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| 1. | Title | Title of document | SIDCER informed consent form: principles and a developmental guideline |
| 2. | Creator | Author's name, affiliation, country | Nut Koonrungsesomboon; Graduate School of Biomedical Sciences, Nagasaki University,; JP |
| 3. | Subject | Discipline(s) | |
| 3. | Subject | Keyword(s) | |
| 4. | Description | 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. |
| 5. | Publisher | Organizing agency, location | Forum for Medical Ethics Society |
| 6. | Contributor | Sponsor(s) | |
| 7. | Date | (YYYY-MM-DD) | 2016-11-30 |
| 8. | Type | Status & genre | |
| 8. | Type | Type | |
| 9. | Format | File format | HTML , PDF |
| 10. | Identifier | Uniform Resource Identifier | https://ijme.in/articles/sidcer-informed-consent-form-principles-and-a-developmental-guideline/ |
| 11. | Source | Title; vol., no. (year) | Indian Journal of Medical Ethics;: Ethics in practice |
| 12. | Language | English=en | en |
| 13. | Relation | Supp. Files | |
| 14. | Coverage | Geo-spatial location, chronological period, research sample (gender, age, etc.) | |
| 15. | Rights | Copyright and permissions | All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal. |