CHEO Research Institute Logo
Decrease Text SizeIncrease Text SizeFacebookTwitterYoutube

Required Elements of an Informed Consent Form

The wording in this list is based on relevant regulations/guidelines/policies. Please refer to the CHEO REB website for specific wording to be used in the informed consent document.

Regulated studies are required to have all the elements listed in columns TCPS2 (Tri-Council Policy Statement), GCP (International Conference on Harmonisation Good Clinical Practice Consolidated Guideline) and CGSB (Canadian General Standards Board). If the study is also subject to the U.S. Food and Drug Regulations, elements in column US CFR (US Code of Federal Regulations 21 CFR 50 and 45 CFR 46) are also required.

All other studies should contain all the elements listed in TCPS2; however depending on the nature of the research, the REB may require additional elements to ensure truly informed consent.

This list is informed by the International Conference on Harmonisation Good Clinical Practice Consolidated Guideline (ICH GCP); Tri-Council Policy Statement (TCPS2); US Code of Federal Regulations (US CFR) 21 CFR 50 and 45 CFR 46; and Canadian General Standards Board (CGSB) “Research ethics oversight of biomedical clinical trials”. The requirements of the Food and Drugs Act and applicable Regulations have been incorporated into the “GCP” column. Items from each of these standards have been grouped together when appropriate. The list was adapted from the Clinical Trials Ontario Informed Consent form checklist.

 Element Number

Requirement

 Description of Element

 TCPS2

GCP 

CGSB 

US CFR 

 General

 1

X

      The identity of the Researcher

 2

X

      The identity of the Sponsor/Funder

 3

        The study title
 Introduction

 4

 X

X

X

A statement that the participant is being invited to participate in research

 5

X

X

X

An assurance that prospective participants are under no obligation to participate and are free to withdraw at any time without prejudice to pre-existing entitlements
 Is there a conflict of interest?

 6

X

 

 

 

Information concerning the presence of any real, potential or perceived conflicts of interest on the part of the researchers, their institutions or the research sponsors

 7

 

 

X

 

A statement concerning any personal benefits that may accrue to the researcher, if applicable and deemed necessary by the REB
 Why is this study being done?

 8

X

X

X

X

A statement of the research purpose in plain language
 What other choices are there?

 9

 

X

X

X

A description of available alternative procedures or courses of treatment that are available outside of the research project

 10

 

X

    The important potential benefits and risks of alternative procedures or courses of treatment that are available 
 How many people will take part in this study?

 11

 

X

X

X

The approximate number of research participants

What will happen during this study? 

 12

 

X

X

  The probability of randomization to each intervention 
 What is the study intervention?; What are the study procedures?

 13

X

X

X

A description of the research intervention and procedures to be used, including clear indication of those aspects that are experimental

 14

X


X


The nature of participation

 15

X

 

 

 

Participants are informed of any therapy that will be withdrawn or withheld for the purposes of the research, and the anticipated consequences of withholding or withdrawing therapy
 Sample collection

 16

X

 

 

 

The type and amount of biological materials to be taken

 17

X

 

 

 

The manner in which the biological materials will be taken, and the safety and invasiveness of the procedures for acquisition

 18

X

 

 

  The intended uses of the biological materials, including any commercial use

 19

 

 

 

The measures employed to protect the privacy and minimize risks to participants

 20

X

 

 

 

The length of time the biological materials will be kept, how they will be preserved, location of storage (e.g., in Canada, outside Canada), and process for disposal if applicable 

 21

X

 

 

 

Any anticipated linkage of biological materials with information about the participant 

 22

 

 

 

The researchers’ plan for handling results and findings, including clinically relevant information and incidental findings 

 23

 

 

 

Information on the participant’s right to request the withdrawal of biological materials, including any limitations on the feasibility of that withdrawal 
 What are the responsibilities of study participants?

 24

 X

 

 An explanation of the responsibilities of the participant
 How long will participants be in the study?

 25

X

X

X

 The expected duration of participation
 Can participants choose to leave the study?

 26

 

 

X

X

The process involved for participation withdrawal

 27

 

 

 

X

The effects of a participant choosing to withdraw

 28

X

 

 

 

Information on the participant’s right to request the withdrawal of data, including any limitations on the feasibility of that withdrawal
 Can participation in this study end early?

 29

 X

X

X

X

Information on stopping rules and when researchers may remove participants from the clinical trial without the participant’s consent

 30

 

 

X

 

A statement identifying those with the authority to modify the research participants participation (such as the Researcher or Sponsor)
 What are the risks and harms of participating in this study?

 31

X

X

X

A plain language description of all reasonably foreseeable risks or inconveniences, to participants, and in general, that may arise from research participation

 32

   

X

 X

A statement that the particular treatment or procedure may involve risks to the participant which are currently unforeseeable 
 What are the reproductive risks?

 33

 

X

X

  A plain language description of all reasonably foreseeable risks to an embryo or fetus or nursing infants, if the participant is or could become pregnant 

 34

   

 X

X

A statement that the particular treatment or procedure may involve risks to an embryo or fetus (if the participant is or could become pregnant) that are currently unknown 
 Are there benefits of participating in this study?

 35

X

A plain language description of potential benefits, both to participants and in general, that may arise from participation 

 36

 

 X

X

 

If there is no known clinical benefit to the participant, the participant shall be informed

 How will the participant's information be kept confidential?                                                                                   *provisions required by the Personal Health Information Protection Act (PHIPA) must also be considered and included when applicable. 

 37

X

 

 

 

An indication of what information will be collected about participants and for what purpose

 38

X

X

X

 

An indication of who will have access to information collected about the identify of participants, including specification that the monitor(s), auditor(s), the REB and the regulatory authority(ies) will be granted direct access to the participant’s original medical records for verification of clinical trial procedures and data

 39

X

X

X

 

A description of how confidentiality will be protected and, to the extent permitted by the applicable laws and regulations, records identifying the participant will not be made publicly available

 40

X

 

 

 

A description of the anticipated uses of data 

 41

X

 

 

 

Information indicating who may have a duty to disclose information collected, and to whom such disclosures could be made

 42

 

 

X

 

Any limits to the confidentiality of the research records

 43

 X

 

 

 

The measures undertaken for dissemination of research results

 44

 X

X

 

 

If the results of the trial are published, the participant’s identity will remain confidential
 Will information about this study will be available online?

 45

 

 

 

X

The following statement shall be provided to each clinical trial to each clinical trial participant: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."
*Mandatory for inclusion, verbatim, in US FDA regulated clinical trials
 What is the cost to participants?

 46


X

X

X

Any anticipated expenses associated with participation in the clinical trial
 Are participants paid to be in the study?

 47

X

X

X

X

A description of the compensation, if any, that will be provided to the participant in the event that he/she is injured during the research 

 48

X

X

X

 

Information about any payments, including incentives for participants and reimbursement for participation related expenses 

 49

 X

 

 

 

Information on the possibility of commercialization of research findings 

 50

 

X

X

X

A description of the type of response that will be undertaken if injury occurs to a participant during the research (e.g., that treatment will be made available and covered by[X]), or that no such response is planned 

 51

X

X

X

X

A statement that the participant has not waived any legal rights/rights to legal recourse in the event of research-related harm 
 What are the rights of participants in a research study?

 52

X

X

X

X

An assurance that participants will be given, in a timely manner throughout the course of the research project, information that is relevant to their decision to continue or withdraw from participation 
 Whom do participants contact for questions?

 53

X

X

X

X

The identity and contact information for a qualified individual who can explain the scientific or scholarly aspects of the clinical trial (e.g., for further information about the clinical trial)

 54

X

X

X

X

The identity and contact information for an appropriate individual outside the research team whom participants may contact regarding possible ethical issues in the research (e.g., for questions about participant rights)

 55


X

X

X

The person to contact in the event of research related injuries
 Signatures

 56

X

X

X

X

Signature and date of signature of the participant (or their substitute decision-maker/legally authorized representative, if applicable)

 57

 

X

 

 

Signature and date of the person conducting the consent discussion

 58

 

X

 

 

Signature and date of person assisting in the consent discussion (if participant or their substitute decision-maker/legally authorized representative, as applicable, is unable to read or if translator is used)

Take Action
Quick Links

Our Researchmagnifying glass

abcefg hijklmnopqrst uvwxyz