As Appalachian State University adjusts its operations in order to respond to the ongoing Coronavirus Disease 2019 (COVID-19) pandemic, the Office of Research Protections has developed the following requirements for researchers to follow during this novel situation. These requirements were updated on April 2, 2020 and will remain in place until further notice. Below you will find the requirements, followed by answers to questions regarding how this will affect your research, and how you might change your research in response to these requirements. As always, feel free to contact the Office of Research Protections with any questions at firstname.lastname@example.org or 828-262-4060.
Requirement to pause in-person research as of April 2, 2020 until further notice
Research procedures conducted by faculty, staff, and students of Appalachian State University
involving direct, in person interaction with human subjects must be paused immediately in
accordance with the North Carolina statewide stay-at-home order and University guidance. This
includes all in-person interviews, surveys, and any procedures that require physical contact between
researchers and human subjects that are part of exempt and non-exempt research studies. If you are
unclear if your research procedures can continue under this pause, please contact the Office of
Research protections at 828-262-4060 or email@example.com.
Research procedures that can continue on or after April 2, 2020 until further notice
The only research procedures that can be conducted on or after April 2, 2020 until the requirement is lifted are those that do not require in-person contact, such as the following:
- Interviews, surveys, and recruitment and consent procedures that are conducted online, over the phone, or using video-conferencing software.
- Other procedures that do not require contact with research personnel.
- Data analysis procedures, including analysis of data already collected, screening records for eligible subjects, and studies involving secondary analysis of data collected for non-research purposes.
Changes to the review of new applications, modifications, and annual renewal applications on or after April 2, 2020
The Office of Research Protections and the IRB will continue to review new research applications, modifications, annual renewal applications, and requests for exempt, not research, and not research with human subjects determinations. Studies with procedures which involve in-person contact with human subjects will continue to be reviewed as they would be prior to the current situation regarding COVID-19, but these studies will continue to be paused to all in-person procedures until further notice. As is always the case, researchers must follow federal, state, and local laws, and current University policies and guidelines when conducting research. Please contact the Office of Research Protections if you are unclear if the current requirement applies to your study, or for any other questions regarding research with human subjects, at 828-262-4060 or firstname.lastname@example.org.
Below we offer some answers to questions we expect you may have regarding the requirement to pause all in-person research.
Are there any exceptions to the requirements that all in-person research with human subjects is paused?
In some circumstances, procedures that provide direct therapeutic benefit to already-enrolled,subjects or are necessary to ensure subject safety can continue. According to the records of the Office of Research Protections, there are no studies that meet these criteria being conducted by Appalachian State University. If you feel your study does meet these criteria, please contact the Office of research Protections immediately at 828-262-4060 or email@example.com.
Do I need to submit a modification to pause my research?
No, but if you feel that halting procedures related to a Data and Safety Monitoring Plan that was approved by the IRB would increase risk, please contact the IRB immediately to modify your study.
Do I need to submit a modification to change my research in response to the COVID-19 pandemic?
As is always the case, please follow our SOP on modifications and addendums when deciding if you need to submit a modification and contact the Office of Research Protections with any questions. In many circumstances you will need to submit a modification in order to change research procedures from in-person procedures to online or remote procedures, or to make other changes to allow you adapt to the requirement to pause in-person research. However, here are some very specific instances when a modification may not be necessary:
- Adding procedures for contacting subjects to reschedule research appointments, change interviews from in-person to online, or tell them that the study is being paused does not require a modification.
- If the only change is to change an in-person interview to a phone interview or a video- conferencing interview and this will not require the collection of additional data identifiable data—such as IP addresses and email addresses—you do not need to submit a modification.
- If the only change is to change an in person paper-and-pencil survey to an online survey, you will not collect additional data , and you are able to maintain the confidentiality requirements already described in the IRB protocol identifiable data—such as IP addresses and email addresses—you do not need to submit a modification.
If you are unsure if you should submit a modification to make a specific change, contact the Office of research Protections immediately at 828-262-4060 or firstname.lastname@example.org.
If I need to re-collect data after the pause is over that I had collected before the pause, do I need submit a modification in order to do this?
Yes. In some circumstances, researchers will need to collect data and specimens within a certain window of time, for example to measure the effects of a month-long intervention. Unfortunately, this pause may have disrupted this window of time for subjects, making the data collected on a visit before the pause invalid. In this scenario, the researcher may need to repeat some procedures, or start subjects over in the research study. If this is the case, you will need to submit a modification to add additional data collection procedures for some subjects.
Is the Office of Research Protections Office open?
We are currently open and here to help. Check the IRB and the Office of Research Protections websites regularly for updates. Please note that, despite our best efforts, turnaround times may slow down as this office adjusts to some of the yet unforeseen circumstances of operations during this novel event.
As the COVID-19 situation evolves, we will keep you updated on next steps as it relates to ensuring IRB review for all Appalachian State researchers. Please contact us at email@example.com or 828-262-4060 with any questions.