FAQ's and Tips
- Who can I call for assistance in preparing an application and understanding the submission process?
- Does my project need to be submitted to the IRB?
- Does my submission have to be submitted by a meeting deadline?
- How many copies need to be submitted to the IRB (for existing paper protocols)?
- What is a Protocol Preparation Committee (PPC)? Does my department have one? Do I need to submit my application to a PPC?
- When is Scientific Review needed and how many reviews are required?
- I am conducting an activity for purposes of quality improvement (QI). Do QI studies need to be submitted to the SLU IRB?
- At what point does a class project require submission to the IRB?
- What does the IRB stamp mean on a consent document?
- Does HIPAA apply to my project?
- Do I need to report deaths that are expected outcomes on the adverse event report form?
- What 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 subject enrolled in a study at SLU has been admitted to the emergency room for a non-study related illness. Does this event need to be reported to the SLU IRB as a Serious Adverse Event (SAE)?
- I am preparing a change-in-protocol form to add/or delete research personnel on my currently approved SLU IRB protocol, what information is necessary?
- Can subjects be recruited via email?
- 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?
- What is the difference between de-identified and coded?
- What is the difference between conducting research anonymously versus confidentially?
- 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?
- My protocol has been inactive for over a year. How do I re-activate it?
- My study sponsor wants a copy of the IRB membership list. Why does the IRB want us to provide them with a standard letter instead?
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.
Email 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."
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. Although exempt and expedited submissions are not reviewed at a convened meeting, it is good to be aware of these deadlines in case the IRB determines it should be reviewed by full board.
A: All submissions requiring multiple copies should be collated into identical packets. For all submissions, individual documents (e.g. SLU protocol, consent form, etc) should be clipped or stapled individually so that it is easy to distinguish what is being submitted in each packet. NOTE: As of August 1st, eIRB should be used for all new protocol submissions (except HUD, Emergency Use and Compassionate Use applications).Changes in Protocol:
If the changes increase the risk to subjects or make substantial alterations to the protocol, submit an "original" set of revised materials plus three (3) complete copies. Otherwise, submit one (1) "original" set of materials. Please provide the entire revised document (protocol, consent form, etc.) not just the revised pages and be sure to highlight the changes on all sets of materials.
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 by going to the BSS or Biomedical tab, and clicking Contacts & PPC. 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.
A: It depends on the nature of the study. 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:
- has QI data being examined or re-examined to create generalizable knowledge (e.g. abstract, poster, publication, etc.);
- will impose risks or burdens beyond the standard practice to make results generalizable; or
- involves randomization or any element that may be considered less than standard of care.
For further guidance, click here: Study Guidelines
A: If a class project is done with the intent to share information within a classroom, IRB review is not required, because the federal regulations define "research" as a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
However, 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 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 the modified document.
A: If your project invloves 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 seperate FAQ page specific to HIPAA questions.
Adverse Event Reporting
A: The Saint Louis University's Guidelines for Reporting SAE's state:
A serious adverse event is reportable if it occurs between the times of inclusion into the protocol (i.e., after signing informed consent) and continues for the duration and following 30 days of the active intervention phase of the protocol.
However, the guidelines also state:
If the SAE occurs 30 days after the active intervention has stopped, a report may be necessary if there are more stringent reporting requirements set forth in the protocol or mandated by the sponsor.
Therefore, while death is an expected outcome for some study participants, an adverse event report must be submitted to the IRB if the death occurs up to 30 days from the last time the individual received the intervention. You must report it to the IRB within 3 calendar days. Any delay in reporting must be explained.
In most cases, unless more stringent reporting requirements apply, you would not need to report deaths that occurred beyond the 30-day timeline.
Q12: What 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 delivered to the IRB office located in the Caroline Building, room 110, or they can be faxed to 314-977-7730.
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. It is important to provide complete first and last names of the personnel being changed. 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 portential 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.")
Q16: 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.
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:
- 1) A qualified person has determined that there is statistically only a "very small risk" that the information could be used to identify a subject. Data can be de-identified if assigned a random code (not derived from or related to the individual); and
- 2) none of the 18 identifiers are recorded (name, address, social security numbers, etc.)
Coded means that:
- 1) identifying information (name, address, social security number, etc.) that would enable the investigator to readily ascertain the identity of the individual to whom the symbol, or combination thereof (i.e., the code); and
- 2) a key to decipher the code (a master list) exists, enabling linkage of the identifying information to the private information or specimens.
According to the definitions above, both terms are designed to protect the identiy 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 idenity of the subjects providing such information.
A: A study is anonymous if you are NOT recording identifying information (i.e. names, adress, etc.) or detailed demographic information (i.e. race, age, income, educational degree, job title, etc.) about study participants.
A study is confidential if you are recording identifying information about your participants.
In both cases you can assign codes to your participants. If the code is random (cannot be linked back to the subject), it would be anonymous. If the code can be linked back to the subject, the data would be confidential.
Q19: 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.