site visit closing meeting 30 october 2010

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

Local Trainees

Dawn Quizon Moran

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

Standard 1IRB Structure and

Composition

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

Standard 2Adherence to Specific Policies

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


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)


• 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


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.


• 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

Standard 3. Completeness of the Review

Process

3. Completeness of the Review Process

• Review Process• Elements of Review• Board Meeting• Completeness of IEC/IRB Meeting Minutes • Decision Making 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


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


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


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)

Standard 4: After Review Process

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


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


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


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’)

Standard 5Documentation and Archiving

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)

site visit closing meeting 30 october 2010

Documents

irb structure

composition of irb adherence

review protocols

majority of members

specific policiescompleteness

specific policies2

ethical review practices

memberscomprehensive