FAQ: Informed Consent

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"Informed consent" is an ongoing process, which starts well before any consent forms are signed and continues until the subject's participation is completed. It involves meeting with a potential subject, finding out whether he or she is capable of giving consent, and discussing the purpose, risks, and benefits of participation, providing an opportunity for the individual to ask questions and receive answers, and allowing individuals to decide whether to participate. If consent is to be informed, the subjects must genuinely understand and appreciate the consequences of participating in the study. The informed consent process is different from the consent form. The consent form formalizes the agreement to participate and should be designed to document the research process. Obtaining informed consent involves ensuring that the prospective subject appreciates the consequences of their participation; it is not just giving a prospective subject a consent form to sign [TCPS Ch 3].

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Consent forms are legal documents (n.b. while legal such that it would be considered as a source document in a court of law, a consent form is not a contract) that can only be signed by adults (n.b. an exception would be an emancipated minor), and assent forms give minors (i.e., children) the opportunity to convey their own independent decision to participate in research [TCPS Ch 3 –A 3.9-3.10]. A regular consent form should be used for individuals who are 19 years of age (i.e. age of majority in BC) and older and have the decision-making capacity to consent. Consult the FHREB Guidance Notes for initial ethical review for more details about assent and informed consent.

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Yes. View consent/assent form templates.

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The FHREB’s suitable reading level for informed consent forms is grades six to eight. The Flesch-Kincaid Grade Level score is used to assess the readability of a Microsoft Word document.

Follow these steps to display the readability statistics of your Microsoft Word document:
• On the Tools menu, click Options, and then click the Spelling and Grammar tab.
• Select the Check grammar with spelling check box.
• Select the Show readability statistics check box, and then click OK.
• Return to the Tools menu, click Spelling and Grammar.

When Microsoft Word finishes checking spelling and grammar, it displays information about the reading level of the document. The Flesch-Kincaid Grade Level score rates text on a U.S. grade school level. For example, a score of 8.0 means that an eight grader can understand the document. For informed consent forms, aim for a score of approximately 6.0 to 8.0.

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A member of the study staff must obtain consent. This may be the principal investigator or designate. The principal investigator for the study must consider whether there might be the possibility of coercion by virtue of pre-existing relationships (i.e., physician-patient), and demonstrate to the FHREB how this would be minimized. An acceptable approach and when feasible, is to ensure that another member of the study staff obtains consent if the principal investigator has a pre-existing relationship with the prospective subject.

Note: The person obtaining informed consent does not have to be the same person, or only person, that conducts the informed consent discussion.

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The age of majority in British Columbia is 19. This is the age at which parental consent is no longer required.

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Consent is an ongoing, proactive, voluntary engagement. So when the young person reaches the age of majority, their new personal consent is required if new information is to be gathered, i.e. all information gained under the paediatric consent will remain in the study, but gathering further information or continuing to store identifiable biosamples for future research does require the new adult’s consent.

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The witness signature designates only that the subject (or their substitute decision maker) actually signed the form. For this reason, the witness should generally have been present during the consent process. Signature is NOT intended to verify that the subject actually understood the information conveyed, although a witness could refuse to sign if they had a concern about this. Any person who can certify that the person signing is the actual subject can be a witness including a study nurse, the clinic nurse, a clerk, a relative, another doctor, research coordinator, etc.

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Changes to a study must be reviewed and approved by the FHREB before they are implemented. Consent documents may also need to be revised to reflect changes to a study. Subjects already enrolled and actively participating in the study should be informed of the change if it might relate to the subjects' willingness to continue their participation in the study [IHC-GCP 3.3.8].

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The term re-consent is confusing. A better term is ‘renewal of consent’ because it makes clear that renewal of consent applies in a situation in which prior valid consent was obtained and that renewal is required because new information has become available that a reasonable subject would want to be aware of because the new information may affect their willingness to continue to participate or some newly discovered consequence of past participation has come to light. In general, the sponsor will indicate when renewal of a subject’s consent is required. The FHREB will also indicate when, in its judgment, renewal of consent is required. However the FHREB cannot anticipate all the situations in which the sponsor may wish to require renewal of consent.

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Health Canada is the branch of the Canadian government that regulates human research. As such it has broad powers to issue regulations and to monitor compliance. This is all described in the legislation that empowers Health Canada to do this job. You can find out more about Health Canada's role in the regulation of human research on their website.

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Samples can be retained as long as the investigators wish to do so. They must, however, indicate how long the samples will be retained (3 years, 10 years, indefinitely, until they are all used up, are examples of acceptable wording) in the consent form and the length of time must be justified in the protocol. The FHREB will not permit retention longer than can be clearly justified [TCPS Ch 12 – A 12.2].

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Yes, all consent and assent documents need to include the FHREB approval stamp.

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Your study will be a two stage electronic process. 1. The first stage requires preparation of an information sheet rather than a consent form. Prepare an information page about what you are doing, why and what the survey/questionnaire will cover. 2. Then you need to prepare the content for the electronic survey/questionnaire. Both need to be reviewed and approved by the FHREB before use.

The following steps will be required:
1. Make it clear in the information page that the survey/questionnaire is voluntary and that the respondent can access the survey without being committed to submitting it.
2. Indicate whether or not personal identifiers will be extracted or collected; and how subject privacy will be protected– given the electronic trace that is left.
3. Have the questionnaire/survey accessed by the respondent activating a link.
4. Have the questionnaire/survey collected by the respondent activating a “submit” key.
5. Provided your electronic documents are acceptable to the FHREB, this will normally be construed as “implied consent” by completion and submission.