Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.
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ABSTRACT:
SUBMITTER: Happo S
PROVIDER: S-EPMC7604935 | biostudies-literature | 2020 Dec
REPOSITORIES: biostudies-literature
Publications
Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee.
Happo Saara S Keränen Tapani T Halkoaho Arja A Lehto Soili M SM
Journal of empirical research on human research ethics : JERHRE 20200208 5
Several frameworks assist research ethics committees (RECs) in risk assessment of medical studies. However, little is known about how researchers describe risks of the procedures in study protocols and participant information sheets. We examined 349 study protocols and participant information sheets submitted to an REC and evaluated the risk assessments performed for 1,510 study procedures. Risks had been assessed for 399 (26%) procedures in study protocols and for 425 (28%) procedures in partic ...[more]
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