A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects (original) (raw)
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What changes in Research Ethics in Brazil: Resolution no. 466/12 of the National Health Council
Einstein (São Paulo), 2014
Council (CNS, acronym in Portuguese), (1) approves the regulatory guidelines and norms for research involving human beings and constitutes the first national regulatory mark of ethics applied to research. By means of this resolution, the Brazilian system of ethics review was created, composed by the Research Ethics Committees (CEPs, acronym in Portuguese) and the National Research Ethics Commission (CONEP, acronym in Portuguese), also known as the CEP/CONEP System. After 15 years, the process of review of CNS Resolution no. 196/96 was initiated. This involved public consultation during the period of September 12 to November 10, 2011, which resulted in 1,890 suggestions sent electronically and the presentation of 18 documents sent by mail. These contributions, duly tabulated, were submitted to the analysis of participants of the extraordinary National Meeting of Research Ethics Committees that produced a document and submitted it to the CNS.
The Evolution of Research Ethics: The Current International Configuration
The Journal of Law, Medicine & Ethics, 2004
propose in this essay to briefly describe some of the main current stakeholders who issue guidance on I the ethics of human subjects research. This will be preceded by a very brief historical introduction. Prior to World War 11, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People's Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients. And that is, I believe, the sum total of prewar efforts to regulate human experimentation. As you may well imagine, much has been written about the origins and impact of these early activities. These are no less crucial to the history of human experimentation than the nineteenth century Codes of Thomas Percival in England, William Beaumont in the USA, and Claude Bernard in France. And no less so than the well-known Nuremberg Code of 1947. The best source for material on the Code and its origins remains the 1992 book edited by George Annas and Michael Grodin, The N w ' Doctors and the Nuremberg Code: Human Rights in Human Experimentation. For those of you who do not know the details of this Code, I would remind you that it was promulgated by a U.S. Military Rbunal as part of the final judgement in the so-called "Doctors' Ral" (the "Medical Case") held in Nuremberg in 1946-1947. The Code has been the subject of much scholarly attention, notably at a series of Conferences convened to mark its 50th Anniversary in 1997, e.g. in Nuremberg and Freiburg-im-Breisgau. It is noteworthy that in 1946 the American Medical Association published its first principles of human experimentation, while in 1953 the US Department of Defence issued its then "top-secret" Memorandum on Sev S. Fluss, M.S., is a Senior Adviser at the Council for International Organizations ofMedical Sciences, a nongovernmental organization based at WTlO in Geneva. He was formerly Chief of WHO'S Health Legislation Unit, and is the author of numerous publications in thefields of health legislation and bioethics.
The French Law on "Protection of Persons Undergoing Biomedical Research": Implications for the U.S
The Journal of Law, Medicine & Ethics, 2003
ecaiise research involving human subjects exposes people to risk not always for their own potential B benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole. The hilancing of the risk to research participants v e m s the benefits derived from the mearch is perfoiined in many counrries by a system for the p m e d o n of human research participants that is laid out in natioml laws and regulations. In the United States, h system is based on principles enunating from the Nureniberg Code,' the Worlcl Medical Association Declaration of Helsinki: and the report of the National Commission for the Pmecfion of Human Subjects of Biomeclial and Behaviordl Research (the Belmont Rept).) It is expressed concretely in fedenl regulations clealing with "all research involving human subjects conducted, supported or otherwise subject to regulation" by die fedewl goverrunenr' or research in support of an application to the US. Food and Dnig Adminismion for appmval of a new clnig or medical device? AS 1% recently been pointed out, "absent ii universally applicable ethial framework, investigators, IRB members, funders, and others lack coherent guidance on cletennining whether specific clinical rewarch protocols are ediial.'" The adequacy and fairness of the U.S. system have recently come under increasing governmental, public, and political scrutiny? h i o n g the issues being raised are: 1. The adequacy of the system of local institutional review Imards ORBS), which act as research ethics committees, including: ~
BMC Medical Ethics, 2021
Background: This paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs' service to the subject of the clinical trial. Methods: We retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC's files and electronic archives. Results: Almost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation , or minor changes before final approval. Conclusions: Preventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials' final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits.