Institutional Review Board on Human Subjects Research (IRB)
Memo for Primary Investigators
March 23, 2020
RE: COVID-19 Advisement for Human Subjects Research Continuity
In response to the increasing health and safety risks to our campus and local communities, the Office of Graduate Studies and Research (GSR), along with the Institutional Review Board (IRB), encourages all human subjects researchers to establish a research continuity plan for existing IRB-approved protocols. The following guidelines should be followed with respect to research planning and data collection activities until further notice.
All researchers involved in human subjects research should carefully re-assess and continue monitoring the risk/benefit ratio for research participation. We understand that some researchers may need to consider pausing their recruitment of subjects and their data collection at this time. Risks that should be considered include activities that increase likelihood of exposure (participant and research team), research site accessibility and operation procedures, implications for the informed consent process, added stress to participants due to the outbreak, changes in storage/management of data due to not being on campus, etc.
All researchers in the process of participant recruitment should review procedures for facilitating informed consent and consider the potential of an alternative method. Research involving minimal risks may use a verbal process, electronic signature, and/or check box/radio button to indicate consent. Alternative methods for informed consent normally do not apply for research involving greater than minimal risk. The IRB Committee will consider these requests on a case by case basis to determine the feasibility for an alternative consent process. All researchers should submit these requests via an amendment request prior to implementing any changes.
All researchers should review data collection procedures and develop formal, actionable plans for continuing or halting data collection. These plans should include the following considerations: ensuring compliance with University, federal, and state COVID-19 public health advisories and regulations; suspending direct contact with participants for all data collection activities (e.g. interviews, focus groups, large group interventions, public observations); modifying face-to-face data collection procedures to telephone or online formats; ensuring an ongoing consent process is maintained for requesting research participants engagement in remote data collection activities; securely managing data in the event of campus and research site closures; adjusting research protocol timelines, etc.
If data collection activities need to be altered, or another change needs to be made to a protocol in order to protect participants and/or researcher(s), an amendment request should be submitted to the IRB Committee for review and approval prior to the change being implemented. Please visit our website for the application amendment request form.
If an investigator needs to make a change to a protocol due to an immediate risk to research participants and/or the researcher and is unable to submit an amendment request, these changes should be made and then reported to the IRB within 5 days as a reportable, unanticipated event.
All researchers should refrain from convening research team meetings on campus and utilize remote meeting platforms as available. Per President Wight’s correspondence on March 19, “teleworking will continue through the remainder of the semester. We ask that you refrain from coming to the physical campus unless otherwise instructed.”
At this time the SU IRB Committee will continue to review minimal risk research protocols (i.e. exempt and expedited submissions). Any protocol involving more than minimal risk and, therefore, requiring a full board review is postponed until further notice. If the COVID-19 outbreak presents increased risks for individual and/or public health, additional guidelines and/or restrictions to human subjects research activities will be provided to the campus community.
Both our office and the IRB are willing to be a resource to our primary investigators for any questions or concerns. If researchers need to explore applying for amendments to their protocol, we encourage them to visit our website for more information. Additionally, if there are other immediate questions, please contact Donna Knopf ( firstname.lastname@example.org ).
Salisbury University’s Institutional Review Board on Human Subjects Research (IRB) provides guidance to faculty, staff, and students conducting research with human participants. SU’s IRB independently reviews and assesses proposed research to ensure the safety and welfare of human subject participants. The IRB also works collaboratively with researchers to ensure that federal and state regulations are being followed.
SU’s IRB operates under the key principles of the Belmont Report…
- Respect for Persons is the first principle which mandates that subjects voluntarily consent to participate in research, that they are adequately and thoroughly informed about the research and what is required, and that their privacy and confidentiality are protected.
- Beneficence is the second principle which mandates the risks of research are justified by potential benefits to the individual or society and that those risks are minimized.
- Justice is the third and final principle which mandates the equitable distribution of risks and benefits among those who may benefit from the research, meaning that one subset of a population should not take on all the burden of risk and reap all of the rewards; risks and rewards should be applicable and available to all subsets of a community.