IRB Protocol Application Process- Getting Started with a New Protocol

To submit a new protocol, navigate to the "Protocol Application " tab.  The protocol is an electronic document, within the Cayuse IRB software.  After authorizing/authenticating users to gain access to Cayuse IRB, you may complete the protocol and submit it for review by the IRB.

On the other hand, if you wish to develop your IRB protocol using a Word document protocol application as a template, it is available on the "Protocol Application" page under section 4 “To submit an IRB protocol”.  This is useful in the classroom and for practicing. To officially submit the protocol, the content will need to be cut-and-pasted into the protocol within the Cayuse software.

When considering submitting a protocol for IRB review and approval, there are a few questions you should keep in mind. The Compliance Office will evaluate the need for submission based on the following question along with other determining factors;

1. Does my activity involve research?
2. Does the research involve human subjects?
3. Is the human subject research exempt from submission or will be be categorized as exempt from IRB oversight?

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

For the purposes of the IRB, “human subject research” is defined in 45 CFR 46.102(e) 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, conjuncture) 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 (Special topics Research at Cal Poly Pomona by Unaffiliated Investigators in the IRB Policy & Procedures manual. If you wish to submit an IRB protocol to CPP as an unaffiliated investigator, please email the IRB office (irb-office@cpp.edu) the following information/attachments:

1. Your name, title, home institution
2. Summary of your study pertaining to CPP
3. Name of PI
4. Name of co-PI(s) (must be CPP affiliated)
5. 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.)

Submission of the above does not indicate approval from CPP INSTITUTIONAL REVIEW BOARD. 

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. A copy is also contained in the "Letters" tab of the Cayuse submissions page.  It serves as the official notification/letter that the ethical review has been done and your research study has been approved for conduct. 

Per federal regulations, protocols can be approved for conduct for up to one year before the renewal process would occur, unless it is exempted from IRB oversight, in which case the CPP Institutional Review Board will determine the renewal dates.

*The determination is made during the protocol review.

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.

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 below questions, " How to submit a change to an IRB approved protocol".

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 

No.

After the expiration date, you may no longer continue to collect data. According to federal regulation investigators must not engage in research with with subjects after a protocol's expiration date .  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 inquire about options   

*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.  do not ignore those messages if you plan to continue working with human subjects.

Per federal regulation, it is the PI's responsibility to report adverse events of any kind to the IRB. 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 subjects in research investigations from avoidable harms. 

To submit an adverse event report through Cayuse.  Use the "+ new submission" button and choose the option "Incident". 

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.

This is the URL:  http://citiprogram.desk.com/customer/portal/articles/288752-when-will-the-citi-program-mail-fax-or-e-mail-my-official-certificate-?b_id=2337

You can test the consent form by inserting only the text of the document into a readability calculator, like: 

http://www.hemingwayapp.com/