SIDCER informed consent form: principles and a developmental guideline

Abstract

The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In collaboration with the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), we have developed the SIDCER ICF, which could be of value in improving the quality of the ICFs. The three principles underlying the SIDCER ICF were: (i) an ICF contains all the required regulatory elements; (ii) an ICF provides only such information as is relevant for the subject's decision-making; and (iii) an ICF presents information in a simple format that conveys relevant information to the target population. The SIDCER ICF template, with its instructions, was then structured to assist an investigator in developing an enhanced ICF according to the three principles. The applicability of the SIDCER ICF was tested using a phase I study protocol, and a variety of experts with a special interest in ethics and clinical research were invited to evaluate the comprehensiveness of the three-page ICF for the phase I study. The SIDCER ICF template was refined and finalised in accordance with the results and comments from the experts.

Improved pregnant women’s understanding of research information by an enhanced informed consent form: a randomised controlled study nested in neonatal research

“…While the nature of informed consent is generally context-specific, the results of our previous and present studies consistently support the applicability and effectiveness of the general features of the SIDCER ICF methodology in various settings 13 14. This could be attributable to the fact that the SIDCER ICF is concise, organises all the required elements in a simple format, and focuses on relevant information for the participants’ decision-making 12. In addition, the SIDCER ICF makes use of several presentational means including a narrative format, summary boxes, highlight keywords and illustrations, as appropriate.…”

“…Following the SIDCER ICF methodology ensures that the ICF for a particular study is complete with respect to compliance with internationally recognised regulatory ICF requirements 12. The use of the SIDCER ICF methodology in neonatal research could thus ensure or enhance the validity of parental consent obtained.…”

“…The SIDCER ICF (in Thai) was developed following the SIDCER ICF methodology extensively described elsewhere 12. Study-specific information that is essential and relevant to prospective pregnant women’s decision-making on whether to let their baby participate in research was incorporated into the ICF template (available from: http://ijme.in/pdf/appendix1.pdf?v=1).…”

“…The questionnaire (in Thai) consisted of 25 scenarios followed by closed-ended questions addressing 25 required elements of the ICF content: 5 general items, 4 rights of the participant, 8 scientific aspects and 8 ethical aspects 12. Of three answer choices provided in each question, there was only one correct answer with a score of 1, making the maximum score 25.…”

“…The Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) has recently proposed ICF development methodology to address such a need 12. The SIDCER ICF methodology has been shown to be effective in improving participants’ understanding of research information in previous studies, especially among those with lower levels of education 13 14.…”