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Site Visit Closing Meeting 30 October 2010

Site Visit Closing Meeting 30 October 2010. Presented by Dr Anoja Fernando Lead Surveyor UP Philippine General Hospital ERB Survey 28-30 October 2010. Objective and scope of the survey. Objective: To evaluate the IRB for SIDCER recognition

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Site Visit Closing Meeting 30 October 2010

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  1. Site Visit Closing Meeting30 October 2010 Presented by Dr Anoja Fernando Lead Surveyor UP Philippine General Hospital ERB Survey 28-30 October 2010

  2. Objective and scope of the survey Objective: To evaluate the IRB for SIDCER recognition Scope: the survey covers SIDCER recognition requirements: Structure and composition of IRB Adherence to specific policies Completeness of its review process Post-review procedures Documentation and archiving

  3. SIDCER Surveyors Survey Coordinators Juntra Karbwang (WHO-TDR) Cristina Torres (FERCAP) Foreign Surveyors Anoja Fernando (Sri Lanka) Lead Surveyor Magdarina Agtini (Indonesia) Local Surveyor Cecilia Tomas

  4. Local Trainees Dawn Quizon Moran

  5. Survey Objective To assistUP Philippine General Hospital ERB in its quality development via reviewing its ethical review practices and appraising its performance vis-à-vis the SIDCER criteria for recognition.

  6. Survey Methodologies • Office visit • Review SOPs – Chapters 1-10,Version 02, Aug 2010 • Review protocols – 17 • Document review – Membership files, complete meeting minutes not available, SAE files • Interviews • Board Observation – Friday 29 Oct 2010, 9am

  7. Protocols reviewed • 2010002 • 023 • 039 • 045 • 053 • 063 079 • 104 • 111 • 122 2008 012 034 039 2009027 056 087 014

  8. Persons interviewed EC Chairperson – Dr. Patricia Khu EC Secretary – Dr Gemma Uy Ms Daisy Manlangit EC staff- Ms Eleanor Mercado EC members (2-3) Medical doctor/scientist Dr Ryner Carrillo Dr Jorge Ignacio Lay person/non affiliated Ms Edna Cunanan

  9. Survey Framework • International Guidelines • National Guidelines • Vision-Mission of UP Philippine General Hospital • ERB EC SOPs • SIDCER Survey Program SOPs

  10. Standard 1IRB Structure and Composition

  11. 1. IRB Structure and Composition • Membership requirements • Administrative requirements • Membership Initial and Continuous Training • Management of Conflicts

  12. 1. IRB Structure and Composition GOOD PRACTICES Composition of ERB good (gender mix, expertise) Office staff (3) knowledgeable and efficient Members are appointed by the Hospital Director Terms of reference are available Conflict of interest documents are signed by majority of members Members have initial and continuing training Organizational chart is available Highly qualified and competent officers Dedicated and committed members

  13. Recommendations Honorarium should be provided to members for reviewing protocols Prepare a roster of independent consultants for expertise needed by the ERB Recruit a member of Medicine department for Team B Complete training records, confidentiality and COI, CVs for new staff and members 1. IRB Structure and Composition

  14. Standard 2Adherence to Specific Policies

  15. 2. Adherence to Specific Policies • Management of IRB • Availability of SOPs • Areas and Functions covered by the SOPs • Continuous review of SOPs • Guideline for Protocol Submission • Adherence to national and international guidelines

  16. 2. Adherence to specific policies Good practices SOPs have been revised (2008, 2010) SOPs have been signed and approved SOPs are available to all members Comprehensive SOPs to cover major areas of operation International, national and institutional guidelines are available in the office

  17. 2. Adherence to specific policies Recommendations • Improve formatting of SOPs: • Include history of SOP for each chapter • Use third person consistently • Chapter number with title • Check inconsistencies between the flow chart and detailed instructions (Chapter 2.3)- Add SOP training to topics for training (p 21)

  18. 2. Adherence to specific policies • Recommendations • Complete sections of SOPs: • 2.1 (Constituting ERB) Add responsibilities of members • 8.2 (Preparation and Conduct of Meetings) Add and define quorum requirements for the meeting • Prepare an assent form template to assist investigators to prepare one. • 3.1 Prepare an application form to provide standard information to the ERB

  19. 2. Adherence to specific policies Recommendations • Use correct terminology in SOPs: • 6.3.1 Board A and B (instead of Team A and B) • 6.3.1 -Delete ‘consensus’ meeting and ‘consensus’ form. Restate the function of Board Secretary (Team Secretary) • 6.4 – ERB Secretary name should be distinguished from Board Secretary • Form 8.2 – Revise to conform with the form currently used and change ‘consensus’ to Board decision • Review consensus procedures during board meeting • 3.2 – (page 34) 9 – “recommendation” instead of “decision “protocol evaluation form” not “decision form”. “Board” meeting not “team” meeting.

  20. 2. Adherence to specific policies • Recommendations 8.2 – Clarify how COI of board member is managed during the meeting (joining discussion and consensus building, p.76-77) 3.1 – Mention electronic database entry of submitted protocols 6 – Introduce the concept of SUSAR in SAE management Provide instructions about ERB management of SAE reports Include local guidelines in the list of references

  21. Standard 3. Completeness of the Review Process

  22. 3. Completeness of the Review Process • Review Process • Elements of Review • Board Meeting • Completeness of IEC/IRB Meeting Minutes • Decision Making Process

  23. 3. Completeness of the Review Process Good Practices • Use of expedited and full board review procedures • Assessment forms available • Use of 2 primary reviewers for expedited and 3 for full board (medical and non medical) • Sufficient time for members to prepare for review • Regular meetings are held and schedule is set • Good attendance during meetings • Technical and ethical issues are raised • Reviewer Assessment forms are submitted to the board secretary before the board meeting

  24. 3. Completeness of the Review Process Good Practices Good discussion of issues during the board meeting Chair facilitated interview with PI well Investigators learn from the comments made by board members and are made aware of proper safeguards Lay persons contributed to a good discussion Agenda and minutes are available Real time recording of the minutes on the template Technical and ethical issues are discussed Agenda and minutes are available

  25. 3. Completeness of the Review Process Recommendations Protocol review • Reviewers should make comments on the various points in the assessment form (design, risks, vulnerability, etc.) • Make a vulnerability assessment about the type of participants used and recommend measures to protect them • Improve risk assessment and consider not only the physical risk related to intervention but risks involved when using patients with serious illness and chronic diseases

  26. 3. Completeness of the Review Process Recommendations Board Meeting Standardize the summary presented by the reviewer (objectives, methods, outcomes, etc.) to enable other board members to better understand the issues Organize the discussion during board review and group issues systematically (technical, ethical, ICF) Improve the review of ethical issues and comment about risks, vulnerability, etc.(+Cristina’s suggestion) Send the agenda with summaries of protocols before a board meeting for other members to prepare comments Send the minutes of the previous meeting approximately one week before the meeting for the board members to review and make comments and facilitate approval during the meeting

  27. 3. Completeness of the Review Process Recommendations Board Meeting Refer to international and national guidelines when discussing ethical issues (e.g. use of placebo and Declaration of Helsinki) Revisions required should be clearly summarized at the end of the discussion of each protocol

  28. 3. Completeness of the Review Process Recommendations Improve the minutes of the meeting Focus on issues discussed and organize the discussion into themes, rather than presenting a transcript of comments Signatories should indicate the date when they sign the minutes Check the inconsistencies between risk assessment and comments made by reviewers Separate expedited review list into 2 sections, initial review and review of revisions Check inconsistency between attendance list and names of reviewers in the discussion section Change ‘Consensus’ to Board Decision Record only what is discussed during the meeting (Exclude comments sent earlier by reviewers)

  29. Standard 4: After Review Process

  30. 4. After Review Process Approval letter and communication with investigators about board action Submission of reports Progress Final SAE Site visit Response to participant queries

  31. 4. After Review Process Good practice • Communication of board action sent promptly to the investigators • Approval letter states the responsibilities of the investigator after approval of the protocol • Site visit was done • Final reports are required before clearance of trainees

  32. 4. After Review Process Recommendations • Improve the approval letter to state: • Date of board meeting • Version and date of documents (protocol, ICF, advertisement) approved • Annual progress report • Inform and educate investigators about possible SAEs when dealing with high risk patients (ICU. renal failure, neonates, etc.) and their responsibility to report them even if unrelated

  33. 4. After Review Process Recommendations Improve Form 6.0 (SAE Report) to include a section of investigator SAE assessment (expected, unrelated) Communicate with investigators to follow up final reports Continuing review (progress, final reports, etc.) should be done at least once a year for approved protocols. (Do not say ‘no continuing review’)

  34. Standard 5Documentation and Archiving

  35. 5. Documentation and Archiving Good practice • Office files are secure and kept under lock and key • Active files are separate from completed files • Office space is adequate • Database is available • Sufficient equipment to support EC functions • Back up for database is done regularly

  36. Recommendations Prepare bigger flow charts to better inform the investigators Organize the protocol files: Use binders Prepare a table of contents for each file according to SOP Complete the contents of the protocol file to indicate the dates of submission. 5. Documentation and Archiving

  37. Post-Visit Activities • Visit Certification from FERCAP • Finalization of Survey Report by the Team • Submission of Report to Forum Secretariat after the survey visit (by 10 November) • Consideration of the report by the SIDCER Committee • Communication with EC: Findings and recommendations for recognition, follow-up action or a follow-up visit (by 15 November)

  38. Thank You!

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