Special Situations
Illiteracy or Visual Impairment
An impartial witness should be present during the entire discussion when the potential participant or the legally acceptable representative (LAR) is unable to read the informed consent document (i.e., illiterate or visually impaired). An impartial witness is a person, who is independent of the research team, who cannot be unfairly influenced by people involved in the project, who attends the informed consent process if the prospective participant or LAR cannot read the informed consent form and who reads the informed consent form and any other written material supplied to the individual.
Non-English-Speaking Participants
The Principal Investigator is responsible for ensuring that non-English speaking participants are provided with an informed consent form/document in the most appropriate language, or an appropriate interpreter is present during the informed consent process.
If the assistance of an interpreter is used, it must be documented. If the interpretation takes place in person, the interpreter must sign and date the consent form. If the interpretation is conducted remotely (e.g., telephone) the name of the interpreter and the date of the interpretation must be documented in the consent form by the study staff and information of the interpreter will be included in the study file, including contact information.
Vulnerable Populations and/or Sensitive Topics
For projects that would typically require written informed consent, there may be special circumstances where the research ethics board would consider alternative methods of informed consent with appropriate justification and the presence of an impartial witness. This may include projects which involve vulnerable populations or projects involving sensitive topics where identification of the participant places them at undue risk so that they either cannot or will not sign an informed consent form. The researcher must submit a written script for approval, which contains the basic elements of informed consent. The script must be read to the potential participant in the presence of the impartial witness. The researcher should document the verbal consent process in the research records using a unique participant identifier in place of their name.
Participants Incapable of Providing Informed Consent
In principle, incompetent individuals (those who are incapable of giving free and informed consent), should not be participants in research. It is recognized however, that important projects would be impossible without involving participants who are incapable of giving consent, particularly projects which are designed to benefit those very participants. Special procedures are required to ensure the free and informed consent and the autonomy of these individuals are considered.
Children
*The age-based approach to consent provided below is for guidance only. The final determination should be made based on decision-making capacity as long as it does not conflict with any laws governing research participation (see Article 3.3, TCPS 2).
In general, the consent of the parent or guardian is required for minors up to the age of 18. However, there may be research projects designed for a condition or participant population for which parental or guardian permission is not a reasonable requirement to protect the participant and such requirement may be waived (see section for waiver of parental consent).
For minors up to 6* years of age, in addition to parental/guardian consent, the child should be provided with appropriate information on the project procedures directly affecting them.
For children aged 7* and older, the child’s willingness to participate in research must be assessed after they have been involved in a process that describes the purpose and procedures of the project, using terms and concepts that are developmentally and cognitively appropriate. Prior to the discussion, a member of the research team should consult with the parent/guardian to determine whether they want to present the information or if a member of the research team is to present the information to the child. At some point prior to enrolling the child in the research, the member of the research team must either observe the parent/guardian discussion or assess the child’s understanding and when appropriate, provide additional information to ensure the child is adequately informed.
It is recommended that an age-appropriate assent form be developed, which can be incorporated into the assent process for children 7-13* years of age. After consultation with the parent/guardian for permission to present the form and an assessment of the child’s cognitive skills, the child should be encouraged to read the form or have it read to them. If the parent/guardian does not want their child to read the form, the form can be used as a reference during the consent process.
When preparing assent forms for children it is especially important to convey information that is sensitive to their perspective on the procedures, risks, discomforts, and inconveniences using terms that are developmentally and cognitively appropriate. The form should be as brief as reasonably possible and no longer than two pages plus one page for the signatures required. The assent form should include all the required elements or justification should be provided in the Harmony Health Research Application why the elements have not been included.
From the age of 14*, children who are able to read should be encouraged to read the informed consent form or an age-appropriate assent form. The child should sign the assent or informed consent form if they agree to participate. If the child does not want to sign the form but displays their willingness to participate, the discussion and their willingness must be documented.
For children of any age, their objection to participating in research should be binding unless the intervention holds out a prospect of direct benefit that is important to the health or wellbeing of that child and is available only in the context of research. It would be desirable in these types of projects that a member of the research team first consult the parent/guardian as to what information will be presented and whether the child’s objection to the research would be supported by the parent/guardian. Any objection must be closely evaluated prior to entering the child into the research and the details of the issues documented precisely. Inclusion of a child who has objected and justification for this must be reported in Harmony using the Major Protocol Deviation Form within 3 business days. It is recommended that the decision of cognitively mature children over the age 13* is respected and not solely based on the parent/guardian decision.
Incompetent Adults
Consent for all research projects involving incompetent adults, excluding some emergency research, must be obtained from the legally acceptable representative, prior to the research project activities being initiated.
As with children, the incompetent adult must be involved in a similar consent/assent process to the extent reasonably possible. They must be presented with information in concepts/terms they can understand and their willingness to participate must be assessed and respected when reasonably possible.
In emergency health situations, verbal consent that is witnessed by an individual independent of the research team may be acceptable. This consent procedure may be used only when the LAR has not arrived with the potential participant and is not expected on site within the limited time frame that the research must commence. Where feasible, the LAR should be emailed or faxed a copy of the informed consent form and given time to read it, or the informed consent form must be read/explained to them virtually. The date/time of contact, relationship of the individual who provides consent, and their contact information must be recorded. At the next available opportunity, a signed informed consent form should be obtained.
When a previously incapacitated participant regains decision-making capacity, consent shall be sought for continuation in the project, and for subsequent data collection, examinations or tests related to the research project.