Is there a Sparta IRB Instructions Manual?

Yes. After you log in to SpartaIRB, click on “Help Center” icon which is located on the bottom left hand side. Here you will find helpful guides, which may assist you when submitting to SpartaIRB.

How do I begin to submit a new protocol?

You first have to log in to SpartaIRB which is the electronic system University Hospitals uses for research submissions. Do this by going to https://spartairb.case.edu and sign in using your UH/CWRU username and password. Then on the left hand side click “Library”. The “Library” houses all documents, like templates and policies. Once in the Library you can click on “Templates”. This will bring you to the IRB’s protocol templates. These protocol templates are REQUIRED. You should select the protocol template that is most applicable to your study. For example, if you are planning on conducting a chart review you should select the “HRP-503DATA-Template-Chart Review & Specimens Protocol”. If you cannot figure out which template you should use, feel free to call us. We can help guide you to the correct template.

What happens after I submit?

Once you submit, your study will be assigned to one of our IRB specialists who will perform a “pre-review” on your entire submission. If they find any components missing or need for clarifications, they will send you back to stipulations that must be addressed. Once you have sufficiently addressed all the stipulations, the IRB specialist will either assign your study to a formal IRB board meeting (if your study is greater than minimal risk) or they will expedite your study electronically to an IRB chair for review (if your study is not greater than minimal risk – with few exceptions).

How will I know if there is need for clarifications or when my study is approved?

A notification will be sent to your email that lets you know clarifications have been requested by an IRB specialist. Additionally, if you login into SpartaIRB the state of your submission will be in “Clarification Requested (Pre-Review)”. If your study is reviewed and approved, the IRB specialist will send the approval notification letter via email. The state of your submission will then be in a “Review Complete” state.

How long does it take for a new study to be approved?

This is mainly dependent on how well the initial submission is put together and if there are stipulations sent back to the study team, and how well the study team addresses the stipulations sufficiently. Once the study is in good enough condition to be formally reviewed, it will either be electronically expedited to an IRB reviewer or it will be assigned to the next full board meeting. There is a non-cancer full board meeting every Tuesday and a cancer full board meeting on the 2nd & 4th Thursday of every month. In order to make a full board meeting’s agenda, the submission must be assigned to the meeting ~six days prior to the meeting date (the agenda is sent out prior to the meeting date so that the IRB reviewers have enough time to provide their reviews).

If I’m obtaining written consent from subjects, why did I get a stipulation back from the IRB that I have to apply for a waiver of consent and a partial waiver of HIPAA Authorization?

If you received this stipulation, it is most likely because although you plan to obtain written consent from subjects, you are still accessing patient PHI prior to the consent process to determine subject eligibility. As a result, you may be accessing PHI of patients that you may ultimately deem ineligible for participation and thus never end up consenting. You must request both a Waiver of Consent and a Partial Waiver of HIPAA Authorization when accessing patient PHI for pre-screening purposes to determine subject eligibility.