Protocol Review Process
Q. If my study does not involve human-subject research, how can I get documentation for my records?
A. Please email your request to email@example.com with a summary of your research purpose, procedures and data collection. If you are unsure if your study involves human-subject research, you should contact the IRB office at firstname.lastname@example.org or 209-228-4805. You may also visit Chart 1 under checklists to help make this determination.
Q. What is the review/approval time frame for my protocol?
Exemptions take approximately two to three weeks to review depending on the quality and completeness of the submission and complexity of the study. Modifications for exempt protocols take approximately three to five business days to review depending on the quality and completeness of the submission and complexity of the modification. Once the IRB office sends researchers the initial review comments, the approval time is highly variable depending on researcher response time.
Expedited protocols take approximately four to six weeks to review depending on the quality and completeness of the submission and complexity of the study. Modifications for expedited protocols take approximately ten to fifteen business days to review depending on the quality and completeness of the submission and complexity of the modification. Once the IRB office sends researchers the initial review comments, the approval time is highly variable depending on researcher response time.
Full board protocols (including modifications) take additional review time and are subject to scheduled meeting dates.
Q. How can I change the personnel associated with my protocol after it has been approved?
A. Please initiate the Modification/Amendment submission in Cayuse IRB.
Q. How can I make modifications to my study after it has been approved?
Please initiate the Modification/Amendment submission in Cayuse IRB.
Q. How do I renew my protocol?
Please use the Continuing Review/Renewal Submission in Cayuse IRB. You must submit renewal forms in at least a week before the expiration date if no changes are requested with the renewal. If requesting changes to your protocol with the renewal, please submit at least two weeks in advance of your protocol expiration date.
Q. What is the approval period for my protocol that was reviewed/approved prior to January 21, 2019 (pre-2018 Common Rule)?
A. Exemptions are assigned three-year approval periods.
Expedited protocols are assigned either annual or three-year approval periods. Contact the Office of Research to learn more about what qualifies for a three-year approval period.
Full board protocols are assigned annual approval periods.
Q. What is the approval period for my protocol that was reviewed/approved after to January 21, 2019 (post-2018 Common Rule)?
A. Exemptions and most Expedited protocols no longer require continuing review. Continuing review for Expedited protoclols that might require continuing review if:
The project is regulated by a sponsor that requires continuing review (FDA)
The project involves additional regulatory oversight, such as COI
The research will be conducted internationally and/or research with a reliance agreement
The investigator has had previous serious non-compliance or a pattern of non-compliance
Full Board protocols require continuing review.
Studies (regardless of review type) that have completed subject intervention/interaction and in which activity is limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.
Q. What is the 10-year update submission?
A. For studies that do not require continuing review, researchers must complete a submission at the 10-year mark to either close-out the protocol or confirm it is ongoing and active. This allows the IRB office to close protocols that are no longer active.
Conducting Research or Other Activities with Other Institutions
Q. What if I will be engaged in human-subject research at another UC campus?
A. Principal investigators conducting human-subject research at other UC campus must either get IRB approval from UC Merced or have an active reliance under the UC MOU. Please visit our information page on the UC MOU and the UC Reliance Registry.
Q. What if I will be engaged in human-subject research at a non-UC institution?
A. You must either get IRB approval from UC Merced or enter into an IRB Authorization Agreement (IAA) that allows UC Merced to rely on the other institution’s IRB review. Please visit our information page on IRB Authorization Agreements.
Q. What if I am an unaffiliated researcher wanting to recruit subjects from the UC Merced community?
If you are a non-UC Merced researcher who wishes to recruit from the UC Merced community but is not collaborating with a UC Merced principal investigator, then UC Merced is not engaged in the research, and no IRB review is needed. The non-UC Merced researcher is responsible for abiding by the policies of his/her home institution’s IRB and for obtaining appropriate permission to recruit from UC Merced groups and organizations. Please contact the IRB office for more information at email@example.com.