March 20, 2020
Dear Researchers,
As we all work to navigate the challenges posed by the COVID-19 pandemic, we would like to offer some direct guidance for PIs with open protocols involving human subjects.
As noted in the research guidance letter issued by the Associate Provost for Research and Scholarship/Research Integrity Officer (attached), human subjects research must be paused at this time for any project involving face-to-face interaction. This is due to the risk of viral transmission and ethical principles of research and federal regulations for the protection of human research participants.
Some studies may lend themselves to modification—for example, changing in-person encounters to an online modality. PIs who wish to change their study in any way will need to follow the usual process for submitting an amendment to their protocol. See this link for information: https://www.une.edu/research/compliance/irb . IRB personnel will work through amendments in the order they are received.
Some of you have asked about the possibility of “automatic approvals”. The IRB cannot issue automatic approvals for changes to virtual modality for approved protocols, because each study involves different risks, consent forms will need to change, and the IRB will need to assess the software/platforms proposed for virtual encounters to ensure that confidentiality and privacy of research participants are protected.
We recognize that this may involve significant delays to research, particularly given that the Office of Research Compliance is substantially understaffed at present. We are pleased to share with you that the new Director of Research Integrity is scheduled to start on March 30, 2020.
Our highest responsibility is to the safety of our research participants. We appreciate your patience and understanding during this trying time as we collectively work to ensure it. Please take care and be safe.
Sincerely,
Karen L. Houseknecht, PhD Mary DeSilva, ScD, MS, MSFS
Associate Provost for Research Chair, Institutional Review Board
and Scholarship
Research Integrity Officer