A Guide for Investigators and Research Staff
Below is a list of suggestions on how to get started, resources needed, and an overview of the submission process.
Determine if IRB Review is Required
First, determine if the activities meet the federal definition of "research" involving "human subjects". Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with identifying information about humans is considered to be human subject research and requires review.
These guidance documents will help you to determine whether your activity meets the definition of research involving human subjects:
- Determining Which Activities Require UCLA OHRPP/IRB Review and
- Determining When Collection or Use of Data and Specimens for Research Requires IRB Review
IMPORTANT NOTE: IRB review and approval or certification of exemption must be obtained prior to any contact with human subjects or any use of their specimens, records, or data.
Complete Training Courses
Once you have determined that the activities are research involving human subjects, complete the training courses:
Human Subjects Ethics and Regulations:
- All key research personnel who will work with human subjects must complete the Collaborative Institutional Training Initiative (CITI) Online Human Subjects Protection Training before submission to the IRB. See a definition of Key Personnel.
- Starting July 1, 2021, research teams will be able to add and remove certain key personnel without submitting an amendment using the Edit Study Personnel action.
- Starting July 1, 2021, automatic CITI checks (for initial submission, AMs, and CRs) will be conducted to ensure all key personnel have current human subjects training. If any key personnel have missing or expired training, the system will block submission of the application.
IRB application system:
- UCLA’s online IRB application system allows UCLA investigators to complete an electronic IRB application. For more information on our IRB application system, see Electronic Submission Systems.
Assess Risk & Determine Level of Review
The risk level and types of research procedures will determine which level of review is required. To determine the risk level of your research, see "Conducting Risk-Benefit Assessments".
- Technically exempt from the need for IRB review, but requires submission of an application, and OHRPP confirmation of the certification of exempt status.
- List of the Exempt categories
IRB Review - See Level of IRB Review - Expedited Review and Full Committee Review
- No more than minimal risk: "Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
- Reviewed by a representative or subcommittee of the IRBs.
- List of the Expedited Review categories.
- EXAMPLES: Standard quality of life survey, in-person interview about non-sensitive topics.
- Full Committee:
- More than minimal risks to subjects
- Reviewed by one of five convened IRBs.
- EXAMPLES: Randomized double blind clinical trial of investigational drug to treat terminal disease; behavioral intervention to reduce drug use; one-on-one interviews with a vulnerable population about sensitive topic where privacy and confidentiality cannot be guaranteed.
- UCLA is requested to serve as the reviewing IRB for other institution(s)
- UCLA is requested to rely on another institution for IRB review
- For more information on reliance, see UCLA OHRPP Guidance and Procedures: Reliance and IRB reliance overview.
IMPORTANT NOTE: This determination will help you allow for sufficient time for review of your protocol.
Allow Sufficient Time
The length of time for review and approval depends on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review.
Full committee review:
- Allow 6-8 weeks for Full Committee approvals of initial submissions and modifications.
- Allow 4 weeks for Full Committee approval of continuing review submissions.
- Each of the 5 IRBs meet twice monthly: IRB meeting dates and application deadlines.
Expedited and Exempt review:
- Allow 2-3 weeks for Expedited approvals.
- Allow 1 week for Exempt certifications.
- Allow 1 week for renewals and modifications to expedited and exempt studies.
- Exempt and expedited applications are reviewed in the order received and do not have application deadlines.
Allow extra time during holiday and vacation periods.
Apply for IRB Review
All levels of review use the same webIRB application; the application is designed to branch in response to the information provided about the study procedures.
Develop or collect the following Materials Required for IRB Review before completing the IRB application:
- Funding application (if funded)
- Recruitment and screening materials (flyers, letters) (See Guidance and Procedure: Recruitment and Screening Methods and Materials)
- Consent and assent forms (See Consent, Assent, and Screening Templates)
- Study measures
- If applicable: Investigational Drug/Device Brochures, Package Inserts, Sponsor’s protocol
Understand the IRB Review Process
- OHRPP staff perform an administrative pre-review of submissions to ensure that the information and materials required for the Board to complete their review are included.
- OHRPP staff may send requests to obtain the necessary information. (EXAMPLES: Consent forms are missing, a recruitment process is not described)
IMPORTANT NOTE: Administrative pre-review does not include scientific or scholarly review
- IRB members review all information and materials provided in the IRB application. Investigators are not routinely invited to attend IRB meetings for the review process.
- During the IRB review, you will likely be asked to discuss different aspects of your research, or add information to your application.
- OHRPP staff will communicate the IRB’s decisions and requests to researchers.
- Researchers need to provide the requested information and materials and complete the requested revisions in order to complete the IRB review process.
See detailed explanation of the process of Communication of IRB Actions
Understand Your Responsibilities
- Obtain prospective IRB approval for modifications to previously approved research.
- Obtain IRB continuing review annually, if applicable, or complete annual PI assurance.
- Submit post-approval reports of events that are unanticipated problems that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research.
- Submit closure report when research is complete.