Informed Consent

Consent may be documented in many ways. Verbal or implied consent, with appropriate researcher documentation, may be as legitimate as written consent, and in some contexts may even be more appropriate. The primary focus of ethical concern should be on the quality of the consent. Consent should always be in language that is understandable and not legalistic or too scientific. The consent process should make room for questions, as appropriate to the research context.

In most cases, where a written-and-signed approach to consent is used, the information letter and consent form are best presented as one document. The information letter should begin with an invitation to potential participants and should explain why they have been asked to participate. The body should provide a brief plain-language description of the proposed research project including a description of the project and the nature of participation. An explanation of key ethics issues, such privacy and confidentiality, risks and benefits, and compensation, if any, should follow. The information letter should be written as if it was being sent from the researcher to the participant (i.e. in second person). It should include names of the researchers and their affiliations.

The consent portion of the form should include a brief summary of what will happen from the participant’s perspective. It should note that the study has been explained to the participant, and the participant has had a chance to have his or her questions answered. The basic elements of consent, listed below, are typically relevant regardless of process – whether written in hard copy, via e-mail, on the web, or presented verbally in person or over the phone. However, not all items are appropriate for all protocols, and some additional items may be requested by a Research Ethics Board on a case by case basis.
 

General points

• Present letters on the letterhead of the department/organization undertaking the research
• Ensure the language level is appropriate to the age and reading level of the participant population
• Include the affiliation and contact information for the research team and (where appropriate) research coordinator
• Explain any co-existing roles that might be understood as creating conflict of interest and how these will be managed
• Include a sentence explaining that participants can contact the Research Oversight and Compliance Office – Human Research Ethics Program at ethics.review@utoronto.ca or 416-946-3273 if they have questions about their rights as participants
• Give participants a copy of the information letter to keep for their own reference (this may be implicit)
   

Introductory information

• Word the invitation to participate in a professional and respectful manner
• Ensure that the purpose of the research is consistent with that described in the ethics application form
• If relevant, include the sponsor of the research, particularly if this might affect consent
• Clearly indicate the time commitment and the location of the study
• Explain the reason why the potential participant is being approached and provide a list of relevant inclusion and exclusion criteria
• If relevant, include the number of participants who will be involved
   

Conditions for participating

• There must be an explicit statement that the individual’s participation is voluntary, and that they may refuse to participate, may withdraw at any time, and may decline to answer any question or participate in any parts of the procedures/tasks – all without negative consequences
• Clarify any conditions on withdrawal of data if the participant chooses to withdraw from the study (e.g., if data are anonymized or de-linked, they cannot be withdrawn; similarly, it is almost impossible to withdraw data from a focus group discussion)
• List out the separate options regarding use of audio and video recordings or photographs (including potential use for teaching or presentation purposes), to which participants can consent (or not)
• Include a statement that the participant has not waived their legal rights in the event of harm and, in clinical trials, include stopping rules
   

Risks and Benefits

• Clearly explain, in lay terms, reasonably foreseeable risks, harms or inconveniences and how they will be managed
• Describe mechanisms, where appropriate, for reporting significant risk-related issues or incidental findings that are identified during the study and for providing referrals in response to these issues (e.g. unusual test results and occurrence of emotional distress resulting from participation)
• Mention potential benefits, including information that there is no direct benefit, as appropriate
• Mention information about any payment or compensation for participation or expense reimbursement (but don’t over-emphasize)
   

Access to information, confidentiality, and publication of results

• Clarify information regarding who will have access to the data (including secondary data use)
• Include notice to the effect that the research ethics program may have confidential access to data to help ensure participant protection procedures are followed
• Discuss information regarding partnership agreements with communities who may want/have access to or possibly ownership of the data
• Include relevant information regarding retention and disposition of the data during and after completion of research. Note: destruction of data is not the only acceptable method of disposition. Methods will depend on the identifiability, sensitivity, and richness of the data, and the standards of the researcher’s discipline
• Present, If relevant, different degrees of confidentiality as option
• Describe procedures for maintaining confidentiality, if relevant (e.g., use of study-specific ID numbers, pseudonyms, generic descriptors, composites, or aggregates)
• Mention any foreseeable limits to confidentiality (e.g., for participation in focus groups, research involving key informants or duty to report)
• Clearly state the researcher’s intent to publish or make public presentations based on the research
• Offer a summary of the research results, and a mechanism to provide the summary