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  1. Evidence-Based Guidelines for Low-Risk Ethics Applicants: A Qualitative Analysis of the Most Frequent Feedback Made by Human Research Ethics Proposal Reviewers.Sarven S. McLinton, Sarah N. Menz, Bernard Guerin & Elspeth McInnes - forthcoming - Journal of Academic Ethics:1-24.
    Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. (...)
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  • Polish research ethics committees in the european union system of assessing medical experiments.Marek Czarkowski & Krzysztof Różanowski - 2009 - Science and Engineering Ethics 15 (2):201-212.
    The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: 0–71) projects of (...)
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  • The effect of study type on research ethics committees’ queries in medical studies.Saara M. Happo, Arja Halkoaho, Soili M. Lehto & Tapani Keränen - 2017 - Research Ethics 13 (3-4):115-127.
    Background:Medical research involving human subjects must be evaluated by a research ethics committee before a study is initiated. However, knowledge of REC decision processes, particularly in relation to evaluating the risk–benefit balance in various study types, appears scant.Methods:The study protocols and records of a Finnish university hospital REC were surveyed for a time span of 5 years. All study procedures in each study plan were examined, and the studies were divided into clinical drug trials, clinical trials with medical devices, studies (...)
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