Research Integrity FAQ

Fall 2021

Updated 8/23/2021

IRB / Human Subject Research


Can I currently conduct in person research activities?    

  • 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.

How can I resume or start in-person research? Are there any requirements?    

  • 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.

What if my in-person research project was already approved?    

  • 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/

Is remote research still recommended?    

  • 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.

Do I have to notify FAU's IRB if I am collaborating with researchers at other institutions?    

  • 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.

Can Research Integrity provide assistance with conducting research virtually?    

  • 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.

How do I virtually consent participants for online research?   

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.

This is my first time submitting or, I have not submitted to the IRB in a long time, is training available to help me navigate IRBNet?    

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.

What should I do to change an ongoing study?    

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.

Do I need to submit an amendment to the IRB if I am changing research methods?    

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.

Do I need to submit revised consent forms to the IRB if I am changing to virtual or phone research methods?    

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.

What kind of protocol changes will likely need prior IRB approval?    

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

What about studies reviewed by a non-FAU IRB?    

  • 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.

What documentation is needed from outside institutions?    

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.

What formal agreements are needed between FAU and outside institutions prior to receipt of data or materials?    

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.

What should I do if I have additional questions?    

If you have additional questions, please contact the HRPP team: Judith Martinez, Donna Simonovitch, or Elisa Gaucher.

IBC / Biosafety


Will new registrations continue to be reviewed by FAU's IBC?  

Yes, the FAU IBC will continue to review new registration submissions per normal review procedures. IBC meetings will take place virtually.

What additional biosafety procedures will be needed prior to IBC approval?  

Any project that proposes interaction with study subjects, or sample collection from subjects, will require additional COVID-19 biosafety procedures to avoid potential exposure.

What laboratory procedures are recommended for minimizing exposure to SARS-COV-2?  

OSHA has provided COVID-19 control and prevention guidance for laboratory workers: https://www.osha.gov/SLTC/covid-19/laboratory.html, and ABSA has issued recommendations for handling potential SARS-COV-2 samples: https://absa.org/wp-content/uploads/2020/03/ABSA2020_Covid-19-dr3.pdf

What COVID-19 research can be done at FAU?  

Covid-19 research involving molecular or other types of analyses of human samples (blood, nasopharyngeal swab samples, etc.) will be permitted at a minimum of biosafety Level (BSL)-2 conditions. However, the Institutional Biosafety Committee (IBC) may impose additional requirements (personal protection equipment, work practice controls, etc.) for this type of work.

Can research with isolated SARS-COV-2 virus be done at FAU?  

No, research involving isolation, amplification or propagation of virus will NOT be allowed. Current guidelines require biosafety Level (BSL)-3 facilities for such work. FAU does not currently have the capability to facilitate such work.

Are there any federal guidelines for COVID-19 research?  

Currently, biomedical research laboratory work into COVID-19 is governed by recently adopted Centers for Disease Control and Prevention guidelines: https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html.

Does COVID-19 research require approval by the university?  

At a minimum, all research work with COVID-19-based samples will be required to undergo review by the FAU IBC as well as the Institutional Review Board (IRB), depending on the source of the specimens.

What other responsibilities should researchers be aware of?  

The virus responsible for the COVID-19 pandemic, SARS-CoV-2, will likely be designated a Select Agent in the near future. Therefore, any samples associated with this virus/disease will need extensive cataloging and researchers should consider secure storage of these samples at this time. If SARS-COV-2 is designated a Select Agent, samples may need to be destroyed — this would require verification by the biosafety officer.

Who should I contact if I have questions related to research involving SARS-COV-2, Covid-19 and laboratory biosafety?  

Contact Andrew Donovan, IBC Coordinator, at adonovan@fau.edu, or Frank Novembre, Biosafety Officer, at fnovembre@fau.edu.

IACUC / Animal Subjects Research


Is FAU's IACUC continuing to conduct official business and review protocols?   

Yes, it's remote business as usual for Spring 2021. The IACUC office and the committee continue to conduct official business, including but not limited to: continuing scheduled monthly meetings via a virtual meeting platform, conducting protocol review and approval, accepting reports of and investigating animal welfare concerns, reporting to federal agencies and AAALACi and completing grant congruency reviews.

Will semiannual facility inspections occur?  

Yes, Semiannual facility inspections for Spring and Fall 2021, scheduled for April and October, respectively, will occur as scheduled. The inspection process will adhere to all appropriate safety guidelines including CDC, state and FAU procedures. More information will be forthcoming to PIs via email.

How do I complete the mandatory IACUC training requirements?   

The "Ethical Use of Animals, IACUC Function and the 3R's" training is offered virtually and is available twice a month. Register for the virtual Ethics training via the IACUC Training Calendar.
  • 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 (hutchins@fau.edu) 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).

Who should I contact for assistance with my IACUC protocol or questions about my research program?   

IACUC office staff are available to answer questions and assist in protocol preparation. Please contact Kristen Ware or Dana Mulvaney.