Informed Consent Guidelines1.0 INTRODUCTIONThe process of free and informed consent refers to the dialogue, information sharing and general process through which prospective subjects decide to participate in research involving themselves (Tri-Council Policy Statement, p. 2.1). These guidelines have been developed to use with Policy 1406 and the Tri-Council Policy Statement (TCPS) to describe specific procedures required by the Bannatyne Campus Research Ethics Boards (REBs) when researchers are obtaining free and informed consent from prospective participants.2.0 RELEVANT POLICIESUniversity of ManitobaPolicy 1406: The Ethics of Research Involving Human Subjects. May 25, 2000.TRI-COUNCIL POLICY STATEMENT: Ethical Conduct for Research Involving Humans. August 1998.International Conference on Harmonisation (ICH): Guidelines for Good Clinical Practice. 1998.WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI : Ethical Principals Involving Human Subjects, 2002.3.0 PROCESS TO OBTAIN INFORMED CONSENT3.1 Process Informed consent must be obtained from the participant or if the participant is not able to give consent, from the participants legally acceptable representative (LAR) (e.g. parent, guardian or designated other) prior to involvement in any research related activity. Written evidence of informed consent should be obtained and must be in the case of biomedical clinical trials. If an alternative to written evidence is proposed the researcher must justify to the REB why written evidence will not be obtained. When the attending clinician has knowledge of the research, such knowledge should be shared with the patient in an objective way. The clinician should ascertain whether or not the patient is agreeable to be spoken to by research personnel and may identify only those patients who are interested. Under no circumstances should the clinician actively recruit the patient for a research project. Someone trained and knowledgeable in all aspects of the study and informed consent procedures must observe the informed consent process and be available to answer questions. The informed consent process begins when a member of the research team has the first contact with the participant or the LAR and continues through the course of the study. The initial contact should involve a face-to-face interview where the investigator/delegate gives information in simple, non-technical language that suits the individuals level of understanding and provides adequate opportunities for the participant to ask questions and contemplate participation. After the verbal exchange, the participant should be presented with a consent document and given sufficient time to read the form before agreeing to participate. Prior to obtaining consent, whether it is written or verbal, the researcher/delegate must ensure the prospective participants or the LAR adequately understands the purpose of the research study, the nature and extent of his or her participation, and the risks involved. If the risk is high or the issues are complex it may be necessary to administer a series of oral or written questions to confirm comprehension. To obtain written evidence of consent, have the participant or LAR initial each page of the consent form and sign the final page where indicated. The person obtaining consent must sign the form as well. In special circumstances a witness or translator are required to sign the consent form if involved in the informed consent process. Each signatory is to date his or her own signature.3.2 Special Considerations1. Illiteracy or Visual Impairment:An impartial witness should be present during the entire face-to-face interview when the participant or the LAR is unable to read the 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 trial, who attends the informed consent process if the participant or LAR cannot read the consent form and who reads the consent form and any other written material supplied to the participant.2.Non English Speaking ParticipantsThe Principal Investigator is responsible for ensuring that non-English speaking participants are provided with a consent form/document in the most appropriate language or an appropriate translator is present during the informed consent process.3. Exception to Written Evidence of ConsentThe REB recognizes that written evidence of consent may not always be appropriate if the identification of the participant places them at risk (eg. research examining illegal drug use). Under circumstances such as these, the REB can allow oral consent with a waiver of the requirement for documentation. This requires an oral consent process that uses a REB approved written script, which contains the basic elements of informed consent. The script must be read to the participant in the presence of a witness. T