The IRB staff is happy to help. Contact the IRB 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. 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.
To reach the IRB office, email firstname.lastname@example.org or call 31--977-7744.
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.
If uncertain, or for official determinations of whether IRB submission is required, complete the SLU IRB human subjects research determinations form.
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.
In some departments/schools, there is a Protocol Preparation Committee (PPC) that conducts scientific review of protocols prior to submission to the IRB.
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.
For further guidance, refer to these study guidelines.
If a class research project is designed or 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 or poster) or plan on sharing your data outside of a classroom setting, then you should certainly contact the IRB.
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. For more information, see the consent do's and don'ts.
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.
Learn more about IRB HIPAA requirements
The reporting requirement stipulates that the serious adverse event be reported in three 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.
No. The IRB does not require submission of events that are not reasonably related to the protocol (e.g., motor vehicle accident).
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 training will be required if it does not populate into eIRB.
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, 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).
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.")
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.
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 two standard letters (IRB membership and conflict of interest forms) to address the sponsor's concerns related to IRB compliance.