UCSC IRB - RENEWAL FORM FOR NON-EXEMPT RESEARCH

All research involving human subjects must be reviewed by the IRB periodically, according to the time stated in your approval letter. After 6 years, all projects must be resubmitted in full for Initial Review.

1. PROJECT
Title:
Protocol #:
Funding Agency:

2. PRINCIPAL INVESTIGATOR

Name (Last, First): / Phone:
E-mail: / Department:

3. FACULTY SPONSOR

Name (Last, First): / Phone:
E-mail: / Department:
4. RESEARCH STATUS
Check the appropriate box & submit the attachments requested on page 2.
Enrollment of new subjects is ongoing.
Enrollment of subjects has not been initiated, but is still planned.
Enrollment of new subjects is closed, but current subjects are still undergoing study procedure(s) or being contacted for follow-up.
Research remains active for data analysis only: no subject contact/no additional data collection.
5. SUBJECTS ACCRUED
The number of subjects is defined as the number of individuals who agreed to participate (i.e., those who provided consent or whose records were accessed, etc.) even if all did not complete the study.
a. Total number of subjects enrolled in the research to date:
b. Number of subjects enrolled during the last approval period (since last IRB review):
c. Number of new subjects that you plan to enroll during next approval period:
6. CONFLICT OF INTEREST
If your research is sponsored, has your relationship with the sponsor changed in any way that might require conflict of interest disclosure? (e.g stock purchases, salary, royalty payments, patents, Board position, etc.)
Yes No
Signature(s)
The undersigned accept(s) responsibility for the study, including adherence to federal, state and UCSC policies regarding the rights and welfare of human participants participating in this study. In the case of student protocols, the faculty sponsor and the student share responsibility for adherence to policies.
Signature of Principal Investigator / Date
Signature of Faculty Sponsor / Date

Check enclosed items below:

Please submit a status report containing the following information. If an item is not applicable to your research, please mark N/A.

1. A brief summary of the research project.
2. A copy of the current consent documents, recruitment material, and/or disclaimer forms, and any newly proposed consent documents or recruitment materials. (If your research remains active for data analysis only, you may specify n/a.)
3. A summary of any amendments or modifications to the research since the last IRB review.
4. A summary of any unanticipated* problems or adverse events** involving risk to subjects or study personnel since last IRB review. This includes confidentiality and data security breaches.
5. A summary of any withdrawal of subjects from research since the last IRB review.
6. A summary of any complaints about the research or its conduct since the last IRB review.
7. If new information has become known since last project approval that could affect the risks or benefits to subjects or influence the willingness of subjects to continue in the study:
(a)Attach the new information.
(b)Describe the actions taken, or to be taken, to inform subjects and/or minimize risk.
(c)Describe any recent literature that may be relevant to the risks, benefits, and procedures of the research.
8. Any other relevant information, especially information about risks associated with the research.
DEFINITIONS* What are unanticipated problems?
Unanticipated problems include any incident, experience, or outcome that meets all of the following criteria:
(1) Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and in terms of the characteristics of the subject population being studied;
(2) There is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
(3) Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
**What are adverse events?
The term adverse event includes any untoward or unfavorable medical occurrence (physical or psychological) in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.

Please submit this form electronically to the UCSC IRB at

Campus Mail Stop: Office of Research/IRB

439 Kerr Hall, 1156 High Street, Santa Cruz, CA 95064

Questions can be sent to or you can call us at (831)459-1473

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