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dc.contributor.authorHappo, S
dc.contributor.authorKeränen, T
dc.contributor.authorHalkoaho, A
dc.contributor.authorLehto, SM
dc.date.accessioned2020-03-09T11:45:56Z
dc.date.available2020-03-09T11:45:56Z
dc.date.issued2020
dc.identifier.urihttps://erepo.uef.fi/handle/123456789/8048
dc.description.abstractSeveral 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 participant information sheets. Physical risks were assessed six times more frequently than psychological risks. Risks of medical procedures are not always detailed in study protocols or participant information sheets. Risk descriptions of procedures believed to be familiar to potential participants may be omitted.
dc.language.isoenglanti
dc.publisherSAGE Publications
dc.relation.ispartofseriesJournal of empirical research on human research ethics
dc.relation.urihttp://dx.doi.org/10.1177/1556264620903563
dc.rightsAll rights reserved
dc.subjectrisk assessment
dc.subjectmedical research ethics
dc.subjectmedical study procedures
dc.subjectmedical study protocol
dc.subjectparticipant information sheet
dc.subjectparticipant information sheet
dc.titleRisk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee
dc.description.versionfinal draft
dc.contributor.departmentSchool of Medicine / Clinical Medicine
uef.solecris.id68562782en
dc.type.publicationTieteelliset aikakauslehtiartikkelit
dc.rights.accessrights© Authors
dc.relation.doi10.1177/1556264620903563
dc.description.reviewstatuspeerReviewed
dc.format.pagerange396-406
dc.relation.issn1556-2646
dc.relation.issue5
dc.relation.volume15
dc.rights.accesslevelopenAccess
dc.type.okmA1
uef.solecris.openaccessEi


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