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 firstname.lastname@example.org 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 email@example.com 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?
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. When is a protocol eligible for a three-year approval period?
Exemptions are granted three-year approval periods unless otherwise identified at the time of initial approval. We are also able to provide some flexibility in applying human-subject-research regulations to non-federally supported research. Therefore, expedited protocols might be granted three-year approval periods for research that involves no more than minimal risk to participants; is not supported by federal funds, and is not subject to federal oversight.
Q. What if my expedited protocol becomes ineligible for a three-year approval period while within its current approval period?
A. If there is a change to a protocol that causes it to become ineligible, the principal investigator must immediately submit a Modification/Amendment Submission in Cayuse IRB. A new approval letter will be issued addressing the shortened approval period.
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 firstname.lastname@example.org.
Conducting Research with UC Merced Faculty or Staff Members or Students
Q. What if I want to recruit UC Merced faculty or staff members or students for surveys?