Human Subject Research

Dear SCSU Researchers,

As you are all aware, we are in a period of time when close contact with others increases risks for both individuals and society.  Therefore, all human subjects research that involves in-person contact, including recruitment, data collection, and lab meetings, should be paused.  While it is likely that much of this has already happened due to the loss of access to university facilities and the request of the Governor, any in-person human subjects research that remains active should cease by pausing, amending, or closing the research and notifying the SCSU IRB as appropriate.

COVID-19 makes the risks of the in-person recruitment and data collection greater than the benefits of the research, and research that is not devoted to the public health crisis is not essential. Therefore, investigators are urged to find methods that allow for remote recruitment of and data collection from research participants.

Researchers who feel that their in-person human subjects research is essential to society and have cause to continue, should present the reasons for that conclusion.

Research that involves remote or online activities may continue uninterrupted at this time.

Pauses.  Pausing research does not require researchers to notify the IRB.  It simply means that recruitment and data collection is halted at the discretion of the Principal Investigator.  This research can be resumed when the crisis has passed.  Researchers need only notify the IRB if the research is to be amended or closed.

Amendments. Any amendment to approved research must be submitted to the IRB.  If an in-person research study is to be moved to online activities, an amendment that outlines the new procedures and includes all relevant updated documents must be submitted for review and approved before the changes can be implemented.  These amendments can be submitted through Kuali Protocols.  PLEASE NOTE:  It should be clear in the amendment request as to whether the amendments SUPPLEMENT or REPLACE in-person activities.  If the amendments will replace in-person activities, an amendment will also be needed when this crisis ends, and in-person research activities resume.

If currently enrolled participants will move from in-person to online research procedures, a second consent process should be conducted as the conditions under which they decided to participate have changed.  

If a project was submitted prior to August 2019, researchers should email the IRB Chair (hauseltw1@southernct.edu).  As research approved prior to August 2019 was submitted using the old paper application, a new application may need to be submitted through Kuali Protocols.

Closures.  Investigators have the responsibility of closing their research when data collection has ended.   If a human subjects research study cannot be paused or amended due to the current crisis, it should be closed.  Research that will be ended as a result of the pandemic should be closed using the appropriate IRB process, either in Kuali Protocols or the form found on the IRB website.

Please also know that while the protocol submission process and review is now online through Kuali Protocols, the ability of the IRB to conduct reviews will likely be affected by the switch to becoming an online university for the semester.  In general, we expect that it will take longer than usual to review protocols.  Researchers should plan accordingly.

Thank you for your cooperation in this important matter during this time of crisis.

Sincerely,

W. J. Hauselt, PhD., Chair, Institutional Review Board
Christine C. Broadbridge, PhD., Executive Director, Research & Innovation
Robert Prezant, PhD., Provost and Vice President for Academic Affairs