Vol , Issue Date of Publication: February 29, 2016
DOI: https://doi.org/10.20529/IJME.2016.023

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SIDCER informed consent form: principles and a developmental guideline

Nut Koonrungsesomboon
Junjira Laothavorn
Vichai Chokevivat
Kenji Hirayama
Juntra Karbwang
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.


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©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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