[updated 22 February 2017]
To submit a FAQ not answered on the IRB website, please contact us at email@example.com.
- Where can I find the initial IRB protocol form on the website? How do I apply for IRB approval?
- Where is my eIRB protocol? [This FAQ contains information about protocols that exist in the old eIRB (@tune software) database.]
- Will my study require IRB approval?
- What is CPP IRB's guideline for unaffiliated investigators (non-CPP students, non-CPP faculty, non-affiliated investigators collaborating with CPP faculty)?
- 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 protocol 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, questionnaires) 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 withdrawal (terminate) my project for some reason, e.g., loss or lack of funding, leaving the university?
- I received an expiration notice from the IRB Office indicating my protocol 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 protocol system software available for Macs (Apple computers) or only PCs?
- 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 Cayuse software on my IPhone or IPad?
- How big should my study's sample size be?
- How can I test the consent form I am going to give to participants to make sure it is at an appropriate reading and comprehension level?
- How can I minimize the risk to participants in my study?
- How can I learn more about what Sona is?
For submittal of a new protocol, navigate to the "Getting Started With a New or Exisiting Protocol" tab. The protocol is an electronic document within the Cayuse IRB software. After authenticating to gain access to Cayuse IRB, complete the protocol and submit it for review by the IRB.
You may want to develop your IRB protocol using the Word document protocol application as a template. It is available under the "Forms & Links" tab. This is useful in the classroom and for practicing. To actually submit the protocol though, the content will need to be cut-and-pasted into the protocol within the Cayuse software.
As of 2017, eIRB is no longer supported. Please contact the IRB office if you have more questions about this firstname.lastname@example.org.
Please refer to the following definitions to determine whether your research study will require IRB review and approval. There is a lot of "grey" when interpreting the federal regulations, so after CITI training and looking at the regulations, you may contact the IRB office at email@example.com.
For the purposes of the IRB, “human subject research” is defined in 45 CFR 46.102(f) of the Code of Federal Regulations TITLE 45 DHHS PART 46 PROTECTION OF HUMAN SUBJECTS.
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 IRB can decide on policy that is more restrictive than Federal Policy, though never more lenient.
Please read Section 14.14 Research at Cal Poly Pomona by Unaffiliated Investigators in the IRB Policy & Procedures manual. The IRB office uses the Legacy process to upload studies to the IRB software (Cayuse). If you wish to submit an IRB protocol to CPP as an unaffiliated investigator, please email the IRB office (firstname.lastname@example.org) the following information/attachments:
- Your name, title, home institution
- Summary of your study pertaining to CPP
- Name of PI
- Name of co-PI(s)
- All study documents that were approved by your home institution and IRB approval letter/memo (final IRB protocol, consent forms, recruitment forms, authorizations, data collection documents, IRB approval memos, etc.)
Submitting these items does not indicate approval from CPP IRB.
The approval period depends upon the type of review (full, expedited, or exempt). Typically, most protocols are reviewed by the expedited method which can take 3-6 weeks, provided that the protocol packet is complete. Complete means that the protocol has all of its components and it has passed the administrative review* by the IRB office before it goes to a member of the IRB for ethical review.
*Administrative review can take 1-2 weeks.
When the review process has been completed, you will receive an email informing you that your protocol has been approved. Cayuse generates the approval memo in the body of an email. A copy is also contained in the "Letters" tab of the submissions page.
The approval memo is issued under the signature of the IRB chair. It serves as the official notification that the ethical review has been done and your research study has been approved for conduct.
Investigators may initiate their research after an approval memo from the IRB has been received. Of course, the study really begins with the individual subjects/participants when they sign or accept the consent/assent form to begin participation. But recruitment and the research cannot start until the protocol has been reviewed and approved for conduct.
Yes, and it's dictated by the version of the Cayuse IRB software.
Go to "writing your protocol" to see different examples of protocols as well as tips about writing your protocol.
Note: All students as PIs must have their advisor as co-PI review their protocol prior to submitting it for IRB office (known as administrative or analyst) or member review.
The type of consent form varies depending on the study you will conduct. Go to the "consent forms" tab to view examples and guidelines to help you write your consent (adult) or assent (minor) form.
In the case of most protocols, all data collection documents should be attached to the protocol that is being submitted for approval. If for some reason a document is not finalized, explain this in the “Data Collection” section of your initial protocol, including a description of your intended methodology. Once the documents are finalized, submit them to the IRB office through the Cayuse IRB process.
A protocol cannot be approved for conduct without a review of the data collection documents. A notable exception is when the objective of the protocol is to develop data collection processes such as reliable and validated surveys for example.
Any change to a document that has been previously approved by the IRB will require an amendment form for review and approval.
Should there be any changes to your research plan as described in the approved and current protocol, you will need to submit an amendment, also called a modification. See FAQ #13.
Examples of changes 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 (PIs), co-PIs, and research assistants
- Change of Project Title
- Addition/Deletion of research performance sites
Should there be any changes to your research plan as described in the protocol, after its approval and while still active, go back to Cayuse IRB to complete and submit an amendment, also called a modification. See FAQ #12, too.
Contact the IRB office (email@example.com) for assistance.
Approved protocols must be renewed if interaction with subjects will continue. Choose the option within Cayuse IRB.
At any time prior to the expiration date, the principal investigator (PI) 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 the study. If the PI wishes to close the study, they can use the " + new submission" button within Cayuse and the closure option will appear.
After the expiration date, you may no longer continue to collect data, because you would be engaging with subjects. This is according to federal regulation. However you may continue to work on analysis of the data. This is because the interaction with subjects/participants has concluded.
The Cayuse IRB protocol software sends a renewal reminder as a courtesy to you before the expiration of the approval. If you have received a notice and your project is not complete, contact the IRB office to discuss your situation. Also see FAQ #15. PIs are responsible for knowing the expiration status of their protocol.
If your protocol's expiration date has passed, then you can no longer renew the protocol and you cannot conduct any more research that engages the subjects. This is according to federal regulations.
You must submit a protocol again. It is a de novo process with a new protocol number, IRB member review, submission of all documents, etc. So, it's not good to ignore those messages if you plan to continue working with human subjects.
According to federal regulation, it is the PI's responsibility to report adverse events of any kind to the IRB. Click this link to go to Forms and Links to obtain the adverse event documentation form. 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.
It is also possible to submit an adverse event report through Cayuse. Use the "+ new submission" button and choose the option "Incident".
In Cayuse IRB, the signing process is called certification. There is also a step of declaration. All together, it is a statement by the PI and his/her research team to comply with federal ethical regulations pertaining to human subject research, follow Cal Poly Pomona IRB guidelines, and adhere to what was approved by the IRB during the review of the protocol. These steps are illustrated below to show the things to look for within the protocol.
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.
Have a look at this website in order to better understand determining an appropriate sample size for your research. A statistician or your faculty advisor should also be able to help you in defining your sample size. Sample Size Calculator by Creative Research Systems
You can test the consent form by inserting only the text of the document into a readability calculator, like:
You can also check the readability score through Microsoft Word. While your Microsoft Word document is open, click F7 on your keyboard. This will open the check spelling box. Next, click on "options". Check the box that says " show readability statistics". Click "ok". Go through your spelling errors and either click "ignore once" for them or correct them. After the last word has been corrected or ignored, a window will pop up like the one below. This will show the reading level and reading ease. A higher Flesch-Kincaid reading ease score is better. The Flesch-Kincaid Grade level tells you at which grade level your document is written for.
- Only collect the amount of information that is completely necessary for the research -- if names or addresses of participants are not needed, then don't collect them or don't write them down. If a question about illegal activity, for example, isn't central to the research, the PI should consider removing it. If this type of information is vital for the study, then read on for other steps to take to minimize risks to participants.
- Separate data from identifiers. If they are in the dataset, strip them out ASAP. If they must be kept, store them separately from the sensitive research data and use a coding system.
- Create a robust data security plan. Store data under encryption if possible.
- If collecting information about illegal activity, consider getting a Certificate of Confidentiality from the NIH. A certificate prevents one from having to turn over research data to law enforcement in a subpoena situation. The study does not need to be NIH funded for it to qualify for a Certificate of Confidentiality. Certificates can take time to obtain, so plan accordingly. http://grants.nih.gov/grants/policy/coc/contacts.htm
- Be cautious in how findings will be reported. Taking all of the steps in the world taken to protect data and anonymize it won't mean anything if the PI reports particulars (identifiers) in publications or presentations. For example, "a senior official at a multi-national corporation in a small town said …" has the potential to make the identities of participants easily identifiable.
- Be sure to understand the terms anonymity, confidential, identified, and de-identified.
- Read the data security terms and conditions of web sites, social media pages, survey data collection companies, and other e-sources. It's a hacker's world today.
If any of the above can't help...
- Be clear in the consent form as to what the limits to anonymity and confidentiality are and what risks are for participants. If as a PI all options have been taken to prevent a breach of confidentiality and protect subjects, but a risk remains that someone will be able to identify the participant in publication, make this clear in the ICF to participants so they can decide whether they want to accept that risk or not. A PI may choose to include optional study elements in the consent form such as: "Do you agree to allow me to quote from this interview if I use a pseudonym?"
Please look below for documents that were developed in 2016 in order to explain what the Sona process is and does.