Information about the Human Subjects Protection Program
- What is IRB administration (IRB Admin)?
- What is the role of the Institutional Review Board (IRB)?
- What is research involving human subjects?
- What are the different regulatory classifications that research activities may fall under?
The Role and Responsibilities of the Principal Investigator
- Who is eligible to be a Principal Investigator?
- What training do my staff and I need to conduct Human Research?
- Reporting adverse events/injuries to the IRB
Submitting Protocols to the IRB
- What signatures are required with submission to the IRB?
- Modifications to approved research
- How do I submit a research personnel change?
- How do I close out a study?
- How do I re-open a closed study?
- When are the protocol submission deadlines?
- How do I submit my applications?
- Contact information
Information about Ancillary Reviews
IRB Admin is a component of the Office of Research that provides education, administrative support and record-keeping functions, and conducts audits for the Institutional Review Board (IRB).
There are four campus wide committees (IRBs) thatsafeguard the rights and welfare of all human research subjects andhave the authority to approve, require modifications in, or disapprove all research activities that fall within their jurisdiction. These Committees fall under our Federalwide Assurance (FWA) with the Department of Health and Human Services/Office of Human Research Protections (DHHS/OHRP). UCD assures the government and the public that it will comply with federal regulations for the protection of human research subjects. The function of the IRBs is to ensure adherence to all federal, state, local, and institutional regulations concerning the protection of human subjects in research. The UCD IRB review is required for both funded and non-funded human subjects research.
Research as Defined by Department of Health and Human Services (DHHS)
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Research as Defined by Food and Drug Administration (FDA)
Any experiment that involves a test article and one or more human subjects, and that meets any one of the following:
- Must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act meaning any use of a drug other than the use of an approved drug in the course of medical practice;
- Must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act meaning any activity that evaluates the safety or effectiveness of a device; OR
- Any activity the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
Submitted activities may fall under one of the following four regulatory classifications:
- Not “Human Research”: Activities must meet the organizational definition of “Human Research” to fall under IRB oversight. Activities that do not meet this definition of are not subject to IRB oversight or review. Review the IRB Office’s “WORKSHEET: Human Research (HRP-310)” for reference. Contact the IRB Office in cases where it is unclear whether an activity is Human Research.
- Exempt: Certain categories of Human Research may be exempt from regulation but require IRB review. It is the responsibility of the organization, not the investigator, to determine whether Human Research is exempt from IRB review. Review the IRB Administration’s “WORKSHEET: Exemption Determination (HRP-312)” for reference on the categories of research that may be exempt.
- Review Using the Expedited Procedure: Certain categories of non-exempt Human Research may qualify for review using the expedited procedure, meaning that the project may be approved by a single designated IRB reviewer, rather than the convened board. Review the IRB Administration’s “WORKSHEET: Eligibility for Review Using the Expedited Procedure (HRP-313)” for reference on the categories of research that may be reviewed using the expedited procedure.
- Review by the Convened IRB: Non-Exempt Human Research that does not qualify for review using the expedited procedure must be reviewed by the convened IRB.
At UC Davis, faculty members with paid appointments of 50% or more of full-time may serve as the principal investigator on a research project involving human subjects. In certain situations, students may also assume roles as principal investigators as long as they have a faculty sponsor who fulfills the principal investigator eligibility criteria and who will serve as a faculty advisor on the study.
Investigators and staff conducting research involving more than minimal risk to subjects must complete the Collaborative Institutional Training Initiative (CITI) human subjects online training program. Investigators and staff conducting research involving no more than minimal risk to subjects must complete either the online CITI program or the National Institutes of Health (NIH) Protection Human Research Participants Course (PHRP). Investigators conducting clinical trials are required to take GCP training.
Investigators should serious harms that are unexpected and probably related (>50% likely; “don’t know” = <50%) and as listed on Reportable New Information (HRP-214) . This form must be completed for each event that has occurred at UC Davis and reported to the IRB no later than 5 working days after occurrence.
In compliance with School and Departmental requirements investigators initial submission to the IRB will require the following signatures in addition to the Principal Investigator’s (PI):
All Departments: the Chair’s signature of the PI’s department is required
School of Medicine or School of Nursing: the Dean’s signature is required
Student PI’s, et al. (e.g. grad students, etc.): the Faculty Advisor’s signature is required
These signatures will be collected on the Administrative Approvals (HRP-226).
Modification (HRP-213), Continuing Review Progress Report (HRP-212), or Reportable New Information (HRP-214) submissions will only require the signature of the PI. Exception: if changing the PI on a currently approved study at time of renewal or via modification the Administrative Approvals (HRP-226) form must be submitted with the change request.
Any changes in your research plan must be submitted to the IRB Admin for IRB review and approval prior to implementation of such a change. This includes changes in personnel, interventions, inclusion/exclusion criteria, location of research, advertisements for the recruitment of subjects, and change in number of subjects. To apply complete Modification (HRP-213) form, and submit the required documents for review.
When submitting a currently approved protocol for modification, please submit all appropriate documentation that has been changed for review. The IRB Administration does require that the investigator a copy of all revised documents in “Tracked Changes” format or similarly notated to indicate what changes were made, with “clean” or “unmarked” copies of all revised documents. It is optional to provide the IRB Administration with a summary of changes on a separate memo.
To modify your currently approved research personnel list utilize form Modification (HRP-213). Please remember to submit any additional documentation (e.g. research personnel list, protocol, consent forms) that will also be affected by the personnel change. The IRB Administration does require that the investigator submit a copy of all revised documents in “Tracked Changes” format or similarly notated to indicate what changes were made, with “clean” or “unmarked” copies of all revised documents.
Complete the form Continuing Review Progress Report (HRP-212), attach all requested supplements, have the formed signed by the individuals listed in the form, and provide the requested number of copies to the IRB Administration. Maintain electronic copies of all information submitted to the IRB in case revisions are required. For further information please reference the Investigator Manual, section “How do I close out a study”.
First, if the study has a sponsor, please always check with the sponsor to ensure the sponsor agrees that the study can be closed. Next, follow the process below that best fits your situation:
- If the expiration date of your study has passed since you closed the study the IRB will need to conduct continuing review when it approves re-opening the study (e.g. the date you want to reopen the study is 01/01/2014 and the study expired on 12/31/2013). You will need to submit a Modification (HRP-213) and a Continuing Review Progress Report (HRP-212).
- If the expiration date of your study is less than 60 days from the date you want to reopen the study (e.g., the date you want to reopen the study is 01/01/2014 and the study will expire on 03/01/2014) the IRB will need to conduct continuing review when it approves re-opening the study.You will need to submit a Modification (HRP-213) and a Continuing Review Progress Report (HRP-212).
- If the expiration date of your study is more than 60 days from the date you want to re-open the study (e.g., the date you want to reopen the study is 01/01/2014 and the study will expire on 02/27/2014), you need to submit a Modification (HRP-213).
The Modification form (HRP-213) must include an explanation for the re-opening of the study and outline any changes being made to the protocol. Please remember to submit any additional documentation (e.g. research personnel list, protocol, consent forms) that will also be affected by the re-opening. The IRB Administration requires investigators to submit two copies of all revised documents: (1) one copy should be in a “tracked changes” format so we can easily identify why has changed; and (2) one copy should be a clean document with no marks or tracking indicating the changes that have been made.
Protocol submission deadlines for committee reviews are posted on the IRB Admin website.
Protocols must be received no later than 5:00 PM on the deadline day. Any protocol received after a deadline will be automatically placed on the next deadline schedule.
We now only accepted submissions electronically via the eDocument System.
- UC Davis Sponsored Programs
(For review and processing agreements)
- Medical Dean’s Office
(To secure Dean’s concurrence to conduct research)
- Radiation Use Committee
- Cancer Center Scientific Review Committee
- Investigational Drug Service
(916) 703-4093 or 762-3929
- Research Compliance and Integrity
- Stem Cell Research Oversight
- Institutional Biosafety Committee