DDF4a An Introduction to Informed Consent Forms

The concept of informed consent is a key part of Good Clinical Practice and the ethical principles that have their origin in the Declaration of Helsinki. The vocabulary and style that medical writers normally use, usually tailored for a scientifically educated audience, may not be appropriate for use in informed consent documents. Medical writers who create informed consent documents must adopt a writing style suitable for communicating with the public. On completion of this workshop package, participants should be able to write an informed consent document suitable for use in a clinical trial.

The workshop will start with some information about the historical rationale and ethical principles of informed consent. An overview of the different types of informed consent document will be provided and the regulatory requirements underpinning content, with a specific focus on data privacy, will be discussed. A general process for informed consent form preparation and a suggested general structure will be shared. The workshop will continue with some guidance on style and communicating with trial participants; special emphasis will be placed on identifying and avoiding jargon. Workshop exercises will be used to practice modifying typical source information into wording suitable for inclusion in an informed consent document.

Participant profile: This workshop is aimed at writers who are new to writing informed consent documents.