be magnified during the current Covid-19 pandemic. OBJECTIVE: To explore causes of moral distress in nurses caring for Covid-19 patients and identify strategies to enhance their moral resiliency. RESEARCH DESIGN: A qualitative study using a qualitative content analysis of focus group discussions and in-depth interviews. We purposively sampled 31 nurses caring for Covid-19 patients in the acute care units within large academic medical systems in Maryland and New York City during April to June 2020. ETHICAL CONSIDERATIONS: We obtained approval from the Institutional Review Board at the University of Maryland, Baltimore. RESULTS: We identified themes and sub-themes representative of major causes of moral distress in nurses caring Covid-19 patients. These included (a) lack of knowledge and uncertainty regarding how to treat a new illness; (b) being overwhelmed by the depth and breadth of the Covid-19 illness; (c) fear of exposure to the virus leading to suboptimal care; (d) adopting a team model of nursing care that caused intra-professional tensions and miscommunications; (e) policies to reduce viral transmission (visitation policy and PPE policy) that prevented nurses to assume their caring role; (f) practicing within crisis standards of care; and (g) dealing with medical resource scarcity. Participants discussed their coping mechanisms and suggested future strategies. DISCUSSION/CONCLUSION: Our study affirms new causes of moral distress related to the Covid-19 pandemic. Institutions need to develop a supportive ethical climate that can restore nurses' moral resiliency. Such a climate should include non-hierarchical interdisciplinary spaces where all providers can meet together as moral peers to discuss their experiences.
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COVID-19 , Humanos , Princípios Morais , Pandemias , Pesquisa Qualitativa , SARS-CoV-2RESUMO
Even though the interventions were adapted from standard clinical practice, the way they were provided meant that the care given infants in the study was distinctly different from standard care, with different risk profiles. Parents should have been informed about those differences.
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Lesões Encefálicas/prevenção & controle , Pesquisa Comparativa da Efetividade/ética , Recém-Nascido Prematuro , Terapia Intensiva Neonatal/ética , Oximetria , Oxigênio/sangue , Consentimento dos Pais/ética , Respiração com Pressão Positiva , Projetos de Pesquisa , Retinopatia da Prematuridade/prevenção & controle , Risco Ajustado , Padrão de Cuidado , Revelação da Verdade/ética , Encéfalo/metabolismo , Lesões Encefálicas/etiologia , Lesões Encefálicas/metabolismo , Pesquisa Comparativa da Efetividade/métodos , Pesquisa Comparativa da Efetividade/normas , Pesquisa Comparativa da Efetividade/tendências , Comitês de Ética em Pesquisa , Humanos , Recém-Nascido , Recém-Nascido Prematuro/sangue , Terapia Intensiva Neonatal/métodos , Terapia Intensiva Neonatal/normas , Intubação Intratraqueal , National Institutes of Health (U.S.) , Oximetria/ética , Oximetria/instrumentação , Oximetria/métodos , Oxigênio/metabolismo , Respiração com Pressão Positiva/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Projetos de Pesquisa/normas , Retinopatia da Prematuridade/etiologia , Risco Ajustado/ética , Padrão de Cuidado/ética , Tensoativos/administração & dosagem , Resultado do Tratamento , Estados UnidosRESUMO
Problem: Investigations regarding perceptions of the institutional research integrity climate in the Arab Middle East remain underexplored. Subjects: We surveyed faculty from three Egyptian universities. Method: We utilized the Survey of Organizational Research Climate (SOuRCe) tool, which incorporates seven subscales that measure different aspects of the research integrity climate. Responses were obtained from a 5-point Likert scale. Findings: Of the 228 participants, the subscales 'Regulatory Quality' and '[Lack of] Integrity Inhibitors' received the highest mean scores, whereas the lowest scores pertained to 'Departmental Expectations,' 'Integrity Socialization,' and 'Responsible Conduct of Research´ indicating areas in need of improvement. Conclusions: Academic leaders should set fairer expectations for research and funding for their researchers, ensure junior researchers are socialized into research integrity practices, and promote effective RCR training and availability of RCR policies. We identify specific targeted interventions to enhance the research integrity climate within these institutions.
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BACKGROUND: Studies have shown that medical students and residents believe that their ethics preparation has been inadequate for handling ethical conflicts. The objective of this study was to determine the self-perceived comfort level of medical students and residents in confronting clinical ethics issues. METHODS: Clinical medical students and residents at the University of Maryland School of Medicine completed a web-based survey between September 2009 and February 2010. The survey consisted of a demographic section, questions regarding the respondents' sense of comfort in handling a variety of clinical ethics issues, and a set of knowledge-type questions in ethics. RESULTS: Survey respondents included 129 medical students (response rate of 40.7%) and 207 residents (response rate of 52.7%). There were only a few clinical ethics issues with which more than 70% of the respondents felt comfortable in addressing. Only a slight majority (60.8%) felt prepared, in general, to handle clinical situations involving ethics issues, and only 44.1% and 53.2% agreed that medical school and residency training, respectively, helped prepare them to handle such issues. Prior ethics training was not associated with these responses, but there was an association between the level of training (medical students vs residents) and the comfort level with many of the clinical ethics issues. CONCLUSIONS: Medical educators should include ethics educational methods within the context of real-time exposure to medical ethics dilemmas experienced by physicians-in-training.
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Temas Bioéticos , Ética Médica , Internato e Residência/estatística & dados numéricos , Percepção Social , Estudantes de Medicina/estatística & dados numéricos , Adulto , Fatores de Confusão Epidemiológicos , Estudos Transversais , Currículo/normas , Feminino , Humanos , Internato e Residência/ética , Internato e Residência/métodos , Internato e Residência/normas , Masculino , Maryland , Relações Médico-Paciente/ética , Estudantes de Medicina/psicologia , Inquéritos e QuestionáriosRESUMO
Lately, there has been increased research performed in Egypt. In response, the Egyptian Parliament published its first clinical research law in December 2020. The official version of the law was translated to English from Arabic and back by an accredited translation service. We performed an ethical analysis of the law based on the seven ethical requirements for clinical research proposed by Emanuel et al. and compared it with other regulations in the Arab region. The law contains provisions that fulfill all requirements for ethical research to varying degree. Provisions necessitating the sharing of participants' data and biospecimens by the Central Intelligence Agency requires further specifications to ensure privacy protection. Also, the law poses problematic liabilities that could hamper medical research. Egypt's law compares favorably with other laws in the region. Potential items that require further specification can be addressed in the executive regulations currently being drafted for the law.
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Pesquisa Biomédica , Análise Ética , Egito , Humanos , PrivacidadeRESUMO
BACKGROUND: Several studies reveal a problematic prevalence of research misbehaviors. There are several potential causes of research misconduct but ensuring that scientists hold attitudes that reflect norms of acceptable behaviors is fundamental. AIM: Our aim was to evaluate the psychometric properties (factor structure and reliability) of an "attitude" scale that we adopted from a questionnaire we previously used to investigate the prevalence of research misbehaviors in the Middle East. METHODS: We used data from participants (n = 254) who were involved in our prior questionnaire study to determine the validity of an attitude scale that we adapted from this previous study. We performed exploratory factor analysis (EFA) to determine the factor structure of the attitude scale followed by measures of convergent and concurrent validity. We assessed reliability by computing the Cronbach's alphas of each construct of the attitude scale. RESULTS: EFA indicated that the attitude scale consists of two factors (constructs). Convergent validity was demonstrated by significant correlations of item-item and item-total. Correlation analysis revealed that the attitude constructs were significantly correlated with the Research Misbehavior Severity Score, thereby demonstrating concurrent validity. Cronbach's alphas were greater than 0.75 for both constructs. CONCLUSION: We demonstrated a valid and reliable 20-item attitude scale with two factors related to "acceptability of practices in responsible conduct in research" and "general attitudes regarding scientific misconduct". The use of a validated attitude scale can help assess the effectiveness of educational programs that focus on participants acquiring attitudes that are instrumental in responsible conduct in research.
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Atitude , Análise Fatorial , Humanos , Psicometria , Reprodutibilidade dos Testes , Inquéritos e QuestionáriosRESUMO
Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman. The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review. Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms. Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms.
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Confidencialidade , Termos de Consentimento/normas , Pesquisa em Genética/ética , Consentimento Livre e Esclarecido/ética , Garantia da Qualidade dos Cuidados de Saúde , Revelação da Verdade , Confidencialidade/ética , Confidencialidade/normas , Termos de Consentimento/ética , Escolaridade , Ética em Pesquisa , Humanos , Omã , Projetos Piloto , Revelação da Verdade/éticaRESUMO
BACKGROUND: Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs) in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. METHODS: We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. RESULTS: We obtained responses from 67% (12/18) of the identified RECs. Most RECs (10/12) have standard operating procedures and many (7/12) have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members) with little lay representation (13.7%). Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc); none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. CONCLUSION: Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members with prior training in research ethics, and have written policies. Regarding areas for improvements, many RECs should strive for a more diverse membership and should receive more financial resources and administrative support personnel. We recommend that RECs include more individuals from the community and develop a continuing educational program for its members. Institutional officials should be aware of the resource capacity needs of their RECs.
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Comitês de Ética em Pesquisa , Adulto , Estudos Transversais , Egito , Comitês de Ética em Pesquisa/economia , Comitês de Ética em Pesquisa/organização & administração , Comitês de Ética em Pesquisa/normas , Comitês de Ética em Pesquisa/estatística & dados numéricos , Comitês de Ética em Pesquisa/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação das Necessidades , Inquéritos e Questionários , Carga de TrabalhoAssuntos
Lesões Encefálicas/prevenção & controle , Pesquisa Comparativa da Efetividade/ética , Recém-Nascido Prematuro , Terapia Intensiva Neonatal/ética , Oximetria , Oxigênio/sangue , Consentimento dos Pais/ética , Respiração com Pressão Positiva , Projetos de Pesquisa , Retinopatia da Prematuridade/prevenção & controle , Risco Ajustado , Padrão de Cuidado , Revelação da Verdade/ética , HumanosRESUMO
Health research has increased during the last decade, which has enhanced the importance of research ethics. However, little is known regarding the knowledge, awareness, attitudes, and practices of investigators in Myanmar. To assess awareness, knowledge, and attitudes of post-graduates regarding research ethics and research ethics committees (RECs) and their informed consent practices and to determine the association between their responses and certain independent factors. We conducted a cross-sectional study using a questionnaire that was distributed to a convenience sample of post-graduates at the Defence Services Medical Academy in Myanmar. We used descriptive, t test, and chi-square statistics to analyze the data. Significance was set at p < 0.05. We obtained surveys from 204 participants, which included 177 MSc and 27 PhDs of whom 63.6% had performed research and 86.5% had prior ethics training. Regarding awareness, 92.2% were aware of an REC at their academy, but only 47.1% were "fully aware" of the functions of an REC and only 52.9% stated they were familiar with ethical principles that govern human subject research. More than 90% thought that research involving human subjects should be submitted to an REC and that post-graduates should have training on research ethics. However, several of their attitudes were sub-optimal; for example, 20.2% said that informed consent is only necessary from the community leader of a village rather than from the individual, 32.8% agreed it is acceptable to fabricate research data, and 33.0% believed that ethical review of research should be restricted to international collaborative research. Calculated mean total attitude scores were statistically significantly higher in post-graduates with PhDs compared with those with MSc and higher in those with knowledge of research ethics principles compared with those lacking such knowledge. Significant gaps exist among post-graduates regarding their knowledge, awareness, and attitudes regarding research ethics and RECs. We recommend that post-graduates receive further training in research ethics to ensure the ethical conduct of research. Further studies should be performed to determine the generalizability of our findings to other institutions in Myanmar.
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BACKGROUND: Human subject research has increased in Myanmar since 2010 and accordingly, the establishment of research ethics committees (RECs) have increased to review these research studies. However, characteristics that reflect the operations of RECs in Myanmar have not been assessed. OBJECTIVES: To assess the structures and processes of RECs at Medical Institutions in Myanmar. METHODS: We used a self-assessment tool for RECs operating in low and middle-income countries. This tool consists of the following ten domains: organizational aspects, membership and ethics training, submission arrangements and materials, meeting minutes, policies referring to review procedures, review of specific protocol and informed consent items, communication a decision, continuing review, REC resources, and institutional commitment. We distributed this self-administered questionnaire to RECs from 15 Medical Institutions in Myanmar and one representative from each REC completed this questionnaire and returned it anonymously. We used descriptive, bivariate, and multivariate statistics to analyse the data. RESULTS: Out of maximum 200 points, the total mean score for Myanmar Medical Institutions was 112.6 ± 12.77, which is lower compared to the aggregate mean score of 137.4 ± 35.8 obtained from RECs in other countries. Domains in which the average percentage score was less than 60% included organizational commitment, membership and ethics training, continuing review and REC resources. Many RECs have a diverse membership and appropriate gender balance but, lacked essential policies. CONCLUSION: The results show that for Myanmar RECs there is significant room for improvement in their "structures and processes" as well as the extent of institutionl commitment. The self-assessment tool proved to be valuable method to assess the quality of RECs.
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BACKGROUND: Studies have shown that research participants fail to appreciate the difference between research and medical care, labeling such phenomenon as a "therapeutic misconception" (TM). Since research activity involving human participants is increasing in the Middle East, qualitative research investigating aspects of TM is warranted. Our objective was to assess for the existence of therapeutic misconception amongst Egyptians. METHODS: Study Tool: We developed a semi-structured interview guide to elicit the knowledge, attitudes, and perspectives of Egyptians regarding medical research. SETTING: We recruited individuals from the outpatient settings (public and private) at Ain Shams University in Cairo, Egypt. ANALYSIS: Interviews were taped, transcribed, and translated. We analyzed the content of the transcribed text to identify the presence of a TM, defined in one of two ways: TM1 = inaccurate beliefs about how individualized care can be compromised by the procedures in the research and TM2 = inaccurate appraisal of benefit obtained from the research study. RESULTS: Our findings showed that a majority of participants (11/15) expressed inaccurate beliefs regarding the degree with which individualized care will be maintained in the research setting (TM1) and a smaller number of participants (5/15) manifested an unreasonable belief in the likelihood of benefits to be obtained from a research study (TM2). A total of 12 of the 15 participants were judged to have expressed a TM on either one of these bases. CONCLUSION: The presence of TM is not uncommon amongst Egyptian individuals. We recommend further qualitative studies investigating aspects of TM involving a larger sample size distinguished by different types of illnesses and socio-economic variables, as well as those who have and have not participated in clinical research.
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Ensaios Clínicos como Assunto , Compreensão , Conhecimentos, Atitudes e Prática em Saúde , Sujeitos da Pesquisa , Adulto , Idoso , Fatores de Confusão Epidemiológicos , Egito , Feminino , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Pesquisa Qualitativa , Projetos de Pesquisa , Sujeitos da Pesquisa/psicologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. METHODS: We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. RESULTS: We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. CONCLUSION: While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.
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Comissão de Ética , Pesquisa Biomédica/legislação & jurisprudência , Comissão de Ética/economia , Comissão de Ética/organização & administração , Comissão de Ética/estatística & dados numéricos , Guias como Assunto , Humanos , Região do Mediterrâneo , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Medical research must involve the participation of human subjects. Knowledge of patients' perspectives and concerns with their involvement in research would enhance recruitment efforts, improve the informed consent process, and enhance the overall trust between patients and investigators. Several studies have examined the views of patients from Western countries. There is limited empirical research involving the perspectives of individuals from developing countries. The purpose of this study is to examine the attitudes of Egyptian individuals toward medical research. Such information would help clarify the type and extent of concerns regarding research participation of individuals from cultural, economic, and political backgrounds that differ from those in developed countries. METHODS: We conducted semi-structured interviews with 15 Egyptian individuals recruited from the outpatient settings (public and private) at Ain Shams University in Cairo, Egypt. Interviews were taped, transcribed, and translated. Thematic analysis followed. RESULTS: All individuals valued the importance of medical research; however most would not participate in research that involved more than minimal risk. Individuals were comfortable with studies involving surveys and blood sampling, but many viewed drug trials as being too risky. All participants valued the concept of informed consent, as they thought that their permission to be in a research study was paramount. Many participants had discomfort with or difficulty in the understanding several research concepts: randomization, double-blind, and clinical equipoise. Trust in the physicians performing research was important in deciding to participate in clinical research. The small sample size and the selection bias associated with obtaining information from only those who agreed to participate in a research study represent limitations in this study. CONCLUSION: Overall, individuals in our sample recognize the value of medical research and have a great deal of trust regarding medical research and their participation in research. There were, however, concerns with the level of research risks associated with several types of medical research. Many also demonstrated confusion with certain research methodologies. We recommend 1) enhanced educational efforts regarding general research concepts to enhance the validity of informed consent and 2) further survey studies in other areas of Egypt to determine the generalizability of our results.
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Atitude , Pesquisa Biomédica , Compreensão , Consentimento Livre e Esclarecido , Projetos de Pesquisa , Sujeitos da Pesquisa , Assunção de Riscos , Confiança , Adulto , Idoso , Atitude/etnologia , Pesquisa Biomédica/ética , Pesquisa Biomédica/métodos , Fatores de Confusão Epidemiológicos , Características Culturais , Egito , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais/estatística & dados numéricos , Seleção de Pacientes , Projetos Piloto , Pesquisadores , Sujeitos da Pesquisa/psicologia , Tamanho da Amostra , Viés de Seleção , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The past few years have witnessed several controversies regarding the ethics of conducting research involving critically ill patients, and such research is ethically challenging. DISCUSSION: Research ethics is a changing field, one that is influenced by empirical data, contemporary events, and new ideas regarding aspects of clinical trial design and protection of human subjects. We describe recent thoughts regarding several aspects of research ethics in the critical care context. CONCLUSION: The ability of the research community to conduct research ethically and to maintain public trust would benefit from heightened awareness to the principles and requirements that govern such research.