What to Consider Before Completing an IRB Application

An Overview of Submitting Human Subjects Research

Review the PowerPoint presentation on submitting Human Subjects Research.

Things to consider before submitting an IRB application:

Qualifying as human subjects research

In some cases, a research project that involves human subjects may not meet the federal guidelines for IRB review of human subjects research. For example, a project such as a quality improvement survey or oral history documentary may involve human subjects, but is not considered "research." Alternatively, a project may be considered research, but the data has been de-identified and therefore the research does not involve human subjects. For more information about determining whether your project meets the criteria for human subjects research, see Does my project involve human subjects? You may also contact the Office of Research Compliance (ORCA) with questions.

If your project does not meet the criteria for human subjects research, you do not need to complete an application. However, please review the criteria thoroughly before making this determination as the IRB cannot retroactively approve research.

Funding

Many investigators choose to wait until they hear that a project will likely be funded before submitting an IRB protocol. This saves time for both the PI and the IRB, since many grant applications do not get funded the first time. Most grant applications will allow you to indicate that human subjects review is "pending" or "in process." 

Exempt vs. non-exempt research

Certain categories of human subjects research are considered such low-risk that they may be exempt from IRB review.  For example, projects involving educational research, interviews, surveys, or public observation may be exempt. The UCSC IRB will need to review your exemption request to determine whether your study meets the criteria for exemption. Once an exemption request is approved, the approval is valid for the duration of the described research without having to be renewed. 

For more information about what types of research may receive an exemption, see Exemption Categories.

Research that receives expedited review

Once you have determined that you meet the definition of human subjects research and do not qualify for exempt review, you can determine if your study fits under expedited review.

Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110 if it is determined that the activity:

  • presents no more than minimal risk to human subjects, AND
  • involves only procedures listed in one or more of the following categories 
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
 
The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted.
 
The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal
 
The expedited review procedure may not be used for classified research involving human subjects.

Personnel and completing training

The UCSC IRB oversees research conducted by, or pertaining to UCSC faculty, staff, and students and working with members of the UCSC community. If you do not fall into one of these groups, you may need to pursue IRB review elsewhere.

All non-tenure track faculty engaged in research must complete human research protections training, whether exempt, expedited, or full board review before submitting your full protocol or exemption request. Training is also required of faculty researchers for some federally funded research, such as NIH sponsored research. The CITI training only needs to be completed once and your completion report will be automatically submitted to ORCA for processing. The training will help you better understand and address a broad range of human subjects issues, from logistical to ethical, and promotes compliance with federal guidelines. Completing the training in advance will help ensure timely processing of your submission.

For more information on training requirements, see When is IRB training required? 

Initial Submission: How to choose and submit an IRB application form

Contact the Office of Research Compliance (ORCA) with any questions.