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World Gastroenterology Organisation
World Gastroenterology Organisation

How to Write an Informed Consent Document

The purpose of this portion of the WGO research module will be to assist researchers with the preparation, content and format of an informed consent document. A checklist of items, informed consent templates and a glossary to assist in the simplification of medical terms are some of the key components of this section. Proposed content will include the following:

An informed consent document outlines the research study and expectations for potential participants. The ethical principle of respect for persons requires that subjects be given the opportunity to choose what shall and shall not happen to them; valid informed consent ensures this by: (1) providing disclosure of relevant information to prospective subjects about the research; (2) helping to ensure that there is comprehension of the information, and (3) demonstrating that subjects have provided voluntary agreement to research participation.

Ideally, informed decision-making by research subjects is a process that includes discussion of the research study with the Principal Investigator (PI) and signing the written informed consent document. Ongoing discussion with, and education of subjects, about the study should ideally continue long after the informed consent document is signed.

There are many guidance documents and templates available to assist with the writing of informed consent documents. These documents not only provide guidance on the required elements of informed consent documents, but there are also many helpful tips available regarding ways to reduce the reading level, and improve readability, for study subjects. Selections of helpful links are provided below:

  1. Writing an Informed Consent Document
  2. Informed Consent Templates