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What is an ICF?

An Informed Consent Form (ICF) contains an explanation in lay language of the purpose and other aspects of the clinical trial relevant to the potential participants decision to participate (referred to as Participant Information Sheet, written information, ) as well as documentation of consent (certification of

What is informed consent in the Institutional Review Board?

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.

What is an ICF document?

A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts.

How to write an IRB consent form?

The Consent Form used in a study should be edited to match requirements of the specific study: It should include information about the investigator, the topic under study, and a clear description of purpose, risks, and benefits.

What is an ICF template?

Instructions for Developing an Informed Consent Document General Information. Describe the purpose(s) of this research study in lay terms. Purpose of the Study. Procedures. Risks. Benefits. Compensation, Costs and Reimbursement. Withdrawal or Termination from Study. Confidentiality.