MCGILL UNIVERSITY HEALTH CENTRE OFFICE OF RESEARCH ETHICS - FREE AND INFORMED CONSENT – Understanding the Informed Consent Process Research involving human subjects at the McGill University Health Centre is conducted according to international ethical principles that require a prospective study subject to provide voluntary free and informed consent. The requirement is described in the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (Article 2.1 – 2.8). “A morally valid choice concerning the participation by a subject in research is a choice made: (1) by a competent person; (2) on the basis of adequate information concerning the nature and foreseeable consequences of the research, including all available options; and (3) without controlling influences or ulterior forms of constraint or coercion.” (adapted from the Nuremberg Code). Free and informed consent therefore refers to a person’s choice to become a subject of research and is brought about through dialogue between the research investigator or study representative and a prospective subject and/or the person’s authorized third party. Sufficient time must be allotted to communicate a thorough explanation of the study and of the responsibilities of both investigator and subject. The prospective subject must be given adequate time to consider the information before making the decision on participation to avoid coercion or undue influence. A morally valid choice also includes the concept of assent whenever the prospective subject is deemed not to be legally competent. The free and informed consent process is focused on exchanging questions to establish a dialogue about the research to the satisfaction of the prospective subject or the substitute decision-maker. The discussion is followed by the investigator’s determination that the person realizes what is required of a subject, and recognizes the related risks and potential benefits of participation. A prospective subject provides free and informed consent by agreeing to follow the research rules and procedures for the specified length of time and is asked to sign the Research Ethics Board (REB) approved consent document. The act of signing indicates that an educational process has taken place to the satisfaction of those involved. The signed consent document creates obligations under policy and law for the investigator and signals the subject’s agreement to accept the responsibilities of a study participant. The subject receives a copy of the signed document for future reference. To demonstrate respect for a person’s free and informed consent is viewed, therefore, as an ongoing exchange of information and not simply putting signatures on a piece of paper. The written consent acknowledges that the subject was given all relevant information, was afforded sufficient time to ask questions and consider the decision, and documents the subject’s choice. By “continuing to participate in the research”, a subject is in effect regularly reaffirming thoughtful consent for a voluntary act. If the original disclosure of information was incomplete or the investigator fails to share new information that could influence a subject’s willingness to continue in the study, then the integrity of the process underlying free and informed consent is compromised. Version: 07/02 Seeking Free and Informed Consent Procedures used to obtain informed consent should be designed to educate the target population in terms they can understand. In order for the research subject’s choice to be valid, it must be based upon all relevant information concerning the proposed research. Deciding what is “relevant” involves weighing available options. The investigator or the study representative initiates discussion to provide information concerning the purpose and nature of the study, the potential harms and possible benefits, the procedures involved with participation and, on balance, should not overwhelm the prospective subject with discussion of insignificant details or minutiae. To protect an individual from possible injury arising from cumulative medical acts such as extra blood drawing, exposure to radiation, drug interaction, or similar hazards, an investigator should determine if the prospective subject has recently, or is currently participating in other research. The investigator should directly inform the prospective subject concerning the level of privacy that will be maintained and that it is in the person’s best medical interest to inform the treating physician of participation in the research study. A disclosure of the requirements for documenting participation in the hospital file(s) should be communicated, and that inclusion of any research data in the medical record occurs only at the discretion of the REB. The investigator is obligated to disclose to the prospective subject the existence of any potential conflict of interest disclosed directly to the REB or to an institutional representative. The subject should also be informed concerning possible commercialization of the study findings or material. The investigator is ultimately accountable to ensure that the necessary study-specific information has been communicated effectively and that the written consent document contains all the required elements of free and informed consent. Elements of Free and Informed Consent: 1. A statement that the study involves research; the reason for the subject’s selection; an explanation of the purposes of the research and the expected duration of the subject's participation; a description of the procedures to be followed, and identification of all experimental procedures and approximate number of subjects to be involved in the study; 2. A description of reasonably foreseeable risks or discomforts to the subject and a statement that the treatment or procedure may involve currently unforeseeable risks to the subject or breast-feeding infant (or to the embryo or fetus if the subject is or may become pregnant); 3. A description of any benefits to the subject or others that may reasonably be expected from the research. If there is no benefit to participation for the individual subject, an honest declaration of that fact must be included; 4. A disclosure of appropriate alternative procedures or courses of treatment, if any might be advantageous to the subject. The subject must be informed should any standard treatment be withheld as a result of study participation; Version: 07/02 5. If a subject will receive compensation for expenses incurred by participation, or reimbursement for time and inconvenience, specific information concerning the terms of disbursement must be included. Any additional costs to the subject resulting from participation must be described; 6. For research involving more than minimal risk or including an invasive procedure, explanation must be included as to whether compensation and medical treatment would be available should injury occur, and if so, of what they consist and where further information may be obtained; 7. Anticipated circumstances under which the subject, investigator or sponsor may terminate participation without regard to the subject 's consent, i.e. when in the investigator's opinion, it would be harmful for the subject to continue; 8. A statement that any significant new finding to emerge during the course of the study that may affect the subject's willingness to continue participation will be disclosed to the subject; 9. An offer to answer questions and an explanation on whom to contact for answers to pertinent questions about the research, a research subjects' rights, and whom to contact in the event of a research-related problem. Telephone numbers for all these individuals should be included; 10. A statement that participation is voluntary, that the subject may refuse to participate, or discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. Description of the consequences of a subject's decision to withdraw from the study, if any, and the procedures for an orderly termination of the subject’s participation; 11. A statement describing the extent to which confidentiality of records identifying the subject will be maintained. If study data or specimens will be banked, linked, shared, or otherwise made available to any person or organization other than the investigating team, sponsor and regulatory authorities, the purpose must be explained. If data will become part of the subject’s permanent medical record, the nature of the information and the purpose for the inclusion must be stated; 12. A statement of the offer to the subject to receive a copy of the signed consent document; 13. Space for names and dated signatures of the Subject and Person Conducting the Informed Consent Process to establish which member of the research team discussed the study with the subject. Where applicable, the authorization should include the signature of an authorized third party, including space to indicate relationship to the legally incompetent subject; 14. Space for name and dated signature of a Witness is required if the subject or authorized third party is unable to read. An impartial witness should be present during the entire informed consent discussion to attest that the information was accurately explained and consent freely given. The witness’ signature attests to the voluntary nature of the decision. Version: 07/02 Assent for Research with Children Assent in children is understood as a method of expression significant for recognizing autonomy It