The UConn Health Institutional Review Board (IRB) would like to remind Principal Investigators (PI) and study personnel of existing IRB policies and procedures that are in place and that may be relevant given the potential impact of COVID-19 on research. Because every research protocol is different, the IRB is not issuing a single standard. Principal Investigators are responsible for the oversight of their research, for knowing the nature of their research, and for determining what action, if any, is needed for ensuring appropriate policies and procedures are followed. The following policies may be of particular relevance during this time. Principal Investigators and study personnel should review these policies and determine which actions, if any, are appropriate.
Policy 2011-009.1 – Institutional Review Board – Submission of Materials: In accordance with this policy, if a Principal Investigator determines that a change to the implementation of the protocol is necessary, a request for modification is to be submitted to the IRB. For example, if the PI determines that all subject interviews will be conducted by phone vs. in person, a request for modification should be submitted to the IRB. As with any modification, the change should be clearly described to the IRB. For example, changes that will only occur for a limited timeframe should be described accordingly (e.g. “while the COVID-19 pandemic is ongoing, subject interviews will be conducted by phone whenever possible”). When possible, approval for such changes is to be received prior to the change being implemented. However, if a change in protocol is required to eliminate apparent immediate hazards to subjects, the PI may implement that change and report it to the IRB within five business days. In this type of situation, the change to protocol would be anticipated to be a lasting change and not particular to one subject ,which would be reported per one of the following policies.
Policy 2009-002.0 – Reporting Non-Compliance to the Institutional Review Board: In accordance with this policy, protocol deviations within the control of the research team are to be reported to the IRB within five business days. Non-compliance that is not within the control of the research team and that does not pose risks to subjects is to be reported to the IRB at the time of continuation or study closure, whichever comes first. For example, if a subject declines to come to a study visit due to general concerns about COVID-19, and missing that visit will not place the subject at risk, this would be tracked by the study team and reported to the IRB at study continuation or closure. Likewise, if the institution makes a policy decision that prevents the study team from fully implementing the approved protocol, the deviations would be tracked and reported at study continuation or closure, provided the subjects were not put at risk. For example, if the institution limited access to only those providing or needing clinical care, subjects would not be able to come on site for interview/survey procedures. It is anticipated that the tracking of protocol deviations will be the most prevalent course of action during the COVID-19 pandemic.
Policy 2009-001.0 – Reporting Unanticipated Problems to the Institutional Review Board: An unanticipated problem is any unforeseen occurrence that involves risk to the subject or others, and that is related to or is possibly related to either a research intervention or interaction, or the conduct of the study in general. If a protocol is not able to be implemented and that inability places the subject at risk (e.g. subjects prevented from coming to institution to receive clinical research intervention and the lack of intervention puts the subject at risk), the PI should report this to the IRB. This may be a single missed visit; or it may become a concern after a certain number of visits are missed.
In summary, it is the responsibility of the Principal Investigator to oversee the implementation of the research protocol within the framework of existing IRB policies and procedures. If you have any questions, you may contact one of the IRB Regulatory Specialists.
- Steven MacKinnon for IRB numbers ending in -1 or .1 (firstname.lastname@example.org, 860-679-8729)
- Patricia Gneiting for IRB numbers ending in -2 or .2 (email@example.com, 860-679-4849)