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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 participant’s decision to participate (referred to as Participant Information Sheet, written information, …) as well as documentation of consent (certification of consent), presented within the same document or as separate documents. The purpose of the ICF is to obtain and document freely given informed consent from the trial participant by means of a signed and dated written ICF.
The ICF should include the required elements as defined in ICH E6, such as a general statement and background; purpose and description of the trial design, treatment, and procedures; risks, benefits, and alternative care options; costs/payment and compensation; confidentiality; and participant’s rights.
The ICF should be written in a language that the potential participant understands. It should be simple in style and content. The use of visual aids may facilitate understanding. The language might need to be adapted to country level to ensure compliance with the local requirements.
The ICF can be updated if new information becomes available that might be relevant to the participant’s consent.
The ICF (update) should receive approval/favorable opinion from the institutional review board (IRB)/independent ethics committee (IEC) in advance of use. In the US, a Long Form or a Short Form combined with an oral explanation can be used. When a Short Form consent document is used, the IRB should review and approve the written summary of the full information to be presented orally to the potential participants.
The Medical Writer can be involved in the document development process (eg, writing, circulating for review, implementing comments), after or during development of the Clinical Trial Protocol.
Need for training? Professionals from Emtex Life Science and Emtex Academy have recently developed a new course. Development of the Informed Consent Form
This training is designed to help medical writing professionals effectively write Informed Consent Forms (ICFs) for participants taking part in clinical studies.
FAQ: Informed Consent Form (ICF)
What is an Informed Consent Form (ICF)?
An ICF is a document that provides potential participants with all the information they need to make an informed decision about taking part in a clinical trial and records their voluntary agreement to participate. It needs to be written in a plain language that potential participants can understand.
What information is included in a ICF?
An ICF explains the purpose, procedures, risks, and benefits of the trial, as well as alternative treatment options, confidentiality measures, participant rights, and any costs, payments, or compensation.
When is an ICF needed?
An ICF is needed before a participant can enroll in a clinical trial and must be signed and dated before any trial-related procedures are performed.
How can Emtex Life Science support the preparation of the ICF?
Emtex Life Science can support the ICF process by drafting content, coordinating reviews, and ensuring that the document is clear, easy to understand, and compliant with regulatory requirements.
Why is professional medical writing support valuable for the ICF?
Professional medical writers help translate complex scientific information into an understandable language, improving participant comprehension while ensuring regulatory compliance.