4. Specific Procedures and Guidelines for Research Studies Involving Direct Contact
The following is a listing of required procedures for conducting human subjects research visits that involve direct contact with study participants.
More details are available at https://unchcs.intranet.unchealthcare.org/Pages/2020/novel-coronavirus.aspx.1
- Consider the following measures to reduce direct contact, as applicable: drive through service where available for blood draw only visits rather than participant coming into the clinic/research site, use drive-by visits or mail to supply research participants with study medication/materials and use remote or virtual visits when possible.
- Advance wellness screenings for participants
- If the participant will attend an in-person study visit that is not in the context of an already scheduled UNC Health clinical visit (i.e. visit scheduled specifically for the purposes of the research activities), research personnel must perform telephone wellness screenings and confirm the participant’s appointment no more than 24 hours prior to the scheduled visit.
- If the participant will attend an in-person study visit that will be completed in the context of an already scheduled UNC Health clinic visit (i.e. during a visit with a clinician, study activities will also occur), the study team may choose to omit the advance wellness screening, provided that the participant has already confirmed his/her willingness to meet with study personnel and/or continue with study activities. If there is any uncertainty as to whether the participant will initiate or continue study participation at the scheduled clinical visit, research personnel should perform a telephone wellness screening and confirm the participant’s appointment no more than 24 hours prior to the scheduled visit to reduce the chances of study personnel reporting to campus unnecessarily.
- Documentation of participant wellness screenings
- Research personnel that have Epic access must document the completed screening in Epic for any research visits that occurs at any UNC Health facility.
- For studies occurring in non-clinical spaces or for studies that do not utilize Epic, record of the participant wellness screening should be appropriately documented in the study records.
- For patient, companion, and employee screenings in clinics not located at the UNC Medical Center, refer to the document “UNC Medical Center Outpatient Clinic Screening at the Door” 1 workflow document.
- Research personnel will be subject to daily wellness checks prior to entering any UNC Health/SOM clinical research facility. This may be completed via the UNC Health employee wellness screening mobile application or other methods employed by individual clinics. Any individuals found to be positive for symptoms consistent with COVID-19 will immediately leave the work environment (not enter the facility) and be advised to contact Occupational Health. As much as possible, employees should recognize symptoms in advance and not report to the workplace. If study staff will be conducting visits in non-clinical spaces, the wellness check must be performed by another responsible party (e.g. supervisor) prior to initiating a study visit.
- Research personnel must follow UNC Health’s Mask policy regarding proper usage and storage of masks for employees1, and masks for participants and guests1.
- Individuals must wear eye protection in addition to a face mask for all participant/patient encounters.
- It is recommended for individuals to wear eye protection in addition to a face mask when in close proximity to others (e.g. shared office space, workrooms, etc.)
- Research personnel must be aware of and follow UNC Health’s COVID-19 Visitor1 policy to determine who is permitted to attend visits with participants; all visitors must complete a pre-screening wellness check prior to and on arrival to the clinic or designated research visit location.
- Participants will be re-screened upon arrival to a UNC Health facility by front desk staff. Research personnel must re-screen participants upon arrival for visits that will occur in non-clinical spaces before the visit begins (no symptoms, no fever, etc.) and appropriately document the screening in the study records. Participant will also receive a temperature scan upon arrival at the clinic/research site. Any participant who fails re-screening should be immediately masked and isolated in a private room. Clinical study personnel should be contacted and follow recommendations from Infection Prevention regarding referral for testing. The UNC patient COVID-19 Helpline number is 888-850-2684.
Process to initiate human subjects research studies involving direct patient/participant contact:
- The study PI must review and carefully consider the expected benefits vs. risks for study participants to determine if the study should continue with direct contact visits or assessments (continued participation or recruitment) in the context of COVID-19. If the PI determines the study should continue:
- The PI must complete a basic study information form including his/her attestation to the expected benefit/risk assessment. This assessment should be performed for participants previously enrolled and for new recruitment separately.
- The PI’s Department Chair (and Director of the administering unit, if different) must review and approve/decline according to the risk assessment
- Signed forms approved by the chair and administering unit will be reviewed by a Clinical Research Review Committee to determine if the study may resume.
- As part of the ongoing consent process, the participant should also understand the potential harms of visiting a health care facility at this time and agree willingly to the visit. For example, the risk to a frail elder with a history of cancer and heart disease may be greater by coming to a study visit than the potential benefit from the care provided in the context of the study. Each participant should be given the chance to discuss the expected risks and benefits and make an informed decision regarding participation, along with support from the study team.
- For all studies that have previously been allowed to continue study activities due to direct benefit or will be given permission by the School of Medicine 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 (COVID-19 Participant Discussion Documentation Template). 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.
General guidance for human subjects research studies involving direct patient/participant contact:
- All materials used during study visits should be appropriately cleaned and sanitized before and after each study visit (e.g. chairs, surfaces, exam tables, clipboards, pens, blood pressure cuffs, exercise equipment, etc.)
- Practice good hand hygiene before and after each patient encounter and before preparing a room for a research participant encounter (as always!):
- Wash hands often with soap and warm water for at least 20 seconds.
- If soap and warm water are not readily available, use an alcohol-based hand sanitizer that contains at least 60% alcohol.
- Increase the frequency of cleaning and disinfecting, focusing on high-touch surfaces.
We have developed a template checklist that you may choose to utilize to ensure you are considering all guidelines and recommended procedures prior to conducting a face-to-face visit with research participants.
1. Some key documents from the UNC Health websites are replicated on CRSO website for those without UNCHCS intranet access https://www.med.unc.edu/crso/unc-healthcare-guidelines-for-covid-19/