Informed Connt Guidelines
1.0 INTRODUCTION
"The process of free and informed connt refers to the dialogue, information sharing and general process through which prospective subjects decide to participate in rearch involving themlves" (Tri-Council Policy Statement, p. 2.1). The guidelines have been developed to u with Policy 1406 and the Tri-Council Policy Statement (TCPS) to describe specific procedures required by the Bannatyne Campus Rearch Ethics Boards (REB's) when rearchers are obtaining free and informed connt from prospective participants .
2.0 RELEVANT POLICIES
University of Manitoba Policy 1406: The Ethics of Rearch Involving Human Subjects. May 25, 2000.
TRI-COUNCIL POLICY STATEMENT: Ethical Conduct for Rearch Involving Humans. A
ugust 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 CONSENT
3.1 Process
∙ Informed connt must be obtained from the participant or if the participant is not able to give connt, from the participant's legally acceptable reprentative (LAR) (e.g. parent, guardian or designated other) prior to involvement in any rearch related activity. Written evidence of informed connt should be obtained and must be in the ca of biomedical clinical trials. If an alternative to written evidence is propod the rearcher must justify to the REB why written evidence will not be obtained.
∙ When the attending clinician has knowledge of the rearch, 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 rearch personnel and may identify only tho patients who are interested. Under no circumstances should the clinician actively recruit the patient for a rearch project.
∙ Someone trained and knowledgeable in all aspects of the study and informed connt procedures must obrve the informed connt process and be available to answer questions.
∙ The informed connt process begins when a member of the rearch team has the first contact with the participant or the LAR and continues through the cour 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 individual's level of understanding and provides adequate opportunities for the participant to ask questions and contemplate participation. After the verbal exchange, the participant should be pre
nted with a connt document and given sufficient time to read the form before agreeing to participate.
∙ Prior to obtaining connt, whether it is written or verbal, the rearcher/delegate must ensure the prospective participants or the LAR adequately understands the purpo of the rearch 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 ries of oral or written questions to confirm comprehension.
∙ To obtain written evidence of connt, have the participant or LAR initial each page of the connt form and sign the final page where indicated. The person obtaining connt must sign the form as well. In special circumstances a witness or translator are required to sign the connt form if involved in the informed connt process. Each signatory is to date his or her own signature.
3.2 Special Considerations
1. Illiteracy or Visual Impairment:
An impartial witness should be prent during the entire face-to-face interview when the participant or the LAR is unable to read the connt illiterate or visually impaired. An impartial witness is a person, who is independent of the rearch team, who cannot be unfairly influenced by people involved in the trial, who attends the informed connt process if the participant or LAR cannot read the connt form and who reads the connt form and any other written material supplied to the participant.
2. Non English Speaking Participants
The Principal Investigator is responsible for ensuring that non-English speaking participants are provided with a connt form/document in the most appropriate language or an appropriate translator is prent during the informed connt process.
