title: Recurring themes arising during medical research ethics committee review.
abstract: A standard application form for the ethical review of health-related research studies has recently been adopted by many Irish medical research ethics committees. In order to assess the impact of the new form, we reviewed all comments made by the Beaumont Hospital Ethics Committee during two six-month periods, immediately prior to adoption of the new form (2010), and soon afterwards (2011). Neither volume nor comment type differed significantly between the two observation periods. Participant documentation (information leaflets and consent forms) accounted for the largest proportion of comments (2010; 44%, 2011; 37%). Other common areas prompting queries were study administration (7%), design (12%) and procedures (13%), participant selection and recruitmen (8%), and lastly data protection (9%). Because of these findings, the standard operating procedures of the committee have been revised--use of provided template participant documentation is strongly encouraged, and a "Recurring Review Themes" checklist is highlighted to all applicants.
authors.affiliation: RCSI, 123 St Stephen's Green, Dublin 2. eoinkelleher@rcsi.ie
authors.forename: E
authors.initials: E
authors.lastname: Kelleher
authors.forename: A
authors.initials: A
authors.lastname: Stanton
authors.forename: G
authors.initials: G
authors.lastname: Vale
authors.forename: D
authors.initials: D
authors.lastname: Smith
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration / Q000592:standards*; D003219:Confidentiality; D032962:Consent Forms; D028744:Ethics Committees, Research; D006801:Humans; D007494:Ireland; D010353:Patient Education as Topic; D011996:Records; D012107:Research Design / Q000592:standards*