FAQs related to implementation of the SOM guidelines:
Q1. How do the guidelines apply to non-clinical human subjects research being done in a non-clinical environment (e.g. Marsico or Bondurant)?
A1. The SOM guidelines discussed on this website apply to human subjects studies conducted in any UNC or UNC Health setting, including non-clinical environments.
Q2. Under the current guidelines, may we schedule on-site monitoring visits or site initiation visits? If so, do we need specific approval for those visits?
A2. You are strongly encouraged to continue conducting activities remotely as much as possible. If an in-person visit is required for monitoring or site initiation that may now be scheduled without specific approval, as long as you are able to abide by all of the guidelines including documented wellness screenings, distancing, maximum capacity, and masking requirements.
Q3. For our studies, we do not have patients coming in for specifically for research visits. Our patients come in so frequently for their clinical visits that we usually are able to do any and all research activities during those clinic appointments. How do you suggest we plan for this – increasing the number of people in the clinical space which will increase the number of contacts to the patients, increase the contacts to our research staff, and just by having research staff in the clinic will increase the number of contacts to the clinical staff. My thoughts are to gather all of our PI’s on a call to discuss with them which studies they believe warrant this extra exposure to all parties. Is this a reasonable plan? Do you have other suggestions?
A3. Having the PIs working in the same clinical area meet to discuss all the protocols collectively is a great start. The issues that you raise of additional volume of people and additional contacts with patients definitely needs to be considered. In addition to considering which study protocols offer the most potential benefit to the participants, we would suggest you consider ways to limit the amount of people directly involved in direct contact activities. Consider, for example:
- If 5 studies typically each have a primary coordinator, could a single coordinator perform all of the direct contact activities for those 5 protocols and the others handle the remote work?
- If a provider who will already be seeing a patient is listed as personnel on a study protocol, could he/she temporarily assume the responsibilities for the direct contact activities and allow the coordinator to perform all of the remote work?
- Can you effectively reduce the amount of time needed for study visits by limiting the in-person activities to only those that require direct contact? For example, if you typically would do a brief physical exam, administer 2 oral questionnaires, and provide instruction on completing home activities, limit the in-person visit to only the physical exam and schedule a time to call the patient just after her on-site visit to administer the questionnaires and provide instructions (keep in mind that may require IRB approval)
Coordination with clinic staff to ensure that research workflows and plans do not interfere with clinical activities is essential.
Q4. The COVID-19 screening requirements it says that we need to screen subjects 24 hours prior to the visit. What if we are recruiting patients from the inpatient setting? Do we still need to complete a pre-screening in advance of seeing them in the hospital? Additionally, should we still do a screening at the start of the conversation with the patient about the research study?
A4. If a patient is in the inpatient setting, you would not need to do a wellness screening in advance of the visit or at the time of the visit, as they will already be screened by UNC Health.
Q5. Under the SOM guidelines, are we still restricted to conducting studies that require direct contact with participants to those studies that provide benefit to the participants? If so, does this apply even to studies that do not require separate research-only visits?
A5. The SOM guidelines do require a consideration of the risks and benefits to the participants in the setting of COVID-19, but the studies do not necessarily have to provide direct benefit to the participant’s health (as under the previous OVCR guidelines). If a study may offer the participant valuable information or desired opportunities and the risks associated with the activities in the setting of COVID-19 are minimal and all appropriate precautions can be implemented, that study may be permitted to resume direct contact. The risks are going to be very different for healthy adults than they would be for elderly participants or individuals with pre-existing risk factors (significant obesity, diabetes, lung disease, asthma, etc.). Regarding study activities that do not require a separate visit, if for example those study activities will only require 15 extra minutes of in-person time (especially if there is no additional people that need to be involved), the risk/benefit ratio related to COVID will likely be fairly simple to assess because the additional COVID-related risks of participating are going to be very minimal. The assessment of risk may be complicated if the participants would be unable to wear face masks or the study activities would require more than 1 individual to be in very close proximity with the participant for an extended period of time (any of those things that would alter the risks related to COVID). Use the best judgement of the research team to assess risks and benefits and if you decide to proceed, describe in the CRRC form.
Q6. As of June 1, as people are allowed back on campus (labs, etc) – we will no longer have to designate them as CDME, correct?
A6. As we continue to move into Phase 1 of our campus reopening, we are required to update and maintain the CDME designations for our employees that are being returned to campus for some/all of their normal duties. This includes anyone you may wish to return with the ramp-up of lab & research work; if they are going to be working on-site, they must be designated as CDM on-site. There no longer is a premium pay associated with on campus work.
Q7. Once I am approved by the SOM CRRC, are there any other reviews or approvals I may need?
A7. Yes, the CRRC review is limited to assessing whether or not studies are permitted to proceed with direct contact with human subjects in the setting of COVID-19. Additional approvals, reviews, or considerations may be needed, such as:
- Each department, center, and/or unit will be defining a plan to implement the SOM guidelines, including employee work windows, maximum capacity requirements, distancing requirements, and cleaning protocols. Every study team should work with their departments and teams to determine how and when activities may resume.
- If the status of your study is changing or you are modifying any study methods, you may need to submit to the IRB for review/approval.
- If working in clinical spaces, you must coordinate with clinical staff to ensure research activities will not interfere with essential clinical activities or create unnecessary risk.
- If you are working with a core facility, check the core website for important information and be sure to reach out to the core Director to discuss your proposed research activities.
- If doing research at entity hospitals, be sure to discuss your plans with personnel from the UNC Health Office of Research Support and Compliance, ORSC@unchealth.unc.edu.
- If working with UNC Investigational Drug Services (IDS), please know that IDS is working to establish clear guidelines on how and when monitors and sponsor representatives may safely visit IDS. These guidelines will be released by IDS in the near future. Until those guidelines are released, IDS remains closed to non-UNC employees.
Q8. I am working with my Department Chair to review and finalize our departmental plans for re-opening research in our department. Once we have ensured that our plans meet the guidelines, do we need to register or submit them to SOM?
A8. The general departmental plans for adhering to the SOM guidelines do not need to be submitted or reviewed by anyone outside of your department. Your chair (and/or designee) would be responsible for ensuring the plans adhere to all of the SOM guidelines. If you have any questions about the guidelines or want to discuss specific elements, we are certainly happy to review questions. Chairs and Center Directors have been asked to submit (by June 15th) lists of PIs and locations approved for re-opening labs.
Q9. I know monitors are allowed in-person as of yesterday as long “as you are able to abide by all of the guidelines including documented wellness screenings, distancing, maximum capacity, and masking requirements”. I heard somewhere that employees who have traveled outside of the state must quarantine for two weeks. If this is true, I imagine this should apply to monitors as well. Many monitors come from out-of-state. How are we to manage that? Are they not allowed to come at all considering they will have always traveled from another state?
A9. We just received clarification that the current travel rules do not require quarantine following out-of-state travel, as long as the individual is not exhibiting symptoms. If an individual has traveled from out-of-country, or traveled from anywhere else and is exhibiting symptoms, that would then require a quarantine. Please note, HIM is still requiring requests for monitor access to Epic to be made using the remote access process.
Q10. We have 3 sites under the UNC IRB participating in our study. Our study design requires collection of survey data and blood specimens in the clinic in concert with a specialty clinic visit. In this scenario each clinic is committed to following its institutional guidelines for screening patients for COVID for clinic visit – but not all require a 24 hour pre-visit screen. The UNC team has decided to do the research in a totally remote manner, without collecting blood or surveys in clinic (they will not use the COVID information sheet for research because patients will come in ONLY for a clinic visit – no research component is included in the planned clinic visit). At other non-UNC sites, their teams are back in the clinic with face-to face visits clinically and for research visits according to their institutional guidelines.We should not have to tell our other sites that they can only do remote as UNC is doing – correct? Thus I want to confirm that it is OK for one site to do partial research visits remotely while another will be able to do the entire research visit as planned including face-to-face research visits.
A10. The SOM guidelines pertain to human subjects studies that are conducted at a UNC or UNC Health facility and/or to activities that are conducted directly by UNC personnel. So although the other sites are covered under the UNC IRB, it sounds like the activities at those sites are not subject to the SOM COVID-related guidelines. So as long as you update your IRB application to reflect the plans for each site and the other sites are following their institutional guidelines related to COVID, that should be appropriate. Since you are not requesting to initiate any in-person activities at UNC or by UNC personnel at this time, you would also not need to submit the research review form at this time. Please consult with the UNC IRB about utilization of the IRB-required COVID information sheet for study participants at your non-UNC sites.
Q11. For observational studies with minimal risk and minimal benefit, does the CRRC have the opinion that a face-to-face visit to the Clinical and Translational Research Center is no more risk than encountered in everyday life?
A11. We can’t answer that question broadly for any observational, minimal-risk, minimal-benefit studies conducted in the CTRC, but generally the things that the SOM review committee states need to be considered regarding COVID-related risks are the participant population (any high-risk groups), the amount of time required for the visits, the amount of people who must come into close contact with the participant, whether the participant and all staff can reliably wear masks throughout the visits, etc. The CTRC certainly has appropriate protection measures in place, so if the amount of time required for the visit is (or can be) limited and the appropriate protections can be in place AND the study, although observational, may provide the participant with desired information or opportunity, it is likely that the PI could determine that the potential benefits outweigh the COVID-related risks.
Q12. The guidelines say that we must conduct a wellness screening by phone 24 hours in advance of a study visit. What if we can’t reach a participant in advance of a study visit to perform a wellness screening?
A12. First, please note you must document your attempts to reach the participant by phone to conduct the wellness screening. If you are unable to reach them by phone in advance of the visit, a member of your study team should plan to meet the participant outside of the clinic (preferably outside of the facility) to perform the wellness screening before the participant enters. Please remember the purpose of the conducting the wellness screenings in advance is to ensure only non-symptomatic patients visit our facilities, but also, importantly, to minimize the need for research staff to report to campus for any visits that may be cancelled or otherwise unable to continue.
Q13. Will UNC or SOM provide face masks for each participant in my human subjects research program? I would need 30-40 masks per week.
A13. No. If your participants will be seen in a UNC Health facility, they will be screened at the front door and provided a mask before being allowed to enter the facility. For now, it seems that this process is likely to continue. For those engaged in face-to-face contact with patients outside of UNC Health facilities, you will need to obtain a supply of face masks for participants. The OVCR is currently working to establish a web-based form to allow research teams to order masks.
Q14. Will UNC-CH or UNC SOM provide face shields or eye protection for research personnel engaged in human subjects research for use when participants are not reliable in their use of face masks?
A14. No. You will need to obtain your own face shields, which are reusable. They are available from Fisher Scientific and a variety of other sources.
Q15. How many masks should I be able to obtain from UNC SOM? We have heard different numbers from UNC Health, OVCR and SOM.
A15. SOM will provide 2 masks per week for each research worker (employee or student) who is working on the UNC campus. You should not request more masks than needed and not request masks for employees who will continue to work from home.
Q16. We are approved to see two patients for one of our studies. Based upon a recent OVCR Town Hall, I gathered that masks are always needed (known fact), but if you’re in close proximity to a patient (I would assume a physical exam would fit this), a face shield in addition to a mask would be recommended. Can you confirm?
A16. When engaging in any in-person activities, all staff and participants must wear a mask. You should also work diligently to minimize the amount of time required for close contact (less than 6 feet of distance) with others. Those are the two imperatives. If your study activities require extended close contact with participants, that increases COVID-related risks and must be carefully considered to determine if the study activities provide enough potential benefit to warrant that increased risk. This assessment must be completed by the PI, reviewed and supported by the Department Chair, Center Director (if applicable) and independent members of the SOM Clinical Research Review Committee. Use of a face shield may be warranted in those circumstances and may reduce COVID-related risks, but that assessment should be made on a study-by-study basis considering the unique study logistics and participant populations.
If the research participant is unable to wear a mask for the entirety of the visit, then staff must wear eye protection (e.g. face shield, face mask with attached face shield, safety glasses or goggles) in addition to the mask. Eye protection can be disinfected and reused until broken or damaged. Additional PPE is required if the treatment or assessment results in an aerosol generating procedure or when caring for COVID-19 positive patients or those who are under investigation for COVID-19.
Q17. In the SOM Research Readiness Review form, it asks us to provide an explanation of the COVID-related risks and expected benefits of participating for study subjects. Our study activities typically involve several 1-2 hour visits in the CTRC, during which study personnel would be within 6 feet distance from study participants. Can we sufficiently minimize the COVID-related risks by having our study personnel wear additional PPE (e.g. face shields, gloves, gowns, etc.)?
A17. No, your primary efforts to minimize COVID-related risks for study participants should be decreasing the amount of time spent in close contact with participants. For that typical 1-2 hour visit, are there any activities that could be performed remotely (e.g. completion of surveys, explanation of procedures, etc.)? Because of the limited nature of PPE, we do not recommend utilizing additional PPE beyond what is recommended/required and the decision to use additional PPE should be made on a case-by-case basis after careful consideration by the PI, the Department Chair, the Center Director (if applicable), and independent members of the SOM Clinical Research Review Committee.
Q18. If we have a monitoring visit scheduled (following all SOM guidelines) and the monitor will enter through the hospital, what entrance should they use? What procedures do we need to follow? In the past, I would meet the monitor at the cancer hospital door and escort them to our offices in the Medical School Wings buildings.
A18. Only staff with a UNC badge displayed are permitted to enter through the hospital employee entrances so the monitor would need to go through the patient/visitor entrance and state that they are there to carryout business-related activities in the hospital. Per Guest Services, the monitor will need to show some type of work ID to enter and explain who they are there to see. Someone from the study team should meet the monitor at the entrance and escort them to your offices. We suggest providing your monitor with a phone number to reach you in case there are any issues upon arrival.
The monitor should also be pre-screened the day before they arrive for the visit to ensure they are without symptoms and to remind them of the mask policy. Please be sure to provide feedback to let us know how the process worked/didn’t work so that we can contact Guest Services to work through any problems.
Q19. Our study participants are all coming in for clinical visits. The clinic does not call the patients 24 hours in advance of their appointments for COVID screening. If the clinical care guidelines for our clinic do not require the pre-screening within 24 hours, then could this requirement for SOM research be removed in those cases?
A19. If a 24 hour advance COVID screening is conducted by clinical staff, research staff may use documentation of that screening instead of performing a repeated screening for research purposes. However, if a clinic does not perform COVID screenings by phone in advance of the clinic visit, that pre-screening should still be conducted by research staff. This is recommended to ensure that participants are aware of the COVID-related workflows and importantly, to ensure that research staff do not report to campus unnecessarily for research visits that may not take place (due to COVID symptoms or cancellation for any other reason). Additionally, presentation of a participant who screens positively for COVID symptoms at the research site is going to require workflows that most research teams are not going to be familiar with and potentially ill-prepared to execute including isolation, informing the participant that they need further screening, and referral to care.
Q20. Now that our research studies are re-opening, our needs for monitor access are also increasing, as required per protocol and contract agreements with our sponsors. Most of our monitoring visits can continue remotely, but some will need to take place on-site. How should we go about getting Epic access for our monitors?
A20. As of now, even if your monitor will be on-site, all requests for monitor access must still go through the remote request process. The initial allowance from the Epic Research team and Health Information Management (HIM) was to allow remote access for situations in which the monitoring visit could not reasonably be postponed until on-site restrictions were lifted. Now that clinical research activities are ramping up, HIM and the Epic Research team are working to define and optimize the workflows to ensure monitoring activities may continue as needed, while maintaining adherence to all security considerations. If you need to obtain monitor access to Epic, please continue to complete the remote request form and be sure to specify “Normal Operations.” Please note, with current volumes, remote visits are typically scheduled approximately 2 weeks out.
Q21. Per UNC/SOM guidelines, monitors (even those traveling from out of state) are allowed to visit if an in-person visit is deemed necessary and the study staff perform all of the wellness screenings and meet all of the other regulations (related to distancing, masking, cleaning, maximum capacity). However, new UNC Health guidelines say that anyone traveling from out-of-state must have approval from the Health Vice President. What do we need to do?
A21. If you determine that an on-site monitoring visit is necessary and the monitor will need to visit any UNC Health facility, you must also seek and obtain written approval from the appropriate clinic director(s)/administrator(s) prior to the visit.
FAQs related to the SOM clinical research review process:
Q22. Do we need to submit the SOM research readiness form for studies that the IRB has deemed not human subjects research (NHSR)? Although our project is not human subjects research, it is a program evolution that involves direct contact activities with people.
A22. If the IRB has determined that the activities do not qualify as human subjects research, you do not need to complete the SOM research review form. However, we do urge everyone to ensure you are taking appropriate precautions with people that you are interacting with even if they are not technically research subjects. The same principles apply. Be mindful of what you are doing, who may benefit and who may be harmed by any additional exposure risk, and do everything possible to minimize risk if you determine it is ethical and appropriate to continue with the non-research activities in the setting of COVID-19.
Q23. Is it possible for another party to pre-populate the form and then the PI sign off after review?
A23. Yes, you can save progress on the form and the PI can go in to review and sign-off. It is just very important that the PI make the careful assessment of the expected risk/benefit in the context of COVID-19 for the studies under his/her direction.
Q24. Our human subject research protocol is conducted at NCSU, but UNC is the IRB of record. Do we need to complete the SOM research review form?
A24. The review process established by the UNC SOM applies to studies conducted at a UNC (or UNC Health) facility and/or to study activities that are managed by UNC personnel. Will any UNC personnel be involved in the study activities at NCSU? If so, then we would ask that you complete the UNC SOM readiness review form. If no UNC personnel are involved in the direct activities and no activities are taking place at a UNC facility, you would not need to complete the SOM review form.
Q25. We want to initiate a study we had previously put on hold, but we will be able to complete all study activities remotely and won’t have direct contact with participants. Do we need complete the SOM research review form?
A25. No, you only need to complete the form if/when you plan to initiate activities that will involve direct contact with study participants.
Q26. We will be submitting the form to restart in-person visits for a study. Our initial thought was to have a staged approach of ramping up (i.e. start in-person visits that are <10 min while still restricting longer visits, eliminating some assessments that cannot be done virtually, etc). Will we need to resubmit each time we want to increase what we are doing? After much consideration and discussion, our goal is to start with as minimal interaction as is possible to still answer our research questions and as things improve bring back additional components to the study. Not exactly sure how to spell all of that out on the form. I didn’t want it to look like we were starting at 100%, but I also didn’t want to limit us so that later we couldn’t add back in additional components.
A26. Your phased plan sounds like a reasonable strategy. In the form (the two questions that ask for free text response about your considerations of the risks and benefits for participants in the setting of COVID-19), I recommend describing the full ramp-up/phased strategy to let the committee know how you are considering the risks and at what stages you will consider opening up the next phase (what will prompt you to move to the next phase).
Q27. We saw the research review form for PI’s to fill out if we resume study visits after June 1st. If at this time we are not sure when exactly our team will be able to enroll/ follow up in person with subjects, can we fill out at a later date when we are able to? Currently one of our studies we can do 100% virtual, but our other studies we are unsure will resume with recruitment.
A27. Absolutely – we would prefer you to only complete the form once you are ready to initiate those direct participant contact activities, so that can be done in the future once you are ready.
Q28. In the form, one question asks if we have established who will be the responsible party for completing and documenting wellness checks for employees. OVCR has said that staff should self-check their wellness, so there does not need to be a point person to “check-in” with when reporting to offices. Clinical/UNCH spaces have their own wellness checks, and our staff complete those when reporting to those spaces. However, this questions appears to indicate a wellness check needs to be conducted and documented in all workplace settings. Can you clarify?
A28. Per the SOM-specific guidelines, if an employee will have direct contact with study participants (in any setting), the employee wellness check needs to be completed and documented by a “responsible party.” That could be someone from your team (e.g. supervisor), or if you will only see participants in clinical spaces, could certainly be the clinical staff. So if a coordinator is coming in and will only be in a private office space without contact with participants, he/she can complete the self-wellness screenings. At whatever point that employee will proceed to engage in participant contact, the wellness check should be administered by another responsible party and documented appropriately. The wellness check could be completed by telephone.
Q29. The SOM guidance says we have to separately assess the risks in the setting of COVID-19 for both new enrollment and previously enrolled subjects. Does that mean we need to submit the form twice for a study that will have contact with previously enrolled and newly recruited subjects?
A29. No, you only need to complete one form for the study. There are two separate questions in the form that ask you to consider and describe the risk/benefit assessment for previously enrolled and newly recruited participants as separate groups of participants.
Q30. All of our study activities are occurring in India. Do we need to complete the SOM research review form?
A30. If no UNC personnel are involved in those direct contact activities with participants in India, then you do not need to complete the SOM review form.
Q31. We are doing several observational studies for which we are only collecting blood from participants. Would those studies require review by the SOM committee?
A31. Yes, if you will have any direct contact with participants for the purposes of research, those studies must be submitted for review. The guidelines and requirements apply to all human subjects research studies.
Q32. Can you provide clarification regarding the high risk patient population questions on the form (e.g. including participants over 65 years old, those living in a nursing home, people with lung disease, heart conditions, etc.)? Should we be answering “yes” only if the protocol specifically is recruiting from the identified high-risk patient populations or “yes” if the protocol does not specifically exclude a high-risk patient population? For instance, we are not looking to recruit people with liver disease, but we also do not exclude them. Also, we’re not targeting older adults, but our enrollment criteria does not have an upper age limit, so we may enroll people over 65 years old.
A32. The intent of those questions is actually to assess if any participants may fall into any of those high-risk categories, regardless of whether or not they are specifically targeted for recruitment. So if you anticipate you may enroll subjects that fall into any of those categories, mark yes and add a brief statement of any additional considerations or precautions to be taken with participants meeting that criteria.