Jun 1, 2020 10:00 – Slides available here and Audio Recording of the presentation here.
Updated June 10, 2020 (Originally posted May 25, 2020)
UNC Research Community,
As UNC-Chapel Hill begins to increase the volume of research conducted on campus in a phased, safe, and sustainable way as communicated in the OVCR’s May 23, 2020 communication, the UNC-Chapel Hill’s Office of Human Research Ethics wanted to update our research community with answers to questions individuals may have over the next several days. We would like to remind everyone of the following:
- Whenever possible, studies that were modified to conduct study visits/procedures via virtual/phone/remote formats need to continue to conduct procedures as modified.
- Studies being submitted to the IRB for initial approval should include virtual/phone/remote formats for as many procedures as possible.
- For paused studies, when possible to modify some or all face-to-face procedures to virtual/phone/remote formats prior to re-starting the study.
- Ensure all research staff have knowledge of and adherence to each department’s plan to appropriately increase volume and OVCR’s guidance.
General Questions:
1. What do I need to do if I will be resuming direct (in-person) interactions with subjects?
For all studies that have previously been allowed to continue study activities due to direct benefit or will be given permission by their department to resume activities in alignment with the OVCR’s updated guidance will be required to provide an information sheet to subjects (unless enrollment is due to a COVID diagnoses and treatment), that outlines the risk of COVID-19 and the risk mitigation strategy that has been outlined. This is an information sheet only and does not need to be signed, however the conversation with participant’s, the risk analysis for subject by subject continuation, and the outcome of the discussion should be documented in the subject’s research record. The information sheet and approval letter are attached.
Provided that the consent template is used verbatim, except where “X’s” have been inserted to allow for study specific information, then the use of this template does not need to be submitted to the IRB for approval. Please retain a copy of the “COVID Information Sheet Approval Letter” in your study files. If you would like to make changes to this information sheet, outside the “X’s” for general information, either to add, remove language, or your procedures for risk mitigation are different, this requires the submission of a modification including a risk analysis to the IRB.
If you are resuming research activities after June 1, 2020 and were not provided permission previously by the OVCR’s office and need to make changes to this IRB-approved COVID Information Sheet, you may not begin activities until those changes have been submitted, reviewed, and approved by the IRB. If you were previously given permission by the OVCR’s office as your study provided direct benefit, you may continue, however the COVID information sheet above should be used until the modification altering language is approved, if alteration of language is necessary.
This information sheet is institution-wide and reflects UNC’s guidance and OVCR’s institutional policy, this information sheet, or another approved by the UNC-IRB should be used for all research being conducted by UNC-Chapel Hill regardless of IRB of record. If you have questions about this please reach out to John Roberts the Associate Director of Regulatory Affairs and Compliance.
2. Do I need to submit this updated Information Sheet to the UNC IRB?
Please continue to follow the same guidance as sent on 5/25/2020: “Provided that the consent template is used verbatim, except where “X’s” and red formatting have been inserted to allow for study specific information, then the use of this template does not need to be submitted to the UNC IRB for approval. Please retain a copy of the “COVID Information Sheet Approval Letter” in your study files. If you would like to make changes to this Information Sheet, outside the “X’s” and red formatting for general information, either to add or remove language, or your procedures for risk mitigation are different, this requires the submission of a modification including a risk analysis to the IRB.
3. My study population includes non-English speakers. Where do I find translations of the Information Sheet?
UNC-OHRE does not require certified translations of the Information Sheet as the information sheet does not require signature and confirmation of a participants continuation may be obtained verbally. If the use of a translator is available to you as part of other research procedures they can assist with sharing the information with the subject verbally. The research record should reflect that the information was shared verbally with the individual and that an interpreter was utilized. The OHRE has translated the COVID Information Sheet in Spanish and has included the approval letter, Spanish COVID Information Sheet, and a translation certification. As Spanish is our most common translated language the OHRE has provided this to our research community, if the study team would like a translated physical copy, as with other study documents requiring translation, the study team will be responsible for obtaining translation services. Provided the Information Sheet is translated without revisions, you do not need to submit any translated Information Sheets to the IRB for approval. If you need to modify the Information Sheet and it also requires translation, it should be submitted to the IRB for review and approval, including the translation verification form. As a reminder discussing verbally with the subject is still acceptable and a translated copy is not a requirement.
4. What should I do if I need to alter or modify my previously approved IRB processes and procedures due to some activities resuming on campus?
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 these 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) even if your department has approved the activities, a modification must be submitted unless as outlined in #1:
- Please state “COVID-19” in the Cover Page.
- Please note in your modification that this has been permitted by your departments plan and that OVCR’s guidance will be followed in regard to PPE and social distancing requirements when possible. If your study team is not able to follow the social distancing requirements, PPE, or other portions of the OVCR’s guidance this should be identified in the modification description with additional analysis of how risks will be mitigated for review and that this has been determine to be permissible by the department’s resumption plan.
- Please include a risk analysis statement (e.g., resuming blood draws does not increase risk to subjects as they will only be having additional blood taken at an existing clinical blood draw by the same laboratory technician).
- 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. Please refer to the COVID Submission Table (attached and updated) and the Consent Processes Table that is dependent upon study risk level and applicable regulations (attached).
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.
5. Can I resume in person interactions if my department has not given me confirmation or a determination to do so?
No, as these plans are unique to each school’s research program and have received consultation from the University’s Infectious Disease and Epidemiology experts. The OHRE/IRB will not be permitting any plans that have not been vetted through this process as our Infectious Disease and Epidemiology experts and School’s leadership have a much clearer understanding of department specific strategies for risk mitigation that require in-depth knowledge of research location, office or clinical spaces, staff and PPE available.
Not following the departments research plan and either inappropriately resuming activities, or resuming activities that didn’t follow the plan for appropriate protections as identified by the Department, Infectious Disease, or the OVCR’s office would constitute noncompliance and should be reported as an NSI.
Please refer to the communication sent by the OVCR’s office on 5/23/2020.
6. What if I have a potential subject who is in isolation and I need to be able to consent them for a greater than minimal risk and FDA regulated study?
The 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.
- 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. IRB’s are unable to prospectively approve the processes for Emergency Consent Procedures and is only permissible on a subject by subject basis permitting it meets the criteria as determined by the study physician and independent physician.
- UNC Consent Process for Isolation
- 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.
7. Will the OHRE Office be open or will the IRB still meet?
The UNC-Chapel Hill OHRE-IRB have continued to review during this time period, and since March 13, 2020 have finalized over 5,700 submissions. Our office has reviewed over 700 modifications related to COVID, and over 95 new studies specific to COVID and we want to thank the entire research community for their kindness and patience with the process. The staff will continue to work remotely and hold meetings remotely without change to the currently posted schedule, and have outlined the following processes:
Phone Calls
Individual OHRE staff have virtual voicemails and will receive all voicemails remotely to be able to return calls within 1 business day (Monday through Friday). The OHRE main line will also be checked every 4 hours during business days to ensure we are returning calls within a business day.
COVID-Related Modifications/Changes
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.
Continuing Reviews
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.
NSI-Safety Information
As UNC-Chapel Hill has not suspended operations it will be enforcing the 7-day reporting period.
Reliance Related Questions:
UNCs IRB is providing oversight for external institutions, organizations, or clinics:
1. Do all of the sites that rely on the UNC IRB review have to use the UNC Information Sheet or can they use their own and do I need to submit a modification?
All sites (including UNC Network Entities and Affiliates) that rely on UNC’s IRB and intend to resume face to face interactions with subjects must use the UNC Information Sheet. If you would like to make changes to this Information Sheet, outside the “X’s” and red formatting for general information, either to add or remove language, or your procedures for risk mitigation are different, this requires the submission of a modification including a risk analysis to the IRB. The alternative may be their local institution’s version of the document or another form of communication that would need to be assessed by the UNC IRB. Many alternatives will need to be reviewed on a case by case basis. Every study that intends to resume face to face activities must submit a modification to the UNC IRB for review that describes the response from each institution and indicate whether the site will use our Information Sheet or an alternative.
2. How do I know which sites should use the Information Sheet and which will not?
If a site has face to face interactions at a non-UNC site, study teams will need to consult with each site to determine if they have their own alternative to the Information Sheet or need to use the one provided by UNC. If they are utilizing UNC’s Information Sheet, they do not need to submit a modification, however if they are using patient facing information sheets/materials, or requesting not to provide information on COVID this will need to be submitted to UNC’s IRB if we are their IRB of record.
3. What if the external sites are not allowed to resume activities but our department has approved UNC to resume?
The sites should follow their local institution’s directives with respect to resuming activities. Typically the more restrictive stance will prevail. If UNCs department has not approved the UNC team to resume, no sites should resume. If UNCs department has approved the UNC team to resume, but the sites local policy does not, the site should not resume face to face contacts until they are cleared to resume by their home institution.
My study is relying on an external IRB:
1. Do we need to submit the Information Sheet to the Commercial IRB’s if we are relying on them?
We have had it confirmed from both WIRB and Advarra that as this reflects institutional guidance and is not study specific this does not need to be reviewed, provided you are utilizing it with only the XXX/red formatting-templated changes, as previously discussed. If you want to make other changes that are not covered by the broad approval letter attached and within the current template then you will need to seek study by study approval from the commercial IRB’s.
2. Do I need to submit the Information Sheet to the reviewing IRB if I am not relying on a commercial IRB?
Use of the Information Sheet is considered a local institutional requirement and is part of UNCs local context. We recommend reaching out to the lead/reviewing site and confirming if they would like this information to be reviewed by their IRB, please provide them a copy of the approval letter included.
3. The external IRB has provided me with their own version of something like this Information Sheet. Do I need to use both?
We would request that you at least share the UNC Information Sheet and approval letter with the external IRB, and request to utilize this form. If they will not permit the use of the local form, please reach out to John Roberts, so that it can be appropriately assessed on a study by study basis.
In addition, OHRE staff will be available for phone calls. If calls go to voicemail, calls are expected to be returned within 24 hours (Monday through Friday) if immediate callback is not available.
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)
cassandra.myers@unc.edu