How is the Community Involved with the Ethics of Health Research? Elaine C. Wychreschuk

1. How is the Community Involved with the Ethics of Health Research? Elaine C. Wychreschuk Atlantic Representative, Canadian Arthritis Network Consumer Advisory Council, and Member of the Human Research Ethics Board, Newfoundland and Labrador Aim Results The community member is an equal member of the HREB, undertaking the same training, orientation, and following the same policies and principles as all other members. See further details below. This poster will provide information about how community members are involved in the oversight of health research provided by the Health Research Ethics Authority (Authority) in Newfoundland and Labrador. • Appointment & Education • Recruited through media ads • 3 year term • Volunteer position • Same orientation as other HREB members • Must complete TCPS2 training module • Must attend relevant seminars, workshops & educational sessions Background Newfoundland has a unique genetic status as it is one of the few sites world-wide with a founder population – which facilitates genetic research and discovery greatly. In the mid-1990’s patients who had participated in a genetics study discovered no researchers from Newfoundland and Labrador had been involved and the researchers had left nothing – no records, no contact numbers, no clinical follow-up and no feedback to participants. There had been no adherence to issues of consent, privacy and confidentiality. Subsequently, the Government of NL took steps to ensure regulation of all health research conducted in the province. • Role • Share same duties & responsibilities as all HREB members: • Review all studies • Participate in the analysis & discussion of the proposals • Equal voting privileges. Community Member • Value • To reflect the perspective of research participants in areas of: • How research subjects are recruited • Privacy issues • Consent forms • Dissemination of research results • Especially valued when participants are vulnerable and/or risks are high Methods • The Authority must follow the legislated processes, procedures and guidelines. Some of these are outlined below. • Who makes the appointments to the Health Research Ethics Board (HREB)? • Health Research Ethics Authority in consultation with: • Minister of Health and Community Services • President of Memorial University and • Chief Executive Officer of the Eastern Regional Health Authority. • Where does the Authority derive its mandate and authority? • Health Research Ethics Authority Act, Newfoundland and Labrador • What guidelines are followed by the HREB? • Health Research Ethics Authority Act, NL • Personal Health Information Act, NL • Tri-Council Policy Statement on the Ethical Conduct for Research Involving Humans, 2010 (TCPS2) • ICH-Good Clinical Practice • Mandatory appointments to the HREB? • Individuals: • with experience in the conduct of health research involving human subjects • knowledgeable in ethics • knowledgeable in the law related to health research involving human subjects • to represent the general public. “The points of view shared by our community members -- as non-scientists, non-health care workers, non-university researchers -- are key to the successful review of clinical research.” Fern Brunger, PhD, Associate Professor of Health Care Ethics, Memorial University Conclusions The Community Member of the HREB plays a valuable role, representing the public’s perspective on the team reviewing research proposals involving human subjects. Acknowledgements Thank you to Dr. Fern Brunger, Dawn Richards and Katy Miller for poster formatting help, and the Canadian Arthritis Network.