This section provides answers to frequently asked questions about human subjects research.

How do I submit a protocol for IRB review?

The IRB review process is conducted through the Streamlyne system.

You can find instructions on how to create, complete, and submit a new protocol on the Streamlyne Info Page, in the Streamlyne Help Documents section, click on the header "Streamlyne: IRB Protocols". Starting with the document named Module 3.0: Initiating a new protocol, each of the rest of the modules 3.x correspond with a tab on the left-hand side of the protocol, and give you instructions on how to fill them out, including screenshots.

Once you have logged in to Streamlyne and clicked on Main Menu -> IRB, you should see a "+ Create New" box next to the words IRB Protocol. If you do not, this means that your permissions need to be updated. You'll need to go to the Streamlyne Info Page, and on the right side of the page, under Streamlyne Request Forms, click the first link that says "Request Streamlyne Access", and fill out the form. You'll need to check YES for access to submit IRB protocols.

What "Protocol Role" should I use for my Faculty Supervisor?

A Faculty Supervisor should be listed as a Co-Investigator. This will allow the study to show up for the faculty member when looking at the “All My Protocols” search, or when a study is searched for by investigator name.

How do I determine which Protocol Role to use for the personnel on my study?

The options for Protocol Role for any study personnel are Co-Investigator, Data Integrity Manager, Principal Investigator, and Study Personnel.

There can only be one Principal Investigator. If, for example, you have a faculty member and three students working on a protocol, and you generally refer to the study as “Student-A’s research”, then Student-A should be designated the Principal Investigator.

Study Personnel is most often used when there are multiple student researchers who are primarily assisting on the study. They are not necessarily integral to the research process. Most people associated with your study will likely be added as Co-Investigators. The primary difference is that Co-Investigators are required to approve submissions, while Study Personnel are not. A faculty member doing research who has multiple graduate assistants, for example, might wish to list them all as Study Personnel, so as not to tie up the submission process waiting for everyone to login and approve the submission before it is sent for review.

A Data Integrity Manager is usually listed when a study is conducted by several groups of investigators over multiple research sites. This person would be the one to oversee the entire data collection process and compile all the data.

Streamlyne has given me the error, “This Investigator/Co-Investigator with affiliation type Student Investigator does not have any matching supervisors.” What do I do?

This means that you have someone in the Personnel tab listed with the Affiliation Type (under Person Details) of Student Investigator, but no one is listed with the Affiliation Type of Supervisor. If the Faculty Mentor is listed in the study personnel already, go to their entry in the Personnel tab, click SHOW next to Person Details, pull down the drop-down box for Affiliation Type, and change it from Faculty to Supervisor. If the Faculty Mentor is not listed in the Personnel, you need to add them as a Co-Investigator, and give them the Affiliation Type of Supervisor.

Streamlyne will only let me put investigators from UA in the Personnel tab. Where do I list a collaborating investigator from another institution?

Please list any collaborating investigators who are not in the Streamlyne system in a NOTE in the Notes & Attachments tab. Please include their name, contact information, and affiliation with any other institution. If they are affiliated with an institution that has their own IRB, please be sure to answer YES to the question in the protocol Questionnaire tab which asks if the protocol requires review by another IRB, and include that institution’s information where requested in the Protocol tab.

How do I determine if my protocol (amendment/renewal) has been successfully submitted to the IRB?

To check the status of your protocol, login to Streamlyne and go to Main Menu -> IRB -> All My Protocols, scroll down past the search boxes, and on the row of the protocol you’re wondering about, look at the column that says “Protocol Status”.

• If it says “Pending/In Progress”, you have not yet submitted it. Click EDIT on the left-hand side of the row to open the protocol, review your study to be sure the submission is complete, and then go to Protocol Actions -> Request an Action -> Submit for Review. Complete the drop-down and checkboxes (and don't worry about getting the answers 'right' in this section, as the IRB Coordinator can and does change them during the review process as needed), and then click 'Submit'. Wait until the page reloads and check the top of the screen to see whether it says that the protocol was successfully submitted or tells you that there was an error; if you receive an error message, contact the IRB Coordinator for assistance in fixing the problem.

• If the protocol status says “Submitted to IRB”, then you have submitted it. It may still be in routing, but it has started the submission process. To check where the protocol is in routing to determine whether it has reached the IRB Coordinator, click VIEW on the left-hand side of the row to open the protocol, and then go to Protocol Actions -> Route Log, and look whose name is under the section Pending Action Requests.
  • If the Pending Action lists IRBAdmin, then congratulations! It has reached the IRB review queue!
  • If the Pending Action lists one or more of the investigators, then that/those investigator(s) need to login to the protocol, review it, and go to the Protocol Actions tab, scroll to the bottom of the page, and click the Approve or Disapprove button accordingly.

What Protocol Type or Submission Type (exempt/expedited/full board or category 1/2/3, etc.) do I choose?

It is not important that you get the Protocol Type or the Submission Type correct. If you know what type of review you expect your protocol will require, that’s fine, but if you don’t, just pick one. The Coordinator can and does change that during the review process as needed; we do not expect the researcher to know the correct level of review required, but Streamlyne requires a review type to be entered for a protocol to be started into the routing process.

How do I get a copy of the approval letter for my protocol?

There is a link to your approval correspondence directly in the email that Streamlyne sends informing you of your protocol's approval or exempt determination. If you can't find that email or have deleted it, you can always find your approval letter in the protocol itself. You need to open the protocol (login to Streamlyne and click on Main Menu -> IRB -> All My Protocols, scroll down past the search boxes, and then click 'view' on the line for this study), then click on Protocol Actions -> Summary & History -> History, and click on SHOW next to the first line that says Correspondence, then click View.