ࡱ> npijklm#` bjbj\.\. 1r>D>DV*BBB8z+ hb "BBB|\        $h\ ggg BB :EEEgBB Eg EEVB "WB% & <+ TWWW@Z@E?4s  j+ gggg$ޏd ޏ SURVEY B INSTITUTIONAL REB REVIEW PROCESS TO BE FILLED OUT BY EACH INSTITUTIONAL REB REB GOVERNANCE 1. Is there an institutional policy for REB membership, terms of reference, terms of office etc.?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please attach a copy or provide the web link.  FORMTEXT       2. How many members on the REB?  FORMTEXT       3. What is the current gender balance?  FORMTEXT       Males  FORMTEXT       Females 4. What is the expertise balance of the REB? (Numbers may add up to more than the number of REB members if there is multiplicity in expertise). Number of members with expertise in Research  FORMTEXT       Number of members with a legal background  FORMTEXT       Number of members with an ethics background  FORMTEXT       Number of community members  FORMTEXT       Others  FORMTEXT       5. How is the REB Chair chosen? (If applicable, cite specific sections of the institutional policy.)  FORMTEXT       6. What are the terms of office? Chair  FORMTEXT       Members  FORMTEXT       Not specified  FORMTEXT       7. Explain successful processes that you have used to recruit a community member of the REB.  FORMTEXT       8. Explain how you recruit other REB members. (If applicable, cite specific sections of the Institutional policy.)  FORMTEXT       9. Do you have difficulty seeking REB members?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please check all that apply.  FORMCHECKBOX  Recruiting individuals with expertise in research methodologies  FORMCHECKBOX  Recruiting individuals who have formal training in ethics  FORMCHECKBOX  Recruiting qualified individuals who can commit the time  FORMCHECKBOX  Recruiting community members  FORMCHECKBOX  Other (Please explain.)  FORMTEXT       10. What decision-making process is used by the REB in giving ethics approval?  FORMCHECKBOX  Consensus  FORMCHECKBOX  Majority  FORMCHECKBOX  Other (Please specify.)  FORMTEXT       11. How often does the REB meet?  FORMTEXT       times a month Other (Please specify)  FORMTEXT       12. Are the meetings &  FORMCHECKBOX  Scheduled  FORMCHECKBOX  Ad hoc as needed 13. What records does the REB keep and for what length of time? Please check all that apply. TYPES OF RECORDS  LENGTH OF TIME (YEARS) FORMCHECKBOX  Ethics review applications FORMTEXT       FORMCHECKBOX  Protocols FORMTEXT       FORMCHECKBOX  Minutes of meetings FORMTEXT       FORMCHECKBOX  Signed consent forms FORMTEXT       FORMCHECKBOX  Correspondence FORMTEXT       FORMCHECKBOX  Annual Reports FORMTEXT       FORMCHECKBOX  Adverse Event Reports FORMTEXT       FORMCHECKBOX  Case Monitoring FORMTEXT       FORMCHECKBOX  Amendments to Approvals FORMTEXT       FORMCHECKBOX Other FORMTEXT       14. Describe the administrative support provided to the REB and what proportion of a full time position is spent by each person on REB related activities. TYPE OF ADMINISTRATIVE SUPPORT  PROPORTION OF A FULL TIME POSITION  FORMTEXT        FORMTEXT       FORMTEXT        FORMTEXT       FORMTEXT        FORMTEXT       15. Please indicate any types of compensation provided to REB Chairs or members. REB CHAIR  REB MEMBERS FORMCHECKBOX  None FORMCHECKBOX  None FORMCHECKBOX  Release Time from Teaching FORMCHECKBOX  Release Time from Teaching FORMCHECKBOX  Honorarium FORMCHECKBOX  Honorarium FORMCHECKBOX  Travel Funds FORMCHECKBOX  Travel Funds FORMCHECKBOX  Other, please describe  FORMTEXT        FORMCHECKBOX  Other, please describe  FORMTEXT       16. Do REB members serve as an institutional resource on ethics issues in research involving humans?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, does the REB participate in any of the following activities? Please check all that apply.  FORMCHECKBOX  Ethics training for graduate students  FORMCHECKBOX  Ethics training for faculty  FORMCHECKBOX  Ethics training for research partner organizations  FORMCHECKBOX  Development of ethics training materials for classroom use  FORMCHECKBOX  Other REB PROCEDURES 17. When conducting ethics reviews, what guidelines are used? Please check all that are used by the REB.  FORMCHECKBOX  Institutional ethics review policy  FORMCHECKBOX  Tri-Council Policy Statement (TCPS)  FORMCHECKBOX  REB guidelines  FORMCHECKBOX  Institutional faculty handbook  FORMCHECKBOX  Good Clinical Practice GCP (Health Canada)  FORMCHECKBOX  Action Plan from the Ministry of Health (QUEBEC)  FORMCHECKBOX  Civil Code (QUEBEC)  FORMCHECKBOX  Council for International Organizations of Medical Sciences (CIOMS)  FORMCHECKBOX  Canadian Psychological Association  FORMCHECKBOX  Other  FORMTEXT       18. Does the REB collect information about the sources of funding for research that requires an ethical review?  FORMCHECKBOX  No  FORMCHECKBOX  Ad hoc basis  FORMCHECKBOX  Always 19. Provide the percentage of all ethics reviews (Full and expedited) by source of funding: SOURCE OF FUNDING  PERCENTAGE- external granting agency with peer review FORMTEXT      - external granting agency without peer review FORMTEXT      - internal support FORMTEXT      - contract research FORMTEXT      - unfunded research FORMTEXT      - Other FORMTEXT       20. Are there types of research that involve human participants that are not currently reviewed by the REB?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain.  FORMTEXT       21. Does the REB develop policies as well as review research projects?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain.  FORMTEXT       22. How many full committee ethics reviews did the REB initiate in the last fiscal year (May 1  April 30)?  FORMTEXT       23. How many expedited minimal risk ethics reviews did the REB initiate in the last fiscal year (May 1  April 30)?  FORMTEXT       24. Provide your best estimate by percentage of the approval process for these ethics reviews. APPROVAL PROCESS  PERCENTAGE ESTIMATIONFull ReviewsExpedited Reviews- approved without modification FORMTEXT       FORMTEXT      - approved with minor modifications, such as editorial changes to the consent form or cover letter FORMTEXT       FORMTEXT      - approved with major modifications, such as research design or content of the informed consent process. FORMTEXT       FORMTEXT      - approved but subsequently approval rescinded FORMTEXT       FORMTEXT      - not approved FORMTEXT       FORMTEXT      - ongoing, no approval at this time FORMTEXT       FORMTEXT       25. Who is responsible for reviewing and approving research projects deemed to be of minimal risk?  FORMCHECKBOX  Reviewed and approved by the REB committee  FORMCHECKBOX  Approved by the REB Committee  FORMCHECKBOX  Reviewed by the REB Chair  FORMCHECKBOX  Reviewed and approved by the REB Chair  FORMCHECKBOX  Reviewed by an REB subcommittee  FORMCHECKBOX  Reviewed and approved by an REB subcommittee  FORMCHECKBOX  Reviewed by the administrative staff for the REB  FORMCHECKBOX  Reviewed and approved by the administrative staff for the REB  FORMCHECKBOX  Other (Please explain.) 26. Please indicate how the REB deals with research design issues for both expedited and full review research proposals.  EXPEDITED REVIEW  FULL REVIEWDoes the REB consider quality of research design? FORMCHECKBOX  No If no, please go to next question.  FORMCHECKBOX  Yes  FORMCHECKBOX  No If no, please go to next question.  FORMCHECKBOX  YesIf yes, who does the peer review? FORMCHECKBOX  Accept peer review of external funder  FORMCHECKBOX  REB reviews quality issues  FORMCHECKBOX  Other  FORMCHECKBOX  Accept peer review of external funder  FORMCHECKBOX  REB reviews quality issues  FORMCHECKBOX  Other Is the peer review process prescribed in the institutional ethics policy? FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  No 27. Please indicate how continuing review/monitoring is carried out for both expedited and full review research proposals.  EXPEDITED REVIEW  FULL REVIEWIs there a person responsible for continuing review/monitoring of research projects?  FORMCHECKBOX  Yes  FORMCHECKBOX  No FORMCHECKBOX  Yes  FORMCHECKBOX  NoIf yes, please indicate how continuing review/monitoring is carried out for both the expedited and full review of research proposals.  FORMCHECKBOX  Reviewed by the REB committee  FORMCHECKBOX  Reviewed by the REB Chair  FORMCHECKBOX  Reviewed by the Administrative stafffor the REB  FORMCHECKBOX  Other (please explain)  FORMTEXT       FORMCHECKBOX  Reviewed by the REB committee  FORMCHECKBOX  Reviewed by the REB Chair  FORMCHECKBOX  Reviewed by the Administrative staff for the REB  FORMCHECKBOX  Other (please explain)  FORMTEXT       Please indicate which of the following activities are parts of the continuing review/monitoring process for research projects reviewed as minimal risk. Please check all that apply.  FORMCHECKBOX  Annual report  FORMCHECKBOX  Adverse event reports  FORMCHECKBOX  End of protocol/research project  FORMCHECKBOX  Other (please explain)  FORMTEXT       FORMCHECKBOX  Annual report  FORMCHECKBOX  Adverse event reports  FORMCHECKBOX  End of protocol/research project  FORMCHECKBOX  Other (please explain)  FORMTEXT      How are researchers informed of their responsibility to provide information for continuing review? FORMCHECKBOX  Not informed  FORMCHECKBOX  By the administrative staff for the REB  FORMCHECKBOX  REB ethics approval letter  FORMCHECKBOX  Institutional ethics policy  FORMCHECKBOX  Other FORMCHECKBOX  Not informed  FORMCHECKBOX  By the administrative staff for the REB  FORMCHECKBOX  REB ethics approval letter  FORMCHECKBOX  Institutional ethics policy  FORMCHECKBOX  OtherIs it obligatory for researchers to report to the REB any change in research design? FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  28. Does the REB consider conflict of interest issues?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please indicate all types of conflict of interest that are considered.(Please reference institutional policy if applicable.)  FORMCHECKBOX  REB members conflict of interest with research being reviewed  FORMCHECKBOX  REB members personal beliefs and values as they impact on judgments made about research topics  FORMCHECKBOX  Self-funded research  FORMCHECKBOX  Pressures to publish for promotion, tenure, professional award, enhanced esteem  FORMCHECKBOX  Financial incentives to researcher of family member  FORMCHECKBOX  Dual hats of physicians as researchers, teachers as researchers, teachers as graduate student researchers.  FORMCHECKBOX  Other (please explain)  FORMTEXT       29. What is the procedure for the evaluation of multi-centre proposals? Please check all that apply.  FORMCHECKBOX  No difference in procedures  FORMCHECKBOX  Evaluation by research location of principal investigators (PIs) is acceptable  FORMCHECKBOX  Handled on an ad hoc basis  FORMCHECKBOX  Have developed institutional level collaborative agreements  FORMCHECKBOX  Other  FORMTEXT       30. For protocols falling under the Good Clinical Practice Guidelines (GCP), does the REB follow a different review process?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain.  FORMTEXT       Has a recommendation by the REB to stop or alter a research proposal or protocol ever been stopped or ignored by your institution?  FORMCHECKBOX  No  FORMCHECKBOX  Yes REB CONCERNS 32. Please indicate the REB level of concern and intensity of REB committee time for each of the selected area of the ethics review process.  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  FORMTEXT        FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT      Financial Aspects for Research participants FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT        FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       Financial Aspects for researchers FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT        FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       Urgency of Timelines FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT        FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       Adequate Administrative Support FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT        FORMCHECKBOX   FORMTEXT       FORMCHECKBOX   FORMTEXT       Resource Impact of Ethics Reviews  FORMCHECKBOX   FORMTEXT       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Provide an estimate of the amount of time spent by each of the following person(s) in carrying out ethics reviews during the last fiscal year (May 1- April 30) Type of ActivityAmount of Time (HOURS)Meetings of the full REB FORMTEXT      Meetings of Executive or Subcommittees FORMTEXT      By the Chair in administrative/preparative work FORMTEXT      By individual members reviewing proposals FORMTEXT      By individual members in background reading FORMTEXT       REB TRAINING 34. How do you train REB members?  FORMCHECKBOX  Orientation workshop for new members  FORMCHECKBOX  Ongoing training for REB members  FORMCHECKBOX  Written information only like ethics policies, Tri-Council policy  FORMCHECKBOX  Other  FORMTEXT       34.1 What opportunities are there for education?  FORMTEXT       RESEARCHER PROCEDURES FOR ETHICAL REVIEWS 35. Does the REB have specific guidelines for researchers when submitting a research project for ethics review?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please provide a copy or the web link for the site-visit team.  FORMTEXT       36. Does the REB have specific guideline cover letters and consent forms for researchers when submitting a research project for ethics review?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please provide a copy or the web link for the site-visit team.  FORMTEXT       37. On average, how long does it take from the time of an ethics review submission to approval?  FORMTEXT       (in weeks). 38. What factors impact the length of time?  FORMCHECKBOX  Difficulty to find time for the REB to meet  FORMCHECKBOX  Insufficient secretarial support  FORMCHECKBOX  Workload of the committee  FORMCHECKBOX  Poorly written applications  FORMCHECKBOX  Other (Please specify.)  FORMTEXT       39. In what ways do researchers interface with the REB?  FORMCHECKBOX  Written submissions only  FORMCHECKBOX  Make a presentation to the REB :  FORMCHECKBOX  At the researcher s request  FORMCHECKBOX  By invitation only  FORMCHECKBOX  Required to make a presentation in all cases  FORMCHECKBOX  Other  FORMTEXT       40. Are there established procedures to appeal a decision of the REB?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain and answer 41.1 to 41.4.  FORMTEXT       41.1 What are the grounds for appeal?  FORMTEXT       41.2 By whom is the appeal heard?  FORMTEXT       41.3 What is its composition?  FORMTEXT       41.4 Has the mechanism ever been used?  FORMTEXT       41. Does the REB have a mechanism for obtaining feedback from researchers about the ethics review process?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain.  FORMTEXT       42. Does the REB have a mechanism for obtaining feedback from research participants about the ethics review process?  FORMCHECKBOX  No  FORMCHECKBOX  Yes If yes, please explain.  FORMTEXT       43. Does the REB permit research participants to meet with the REB? Please check all that apply.  FORMCHECKBOX  Not applicable  FORMCHECKBOX  With REB support staff  FORMCHECKBOX  With REB chair  FORMCHECKBOX  Full REB Committee  FORMCHECKBOX  Other (Please explain.)  FORMTEXT       CONCLUDING THOUGHTS 44. Are there particular issues related to ethics reviews of human research that you are interested in discussing with the Site-Visit Team?  FORMTEXT       45. Do you have any reflections on the institutional process in the implementation of the Tri-Council Policy Statement (TCPS) or other guidelines that may be of interest to discuss with the Site-Visit Team?  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