eIRB Basic Instructions
Before Submitting a Protocol:
1. Review regulations, policies, procedures, etc. - Review the other pages of the IRB web site 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 people involved in conducting the research (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 - Human Subjects Training.
3. See the Power Point demonstration for instructions on how to navigate the eIRB site - How to create an eIRB protocol.
4. Request Authentication - The eIRB refers to PIs and co-PIs as users. To gain access to the eIRB, a user must be authenticated, which means the Research Compliance Office must create an account for you. Send us an email to firstname.lastname@example.org with details including:
- Highest degree attained (PhD, MS, BS, etc., as appropriate)
- First and last name
- Bronco ID
- Bronco email (csupomona email; Gmails and others don't work in the system)
- Status (faculty, staff, student, unaffiliated, etc., as appropriate)
- Phone number
Users from outside of Cal Poly Pomona may also authenticate by this method and will need to include with whom they are collaborating. Users with no Cal Poly Pomona connection, known as unaffiliated PIs, may also authenticate and will need a facilitator to be able to conduct a human research study at Cal Poly Pomona.
Logging into the eIRB:
1. The eIRB access portal is to gain access to the e-IRB site. All steps are required. For those PIs who have already met all of the criteria, simply check the boxes and you'll be in the eIRB quickly.
2. Being assigned a protocol number - When opening and starting the writing of a protocol, the eIRB system automatically assigns and attaches a protocol number (now four digits with year, e.g., #14-1234) to the effort. That is kept through all stages of drafting, submitting, and reviewing the protocol. It can be used immediately on the ICF (informed consent form), survey instruments, recruitment flyers, etc.
3. Sending eMail messages - The eIRB generates many emails to inform PIs, IRB members, and the Research Compliance Office of the activity associated with protocol processing. Many indicate a status change through the stages of protocol review. Should something not be clear, please advise the Research Compliance Office.
4. Protocol Stages - The creation of a protocol on the eIRB starts at the draft stage, where it is assigned a number. The PI answers all of the questions which describe the proposed human study (which will be read by the IRB reviewer), attaches documents, and "signs" the protocol. After this, the protocol package begins to move through the following stages:
Administrative Stage - The Compliance Office performs a review to satisfy regulatory requirements and clarify any points before sending the protocol to an IRB member to review. When that is done, the protocol moves to either:
"Designated IRB review" for expeditable-type protocols or "Full review" - When there is greater risk or the protocol involves vulnerable subjects. During this review, there is direct exchange and negotiation via the eIRB between the IRB member(s) reviewing the protocol and the PI(s) to clarify any ethical or human subjects protection issues, leading to approval to conduct the study. Comments and revisions of the protocol are tracked and kept by the eIRB software.
Chair Stage - A completed protocol moves and the IRB chair "signs off" to indicate the review for human subject’s protections is satisfactory and the study may be conducted. It is important to note that the IRB and chair are not approving the research per se, but rather the conduct of the study from a risk mitigation perspective on behalf of the potential subjects/participants. This action generates the approval memo to the PI(s).
5. Checking out and in the protocol - The eIRB uses this term to signify when one PI checks out and revises the protocol. Until it is checked back in, other PIs can see it in read-only mode; changes are not possible. See the training Power Point for how to do this. Should help be needed, the Compliance Office can check-in a protocol in extreme circumstances, but the initial responsibility lies with the research team.
Attaching documents -
1. Training - CITI training or equivalent is still required. [An option is being developed where transcript data from CITI are automatically entered into the eIRB. Stay tuned - more "construction".]
2. Teams and sharing - The eIRB 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 eIRB.
3. 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".
4. The MS Word protocol and the eIRB - The current and blank MS Word version of the protocol will be kept on the IRB web site as a teaching tool (e.g., useful in research methods classes where an actual protocol won't be submitted to the eIRB system). Hint: Use the MS Word protocol to develop the protocol, then cut-and-paste into the eIRB. The eIRB has an icon to print off a draft of the eIRB protocol.
5. Signing process- The signature page (i.e., the hard copy with "wet" signatures) is no longer required with the eIRB, since the authentication process occurs while accessing the site, thereby establishing the identity of the PI. The protocol cannot be submitted past the draft stage for review without all signatures (PI and all co-PIs) included in the eIRB. These are e-signatures, which mean the PI must actually enter the eIRB site. Further, this indicates an understanding of -- and compliance with -- the protocol contents and Cal Poly Pomona IRB policies.
6. Approval email - When the review has been completed, an approval email memo to conduct the research study will be issued as a PDF, email attachment under signature of the IRB chair. Make sure to obtain a duplicate.
7. Renewals - The eIRB will send reminder notices at 60, 30, 15, and 1 day 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.