Retrospective research: What are the ethical and legal requirements?

Details

Ressource 1Download: BIB_007EFF802A9F.P001.pdf (219.64 [Ko])
State: Public
Version: Final published version
Serval ID
serval:BIB_595DD1AA0F2D
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Retrospective research: What are the ethical and legal requirements?
Journal
Swiss Medical Weekly
Author(s)
Junod V., Elger B.
ISSN
1424-3997 (Electronic)
ISSN-L
0036-7672
Publication state
Published
Issued date
2010
Volume
140
Pages
33-40
Language
english
Notes
Publication types: Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.Publication Status: epublish
Abstract
Retrospective research is conducted on already available data and/or biologic material. Whether such research requires that patients specifically consent to the use of "their" data continues to stir controversy. From a legal and ethical point of view, it depends on several factors. The main criteria to be considered are whether the data or the sample is anonymous, whether the researcher is the one who collected it and whether the patient was told of the possible research use. In Switzerland, several laws delineate the procedure to be followed. The definition of "anonymous" is open to some interpretation. In addition, it is debatable whether consent waivers that are legally admissible for data extend to research involving human biological samples. In a few years, a new Swiss federal law on human research could clarify the regulatory landscape. Meanwhile, hospital-internal guidelines may impose stricter conditions than required by federal or cantonal law. Conversely, Swiss and European ethical texts may suggest greater flexibility and call for a looser interpretation of existing laws. The present article provides an overview of the issues for physicians, scientists, ethics committee members and policy makers involved in retrospective research in Switzerland. It aims at provoking more open discussions of the regulatory problems and possible future legal and ethical solutions.
Keywords
Biomedical Research/ethics, Biomedical Research/legislation & jurisprudence, Ethics, Research, Guidelines as Topic, Humans, Informed Consent/ethics, Informed Consent/legislation & jurisprudence, Presumed Consent/ethics, Presumed Consent/legislation & jurisprudence, Retrospective Studies, hic" UI="D013557">Switzerland
Pubmed
Web of science
Open Access
Yes
Create date
09/02/2015 16:11
Last modification date
20/08/2019 15:12
Usage data