University of Colorado Denver
Colorado Multiple Institutional Review Board
Standard Operating Procedures
SOP - Relationship Between COMIRB and Non-Affiliated Site
Version #: 006 Effective Date: 05/01/11 Supersedes Document: 005
This Policy Pertains to: all protocols under the purview of both COMIRB and a non-affiliated IRB or institution
Responsibility for executing this policy: Non-affiliate coordinator, Director, Chairs
Last Reviewed on: 03/30/11 Result: Updated
Approval Authority: Director
Approved by: Alison Lakin Date: 05/01/11
1. PURPOSE
To describe the review process and responsibilities of COMIRB and a non-affiliated IRB or institution, to provide continuity and regulatory adherence in overseeing outside IRB protocols or non-affiliated sites
2. POLICY
All studies that are under the purview of both COMIRB and a non-affiliated institution or another IRB where that outside agency is the IRB of record or where COMIRB is designated as the IRB of record, must comply with the federal regulations on human subject protection. The IRB authorization agreement or contractual relationship between the two institutions must be kept on file at both institutions, and provided to OHRP upon request.
3. SPECIFIC POLICIES
3.1 COMIRB CEDES to an OUTSIDE IRB
Conditions under which COMIRB considers establishing an outside IRB as the IRB of record:
a) When the preponderance of research activity occurs at only one institution and the secondary institution’s engagement in research is limited to data analysis, protocol design contribution, laboratory analysis, or other non-research subject contact activity.
b) When funding is limited as in the case of expanded access protocols, and the research is being carried out primarily for the benefit of the subjects rather than scientific endpoints and/or marketing potential.
3.1.1 The COMIRB Director discusses the study with the PI and determines if it is an appropriate study to cede to another IRB and if this is an appropriate IRB for COMIRB to utilize.
3.1.2 If COMIRB has not previously ceded to this IRB then the Director contacts the IRB directly to discuss the possibility of entering into this relationship and determines if the policies and procedures used by the other IRB are appropriate (if the other IRB is not accredited). Once a new relationship has been established with an external IRB, the Director will add the IRB to its FWA within 30 days of signing the IRB Authorization Agreement or Contract.
3.1.3 The IRB Specialist gives the Chair a copy of the protocol packet that was submitted to COMIRB by the PI. This includes the COMIRB application (sections A-G only), Attachment A – Multi-Site Studies, the protocol, initial approval letter from the IRB of record, reviewer’s comments or feedback letter from initial review of IRB of record, stamped approved consent form and any other documents approved from the IRB of record, HIPAA form (from institution of IRB of record), and a copy of the IRB Authorization Agreement.
3.1.4 The IRB Specialist enters the finalized IRB Authorization Agreement into the tracking spreadsheet kept on the K drive and puts a copy into the Notebook B. A copy of all contracts formalizing the relationship between COMIRB and the Outside IRB are kept in the Director’s office and tracked on a spreadsheet on the K drive.
3.1.5 The Chair reviews the protocol submission using the reviewer checklist for outside agencies. After completion the packet and reviewer comments are returned to the IRB Specialist.
3.1.5.a If the protocol is approved by the COMIRB Chair, the IRB Specialist e-mails a COMIRB outside IRB approval letter to the PI and primary contact (if applicable). If the protocol receives minor modifications, the IRB Specialist sends this communication to the PI and primary contact (if applicable). When the response is received, the process again follows 3.1.5.
3.1.5.b If the protocol is not approved by the chair, the protocol is submitted to the full board for review. COMIRB will then remain the IRB of record for all UCD and Affiliated sites.
3.1.6 All approval letters for continuing review and corresponding consent forms will be provided to COMIRB by the outside agency, upon request from COMIRB.
3.1.7 COMIRB remains responsible for ensuring compliance with the outside IRB’s determinations and with the terms of UCD’s Federal Wide Assurance.
3.1.8 COMIRB will receive notification from the outside IRB or the investigator when the study is closed.
3.1.9 Principle investigators and co-investigators of this institution must comply with COMIRB requirements even if COMIRB is not the IRB of record.
3.2 COMIRB AS THE IRB OF RECORD for Non-Affiliated Sites
3.2.1 An IRB Authorization Agreement or Research Contract must be established between the two IRBs that have oversight responsibility for the protocol before the study can be approved and the Non-Affiliated Site is required to add the COMIRB panels to its FWA.
3.2.2 The “Multi-Site studies” attachment should also be submitted with the COMIRB application for initial review. A completed IRB Authorization Agreement or contract must be on file with COMIRB before research can be conducted at a non-affiliated site.
3.2.3 The Director in conjunction with the Vice Chancellor for Research and the Assistant Vice Chancellor for Regulatory Compliance negotiate any contracts establishing COMIRB as the IRB of record. Details of all contracts with Non-Affiliated sites are available on the K Drive. Hard copies are kept in the Director’s office.
3.2.4 All approval letters, including for initial review, continuing review, consent forms, amendments, and advertisements, and all correspondence with the investigator are available to the outside IRB upon request. Relevant minutes of COMIRB meetings will be made available to the outside IRB upon request.
3.2.5 The outside IRB remains responsible for ensuring compliance with COMIRB’s determinations and with its responsibilities under its Federal Wide Assurance.
3.2.6 The IRB authorization agreement or contract must be kept on file at both institutions and provided to OHRP upon request.
3.2.7 The IRB Specialist monitors all reports from OHRP listing one of the COMIRB panels on their FWA. If the COMIRB office has no documentation to indicate that a relationship exists, then the site will be flagged. The IRB Specialist will contact the institution and if no action is taken by the other institution, the Director will send a formal letter requesting removal from their FWA.
3.3 FILE FOLDER ORGANIZATION FOR OUTSIDE AGENCY STUDIES
3.3.1 All protocol packet contents will be filed in each outside IRB study file (yellow folder)
per CP-017 and recorded in the Database.
3. RESPONSIBILITY
It is the responsibility of the IRB Specialist to implement this SOP.
The COMIRB IRB Specialist is responsible for review and implementation of the SOP.
The COMIRB Director is responsible for day-to-day oversight of this SOP.
4. APPLICABLE REGULATIONS AND GUIDELINES
45 CFR 46.103, 108, 109
21 CFR 56. 103, 108, 109
OHRP Guidance:
General Guidance on the Use of Another Institution’s IRB, 1991
Update - Suitability of a Designated Institutional Review Board (IRB), 1997
Knowledge of Local Research Context, 1998 updated 2000
5. ATTACHMENTS
CF-017 Study File Folder Organization
CF-143 Chair Reviewer Checklist for Outside Agency Protocols
Checklist for Outside Agency Protocols/Outside Agency IRB of Record
Checklist for Outside Agency Protocols/COMIRB IRB of Record
6. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY
Who / TaskAssistant Vice Chancellor for Regulatory Compliance / Signs all IRB Authorization Agreements deemed appropriate
Legal Counsel, Director and Assistant Vice Chancellor for Regulatory Compliance / Negotiate all contracts with Outside Agencies
Director / Ensures COMIRB’s FWA is current and ensures Outside Agency or IRB relying on COMIRB has COMIRB on their FWA; updates COMIRB FWA as needed. Maintains relationship with other IRBs utilized by COMIRB. Maintains file on external contracts.
Chairs / Conduct in-house review of all protocols for which COMIRB has ceded to an external IRB
IRB Specialist / Maintains tracking spreadsheet on K drive of relationships established with other IRBs and institutions
IRB Specialist / Oversees internal review of studies for which COMIRB has ceded to an external IRB, ensures appropriate records kept
Compliance Officer at meeting / Ensures that an IRB Authorization is submitted for review or that the requirement is entered in the minutes
Guidelines:
COMIRB CEDES to an OUTSIDE IRB
1) For those protocols that meet conditions as described in this SOP, under section 3.1, and where the PI is a faculty member of UCD or its affiliates, COMIRB will cede to an outside IRB of record. The PI will contact the COMIRB Director or Assistant Director for permission to cede. After this is obtained, the PI will complete the Authorization Agreement and obtain signature from the outside IRB’s signatory official. After the form has been completed, the PI will send it to the COMIRB Director, Assistant Director, or IRB Specialist, who will obtain the signature from the UCD Vice Chancellor for Research. The Authorization Agreement will then be given to the IRB Specialist who will attach it to the submission packet, when it is received. The Authorization Agreement will also be entered on a tracking spreadsheet on the K drive and a copy of the finalized Agreement will be placed in Notebook B.
2) The initial review packet will contain the COMIRB Application (sections A-G only), Attachment A – Multi-Site Studies, the protocol, Letter of Approval from the IRB of record, reviewer’s comments or feedback letter from initial review of IRB of record, stamped approved consent form from outside IRB, HIPAA form (from institution of IRB of record) and any other approved documents. One packet will be sent to COMIRB.
3) The packet will be received at the COMIRB front desk and given to the IRB Specialist. The Specialist will do internal review of the packet, ensuring all necessary documents are included. The Checklist for Outside Agency Protocols/Outside Agency is IRB of Record will be completed. The Specialist will assign a Protocol number and enter the Protocol information (Sponsor, Project number, Personnel and Sites) into the database, using the information from the COMIRB Application. Also, education status will be checked for each study personnel, to ensure that the online CITI Basic Course and CITI HIPS course have been completed. The packet will be placed in a yellow file (according to SOP - Study File Folder Organization), and left in the Specialist’s office, until the chair review has been completed.
4) The packet will be given to the applicable adult or pediatric Chair for review, in addition to the Chair Reviewer Checklist for Outside Agency Protocols (CF-143). After the Chair has reviewed the packet and completed the Checklist, it will be returned to the IRB Specialist, who will enter the action into the database. If the protocol has been approved, a COMIRB Outside IRB Certificate of Approval will be e-mailed to the PI and primary contact. A copy will also be placed in the yellow file folder under “Approval Letters.” The yellow file will be placed alphabetically in the Outside Agency files, in the COMIRB file room.
5) If the protocol has not been approved and minor modifications are required, those minor modifications will be typed into the database, and e-mailed to the PI on a feedback letter. A copy of the letter will be placed in the yellow file under “Reviewer Comments. The PI will be required to submit the changes within 4 months, or the protocol will be administratively closed. After the PI submits the requested changes, they will be given to the same Chair, who will re-review the protocol. The Approval process will be the same as point 4.
6) If the protocol is deferred to full board, the comments will be typed into the database, and e-mailed to the PI on a feedback letter. The PI will be asked to submit 18 copies of the initial review packet with the requested changes, and the protocol will be assigned to the applicable full board panel for review. The PI will be required to submit the changes within 4 months, or the protocol will be administratively closed. After the PI submits the packets, the review process will be the same as the COMIRB full board review (detailed in COMIRB process mapping). The Approval process will be the same as point 4.
7)
8) The PI (or outside IRB of record) will provide Approval Certificates for all Continuing Reviews every three years until the study is closed. The Specialist will enter the continuing review in the database and extend the protocol another three years.
9) When the PI closes a protocol, they will send COMIRB a closure notice. This will be entered into the database. A hard copy of the notice will be printed and placed in the yellow file. The file will be pulled from the Outside Agency files and placed in the ‘Closed’ files.
COMIRB AS THE IRB OF RECORD for Non-Affiliated Sites:
1) The COMIRB Application or Change Form will be received at COMIRB for full board or expedited review. Attachment A is completed if one or more of the study sites listed is a non-affiliated site.
2) Before the study site can be approved, a Research Contract or IRB Authorization Agreement must be in place between COMIRB and the non-affiliated site. The panel coordinator will check with the IRB Specialist as to whether a Contract has previously been established with the site(s). If a contract is not in place, an Authorization Agreement must be obtained. PI receives permission from Director for COMIRB to be IRB of record. The Authorization Agreement Form will be sent by the COMIRB panel coordinator to the PI to be completed. After the PI has submitted the form back to the panel coordinator, it will be given to the IRB Specialist who will obtain the final signature from the UCD Vice Chancellor for Research. The Agreement is listed on the spreadsheet located on the K drive and a copy is placed in Notebook A. Lastly, the panel coordinator must ensure that COMIRB is covered under the non-affiliated site’s FWA. The FWA list can be found under OHRP website.