Ancillary Reviews

Some projects involve activities that require specialized review outside of the IRB. For example, when a study involves radiation, the research must undergo review by the Radiation Use Committee (RUC). At the IRB, we refer to these as ancillary reviews.

Some ancillary reviews affect subject safety and therefore the IRB cannot approve a project until the ancillary review is complete. In most cases the research team is responsible for applying to the ancillary committee or reviewing applicable policies to ensure compliance with requirements. If the ancillary review impacts subject safety or the ability to conduct the research successfully, the IRB will require proof of the ancillary committee’s determination as part of the application for initial review. In these cases, the IRB will not issue approval until the ancillary review is complete. The list below is broken into three sections to assist research teams in understanding how the requirement will impact their IRB application and review process.

In This Section

Proof of Ancillary Review Required to Secure IRB Approval

Proof of Ancillary Review not Required with Initial IRB Application

Researchers May be Contacted by Institutional Partners as Necessary

Proof of Ancillary Review Required to Secure IRB Approval

The IRB ensures compliance with ancillary reviews in this section by requiring proof of ancillary review prior to approval of the initial IRB Application.

UC Davis Comprehensive Cancer Center (UCDCCC) Scientific Review Committee (SRC)

A critical activity for National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers is a mechanism for assuring rigorous internal oversight of the scientific aspects of all cancer-related clinical research. SRC is responsible for the scientific review of protocols and has the sole authority to authorize activation of cancer-related clinical studies.

SRC review is required for all cancer-related, hypothesis-driven clinical research studies. UCDCCC defines cancer-related research as any patient-oriented, epidemiological/behavioral or health services research that involves:

  • Participants with cancer or pre-cancer, or
  • Participants with a high risk of cancer (e.g., liver cirrhosis, metabolic dysfunction, or genetic predisposition/family history, etc.), or
  • Participants with known cancer risk factors (e.g., tobacco smoke, air pollution, etc.), or
  • Any health services research designed to evaluate the delivery, processes, management, organization, or financing of health care related to cancer or known cancer risk factors

Research exempted from SRC review are in vitro studies that utilize human tissues that cannot be linked to a living individual, tissue banking, studies that do not require patient consent (e.g., retrospective chart reviews) and/or studies that are not cancer-related (this includes research that enrolls participants with the above conditions or risk factors, but the research objectives are of little or no known relevance to cancer).

Principal Investigators must submit a Cancer Center Scientific Review Form to  the SRC for the review and approval of their research.

Submission to SRC also ensures all cancer-related clinical research is appropriately documented and reported to the NCI as required by the UCDCCC’s cancer center support grant.

SRC Approval is not required for Single Patient IND trials.

Contact: Protocol Review and Monitoring System Administration

Radiation Use Committee (RUC)

Radiation Use Committee (UC Davis Health intranet or VPN required to view) review is required when a protocol involves the use of radioactive materials, radiopharmaceuticals, diagnostic x-rays, fluoroscopy, or any other external radiation source in human research. For the purpose of the RUC, research is defined as any procedure not routinely performed for patient diagnosis or therapy.

The purpose of RUC review is to ensure the research complies with UC Davis’s Radioactive Material License and state and federal regulations.

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.

Institutional Biosafety Committee (IBC)

Institutional Biosafety Committee review is 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

The purpose of IBC review is to ensure research complies with NIH Guidelines and UC Davis requirements. IBC review includes review by Occupational Health. The outcome of IBC 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.

When research involves recombinant DNA or stem cells, Principal Investigators must submit a Biological Use Authorization (BUA) via UC Biosafety prior to IRB review. In these instances, the IRB will not review a new project submission until a BUA has been uploaded to IRBNet.

Conflict of Interest Committee (COIC)

All Investigators responsible for the design, conduct or reporting of the research must submit required disclosures to the Institution via the eCOI system. Required disclosures are described in HRP-055.

For New Projects, disclosure is required if:

  • The study is PHS funded
  • The study is privately funded or supported
  • The study is FDA-regulated
  • Any Investigator has a significant financial interest and the research is unfunded and not FDA-regulated

The COIC at UC Davis is focused on evaluating financial interests related to research projects. The COIC shares documentation and information with the IRB, so there is no need to upload COIC-related documents to IRBNet.

See our Conflicts of Interest webpage for more information.

Radiological Services Requested (RSR)

Radiological Services Request review is required when research involves any imaging modality. This includes imaging which generates ionizing radiation (e.g. x-rays, CT scans, etc.) and imaging which does not (e.g. ultrasound).

The purpose of RSR review is to ensure there are adequate resources in the Department of Radiology to complete imaging for research or to train the research team.

Principal Investigators must submit the Radiology Service Request Form and any required documentation to the Radiology Research Committee for review and approval of their study prior to IRB approval.

  • Email: [email protected]
  • Phone: (916) 734-6464 (please ask to speak with a member of the clinical research team)

Pathology and Laboratory Clinical Research Oversight Committee (CROC)

CROC (UC Davis Health intranet or VPN required to view) review is required when research involves any laboratory testing or clinical laboratory sample retrieval, including tissue specimens.

The purpose of CROC review is to discuss the services investigators need from the Pathology Department and determine whether the services can be provided, and, if so, how. Contact the Department of Pathology and Laboratory Medicine before designing your study. Certain types of laboratory tests, activities, and tissue examination may require prior approval by the Laboratory Section Medical Director.

Principal Investigators must submit the Pathology Intake Form and any required documentation to CROC for review and approval of their study prior to IRB approval.

Proof of Ancillary Review not Required with Initial IRB Application

The IRB does not require proof of ancillary review for ancillary committees in this section. However, it is the researcher’s responsibility to ensure compliance with ancillary reviews in this category.

Information Technology (IT) Evaluations for Research

IT evaluation is required when research includes implementation or use of new applications, systems or devices that collect and/or transmit sensitive identifiable information such as Protected Health Information (PHI) or Personally Identifiable Information (PII).

The purpose of IT evaluations for research are to determine if a new technology is secure and complies with UC policies as well as state and federal regulations. UC Davis and UCD Health have separate policies for IT requirements. Researchers are responsible for compliance with the appropriate policies.

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

  • Mobile devices that are used to gather research data on human subjects
  • Cloud services that are used in research data collection, transmission, and storage
  • Software that would be implemented on the UCDH network or that would be used to access the UCDH network
  • Clinical devices that require network access or involve data transfer

Principal Investigators may obtain IT evaluation of their study at any time in the IRB approval process. However, it is critical that IT evaluation occurs prior to the start of the study. Contacting the IT Department prior to submitting to the IRB may avoid delays in study start-up related to new technologies.

Technology Transfer Office (TTO)

An advance agreement, such as a material transfer agreement (MTA), data transfer agreement (DTA), or confidentiality agreement (CDA), must be in place to transfer or receive tangible research material or raw datasets with another researcher, institution, or company. The TTO is responsible for setting up such advance agreements.

The purpose of these advance agreements is to:

  • Prevent misunderstandings about who has which rights to do what to/with the material
  • Address liability for flaws or problems that may occur
  • Ensure researchers can publish under academic freedom

Principal Investigators may submit required documentation to the TTO for review and approval of their study at any time in the IRB approval process. However, it is critical that an advance agreement is in place before any material or data is actually transferred. Unfortunately, these agreements are sometimes low priority for other entities, so advance notice can help the TTO team meet researcher deadlines.

Stem Cell Research Oversight Committee (SCRO)

SCRO review is required for all UC Davis research activities involving human stem cell research, regardless of the type of stem cells or whether the stem cells are adult or embryonic.

The purpose of SCRO review 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 submit an Application to Conduct Human Stem Cell Research to obtain review and approval of their research study after IRB review and approval.

Family Educational Rights and Privacy Act (FERPA)

FERPA applies when research involves access to educational records or student health records. There are three ways to comply with FERPA when accessing student records for research:

    1. Obtain consent to access education records for research (not to be confused with consent for participation in research)
    2. Access education records as a Campus Official
    3. Receive de-identified data

The UC Davis Registrar’s Office is responsible for FERPA compliance at UC Davis. Principal Investigators are responsible for contacting the Registrar’s Office prior to beginning research to ensure FERPA requirements are met. See our Student Records and FERPA webpage for more information.

Researchers May be Contacted by Institutional Partners as Necessary

Each ancillary committee in this section is responsible for contacting researchers only if a study must meet the requirements of that specific ancillary committee. Researchers are not expected to initiate review for any of these ancillary committees, nor does the IRB require proof of ancillary review for ancillary committees in this category.

Inpatients

Research teams may be contacted by the Center for Nursing Science when a protocol involves participants who are inpatients at UC Davis Health. The purpose is to ensure appropriate nursing resources are in place to support the research. Principal Investigators are not responsible for initiating contact with the Center for Nursing Science.

Community Engagement

Community Engagement Program

The Community Engagement program is a well-established resource linking investigators and community partners to implement the mission of building capacity and infrastructure for clinical and translational research among investigators, patients, health care providers, policymakers, and community-based organizations. The program leverages institutional centers and resources focused on community and stakeholder partnerships. This resource can help researchers forge relationships with community partners, California health agencies, and elected officials around health and healthcare issues through collaborations. The Research and Education Community Advisory Board supports health-related communication and partnerships and bridges researchers with underserved communities. The Community Review Board provides a specialized consultation session for health researchers developing community- or patient-centered research proposals.

Principal Investigators may obtain more information about the Research and Education Community Advisory Board and the Community Review Board by visiting the Community Engagement program’s webpage. In addition, Principal Investigators may be contacted by members of the Community Engagement program if they identify that they are conducting community-engaged research in their Initial Review Application.

Click here to learn more and schedule a consultation.

Health Equity Resources and Outreach (HERO) Program

The HERO Program supports greater and more diverse public participation in the design, implementation, and communication of health research.  HERO collects, creates, and shares tools, resources and best practices, offers consultations and training in engaging diverse communities, brokers connections to community partners, and organizes events and projects to support effective dialogue, collaboration, and mutual learning by professional researchers and the public. HERO’s focus is on special populations––groups and individuals underrepresented in scientific studies, especially children, adolescents, and older adults, as well as refugees, women, minoritized communities, rural residents, and people affected by rare diseases.

In addition, principal investigators may be contacted by members of the HERO program if they identify that they are conducting community-engaged research for special populations in their Initial Review Application.

Click here to learn more and schedule a consultation or contact HERO.

Additional Resources

For researchers seeking tools to engage with special populations are:

Clinical Trial Posting on StudyPages and ClinicalTrials.gov

StudyPages

If a study is a clinical trial, it will automatically be posted to UC Davis StudyPages to advertise for recruitment. The Initial Review Application allows research teams to provide the email address of the study team’s primary contact for subject recruitment. Research teams may be contacted by the Clinical Trails Office regarding Study Pages.

ClinicalTrials.gov

If a study is a clinical trial, it may be required to be registered on ClinicalTrials.gov. For guidance on ClinicalTrials.gov registration requirements, please refer to this flow chart or contact the Clinical Trials Office.