Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction

Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.     

中医药研究的伦理审查与实践

结合中医药研究的临床特点,在分析伦理审查的原则,伦理委员会在国内的发展基础上,重点结合中医药研究方法和在伦理审查中的特点,对如何建立一系列完整的伦理委员会审查管理制度,任命制度,委员继续教育制度,伦理审查程序,研究过程中不良反应的监测制度,文件的保存和归档制度,知情同意签署制度,对药品、临床研究项目等涉及人体的临床试验伦理审查与监督方面等问题进行了探讨,以便最大限度保护受试者利益。     

Deferred consent. A new approach for resuscitation research on comatose patients

Methodological constraints inherent in the rapidly growing field of resuscitation research have created an apparent conflict with newly promulgated federal regulations, especially those concerning informed consent requirements. We propose that two new concepts be applied to resuscitation research to satisfy the current federal regulations governing biomedical research. The first of these concepts is "minimal differential risk," ie, in resuscitation medicine, the difference between the risk of an undesirable outcome when standard, commonly accepted therapy may be used and the risk of an undesirable outcome with experimental therapy is minimal. The second concept is "deferred consent," ie, obtaining consent to continue with an experimental therapy after administration of that therapy has already begun. We believe that the emergency exception to informed consent applies to resuscitation research. Recognition of the applicability of these concepts to resuscitation research should allow compliance with federal and state regulations that otherwise might inhibit or preclude such research endeavors.     

生物医学科研伦理可持续发展之研究

我国生物医学科研伦理的发展经历了不到10年的时间,作者简要归纳了我国目前伦理委员会的工作存在的综合问题,其中主要为:知情同意不充分、目前的审查相对宽松、伦理委员会自身科研伦理审查的能力和对本单位提供教育均较缺乏和尚未顾及到审查通过之后的持续审查等.本文通过了解美国在发展过程中存在的问题和我国的现状进行比较,发现存在诸多相似之处,因此着重介绍了其改革思路--地区性伦理审查模式,以资借鉴.作者的目的是就我国进行科研伦理能力建设、继续进行培训、加强政府监管和需要注意的文化因素等方面提出自己的初步设想.     

Protecting the privacy of family members in survey and pedigree research

The recent controversy at Virginia Commonwealth University involving research ethics raises important and complex issues in survey and pedigree research. The primary questions are whether family members of survey respondents themselves become subjects of the project and if they are subjects whether informed consent must be obtained for investigators to retain private information on these individuals. This article provides an analysis of the ethical issues and regulatory standards involved in this debate for consideration by investigators and institutional review boards. The analysis suggests that strong protections for the rights and welfare of subjects and their family members can be incorporated into survey and pedigree research protocols without hindering projects with extensive consent requirements.     

The costs of an institutional review board.

The Institutional Review Board (IRB) at the University of Texas Health Science Center at San Antonio is charged with the responsibility of review of all protocols involving human subjects in research. A large medical institution has many clinical protocols requiring review. The review of hundreds of protocols per year requires much time from the IRB staff, the committees which review the protocols, and the investigators who prepare them. This cost is borne by the institution. Additional federal regulations add to the complexity of review and require additional time on the part of all concerned. An attempt has been made to document the costs of operation of the IRB in a single group of institutions. About 850 new or renewal applications are reviewed each year for $100,000 or about $100 per application.This is a sizable financial burden to be placed on the average medical school. Legislation is now proposed to support IRB activities by direct grants from the federal government.     

12th Annual College of Medicine Research Dissemination Meeting,November 29th, 2008

Objectives

This study was aimed at understanding cultural attitudes, beliefs and perceptions to biomedical research, community consultation and informed consent process in peri-urban and rural settings in Malawi. It attempted to provide a base for informing, reforming and improving informed consent policy and practice by describing the local cultural attitudes and perceptions to research, autonomy, informed consent process and community consultation. It also assessed the validity of the Western concepts of informed consent and autonomy in a Malawian (African) setting.

Methods

The study employed both qualitative and quantitative research methods. Data were obtained from research participants during focus groups and individual interviews. 50 FGDs were conducted with 494 research participants. Individual interviews were conducted with 319 participants drawn from 5 different clinical trials in Lilongwe and Blantyre. The data were analyzed both manually and electronically.

Results

A majority of research participants described biomedical research as activities associated with preventive health measures such as community assessment and health education. This was common among the refusers and non-participants. Most research participants could differentiate between biomedical research and standard health care; but the difference was seen in the quality of care, rather than procedures involved. Among the category of participants, the need to receive better medical treatment was said to be their motivating factor to participate in biomedical research. 94.6% (298) of clinical research participants said they understood the study objectives, but only 21.8% (65) were able to state them correctly. 92% (294) of participants understood the informed consent procedure and its meaning. 33% (97) of those who perceived benefits of participation mentioned the care provided to them in clinical research as one of the benefits. 16.6% (52) acknowledged existence of risks to their participation in the clinical research; and were able to name the risks involved While 98% (313) said they joined clinical research freely, only 92% (294) understood the informed consent procedures. 90.9% (290) informed their partners/relatives about study participation; rather than seeking permission, 64.4% (187) said they did so “to let them know what was happening.” 84.6% (270) had no problem with allowing their samples to be stored for future research.

Conclusion

People who refuse to take part in biomedical research do so with an impaired understanding of its meaning and objectives due to rumors associated with biomedical research. There is a knowledge gap between real and perceived objectives among those who participated or were participating in biomedical research. People are motivated to take part in biomedical research by the “quality of care” provided to research participants. Participants understand their voluntary participation in research and understand the informed consent procedures; with community consultation seen as customary and preceding individual consent. People accept to participate in clinical research with knowledge of the existence of risks to their participation. Preference of signing or thumb printing is contrary to the Western concepts which allude to oral consent to be sought in illiterate communities. Communities have a good attitude towards biomedical research but are put off by researchers who

• do not follow customary procedures like community consultation and
• do not give feedback of results after the research is over.

Recommendations

Researchers should state objectives in simple terms and should remind participants about the objectives throughout the study. Researchers should clearly explain why each procedure is being done or why materials are being given to participants in biomedical research. Researchers have social obligations to provide services to communities where they recruit participants. Researchers have to engage communities before initiating biomedical research in communities or health centres; community engagement would help to dispel rumors associated with clinical research and would encourage community members to participate.

• Malawi Med J. 2009 Mar; 21(1): 34–43.
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• Rotavirus gastroenteritis in children in Blantyre, Malawi

Malawi Med J. 2009 Mar; 21(1): 34–43.

Rotavirus gastroenteritis in children in Blantyre, Malawi

NA CunliffeAuthor information Copyright and License information DisclaimerDepartment of Medical Microbiology, University of Liverpool, UKCopyright © Malawi Medical Journal     

The research subject advocate at the University of Hawai'i Clinical Research Center: an added resource for protection of human subjects

In early 2001 the National Institutes of Health (NIH) created the Research Subject Advocate (RSA) position as an additional resource for human subjects protection at NIH-funded Clinical Research Centers (CRCs) to enhance the protection of human subjects participating in clinical research studies. The purpose of this article is to describe the RSA position in the context of clinical research, with a particular emphasis upon the role of the RSA in one of the five CRCs funded by the NIH Research Centers in Minority Institutions (RCMI) program. Through participation in protocol development, informed consent procedures, study implementation and follow-up with adverse events, the RSA works closely with research investigators and their staff to protect study participants. The RSA also conducts workshops, training and education sessions, and consultation with investigators to foster enhanced communication and adherence to ethical standards and safety regulations. Although it is too early to provide substantive evidence of positive outcomes, this article seeks to illuminate the value of the RSA position in ensuring that safety of research participants is accorded the highest priority at CRCs. Based upon initial results, we conclude that the RSA is an effective mechanism for achieving the NIH's goal of maintaining the utmost scrutiny of protocols involving human subjects.     

医院知情同意权行使主体的伦理现状调查

目的了解医院医务人员、患者及其家属对医院知情同意权行使主体的伦理认知现状并进行分析。方法对医生、患者、家属采用自行设计的问卷进行调查,其中对126位医生进行问卷调查方式;对150名患者、148名家属采用问卷访谈形式进行访谈。结果在法律认知上,仅56%的医务人员,20%的患者,8.8%的患者家属完全同意知情同意权行使主体是其本人;在伦理认知上,以患者本人为知情同意权的行使主体,86.5%的医务人员,54%的患者,45.3%的患者家属认为能尊重患者;55.5%的医务人员,82.7%的患者,48%的患者家属认为能对患者有利;84.9%的医务人员,34.7%的患者,14.9%的患者家属认为要贯彻患者的自主选择权。结论在中国传统文化背景下,知情同意权行使主体的法律规定与伦理认知存在巨大差异,为医院医疗纠纷留下隐患;医务人员作为知情同意的告知者,要在有关法规指导下,掌握好告知权限,以适用当前伦理认知现状。     

Status of informed consent in the original articles published in a medical journal of Bangladesh

Informed consent and other ethical issues are included in every guideline of research ethics. Taking informed consent from the participants is essential in human health research. The health researchers are not addressing adequately the issues of informed consent and other relevant issues. In many of the published articles in our country, there is no mention of informed consent and other relevant ethical issues. In this study, a 5-years retrospective review was performed on the original articles that described research involving human subjects, and published in the "Journal of Bangladesh College of Physicians and Surgeons" in the period of 1999 to 2003. The objectives of this review were: i) to document whether the author has mentioned about informed consent in the published original article; and ii) to document whether the author has addressed the informed consent procedure in appropriate details. Fifty three original articles were reviewed, only in 7(13.2%) articles the author has mentioned that informed consent was taken from the participants. In 19 (63%) articles, where the subjects were minors or incompetent, there was no mention from whom informed consent was taken. Only in 2(3.7%) articles, the authors have mentioned about the approval of Ethical Review Committee, and in 4(7.5%) articles about the funding agency. Other ethical issues were also ignored. The study documents deficiencies in informed consent and relevant ethical issues in the published articles. This finding demands greater attention to ethical standards on the part of investigators and the editors.     

Ethical review of health research: a perspective from developing country researchers

BACKGROUND: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). METHODS: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. RESULTS: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. CONCLUSION: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.     

The stipulations of one institutional review board: a five year review

OBJECTIVES: This study was designed to explore the prevalence and types of stipulations (such as clarifications or changes) required of investigators by the institutional review board (IRB) of one institution over a five year period. DESIGN: Stipulations to research proposals (n = 124) were documented from the minutes of the IRB meetings. SETTING: Community hospital. PARTICIPANTS: IRB submissions. Main measurements: Number and type of IRB stipulations. RESULTS: Nineteen research submissions (15.3%) were approved without any stipulations. For the remainder, the majority of stipulations related to consent forms (74.2%). CONCLUSIONS: Consent forms appear to be at highest risk for IRB stipulations. Being aware of high risk areas before submission of research proposals may reduce the frequency of stipulations required of investigators.     

人类辅助生殖技术研究与实施中知情同意的伦理思考

近20年来，随着我国经济市场化和社会法制化的转型，传统的医院和家属决定医疗措施的模式已经不能充分保护患者的权益，对病情的知情权和治疗措施的决定权已经被动地移到患者本人。然而在辅助生殖技术领域知情同意更为特殊。由于生殖涉及夫妻双方和家庭，知情权有时与隐私权形成尖锐地对立；患者是否能自愿选择，也仍然受到了女性的弱势社会地位、来自家庭和社会的各种压力的影响；辅助生殖技术是在其尚不成熟时开始临床应用的，其科研探索和医疗行为的性质同时并存。这些问题须引起伦理学界的高度关注。从伦理角度而言，对于辅助生殖技术，政府和行业协会应当通过制度和行业规范保障社会公益性不受到损害，病人的普遍利益得到保护，而知情同意则是针对特定的个人进行权益保护的防线。     

Research on human subjects: Australian ethics committees take tentative steps.

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported.     

论医学研究知情同意的伦理审查

伦理委员会与知情同意书是保障受试者权益的主要措施。因此,伦理审查工作需要加大对知情同意的审查力度,注重研究受益和风险的平衡,维护受试者权益和安全。知情同意是人体生物医学研究的主要伦理要求之一。知情同意的伦理审查一般要考虑以下要点：信息的完整、充分性;知情同意书签署过程;用语的规范性;知情同意书风险处置等。     

对我国伦理审查委员会建设的探讨

我国伦理审查委员会已初具规模,但需要进一步完善。为加强伦理审查委员会建设,从以下六个方面进行探讨:性质、功能和职责;组成、成员聘用和要求;设置、报批和注册;审查的依据、目的和原则;审查的范围和程序以及对其监管。     

Evaluating the work of ethical review committees: an observation and a suggestion.

Eight research protocols which had previously been approved by Ethical Research Committees (ERCs) were reviewed in simulated review committees set up during a symposium on medical ethics. Only three protocols were considered to provide fully adequate information to allow ethical review and only one protocol was thought to provide sufficient guarantees on the ethical issues raised by the proposed research. For five other protocols additional safeguards were considered necessary, in particular covering the problem of informed consent. Two protocols were considered to raise unresolvable ethical issues. This artificial exercise does not establish that review by ERCs is ineffective. It does highlight the lack of objective criteria in ethical review. Peer review by exchange of protocols between ERCs could assist in increasing the consistency in the application of ethical standards.     

做好伦理委员会主席之我见

伦理委员会主席在伦理委员会中扮演着一个相当重要的角色。他必须是一个相当热情和热心于伦理委员会工作的领导者,他必须是一个医学、法学、伦理学和管理学的专家。伦理委员会主席的主要职责就是要积极鼓励伦理委员会委员做好伦理评审工作,不要受任何外界因素的干扰。     

Emergency research in children: options for ethical recruitment

The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.