Completeness of consent forms in research proposals submitted to an ethics review committee

Abstract

This was a descriptive cross-sectional study which analysed the consent forms submitted to the ethics review committee at the faculty of medicine of the University of Kelaniya, Sri Lanka, between January 2007 and December 2008. Of the 145 consent forms reviewed, 94.5% (137) explained the purpose of the study, 77% (111) included a statement that participation was voluntary, 44% (64) stated that refusal of participation did not affect care, 65.5% (95) mentioned the ability to withdraw consent at any time, 79% (115) that confidentiality of records would be maintained and 45.5% (66) that further clarifications were possible. Thirty nine (75%) of 52 eligible consent forms described the potential benefits and 19% (18) of 93 consent forms explained that there were no benefits to the participants. Twenty eight (59%) of 47 eligible consent forms described possible risks or discomfort to patients and 30% (29) of 98 consent forms explained that there were no risks to the participants. In conclusion, essential elements of the consent forms were missing in this study. It is recommended that a checklist of compulsory elements to include on forms be used before proposals are submitted to an ethics review committee.