IRB Information

Institutional Review Boards (IRBs) are the administrative bodies that review and monitor human subjects research in the United States. That means that UC Berkeley’s IRB has the authority to approve and disallow all research procedures that the Aly Lab performs.

To conduct research, Aly Lab members must be authorized under an active IRB protocol to perform all of their research procedures!

The IRB does not approve vague “umbrella” protocols meant to cover lots of different studies. The IRB wants protocols to be very specific about what participants will do. For this reason, most lab members must write their own Institutional Review Board (IRB) protocols and submit them to the IRB at Berkeley. The exception is if your research happens to fall within the scope of an IRB protocol the lab already has.

In addition to writing and submitting their own protocol, Aly Lab members must also maintain their IRB protocol until they decide to close it.

Before you write your protocol, check out the Guide to the IRB Review Process and do all the required trainings.

Building Your IRB Protocol

This may sound like a lot, but don’t worry! Building and maintaining your IRB protocol is not super difficult. As noted above, the Guide to the IRB Review Process provides a great introduction to how it’s done.

The Aly Lab has standard language to get you started making your own IRB protocol, as well as some documentation to help you navigate the process of submitting/maintaining your protocol, which makes the process much easier. When you are ready to begin writing your own protocol, reach out to the Aly Lab manager for access to the IRBtemplate directory, which contains information to get you started. This IRB template folder has example documents/forms, full example protocols that have been used in the past, and generally serves as a hub for all things IRB-related in the Aly Lab.

Upon approval of your own IRB protocol, please contact the Aly Lab manager to share your experience of getting approved, and any new language/documents used. We aim to update the IRBtemplate folder based on lab members’ experiences, and keep a record of how to address specific tasks that the IRB may assign before approval (irbTemplate / submissionAttempt_updates). Having a hub for this information really facilitates the process for future Aly Lab members, so please pay it forward! As you operate your own IRB protocol, add procedures, and interact with the IRB, keep in contact with the lab manager about any substantial or new amendments so that they can update this IRBtemplate directory with useful information gleaned from the process.

Maintaining Your Protocol

After lab members submit their initial protocol and receive IRB approval, lab members must also renew their protocols. This requires the submission of various pieces of information every year to the IRB — like any new findings, any protocol violations, and the demographics data from participants accrued.

In addition to renewals, lab members are also responsible for submitting modifications. Submitting modifications is mandatory when you wish to amend any aspect of your protocol not already covered. All changes to research procedures you wish to conduct through the course of your time in the Aly Lab must be reflected in your IRB protocol and approved before they can be performed — big or small. This includes, for example, any changes in documents being used (e.g., recruitment flyers, demographics and consent forms, survey forms, stimuli, etc.); any changes regarding personnel authorized to interact with participants/data (e.g., new RAs, collaborators); changes to general experiment procedure; etc.

Lastly, members of the Aly Lab must officially close their protocol before leaving the lab.

eProtocol

Protocols are built, submitted, modified, renewed, and closed on Berkeley’s eProtocol platform.

Audits

All IRB protocols are subject to audits by the IRB, and if an audit finds you to be in violation of IRB guidelines or the protocol under which a given study is being conducted, penalties can include suspension of human research privileges; it is critical that you properly use and maintain all documents under your protocol(s) in accordance with the IRBs rules! Ensure that all questions or concerns that you may have about your protocol are answered by the lab manager or Mariam when you have them to avoid problems down the line.

Timeline Guideline

Getting approval may take quite a bit of time! Expect something like 3–12 weeks from submission before approval may be granted, depending on time of year, complexity and perceived risk of the procedures; how much the IRB wishes for you to amend your protocol upon submission; etc. It is common for the IRB to deny your initial approval and require multiple alterations and resubmissions before they are willing to approve your protocol. (And note that each resubmission will require at least another couple of weeks to hear back.)

Subsequent submissions upon initial approval — i.e., modifications and renewals — can also take a significant amount of time to be approved: expect at least 3 weeks to even hear back from the IRB, and build in extra weeks to your timeline in case the IRB does not initially approve the modification or renewal. The IRB has full license to deny any protocol submission, and may require substantial alterations to submissions which then must be resubmitted and sent back to the end of the queue.

Await Full Approval For Procedures

Note that you cannot use newly-authorized procedures or documents until receiving the official notice of approval.

fMRI Protocol

Lab members whose procedures fall strictly under the approved language of the Aly Lab’s MRI protocol are able to simply be added to that protocol and begin conducting research. To be added, contact the Aly Lab manager, and note that you still must wait for the IRB to approve your addition to the protocol before conducting your intended research. Upon being added, the lab manager will give you access to the MRI protocol documents so you can get started running MRI experiments. Studies that fall outside of the purview of the lab’s existing MRI protocol will require the creation of your own IRB protocol; the Aly Lab generally aims to minimize additions to the lab-wide MRI protocol to keep the protocol from becoming unwieldy and bloated with many different sub-projects. Small additions or amendments to the protocol (e.g., adding stimuli), however, may be possible.

Contact the lab manager to discuss anything additional you would need to have approved to see if the lab-wide protocol might be able to accommodate your research plans.

Standard Operating Procedure

Regardless of the protocol you are operating under, you must abide by the Aly Lab IRB guidelines set out in our Standard Operating Procedure document.

Before conducting research in the Aly Lab, you must read and sign the SOP document, and send it to Mariam and the lab manager. This document lays out good practices for creating/using/maintaining IRB protocols in the Aly Lab, and is intended to be a reference document that is helpful. If you feel something that would be helpful is missing from this document, contact the lab manager so they can amend it!