GUIDELINES & TEMPLATES
Malaysian Guideline for Good Clinical Practice, Fourth (4th) Edition
Malaysian Guideline for Safety Reporting of Investigational Product, First (1st) Edition
International Ethical Guidelines for Health-related Research Involving Human, 2016
Declaration of Helsinki, Ethical Principles for Medical Research Involving Human subject, Fortaleza, Brazil 2013
Malaysia Decentralised Clinical Trial (DCT) Guidance Document
Guideline for Herbal Medicine Research, First (1st) Edition
Malaysian Guideline for Independent Ethics Committee Registration and Inspection, First (1st) Edition
IREC User’s/Investigator’s Guidelines
IREC Standard Operation Procedure Version 2, Revision 5
Templates for Informed Consent Form
Templates for informed consent forms
Notes to researchers
The language used throughout form should be at the level of a local student of class 6th/8th
Please note that these are templates developed by the WHO ERC to assist the Principal Investigator in the design of their informed consent forms (ICF). It is important that Principal Investigators adapt their own ICFs to the outline and requirements of their particular study. The logo of the Institution must be used on the ICF and not the WHO logo.
The informed consent form consists of two parts: the information sheet and the consent certificate.
Do not be concerned by the length of these templates. They are long only because they contain guidance and explanations which are for you and which you will not include in the informed consent forms that you develop and provide to participants in your research.
These templates include examples of key questions that may be asked at the end of each section, that could ensure the understanding of the information being provided, especially if the research study is complex. These are just examples, and suggestions, and the investigators will have to modify the questions depending upon their study.
In these templates:
- square brackets indicate where specific information is to be inserted;
- bold lettering indicates sections or wording which should be included;
- standard lettering is used for explanations to researchers only and must not be included in your consent forms. The explanation is provided in black, and examples are provided in red in italics. Suggested questions to elucidate understanding are given in black in italics.
Disclaimer: This information was adopted from WHO ERC website. Link to original site: WHO ERC