Getting Started With a New or Existing Protocol
[updated 15 February 2018]
5 Steps to IRB Success
Prior to conducting human subjects research (HSR), HSR investigators (also known as PIs for principal investigators) must:
Approval/Review Timeline: 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.
1. Complete CITI training. Instructions
2. Request authentication. If this is your first time submitting an IRB protocol in Cayuse and/or are receiving the following message at log-in "We're sorry. This account has been disabled on the Cayuse424 system", please email the following information to email@example.com to be added into the system:
- Highest degree attained (PhD, 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., firstname.lastname@example.org)
- Status (faculty, staff, student, unaffiliated, etc., as appropriate)
- CPP College and Department
Once the office creates the authentication, the system needs to update overnight before the PI can access his/her account in Cayuse IRB.
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.
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 https://cpp.cayuse424.com/
5. Know about 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.
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!). Learn how to renew here!
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.
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 Cal Poly Pomona 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. In Cayuse IRB, learn how to do it here! 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. Learn how to submit a closure!