Research Ethics Committees in the Field of Health-Related Human Research - A European Perspective and the Case of Austria

被引:2
作者
Stuehlinger, Verena [1 ]
Hackl, Michael [2 ]
机构
[1] Univ Hlth Sci, Dept Publ Hlth & Hlth Technol Assessment, Div Hlth Policy Adm Econ & Law, RCSEQ,UMIT,Fhg,Med Informat & Technol, Hall Tyrol, Austria
[2] Univ Hlth Sci, Dept Nursing Sci & Gerontol, Med Informat & Technol, RCSEQ,UMIT,Fhg, Hall Tyrol, Austria
关键词
human research subject protection; research participant protection; research ethics committees; health-related research; biomedical research; EU clinical trials regulation;
D O I
10.1163/15718093-12341329
中图分类号
D9 [法律]; DF [法律];
学科分类号
0301 ;
摘要
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.
引用
收藏
页码:387 / 400
页数:14
相关论文
共 18 条
[11]   Public Health Innovation and Research in Europe: introduction to the supplement [J].
McCarthy, Mark ;
Paget, Dineke Zeegers .
EUROPEAN JOURNAL OF PUBLIC HEALTH, 2013, 23 :2-5
[12]  
National Bioethics Advisory Commission (NBAC), 2001, ETH POL ISS RES INV
[13]  
OECD, 2012, REC COUNC GOV CLIN T, P167
[14]   Toward a national framework for the secondary use of health data: An American Medical Informatics Association white paper [J].
Safran, Charles ;
Bloomrosen, Meryl ;
Hammond, W. Edward ;
Labkoff, Steven ;
Markel-Fox, Suzanne ;
Tanc, Paul C. ;
Detmer, Don E. .
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION, 2007, 14 (01) :1-9
[15]  
Stuhlinger V., FILLING GAP ESTABLIS
[16]  
*WHO, 2002, SURV EV ETH REV PRAC
[17]  
WHO World Organization for Animal Health, 2014, OBESITY INEQUITIES G, P1
[18]  
World Health Organization, 2000, OP GUID ETH COMM REV