- 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.
FAQs for Research Mentors
- How do I get IRB help?
- What training do I need as a mentor?
The “For Researchers” page of the UH Clinical Research section of the website is a helpful place to search for information about the research process at UH and also required trainings. If not already completed, you will need CREC Certification (by taking CITI BASIC) and Investigator Training prior to submitting anything to the IRB. As you likely know, NIH-funded projects require GCP training (ICH – GCP Guidelines). A free option is available within the CITI Program (https://www.citiprogram.org).
- What training does my resident or fellow need?
The same training as a mentor in the answer above (in fact everyone listed on the study personnel table needs to be CREC certified.)
- What training does my medical student need?
Even if he/she has access to the AEMR or UHCare via clerkships, students are not UH employees and must be Research Credentialed in order to access UH PHI. The research credentialing page of the website details the credentialing process and you can contact the Research Credentialing office at UHResearchCredentialing@UHhospitals.org for help as needed.
- What is SpartaIRB and how do I access it?
SpartaIRB is the new electronic IRB submission system. If you do not have an account, there are instructions on the log in page for how to request. You will sign in with either your UH or Case credentials.
There are 2 main tabs: “My Inbox” and “IRB”. If you go to “IRB,” then to “Library” and then to the “General” tab you will find the Investigators Manual for IRB Submissions (HRP-103 – UH Investigator Manual) which has all of the IRB policies in a single document. Use the [Ctrl] F “Find” feature to find information on whatever topic you would like to peruse.
The Investigators Manual for IRB Submissions is also available on the IRB Policies webpage.
- How do I get help in SpartaIRB?
Go to “IRB,” then to “Help Center,” and then to “Guides.” There you will find guides for submitting a new protocol, continuing reviews, adding personnel, etc.
- What do I actually submit in SpartaIRB?
You will submit your protocol on a template. These templates (protocols, consents, and assents) can be found in the Templates section in the SpartaIRB Library and are REQUIRED for submissions. Note that there are both CWRU and UH templates – wherever there is the option, please choose the UH templates. You are required to submit the templated protocol, any informed consent and/or assent forms, and all “patient-facing” materials (advertising, letters, surveys, etc). You will likely need to submit your data collection forms also (and linking log if using one – ask if unsure).
- What is the difference between an Expedited study and an Exempt one?
In general, Exempt studies have to clearly fit into one of the specific Exempt categories and would go on the Exempt protocol template (HRP-503EXEMPT). Exempt studies need to meet certain criteria, and generally if the data being collected is either sensitive or identifiable, the Expedited review is more appropriate.
Expedited studies include surveys, interview studies, chart reviews, and other not greater than minimal risk studies. An excellent summary can be found on this website. Expedited studies are often submitted on a chart review (HRP-503DATA) or a Social, Behavioral and Educational Research template (HRP-503SBER), but please review the descriptions to be sure you use the correct template.
- Does Quality Improvement work need to be submitted to the IRB?
The IRB always recommends that you submit proposed QI work for a determination of Not Human Research on HRP-503NHR. There may be components of the QI that are research and it can be difficult to see this clearly in your own work. Having a determination ahead of time can ensure you are on the right track.
- Do Case Reports need to be submitted to the IRB?
These also should be submitted for a determination of NHR. For 3 cases or less, the NHR submission is correct; if >3 cases (a case series) please submit as Expedited. You will obtain permission from the subject(s) of the case report but not informed consent – this is not an IRB specification but is almost always a requirement of journals.
PLEASE CALL THE IRB AT 216-844-1529 AND COLLABORATE WITH AN IRB SPECIALIST BEFORE SUBMISSION.
The specialists can help you with many aspects of submissions and planning. Please identify your statistics person and collaborate with him/her to complete a sample size calculation and analysis before submitting.