Nature and extent of changes in the patient's information sheets of international multicentre clinical trials as requested by Spanish Research Ethics Committees

Research Ethics Committees’ Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols

“…This article addressed a basic descriptive question—“what are the ethical issues raised by RECs reviewing biomedical research in South Africa?” The most frequent ethical issue identified in our study was informed consent—a finding comparable with similar studies in South Africa (Clarke, 2014; Cleaton-Jones, 2010; Tsoka-Gwegweni & Wassenaar, 2014), the United Kingdom (Angell, Bryman, Ashcroft, & Dixon-Woods, 2008; Boyce, 2002), the United States (Lidz et al, 2012), Thailand (Adams et al, 2017), the Netherlands (van Lent, Rongen & Out, 2014), France (Decullier, Lhéritier, & Chapuis, 2005), Brazil (Bueno et al, 2009), Spain (Dal-Ré, Morejón & Ortega, 2004; Martín-Arrabis, Rodríguez-Lozano, & Arias-Díaz, 2012), and Finland (Hemminki, Virtanen, & Regushevskaya, 2015). A German study reported that of 1,299 queries, 53% concerned the patient information and consent document (Russ, Busta, Riedel, Zollner, & Jost, 2009).…”

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

“…Inadequately described risks of study procedures have been reported to be one of the most common reasons why RECs request clarifications or demand amendments to research protocols and participant information sheets (Adams et al, 2013;Dal-Re et al, 2004;Lopez-Parra et al, 2012;Happo et al, 2017), and our present findings are in line with these observations. However, there is still limited knowledge as to why researchers appear to focus on the presentation of certain potential study procedures risks more than others.…”

The Multidimensional Nature of Research Ethics: Letters Issued by a French Research Ethics Committee Included Similar Proportions of Ethical and Scientific Queries

“…Several prior studies have focused on REC letters. Some focused on specific documents, especially information sheets (Dal-Ré et al, 2004). Other authors presented their results according to the documents involved or according to the ethical principle that the query was based on (Hemminki et al, 2015; Martín-Arribas et al, 2012; Russ et al, 2015; Silaigwana & Wassenaar, 2019).…”

“…Analysis of REC letters to researchers enables the definition of what RECs identify as attributions in their role as gatekeepers. In most cases, authors classify REC queries according to predetermined categories on the basis of ethical guidelines, whereas other authors base their analyses on identifying problematic documents within research folders (Dal-Ré et al, 2004; Happo et al, 2017; Hemminki et al, 2015; Lukaseviciene et al, 2020; Martín-Arribas et al, 2012; Silaigwana & Wassenaar, 2019; Tersmette & Engberts, 2017). Informed consent is the most frequent topic of queries from RECs (and therefore, informed consent documents are the most common problematic documents) (Boyce, 2002; Decullier et al, 2005; Tsoka-Gwegweni & Wassenaar, 2014).…”