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|Overview of NCI CIRB Initiative
Responsibilities of the NCI CIRB
Principal Investigator Responsibilities
Responsibilities of the UTSW IRB
|New Study Submission Process to UTSW IRB
The Central Institutional Review Board (CIRB) Initiative is sponsored by the National Cancer Institute (NCI) in consultation with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP).
The CIRB provides the UT Southwestern Institutional Review Board (IRB) review of adult and pediatric national multicenter cancer treatment trials that can streamline IRB local reviews and yet maintains a high level of protection for the human research participants. The primary function of the NCI CIRB is to perform initial and continuing review of the study, as well as to review and monitor all potential unanticipated problems or serious or continuing noncompliance.
The Adult CIRB may review Cancer Therapy Evaluation Program (CTEP) sponsored Phase 3 Adult clinical trials coordinated by the following NCI Clinical Trials Cooperative Groups: ACOSOG, CALGB, ECOG, GOG, NCCTG, NCIC CTG, NSABP, RTOG, and SWOG. The CIRB reviews other trials upon request from CTEP.
UT Southwestern IRB has an agreement with the NCI CIRB. This agreement allows Investigators who wish to participate in Cooperative Group Trials approved by the NCI CIRB to take advantage of these approvals and request that UT Southwestern IRB agrees to rely on NCI CIRB approval.
- Perform initial reviews of new cancer cooperative group protocols, discuss any issues with the lead organization and study chair, and make a final decision to approve or disapprove the protocols
- Review and establish local context considerations through the use of the Annual Institution Worksheet About Local Context and the Annual Principal Investigator (PI) Worksheet About Local Contex;
- Maintain and disseminate to UTSW’s IRB the CIRB applications, protocol reviews, letters to study chairs, approvals and disapprovals, and minutes of the CIRB meetings
- Conduct Continuing Reviews, reviews of potential unanticipated problems or serious or continuing noncompliance, reviews of protocol amendments, reviews of Data Safety Monitoring Board (DSMB) reports, and reviews of any other documents submitted by the lead organization or study chair
- Notify the IRB of any new materials that have been reviewed for an active protocol and any changes in the protocol approval status
- Institute a Board membership that satisfies the requirements of 45 CFR 46 and provide special expertise as needed from Board members or consultants to adequately assess all aspects of each study
- Distribute to UT Southwestern IRB the roster of CIRB membership and the Standard Operating Procedures and policies
- Provide CIRB members with proper initial and continuing education on topics relevant to human subject protections
- Inform the IRB immediately if there is ever a suspension or restriction of the CIRB's authorization to review protocols
- Advise the UT Southwestern IRB of any policy decisions or regulatory matters that might affect our reliance on CIRB reviews or performance of the research at UTSW
- Assume ultimate responsibility for all aspects of the study.
- Maintain a copy of the IRB acknowledgement letter in the study file for audit purposes.
- Review the CIRB website regularly to keep current with all information including amendments to CIRB-approved studies. UT Southwestern requires study amendments be submitted if modifications require a change to the informed consent document. Amendments will be submitted using the UTSW modification form through eIRB system.
- Track study expiration dates to prevent study approvals from expiring. UT Southwestern requires continuing review submissions annually including a copy of the NCI CIRB approval letter.
- Submit potential unanticipated problems or serious or continuing noncompliance to the NCI CIRB via the IRBManager system.
- Comply with the CIRB’s requirements and directives.
- Report to the CIRB the names of any Component or Affiliate Institutions that rely on the Signatory Institution’s IRB.
- Ensure the safe and appropriate performance of the research at the Signatory Institution and at all Components and Affiliates. This includes, but is not limited to:
- Ensuring the initial and ongoing qualifications of investigators and research staff
- Overseeing the conduct of the research
- Monitoring protocol compliance
- Maintaining compliance with state, local, or institutional requirements related to the protection of human subjects
- Providing a mechanism to receive and address concerns from local study participants and others about the conduct of the research
- Investigating, managing, and providing notification to the CIRB of any study-specific incidence, experience, or outcome that seems to rise to the level of an unanticipated problem and/or serious or continuing noncompliance
- Provide updates to the CIRB whenever a principal investigator is no longer the responsible party for a study under the purview of the CIRB
- Notify the CIRB when a regulatory deficiency has been cited on an audit that occurred during the time that the CIRB was responsible for study review
- Complete and submit the Annual Institution Worksheet About Local Context, the Annual Investigator Worksheet About Local Context, and any other worksheets required by the CIRB for participation
- Decide on a study-by-study basis whether to open the study through the CIRB or to conduct its own local IRB full Board review. Indicate the decision to open a study through the CIRB by submitting a Study-Specific Worksheet About Local Context
Responsibilities of the IRB regarding the local informed consent document
- Use CIRB-approved boilerplate language:
Note: Including Health Insurance Portability and Accountability Act (HIPAA) Authorization language as part of boilerplate language is permitted. The CIRB does not approve the HIPAA Authorization language as it does not function as a Privacy Board; however, the CIRB will accept HIPAA Authorization language when submitted as part of the boilerplate.
- Incorporate the HIPAA language that has been provided as part of UT Southwestern boilerplate language
- Make no language changes to the informed consent document with the exception of CIRB-approved boilerplate language
- Obtain CIRB approval of changes to the boilerplate language prior to implementation
- Maintain a regulatory file for each study under CIRB purview as per local institution and Cooperative Group policy
- Conduct full board review of any study enrolling prisoners, since the CIRB is not constituted to review studies enrolling prisoners
Further Delineation of Responsibilities by Topic
Assent (for pediatric trials): The CIRB makes the determination whether assent of the child is required. Local institutional policy regarding whether and how to document assent is provided as part of the local context considerations.
HIPAA: Compliance with HIPAA regulations are considered an institutional requirement and remain the purview of the local institution.
Incompetent Adults: The CIRB determines whether ‘individuals with impaired decision making capacity’ as a category are eligible for a study. The local institution provides the details regarding state law and institutional policy regarding the authority of legal guardians to consent to research, as well as documentation of proxy consent as part of the local context considerations.
Prisoners: The CIRB is not constituted to review studies eligible for prisoners, per 45 CFR 46 Subpart C, so cannot be the IRB of Record if the local investigator wants to enroll a prisoner. If the local investigator wants to enroll prisoners on a particular study, the local IRB must conduct a full board review of that study per Federal regulations.
New Study Submission Process to the IRB
Please have the following documents available when completing the eIRB application (unless otherwise indicated):
- Consent Form (The CIRB-approved consent document should be prepared using the UT Southwestern header with listed local personnel; local contact phone numbers; number of subjects to be enrolled at this site; addition of study-specific radiation safety risks language; addition of the timeline in the signature section; and other additions as previously approved by NCI CIRB via submission of a Study Specific Worksheet through IRBManager system on NCI CIRB website.)
- Special Considerations for Non-English Informed Consent Document:
- As per NCI CIRB, it is required to have CIRB approval of translations of the informed consent document prior to implementation (unless otherwise specified). Approval of translation can be done through submission of Study Specific Worksheet. Submission of an official translation certificate to CIRB will be required
- Special Considerations for Non-English Informed Consent Document:
- UT Southwestern HIPAA Authorization
- Study Drug Investigator’s Brochure (if applicable)
- Protocol (latest version)
- Notification Letters (including initial NCI CIRB study approval letter and any subsequent NCI CIRB continuing review approval letters (if applicable))
- Subject Recruitment Materials (if applicable)
View instructions on how to submit your study through eIRB.
The UT Southwestern IRB-designated Chair will conduct a review of the NCI CIRB approval of the study submitted by the PI to UT Southwestern IRB. The IRB Chair will review the submission and any other materials available on the CIRB web site.
The IRB Chairperson has the authority to accept the CIRB approval “as is” or decide not to accept the CIRB review and require that the PI submit a protocol for full board review in accordance with the standard full board submission procedures.
If additional changes are required to the consent form boilerplate language, UT Southwestern IRB will submit a revised Annual Institution Worksheet About Local Context to NCI CIRB.
Once the study is acknowledged by UT Southwestern IRB, it sends a CIRB acknowledgement notice to the PI. The date of protocol expiration is set to the expiration date of the CIRB approval letter.
The UT Southwestern IRB will notify the CIRB Administrative Office each time it accepts the CIRB review of a protocol.
The PI will complete the Notice of Study Closure and submit it to the IRB via eIRB when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing).
- All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained).
- No further contact with subject is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary).
- Analysis of subject identifiable data is no longer necessary (i.e., subjects’ records will no longer be required or all data/specimens have been de-identified. This includes review of source documents by study sponsors.
- The sponsor or sponsor representative has agreed the study may be closed at this site.