Undergraduate Research Involving Human Subjects Should not be Granted Ethical Approval Unless it is Likely to be of Publishable Quality

Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.     

A welcome guide for evaluating medical research involving human subjects

In 1999, the Dutch Medical Research Involving Human Subjects Act came into force. The principal aim of this Act is to provide protection for human subjects who take part in medical research. Medical research involving human subjects may only be carried out after it has been approved by a recognised medical ethics committee. A central committee (Dutch acronym: CCMO) regulates the recognition of the local medical ethics committees and monitors their performance. For some types of research the protocol has to be reviewed by the CCMO itself. These are: non-therapeutic research involving children and mentally incompetent patients and research on gene therapy, xenotransplantation and embryos. The CCMO has recently published a guide for the local medical ethics committees. It presents an excellent overview of all the legal and practical aspects of the work of medical ethics committees. The guide is highly recommended.     

Ethics Committees in Croatia in the Healthcare Institutions: The First Study about their Structure and Functions, and some Reflections on the Major Issues and Problems

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees. SETTING: Croatia six years after the implementation of the Law on the Health Protection. MAIN MEASUREMENTS: Structure and function of ethic committees in the healthcare institutions. RESULTS: 46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work. CONCLUSIONS: Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.     

Time for professionalising the system of medical ethics review in the Netherlands

In two recent papers, a radical change of the review system for medical ethics review committees was proposed. The current systems in Great Britain and Australia were described and it was suggested that the extended roles and responsibilities of the medical ethics review committees could not be fulfilled by the present committees. It was proposed that professional medical ethics committees be established with full time members who would receive an appropriate honorarium. The Netherlands has a decentralised system of medical ethics review, which is based on peer review. A radical change of the current system of medical ethics review is not warranted. There is however a need for further improvements to the current peer-review system. An important aspect of this improvement is an honorarium for the members as well as a budget for training and for the adequate scientific and administrative support of the committee by a secretariat. The fees levied for reviewing each protocol could in part finance the committee and its secretariat. However, these fees will probably not meet all of the costs. Therefore the centres involved in medical research should consider supporting their committees. It is in their interest to demonstrate their wish to protect those persons who consent to participate as research subjects. This will maintain the confidence of both the public and future participants in clinical trials. Furthermore, an efficient and adequate system of ethical review will support a balanced view towards medical research with human subjects and will also contribute to a positive image of the centre also as an attractive environment for medical professionals.     

Judging the ethics of qualitative research: considering the "ethics as process" model

Decision-making about the ethics of qualitative research is problematic where the research design is emergent, and the balance between risks and benefits for research subjects are difficult to ascertain prior to study implementation. The discourses of health/medical research ethics and those of social research are shown to be divergent and, furthermore, where ethics committees tie themselves to the health/medical model of ethical decision-making, qualitative research approaches can be disadvantaged. Having demonstrated the dual discourses and their relevance to qualitative research ethics, a critical review of current approaches to maximising the success of qualitative research proposals being considered for approval by ethics committees is undertaken. This leads to a call for a system of monitoring qualitative research so that the "benefit to risk" ratio is always on the side of benefit. This has implications for the ways in which ethics committees are organised and the ways in which they function.     

Members of research ethics committees accepted a modification of the randomized consent design

BACKGROUND AND OBJECTIVE: The use of randomized consent designs has been subject of methodologic and ethical controversy. In most Western countries, research ethics committees make the decision as to whether a randomized consent design can be applied. The purpose of the study is to assess to what extent a randomized consent design and a modification of this design is accepted by research ethics committees, in terms of ethics, health law, and methodology. METHODS: A postal survey was conducted among members of research ethics committees in the United Kingdom, and in The Netherlands, with professional competence in ethics, (health) law, methodology, or clinical practice. RESULTS: In both the UK and in The Netherlands, the modified randomized consent design appears to be statistically significantly more acceptable than the randomized consent design, with respect to ethical and judicial aspects. The overall rejection rate of the randomized consent design was 66% in the UK and 59% in The Netherlands. However, the modified randomized consent design was rejected by 47 and 41% in the two countries, respectively. CONCLUSION: the modified randomized consent design appears to be more acceptable than the randomized consent design. To increase consistency in the way research ethics committees handle study protocols, a discussion about the use of randomized consent designs appears necessary.     

Research and hospital ethics committees in Switzerland

This paper presents the situation concerning research and hospital ethics committees (HEC) in Switzerland. In fact, HECs are almost nonexistent. All the so-called "Ethics Committees" deal with the review of research projects. As there is no legislation governing research on human subjects, the Swiss Academy of Medical Sciences (SAMS) has issued guidelines concerning research on human subjects and, more recently, guidelines concerning Research Ethics Committees (REC). There is a wide disparity in the composition and the functioning of these committees, however. Half of them belong to university hospitals. Six of them review two-thirds of all reviewed protocols. Many RECs function more as educational bodies to enhance the quality of submitted protocols than as committees having the task to control and prohibit particular research projects.     

Early termination of the multicentre randomised clinical trial to evaluate the benefit of testing for thrombophilia following a first venous thromboembolism: the NOSTRADAMUS study

The NOSTRADAMUS study (ISRCTN07836779) was prematurely terminated due to low inclusion rates. There were several causes for this low inclusion: delay of approval by medical ethics committees, competition with industry-initiated intervention studies with a higher financial compensation, and the lack of study staff and allowance of expenses. We advise restraint with respect to testing for thrombophilia in patients with a first deep vein thrombosis or pulmonary embolism, as the benefit of this procedure has yet to be demonstrated.     

Today's ethics committees face varied issues. A CHA survey reveals committees' functions, authority, and structure

In a survey of Catholic Health Association member hospitals, 92 percent indicated they have formal ethics committees at their institutions. Sixty-two percent said their ethics committees were formed between 1983 and 1989. The survey found that current ethics committees are still committed to their traditional roles--education, policy development, and case review--but the education is directed to more diverse audiences than in the past. Support for medical and nursing staffs may be emerging as another possible function of ethics committees. The issues that precipitated the formation of institutional ethics committees have become more complex. In particular, questions involving the appropriate use of technology, the renewed awareness of patients' rights, changing relationships among healthcare providers, and conflicting social values have continued to require the intervention of ethics committees. However, the frequency with which respondents said their committees provide case consultations seems lower than it should be if committees were used to their full advantage. The institutional ethics committee can play a part in enlarging the current healthcare reform debate and promoting moral values. It can address such important questions as, Should the well-being of individuals take precedence over the well-being of communities?     

Medical ethics committees in Hungary Dr. Bela Blasszauer

Hungarian medical ethics committees were established at the end of the 1950s. They came into being on the Communist Party's initiative. They could hardly be called "interdisciplinary" since their membership was made up of high-ranking physicians and a few head nurses. Their main task was to counter the practice of "tipping." Medical ethics and "tipping" were practically synonymous. These committees did not confront or try to resolve ethical problems concerning such issues as patient rights, informed consent, refusal of treatment, human experimentation, abortion, etc. These committees - whether it is believable or not - belonged to the Physicians Health Workers Trade Union. They were under the guidance and supervision of this social organization. The public was excluded from their meetings, and the committees' duty was to follow the health laws which were supposed to have given excellent ethical guidance. Even in a textbook on medical ethics used at one of the medical universities, written by a psychiatrist, the health laws were presented and explained back and forth. Of the 88 pages only 23 dealt with morals in general and the Hippocratic tradition. The Hungarian National Health Service as well as its medical ethics committees are similar in many respects to the Soviet and Eastern European countries' health care system and ethics committees. Since radical changes have taken place in these so-called "former" communist countries, it can only be hoped that these committees will eventually develop into groups who will deal directly with the moral questions or medicine and health care.     

Protecting human research from an invasion of privacy: the unintended results of the Commonwealth Privacy Act 1988

In accordance with the Privacy Act 1988 (Cth), interium guidelines for the protection of privacy in the conduct of medical research have been issued by the National Health and Medical Research Council (NHMRC) with the approval of the Privacy Commissioner. The guidelines are intended to ensure that the privacy of the individual is not interfered with when a researcher seeks the release of personal information held by a Commonwealth agency, or when a Commonwealth agency conducts medical research, and to ensure that the conduct of medical research is not inhibited by the privacy legislation. However, the procedures established by the guidelines and the responsibilities placed upon researchers and institutional ethics committees could themselves have the effect of inhibiting research. In considering amendment, NHMRC and the Privacy Commissioner are urged to produce final guidelines which do not act as the straw to break the back of the current system of institutional ethics committees, which seeks to ensure proper ethical scrutiny and the facilitation of human research.     

No-fault medical liability in Virginia and Florida. A preliminary evaluation

State governments are experimenting with a variety of innovative approaches to the current tort system for medical malpractice liability. One such approach is to apply the concept of no-fault liability to medical practice. States such as Virginia and Florida have already adopted a limited version of such a concept. This article examines the problems of the current tort system, different types of no-fault medical insurance alternatives and their advantages, and the experiences of the states of Virginia and Florida with their limited no-fault malpractice insurance systems. The author concludes that the concept of no-fault compensation for medical malpractice is a promising remedy. However, it is a medicine that will require more testing before it can be pronounced a cure for the disease that plagues the current system.     

Changing defaults in biobank research could save lives too

In an effort to increase the amount of organs available for transplantation, many countries have implemented presumed consent for organ donation. Presuming a wish to contribute to medical advances through biobank research on previously taken tissue samples could similarly improve health and wellbeing. In this article we analyze common arguments for and against presumed consent for organ donation and assess their relevance in the context of biobank research. In spite of obvious differences between biobank research and organ transplantation the cases for implementing presumption of a positive attitude appear quite analogous. It has repeatedly been shown that a majority of the general population supports these projects and selecting informed consent as the default position decreases the amount of organs and samples available and thus reduces the prospect of promoting health. We conclude that instead of presuming that individuals do not wish to contribute to the advancement of healthcare through biobank research on previously taken samples, ethics committees should presume that they do.     

Ethics committees and health services research

Ethics committees in Britain were set up to consider clinical research. Increasingly, however, they are receiving applications for health services research which often involves several or many centres. The performance of 23 ethics committees was examined through a case-study of an application for a multi-centre non-experimental study of prostatectomy. Although all the committees approved the study, long delays occurred (mean 11.5 weeks, range 3-32 weeks), particularly in teaching districts which dealt with large numbers of applications. The composition of the committee and the frequency with which it met were not associated with the time taken to reach a decision. Some delays might be reduced by improving the design of the application forms and ensuring that at least one member of the committee has an understanding of health services research methods. Although such measures might improve the performance of committees, applicants are likely to remain in a logistic trap between funding bodies, clinicians, and ethics committees. In addition, until committees temper their concern for individualistic medical ethics with a collective ethic of the common good, health services research may continue to experience delays and difficulties.     

Evaluación de los aspectos metodológicos, éticos,legales y sociales de proyectos de investigación en salud con datos masivos (big data)

The current model for reviewing research with human beings basically depends on decision-making processes within research ethics committees. These committees must be aware of the importance of the new digital paradigm based on the large-scale exploitation of datasets, including personal data on health. This article offers guidelines, with the application of the EU's General Data Protection Regulation, for the appropriate evaluation of projects that are based on the use of big data analytics in healthcare. The processes for gathering and using this data constitute a niche where current research is developed. In this context, the existing protocols for obtaining informed consent from participants are outdated, as they are based not only on the assumption that personal data are anonymized, but that they will continue to be so in the future. As a result, it is essential that research ethics committees take on new capabilities and revisit values such as privacy and freedom, updating protocols, methodologies and working procedures. This change in the work culture will provide legal security to the personnel involved in research, will make it possible to guarantee the protection of the privacy of the subjects of the data, and will permit orienting the exploitation of data to avoid the commodification of personal data in this era of deidentification, so that research meets actual social needs and not spurious or opportunistic interests disguised as research.     

A "next generation" ethics committee. St. Joseph Health system has integrated performance-improvement features into its ethics work

Understanding the limitations that accompany the traditional model of ethics committees, St. Joseph Health System (SJHS), Orange, CA, has been working to integrate ethics expertise and quality-improvement methodology into its "Next Generation Model" (NG Model) for such committees. However, moving from a traditional structure to the NG Model (introduced to SJHS facilities in 1999) brought some challenges, not the least of which was a deep-rooted culture of resistance to change. Following a 2004 audit of how the NG model was working, some common challenges were identified. To deal with those challenges, SJHS developed some tools and techniques that have helped ease the ongoing transition. These tools have helped the system's ethics committees address such issues as collaboration for the sake of organizational integration, setting goals, and measuring performance of various ethics roles.