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Cancer-Related Protocols

Background

The Chao Family Comprehensive Cancer Center (Cancer Center) Protocol Review and Monitoring Committee (PRMC) reviews all human studies involving participants with cancer, at risk for cancer, any active intervention (e.g. behavioral or pharmacological) involving cancer or pre-cancerous participants, or participants of a study involving a specific cancer focus (e.g. program evaluations, quality of life survey health education, etc.).

The PRMC has overall responsibility for evaluating scientific merit, statistical design as applicable to the study, and accrual*.  The PRMC has ongoing oversight of all institutionally supported studies, pharmaceutical sponsored trials, and those that have undergone external scientific peer review (with the exception of cooperative group studies).

There are three levels of PRMC review: Exempt, Expedited and Full Committee. These levels of review are similar to the IRB Levels of Review but include several differences as the committee reviews focus on science, statistics, and accrual*.

 *For studies that do not involve subject consent, accrual refers to the number of Specimens, Documents and Records accessed or acquired.

Criteria for PRMC review

PRMC review is required prior to IRB review if the research meets all of the following criteria:

    1.  Investigator-authored research;
    2.  Involves biomedical/clinical research including clinical investigations;
    3.  Involves greater than minimal risk to subjects (i.e., requires full board review); and
    4.  Has not received peer review for scientific merit.

Note: Documentation of PRMC review including committee comments is required prior to inclusion on an IRB agenda.

PRMC review prior to IRB review is NOT required for any of the following:

    1.  Research involving no more than minimal risk to subjects (i.e., Exempt and Expedited categories of research).
    2.  Research that is industry-authored (i.e., for-profit pharmaceutical or medical device entities)
    3.  Research that is federally-sponsored or sponsored by other non-profit entities (e.g., private foundation, other academic institutions) with documentation of peer review for scientific merit.

Note: The UCI IRB reserves the right to require scientific merit review prior to IRB review or prior to IRB approval for any research.

Exempt PRMC Studies

Although the category is called exempt, this type of research does require PRMC initial review and registration. The exemption process is similar to expedited review but much less rigorous than full committee review.

The following types of studies may qualify for PRMC exemption:

  • Studies which do not involve active intervention with subjects.
  • Studies which do not include the creation, use, disclosure of Protected Health Information (PHI). PHI is information that can be linked to a particular person and that is created, used, or disclosed in the course of providing a health care service (i.e., diagnosis or treatment). For more information and examples of PHI, please see: Protected Health Information (HIPAA).
  • Studies which do not use Cancer Center resources such as the Clinical Research Office (CRO) for data management, the Regulatory Affairs Office (RAO) for IRB and regulatory management, physical Cancer Center space, and/or Cancer Center funding.
  • Studies that are closed to accrual.
  • Studies that solely involve retrospective chart and/or database review procedures.
  • Biorepository protocols that solely involve specimen and/or data banking.

These studies must neither involve PHI nor any other subject identifiable information with the exception of retrospective chart and/or database reviews and biorepository protocols. 

Exempt PRMC studies require completion of the PRMC Application and Reviewer Sheet found in the PRMC_forms folder on the PRMC website.

This application and the following protocol documents should be sent to the PRMC at CancerCenter_Committees@health.uci.edu for exemption approval:

  • IRB Application (drafts acceptable)
  • Sponsor’s Protocol (if applicable)
  • Investigator's Brochure (if applicable)
  • Protocol Narrative
  • Informed Consent Form(s) (if applicable)

Exemption requests take about 5-7 business days to approve, and the signed approval is sent to the Lead Researcher and submitter (if applicable). The Lead Researcher must include the exemption approval documentation with the IRB submission to verify PRMC clearance.

Note: After PRMC exemption, a study will no longer need PRMC review at the time of IRB review unless one of the following occurs:

  • The science or statistical design of the study changes such that a modification request will be sent to the IRB.
  • The study is modified to include the use, creation, or disclosure of PHI and/or other subject identifiable information.
  • The study re-opens for the accrual of subjects, specimen collection, and/or chart and database review.

Non-Exempt PRMC Studies

Non-Exempt PRMC studies include all Expedited and Full Committee studies. Studies that involve interventions with subjects and/or use of Cancer Center resources (please see above), are considered non-exempt and require review by the PRMC. All non-exempt PRMC studies require annual review prior to IRB continuing protocol review and approval. These studies also require review by the PRMC when the science or statistical design of a study is revised.

Expedited PRMC Studies

The following types of studies may qualify for PRMC expedited review:

  • Studies that do not involve active intervention with subjects but involve the creation, use, or disclosure of PHI.
  • Studies that do use Cancer Center resources such as the Clinical Research Office (CRO) for data management, the Regulatory Affairs Office (RAO) for IRB and  regulatory management, physical Cancer Center space, and/or Cancer Center funding.
  • Studies that involve less than minimal risk to human subjects.
  • Studies that involve greater than minimal risk but receive external peer review in addition to PRMC review.

Expedited PRMC studies require completion of the PRMC Application and Reviewer Sheet found in the PRMC_forms folder on the PRMC website.       

This application and the following protocol documents should be sent to the PRMC at  CancerCenter_Committees@health.uci.edu for expedited approval:

  • IRB Application (drafts acceptable)
  • Sponsor’s Protocol (if applicable)
  • Investigator's Brochure (if applicable)
  • Protocol Narrative
  • Informed Consent Form(s) (if applicable)
  • IRB modification request(s) from the last IRB approval period are required for renewals.
  • IRB approval letter(s) from the modifications above are required for renewals.
  • Documentation of external scientific peer review for studies that involve greater than minimal risk.

The PRMC reserves the right to request further study documentation if warranted.

Similar to exempt PRMC studies, expedited requests take about five to seven business days to approve, and the approval documentation is sent to the Lead Researcher and submitter (if applicable) as well as the IRB.  The Lead Researcher is encouraged to retain the approval documentation to verify PRMC clearance.

Full-Committee PRMC Studies

Proposed human subject research studies that do not fall into either the exempt or expedited review categories must be submitted for full committee review. Full committee review is the most rigorous level of review and, accordingly, is generally reserved for studies that present greater than minimal risks to subjects and involve a more complex scientific or statistical design than exempt and expedited studies.

The full committee meets once a month to review new and continuing protocol applications as well as modification requests (for scientific and/or statistical design changes), and the PRMC conducts re-review of studies which fail to meet the PRMC Accrual Policy requirements or have other accrual concerns.  The PRMC full committee schedule for submission deadlines and meeting dates may be found on the PRMC website.

Completion of the PRMC Application and Reviewer Check Sheet found in the PRMC_forms folder on the PRMC website and submission of the following protocol documents to the PRMC at CancerCenter_Committees@health.uci.edu are required for full committee approval:

  • IRB Application (drafts acceptable)
  • Sponsor’s Protocol (if applicable)
  • Investigator's Brochure (if applicable)
  • Protocol Narrative
  • Informed Consent Form(s) (if applicable)
  • IRB modification request(s) from the last IRB approval period are required for renewals.
  • IRB approval letter(s) from the modifications above are required for renewals.

The PRMC reserves the right to request further study documentation if warranted.

Note:  The PRMC provides written critiques to the Lead Researcher and submitter.

All non-exempt protocols must receive PRMC final approval prior to commencing subject enrollment activities.

Additional Information about the PRMC

All questions or comments concerning PRMC submission and review should be directed to the PRMC at CancerCenter_Committees@health.uci.edu.

For matters requiring urgent attention, please contact:

Christine Hui, MPH, Asst. Director, Clinical Research Operations
Email:cnhui@uci.edu

For additional information about the PRMC review process, please visit the PRMC website.

Note: This website is located on the UCIMC Intranet, which requires HSIS intranet access. All School of Medicine employees have access to the HSIS intranet. Once you log on to the Cancer Center website, click on "Shared Documents," “Resources for Clinical Investigators,” and Protocol Review and Monitoring Committee (PRMC)” to access information about the PRMC.

If you do not have HSIS intranet access, please contact one of the Regulatory Affairs Office staff for instructions on how to submit to the PRMC.

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