046 Challenges in receiving research ethics committee approval for studies involving children and young people with life-limiting conditions and life-threatening illnesses: analysis of research ethics committee minutes and correspondence with principle investigators

Abstract

Background Research ethics committees (RECs) are identified as one of the biggest barriers to research with vulnerable populations, such as children and young people with life-limiting conditions or life-threatening illnesses (CYP with LLC/LTI). Despite this, REC concerns for research with this population and their correspondence with principle investigators during the research approval process remains unknown. The aim is to explore the challenges in receiving REC approval for studies involving CYP with LLC/LTIs, focusing on the primary concerns of the REC and the ways these are addressed by the research team. Methods Analysis of REC meeting minutes, REC decision letters, and researcher response letters were conducted for all studies involving CYP with LLC/LTIs reviewed in the United Kingdom between March 2011–2016. Results REC meeting minutes and decision letters were received for 77 studies, with 27 researcher response letters provided. Though most REC concerns were general, relating to participant information sheets, methodological issues, or formatting errors, a number of concerns specific to CYP with LLC/LTIs were also identified, such as the age of consent/assent or the need to involve clinical teams in recruitment. Overall, RECs raised 279 concerns in their correspondence with investigators, most of which resulted in changes to research methods or documentation. Conclusions Research protocols involving CYP with LLC/LTIs usually require multiple changes before REC approval is given. Many of the main REC concerns, such as formatting issues or insufficient detail, can be easily resolved with attention to detail or peer review prior to submission. Others, such as recruitment methods or consent procedures, require more detailed consideration of study methods to ensure they appropriately consider the needs of CYP with LLC/LTIs. Understanding REC concerns may help researchers consider potential issues more thoroughly before submission, reducing the impact of RECs as a barrier and improving research quality overall.