Clinical Consent Form (template)

The following consent form is provided for illustrative purposes only and must be adapted to accurately reflect the proposed project.

This consent form is intended for use with clinical trials.

It is consistent with the major principles set out in the following among other documents:

  • The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition (2010)
  • Acts and regulations concerning clinical trials, including:
  • Canada: Food and Drugs Act, R.S.C. (1985), c. F-27; Part C, Division 5, of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects);
  • USA:FDA Regulations Relating to Good Clinical Practice and Clinical Trials;
  • TheInternational Ethical Guidelines for Biomedical Research Involving Human Subjects(Council for International organizations of Medical Sciences,2003);
  • TheInternational Conference on Harmonisation (ICH), Guideline E6: Guideline for Good Clinical Practice: Consolidated Guidelines(of the ICH, on Technical Requirements for Registration of Pharmaceuticals for Human Use), 1996, adopted by Health Canada in 1997.
  • The Universal Declaration on Bioethics and Human Rights (UNESCO, 2005);
  • The Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (World Medical Association, October 2008).

A consent form is a tool designed to facilitate the overall consent procedure where "consent" means “free, informed and ongoing consent," and where the terms "free" and "voluntary" are used interchangeably.”(Ref.: Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd Edition, Chapter 3).

If you intend to include an optional study within this main study in order to obtain human biological material (e.g., blood, saliva or skin samples) under the operational study, please refer to the “Consent Form for Optional Component of a Study” (template).

Instructions:

  • Ensure that the consent form distributed to participants is consistent with the research protocol and, as applicable, the clinical expert’s notice (experimenter’s guide or researcher’s brochure).
  • Omit italicized sections from the final version.
  • Check that the level of language used is appropriate: grade 8 level is recommended.
  • Express all scientific terms in plain language. Ex.: "DNA: A molecule that contains all of the genetic information required to direct cell activity in our body. DNA provides a series of instructions that determine the hereditary traits of an individual, such as eye colour or blood type.”
  • Use the generic names of drugs (medications), except in the case of products comprising several ingredients. The commercial name may be used in such cases only.
  • Avoid using abbreviations or acronyms, etc.
  • Use terms consistently.
  • As applicable, specify the number, date and version of the research protocol related to the consent form.
  • At the bottom of the page, add "Consent Form - version # dated --/--/---- "
  • Number the pages 1/N, 2/N, 3/N … N/N.
  • Include the Hôpital Montfort logo and the logo of organizations participating in the research, as applicable.
  • Correct all typos and grammatical or syntactic errors.
  • Carefully check that the French and English versions of the document are an exact match for content, style and intent.

Please begin with the following information:

11. GENERAL INFORMATION

Project Name: Enter the project’s official name.

Principal Researcher’s Name(and supervisor’s name, as applicable): Specify his/her affiliation(s) (department, faculty or institute) and contact information(work and non-personal telephone numbers and email addresses).

Names and Contact Information of Co-researchers: Specify their affiliation(s) (department, faculty or institute) and contact information (work and non-personal telephone numbers and email addresses). State the name of the principal researcher affiliated with Hôpital Montfort.

Emergency Contact: As applicable, give the name and contact information for the person to call in the event of an emergency.

Funding Source: Specify the name of the organization funding or sponsoring this portion of the research. If none exists, specify accordingly. This portion of the study is funded by (sponsor’s name, funding organization, pharmaceutical company, other). State whether the principal researcher is receiving financial compensation for recruiting participants. State whether participants can ask to receive relevant information.

Conflicts of Interest: Specify whether or not there are any apparent or potential conflicts of interest and disclose any likelihood of marketing the results, as applicable. If none exists, specify accordingly (ex.: specify whether the principal researcher and/or the institution have a financial interest in the company funding the project) (for advice given concerning the methodology, travel expenses, studies, etc.), and/or whether the principal researcher and/or the institution have a financial interest in the company funding the project. (Note: Participants have the right to request details.)

2. INTRODUCTION

To ensure that participants feel free to knowingly agree or decline to participate in the research project, you may introduce the document with a paragraph such as: Before agreeing to participate in this research project, please take the time to read and carefully consider the following information. This document explains the purpose of the research project, its procedures, benefits, risks and drawbacks. Please ask the person who gave you this document any questions you consider relevant.

3. INVITATION TO PARTICIPATE

I am being asked to participate in the above-named research project conducted by (researcher’s name and affiliation) or conducted by (student’s name) of (name of department, faculty or institute) under the supervision of (professor’s name) of the (name of department, faculty or institute).

Call attention to the voluntary nature of the participation: I am free to participate in this optional study or not. My decision to participate or withdraw from the study will not affect the quality of service provided to me now or in the future in any way.

4. PURPOSE

The purpose of the study is to (state why the research is being performed and explain its objectives).

The main purpose of this study is to help other patients in the future. Although this study may be of benefit to (certain participants during the course of the study or other persons in the future), this clinical study involves (evaluating a therapy (with medication as applicable) or experimental procedure), and is therefore primarily intended to general knowledge and not to provide a therapy. (Ref.: TCPS 2, Chapter 11, paragraph on Therapeutic Misconception)

Please specify whether this is a Phase I, II, III or IV study and explain to participants what this means in plain language.

5. INCLUSION/EXCLUSION CRITERIA

Describe the inclusion and exclusion criteria applicable to this portion of the study.

6. PARTICIPATION

My participation will essentially consist of (example: attend sessions, number of sessions and length of each session/procedure) during which (description of tasks to be performed by participants). (Sessions) are planned (place, date, time and length of each session). I will also be asked (examples: to complete questionnaires, participate in interviews, group meetings, etc.; please specify the length of each task).

Notes:

a. If the research involves the use of a placebo, explain the term as follows the first time you use it: "a substance that appears the same as the drug used in the study but that has no known effect”.

b. If the project is a randomized clinical trial, explain the randomization process in plain language (e.g., random placement in a group and, as applicable, describe what it means when the attending physician is unaware of what the participant is taking (blinding));

c. Please clearly distinguish between procedures used in standard treatments and the procedures specific to the clinical trials. A summary chart may be used for simplification.

d. If the research involves any radiation exposure, the amounts must be explained in comparison to radiation exposure over x number of days (ex., an x-ray of your lungs exposes you to the same amount of radiation that you would normally be exposed to over an x-day period).

Alternatives to Participation: As applicable, specify the options (ex.: other therapeutic treatments or palliative care) available to participants if they choose not to participate in your project or to withdraw during the course of the study.

7. BENEFITS

My participation in this research will (explain the nature of any benefits to):

  • the participant (if there are no direct benefits to the participant, inform the participant accordingly);
  • others; and,
  • the advancement of knowledge.

8. RISKS

I understand that since my participation in this research (example: requires me to provide personal information), there is some possibility that it will result in (describe possible risks of emotional, psychological, physical, social, financial or other discomfort). Specify the support measures you plan to offer participants to mitigate any possible risks.

In the case of drug trials, you must include a description of any possible and probable unwanted side effects, including a probability percentage (ex.: 4people in 100 experienced dizziness) that each might occur.

For a study free of any apparent risk, you may simply mention the following: No known risks are involved in participation in this research.

9. MARKETING OPPORTUNITIES / WAIVER

An analysis of my sample could contribute to creating commercial products from which I may not derive any financial benefit.

10. DATA CONSERVATION

The data gathered (please specify the data gathered, i.e., in paper or electronic format; examples: tapes, questionnaires, transcripts on compact disks, notes, etc.)will be kept in a secure manner (describe how and where data will be stored, who will have access to it and how long it will be conserved. NB: If data is transferred or shared between several sites, specify the data conservation methods used at each site).

11. CONFIDENTIALITY AND ANONYMITY

I have the researcher’s assurance that any information I share with him (her) will be kept strictly confidential. I expect that the content will be used only for (specify the purpose for which the gathered data will be used) and with respect for confidentiality (explain how confidentiality will be protected). However, there is some possibility that research records identifying me (in the case of questionnaires concerning identifying data) will be examined in the presence of the researcher by a representative of the organization sponsoring or funding the research (state the name of the organization, the pharmaceutical company, the ICRS or other), Health Canada, the U.S. Food and Drug Administration (if relevant) and the Research Ethics Board for research control purposes. However, I have been given assurances that no record identifying me, by name or initials, for example, will be permitted to leave the researcher’s office. (If confidentiality cannot be protected by reason of a legal obligation, please state so explicitly and give the reason.)

Anonymity is guaranteed as follows (description of how participant anonymity will be achieved. If anonymity cannot be guaranteed, please state the reason and specify the risk that could result (to the participant, organization, etc.). Please state whether the participant’s identity will be disclosed in publications.

In the case of focus groups, researchers are required to explain the two types of confidentiality applicable: 1) researchers can ensure the confidentiality of the information, but 2) cannot offer guarantees on behalf of other participants.

Since March 7, 2013, the Food & Drug Administration has required that the following text be included verbatim in all consent forms for clinical trials required to meet US regulations:

On the English form:“A description of this clinical trial will be available on 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.” (Ref: 21 CFR 50.25(c)).

On the French form: "Ainsi que l’exige une loi américaine, une description de cette essai clinique est disponible sur le site . Ce site Web n’inclura aucune information permettant de vous identifier. Au plus, ce site Web présentera-t-il un résumé des résultats. Il vous est possible de faire une recherche sur ce site en tout instant.(Translation)"

12. VOLUNTARY PARTICIPATION

My participation in the study is voluntary. I am free to withdraw at any time or to refuse to answer certain questions without exposing myself to any negative consequences (specify whether any perception of undue influence may exist, for example, where the researcher is in a position of authority over the participant). If I decide to withdraw from the study, the data gathered up to that time will be (specify what will happen to data gathered up to the time of the participant’s withdrawal).

Mention that participants (or their lawful representative) will be informed at the appropriate time if any new information arises that might affect their interest in continuing to participate in the study.

13. REIMBURSEMENT/COMPENSATION

State whether any compensation is being offered: refunded parking charges, bus tickets, monetary compensation for time spent on the research and lost for regular activities, a token gift [specify the item to be given], a coupon, etc. If no compensation is offered, enter: I will not be receiving any compensation for my participation in the research.

14. NOTIFICATION OF RESULTS

Also specify how participants will be notified of the research results (publications or other means):

I will be able to contact the research team to obtain information about the progress of the research.

If a scientifically corroborated result of significance to my health is found and if preventive measures or treatments are available, I wish to be informed by a physician:

Yes:

No:

The disclosure of such information places me and my family at risk in certain regards: anxiety, stress, discrimination (employers, insurers, etc.) and could affect my decision to have children.

15. CIVIL LIABILITY

Please notify participants of their right to legal recourse in a sentence such as: My consent to participate in this study does not affect my right to seek legal recourse in any manner whatsoever. If my participation causes me any prejudice, I reserve the right to take any available legal recourse against the various research partners.

16. CONSENT

Acceptance:

I, (participant’s name), agree to participate in this research project conducted by (researcher’s name) or by (student’s name) under the supervision of (professor’s name). For any further information concerning this study, please contact the researcher or the researcher’s supervisor.

For information concerning ethical aspects of this research, I may contact the Hôpital Montfort Research Ethics Board, 745-A Montreal Road, Ottawa, Ontario by telephone at 613-746-4621, extension 2221, or by email at .

There are two copies of the consent form, one of which I may keep.

Participant’s Signature: (Signature)Date: (Date)

Researcher’s Signature: (Signature)Date: (Date)

If a participant is unable to read the consent form (blind, etc.) or unfit to provide consent (child, cognitive impairments, etc.), space must be added for the signature of a witness or authorized third party. N.B. Do not include this section if it does not apply to your project. If necessary, refer to TCPS 2 for more details: Chapter 3, The Consent Process (p. 29-48) and Chapter 11, Clinical Trials (p. 167-189).

Version dated July 23, 2014

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