Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee

Saara Happo; Tapani Keränen; Arja Halkoaho; Soili M. Lehto

doi:10.1177/1556264620903563

Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee

Saara Happo^*
, Tapani Keränen
, Arja Halkoaho
, Soili M. Lehto

^*Corresponding author for this work

Research output: Contribution to journal › Article › Scientific › peer-review

3 Citations (Scopus)

Abstract

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 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.

Original language	English
Pages (from-to)	396-406
Number of pages	11
Journal	Journal of Empirical Research on Human Research Ethics
Volume	15
Issue number	5
DOIs	https://doi.org/10.1177/1556264620903563
Publication status	Published - 2020
Publication type	A1 Journal article-refereed

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this study was supported by the Finnish Cultural Foundation (Grant No. 65161499).

Keywords

medical research ethics
medical study procedures
medical study protocol
participant information sheet
risk assessment

Publication forum classification

Publication forum level 1

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10.1177/1556264620903563Licence: CC BY

Cite this

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abstract = "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 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.",

keywords = "medical research ethics, medical study procedures, medical study protocol, participant information sheet, risk assessment",

author = "Saara Happo and Tapani Ker{\"a}nen and Arja Halkoaho and Lehto, \{Soili M.\}",

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doi = "10.1177/1556264620903563",

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N1 - Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this study was supported by the Finnish Cultural Foundation (Grant No. 65161499). Publisher Copyright: © The Author(s) 2020. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

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Risk Assessment of Medical Study Procedures in the Documents Submitted to a Research Ethics Committee

Abstract

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