- How often does the IRB meet?
- What is the institution’s federal-wide assurance (FWA) number, and what is the expiration date?
- When is the IRB submission deadline, and when should I expect to receive approval?
- Are any approvals required other than that of the IRB?
- Is an executed clinical trial agreement required prior to IRB submission?
- Does my research qualify for IRB exemption? If “Yes” what do I need to submit?
- Does my research qualify for Expedited Review? If “Yes” what do I need to submit?
- How do I enroll a non-English speaking patient?
- Does my research require Informed Consent/HIPAA Authorization? If “No” what do I need to submit?
- I would like to utilize a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE). Do I need to submit the full Initial IRB Application Form and consents?
- Who can I talk to if I have a question about my research project?
Q: How often does the IRB meet?
A: The IRB meets the 1st Tuesday of every month. In rare cases where a secondary session is needed (usually due to high volume of submissions), the additional meeting time is usually on the 3rd Wednesday of the same month. Depending on holidays the meeting may be rescheduled. Check the posted schedule of meeting dates.
Q: What is the institution’s federal-wide assurance (FWA) number, and what is the expiration date?
A: The SLUHN FWA number is 00003557 with an expiration of 5/19/19
Q: When is the IRB submission deadline, and when should I expect to receive approval?
A: All submissions are generally due by the 20th of each month for review at the next scheduled IRB meeting (1st Tuesday of following month). You should generally receive approval or review comments within 2 weeks of full board review.
Q: Are any approvals required other than that of the IRB?
A: There are certain types of studies that may require other approvals prior to/in addition to IRB approval. Some examples may include studies using certain levels of radiation, studies involving recombinant DNA or other forms of gene therapy, or studies in which the PI is not employed by SLPG. Please contact the IRB Administrator for more information as to whether your study requires any other committee reviews.
Q: Is an executed clinical trial agreement required prior to IRB submission?
A: An executed clinical trial agreement is not required prior to IRB submission, but the centralized Clinical Trials Office (CTO) or SLUHN General Counsel must be contacted to initiate contract negotiations in line with institutional policies and procedures.
Q: Does my research qualify for IRB exemption? If “Yes” what do I need to submit?
A: Only the IRB can make the final determination as to whether your research qualifies for exemption. However, please review the IRB Exemption criteria on the “Request for IRB Exemption” form or the Exempt Study tab. If you feel that your research may qualify for exemption, please complete the “Request for IRB Exemption” form, and submit along with all other required documents as outlined on Page 1 of the form.
Q: Does my research qualify for Expedited Review? If “Yes” what do I need to submit?
A: Only the IRB can make the final determination as to whether your research qualifies for expedited review. However, please refer to the “Expedited Review Categories and Determination” form to assess whether your research may qualify for expedited review.
Regardless of whether your research qualifies for expedited review, or if it must be reviewed by the full, convened Board, the “Initial IRB Application” form along with all other documents as outlined on the “IRB Submission Checklist” must be completed and submitted for review.
Q: How do I enroll a non-English speaking patient?
A: Please refer to IRB Policy IC 605. Depending on the native language of the patient, SLUHN may already have a translated “Short Form Consent” for use. Please check with the IRB Administrator if we have an already translated Short Form Consent available. If an already translated Short Form Consent is available, you will need to submit the translated Short Form Consent and the Letter of Authentication, along with a summary of the study, inclusive of all pertinent components required for informed consent for IRB approval. Once your receive the approved documents from the IRB, the study summary should be provided to the Cyracom language line translation service who will then translate the study summary verbally to the non-English speaking patient, serving as review of the consent. You will need to ensure an impartial Witness (cannot be involved in the study; family member is preferred) who speaks the patient’s native language is also present during this consent process. If the patient decides to participate, they must sign the Short Form Consent, along with the Witness and the person conducting the consent interview.
If an already translated Short Form in the subject’s native language is not available, you may have the “Short Form Consent” template translated into the subject’s native language by Cyracom, and submit the translated Short Form Consent, Letter of Authentication, and study summary to the IRB for approval, and proceed with the steps as outlined above. The translated Short Form Consent will then be available for future use in other studies.
NOTE: Having a translator present during the consent interview to do an ad hoc translation of the consent form is not permitted under federal regulations.
Q: Does my research require Informed Consent/HIPAA Authorization? If “No” what do I need to submit?
A: All research involving human subjects requires informed consent and HIPAA authorization unless specifically waived by the IRB per Federal regulations. Please refer to IRB Policy IC 601 and IRB Policy IC 606. Only the IRB can make the final determination as to whether a research study qualifies for Waiver of Informed Consent/HIPAA Authorization. However, if you feel that your study may qualify for this waiver, you will still need to submit the “Initial IRB Application” form along with the “Request for Waiver of Subject Authorization” form, the “HIPAA De-Identification Certification” form, and all other pertinent documents as outlined in the “IRB Submission Checklist” for IRB review and final determination of whether informed consent and HIPAA authorization may be waived.
Q: I would like to utilize a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE). Do I need to submit the full Initial IRB Application Form and consents?
A: No. Please refer to IRB Policy SC 503. There is a specific IRB application form for HUD approval, “IRB Application for Humanitarian Use Device” which should be completed and submitted to the IRB along with the documents outlined on Page 1 of that form. This must be reviewed by the full, convened Board.
While the regulations do not require a consent form as the device will be used outside a research setting, the IRB will make a determination as to whether to require a consent form. Alternatively, the IRB may require that both the investigator and the subject sign the Device Brochure to indicate that the subject and the investigator have had a discussion about the HUD and that the subject has understood what the device is.
All HUD device use should be recorded in real-time (or within 5 days in emergency situations) in a standardized log book, which must include the following:
- Date and time of device placement
- Name, age, and medical record of patient receiving the device
- Unique device identification number
- Documentation of procedure consent process, with evidence of discussion regarding the device being used classified as “Humanitarian Use Device” or if separate consent not required, the nature of HUD must be disclosed under routine consenting process and documented as such
- Name(s) of individual(s) involved in the consent process, as well as evidence of information materials (i.e., product brochures) being given to the patient
Q: Who can I talk to if I have a question about my research project?
A: If you have questions about externally funded clinical trials, such as budgets, contracts, and the start-up process, please contact Tracy Butryn, Network Director of Clinical Trials and Research (484-526-5190; Tracy.Butryn@sluhn.org).
If you have questions about internally supported research, such as research design and implementation, statistical methodology, poster presentations, and manuscript writing, contact Dr. Jill Stoltzfus, Research Institute Director (484-526-4942; Jill.Stoltzfus@sluhn.org).
If you have questions about the IRB submission process, such as which forms to use, deadlines for submissions, and appropriate policies/procedures, contact Jayne Silva, IRB and Research Institute Administrative Coordinator (484-526-6742; Jayne.Silva@sluhn.org).