- Will my study require IRB approval?
- Where can I find the initial IRB protocol form on the website? How do I apply for 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 informed consent?
- 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 expire. 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?
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. Thisincludes 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.
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
1) Navigate through the “Getting Started with a Protocol” tab.
As of August 2014, the IRB office has fully transitioned to the eIRB system for protocol submission. All the information regarding instructions and submittal are available on this tab.
2) See the Power Point demonstration for instructions on how to create and navigate the e-IRB.
3) Request Authentication.
The eIRB refers to PIs, co-PIs, and research advisors as users. To gain access to the eIRB, a user must be authenticated, which means the Compliance Office must create an account. Send an email to email@example.com with details including:
Salutation (PhD,MS, BS, etc.)
First and last name
Bronco email (csupomona email)
Status (faculty, staff, student, unaffiliated, etc.)
Users from outside of Cal Poly Pomona may also authenticate by this method and will need to include with whom they are collaborating. Users with no Cal Poly Pomona connection, known as unaffiliated PIs, may also authenticate, but will need a campus facilitator to be able to conduct a human research study at Cal Poly Pomona.
4) Complete CITI training.
All people involved (the regulatory term is engaged) in conducting the research (investigator, advisor, and co-investigators) are required to complete CITI training for approval of your IRB protocol. The following link takes you directly to the CITI web page for coursework on aspects of research with human volunteers. Go to the section on "Continuing Education and Training" for instructions and details as well as other training opportunities.
PI encouragement - In case you feel discouraged by the effort and comments while submitting your IRB protocol for review and approval, this is a reflection by someone who can sympathize with you.
5) Loggin into the eIRB.
After requesting and receiving an eIRB user ID and password, please visit the eIRB access portal to enter the eIRB Website.
To Continue WIth an Existing Protocol
If you have already created a protocol on the eIRB and wish to continue working on it, you may access the eIRB website by clicking on this link and entering your user information:
*This does not apply to protocols that were submitted and approved prior to August 2014 through the former hard-copy submittal method. If you wish to make amendments or renew an approved protocol, please email us at firstname.lastname@example.org. Be sure to provide the protocol number in the the email subject and body as "Protocol ##-#### renewal" or "Protocol ##-#### amendment."
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.
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.
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 the all human subject that will participate in the study.
How long does my approval last?
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.
Where can I find information on informed consent?
The type of consent form varies depending on the study you will conduct. Go to “consent forms” tab to view guidelines to help you write your consent form.
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.
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
How do I submit a change to an IRB approved protocol to the IRB?
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.
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.
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 the 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.
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 expire. 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.
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.