ࡱ> #` hbjbj\.\. 4>D>Da&&&& T8jl""""#(+L7777777$9h(<b7c,##c,c,7""8515151c,v""751c,75151V5Y7"^ 0tƂA&,:A7 7$808M7 <-<Y7<Y7@c,c,51c,c,c,c,c,77+1 c,c,c,8c,c,c,c,bb  SURVEY A GOVERNANCE ISSUES RELATED TO ETHICS REVIEW PROCESSES IN HUMAN RESEARCH TO BE FILLED OUT BY ADMINISTRATION Does your institution have an ethics policy for human research?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please attach a copy or provide the web link.  FORMTEXT       Who approved this ethics policy for human research?  FORMCHECKBOX  Board of Governors  FORMCHECKBOX  Senate  FORMCHECKBOX  Administration  FORMCHECKBOX  Other (please specify)  FORMTEXT       From whom does (do) the REB(s) derive their (its) authority?  FORMCHECKBOX  Senate  FORMCHECKBOX  Board of Governors  FORMCHECKBOX  Other (Please explain)  FORMTEXT       Identify the administrative office that has overall responsibility for ethics review processes related to human research.  FORMTEXT       Does your institution have a single REB?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please go to Question 9. Please provide the names of all institutional REBs.  FORMTEXT       What is the organizational structure for the REBs?  FORMCHECKBOX  Several REBs report to a central committee.  FORMCHECKBOX  All institutional REBs are independent from each other.  FORMCHECKBOX  Other (Please explain)  FORMTEXT       7. How is the workload distributed among the different REBs? Please describe.  FORMTEXT       8. Are research projects ever reviewed by more than one institutional REB?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, describe under what circumstances.  FORMTEXT       9. Can administration overrule a decision of the REB?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, how frequently has this happened in the last year?  FORMTEXT       Please reference the institutional policy that deals with this issue.  FORMTEXT       10. What is the mandate of the REBs in your institution? Please check all that apply.  FORMCHECKBOX  Human research  FORMCHECKBOX  Animal  FORMCHECKBOX  Environmental ethics  FORMCHECKBOX  Other (please specify)  FORMTEXT       11. Please indicate any types of human participant research, which is not reviewed by an institution-based REB.  FORMCHECKBOX  Undergraduate research  FORMCHECKBOX  Case studies  FORMCHECKBOX  Chart review  FORMCHECKBOX  Stem cells  FORMCHECKBOX  Use of National and provincial databases  FORMCHECKBOX  Adjunct faculty research  FORMCHECKBOX  Research partnerships where a faculty member is not the Principal Investigator (PI) and the research is reviewed by another institution  FORMCHECKBOX  Research with partners where there are institutionally approved collaborative research review agreements  FORMCHECKBOX  Other (please specify)  FORMTEXT       12. What is the process used by the REB for determining whether research is deemed to be minimal risk? (If applicable, cite specific sections of the institutional policy).  FORMCHECKBOX  Standard institutional policy for REBs  FORMTEXT        FORMCHECKBOX  Determined at the REB level  FORMCHECKBOX  Other (please explain)  FORMTEXT       13. How are expedited reviews for research deemed to be of minimal risk handled? (If applicable, cite specific sections of the institutional policy).  FORMTEXT       14. Does your institution, have departmental ethics review committees for human research?  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FORMCHECKBOX  Undergraduate research  FORMCHECKBOX  Class research projects  FORMCHECKBOX  Other (Please explain.)  FORMTEXT       15. Does your institution have on file department level guidelines for ethics reviews?  FORMCHECKBOX  Some department level guidelines  FORMCHECKBOX  All department level guidelines  FORMCHECKBOX  No, if no, do you have a plan for obtaining these department ethics review guidelines?  FORMTEXT       16. Does the REB produce an annual report? Who receives the annual reports from the department ethics reviews? Please attach a copy of the most recent report.  FORMTEXT       17. Is there an institutional policy on non-compliance?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, what are the potential consequences to the investigator for non-compliance? Please check all that apply.  FORMCHECKBOX  No consequence  FORMCHECKBOX  Internal funds suspended  FORMCHECKBOX  Specific research project is cancelled  FORMCHECKBOX  Disciplinary action taken  FORMCHECKBOX  Problem referred to REB  FORMCHECKBOX  Other (Please explain.)  FORMTEXT       18. Does your institution give REBs any formal duty to conduct or participate in formal inquiries concerning allegations of breaches in scientific integrity?  FORMCHECKBOX  No  FORMCHECKBOX  Yes 19. Do your REBs conduct ethics reviews for individuals or organizations not affiliated with the institution?  FORMCHECKBOX  No If No, proceed to question 22.  FORMCHECKBOX  Yes 20. What criteria does the institution use in determining whether to carry out ethics reviews for individuals or organizations not affiliated with the institution? (If applicable, cite specific sections of the institutional policy.)  FORMTEXT       21. Is the institution compensated financially for conducting the ethics reviews for individuals or organizations not affiliated with the institution?  FORMCHECKBOX  No  FORMCHECKBOX  Yes 22. Does your institution have a policy on continuing review/monitoring of REB-approved research?  FORMCHECKBOX  Yes If yes, please attach a copy or a web link if the policy is separate from the ethics review policy  FORMTEXT        FORMCHECKBOX  No If no, please describe your institution s plans to develop a continuing review/monitoring process.  FORMTEXT       23. Are there particular issues related to ethics reviews of human research that you are interested in discussing with the Site-Visit Team?  FORMTEXT       24. Do you have any reflections on the institutional process in the implementation of the Tri-Council Policy Statement (TCPS) that may be of interest to discuss with the Site-Visit Team?  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