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Purpose

The purpose of this guideline is to:

• Provide clear guidance on the role and importance of the informed consent process for research involving human participants.  

Background

Obtaining informed consent from participants is a fundamental ethical requirement. Informed consent ensures that participants understand the research, including all foreseeable risks and benefits. Article 3.2 in the TCPS 2 specifies that “researchers shall provide to a prospective participant, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project.” Informed consent must be given voluntarily and can be withdrawn at any time. If a participant withdraws consent to participate, they may also request the withdrawal of their data or human biological materials (as applicable). The research ethics office has created informed consent templates. Follow the template to ensure you have included all required language and information: /vpr/ethics/guidelines-policies.

Voluntary Consent and Withdrawal of Consent

Per TCPS 2: “The voluntariness of consent is important because it respects human dignity and means that individuals have chosen to participate in research according to their own values, preferences and wishes.”

There are three factors that could impact the voluntariness of consent:

1. Undue Influence: this can occur when potential participants are recruited by an individual in a position of authority, thus creating an imbalance in power. For example, employer and employee, teacher and student, or treating doctor and patient. The researcher should identify if there is any potential undue influence in their recruitment methods and try to eliminate these as much as possible. Participants’ previous entitlement to care, education and other services should not be impacted or prejudiced by their decision to participate in a research study.  
2. Coercion: This is a more extreme version of undue influence and involves a threat of harm or punishment for failure to participate and would thus negate the voluntariness of informed consent. Researchers should ensure all recruitment methods and materials eliminate any elements of potential coercion.
3. Incentives: Incentives are anything offered to participants, monetary or other, for participation in a research study. Incentives are often used to encourage participation in research and therefore have the potential to impact voluntariness of participation. Incentives should not be so large as to influence participants to disregard risks associated with participation. The researcher should justify the use of incentives to the Research Ethics Board (REB), who will consider the possibility of undue influence. If a participant does not have the ability to make decisions for themselves, then their authorized third parties should not receive an incentive but may accept incentives on behalf of that participant.

To maintain the element of voluntariness, participants must be free to withdraw their consent to participate in the research at any time and should not suffer any disadvantage when withdrawing. Any payment due prior to the point of withdrawal should not be withheld. If the study has a payment schedule, then participants should be paid in proportion to their participation prior to withdrawal. The informed consent form/process should outline any circumstances that do not allow withdrawal of data or human biological materials (e.g., anonymous survey submission). Researchers must provide the REB with a rationale for these circumstances. Participants should also be informed that their data/results can not be withdrawn once they are published.

Informed Consent Information

In order for potential participants to give true free and informed consent, they must be provided with all the information required to make the decision to participate in the research project. The research study/data collection should begin only after a participant, or their authorized third party, have provided consent. There are exceptions to this requirement, as outlined in the TCPS 2, Articles 3.7A, 3.8, 5.5A and 5.5B. Refer to the Guidelines on Waiver of Consent and Guidelines on Alterations to Standard Consenting Procedures, found on the Queen’s Research Ethic’s website for more information: /vpr/ethics/guidelines-policies. Researchers shall provide potential participants with the following information, as applicable for their research (Note:  Other information maybe required based on local polices and other regulations):

• Purpose of the study
• Study procedures
• Risks/Benefits
• Participant responsibilities when enrolled in the study
• Withdrawal from the study
• Confidentiality
• Reimbursement/Incentives

Participants should be given enough time to understand the information provided in the informed consent process and should have the ability to ask questions. The key to true free and full informed consent is that the participant understands the information being presented to them about the research study. Researchers should ensure that simple language is used when providing this information. It should also be presented in a language that the participant can understand. See below for steps in the consenting process.

Decision-Making Ability

Determining whether a participant has the ability to make decisions is paramount to determining if a participant is giving informed consent. Researchers must determine an individual’s ability to make decisions while performing the informed consent procedures/discussion. There is no age of consent in Ontario, and it is up to the researchers to determine an individual’s ability to understand all the information presented to them about the study, especially the risks and benefits. The determination of decision-making ability is not static and may change during the course of a research study. It may also be determined by the nature and complexity of the research study.  For example, an individual may have the decision making ability to participate in a study that is asking about the food they consumed today but not for a complex clinical trial involving a drug.
Individuals who lack decision-making ability on their own should not be unfairly excluded from the benefits of research participation nor should it be used to inappropriately include them in research. Authorized third parties should be asked to make a consent decision on behalf of a potential participant who lacks decision-making ability, these individuals should be aware of the legal responsibilities when providing this consent.
Researchers and the REB should determine the ethical considerations regarding individuals who lack decision-making ability. The REB should determine the following conditions are met:

• Participants who lack decision-making ability are allowed to the greatest extent possible to decide to participate in research. Participants may be capable of verbally or physically assenting, or dissenting, to participation in the research study. This assent may not be sufficient to be true informed free consent however their expression of assent or dissent must be respected.
• Initial and ongoing consent is sought from an authorized third party, who is not a member of the study team.
• The research being conducted will provide direct benefits to the participants (or another person in the same category). If there are no direct benefits to the participants, then the research should pose minimal risk and burden.
• The researcher will promptly seek the participant’s consent if they regain or attain decision-making ability during the course of the research study.
• When individuals have signed a research directive about future research in the event of lost capacity or death, the REB, researchers and authorized third parties should be guided by these directives.

Ongoing Consent

Informed consent is obtained prior to a participant being enrolled in a research study, but consent is an ongoing process that continues until the end of a participant’s involvement in the study. The researcher must bring to the participant’s attention any information or changes to the research project that may affect them and their free and informed consent to continue in the research study. Another important element of ongoing consent is potential changes in participants’ decision-making ability during the research study. If applicable, researchers should have a mechanism in place to evaluate participants decision-making ability to provide informed consent throughout the study.

Incidental Findings

An incidental finding occurs when, during the course of research, a discovery is made about a research participant that is outside the purpose of the research study. For example, the discovery of an unrelated disease on a test done as part of the research study. An incidental finding is considered to be a material finding if it is determined to have significant welfare implications for the participant or potential participants. Researchers should determine if an incidental finding is material. If the researchers do not have the expertise to evaluate any incidental findings, they should seek expertise. The initial consent process should outline the likelihood of material incidental findings and provide information on plans to disclose such findings to participants.

For research where material incidental findings are not foreseeable but are discovered during the course of the research, the researcher should report the discovery to the REB. Disclosure of material incidental findings to participants should occur when participants have consented to receive this information. Where the researchers have outlined that these will not be disclosed, and a finding is discovered, researchers should consult their REB to determine whether there is sufficient ethical basis to disclose the finding(s) to the participants, and if so, how to do so. In some cases, incidental findings may trigger legal reporting obligations. The possibility of this should be outlined in the initial consent process. In some instances, disclosure of incidental findings may not be possible. If this is the case, the researcher should provide justification to the REB.

Documentation of Consent

The informed consent process should be documented by the researcher either in a signed written consent form or by another appropriate means of documentation. Other acceptable methods of documentation include verbal consent, field notes, or other strategies. If written consent is not the method chosen, the REO and Queen’s REBs recommend that participants are given a written document, commonly called a letter of information (LOI), that outlines the research study. One exception to this, is if this would compromise the safety or confidentiality of the participant.
There are many different types of consent including:

• Written informed consent
• Verbal consent
• Implied consent
• Broad consent
• Assent

To provide free full and informed consent, the types of informed consent listed above may include the ability for a participant to consent to certain portions of a study, while declining participation in other portions of a study. Please also refer to the Research Ethics Board Guidebook for more information about documentation of consent: /vpr/ethics/guidebook