IRB Application Process
Protocol Application Process- Getting Started With a New or Existing Protocol
Welcome to the IRB Guidance page
This page is designed to help researchers navigate the Institutional Review Board (IRB) process for research involving human participants. Whether you're a student, faculty member, staff researcher or external collaborator, understanding your responsibilities is key to conducting ethical and complaint research.
See below details about research including human subject.
Step 0: Does your study require IRB review?
Before proceeding, determine whether your project qualifies as human subject research.
Disclaimer: The survey is a helpful starting point, but researchers should always consult with the IRB Office to confirm results.
IF your project does require IRB review, follow the 5 steps to IRB Success outlined below.
IRB Approval Process
Pre-Review Stage
IRB Review Stage
Expedited Review
- 1-2 IRB reviewers
- No more than minimal risk to participants
- Duration 2-3 weeks after Pre-Review
Full-Board Review
- Convened IRB board reviewers
- More than minimal risk to participants
- Duration months after Pre-Review
Exempt Determination
- IRB analyst or 1 IRB member reviewer
- Less than minimal risk to participants
- Duration 1-2 weeks after Pre-Review
5 Steps to IRB Success
*Please be advised that review timelines may be extended during the upcoming holiday period due to limited reviewer availability. We appreciate your understanding and encourage you to plan accordingly if you have time-sensitive research activities.
For student research guidance- Review the
Please ask questions at any stage of the process. The IRB Office is available and can help facilitate the review. You may reach us at 909-869-3713 (or 3771) or irb-office@cpp.edu See also the Institutional Review Board Staff Directory for additional contacts (IRB Chair and IRB Administrator)
STEP 1: Complete CITI training
- CITI training should be completed by PIs and all personnel listed on the protocol engaged in research
- CITI training is free for our campus community
- Registration tutorial
- Go to the and create an account
- Register using your Bronco email and any password you choose.
- Select 起点传媒 as the institution
- Provide your Bronco ID under "employee number"
- Selecting Courses
- select the group basic CPP Introduction to human subjects 101 Or
- Select CEIS Mandated Social Science Research (required for many social sciences)
- You must complete all courses with a passing score of 80% to receive a certificate of completion
- When finished a Certificate of completion and CITI transcript will be available.
- Certificate of completion should be provided to your Principle Investigator, Faculty Advisor or Professor
- CITI training is valid for five years, at which point, a renewal training must be completed.
- External (non-CPP) investigators must submit a transcript that lists all completed modules so the IRB can compare equivalency with CPP-required courses.
STEP 2: Request authentication
If this is your first time submitting an IRB protocol in Cayuse please email the following information (listed below) to irb-office@cpp.edu to be added into the system, additionally send a screenshot of your error message ( when attempting to log in https://cpp.cayuse424.com error message will read "We're sorry. This account has been disabled on the Cayuse424 system"):
- Highest degree attained (Ph.D., MS, MA, BS, BA, associates, high school, etc., as appropriate)
- First and last name
- Bronco ID (the nine-digit number, which will eventually be used to link with CITI training data)
- Bronco email (e.g., billybronco@cpp.edu)
- Status (faculty, staff, student, unaffiliated, etc., as appropriate)
- CPP College and Department
STEP 3: Train yourself to use Cayuse IRB
- Review the Cayuse tutorial “Submitting a New Protocol” to learn how to navigate, complete, and submit an IRB protocol.
- Blank IRB Protocol Template
STEP 4: To submit an IRB protocol
Enter the Cayuse IRB site using your Bronco Credentials (from #2 above) and start a "new study".
- For the Cayuse IRB site to start or continue with an existing protocol, use the ( )
STEP 5: IRB protocol upkeep
To revise, amend (modify), renew, report an adverse event, or close your IRB protocol, follow as below:
Revise: After your protocol has been submitted to the IRB office, it will most often be returned to the PIs with comments. Learn how to navigate through revisions (ppt).
Amend (modification): After IRB approval, when the PI(s) would like to change things to the approved protocol, they must submit an Amendment Submission.
Renew: When the protocol is close to the expiration date, the PIs will receive notifications. If they wish to renew the approval period for an additional year (the usual amount of time), a Renewal Submission must be submitted before the expiration date (earlier is better!).
Adverse Event (Incident): Sometimes things in research just don't go as planned. Researchers may encounter "adverse events" and unanticipated problems. Taken from OHRP, an adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom or disease temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. Adverse events encompass both physical and psychological harms. Adverse events must be reported to the IRB within 48 hrs. through the Cayuse system.
Unanticipated problems include any incident, experience, or outcome that meets all of the following criteria
- Unexpected (in terms of nature, severity, or frequency) given a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Potential examples that relate to the typical kinds of research conducted at 起点传媒 include (but are not limited to): an accident on the treadmill, a loss of datasheets with personally identifiable information, an emotional breakdown during a psychological interview, sickness following a food taste study, or a parent questioning the assent process of her child in an education project. And neither are all adverse events directed at the subject; for example, a vial of blood that breaks poses a bio-hazard to others. As a PI (principal investigator), one needs to think about the risks (the what-ifs) associated with the proposed research when writing the protocol; however, it is recognized that not everything is predictable.
According to 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 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 necessitate a fresh look at the risk/benefit ratio and possibly a revision to the informed consent process.
Closure: If the data collection portion of the study is completed, a Closure Submission is submitted.
FAQs
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;
- Does my activity involve research?
- Does the research involve human subjects?
- 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 .
Human subject - a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- 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 起点传媒. 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 起点传媒 by Unaffiliated Investigators in the IRB . 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:
- Your name, title, home institution
- Summary of your study pertaining to CPP
- Name of PI
- Name of co-PI(s) (must be CPP affiliated)
- 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 from the CITI group on how to obtain your CITI training report and determine whether your research ethics training needs to be renewed/updated.
You can test the consent form by inserting only the text of the document into a readability calculator, like (https://www.hemingwayapp.com)