Before Starting a Protocol
[updated 27 February 2017]
Before starting a protocol:
1. Review regulations, policies, procedures, etc. - Review the other pages of the IRB web site (e.g., Policies & Procedures, Hints, Help and Examples) for information and details regarding the essence of the human study protocol process. Much has not changed, but DHHS/OHRP might issue a new federal requirement or the Cal Poly Pomona IRB might approve a new guideline.
2. Complete CITI training - All persons involved (engaged) in conducting the research (PIs, 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.
3. Become familiar with and know how to navigate the Cayuse IRB website - Use this document to teach yourself features in the Cayuse "sandbox" which means you can play around in the training evironment. Other important documents for CAYUSE are found below. You can also view the PowerPoint tutorial that walks you through the submission process.
4. Request authentication - See the related tab on what is needed. Once you have been authenticated (takes overnight), you may access the system by using YOUR BRONCODIRECT USERNAME AND PASSWORD. Users from outside of Cal Poly Pomona will need to contact the Research Compliance Office for assistance. They may be able to authenticate through a collaboration with a Cal Poly Pomona faculty member. Users with no Cal Poly Pomona connection, known as unaffiliated PIs (see also section 14.14 of the policy and procedures manual), will need a facilitator to be able to conduct a human research study at Cal Poly Pomona.
Hints and notes:
1. Teams and sharing - Cayuse IRB facilitates it such that research teams can work together on drafting protocols and reading IRB member reviews. For example, a professor can look at all of her students who have IRB protocols in the Cayuse IRB system.
2. Reviews from the IRB member(s) - The member(s) will post both 1) comments, which are required to be addressed because they are IRB regulatory concerns and 2) suggestions, which are not required, but reflect thoughts and ideas coming from a researcher's perspective reading the protocol "fresh." The image shows a response to an IRB analyst's comment and what the PI did. For more examples and help on how to view and respond to IRB member's review comments on your CAYUSE protocol.
If you are an IRB committee member and would like help on how to review a protocol using CAYUSE.
3. The MS Word protocol - The current and blank MS Word version of the protocol will be kept on the IRB web site as a teaching tool (e.g., it is useful in research methods classes where an actual protocol won't be submitted to the e-system). Hint: Use the MS Word protocol to develop your protocol, then cut-and-paste the sections into Cayuse IRB. The software has a function to print off a PDF of the protocol. Unfortunately, some characters (quotes " for example) don't translate well.
4. Signing process - The signature page (i.e., the hard copy with "wet" signatures) is no longer required with Cayuse IRB, since the authentication process occurs while accessing the site, thereby establishing the identity of the PI. But there is still a certification process. The protocol cannot be submitted past the draft stage for review without all certifying "signatures" (PI and all co-PIs) included. Further, this indicates an understanding of -- and compliance with -- the protocol contents and Cal Poly Pomona IRB policies. See FAQ# 21 for images.
5. Approval email - When the protocol review has been completed, an approval email memo to conduct the research study will be issued. A copy is kept within the "Letters" tab of a protocol.
6. Renewals - The Cayuse system will send reminder notices at 45, 30 and 15 days before a protocol expires, so that the PI(s) have adequate time and opportunity to renew it. It is the PI’s, not the IRB’s, responsibility to renew their protocol before it expires. For an explanation on how to renew your previously approved IRB protocol in Cayuse.
7. Amendments - For information on how to amend/modify your previously approved IRB protocol in Cayuse.