Dear Members of the UNC Research Community,
As UNC-Chapel Hill is closely monitoring the spread of the coronavirus and COVID-19 and information is being shared with campus at https://www.unc.edu/coronavirus/, the UNC-Chapel Hill’s Office of Human Research Ethics wanted to update our research community with answers to questions that have been raised over the last several days.
The Office for Human Research Ethics (OHRE) has worked with the Office of Clinical Trials (OCT) and the Clinical Trial Quality Assurance (CTQA) program to create the following information when consenting subjects for a greater than minimal risk and FDA regulated study in isolation rooms. Please find an algorithm and a checklist.
- Consent Process Algorithm
- The algorithm is to serve as a decision tree in determining what consent processes are available to subjects in isolation for greater than minimal risk and FDA regulated research.
- The checklist is an aide when alternate consent documentation processes are required for studies when a signed informed consent document cannot be collected from the subject’s location and included in the study records (e.g., a COVID patient’s isolation room). This consent process is permissible for all studies including FDA regulated (FDA March 2020 Guidance) for the duration of the public health emergency in relation to COVID-19. A modification to utilize this process does not need to be submitted to the IRB.
Please note, utilizing this process is never to be considered the standard consent process and an adequate reason for utilization (e.g. spread of COVID in COVID patient’s room) must be documented in the utilization checklist.
Please let us know if you have any questions, the CTQA Program (Val Buchholz) continues to be a great resource and available via email if you have questions about documentation and research records.
Also as a note this does not change or alter the COVID-19 for Clinical Research statement that clinical research that provides an immediate benefit for the health and well-being of a participant should continue; however, as a reminder this work is subject to guidance and direction from UNC Health. The UNC Health coronavirus website should be consulted for direction regarding such research. Please refer to the Office of the Vice Chancellor for Research COVID-19 for additional information.
Please refer to the COVID-19 NRP slides regarding remote consenting options based on risk level, and isolation status, as well as submission requirements, clinical trials.gov and OVCR’s policy in relation to operations as presented by Christine Nelson and Cassandra Myers on the 4/16/2020 NRP session.
1. What should I do if I need to alter my previously approved IRB processes and procedures due to coronavirus or COVID-19?
COVID-19 Screening Purposes Only
If you need to screen subjects for coronavirus or COVID-19, this is not considered a “research activity” and can be done without IRB approval, provided you are not using this data for research purposes.
Research Design Modifications
If you need to alter your research processes from currently IRB approved processes or forms due to coronavirus or COVID-19 (e.g., consent, administering surveys through a different mechanism, or personnel changes to ensure coverage) please submit these as modifications and in the coversheet please state “COVID-19” and include your justification. Please ensure the modification description also includes any changes to the consent processes including alterations/waivers of signature or other elements as required, as depending upon the risk of the study and activities, consent processes may not be able to be altered per federal regulations. For example, studies conducted under an IND or IDE require a written signature be obtained prior to beginning treatment or other “greater than minimal” risk activities, therefore; a verbal consent process cannot replace the signed consent form.
Subjects requiring samples to be drawn as part of their research participation may be allowed to have samples collected at another organization, such as their local provider clinic, provided that this group routinely provides sample collections as a service. If a subject is unable to travel to UNC there may be other options available for them to have a sample collected for research purposes. Please consult with OHRE for further guidance.
As a reminder, initiating research or modifications to research without IRB review and approval is not permitted, except where necessary to eliminate apparent immediate hazards to the human subjects per DHHS OHRP and FDA regulations.
2. What do I need to do if my study does not provide immediate benefit and I’m going to postpone or suspend activities for the entire study?
Please submit a modification in IRBIS and in the Coversheet, state “Suspension of Activities-COVID RELATED”, please do not include other modifications in this submission. If you are only requesting to suspend certain activities and continue to conduct research activities that do not include direct involvement please submit a modification to the IRB and if this alters the consent process, please provide appropriate details.
3. What technology can we utilize to conduct our human subject research activities remotely to avoid direct interactions?
As a reminder when you certify your submissions in IRBIS researchers are confirming that they will utilize appropriate IT systems for the information they have as designated by the assigned IRBIS security tier, this also includes sharing data with sponsors or others outside of UNC, and these requirements are still in place.
The Safe Computing at UNC site and specifically Zoom at UNC can both be used as resources to help identify strategies or ways to appropriately communicate and share, which may include solutions such as “OneDrive and Office 365”. Identifying appropriate settings and accounts in relation to the studies needs and activities (e.g., FDA Part 11 Compliance, PHI, and FERPA) can be very complex depending upon the study and the OHRE recommends contacting your Information Security Liaisons (ISL)/IT Liaison and involving them prior to submitting. Your Information Security Liaisons (ISL)/IT Liaison can be identified in your IRBIS submission and is specific to your department or can be accessed at: https://safecomputing.unc.edu/data/information-security-liaisons/.
4. What should I do if my monitor’s visit from my sponsor is cancelled?
Provided there have been no unreported events that meet the reporting requirements outlined in SOP 1401 that place subjects at immediate risk of harm, and neither the sponsor nor the study team has determined that subject’s participation should be suspended, research may continue as approved provided the study has not expired with the IRB of record.
5. Will the OHRE Office be open or will the IRB still meet?
The UNC-Chapel Hill OHRE staff are prepared to work remotely and continue to hold meetings remotely without change to the currently posted schedule, and have outlined the following processes:
Individual OHRE staff have virtual voicemails and will receive all voicemails remotely to be able to return calls within 1 business day. The OHRE main line will also be checked every 4 hours during business days to ensure we are returning calls.
Please identify in the cover memo that the revisions are related to COVID-19, so that it can be triaged appropriately as outlined above in question #1.
During this time period we will prioritize continuing reviews, however if a study does expire, please remember that federal regulations do not allow for research activities to continue, unless by not completing the research intervention subjects would be placed at imminent risk of harm. If this occurs, please complete a protocol exception request (attached) at the earliest opportunity and submit through IRBIS.
The UNC OHRE will not be enforcing the 7-day reporting period if UNC-Chapel Hill suspends operations, however these should be submitted as soon as possible.
In addition, OHRE staff will be available for phone calls. If calls go to voicemail, calls are expected to be returned within 24 hours if immediate callback is not available.
6. What can I do in an emergency if someone/patient needs access to an investigational drug, biologic or device and I don’t have IRB approval already?
As a reminder, an emergency use of an investigational drug, biologic or device is permissible without prior IRB approval regardless of UNC’s campus status if the following criteria are met:
a) A human subject in a life-threatening or severely debilitating situation exists necessitating the use of the investigational drug, biologic or device;
b) No standard acceptable alternative treatment is available; and
c) Because of the immediate need to use the investigational drug, biologic or device, there is not sufficient time to use existing procedures to obtain IRB approval.
Emergency use events must be reported to the IRB within 5 working days, both the form and the SOP (page 14) are attached if needed. The OHRE has designated several chairs that can consult about the process, if desired, and that can help initiate and receive submissions of mandatory reporting during the 5 working day timeline if UNC-Chapel Hill suspends operations.
Complete the “Report of Emergency Use of a Test Article to the IRB”, place “Emergency Use” in the subject line and email to: Cassandra Myers and Mike Matamoros.
If you anticipate using the same investigational agent to treat COVID-19 for multiple patients, please consult with the OHRE as soon as possible as per the FDA, subsequent uses of the investigational drug at the same institution would require prior IRB review and approval.
Please let our office know if you have any questions,
Cassandra Myers, CIP
Director, Office of Human Research Ethics
University of North Carolina at Chapel Hill
720 Martin Luther King Jr. Boulevard
Chapel Hill, NC 27599-7097
919.966.6893 (Office Line)| 919.966.3113 (Main Line)