Ran Goldman

Emergency Physician, BC Children's Hospital

Ran Goldman

Prof. Goldman was the Chief of the Pediatric Emergency Department at the BC Children’s Hospital in Vancouver, Canada. He is a Pediatric Emergency Physician who was trained in Pediatrics and Clinical Pharmacology and Toxicology. He is the Director of the Pediatric Research in Emergency Therapeutics research program, a Professor in the Department of Pediatrics at the University of British Columbia and a Senior Clinician Investigator at the BC Children’s Research Institute. Over the last three decades he is serving on academic and non-academic research ethics boards, trained numerous healthcare providers in the field of clinical and research ethics, and is a consultant in the field of Exception from Informed Consent. Dr. Goldman published over 300 peer-reviewed papers in the medical literature.

All Sessions by Ran Goldman

  • Thursday, May 1


  • 14:55  - 15:25
    Exception from Informed Consent in Emergency Research - Canadian Challenges and Opportunities

    DESCRIPTION OF SESSION

    In the United States conducting trials under Exception from Informed Consent (EFIC) have been applicable only under narrow clinical circumstances when prospective informed consent is not possible. Research Ethics Boards (REBs) are able to approve such studies under a clear regulation framework, including the conduct of public disclosures and community consultations. Canadian TCPS2 regulation mandates appropriate use of a waiver or deferral of consent model. Conducting trials in Canada that includes patients in critical conditions such as in the Emergency Department (ED), when a legally authorized representative is not available, may include exception from consent for serious compromise to health, but stipulates that the intervention should not be greater risk than standard of care, or clearly justified by the benefit. This creates some significant challenges for investigators in the field of emergency and intensive care, especially in cases of scientific equipoise. Furthermore, Exception from Informed Consent trials usually seek subjects in numerous sites, in order to achieve an appropriate sample size for exceptionally rare conditions. This represents further challenges when studies seek participation of sites in the USA and in Canada, when REBs framework is different. This active session will focus on the foundation of Exception from Informed Consent trials, and ways REBs can review this unique type of studies in order to allow investigators to advance emergency and intensive care related trials. A focus in the session will be on the differences and opportunities for Canadian REBs when reviewing Exception from Informed Consent trials conducted across the border (USA and Canada). We will review examples of clinical circumstances when prospective informed consent is not possible, including studies that were conducted in Canada.
    Sessions




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Ran Goldman