title: 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.
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Graduate School of Biomedical Sciences, Nagasaki University, Japan,. nkoonrung@gmail.com.
authors.forename: Nut
authors.initials: N
authors.lastname: Koonrungsesomboon
authors.affiliation: Chulabhorn International College of Medicine, Thammasat University, Thailand,. j.laothavorn@gmail.com.
authors.forename: Junjira
authors.initials: J
authors.lastname: Laothavorn
authors.affiliation: Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Institute for the Development of Human Research Protection, Ministry of Public Health, Nonthaburi, Thailand,. vichaichok@yahoo.com.
authors.forename: Vichai
authors.initials: V
authors.lastname: Chokevivat
authors.affiliation: Department of Immunogenetics Institute of Tropical Medicine, Nagasaki University; Forum for Ethical Review Committees in the Asian and Western Pacific region (FERCAP),. hiraken@nagasaki-u.ac.jp.
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirayama
authors.affiliation: Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University; Strategic Initiative for Developing Capacity in Ethical Review (SIDCER),. karbwangj@nagasaki-u.ac.jp.
authors.forename: Juntra
authors.initials: J
authors.lastname: Karbwang
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002985:Clinical Protocols; D032882:Comprehension; D032962:Consent Forms / Q000592:standards*; D026724:Ethical Review; D006801:Humans; D007194:India; D007258:Informed Consent