20, avenue Appia – CH-1211 Geneva 27 – Switzerland – http://intranet.who.int/homes/rpc/erc – http://www.who.int/rpc/research_ethics
(This template is for either clinical trials or clinical research)
(language used throughout form should be at the level of a local student of class 6th/8th)
Notes to Researchers:
1. Please note that this is a template 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.
2. The informed consent form consists of two parts: the information sheet and the consent certificate.
3. Do not be concerned by the length of this template. It is long only because it contains 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.
4. This template includes 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.
5. In this template:
• 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.
TEMPLATE ON FOLLOWING PAGE
[Name of Principle Investigator]
[Informed Consent form for...