- 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.
Quality Improvement FAQs for Clinical Researchers
- I am confident my protocol is quality improvement. Why do I need IRB review?
All Quality Improvement protocols should be submitted to the IRB with a request for a determination of “Non-Human Subjects Research.” This is institutional policy. The researcher should not make this determination even when he/she is confident the work is QI, because when information is gathered about human subjects the Code of Federal Regulations regarding Protection of Human Subjects is relevant (45 CFR 46) and compliance with the regulations is a federal mandate.
- I don’t want to publish my Quality Improvement project. Do I still need to submit it to IRB?
Yes. Intent to publish does not distinguish Quality Improvement from research, or determine if the protocol is Exempt or not (i.e. Non-Human Subjects Research determination).
- So what is the difference between Research and Quality Improvement, anyway?
Research is “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge…” (45 CFR 46.102(d)); quality improvement is an activity conducted by one or more institutions “…whose purposes are limited to: (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes”.*
In other words…*US Department of Health and Human Services Office of Human Research Protection Quality Improvement FAQ
A protocol that has comparative intervention arms (of any type, including behavioral, medical, device related or surgical) is research, and any protocol that tests a new procedure or intervention is likely to be considered research. On the other hand, protocols that apply an already evidence-based intervention or intervention bundle (i.e. one that has been documented as effective in published research trials) to all patients with a specific condition, are likely to be considered quality improvement. In general quality improvement is intended to impact only those individuals who are being treated, whereas research is intended to be generalizable.
- When is my Quality Improvement project also considered research?
Fortunately the OHRP website has a great Q and A for this, which follows here:
Q: Are there types of quality improvement efforts that are considered to be research that are subject to HHS human subjects regulations?
A: Yes, in certain cases, a quality improvement project may constitute non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA. For example, if a project involves introducing an untested clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human subjects research under the HHS regulations
- If my Quality Improvement project is NOT determined to be Non-Human Subjects Research, and parts of it are considered research, does this mean I have to obtain informed consent from all subjects (patients and/or providers)?
The short answer is “no”. But again, the OHRP website has the response to this important question, and it just boils down to the HHS requirements for waiving informed consent:
…the HHS regulations protecting human subjects allow an IRB to waive the requirements for obtaining informed consent of the subjects of the research when
- the risk to the subjects is minimal
- subjects’ rights and welfare will not be adversely affected by the waiver
- conducting the research without the waiver is not practicable, and
- if appropriate, subjects are provided with additional pertinent information after their participation (45 CFR 46.116(d))
Other applicable regulations or laws may require the informed consent of individuals in such projects independent of the HHS regulations for the protection of human subjects in research.
- We are doing a project in which there is an educational offering for residents about errors in medicine, with a pretest and a posttest. Surely this is Quality Improvement!
Not necessarily. Things to consider include: Is the educational offering mandatory or voluntary? Are the pre and posttests being used to evaluate the residents? Recall that trainees and employees are a vulnerable population, so additional protections may be needed.
A protocol which includes educational research may be appropriate for a determination of Exempt status category 1 (“Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
- research on regular and special education instructional strategies, or;
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.”)
- What if I have more questions?
Talk with your Departmental Review Chairperson, or call the IRB at 216-844-1529. We want to talk to you and help you avoid frustrations!
- What is a PI proxy?
A PI proxy is an individual listed on the study's personnel table who has the ability to submit modifications, continuing reviews, study closures and responses to clarifications to the IRB on behalf of the PI.
- Is a PI proxy the same thing as a Primary Contact?
No. A PI proxy can submit to the IRB after initial approval and must be assigned by the PI. A Primary Contact can create submissions,but does not have the ability to submit to the IRB.
Anyone can assign Primary Contacts. Both PI proxies and Primary contacts receive email notifications from SpartalRB.
- Who can be a PI proxy?
Anyone who is approved on the study's personnel table can be assigned as the PI proxy.
- How many people can be PI proxy?
There is no limit to the number of individuals who can be assigned as the PI proxy.
- Who can assign a PI proxy?
Only the Principal Investigator of the study can assign a PI proxy.
- How do I assign a PI proxy? Do I have to submit a modification to assign a PI proxy?
In SpartaIRB, there is an “Assign PI Proxy” button. The PI can then select anyone from the study table and instantly assign them as a PI.
Please note that the PI must assign the PI proxy from the study’s main workspace. The “Assign PI Proxy” button is not available from Modification or Continuing Review workspaces.
- When should I assign a PI proxy?
While the PI can assign a PI proxy at any time, it is suggested that the PI do it on a new study after department review is complete and the study is ready to be submitted to the IRB.
- My study is in pre-submission, but I do not have a “Submit button.” How do I submit to the IRB?
Only the PI can submit a new study to the IRB. For follow-on submissions, you will need to do one of these three things:
- Have the PI submit to the IRB
- Have the PI proxy submit to the IRB
- Have the PI assign you as the PI proxy so you can submit
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.