COVID-19: IRB Directives
Updated: May 18, 2022
In response to trends in local COVID-19 infection rates and vaccination status, the IRB has decided to lift current COVID-19 restrictions on in-person human subjects research. This means the maintenance of a research-specific contact tracing mechanism and the COVID-19 addendum to the informed consent document is no longer required. The IRB has produced an abbreviated COVID-19 guidance document that is available if required by a reviewer for a specific research protocol or for any researchers who chooses to provide it to their participants.
The IRB will continue to support compliance with public health directives and other University mandates including the University masking policy. See the Villanova University COVID-19 Campus Information page for more information. Researchers should be prepared to respond to potential cycles in community transmission and local government directives that may result in resumption of protective measures in the interest of participant and researcher health and safety.
Please contact the IRB at IRB@villanova.edu if you have any questions.
August 23 Communication
*As of April 11, 2022, for research with children under 12, sub-committee review is no longer required. Modification submissions may follow the normal designated reviewer process.*
Dear Villanova Researcher,
The Villanova IRB is pleased to announce the resumption of in-person human subjects research with the following considerations:
Researchers must use the COVID-19 addendum with the appropriate informed consent document when enrolling participants to ensure they understand COVID-19 specific risks.
Researchers must use a contact tracing mechanism for any potential necessary public-health official follow up. The IRB has provided a suggested tracing log available on the IRB website.
Special consideration for participants under 12 years old who do not currently have access to the COVID-19 vaccine (see below).
Procedure to resume previously approved in-person research:
For research involving only adults and children 12 and older:
Complete the IRB’s Return to Research Qualtrics survey. Within the survey you will be asked to acknowledge the responsibilities outlined above. You will receive a customized message at the end of the survey indicating whether your in-person research may resume. The survey must be completed only once per PI and is applicable for those with exempt, expedited, and/or full board protocols.
The streamlined process described above is applicable only for resumption of in-person activities that were already approved by the IRB. Any modification to your study from the previously approved protocol (including but not limited to personnel changes, changes in procedures, etc.) must be submitted via Cayuse using the normal modification process.
For research involving children under 12:
Submit a modification via Cayuse to request resumption of in-person activities. You will be asked to describe how you are mitigating risk of virus transmission for this vulnerable population not currently eligible for vaccination from COVID-19 (i.e. requiring masks, social distancing, etc.). This modification will be reviewed by a designated sub-committee of the IRB using the normal modification timeline.
Please note that if your study has expired during the suspension of in-person research, you must submit a renewal, status update report, or new IRB protocol to resume your research.
The IRB is looking forward to a productive semester and wishes you well in your research. Please contact the IRB at IRB@villanova.edu if you have any questions about the guidance and procedures described above.
June 29th, 2021 Communication
On June 28, 2021, the University announced that Return to Research Lab Plans would no longer be required as we recover from the COVID-19 pandemic and move toward more normal operations. Since April 2021, the IRB has initiated a phased return to in-person research activities based on University and public health guidance as you will read in the series of communications circulated previously. In light of the announced full re-opening of research labs, the IRB will work to develop a plan for the full resumption of in-person research in time for the start of the fall semester. Do send along any comments, questions or concerns about our phased efforts to safely resume normal in-person research activities to irb@villanova.edu.
June 24th, 2021 Communication
Update on Limited Return to In-Person Research: Categories Expanded
Some of the existing categories eligible for consideration for in-person human subjects research activities have been expanded as of June 24th, 2021. Details of the newly expanded categories are set forth below, together with a list of all categories previously determined to be eligible for consideration:
Existing Categories Eligible for Consideration |
Expanded Categories Eligible for Consideration ****NEW as of June 24, 2021***** |
Collaborative Exempt research approved by another institution for in-person research activities to be conducted on that institution's campus. Such research is subject to the external institution’s safety protocols and will not undergo the safety certification process applicable to studies conducted on the Villanova campus (e.g. another institution’s IRB has determined a protocol to be exempt and Villanova personnel are not the targeted participants).
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Collaborative Expedited research approved by another institution for in-person research activities to be conducted on that institution's campus. Such research is subject to the external institution’s safety protocols and will not undergo the safety certification process applicable to studies conducted on the Villanova campus (e.g. another institution’s IRB is the lead IRB via a fully executed Reliance Agreement, and Villanova personnel are not the targeted participants).
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On-campus research activities in which the research participants are not asked to engage in any behaviors that are different than what their activities would be if they were not research participants (e.g., sharing the same physical space where such pre-existing interactions are occurring). On-Campus research activities require an approved EH&S Safety Plan.
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Off-campus research activities in which the research participants are not asked to engage in any behaviors that are different than what their activities would be if they were not research participants (e.g., sharing the same physical space where such pre-existing interactions are occurring, provided the research environment is appropriate based on CDC and applicable public health guidelines. Unlike on-campus research activities, no Villanova EH&S evaluation is required for off-campus research activities.
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There is no physical interaction between study participants and/or participants and the PI (e.g. a study for which participants must be engaged in-person due to study-related software only available on lab computers and the study team directs participants from a remote location with no physical contact or sharing space). Note: These research activities require an approved EH&S Safety Plan.
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No change |
As before, these categories are being considered on a case-by-case basis. Researchers must request these limited exceptions to the current suspension of in-person human subjects research using the procedure outlined below. In all cases, if remote operations are possible, research activities must remain remote.
Procedure for the Categories listed above (please note additional requirement applicable to expedited research approved by another institution)
To be considered for an exception to the in-person activity suspension, researchers must:
• Submit a protocol modification or an initial submission that includes the following elements:
o A procedure for providing participants with the COVID-19 Consent Addendum (Guidance for Study Participants) to inform them of additional risks involved with in-person research activities associated with COVID-19.
o Contact tracing procedures to ensure readiness to cooperate with Villanova healthcare personnel in the event of a positive COVID-19 case. A template log is available on the IRB website. Cooperation with public health initiatives supersedes confidentiality protections and is explicitly addressed in the Informed Consent Addendum.
o A justification (provided via Cayuse) as to why study procedures cannot be conducted remotely.
o An acknowledgment of the IRB’s Human Subjects Research during the COVID-19 Pandemic Roles and Responsibilities assurances, found on the Cayuse landing page.
• For expedited research approved by another institution for in-person research activities to be conducted on that institution's campus, obtain an executed agreement to rely on an external organization for the review/approval of the human subject research and obtain IRB approval from the external organization for the proposed human subjects research activities. Please contact the IRB Office (IRB@villanova.edu) for information related to relying on an external organization and reliance agreements.
As a reminder, if requesting on-campus in-person research, PIs must:
• Receive approval of a research Safety Plan from the Dept. of Environmental Health and Safety (EH&S). A template safety plan is available on the IRB’s website and must receive approval from EH&S. This plan must be approved before approaching the IRB to request an exception.
o If the PI’s lab has not already been cleared by EH&S for “return to research” outside of the human subjects research context, then the human subjects research safety plan must also include relevant information for that determination to be made at the same time. Find more information about this process on the University’s “Return to Research” webpage.
NOTE: Additional procedures may be required depending on the nature of the research protocol.
Please contact the IRB at IRB@villanova.edu if you have any questions about the guidance and procedures described above.
May 19th, 2021 Communication
Update on Limited Return to In-Person Research: New Categories Added
Last month the IRB released information regarding a limited return to in-person human subject research activity. This email serves to notify you of two additional categories of research now being considered for resumption.
The new categories eligible for consideration are studies in which:
• There is no physical interaction between study participants and/or participants and the PI (e.g. a study for which participants must be engaged in-person due to study-related software only available on lab computers and the study team directs participants from a remote location with no physical contact or sharing space).
• Collaborative exempt research approved by another institution for in-person research activities to be conducted on that institution's campus. Such research is subject to the external institution’s safety protocols and will not undergo the safety certification process applicable to studies conducted on the Villanova campus (e.g. another institution’s IRB has determined a protocol to be exempt and Villanova personnel are not the targeted participants).
These study types are added to the existing study type already considered:
• Research activities in which the research participants are not asked to engage in any behaviors that are different than what their activities would be if they were not research participants (e.g., research activities that occur in classrooms where students are already gathering for learning experiences, activities involving already-occurring athletic activities, etc.)
As before, these categories are being considered on a case-by-case basis. Researchers must request these limited exceptions to the current suspension of in-person human subjects using the procedure outlined below. In all cases, if remote operations are possible, research activities must remain remote.
Procedure
To be considered for an exception to the in-person activity suspension, researchers must:
• Receive approval of a research Safety Plan from the Dept. of Environmental Health and Safety (EH&S). A template safety plan is available on the IRB’s website and must receive approval from EH&S. This plan must be approved before approaching the IRB to request an exception.
o If the PI’s lab has not already been cleared by EH&S for “return to research” outside of the human subjects research context, then the human subjects research safety plan must also include relevant information for that determination to be made at the same time. Find more information about this process on the University’s “Return to Research” webpage.
• Submit a protocol modification or an initial submission that includes the following elements:
o A procedure for providing participants with the COVID-19 Consent Addendum (Guidance for Study Participants) to inform them of additional risks involved with in-person research activities associated with COVID-19.
o Contact tracing procedures to ensure readiness to cooperate with Villanova healthcare personnel in the event of a positive COVID-19 case. A template log is available on the IRB website. Cooperation with public health initiatives supersedes confidentiality protections and is explicitly addressed in the Informed Consent Addendum.
o A justification (provided via Cayuse) as to why study procedures cannot be conducted remotely.
o An acknowledgment of the IRB’s Human Subjects Research during the COVID-19 Pandemic Roles and Responsibilities assurances, found on the Cayuse landing page.
Please contact the IRB at IRB@villanova.edu if you have any questions about the guidance and procedures described above.
April 6th Communication
Limited Return to In-Person Research Activities
As you are aware, in-person activities have been suspended for all Human Subjects Research overseen by the Villanova IRB since the beginning of the COVID-19 global health emergency in March 2020. The IRB’s fundamental consideration for the decision on how and when to restart in-person human subjects research is the protection of involved participants, with researcher safety also an important factor. Scientific understanding of the virus, its transmission, and effective mitigation efforts, such as vaccines, are still emerging. The situation “on the ground” is highly variable by location, and the local contexts are subject to rapid change. These conditions make it difficult to assess and mitigate risk to research participants and researchers.
However, it is clear that there is also risk of harm by omission in suspending research and therefore the creation of some knowledge for longer than is absolutely required. While the IRB has focused on helping researchers modify their protocols to conduct their research online, it is important to note that there are certain populations, topics, and methodologies where online research is not feasible.
Therefore, the IRB will offer the opportunity for researchers to request limited exceptions to the current suspension of in-person, human subjects research. Requests will be considered on a case-by-case basis. In all cases, if remote operations are possible, research activities must remain remote.
The IRB will employ a phased approach to accepting these requests. The first phase will accept requests for research activities in which the research participants are not asked to engage in any behaviors that are different than what their activities would be if they were not research participants (e.g., research activities that occur in classrooms where students are already gathering for learning experiences, activities involving already-occurring athletic activities, etc.) Only on-campus activities will be considered in this phase.
Requests will be accepted until conditions dictate an adjustment – loosening or expanding – based on emerging science, the spread of the pandemic, and overall environmental conditions, and expansions of accepted activities will proceed according to the same considerations.
Procedure
To be considered for an exception to the in-person activity suspension, researchers must:
· Receive approval of a research Safety Plan from the Dept. of Environmental Health and Safety (EH&S). A template safety plan is available on the IRB’s website and must receive approval from EH&S. This plan must be approved before approaching the IRB to request an exception.
o If the PI’s lab has not already been cleared by EH&S for “return to research” outside of the human subjects research context, then the human subjects research safety plan must also include relevant information for that determination to be made at the same time. Find more information about this process on the University’s “Return to Research” webpage.
· Submit a protocol modification or an initial submission that includes the following elements:
o A procedure for providing participants with the COVID-19 Consent Addendum (Guidance for Study Participants) to inform them of additional risks involved with in-person research activities associated with COVID-19.
o Contact tracing procedures to ensure readiness to cooperate with Villanova healthcare personnel in the event of a positive COVID-19 case. A template log is available on the IRB website. Cooperation with public health initiatives supersedes confidentiality protections and is explicitly addressed in the Informed Consent Addendum.
o A justification (provided via Cayuse) as to why study procedures cannot be conducted remotely.
o An acknowledgment of the IRB’s Human Subjects Research during the COVID-19 Pandemic Roles and Responsibilities assurances, found on the Cayuse landing page.
Please contact the IRB at IRB@villanova.edu if you have any questions about the guidance and procedures described above.
August 11th Communication
IRB COVID-19 Directive Regarding Modifications
On March 23rd the Villanova IRB released a directive suspending in-person research activities. In accordance with that change and due to the need to eliminate apparent immediate hazards to participants, the IRB allowed a temporary procedure change. This exception stated that while under these extraordinary circumstances, substitution of telephone, web conferencing and secure electronic communication (Zoom, Qualtrics) for data collection procedures normally completed in-person were allowable without first notifying the IRB. Researchers were expected to notify the IRB within 10 business days of implementing the change.
As the public health crisis has persisted, many researchers have already adapted their studies to remote operations so that they may continue collecting data. Given the current state of the pandemic, the IRB has determined that this 10-day notification grace period will expire as of August 25, 2020. That is, the last day for researchers to adapt their studies to remote operations without prior approval before the IRB reverts back to the typical modification process is August 25th.
After August 25th, to remain in in compliance with IRB policy, any changes you would like to implement to any approved IRB protocol will need to undergo the typical modification process, which involves the PI submitting a modification application and awaiting approval prior to implementing any changes.
Thank for you for your attention to the many communications we’ve sent in the recent past as we adapt to this unprecedented challenge.
July 28th Communication
IRB Return to Research Plan: Remaining in Phase One
On July 3, all counties in the Commonwealth of Pennsylvania entered the Green Phase in the state’s reopening plan. The green phase eases most restrictions with the continued suspension of the stay at home and business closure orders and triggered our consideration to progress to Phase Two in our Return to Research Plan and allow for the resumption of limited in-person research. While this phase will facilitate a return to a “new normal,” it will be equally important to continue to monitor public health indicators and adjust orders and restrictions as necessary to ensure the spread of disease remains at a minimum.
As we considered the resumption of in-person research, we observed that after the state reopened, there were reports of rising numbers of cases of COVID-19 with new restrictions implemented. In light of the fluidity of the situation, the IRB will continue to proceed cautiously. As such, the current directive that no in-person human subjects research is allowed remains in place. This directive will be revisited by the IRB with further guidance issued on a routine basis. The IRB does not take lightly the restrictions that have been placed on human subjects research; we understand that the limitations on in-person activities have substantial impacts on the Villanova research community. However, consistent with the mission of the Institutional Review Board, participant welfare must be the top priority as we continue to adjust to our new environment. We appreciate the adaptability many of you have shown in transitioning to remote data collection. If you have not yet made this switch and would like to, please find more information about your options as well as additional information on the phased plan on the IRB’s COVID-19 website.
The IRB will continue to monitor the ever-changing situation on a routine basis to evaluate the best way to support Villanova research while honoring the critical purpose of the Board. We want to take a moment to thank you for your cooperation and understanding as we have collectively been navigating uncharted waters for the past several months. We appreciate that you share in our collective effort to maintain the health and safety of research participants and all members of the Villanova research community.
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 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.