1 Research Committee for Scientific and Ethical Questions (RCSEQ), UMIT, fhg, Department of Public Health and Health Technology Assessment, Division of Health Policy, Administration, Economics and Law, UMIT, University for Health Sciences, Medical Informatics and Technology, Hall Tyrol, Austria
2 Research Committee for Scientific and Ethical Questions RCSEQ) UMIT, fhg, Department of Nursing Sciences and Gerontology, UMIT, University for Health Sciences, Medical Informatics and Technology, Hall Tyrol, Austria
Human subject abuse and patient harm through medical research have led to the establishment of Institutional Review Boards (irbs or Research Ethics Committees (recs)), who independently scrutinise research protocols. In the field of trials with medicinal products as well as trials testing medical devices, an obligation for submission prior to realisation is granted within Europe through European directives. However, regulation of other fields of health-related research, e.g., psychological trials, public health and epidemiological studies or healthcare research is the responsibility of eu Member States; and European laws differ widely. The article gives an overview of European regulations in the field of rec review requirements, critically analyses Austrian legislation in this field and describes an institutional solution for legislative gaps in Austria — the Research Committee for Scientific and Ethical Questions (rcseq). Finally, important European initiatives for the future are pointed out.
See also: J. Berg and N. Deming‘New Rules for Research with Human Participants?’Hastings Center ReportNovember-December 2011 10-11; Department of Health and Human Services Human Research Protections: ‘Enhancing Protections for Research Subjects and Reducing Burden Delay and Ambiguity for Investigators Advance notice of proposed rulemaking’ Federal Register 76 (143) (26 July 2011) available at http://www.hhs.gov/ohrp/humansubjects/anprm2011page.html (28.3.2014).
See also A. Iltis‘Introduction: Vulnerability in Biomedical Research’Journal of Law Medicine & Ethics(2009) 6-11 at p. 10: “The concept of vulnerability figures prominently in the research ethics literature and the regulations governing human research in the u.s. call on irbs and investigators to provide special protections to vulnerable participants. Yet questions concerning who is vulnerable and what protections may be effective in reducing or eliminating the source or effects of their vulnerabilities remain unanswered.”