COVID-19: IRB Directives

Depiction of Corona Virus

Updated: June 25, 2020 9:30 a.m.

June 25th Communication

Returning to Research

As communicated in the March 23rd IRB directive, all research with human subjects is currently required to be conducted remotely to reduce the potential spread and impact of the COVID-19 pandemic. Thank you for your cooperation with that notice and for being willing to either suspend or postpone your research or adapt to remote data collection.

As Governor Wolf begins to reduce state-level restrictions on non-family person-to-person contact, the IRB has considered implications for human subjects research. As always, the top priority in such considerations is the safety and welfare of human participants involved in research, as well as the safety of Villanova faculty, staff, and students. These needs for safety must be balanced with the need for researchers to return to their livelihoods and the desire to facilitate the conduct of ethical and compliant research with great benefit to society.  Please consult the Returning to Campus: Research Plan website for more information.

In alignment with broader institutional decisions, the IRB recommends a gradual phased approach to return to research with human subjects. Exact timing of these phases is still to be determined in conjunction with federal, state, and local regulations and guidance. Further communication will come when dates are determined.                

Phase One (Current): All research that can be done remotely should be done remotely. No in-person interaction permitted.

Phase Two (expected no sooner than when the county in which your research occurs changes to “green” status, or comparable if research is not conducted in Pennsylvania): Research that involves limited in-person interaction is permitted if recruitment and research conduct involves the interaction of 10 or fewer participants and research team members. See additional considerations below.

Phase Three (expected no sooner than when the University resumes normal, unrestricted operations): Research that involves or calls together large groups of people (more than 10) or requires the researcher to be exposed to many individuals may resume in-person. This may include focus groups with more than 10 participants and research for which recruitment and other activities happen at schools, museums, camps, or other highly populated public spaces. See additional considerations below.

Additional considerations:

·         All procedures and necessary approvals as set forth in the Returning to Campus: Research Plan must be followed. (Including ensuring approval from department, college, and EHS before returning to research labs and completing mandatory training for example.)

·         If your research can be conducted remotely, the IRB recommends that you continue to do so regardless of which phase of reopening is active.

·         All in-person interactions must adhere to the strictest of recommended PPE usage (face masks, gloves, cleaning of shared surfaces) and physical distancing practices to limit the chance of virus transmission until further notice. See the EH&S COVID-19 Resources website for more information.

·         PIs are responsible for communicating this guidance to research personnel under their supervision (e.g., students and other research team members) and ensuring that it is adhered to. PIs have the ultimate responsibility to ensure PPE is worn and cleaning procedures are followed, including providing supplies for these measures. 

·         The University will be responsible for determining when outside visitors (including research participants) are permitted to campus. This decision is independent from any IRB directives.

IRB Protocol Modifications:

If you submitted a modification to your approved protocol to adapt your study to remote operation, please note that your in-person data collection methods are still approved and you may return to them when permitted, based on the phases outlined above. You do not need to submit a modification to your research protocol to return to the methods that were previously in use, as long as those original methods are not being changed and the original study has not expired. If your original data collection methods must be altered in some way after returning from remote operations, then you must submit a modification to the IRB as usual and wait for approval before proceeding.

As always, the IRB members and ORP staff are ready and willing to assist you as you navigate this transition phase, and we appreciate your patience as we continue to manage this complex environment. Please reach out if you have any questions or concerns about this guidance. Thank you again for assisting in the mitigation of research risks to subjects or others related to COVID-19.

March 31st Communication

Dear Villanova Researchers,

As you may have already heard from the Associate Vice Provost for Research, Amanda Grannas, non-critical on-campus research activities must be suspended in order to protect the health and safety of the Villanova community. As indicated in the same briefing, the Institutional Review Board (IRB) has issued a corresponding directive requiring all human subjects research activities be conducted remotely effective immediately. The full announcement can be viewed by visiting the IRB’s COVID-19 Directives webpage.

We want to be sure all personnel involved in research understand their responsibilities as we transition. If you are the Principle Investigator on a project, you must ensure that your students and other study staff understand that they are not permitted to interact directly with human subjects until further notice. This includes projects that are being conducted by students in pursuit of a degree or honor’s designation. If data collection (for a student project or otherwise) can continue remotely (telephone, web conference, online survey platform) you may adapt your study to be carried out without direct person-to-person contact.

The IRB and ORP have adopted the following changes to facilitate adaptation:

  • Under ordinary circumstances, procedural changes to IRB protocols may not be made without obtaining IRB approval in advance. An exception may be available when the IRB or PI determines that changes are necessary to eliminate apparent immediate hazards to participants. Therefore, while under these extraordinary circumstances, substitution of telephone, web conferencing and secure electronic communication (Zoom, Qualtrics) for data collection procedures normally completed in-person are allowable without first notifying the IRB. 
  • If your active research protocol is affected by the VU IRB COVID-19 Directives, you must notify the IRB within 10 business days of implementing a change to your protocol.  Such notification should take place by completing a modification application for your protocol via Cayuse IRB so that there is a record of implementation of these procedures. (If you are not in active data collection, already have remote data collection procedures in place, or will simply pause your research until this restriction is lifted, you do not need to be in contact with the IRB.)
  • If the participants’ research experience will be different due to the remote operation directive than it otherwise would have been, you will need to be sure to accurately convey the new experience in your Informed Consent Document/Process. In order to reduce burden on researchers, reviewers, and administrative staff, the IRB has allowed a temporary addendum cover sheet to be added to already-approved consent forms explaining those changes. This cover sheet should clearly explain to participants how their experience will differ from the text of the original document. We have developed a template to assist in the creation of such a cover sheet, which is available on the IRB COVID-19 Directives website. Your cover sheet should be attached to the modification application you submit to the IRB.
  • If your study was not already approved with a waiver of documentation of consent (meaning that the IRB determined it is appropriate for you to not collect a signed consent document), you must continue to collect signatures electronically (e.g. a scanned signed document or a typed “signature”) . If you believe collecting electronic signatures presents an additional risk to your participants, please contact IRB@villanova.edu to discuss other options.

IRB staff remain available and willing to assist with the transition to remote data collection. Please reach out to IRB@villanova.edu with any questions. Stay safe and healthy!

 

March 23rd Directive:

Villanova University is currently experiencing an unprecedented series of events in response to the national outbreak of COVID-19. The University and the Institutional Review Board (IRB) are heeding the guidance of local, state and national leadership to reduce the spread of the virus.

This document is to provide the University’s research community with information regarding the review and conduct of human subject research in this time of social distancing. As was communicated in the March 13 briefing from the Office of the President, Villanova’s campus is closed to the public. This will no doubt have an impact on human subject research. However, the IRB will remain operational during this time of social distancing.

  • IRB staff will be working remotely and will still respond to e-mails and voicemails.
  • Though it will not be possible for IRB staff to meet with study teams in person, phone and web conferences remain an available option for consultation.
  • The review process will continue as normal (weekly review batches will be distributed to reviewers each Friday including all complete submissions received by Thursday at noon)
  • Reviewers are still expected to return their initial decision within two weeks of each Friday’s assignment. However, we ask for understanding from researchers if there are longer than usual wait times for initial decisions. Most reviewers are faculty who are quickly adjusting to new demands on their time like lack of childcare and un-planned remote teaching.

To protect the welfare of both our investigators and research participants, the IRB mandates that all human subject research activities must be conducted remotely effective immediately. In particular, research participants are no longer permitted to travel to campus, and Villanova personnel must not travel to participants' homes.

These changes will be in place until further notice. As necessary, the IRB will adjust this directive and post changes to this page. For up-to-date University information, please see Villanova’s COVID-19 website. For guidance on best health safety practices, consult the resources available at the federal, state and local levels such as the CDC or the Pennsylvania Department of Health

In this time of public health concern, the following change to IRB process will occur:

Under ordinary circumstances, procedural changes to IRB protocols may not be made without obtaining IRB approval in advance. An exception is available when changes are necessary to eliminate apparent immediate hazards to participants. Therefore, while under these extraordinary circumstances, substitution of telephone, web conferencing and secure electronic communication (Zoom, Qualtrics) for data collection procedures normally completed in-person are allowable without first notifying the IRB. If you did not already have plans for a remote informed consent process, please reach out to the IRB staff to discuss options for consenting your participants from a distance. These methods may be added when possible and practical for mitigating research risks to subjects or others related to COVID-19.

If your active research protocol is affected by the VU IRB COVID-19 Directives, you must notify the IRB within 10 business days of implementing the change. (If you are not in active data collection, you do not need to be in contact with the IRB.) Such notification should take place by completing a modification application for your protocol via Cayuse IRB so that the IRB has a record of implementation of these procedures.

**IMPORTANT** Please do not include other changes to your study in these special modification submissions beyond those required to conduct study procedures remotely.

Key Resources

Contact Information

Research Administration Offices

Middleton Hall Rm 1st
800 Lancaster Avenue
Villanova, PA 19085

Office of Grants & Contracts 

For questions, contact ResAdmin@villanova.edu or 610-519-4220.

Office of Research Protections

For IRB, IACUC or IBC questions, contact orp@villanova.edu  or 610-519-4228

To report Compliance Issues call EthicsPoint Hotline toll free 1-855-236-1443 or email orp@villanova.edu