世界卫生组织知情同意书模板

发表于 2023-06-08

Informed Consent Form Templates

Notes to Researchers:

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.

Informed Consent for Clinical Studiesdoc, 154kb

Consent for Storage and Future Use of Unused Samplesdoc, 92kb

Informed Consent for Qualitative Studiesdoc, 124kb

Informed Assent for Children/Minorsdoc, 129kb

Informed Parental Consent for Research Involving Children (qualitative)doc, 134kb

Informed Parental Consent for Research Involving Children (clinical)doc, 150kb

From:

http://www.who.int/rpc/research_ethics/informed_consent/en/


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