- Where can I find the initial IRB protocol form on the website? How do I apply for IRB approval?
- Will my study require IRB approval?
- When can I expect a final decision about my protocol?
- How will I be notified when my protocol is approved?
- When can I begin my research?
- How long does my approval last?
- Are there any formatting requirements for protocols submitted to the IRB office?
- Where can I find information on the informed consent process?
- What if data collection documents (e.g., survey, recruitment flyers, questionnaire) are not yet finalized when I submit my protocol?
- What kinds of changes to my research study require the submission of an amendment to my protocol?
- How do I submit a change to an IRB approved protocol to the IRB?
- How often must I renew my IRB approval?
- I received a renewal reminder from the IRB office, but my project is complete (data collection, follow-up and analysis are complete). What should I do?
- Can I continue to work on my research study if I have received a notice indicating that my approval has expired?
- What do I do if I need to terminate my project due to loss or lack of funding?
- I received an expiration notice from the IRB Office indicating my approval has expired. What should I do if my protocol's expiration date has passed and I intended to renew?
- How do I report an adverse event/unanticipated problem?
- Is the eIRB system available for Macs (Apple computers) or only PCs? How do I disable the pop-up blocker on a Mac?
- How do I electronically sign my protocol?
- What can I expect from an IRB review?
- Where can I print out my CITI training report?
- Can I access the eIRB on my IPhone or IPad?
- How big should my study's sample size be?
1. Where can I find the initial IRB protocol form on the website? How do I apply for IRB approval?
For Submittal of a New Protocol, navigate through the "eIRB Basic Instructions" tab.
2. Will my study require IRB approval?
Please refer to the following definitions to determine whether your research requires IRB approval and contact the Cal Poly Pomona IRB.
For the purposes of the IRB, “human subject research” is defined in 45 CFR 46.102(f) of the Policies and Procedures for Human Research Protection . In addition, student research, if it involves human subjects as defined in 45 CFR 46.102(f) is
included, even if the activity does not meet the definition of research in the same section.
Human subject - a living individual about whom an investigator (whether professional or student) conducting research obtains:
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject. This includes survey and questionnaires, even if there is no direct contact between the investigator and subject.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, medical records or student records). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
Not all human subject research falls under Federal Policy, and there may be differences in the types of review required based on the potential risk to the subjects. However, only an IRB can determine if a given research project falls under Federal Policy, or which aspects of the policy apply. Under Federal Policy, an authorized IRB can decide on policy that is more restrictive than Federal Policy, though never more lenient.
3. When can I expect a final decision about my protocol?
Approval period depends upon the type of review (full, expedited, or exempt). Typically, most protocols are reviewed by the expedited method which can take up to two to four weeks, provided that the protocol packet is complete. Use the self-check list (DOC) to evaluate your protocol before submitting it for IRB review; doing so is likely to accelerate the process.
4. How will I be notified when my protocol is approved?
When the review has been completed, you will be sent an approval memo. The approval memo is issued under signature of the IRB chair and it serves as the official notification that your research study has been approved.
5. When can I begin my research?
Investigators may begin their research after an approval memo from the IRB has been received and the IRB approved consent form (if applicable) has been signed by all human subjects that will participate in the study.
6. How long does my approval last?
7. Are there any formatting requirements for protocols submitted to the IRB office?
Go to "writing your protocol" to see different examples of protocols as well as tips to writing your protocol.
Note: All students must have their advisor review their protocol prior to submitting it.
8. Where can I find information on the informed consent process?
The type of consent form varies depending on the study you will conduct. Go to the "consent forms" tab to view guidelines to help you write your consent or assent form.
9. What if data collection documents (e.g., survey, recruitment flyers, questionnaire) are not yet finalized when I submit my protocol?
In the case of most protocols, all data collection documents should be attached to the protocol that is being submitted for approval. Any change to a document that has been previously approved by the IRB, will require an amendment form for review and approval.
If for some reason a document is not finalized, explain this in the “Procedures” section of your initial protocol, including a description of your intended methodology. Once the documents are finalized, submit them to the administrative reviewer (the staff responsible for administrative support to the IRB) assigned to your protocol.
10. What kinds of changes to my research study require the submission of an amendment to my protocol?
Should there be any changes to your research plan as described, please advise the IRB, because you may be required to submit an amendment.
These changes may include, but are not limited to:
- A change of study design, methodology, or recruitment methods
- Changes to any data collection documents, including surveys and questionnaires
- Changes to consent documents
- Changes to the population proposed in the approved protocol
- Changes in funding
- Addition/Deletion of investigators
- Change of Project Title
- Addition/Deletion of research performance sites
11. How do I submit a change to an IRB approved protocol to the IRB?
12. How often must I renew my IRB approval?
Approved protocols may be renewed if interaction with subjects will continue. Send an email to email@example.com describing in detail the reason for the renewal (e.g., collection of additional data from more subjects). Completion of a new protocol in this circumstance may be requested by the IRB.
13. I received a renewal reminder from the IRB office, but my project is complete (data collection, follow-up and analysis are complete). What should I do?
At any time prior to the expiration date, responsible project investigators may request closure of the protocol if research activities including data collection and analysis are complete. If all data collection and analysis are complete, it would be appreciated that you advise the IRB of the completion of your project.
14. Can I continue to work on my research study if I have received a notice indicating that my approval has expired?
After the expiration date, you may no longer continue to collect data, however you may continue to work on analysis of data. The IRB office sends a renewal reminder as a courtesy to you before the expiration of the IRB approval. If you have received a notice and your project is not complete, contact the IRB office to discuss your situation.
15. What do I do if I need to terminate my project due to loss or lack of funding?
16. I received an expiration notice from the IRB Office indicating my approval has expired. What should I do if my protocol's expiration date has passed and I intended to renew?
If your protocol's expiration date has passed, then you can no longer renew the protocol but must submit the protocol again. It is a de novo process with a new protocol number, IRB member review, submission of all documents, etc.
17. How do I report an adverse event/unanticipated problem?
According to federal regulation, it is the PI's responsibility to report adverse events of any kind to the IRB. Click this link to obtain the adverse event documentation form (DOC). Reporting adverse events promptly will enable the IRB and university research community to respond appropriately, to help the researchers continue their work, and to protect human volunteers in research investigations from avoidable harms. The criteria of how unexpected, how related, and how serious the event was will be evaluated and may need a fresh look at the risk/benefit ratio and possibly a revision to the informed consent process.
18. Is the eIRB system available for Macs (Apple computers) or only PCs? How do I disable the pop-up blocker on a Mac?
19. How do I electronically sign my protocol?
20. What can I expect from an IRB review?
21. Where can I print out my CITI training report?
Follow this link for instructions from the CITI group on how to obtain your CITI training report and determine whether your research ethics training needs to be renewed/updated.
22. Can I access the eIRB on my IPhone or IPad?
23. How big should my study's sample size be?
Please refer to this website in order to better understand determining an appropriate sample size for your research. Your faculty advisor should also be able to help you in defining your sample size.
Sample Size Calculator by Creative Research Systems