General Questions About Submitting to the IRB
A: The IRB staff is happy to help! Please contact the IRB office if you or your research group would like to arrange for an IRB staff member to provide an educational session. IRB Coordinators are assigned to support specific departments. Please refer to the Coordinator Assignments to determine who supports your unit. In addition, the IRB hosts 101 courses designed for new investigators. A schedule is available on the Training and Education page of the website.
To generally reach the IRB Office, e-mail email@example.com or call the IRB office at 977-7744.
A: All faculty, staff and students at Saint Louis University conducting research involving human subjects must submit their research protocol to the IRB for review and approval prior to commencing the project. In order to assist investigators in deciding whether a planned activity constitutes as research involving human subjects, the IRB has created the educational brochure, "Is Your Project Human Subjects Research? A Guide for Investigators" and a Human Subjects Research Determination Checklist to assist in determinations. For official determinations of whether IRB submission is required, complete the SLU IRB Human Subjects Research Determinations Form.
Q3: Does my submission have to be submitted by a meeting deadline?
A: Full board applications must be submitted by the deadline to be assigned to the next IRB meeting. Exempt and expedited submissions do not - they are reviewed as submitted.
A: In some departments/schools, there is a Protocol Preparation Committee (PPC) that conducts Scientific Review of protocols prior to submission to the IRB. A list of PPC contacts is available on our website. If your department or school has a PPC, you must submit your protocol to the PPC for review prior to submitting to the IRB. The PPC will review your protocol for scientific merit and adherence to IRB instructions. This process is built into eIRB.
A: Scientific Review is required for all non-sponsored research protocols excluding Biomedical Exempt Submissions. At least one scientific reviewer is required to approve the protocol in eIRB. See Guidance.
A: It depends on the nature of the activity. QI studies are studies where the intent is to promote "betterment" of a process of care, clinical outcome, or institutional practice. You must submit to the IRB if your project:
For further guidance, click here: Study Guidelines
A: If a class research project is designed/done with the intent to develop or contribute to generalizable knowledge.
If you plan to publish your data in any way (e.g. abstract, article, poster) or plan on sharing your data outside of a classroom setting, then you should certainly contact the IRB.
A: The approval stamp date corresponds with the date that the IRB gave the study approval (e.g., the IRB meeting date). The approval termination is the date that IRB approval of the study expires (typically one year from the approval date, but could be less). If a consent document was modified during the approval period, the stamp would also have the date that the change was approved (it corresponds with the date that the IRB signed a change-in-protocol form.)
Subjects who enroll on a study must sign a valid consent document (i.e., the study approval has not expired). This consent is valid for the duration of the subject's participation unless changes to a study require a subject to be re-consented with a modified document.
A: If your project involves recording identifiable personal information with health information (PHI), then HIPAA applies. See the HIPAA tip sheet for scenarios to help you. The HIPAA page on this website also has a separate FAQ page specific to HIPAA questions.
Adverse Event Reporting
Q11: If a serious adverse event occurs on a Friday night after IRB office hours and it is not possible to submit a complete adverse event report to the IRB within the reporting timeline of 3 calendar days?
A: The reporting requirement stipulates that the serious adverse event be reported in 3 calendar days. If some details of the report cannot be completed, submit the report with a statement that a revised report will be submitted to the IRB when the details are known.
SAE reports can be submitted in eIRB during all hours.
A: No. The IRB does not require submission of events that are not reasonably related to the protocol (e.g., motor vehicle accident).
Amendments to Protocol
A: Be sure to describe in detail which personnel are being deleted vs. which personnel are being added. You must also provide a brief description of the new study personnel's roles and responsibilities for the project (e.g. Joe Smith, the new research coordinator, is responsible for screening potential subjects, obtaining informed consent, and follow-up calls). Also, when adding new personnel, proof of CITI training will be required if it does not populate into eIRB.
A:Yes. However, it is important to state, in your protocol, how the email addresses were obtained (i.e., The PI is a professor and has email addresses of his students in a distribution list, or the potential subjects have agreed to be contacted for research by signing up for a registry online, or the list has been made accessible for research purposes to the PI).
The IRB has received complaints from subjects who believe their privacy was invaded because they received correspondence from unfamiliar investigators. Therefore, when contacting subjects directly (via mailed letter or email message), the introductory paragraph should include a general statement regarding how the investigator obtained the subjects' contact information (e.g., "We are contacting members of the XXX Association regarding..." or "You are receiving this questionnaire because you are a health care provider in the state of Missouri.")
Q15: I am a new SLU employee who will be conducting human research. I have completed a human subject's protection course online from my former institution that covered the same topics as the CITI IRB training course. Is it necessary that I take the CITI course, or is the certificate from the other course sufficient?
A: As long as you have completed a training course on protecting human subjects in research (i.e., covering such topics as ethical codes, special populations, the consent process, HIPAA, etc.), your certificate of completion is sufficient documentation. You must submit a copy of this certificate with your application to the SLU IRB. The IRB will do a comparison between content of the course you completed versus our required content; if drastic differences are found, you may be required to take SLU's CITI course.
A: De-identified, according to HIPAA (or "the Privacy Rule") means health information about [an individual] that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual is not individually identifiable health information. (45 CFR 164.514 (a-b)).
Data can be de-identified if:
Coded means that:
According to the definitions above, both terms are designed to protect the identity of the subject in combination with information recorded for the study. Coding can be a method used to protect identifiable health information. Coding may also be used in studies that do not collect health information. If a study is collecting private or sensitive information (e.g., alcohol consumption, sexual orientation, abuse history), but not health information, coding is a method that can be used to protect the identity of the subjects providing such information.
Q17: We have a study that uses data and/or specimens that were collected as part of another research protocol. We are able to link the data and/or specimens to the participants. Does this qualify for exempt or expedited review?
A: Expedited. However, to qualify for expedited review under category #5, the research data being studied must be archival (on the shelf).
A: The project will need to be resubmitted as a new application.
A: The sponsor needs to make sure an investigator is using an IRB that complies with the requirements from 21 CFR 56 [see 21 CFR 312.23(a)(1)(iv)]. The sponsor views a membership list as one marker of compliance. The FDA information sheets (see "Sponsor-Investigator-IRB relationship" in the 1998 update) state:
FDA regulations [21 CFR 312.23(a)(1)(iv)] require that a sponsor assure the FDA that a study will be conducted in compliance with the informed consent and IRB regulations [21 CFR parts 50 and 56]. This requirement has been misinterpreted to mean that it is a sponsor's obligation to determine IRB compliance with the regulations. This is not the case. Sponsors should rely on the clinical investigator, who assures the sponsor on form FDA-1572 for drugs and biologics or the investigator agreement for devices that the study will be reviewed by an IRB. Because clinical investigators work directly with IRBs, it is appropriate that they assure the sponsor that the IRB is functioning in compliance with the regulations.
Some sponsors operate outside of the United States and have asked for a written statement that the IRB is in compliance with the ICH guidelines. They commonly refer to 5.11 ("Confirmation of Review by IRB/IEC"). These are guidelines only and are not regulations.
The Saint Louis University IRB membership often changes (especially during the course of the study which can be several years). Therefore, in response to these requests, the IRB provides 2 standard letters (IRB Membership and Conflict of Interest form) to address the sponsor's concerns related to IRB compliance.