Procedures

Canadian Fabry Disease Initiative Study Independent Scientific Oversight Committee

REVIEW: Independent Scientific Oversight Committee (ISOC)

Steps

1) Prior to review:

• Committee members are sent copies of the CIHR Policy on Confidentiality, Conflict of Interest and Privacy Issues in Peer and Relevance Review and complete and return the ISOC Compliance and Conflict of Interest Form.
• Committee members who are determined by CIHR to be in a position of real conflict of interest will be asked to step down from the Committee.

2) Review

• Reviewers receive the Canadian Fabry Disease Initiative (CFDI) Study progress report on an annual basis, and any proposed changes to the study protocol on an ad hoc basis (see CFDI Study Request for Protocol Amendment Form), for individual consideration prior to a Committee meeting or teleconference.
• Members are asked to prepare informal notes for the meeting/teleconference. These individual notes are for personal use only and will not be formally documented.
• Review criteria:

Review Criteria	Committee Assessment
Work progressing as planned to meet objectives as set out in the Study protocol	Satisfactory or Specific issues need to be addressed and/or Specific elements need clarification.
Scientific validity of any interim data and analyses if applicable	Satisfactory or Specific elements require revision and/or Specific elements need clarification.
Scientific validity of any proposed changes to protocol (may be included in annual progress reports and/or submitted to the Committee on an ad hoc basis)	Satisfactory or Specific elements require revision and/or Specific elements need clarification.
Ethical Issues, including safety of research participants (copies of Data and Safety Monitoring Board reports to be reviewed)	No outstanding issues or Specific issues need to be addressed and/or Specific elements need clarification.
Appropriateness of research expense reports	Satisfactory or Specific issues need to be addressed and/or Specific elements need clarification.

3) Opportunity for the Research Team to inform the Committee of the unique Study context.

• At the initial meeting of the Oversight Committee, before committee deliberations, the Research Team is invited to present their first progress report and answer questions. This is an opportunity for the Committee members to be informed of the unique context of this study and to ask questions.
• Presentations from the Research Team at subsequent Committee teleconferences or meetings are to be at the discretion of the Chair.

4) Committee consideration of the annual progress reports, any proposed changes to the Study protocol and/or any recommendations made by the Data and Safety Monitoring Board.

• An initial face-to-face meeting of the Committee is encouraged; subsequent deliberations may be conducted by teleconference, at the discretion of the Chair.
• The Committee reaches consensus on an interim assessment, including any specific issues to be addressed or elements clarified by the research team, and plans how the Committee will deal with the expected response from the research team. If necessary, the Committee will put matters to the vote but only the majority assessment will be documented. Ex-officio members do not have voting rights.
• The Committee will seek an opinion from CIHR Legal Counsel if there is any uncertainty about the appropriate protection of privacy or confidentiality in the content of documents to be released publicly.
• If there are no issues to be addressed or clarified, or revisions needed, the Committee prepares and documents a final assessment report at this stage (and proceeds to Step #7).

5) Opportunity for the Research Team to comment on the Committee's interim assessment and/or revise the progress report or proposed amendments to the protocol, within two weeks of notification.

6) Committee reconsideration, within two weeks of receipt.

• The Committee considers the Research Team's revisions to the annual progress report, proposed protocol amendments, and/or comments.
• The Committee prepares and documents its assessment, including in this report a summary of any issues raised and responses from the Research Team.

7) The Secretariat prepares a plain language summary of the research team's annual progress report.

• The Secretariat consults the Committee on key messages and elements to highlight in the plain language summary of the annual progress report for public release.
• The Secretariat drafts the plain language summary with opportunity for review and revision by the Committee and the Research Team, with prompt turn around time.

8) Advance notification to the Research Team and Funders.

• The Committee's final assessment is sent to the Research Team and the Funders in advance of public release.
• The Research Team's annual progress report in full and lay summary form will be provided to the Funders in advance of public release. Advance notice means 60 days prior notice if the annual progress report contains clinical findings, and 2 weeks prior otherwise.
• Any proposed changes to the Study protocol will be reported to the Funders in a timely manner after the Committee review process.

9) Annual public release on CIHR's web site of:

• Study annual progress reports (including any changes made to the Study protocol) with lay summaries.
• Committee's final assessment report.

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Forms

• ISOC Compliance and Conflict of Interest Form
• CFDI Study Proposed Protocol Amendment Form