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Varying ethics rules in clinical research and routine patient care--research ethics committee chairpersons' views in Finland.
- Source :
-
Health research policy and systems [Health Res Policy Syst] 2014 Mar 25; Vol. 12, pp. 15. Date of Electronic Publication: 2014 Mar 25. - Publication Year :
- 2014
-
Abstract
- Background: To present empirical data on how the variation in regulating clinical research and patient care was perceived in Finland between 2009 and 2012.<br />Methods: Notes of interviews with 22 research ethics committee (REC) chairpersons were analyzed to identify whether differences in the regulation of clinical research and patient care were addressed. REC chairpersons' opinions on three imaginary cases of clinical research projects challenging current research ethics rules (vignettes) were requested with a questionnaire; 18 of the 22 interviewed chairpersons responded.<br />Results: Based on REC chairpersons' interviews, the differences between care and research regulation were not considered important issues in Finland. In the vignettes, REC chairpersons' assumptions on how their REC would decide varied in regard to allowing research without informed consent, while solutions that are not allowed by current law were even anticipated. Mostly, but not always, the chairpersons' own personal view agreed with their REC.<br />Conclusions: The distinction between care and research regulation has not been publicly challenged by Finnish RECs, even though it is a challenge when research relevant to health care is carried out. There is a need for debate and changes in laws and practices.
- Subjects :
- Biomedical Research legislation & jurisprudence
Cluster Analysis
Ethics, Research
Female
Finland
Humans
Male
Randomized Controlled Trials as Topic ethics
Randomized Controlled Trials as Topic legislation & jurisprudence
Attitude of Health Personnel
Biomedical Research ethics
Ethics Committees, Research
Patient Care ethics
Subjects
Details
- Language :
- English
- ISSN :
- 1478-4505
- Volume :
- 12
- Database :
- MEDLINE
- Journal :
- Health research policy and systems
- Publication Type :
- Academic Journal
- Accession number :
- 24666735
- Full Text :
- https://doi.org/10.1186/1478-4505-12-15