Do I really have to write an IRB protocol? Yes. Nearly every project requires approval, and for the few that do not (some quality improvement projects, use of publicly available de-identified data) you will still need to contact the IRB for an exemption from review.
Basic IRB information
- There are 3 types of protocols:
- Exempt: this is the simplest and has the fewest security issues. No PHI (protected health information like MRN, name, dates of procedure or service, ZIP code or address, etc) can be recorded. You can view records but you cannot record any PHI and you cannot access individual records more than once. Examples of Exempt protocols are anonymous surveys, many educational or curriculum improvement projects, and projects using only existing de-identified datasets.
- Expedited: These are low risk protocols that allow for collection of PHI and for minimal risk studies. Minimal risk studies include chart reviews in which you are recording PHI, studies that require saliva collection or a single blood draw, and some behavioral studies. Most resident chart review projects are Expedited so that student data entry can be checked (which requires recording the MRN or other identifier).
- Full Board Review: These are the highest risk studies and include randomized controlled trials, drug studies, clinical trials, and any studies that involve more than minimal risk to participants.
Also, there are
- Protocols exempt from review: These are not the same as Exempt protocols. These are protocols that the IRB has determined do not need to be reviewed and you must obtain this documentation from the IRB prior to starting the project. In general, these are protocols that are internal and do not access or record PHI (like quality improvement studies) or projects using publicly available data. You must submit the study through iRIS (IRB website) and choose the appropriate option to obtain your exempt from review status.
- Case studies: the IRB has a special category for case studies. Many journals require this even if the patient in your case study is not identifiable.
- The submission process is entirely online. You can access the IRB through the iRIS website (right click -> open new tab to open in a new window).
- Online forms are dynamic. That is, options and items change depending on previously selected items. Make sure you complete all necessary items in each section. Not every subsection/sub-item is shown in these tutorials.
- For full instructions, see the IRB's documentation. For quick instructions for an exempt or expedited protocol, see below. Your research mentor and the Research Director may have examples of similar protocols that you can modify for your project.
- NB: everyone added to your protocol (PI, CoPIs, medical students, nurses, people consenting subjects, etc) must have the following:
- current CV uploaded into iRIS
- Attestation and Disclosure Form completed in iRIS
- CITI training completed
- IRB may return your protocol to you without review if these things are not completed. In some circumstances you protocol will be reviewed but not approved until stipulations are met or resolved.
- If you add the Research Director as a CoPI, he/she can view your protocol and provide editing help/protocol suggestions. This also allows for continuity - if someone else takes over your project, or you forget to close it out when you're finished - the RD can facilitate these things. However it is not required.
- The final step of your protocol is to upload any required documents. These may include:
- written protocol (required for all protocols - you can use the final version of the protocol that you submitted to the Research Working Group)
- data collection sheet
- any communication you will have with subjects, including texts of emails you will send
- letter of agreement/support from outside locations
- consent document (either a consent or HIPAA waiver is required for all studies)
- HIPAA waiver form
- certificate of translation
- UofL Branding Dept approval letter
- UofL IRB forms are here IRB website
How to Write a Protocol
- General instructions for new protocols (all types): Starting a New Protocol
- Specific instructions for completing Non Human Subjects Research protocols (start with above link): NHSR
What Happens Next?
Your protocol will be sent to the IRB staff for a pre-review and you will be notified if there are any omissions, missing documents, or incorrectly explained sections. Once the pre-review is complete, your protocol will be forwarded for review. Exempt protocols generally take a few business days and Expedited a couple of weeks, depending on complexity. Full Board studies are reviewed by the convened IRB and so generally take longer. Full Board studies may require additional information or revision after Board review, so plan accordingly. You will be notified via email both of pre-review requirements and of protocol approval.
Your protocol must also be approved by the appropriate hospital research office. You will be contacted by email if the office needs any additional information or clarification. You cannot start your project until you have both IRB and Hospital Research Office approval.
Edits and Amendments
- To edit a protocol that you have saved but not yet submitted:
- bring up the My Studies list of protocols
- click the notebook/pencil icon on the far left of the study line
- To amend an approved protocol, do the same as above to find the protocol.
- then, in the left hand pane, scroll down until you see the Amendments section.
- click the appropriate item.
- click the Add New Form button at the top and fill out the information.
- You do not have to suspend work on your project during amendment review. However, you cannot implement the changes in the amendment until it's approved. E.g., the medical student that you're adding to help you with your charts cannot begin work until the amendment is approved, but you and the others on the protocol can continue.
Closing your Study
When you are finished with your study (which means manuscript written, posters done, no one else is going to continue your study, data is archived appropriately, de-identified data saved if appropriate), contact your PI and confirm it is ok to close out your IRB protocol. If your PI agrees, please go in to Amendments (use above instructions) and submit a request to close the study.