Guidance for Human Subject Research
This guidance is designed to assist you in conducting human subject research in this new era of precautions, which we expect to last for 12-18 months and possibly beyond. Physical distancing, masking, increased cleaning precautions and other modifications will become common.
Please note: Clinical researchers must complete a study interest form before pursuing COVID-19 human subjects research studies, including interventional clinical trials and observational studies. A central team is working to ensure URMC offers studies that best suit our patient populations, harmonizes access to study populations, and helps synergize URMC COVID-19 research response efforts.
Before you start a study, make sure that you have:
- A study visit area that can accommodate physical distancing in both the study visit area and the waiting room.
- Documented procedures that are virtually identical with the URMCProcedures, FDA, CDCProcedures, and the HHS Office Of Human Subjects Protection guidance for human subjects research visits, and the NYS Executive Order regarding physical distancing and masking when in public.
- The ability to screen study participants for COVID-19 symptoms by phone prior to the study visit and at the time of the on-site study visit.
- Adequate personal protective equipment (PPE; proper surgical masks) and hand washing supplies for both study participants and staff.
- All study personnel complete the mandatory MyPath training module on how to put on and take off PPE and on COVID-19 prevention. Visit the MyPath and search "COVID-19" and complete the modules “COVID-19 Safety Training”, “COVID-19 Education.” Then search for “PPE Mask Fit Check, and Face Shield” and complete the corresponding module.
- All study personnel review and have on hand the talking points about how to discuss safety with participants concerned about in-person study visits.
- Cleaning supplies on hand to clean furniture and study equipment that come in contact with the study participant.
- Examined the study protocol and contacted the study sponsor and the IRB, where appropriate, about any modifications, including changes in protocol, remote/virtual/tele-research visits, new risks to study participants, or any other study protocol issues.
- Obtained approval from the Institutional Biosafety Committee (IBC) if you will be collecting any biological specimens or performing any activities that may cause increased risk of COVID-19 exposure to study staff (e.g. sputum specimens, pulmonary function testing, etc.).
- Medical Center Only: Up-to-date respirator certification for all study staff.
- Medical Center Only: Obtained institutional approval from Infection Control and Prevention (275-7716) if your study involves seeing study participants with active COVID-19 infection to conduct the study procedures on the Medical Campus.
We strongly advise conducting several mock study-visit practice sessions so that study personnel can practice the new workflow.
For Arts Sciences and Engineering: during the research startup period we are restricting laboratory and research area occupancy to 1-3 individuals per Principal Investigator lab group at any time. This total includes any outside visitor or study participant and study personnel. Any exceptions will require approval of the Department Chair/Director, and the relevant academic Dean and Research Deans. Principal investigators should communicate their plans to their Chairs/Directors.
Studies involving participants with COVID-19 symptoms or confirmed infection should not be conducted on the River Campus.
- Modifications in study procedures and study conduct need to be approved by the IRB and the study sponsor. When dealing with study sponsors, the UR Clinical and Translational Science Institute Office of Clinical Research can be of assistance. When submitting a modification to the RSRB to revise study procedures in response to COVID-19, rather than add specific procedures for conducting in-person visits, include the following statement: “To ensure appropriate safety precautions when conducting in-person study procedures, the process for conducting in-person visits outlined in the Guidance for Human Subject Research will be followed.”
- Physical or in-person study visits should be replaced with phone or video sessions where possible. This may include using electronic consent (eConsent) for enrollment. Refer to the Guidance for Using REDCap for eConsent for additional information.
- For studies that have safety monitoring, alternative methods for study safety assessments should be evaluated, as research participants may not be able to get to the study site. However, the alternate methods must be sufficient to assure the safety of study subjects. Study sponsors may specify that in-person visits are necessary to fully assure the safety of subjects. This may require a modification to the existing study.
- For clinical trials, consider if study participants can be provided investigational medicinal products (IMPs) at home if they cannot get to the study site. Verbal consent from the participant to provide shipping information, as well as all necessary posting/storage requirements must be provided. Additionally, a risk assessment must be completed by the study team. If the study subject is unable to sign for the package, a follow up phone call is required to ensure the IMPs were successfully delivered.
- Comprehensive guidance on clinical trials and human subjects research conduct can be found in the NIH Extramural Response to Natural Disasters and Other Emergencies webpage and the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency document.
All study personnel who will have direct contact with study participants are required to take a daily Dr. ChatBot health screening survey before reporting to work. This is mandatory to protect our research personnel and participants. Any study personnel with symptoms should not report to work. Faculty and staff who are diagnosed with COVID-19 must report this to Employee Health (585-275-6040), while learners must report their diagnosis to University Health Service.
All study personnel who will have direct participant contact must take the COVID-19 Personal Protective Equipment (PPE) training module, even if you do not expect to have studies with COVID-19 positive participants with active infection. This is important, as you may need to do follow up visits with participants who have tested positive for COVID-19, or who are less than 28 days out from a COVID-19 infection. In addition, this training will go over proper masking. To access the training module on how to don/doff PPE, visit the MyPath and search "COVID-19".
In-Person, On-Site, Study Participant Visits:
Educational material for participants are available on the OHSP website. Use of these documents, for the purposes of participant education, does not require additional approval by the RSRB. If the research was reviewed and approved by an external IRB, study teams should verify with their reviewing IRB whether approval is required prior to use.
All participants, and support persons, who will have an in-person visit should be screened for symptoms of COVID-19. Study coordinators or staff should make sure triage procedures are compliant with HIPAA guidance and consider a multi-step screening process to ensure subjects with symptoms are not missed prior to entering the research study area. While the process for screening depends on facility layout and staffing, the general steps include:
- Pre-screen study participants, and their support person(s). Before the study visit telephone the study subject to discuss COVID-19 and provide them information about what we are doing to protect them (see script). Ask the participant and their support person to check their temperature and gather information about COVID-19 symptoms the day prior to their visit. They may not have a thermometer, and this should not preclude a study visit. If they don’t have a thermometer, ask if they feel as if they have had a fever.
- Advise study participants to check their temperature again at home before leaving for their research study visit (if they have a thermometer) for a fever (T > 100.4°F). Study participants with a fever should have their study visit rescheduled. Advise them they should put on a cloth face covering, regardless of symptoms, before leaving their home.
- Post alerts such as signs and posters at clinic entrances and in strategic places around the facility with instructions for participants with fever or symptoms of respiratory infection to go home and contact their healthcare provider.
- Instruct participants to notify the study coordinator before arriving if they have fever (T > 100.4°F) or symptoms of COVID-19. If they have symptoms, they should go home and contact a healthcare provider. You should postpone the study visit until they are symptom free for 14 days.
- Protect: If the study participant and the subject’s support person(s) arrive and are not already wearing a cloth face covering, provide a face mask. If possible, there should be a barrier (plexiglass) between the study staff and the study participant.
- Screen all study participants and their support persons on arrival. Determine if they have a fever (T > 100.4°F) or symptoms of COVID-19, including cough or shortness of breath, sore throat, fever, muscle aches, headache, new loss of taste or smell, repeated or shaking chills. Individuals who have COVID-19 symptoms should see their healthcare provider. For more seriously ill participants, consider sending them to the Emergency Room if appropriate (participant very short of breath, confused, unable to stand up, for example).
- PCR Testing is only necessary if the participant will receive a procedure that normally requires a PCR COVID-19 test in the context of clinical care. Research procedures that have no clinical counterpart, but could generate significant aerosolized risk (e.g. playing a wind instrument) are considered on a case-by-case basis, but generally would require PCR screening and a higher level of PPE (e.g. N95 masks, barriers, increased ventilation in the area). Please contact the UR CTSI Research Help Desk for assistance with determining if your study procedure requires PCR screening.
- If PCR screening is necessary, it should be performed within 72 hours before the procedure.
- The ordering provider is responsible for notifying the participant of the result (including negative results).
- Positive PCR results must be reported to the Monroe County Department of Health, as required by NYS law. This may mean that you need to modify your IRB consent and protocol, and you should consult with your IRB specialist.
- The study is responsible for the cost of the PCR test.
For research with known COVID-positive participants (e.g. clinical trial to study COVID-19), follow additional information below.
- Physical/Social Distance: Send study participants and the participant’s support person to the appropriate waiting area, and make sure all individuals in the waiting area are separated by at least 6 feet, as per the NY State Executive Order and recommended by the CDC.
- Participants know to be COVID-positive or recovering (<28 days after infection):
- River Campus: Study participants who are COVID-19 positive or recovering should be excluded from in-person study visits until they are determined to be symptom free. These participants should be rescheduled to a later date.
- Medical Center: Participants should wait for their visit and be seen in a separate, high risk study area that isolates them from other study participants and staff to the extent possible (see below for additional information).
Travel Restrictions for Research Participants
If a research study has a participant coming to a UR campus for a research procedure/treatment, they must abide by NY State DOH guidelines for travelers . This includes any NYS quarantine or testing requirements in place on the day they arrive. It includes all modes of travel; driving to NY does not release them from the testing requirements.
- Before travel: Participants must have a negative COVID-19 test within 3 days prior to arrival in NY, and must provide the result to the study team before being allowed to proceed. For study visits to UR, participants will need to be tested even if they come from a state contiguous with NY.
- After arrival: If a participant stays in NYS for 4 or more days, they will need an additional COVID-19 PCR test on day 4 after their arrival.
- Study visit >5 days after arrival in NYS: If the research procedure/treatment occurs 5 or more days after a participant's arrival in NYS, they must have a COVID-19 PCR test performed prior to arriving to the UR campus, per NYS guidelines.
Ordering Local COVID-19 Tests
All study participants will need a printed physician order for testing via a URMC testing center. The ordering physician is responsible for informing the participant of their test result. The study must provide the collecting center a study-specific paper research requisition with a pink “STAT COVID Clinical Trials” sticker with instructions to place the sticker on the outside of the specimen bag, in order to expedite the processing of this sample. Please contact Melissa Allen (Melissa_Allen@urmc.rochester.edu) if you need assistance generating a paper research requisition. The cost of testing is the responsibility of the research study.
URMC COVID Pre-procedure testing centers should be used for testing after arrival. Please do not send study participants to Urgent Care for pre-procedure testing.
Field Work (Off-Site) Study Participant Visits:
When studies are IRB-approved to conduct study visits in the home (see Guideline for Conducting Home Visits) or in off-site locations, it is important that these visits follow similar guidelines with respect to participant pre-screening, masking, use of PPE, and social distancing.
- Pre-screen all study participants, and their support person(s). If you will be meeting with groups, you must screen every individual in the group.
- Defer study procedures or observations with any individual(s) symptomatic for COVID-19.
- Social Distance – Maintain social distancing from all study participants during the study activities.
- Protect study staff and participants. You must wear appropriate PPE (no cloth masks) as outlined below, and your study participants must mask during the visit.
- Fieldwork will require the approval of the department chair.
All research participants who arrive without a mask will need to be provided one, along with their support person. A flyer, available for download and printing, has been created to encourage visitors to ask for a mask. Cloth masks are acceptable protection if the participant(and/or their support person) arrives wearing one. If your department does not have a supply of surgical masks, please connect with your normal supply chain contact to order. If you don’t regularly work with supply chain:
Research participant interviews or contact with research staff must adhere to physical distancing guidelines. Participants should be seen in areas that allow 6 feet of separation at all times, except when contact is necessary to complete study procedures, for example physical examinations or other study procedures that require contact. Signs promoting physical distancing are now available: wall signs , digital displays.
All areas where study participant visits will take place should have hospital-approved hand sanitizer available in the area. When wall-mounted dispensers are available, please use these to sanitize hands. Due to limited supplies of URell and Black Button bottled hand sanitizers, we need to cap distribution to two bottles per request, and prioritize distribution to those areas without wall mounts.
Cleaning Research Participant Rooms and Equipment:
Current recommendations are to follow the clinical guidelines for cleaning rooms and equipment that have been in contact with study participants. Only gloves are needed to clean the room. Standard masking/face covering rules still apply.
- For NON-COVID-19-suspected study participants, continue using your current approved disinfectant for routine cleaning between visits or participants.
- For COVID-19-suspected or positive study participants, especially those with unknown respiratory illness, please use CaviWipes, Clorox Healthcare Hydrogen Peroxide wipes or bleach wipes.
- If you are having trouble accessing supplies
- On the Medical Campus: please call the COVID-19 Operational Support Information line at (585) 602-6843 (internal 2-6843 or C-OVID).
- On the River Campus: Email Greg Meyer (firstname.lastname@example.org)
Study Participant Contact:
You should make sure research staff members who are screening study participants remain six feet away from the participant until screening determines they are symptom-free and do not have a fever (by participant report or active temperature monitoring).
- Screening staff should wear a face mask but do not need to wear PPE if they are separated from study participants b y a physical barrier such as a glass or plastic window. Screening staff should make these interactions as brief as possible by limiting the interaction to screening questions only.
- If a staff member must be within six feet of a study participant, they should use appropriate PPE, including a face mask, gloves and eye protection. A gown could be considered if extensive contact with the participant is anticipated. Cloth face coverings are not considered PPE and should not be worn by the study team member when PPE is indicated.
- Medical Center Only: If a study participant is known to have active COVID-19 (as part of the study), full PPE should be used: a surgical mask, gloves, eye protection and a gown.
Study Monitor Visits
Any part of study monitoring that can be done remotely should be. However, if there are monitoring procedures that must be done in person or are less cumbersome to do in person they can be performed on campus provided the study team and the site monitor follow the procedures laid out in this decision tree guide.
This process depends on:
- whether the site monitor is traveling from a state that is not contiguous with NYS,
- whether the site monitor was in that non-contiguous state for more than 24 hours, and
- whether they will be in NYS for more than 36 hours (inclusive from arrival to departure from NYS).
If these conditions are met, then follow the “yes” pathway in the decision tree. Otherwise follow the “no” pathway.
The site monitor must sign this attestation that they will follow our guidelines and if testing is needed, they will be responsible for paying the cost of the test. A copy of this attestation must be kept by the study team. Electronic signatures are acceptable.
The NYS Traveler Health Form should be completed online by the monitor and a copy kept by the study team.
This COVID-19 test lab requisition must be used if the monitor needs to get a COVID-19 test. The monitor will need to self-pay for the test and then be reimbursed by their employer.
Medical Center Only:
Additional Approvals required for COVID-19 Research
For any study proposing to enroll participants with active COVID-19 infection, approval from the Institutional Biosafety Committee is required as part of IRB review.
For any study proposing to enroll participants with active COVID-19 infection, you MUST obtain institutional approval from Infection Control and Prevention (275-7716) prior to conducting study procedures on site. Studies with participants who have active COVID-19 infection should only be performed on the Medical Campus within the designated research areas.
Visits with COVID-19 Positive Participants
A small number of studies and clinical trials will involve outpatient studies of participants with active COVID-19 infection. These studies will need to be conducted on the Medical Campus, and require a greater degree of vigilance. For these study subjects to come to the study site for their visit, the following steps will be taken (in accordance with SMH Policy 2019 Novel Coronavirus Disease (COVID-19) (2019-nCov) Policies and Procedures):
- The study team and staff will be notified of the participant’s arrival time.
- The study participant will be directed to a designated entry point at the facility - separate from the primary study participant entrance/check-in desk.
- A surgical mask will be placed onto the study participant upon entering the building.
- The study participant will be accompanied directly to an isolation room by a designated staff member donning the required PPE. A negative pressure room is not required unless you are conducting high risk, aerosolizing procedures.
- Isolation practices will be maintained at all times.