英文知情同意如何写(英文版).docVIP

Informed Consent Guidelines 1.0 INTRODUCTION The 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 POLICIES University of Manitoba?Policy 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 CONSENT 3.1 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 inf