Before submitting an IRB application for initial review, first determine if IRB review is required for your project.
All researchers should be conducting their IRB approved protocols in accordance with requirements in the Investigator Manual. This document is designed to guide you through policies and procedures related to the conduct of human research that are specific to University of California, Davis.
UC Davis allows students and/or medical residents to act as Principal Investigators in human subject research. They are required to follow all responsibilities of a researcher under the direction and guidance of a Faculty Advisor.
Responsibilities as they apply to faculty supervising students/medical residents as a Principal Investigator (PI).
Obtaining informed consent is a basic ethical and a legal requirement for researchers, unless the IRB waives this requirement. This section will cover the consent process, documentation, waiver of the informed consent, waiver of the documentation of informed consent, surrogate consent, and consent process for exempt research.
Identification, initial contact, screening and recruitment of potential human subjects form the foundation of the informed consent process. This section will cover how the research team, the study sponsor, and the IRB share the responsibility for creating a recruitment environment that is not only effective but is also ethical and that complies with the federal regulations and guidance.
Covers all of the types of submission you will send to the IRB during the life of your research study, as well as detailed instructions and videos on how to submit them.
The UC Davis IRB has developed forms and templates for use by the UC Davis research community as part of the IRB submission process and consenting of subjects.
The UC Davis IRB has adopted the IRBNet suite of tools, accessible via the internet, bringing electronic protocol management for all submission to the UC Davis research community. This section contains information on how to register an account and detailed step by step submission process.
Describes the process of IRB review at UC Davis and the different levels of review.
Describes how to know when action has been taken on your submission, what the action means, and where to find IRB determination letters and stamped consent forms.
Researchers are required to disclose any related financial interest. A related financial interest is an interest pertaining to or associated with a specific research project that includes income, equity, intellectual property, and/or sponsored travel.
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 IRB has three full board committees that review all human subject research studies that are considered greater than minimal risk to the subjects. The guidelines in this section will describe how our office assigns protocol submissions for review.
The UC Davis IRB requires investigators to report certain events or circumstances that occur during the conduct of a study. Some events must be reported to the IRB within ten (10) working days of the research staff having knowledge of the event.
Steps for developing an effective Corrective and Preventative Action Plan (CAPA).
Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.
For research involving investigational drugs, biologics, or devices the investigators must abide by the FDA regulations.
If you receive a federal grant to conduct human subject research, you are obligated to comply with the applicable regulations of the funding department or agency.
Contains provisions to protect the confidentiality and security of personally identifiable information that arises in the course of providing health care. In this section we will cover how HIPAA applies to human subject research and the responsibility and role of the IRB.
FERPA regulates the disclosure of personally identifiable information from youth education records in all institutions that uses funds from Department of Education. This section specifies the policies and procedures related to research access to education records covered by FERPA.
The Outreach and Training unit within UC Davis’s IRB Administration provides training in the critical area of the protection of human research participants through various venues and methods. Below is a brief description of programs that are available or coming in the near future.
Sites and personnel who are not part of UC Davis are not covered by UC Davis’ IRB review unless certain agreements are in place. If your project or study involves collaboration with any sites and/or personnel outside of UC Davis, you will need to work with the UC Davis IRB and the other individual/institution to ensure that all reliance issues are addressed.
Federal, state, and institutional regulations and policies that oversee human subject research conducted at UC Davis.