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| UBC PROVIDENCE HEALTH CARE RESEARCH ETHICS BOARD | |||||||||||
REVIEW OF HUMAN SUBJECT RESEARCH All research at Providence Health Care involving humans or material or information derived from humans must be reviewed and approved by the UBC Providence Health Care Research Ethics Board (UBC PHC REB) before the project can be activated. The Board's membership and procedures fully conform to the current requirements of the bodies regulating research ethics boards in Canada and North America including the following: Tri- Council Policy Statement on Ethical Conduct for Research Involving Humans US Code of Federal Regulations 21 CFR 50 - Protection of Human Subjects US Code of Federal Regulations 45 CFR 46 - Protection of Human Subjects Office for Human Research Protections (OHRP) of the United States
DOES YOUR QI PROJECT WARRENT RESEARCH ETHICS BOARD REVIEW? The Vancouver Coastal Health and Providence Health Care research institutes (VCHRI and PHCRI respectively) are pleased to jointly support the launch of a new checklist to assist staff in both organizations to determine whether their quality improvement (including quality assurance and program evaluation) projects should be reviewed by a research ethics board before initiating the project. UBC Research Ethics and the UBC REBs most commonly used by PHC and VCH staff - PHCREB, CREB and BREB - also support this initiative. This tool will live on the VCHRI website homepage and can be downloaded for completion. Go to http://www.vchri.ca and click on "VCH/PHC QI & REB review checklist" on the left-hand side. Staff are encouraged to read through the document, and to incorporate the completion of this checklist into their project preparation. As you use the checklist please feel free to provide feedback as it will be reviewed regularly and updated as required. Along that line, please always download the most current version from the website before completing. If you have any questions please contact the following for VCH or PHC questions respectively: Patricia Tait, Coordinator, Strategic Initiatives, VCHRI – patait@vch.ca Michelle Storms, PHCRI Manager Ethical Reviews mstorms@providencehealth.bc.ca FEDERALWIDE ASSURANCE (FWA) Under the US Department of Health and Human Services (DHHS) human subjects protection regulations 45 CFR 46 every institution engaged in human subjects research supported or conducted by the DHHS must have assurance of compliance approved by the US Office for Human Research Protections (OHRP). OHRP Federalwide Assurance (FWA) and Institutional Review Board (IRB) assurance have been obtained for the Univesity of British Columbia and the UBC Providence Health Care Research Ethics Board (REB) noted below with links to the OHRP website (IRB's are known as REB's in Canada). Click on the Type of OHRP Assurance for details about that type of assurance.
WHAT TYPE OF RESEARCH DOES THE UBC PROVIDENCE HEALTH CARE RESEARCH ETHICS BOARD (UBC PHC REB) REVIEW? The UBC Providence Health Care Research Ethics Board reviews clinical and behavioural research applications. WHO CAN SUBMIT TO THE UBC PHC REB? Researchers who are UBC faculty members or who are staff members of Providence Health Care. Researchers from other institutions, students, and trainees must appoint an individual who holds either a Providence Health Care appointment or a UBC faculty appointment as the principal investigator (PI) for the research, unless the researcher, student or trainee holds a PHC appointment or UBC faculty appointment. APPLYING FOR ETHICAL REVIEW All researchers submitting projects involving human subjects must use the Researcher Information Services system(RISe). This is a web based system used by all of the UBC Research Ethics Boards to process applications for ethical review of research involving human subjects. Researcher Information Services System (RISe) Tutorials and Guidance Notes ffor using the RISe system are located on the RISe welcome page. ACCESSING THE RESEARCHER INFORMATION SERVICES SYSTEM To access the Researcher Information Services system (RISe), all researchers and study personnel must have a Campus Wide Login and Password and a 'Researcher Number'. Instructions for Accessing RISe WHAT IS THE DIFFERENCE BETWEEN EXPEDITED AND FULL BOARD REVIEW? Expedited (Minimal Risk) Review means review by the Chair or Associate Chair only and does not have to meet a deadline for full board review. Please note that projects involving genetic research must be submitted for full board approval. The REB Chair or Associate Chair reserves the right to refer the project to full board review if appropriate. In this case, the Principal Investigator will receive an automated notice vis RISe indicating that the project has been re-assigned to full board. WHAT ARE THE SUBMISSION DEADLINES FOR ETHICAL REVIEW? Expedited (Minimal risk) Review There are no submission deadlines for projects meeting minimal risk review criteria. Upon submitting a request for expedited review, the RISe system will send an automated message to the research project principal investigator and primary contact indicating a meeting date for the review. This date is a virtual meeting date, and does not necessarily mean that the application will be reviewed on that specific date. The REB normally reviews minimal risk applications within 2 weeks of the virtual meeting date assigned to the application. Review times may vary according to REB reviewer availability. Full Board Review Applications for full board review must be submitted 3 weeks prior to the full board meeting date. When submitting a new application in RISe it is first electronically routed to the Department you select in RISe for Dept. Head review/approval. It is not until the Department Head approves the study in RISe that it will appear in the REB in-box for screening and review. The REB recommends that submissions for full board review be sent to the Department Head at least 3 days before the REB full board submission deadline date . HOW TO I KNOW IF THE DEPARTMENT HEAD HAS APPROVED THE APPLICATION? The REB does not track the Department Review. It is the Principal Investigator's responsibility to follow-up with their Department Head to ensure the study is reviewed and approved in time for the REB deadline. You can track your submission in RISe by looking at the "Current State" of the application (located at the top left side of the study homepage. When you see the state change from "Department Review" to "REBA Screening" this indicates the REB has received the study.
PROVIDENCE HEALTH CARE POLICY FOR REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS
Researchers from other institutions, students and trainees must appoint an individual who holds either a Providence Health Care appointment or a UBC faculty appointment as the principal investigator (PI) for the research, unless the researcher, student or trainee holds a PHC appointment or UBC faculty appointment. Select this link for the Providence Health Care Policy for Research Involving Human Subjects. ONE RESEARCH ETHICS BOARD OF RECORD - UBC REBS Effective March 21, 2007, all UBC Research Ethics Boards (UBC PHC REB, UBC CREB, UBC BREB and UBC BCCA REB) agreed that each research application reviewed by a UBC REB should have a single REB of Record. This is a change in procedure from the previous policy of Reciprocal Review between the UBC Research Ethics Boards. The purpose of implementing one REB of Record is to avoid the requirement for multiple formal ethical reviews of the same research study. The need to identify one of several possible REBs to be the REB of Record arises when the same Principal Investigator is conducting research at more than one institution under the UBC REBs’ jurisdiction. Under this new policy, the UBC REB that initially reviews a research study normally becomes the REB of Record for the study, but occasionally a project is referred to another of the UBC REBs. Once established as the REB of Record, that REB should deal with all subsequent ethical supervision of that study. This means that the investigator is only required to submit all post approval activity submissions (amendments, annual renewals, etc.) to one REB, regardless of whether or not the research is being conducted at another institution under UBC REBs’ jurisdiction. The Providence Health Care Research Ethics Board should normally be the REB of Record for all research studies carried out at a Providence Healthcare site, and for research studies carried out at other sites (i.e. VGH, Women’s and Children's), by Principal Investigators who hold Providence Healthcare staff appointments. To ensure that institutional specific ethics requirements are met, the Chair of any of the REBs may view the application and study documents approved by the REB of Record. If the UBC PHC REB Chair has questions or concerns, these will be directed to the REB Chair of the REB of Record for resolution. The UBC PHC REB Chair may refer a question or concern to the REB of Record at any time (i.e. before or after the study has been approved by the REB of Record). Under the process of one REB of Record, researchers are still required to obtain approval from the appropriate institution prior to commencing research. PROVIDENCE HEALTH CARE INSTITUTIONAL APPROVAL OF RESEARCH INVOLVING HUMAN SUBJECTS All research involving human subjects must have the written approval of the Providence Health Care Vice President Research prior to the research commencing. The decision of the PHC Vice President Research is contingent upon the receipt of the following documentation.
Please note that Investigators holding a Certificate of Ethical Approval issued by a Research Ethics Board other than UBC PHC REB must apply for PHC institutional approval in circumstances where the research is being conducted at another institution or location but where the investigator, for research purposes, requires access to PHC services, clinical units, patients, staff and to data or tissue held by PHC. For information regarding this requirement, please contact Michelle Storms, Manager Ethical Reviews
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