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Required Elements of Written Informed Consent

General Requirements

  • Clearly explain the purpose of the research project and include a statement that the individual is being asked to participate in a research project.
  • State the expected duration of the individual’s participation. Provide an estimate of the amount of time required for each visit, the overall number of visits, and the overall length of time that will be required to complete participation in the research project.
  • Describe all of the procedures, tests, drugs, questionnaires, etc. that will be used, identifying any that are investigational, placebo, and/or beyond standard of care. Be clear about what interventions or diagnostic procedures are above and beyond the usual care that participants would receive. Full disclosure regarding which research procedures are paid for by the Sponsor is required. Any risks to participants should be clearly stated.
  • Describe any previous research of the intervention in humans; where available, include the numbers of participants involved in such projects.
  • Describe any appropriate alternative procedures or courses of treatment to what is being done as part of the research project. Include a statement that the participant may elect to receive standard treatment instead of participating in research.
  • Provide a statement that a particular investigational procedure/treatment may involve risks to the participant which are currently unforeseeable (or to the embryo or fetus if the participant is or becomes pregnant).
  • Describe any known and reasonably foreseeable risks and discomforts that the participant may experience. Quantify risks wherever possible (e.g., “less than 2%” rather than “rare”).
  • Clearly describe any benefits, or lack of benefits, that the participant or others may experience.
  • Include a statement that any significant new information, which becomes available during the research, which may relate to the participant’s willingness to continue participation, will be provided to the participant.
  • Provide the approximate overall number of participants who will be involved in the project in total across all centres if the project is a multi-centre trial.
  • Provide a statement that participation is voluntary, that the individual may refuse to participate, and that participation can be terminated by the individual at any time without prejudice. Provide instructions on how to exercise this right (note: written notification of withdrawal is not required).
  • Provide a statement that the individual’s participation may be terminated by the Principal Investigator or Sponsor without the participant’s consent. Examples might include: the participant’s medical best interest, funding is stopped, drug supply is insufficient, participant ’s condition worsens, new information becomes available, failure to take the investigational product as described, etc.
  • If applicable, list requirements to disclose any medications, natural health products, alcohol, or drugs currently being taken and any relevant restrictions that the individual is required to follow to continue participation in the clinical trial.
  • Provide a statement indicating the potential financial conflicts of interests of the investigator(s) and institution(s).
  • Provide a statement that medication should be kept out of the reach of children and others for whom it is not intended.
  • Provide a statement regarding any specific individuals who should not participate in the project such as pregnant or breast-feeding people.
  • Provide information about acceptable methods of birth control for individuals of childbearing potential or for individuals who are sexually active. The exact methods of birth control required will be stated in the project protocol and will be dependent on the known toxicities of the investigational product(s) or device(s).
  • For FDA-regulated clinical trials include the following statement:
    “ClinicalTrials.gov is a website that provides information about federally and privately supported clinical trials. A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by US Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”
  • For non-FDA regulated clinical trials include the following statement:
    “ClinicalTrials.gov is a website that provides information about federally and privately supported clinical trials. A description of this clinical trial will be available on www.ClinicalTrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time.”

Specific to Open Label Extension Phases

  • Note that a separate informed consent form will be required for the open label extension phase of the clinical trial.

Specific to Participant Compensation

  • Describe any methods and amounts of payment or reimbursement for expenses that would result from participation in the project. Financial compensation is expected to reimburse the participant for time and out-of-pocket expenses that result from participation in the project. Financial compensation that could influence the participant’s judgement is not acceptable.
  • Provide a statement as to whether compensation and/or medical treatment would be available if a research-related injury occurs and where further information may be obtained.
  • Include a description of any additional costs to the participant as a result of participation in this research project.

Specific to Contacts for Participants

  • Provide the name(s) and phone number(s) of the Principal Investigator and/or member(s) of the research team who may be contacted for information on research-related questions and research-related injury.
  • Provide contact information for CHIPER REB to ensure objective input to questions that the participants may have about their rights when participating in research. Please see the example of the preferred informed consent form wording below:

     

    For questions about your rights as a research participant or about ethical issues related to this project, you may contact the RITHIM Program Officer by email CHIPER@researchmb.ca or phone 204-775-1096 / 1-866-248-4375 (toll-free)

Specific to Participants’ Confidentiality

  • Include a statement of confidentiality that describes how the information from the project and the participant’s identification will be distributed and protected.
  • Indicate how information will be de-identified before it is distributed outside the project site.
  • Include a statement that the Research Manitoba, RITHIM Program may have access to the participant’s confidential information and will protect the confidentiality of that information in compliance with PHIA, to the extent permitted by law.
  • Include a statement that all other organizations who may have access to the participant’s confidential information will protect the confidentiality of that information in compliance with PHIA, to the extent permitted by law.
  • Include a statement that the identity of the participant will be protected, but due to access from all of these organizations, it cannot be guaranteed.
  • Include a statement that the participant will not be identified in any published data.
  • Include a statement that participant’s data will only be used for research purposes.

Formatting

  • The first page of the consent form should contain the logo(s) reflecting the research team’s post-secondary and clinical affiliations
  • The Principal Investigator’s post-secondary and clinical affiliations should be named on the first page 
  • Write the consent form in simple language that is understandable to the general public. Do not use technical or medical language. Write to a grade 6-7 level of understanding.
  • It is preferable to use the word “participant” to refer to the individual who is consenting to participate in the research project.
  • Avoid language that implies judgment, bias, or guilt.
  • Be consistent with the use of pronouns so that there is no confusion regarding who is the participant and who is the investigator. Be consistent and clear when using first vs second person perspective.
  • Each page of the informed consent form, or information sheet needs to state:
    • the exact title of the approved protocol as a header or footer,
    • the page number as well as the total number of pages (e.g., 1 of 5 pages) as a header or footer,
    • a designated place for the participant to initial to show that they have reviewed each page in the footer,
    • document version date in the footer.
  • The final section of the consent must be written in the first person (as “I” statements) and include a statement that:
    • the participant has been informed of the titled project and that they have had all of their questions answered,
    • the participant agrees to participate in the project,
    • the participant has a right to confidentiality,
    • the participant has a right to decline participation or to withdraw,
    • the participant does not waive any of their legal rights by signing the document,
    • the participant will be given a copy of the consent for their records.
  • The informed consent form must have a place for the participant to sign their name, print their name, and date their signature.
  • For individuals incompetent to provide consent, include a place for the individual to sign their assent along with the name and signature of the LAR/parent/legal guardian. A separate simplified assent form may be recommended to be developed.
  • After the participant’s signature section include a statement that the protocol has been explained to the participant and that the participant appears to have understood the research project. This section will be signed by a member of the research team, the individual who has explained the project and obtained the consent.
  • For third party signatures, the form should also have a place for a witness/interpreter to sign their name, print their name and date their signature. By signing the form, the witness/interpreter attests that the information in the Participant Information and Consent Form was accurately explained to and apparently understood by, the participant or the participant’s legally acceptable representative and that informed consent was freely given by the participant or the participant’s legally acceptable representative.

There may be additional requirements for regulated projects under GCP, Health Canada or FDA regulations. It is the researcher’s responsibility to ensure all applicable requirements are met. Please consult our External Resources page for relevant links.