International ethical guidelines for biomedical research involving human subjects

The CIOMS guidelines have been developed and revised with the problems of conducting medical research in less developed countries particularly in mind. The proposed guidelines were first published in 1982, revised in 1993, and have now been published in a third version after a revision process lasting three years. Last month the Bulletin published just one guideline and accompanying commentary. There now follow all the guidelines, without commentary, but with an appendix detailing what should be in a protocol.     

Ethical international research on human subjects research in the absence of local institutional review boards

International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified--external oversight, local oversight and subject involvement--and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.     

谈生命伦理学在医学人体试验中应用的特殊性

为探讨生命伦理学在医学人体试验中的具体应用有其特殊性,说明不能照搬医疗中的自主性原则。本文对临床盲试伦理进行具体分析,发现医学人体试验中的自主性原则应注重受试者的自主决定权而不是知情权;同时,鉴于医学人体试验旨在促进医学发展和社会进步,社会利益也是医学人体试验伦理应考虑的重要因素。因此,自主性原则与社会利益的兼顾才真正符合医学人体试验的伦理道德。     

UNESCO Global Ethics Observatory: database on ethics related legislation and guidelines

The Database on Ethics Related Legislation and Guidelines was launched in March 2007 as the fourth database of the UNESCO Global Ethics Observatory system of databases in ethics of science and technology. The database offers a collection of legal instruments searchable by region, country, bioethical themes, legal categories and applicability to specific articles of the UNESCO Universal Declaration on Bioethics and Human Rights and International Declaration on Human Genetic Data. This paper discusses the background and rationale for the database and its role as a consultative and comparative resource hub for the study of ethics related legal instruments across the world, with the purpose of informing and inspiring relevant stakeholders on the implementation of the principles contained within the UNESCO declarations on bioethics.     

Health service research: the square peg in human subjects protection regulations

Protection of human participants is a fundamental facet of biomedical research. We report the activities of a health service research study in which there were three institutional review boards (IRBs), three legal departments and one research administration department providing recommendations and mandating changes in the study methods. Complying with IRB requirements can be challenging, but can also adversely affect study outcomes. Multiple protocol changes mandated from multiple IRBs created a research method that was not reflective of how substance use screening would be performed in a clinical setting. There was direct conflict between the IRBs' perceptions of participants' protection with the researchers' need to use research methodology that assures the clinical relevancy of results.     

Paying research subjects: participants' perspectives

OBJECTIVE: To explore the opinions of unpaid healthy volunteers on the payment of research subjects. DESIGN: Prospective cohort. SETTING: Southern Alberta, Canada. PARTICIPANTS: Medically eligible persons responding to recruiting advertisements for a randomised vaccine trial were invited to take part in a study of informed consent at the point at which they formally consented or refused trial participation. Of 72 invited, 67 (62 trial consenters, 5 trial refusers) returned questionnaires at baseline and 54 at follow-up. OUTCOME MEASURES: Proportions of persons who agreed or disagreed with three close-ended statements on the payment of research subjects; themes and categories identified by content analysis of responses to an open-ended question. RESULTS: A minority (43.3%) agreed with paying either patient or healthy volunteer participants. Opinions did not change over time. Participants' comments addressed: benefits and drawbacks to research participation; benefits and drawbacks to paying research participants; conditions under which payment of research subjects would be acceptable, and the nature of acceptable recognition. Acceptable conditions were to improve problematic recruitment, to reimburse costs, and to recognise participants, particularly for their time investment. Both non-monetary and monetary recognition of volunteers were thought to be appropriate. CONCLUSIONS: Most unpaid volunteers disagreed with paying research participants. The themes arising from their comments are similar to those that have been raised by ethicists and suggest that recognising the time and effort of participants should receive greater emphasis than presently occurs.