Consent and recruitment
Informed Consent
Researchers must provide full and frank disclosure of all information relevant to free and informed consent - including adequate opportunities to discuss and contemplate participation. Investigators are strongly discouraged from approaching prospective subjects immediately preceding surgery.
Research studies which involve high risk to subjects may require more documentation of the consent process than studies which involve minimal risk e.g., question and answer documentation to confirm language comprehension, witnessing of the consent process.
Capacity to Consent
There is no age of consent. Rather consent is dependent on capacity; i.e., the ability to understand the elements of the information relating to the decision, and the ability to appreciate the reasonably foreseeable consequences of participating or not participating in that specific research project. When the individual cannot give consent, a substitute decision maker i.e., parent or guardian is approached.
Capacity determination can only be conducted by a health care professional as defined in legislation.
Assent
When children cannot give consent, it is still important to engage the child to the full extent possible by giving the child the opportunity to assent (agree) or dissent (disagree) to the research. For non-therapeutic research, the child's dissent overrides parental consent. Parents should be approached before their children are approached for assent.
Telephone Consent
In rare circumstances, witnessed telephone consent will be accepted e.g., if parents do not accompany the child to the hospital i.e., are unavailable to be present for face-to-face discussions and there is a limited time frame within which the research must commence. Where feasible, the consent form should be faxed to the parent for review. At the next available opportunity, however, a signed consent should be obtained.
Consent Form Structure
All consent forms must follow a specified structure and format as detailed in the templates.
Separate consent and assent forms must be written for control group subjects. The Purpose section must explicitly indicate that while the individual does not have the disease or condition under investigation, control group data is necessary for comparison.
Survey Research
Survey research may be accompanied by an explanatory letter in lieu of a consent form outlining the salient issues eg., purpose of the study, amount of time to complete the questionnaire, confidentiality provisions, etc. The cover letter must also indicate that consent is inferred from the completion and return of the questionnaire.
For survey research conducted over the telephone, a telephone script in lieu of a consent form is acceptable. A telephone script consent template is available in the consent templates section.