Standard notes review4/8/2023 If the REB Chair of any institution involved in the research has questions or concerns, these will be directed to the REB Chair of the REB of Record for resolution. Although there is one REB of Record, in order to ensure that institutional specific ethics requirements are being met, the Chair and the Manager of each UBC REB for the institution(s) involved in the research have the ability to view the application approved by the REB of Record. Most sites will, however, require separate approval for resource allocation purposes, e.g. Research conducted by the same researcher at multiple UBC sites needs ethical approval from one UBC-affiliated REB only. One Board of Record: The UBC Research Ethics Boards that review research involving human participants have signed a one board of record agreement allowing approvals by one UBC-affiliated REB to be recognized by the other UBC-affiliated REBs. Requests for such review to satisfy, for example, publication or graduation requirements, will not be entertained. Important Note: None of UBC's Affiliated REBs will review or acknowledge research that has already been conducted. For example, research that involves human blood may require review by both the Biosafety Committee and the Clinical REB. In some cases, a research project may need to be reviewed by more than one Board or Committee. Any other review procedure deemed necessary to protect the rights and welfare of human participants.Īll research on human participants conducted at UBC facilities, (including UBC affiliated hospitals) or undertaken by individuals connected to the University must be reviewed and approved by a UBC sanctioned Research Ethics Board prior to it commencing.Suspension or termination of the approval of a study.Monitoring of the informed consent process.Monitoring to determine that the study is conducted as approved.Review of serious adverse events and other unanticipated events, including protocol deviations.Review of changes in the design or conduct of the study prior to implementation.Review of regular progress reports including renewals.Continuing review activities include, but are not limited to: UBC's REBs are required to conduct continuing ethical review of every approved study. UBCs REBs have the authority to approve, require modifications in, or disapprove any research activity that falls within their jurisdiction. Government or regulated by the US Food and Drug Administration) Common Rule (for studies funded by the U.S. The International Conference on Harmonization Good Clinical Practice: Consolidated Guidelines The Tri-Council Policy Statement TCPS 2 (2018): Ethical Conduct for Research Involving Humans The UBC REBs review and oversee such research to assure that it meets ethical principles and that it complies with all applicable regulations and standards pertaining to human participant protection. Purpose of the REBs: UBC's Research Ethics Boards are autonomous entities whose primary responsibility is to protect the rights and welfare of human participants taking part in research conducted under the auspices of UBC. University administration is responsible for ensuring that sufficient resources are allocated to the UBC Research Ethics Boards to allow them to perform their review, record-keeping and monitoring functions. UBC administration, under the direction of the Vice-President Research, is ultimately responsible for overseeing the protection of human participants involved in research programs conducted by the University. They operate under the authority of UBC Policy #LR9 on "Research and Other Studies Involving Human Subjects". The UBC REBs are established and empowered under the authority of the Board of Governors, through the Vice-President Research. Open All Part A1: The Roles and Responsibilities of the Researcher and the Research Ethics Board If you wish to search for a specific term in the page, please first expand all of the content. Part B: RISe Application Guidance Notes (AGNs) Part A1: The Roles and Responsibilities of the Researcher and the Research Ethics Board Please refer to the separate Post-Approval Activity Guidance Notes on the Office of Research Ethics website for information pertaining to: However, each board may have separate Application Guidance Notes (AGNs) that are based on each individual board's practices and should be read together with the overarching clinical Guidance Notes. They are applicable to all UBC affiliated clinical Research Ethics Boards (REBs) [the Clinical Research Ethics Board (CREB), Providence Health Care REB, Children's and Women's REB, and BC Cancer REB. These Guidance Notes (GNs) provide the most up-to-date overview of the UBC clinical Research Ethics Boards' policies and guidance concerning clinical research ethics at UBC.
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