Ethical review: Standardizing procedures and local shaping of ethical review practices.
Since ethical review practice has developed in relation to specific regulatory regimes and local contexts, it cannot be understood without paying attention to the institutional context of ethical review practices. We believe the tendency towards strong central governance and standardization in ethical review implies a lack of understanding of how specific local institutional contexts actually affect ethical review practices. Our question is: "How do local institutional contexts relate to the way REC's shape their formal mandate, and what are the implications for research governance?" To get in-depth insights in how REC's shape their formal mandates in every-day practice, we did a qualitative ethnographic-sociological study of three Dutch REC's in different contexts: an academic context, a care context and a commercial context. In analyzing these three REC's we paid attention to the procedures operative in REC practices, the cultures and everyday experiences of REC members, the scientific, social and financial resources that are available to REC's, and the evaluative perspective REC's employ. We conclude that specific local, institutional contexts offer valuable resources for ethical review. To track this, insight into the institutional configuration as a whole is necessary. Variations in the ways REC's shape their formal mandate should not be regarded problematic, but rather as fruitful opportunities for public learning.
CAPHRI, School for Public Health and Primary Care, Department of Health, Ethics & Society, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. Electronic address: abcpatricia.jaspers@gmail.com.
Patricia
P
Jaspers
CAPHRI, School for Public Health and Primary Care, Department of Health, Ethics & Society, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. Electronic address: R.Houtepen@maastrichtuniversity.nl.
Rob
R
Houtepen
CAPHRI, School for Public Health and Primary Care, Department of Health, Ethics & Society, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. Electronic address: K.Horstman@maastrichtuniversity.nl.
Klasien
K
Horstman
D003159:Community-Institutional Relations; D003659:Decision Making, Organizational; D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000458:organization & administration*; D006801:Humans; D009426:Netherlands; D036301:Qualitative Research
Accountability; Institutional shaping; Local knowledge; Public learning; Research Ethics Committees (RECs); Standardization; The Netherlands; Trust