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.
· 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.