Drafting Consent Document

It is the Investigator’s responsibility to submit a research consent document drafted according to the MUHC standards. A model consent document prepared by an external sponsor is acceptable when it is modified to comply with the information below. 

The well designed Information and Consent Document provides sufficient information for the prospective subject to make an informed choice concerning study participation. The document must be clear and easy to understand for the individual to comprehend what is expected of a research subject. The consent document provides a written explanation of the research in a readable style to serve as future reference for the study subject and to document that the informed consent discussion took place. As a record of the discussion, the document content should summarize the conversation that took place, contain all relevant details on procedures and the investigational product or experimental intervention being studied, and specify whom to contact should questions arise.

The well designed Information and Consent Document provides sufficient information for the prospective subject to make an informed choice concerning study participation. The document must be clear and easy to understand for the individual to comprehend what is expected of a research subject.

Information at the following links will help the Investigator with drafting an appropriate document:

Information and Consent Document

Prescriptive or formulaic approaches to writing an "information and Consent Document: is to be strongly avoided. Rather, investigators must draft these documents by considering the specific type and nature of the research and the population to be recruited.  The “FRSQ Working Group for the Harmonization of the Information and Consent Document,” produced a template to serve as an educational, informational and guidance resource.  Although designed specifically for clinical trials, it is an excellent reflection tool to help with writing most types of Information and Consent Documents to use for human subjects research. 

The translated English version of this template has been slightly modified from the original French. The most significant modification is the reduced literacy level of the “consent document text” (highlighted in yellow), which remains much higher in the French version. At the MUHC, the recommended literacy level for the information and consent document is Grade 8.

  • For those conducting research on children, please contact the elizabeth [dot] craven [at] mail [dot] mcgill [dot] ca (Pediatric Research Ethics Board Coordinator) for consent and assent templates.
  • English and French versions of the Information and Consent Document must be available to potential participants.  This document can be submitted to for ethics review in either language. Once the document is approved by the REB, a translated version must be submitted and approved. The versions must be consistent with each other.
Genetic Research and DNA Banking

Genetic research aims to characterize and identify genetic factors in diseases and adaptive phenotypes or neutral polymorphisms in families or sub-populations demonstrating genetic, clinical, and demographic characteristics pertinent to study.  Genetic diseases can be hereditary (mendelian), genetic (sporadic, somatic) or multifactorial (predisposition, susceptibility). 

At the MUHC, genomic research is conducted according to procedures for obtaining and using this material and information consistent with classical ethical principles, notably: the respect for human dignity, beneficence/non-maleficence and justice. For the purposes of research oversight, “genetic material” refers to all elements of the human body which can directly or indirectly provide DNA, that is tissue, organs, cells or other substances.  Genetic information obtained in the course of a study is stored under one of the following categories:

  1. nominative
  2. coded,
  3. anonymized (the individual cannot be traced but contains descriptors such as demographic and clinical data)
  4. anonymous (no descriptors at all) 

With the rapid development of technological and genomic knowledge, specific measures of protection, are required for research subjects, (individuals, families or populations), as well as for society as a whole.  McGill University and the MUHC adopted the model consent document developed by the Réseau de Médecine Génétique Appliquée (RMGA) or the Network of Applied Genetic Medicine.

For more discussion on research with human genetic material please refer to the Réseau de Médecine Génétique Appliquée website. 

* adapted from the RMGA website

Consent Checklists

The checklists on our website are tools to assist Investigators with drafting documents used to conduct a human subjects research study.  They are also useful to REB Members who will review the same study documents. The Information and Consent Document must reflect the standards on the Checklists before submitting an application for REB review.  You can use the checklists below to verify content and format of the Information and Consent Document for your study.

Checklists should not be included in the “document package” submitted for REB review.

Checklist Consent Document Content specifies the required Basic Elements of Informed Consent and Additional Elements of Informed Consent that may be required by specific study design as well as “best practice” information.

Checklist for Document Formatting specifies how to structure and design the written presentation of the information to be most useful to a prospective research subject.

Elements of Informed Consent

Elements of Informed Consent refer to the essential information that must be disclosed to a person in order for the informed consent of a research subject or a research subject's legally authorized representative to be legally effective.  The “elements” were first described in US law and consist of a baseline of “basic elements” and a set of “additional elements” that address specific circumstances or conditions required by the research study design. 

Legal requirements for informed consent were instituted as a means to ensure that moral consent would be sought.  The Nuremburg Code states informed consent is morally valid when disclosure and comprehension of Information is discussed in the presences of voluntariness and the competence to consent.  The informed choice to participate as a research subject is expressed as informed consent. 

An REB may require inclusion of additional information it considers would be meaningful to the protection of the rights and wellbeing of subjects or otherwise assist with the decision to participate or not in a research study.

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