Feedback on submissions will be entered into Cayuse Human Ethics by reviewers. All documents included with an IRB submission are examined for compliance. The PI, co-PI (if applicable), and primary contact will receive feedback via email to their @ucsc.edu address.
- Check your email on a regular basis. Responding promptly to these emails ensures that the submission can be reviewed as quickly as possible.
- Once you receive IRB approval, research may begin as written. If changes are needed, submit a Modification Submission in Cayuse Human Ethics. The modification must be approved before changes can be implemented, unless researchers are preventing immediate hazard to subjects.
Review timeline
Submissions are reviewed in the order they are received, and feedback is typically sent within ten business days after a submission is “certified” by the PI (and co-PI, if applicable). Please respond promptly to reviewer feedback to shorten review time. Submission review time depends on:
- The volume of protocols already under review at the time your submission is received.
- The completeness of the submission.
- The complexity of the research.
- Depending on the study procedures being performed, there may be ancillary reviews that affect a study start time, even if not required to obtain an IRB determination.
Examples
- A study in which a team member has a disclosable financial interest would require a COI disclosure and subsequent Conflict of Interest Review Committee (COIRC) review.
- A study that involves use of a transcription service may require Risk Services review/approval in order to process a purchase order for funding the use.
- A study that involves use of a non-UC Santa Cruz approved survey platform (i.e., a platform other than Qualtrics) may require review by the PI’s ITS Divisional Liaison.
- A study that involves collection or use of identifiable UC Santa Cruz student educational records (GPA, SAT test scores, etc.) may be subject to the Family Educational Rights and Privacy Act (FERPA), and thus require investigators to follow the UCSC Policy on Privacy of Student Records.
- A study that involves surveying 500+ UC Santa Cruz students, faculty, or staff or use of a survey that has a campus- or division-wide strategic goal(s) and/or includes questions about campus climate for diversity, equity, and inclusion may require review by the Institutional Research, Assessment, and Policy Studies (IRAPS) unit.
- A study that involves receipt or use of human blood, body fluids, tissues, or cells (including stem cells/cell lines) may require:
- establishment of a Biological Use Authorization (BUA), which would require Institutional Biosafety Committee (IBC) review/approval.
- establishment of an Material Transfer Agreement (MTA), which would require Innovation & Business Engagement Hub review/approval.
- A study that involves receipt or use of secondary data from a non-UC Santa Cruz institution/entity may require establishment of a Data Transfer & Use Agreement (DTUA), which would require Innovation & Business Engagement Hub office review/approval.
- A study that involves the use of human embryonic stem cells (hESC), induced pluripotent stem (iPS) cells, neural progenitor cells, human embryos, human gametes and other potentially pluripotent cells from any source is subject to Stem Cell Research Oversight (SCRO), and thus will require Human Gamete, Embryo and Stem Cell Research (GESCR) Committee review and approval.
Review types
Exempt
Minimal risk research activities that fit into one or more Exempt Categories.
The term “exempt” means that the activities are exempt from most of the requirements of the federal policies for the protection of human subjects, but are still considered human subjects research that require an IRB determination.
Expedited
Also known as non-exempt. Research that does not qualify for exempt review but still involves no more than minimal risk research activities.
Research that qualifies for “expedited” review can be approved without a determination from a convened IRB, but must fit into one or more Expedited Categories.
Full board
Research that is not eligible for exempt or expedited review, and requires discussion and vote at a meeting of the convened IRB to receive a determination.
Ethical principles
The UCSC IRB is guided by the three ethical principles propounded in the Belmont Report of the National Commission for the Protection of Human Subjects. Briefly stated, they are:
- Respect for Persons: means that investigators should obtain the informed consent of all human subjects invited to participate in research. In order to respect subject autonomy, the consent process should include giving subjects full and comprehensible information about the research and provide clear assurances of the subjects’ voluntary participation.
- Beneficence: also defined as concern for the wellbeing of subjects, means that the risk of harm to subjects should be the least possible, and that the sum of benefits to the subjects and the importance of the knowledge to be gained should so outweigh the remaining risk of harm to the subject as to warrant a decision to allow this risk.
- Justice: means that the selection of human subjects should be fair and equitable and that the risks and benefits of research should be distributed among subjects in a fair and equitable manner, with particular concern for subjects whose personal status or condition as children, prisoners, patients, impoverished persons places them in a vulnerable or dependent status.
Regulatory criteria for IRB approval
Before approving a study, the UCSC IRB must determine that all of the following requirements are satisfied:
- Risks to subjects are minimized and are reasonable in relation to anticipated benefits. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.
- Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by, §46.116.
- Informed consent will be appropriately documented or appropriately waived in accordance with §46.117.
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- When appropriate, there are adequate measures to protect the privacy of subjects and to maintain the confidentiality of data.
Administrative check-in and expiration dates
Yearly administrative check-in dates are assigned for human subjects research studies that:
- Involve no more than minimal risk to subjects (as defined by 45 CFR 46.102),
- Are not subject to federal oversight, and
- The UCSC IRB has not determined that an expiration date is otherwise appropriate.
Studies that don’t qualify for administrative check-in dates are instead given expiration dates one year from study approval.
Once an approval has been received, you may begin to conduct research activities.