Research Integrity FAQ
IRB / Human Subject Research
- Yes, FAU has resumed normal operations for the fall semester, effective August 21, 2021. This will include direct researcher to participant interaction in human subjects research.
- Researchers and study subjects are expected to wear face coverings. See below for additional details to get started.
- To begin or resume in-person research, researchers are required to create a project or add a new package in IRBNet and submit the following documents (located in the IRBNet Library) along with your research materials:
- Form 3 - Re-engagement: COVID Information Sheet
- New IRB applications with in-person activities will no longer require a request for justification to resume in-person research but must follow FAU safety guidelines and CDC requirements.
- If your project was approved prior to the pandemic and has been on hold due to COVID restrictions, submit an amendment including the Resource documents and revise your protocol to capture safety measures that will be implemented.
- If your project received approval for in-person research during the COVID environment and already includes the approved Resource documents with safety protocols, no further submissions to the IRB are needed at this time
- Continue to follow the approved safety plan and refer to the current FAU Safety Plan and see the FAU coronavirus page for updates and details at https://www.fau.edu/coronavirus/
- Yes, virtual person to person interaction options is strongly recommended and must adhere to the CDC and university guidance. Researchers are encouraged to adjust their research methods to conduct online surveys, online (virtual) individual interviews and focus groups, when possible.
- Yes, if you have a collaborative project with multiple institutions the lead institution could serve as the single IRB of record and FAU's IRB will need to acknowledge that you as an FAU researcher will be protected. A guidance document for processing an IRB reliance agreement (IAA) is available in the IRBNet Library “Forms and Templates”. Contact the HRPP/IRB personnel for more information.
- Yes, we can assist with discussing options for you to conduct your research in a way that effectively ensures the safety of human subject participants.
- You may also visit the FAU Remote Resources page to learn of the options available to you
- We cannot however assist you in changing your research question or research methodology. This should be discussed with your research team or faculty advisor as appropriate.
Use our e-Consent guidance located in the IRBNet Library as “Reference 9 - E-Consent Guidance” as a resource for virtual consent options. The IRBNet Library also includes various consent form templates for different types of projects such as the consent paragraph for online studies or to use as a verbal script.
Yes, virtual IRB 101 workshops which guide researchers through the submission process including an overview of required submission documents are taking place every 2 weeks. See the IRB Training Calendar to register for an upcoming workshop. Researchers are highly encouraged to participate in this interactive workshop by asking questions or requesting clarification throughout the session. CITI modules continue to be available online for IRB required training.
Submit an IRB amendment in IRBNet. Any changes in IRB-approved research (except projects deemed Exempt) must be submitted to the IRB for review and approval prior to implementing the change.
An exception is when changes are necessary to eliminate apparent immediate hazards to the subject (permitted in both OHRP and FDA regulations) Should this happen, the changes must be reported to the IRB as a protocol deviation within 5 days. If the changes need to be sustained for multiple visits, then an amendment to the protocol should be submitted to the IRB for review and approval.
Yes, any modifications to research procedures such as changes in options for questionnaires, surveys, check-ins, screening, and consenting. Researchers must submit amendments with any changes to their studies as applicable. Please update the protocol with the revisions to the research methods and informed consent process as soon as possible. The research team must secure approval of the modified procedures prior to collecting data with new methods.
Note: If you have any questions about whether a remote option is possible or approvable (especially for consent), contact the HRPP / RI team. We are working to prioritize such amendments.
Yes, informed consent (online) rather than the signed consent form is a change in protocol procedure and needs IRB approval. With appropriate justification and for minimal risk studies modifications in the consenting process is acceptable. Please consult the consent template formats available in IRBNet. For example, for an online survey the template consent paragraph is best suited. Contact Research Integrity if you have questions about consent template format or modifying your consenting procedures.
The following changes would not eliminate an immediate hazard, but may still be desired, so consider doing a proactive amendment for the following circumstances:
- Changing reimbursement for participant compensation/incentives or travel expenses, if travel requirements or compensation changes
- Using digital technology to conduct remote visits/ interviews. Consider what types of technology you may wish to use
- You do not need to submit anything to FAU – IRB unless you are changing the PI, changing the IRB, closing the study or the non-FAU IRB has requested that you contact Research Integrity for guidance. Each non-FAU IRB may have different policies for what to report about suspending enrollment, activities, etc. However, in most cases if you are changing study procedures or moving from paper-based consent to e-consent, you will need to modify the study.
- For multi-site studies, you may need to work with the primary center, lead study team, as part of implementing changes.
- Contact Research Integrity for additional guidance and to facilitate as needed.
At a minimum, a letter/e-mail of cooperation from the institution providing access to patients/samples should be included in the initial communication with the IRB office.
In most situations, projects involving the exchange of data or specimens require either a Data Use Agreement (DUA) or Material Transfer Agreement (MTA). These agreements require institutional legal review as well as a signature from an authorized institutional official. Please contact the Office of Sponsored Programs or Research Integrity for additional information and guidance. DUA and MTA review can occur in parallel to IRB and IBC review, but IRB and IBC review and approval is needed prior to final approval of an agreement.
IBC / Biosafety
IACUC / Animal Subjects Research
- Requests for In-person hands-on training and facilities orientation for researchers working with rodent models are being evaluated on a case-by-case basis by the IACUC. The in-person trainings adhere to all FAU, state and CDC safety guidelines. Please contact the IACUC office (Kristen Ware or Dana Mulvaney) for more information.
- In-person, hands-on trainings continue to resume on an as-needed basis in adherence to FAU, state and Centers for Disease Control and Prevention safety guidelines. Principal Investigators must submit justification requests for hands-on trainings and facilities orientations to the IACUC office, Kristen Ware for review and approval by the IACUC.
- Research personnel will be required to wear an N95 respirator to attend the in-person trainings. Once the request for hands-on trainings have been approved, research personnel must complete the additional steps noted below PRIOR to scheduling the in-person trainings.
- Complete the Respiratory Protection Training via Skillsoft entitled “Respiratory Protection 2.0”. The link to enroll in the training is located on the EH&S website and can be found here: http://www.fau.edu/ehs/training/.
- Contact Henry Hutchinson (email@example.com) for Medical Clearance and Fit Testing instructions To be effective, the respirators must be fitted. Sizing guidance is as follows: men typically wear medium or regular, and about 50% of women wear small and 50% wear medium.
- Obtain medical clearance via the medical clearance form for respiratory protection from Henry Hutchinson. This form must be filled out and submitted for review and approval by Concentra, FAU’s Occupational Health provider. Please note, this is not the same form as the forms submitted for enrollment into the Occupational health program which are attached to this email.
- Fit testing (with Henry Hutchinson).