Ancillary Reviews

In some instances, research will involve certain activities that require specialized review. For example, when a study involves radiation, the research must undergo review by the Radiation Use Committee (RUC).   Ancillary reviews must be initiated by the Principal Investigator. The chart below identifies the required pre- and post- department or other ancillary reviews that must occur before the research activity may begin. If your research meets the requirements for one of the ancillary reviews below, you must submit the research to that Committee according to the Committee’s requirements.

 

Ancillary Committee

Required Prior to IRB Submission

Required Prior to or Concurrent with IRB Review

Required After IRB Approval

Institutional Biosafety Committee (IBC)    

 X

 

Institutional Biosafety Committee (IBC) 

recombinant DNA research

X

 

Conflict of Interest Committee (COIC)

X

Cancer Center Scientific Review Committee (CCSRC) X

Radiation Use Committee (RUC)

X

Stem Cell Research Oversight Committee (SCROC)

X

UCDMC Pathology

 X

Information Technology Evaluations for Research (IT)

 X

Institutional Biosafety Committee (IBC)

Required when research involves:

    • Recombinant DNA
    • Materials that are infectious (or potentially infectious) to plants, animals, or humans (including replication-defective viral vectors)
    • Materials that fall under the Cal OSHA Bloodborne Pathogen Standard. This includes any work with human cell lines, human blood or blood products, and human body fluids
    • Storage of biohazardous materials that are not being used

Purpose is to see if research complies with NIH Guidelines and UC Davis requirements

Includes a review by Occupational Health

Outcome of review includes:

    • A recommendation for the level of medical surveillance of personnel associated with the research project
    • Recommendations for modifications, curtailment or termination of any projects when such actions are in the best interest of the health and safety of the community.

Researcher must contact the IBC prior to conducting research

Contact IBC to determine review requirements.

Website:  http://safetyservices.ucdavis.edu/article/biological-use-authorization-bua

Phone: (530) 752-1493

Conflict of Interest Committee (COIC)

Researchers are required to disclose actual and potential conflicts of interest (including significant, related financial interests) to both the Conflict of Interest Committee and the IRB.

The IRB evaluates conflicts of interest with attention to human subjects protection and the rights of participants. Specifically, investigators are required to disclose and manage any actual or potential conflict between the conduct of their research and the private and/or personal interests of any investigator or member of the key research staff.  Oversight of conflicts ensures transparency with research subjects and incorporates the principle of equipoise among investigators and in study design.

The Conflict of Interest Committee (COIC) at UC Davis is focused on evaluating financial interests related to research projects.  The COIC shares documentation and information with the IRB.  The IRB has the final authority and may add requirements that are not included in the management plan of a COIC determination.

Investigators should note the following:

  • Submission to the COIC is required when an investigator or member of key research staff have an actual or perceived conflict of interest as defined by institutional policy and applicable federal and state regulations.
  • The purpose of COIC review is to determine whether the conflict would cause bias during the research.
  • Investigators must also report any COI on the Initial Review Application submitted to the IRB, and each Continuing Review Report form, and submit any change of COI as a modification to the research.
  • The COIC informs the IRB of its determinations and management plans.
  • Both the COIC and the IRB may require changes to the research documents, and these revisions must receive IRB approval before research can proceed.
  • For additional information, see SOP: FINANCIAL CONFLICTS OF INTEREST [HRP-055])
  • If a potential or actual financial conflict is pending with the COIC at the time of IRB review, the IRB will review the research and may require the COIC review to be completed before approval is granted.
  • Website: http://research.ucdavis.edu/policiescompliance/coi/
  • Phone: (530) 754-7754

Cancer Center Scientific Review Committee (CCSRC)

Required when the protocol involves participants with cancer or data about cancer patients

The purpose is to provide a centralized mechanism for prospective evaluation of scientific merit, resource allocation, and clinical cancer research monitoring

Principal Investigators must contact the CCSRC for the review and approval of their research

The IRB will not review the submission until CCSRC review is completed, when required

Phone: (916) 734-2596

Radiation Use Committee (RUC)

Required when research involving humans as participants uses radioactive materials and ionizing radiation (including diagnostic x-rays/fluoroscopy/ DEXA)

Purpose is to ensure the research complies with UC Davis’s Radioactive Material License and state and federal regulations

The IRB will not review the submission until RUC review has been completed, when review is required

Principal Investigators must contact the Radiation Use Committee for review and approval of their study prior to IRB review and approval. The RUC may require amendments to the design of the study, restrictions, or specific wording in the informed consent document.

The IRB will withhold approval of a research study involving radiation without the prior approval/exemption of the Radiation Use Committee.

Phone: (916) 734-3355

Stem Cell Research Oversight Committee (SCROC)

Required when the research includes obtaining human tissue for use in developing embryonic stem cell lines

The purpose is to:

    • Determine the scientific merit of the protocol
    • Ensure the research complies with relevant state and federal law and guidance
    • Facilitate education for investigators conducting research involving human adult and embryonic stem cell research

Principal Investigators must contact the Stem Cell Research Oversight Committee to obtain review and approval of their research study after IRB review and approval.

Phone: (530) 752-2454

Website: http://research.ucdavis.edu/policiescompliance/stem-cell-research/

UCDMC PATHOLOGY

Required when research involves any laboratory testing or clinical laboratory sample retrieval, including tissue specimens through the UC Davis Medical Center

The purpose is to discuss the services investigators need from the Pathology Department and determine whether and how the services can provided.

Phone: (916) 734-2112

Website: http://www.ucdmc.ucdavis.edu/pathology/research

Email: hs-pathresearch@ucdavis.edu

Contact the Department of Pathology and Laboratory Medicine in advance of designing your study. Certain types of laboratory tests, activities, and tissue examination may require prior approval by the Laboratory Section Medical Director .

Information Technology (IT) Evaluations for Research

Required when research includes implementation or use of new applications, systems or devices that collect and/or transmit Protected Health Information (PHI) or Personally Identifiable Information (PII)

Purpose is to determine if the new technology is secure and complies with UC policies as well as state and federal regulations

Some examples of research-related technologies that have been evaluated include:

  • Mobile devices that are used to gather research data on human subjects
  • Software that would be implemented on the UCDHS network or that would be used to access the UCDHS network
  • Clinical devices that require network access or involve data transfer

Email: ITevaluation.newtechnology@ucdmc.ucdavis.edu

Website: http://intranet.ucdmc.ucdavis.edu/it/documents/IT_Eval.shtml

Principle Investigators must obtain IT evaluation prior to the start of the study. Contact the IT Department prior to submitting to the IRB to avoid delays in study start-up.