Site Visit Closing Meeting30 October 2010
Presented by Dr Anoja FernandoLead Surveyor
UP Philippine General HospitalERB Survey
28-30 October 2010
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
SIDCER Surveyors
Survey CoordinatorsJuntra Karbwang (WHO-TDR)Cristina Torres (FERCAP)
Foreign SurveyorsAnoja Fernando (Sri Lanka) Lead
SurveyorMagdarina Agtini (Indonesia)
Local SurveyorCecilia Tomas
Survey Objective
To assist UP Philippine General Hospital ERBin its quality development via reviewing its ethical review practices and appraising its performance vis-à-vis the SIDCER criteria for recognition.
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
Protocols reviewed
2008 012 034 039
2009 027 056
087 014
2010 002 023
039 045 053 063 079 104 111
122
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
Survey Framework
• International Guidelines• National Guidelines • Vision-Mission of UP Philippine General
Hospital• ERB EC SOPs• SIDCER Survey Program SOPs
1. IRB Structure and Composition
• Membership requirements• Administrative requirements• Membership Initial and Continuous
Training • Management of Conflicts
1. 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
RecommendationsRecommendations• 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. 1. IRB Structure and Composition
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
2. Adherence to specific policies2. 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
2. Adherence to specific policies2. Adherence to specific policies
RecommendationsRecommendations•Improve formatting of SOPs:Improve formatting of SOPs:– Include history of SOP for each chapterInclude history of SOP for each chapter– Use third person consistentlyUse third person consistently– Chapter number with titleChapter number with title– Check inconsistencies between the flow chart Check inconsistencies between the flow chart
and detailed instructions (Chapter 2.3)-and detailed instructions (Chapter 2.3)-
Add Add SOP training to topics for training (p SOP training to topics for training (p 21)21)
2. Adherence to specific policies2. 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
2. Adherence to specific policies2. 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.
2. Adherence to specific policies2. Adherence to specific policies
• Recommendations8.2 – 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 protocols6 – Introduce the concept of SUSAR in SAE managementProvide instructions about ERB management of SAE reportsInclude local guidelines in the list of references
3. Completeness of the Review Process
• Review Process• Elements of Review• Board Meeting• Completeness of IEC/IRB Meeting Minutes • Decision Making Process
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
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
3. Completeness of the Review ProcessRecommendationsRecommendations
Protocol reviewProtocol review• Reviewers should make comments on the Reviewers should make comments on the
various points in the assessment form various points in the assessment form (design, risks, vulnerability, etc.)(design, risks, vulnerability, etc.)
• Make a vulnerability assessment about the Make a vulnerability assessment about the type of participants used and recommend type of participants used and recommend measures to protect themmeasures to protect them
• Improve risk assessment and consider not Improve risk assessment and consider not only the physical risk related to intervention only the physical risk related to intervention but risks involved when using patients with but risks involved when using patients with serious illness and chronic diseasesserious illness and chronic diseases
3. Completeness of the Review ProcessRecommendationsRecommendations
Board MeetingBoard Meeting• Standardize the summary presented by the reviewer Standardize the summary presented by the reviewer
(objectives, methods, outcomes, etc.) to enable (objectives, methods, outcomes, etc.) to enable other board members to better understand the other board members to better understand the issues issues
• Organize the discussion during board review and Organize the discussion during board review and group issues systematically (technical, ethical, ICF)group issues systematically (technical, ethical, ICF)
• Improve the review of ethical issues and comment Improve the review of ethical issues and comment about risks, vulnerability, etcabout risks, vulnerability, etc.(+Cristina’s suggestion).(+Cristina’s suggestion)
• Send the agenda with summaries of protocols before Send the agenda with summaries of protocols before a board meeting for other members to prepare a board meeting for other members to prepare commentscomments
• Send the minutes of the previous meeting Send the minutes of the previous meeting approximately one week before the meeting for the approximately one week before the meeting for the board members to review and make comments and board members to review and make comments and facilitate approval during the meetingfacilitate approval during the meeting
3. Completeness of the Review Process
RecommendationsRecommendations
Board MeetingBoard Meeting• Refer to international and national Refer to international and national
guidelines when discussing ethical issues guidelines when discussing ethical issues (e.g. use of placebo and Declaration of (e.g. use of placebo and Declaration of Helsinki)Helsinki)
• Revisions required should be clearly Revisions required should be clearly summarized at the end of the discussion of summarized at the end of the discussion of each protocoleach protocol
3. Completeness of the Review Process
RecommendationsRecommendations• Improve the minutes of the meetingImprove the minutes of the meeting
– Focus on issues discussed and organize the discussion into Focus on issues discussed and organize the discussion into themes, rather than presenting a transcript of commentsthemes, rather than presenting a transcript of comments
– Signatories should indicate the date when they sign the Signatories should indicate the date when they sign the minutesminutes
– Check the inconsistencies between risk assessment and Check the inconsistencies between risk assessment and comments made by reviewerscomments made by reviewers
– Separate expedited review list into 2 sections, initial review Separate expedited review list into 2 sections, initial review and review of revisionsand review of revisions
– Check inconsistency between attendance list and names of Check inconsistency between attendance list and names of reviewers in the discussion sectionreviewers in the discussion section
– Change ‘Consensus’ to Board Decision Change ‘Consensus’ to Board Decision – Record only what is discussed during the meeting (Exclude Record only what is discussed during the meeting (Exclude
comments sent earlier by reviewers)comments sent earlier by reviewers)
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
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
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
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’)
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
RecommendationsRecommendations• 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
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)
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