Guidance for Human Subject Research
Research Redesign in the COVID-19 Era
This guidance is designed to assist you in planning for an impending gradual expansion of human subject research. We have a 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.
The gradual expansion of human subject research at the University of Rochester depends on corresponding expansion of Medical Center clinical operations including regular clinic visits and elective surgeries and procedures and, on both the River and Medical Campuses, opening up the laboratory research areas. For most human subject research, we cannot resume clinical research until the Governor releases Rochester from the stay at home order.
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.
PLEASE NOTE THAT THESE DATES MAY CHANGE DEPENDING ON LOCAL OR GOVERNMENT ADVISORIES.
Type of Study
Interventional clinical trials enrolling COVID-19 study subjects (e.g. vaccine trials, medication trials, etc.) – these are currently ongoing and not paused.
Interventional clinical trials enrolling study subjects who have no other treatment options or have life-threatening conditions (oncology clinical trials, stroke studies, ICU studies) – these are currently ongoing and not paused.
Observational studies enrolling COVID-19 study subjects (including sample collection, biobank project).
Interventional clinical trials enrolling study subjects that have other treatment options and whose conditions are not life-threatening. This will include trials for conditions that are moderate to serious (device implantation, medications).
All other human subjects research. This would be the remainder of the studies with human subjects that require contact with the subject.
We also want to emphasize that the gradual expansion will likely take time. We suggest that each Principal Investigator (PI) and department assess start up capacity and stagger the restart. In addition, please be mindful that the Research Subjects Review Board and the Western Institutional Review Board (for clinical trials) will be handling multiple requests for study modifications. Please be respectful of their workflow and bandwidth.
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 subject 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 subjects symptomatic for, or actively infected with, COVID-19 should not be conducted on the River Campus.
Before you restart your 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 subjects 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 subjects 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 the modules “Coronavirus: COVID-19”, “COVID-19 Education” and “PPE Mask Fit Check, and Face Shield”.
- All study personnel review and have on hand the talking points (see below) about how to discuss safety with subjects concerned about in-person study visits;
- Cleaning supplies on hand to clean furniture and study equipment that come in contact with the study subjects (see below);
- 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 subjects, 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.); and
- 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 subjects 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.
- 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 subjects 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 subjects can be provided investigational medicinal products (IMPs) at home if they cannot get to the study site. Verbal consent from the subject 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 subjects. 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 subject 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 subjects with active infection. This is important, as you may need to do follow up visits with subjects 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 Subject Visits:
A flyer for Subject Information on Study Visits during COVID has been approved by the Research Subject Review Board and is available on the OHSP website. Please use this as a tool to help subjects understand what they can expect when a study visit occurs. This flyer does not require additional approval by the RSRB to be used.
All subjects, 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 subjects, 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 below). Ask the subject 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 subjects 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 subjects 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 subjects with fever or symptoms of respiratory infection to go home and contact their healthcare provider.
- Instruct subjects 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 subject and the subject’s support person(s) arrive and are not already wearing a cloth face covering, provide a face mask (see below). If possible, there should be a barrier (plexiglass) between the study staff and the study subject.
- Screen all study subjects 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 subjects, consider sending them to the Emergency Room if appropriate (subject very short of breath, confused, unable to stand up, for example). For research with known COVID-positive subjects (e.g. clinical trial to study COVID-19), follow additional information below.
- Physical/Social Distance: Send study subjects and the subject’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.
- Subjects know to be COVID-19 positive or recovering (<28 days after infection):
- River Campus: Study subjects who are COVID-19 positive or recovering should be excluded from in-person study visits until they are determined to be symptom free. These subjects should be rescheduled to a later date.
- Medical Center: Subjects should wait for their visit and be seen in a separate, high risk study area that isolates them from other study subjects and staff to the extent possible (see below for additional information).
Field Work (Off-Site) Study Subject 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 subject pre-screening, masking, use of PPE, and social distancing.
- Pre-screen all study subjects, 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 subjects during the study activities.
- Protect study staff and subjects. You must wear appropriate PPE (no cloth masks) as outlined below, and your study subjects must mask during the visit.
- Fieldwork will require the approval of the department chair.
All research subjects 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 subject (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 subject interviews or contact with research staff must adhere to physical distancing guidelines. Subjects 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 subject 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 Subject Rooms and Equipment:
Current recommendations are to follow the clinical guidelines for cleaning rooms and equipment that have been in contact with study subjects. Only gloves are needed to clean the room. Standard masking/face covering rules still apply.
- For NON-COVID-19-suspected study subjects, continue using your current approved disinfectant for routine cleaning between visits or subjects.
- For COVID-19-suspected or positive study subjects, 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 (email@example.com)
Study Subject Contact:
You should make sure research staff members who are screening study subjects remain six feet away from the subject until screening determines they are symptom-free and do not have a fever (by subject 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 subjects by 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 subject, they should use appropriate PPE, including a face mask, gloves and eye protection. A gown could be considered if extensive contact with the subject 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 subject 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.
Medical Center Only: Additional Approvals required for COVID-19 Research
For any study proposing to enroll subjects with active COVID-19 infection, approval from the Institutional Biosafety Committee is required as part of IRB review.
For any study proposing to enroll subjects 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 subjects who have active COVID-19 infection should only be performed on the Medical Campus within the designated research areas.
Medical Center Only: Visits with COVID-19 Positive Subjects
A small number of studies and clinical trials will involve outpatient studies of subjects 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 subject’s arrival time.
- The study subject will be directed to a designated entry point at the facility - separate from the primary study subject entrance/check-in desk.
- A surgical mask will be placed onto the study subject upon entering the building.
- The study subject 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.
Script for Discussing Safety Information with Study Subjects
I can certainly understand your concerns—this is a worrisome situation, and we’re all trying to decide what the best way is to keep ourselves and our families safe. I’d like to share what University of Rochester Researchers are doing to make sure you stay as safe as possible while participating in research studies here. These processes are recommended by our Infection Prevention experts.
- All study investigators, coordinators, nurses and staff in our research areas are wearing masks, and we’ll also provide a mask to you and anyone who comes with when you arrive, if you don’t have one.
- We also require all of our employees to screen themselves for symptoms daily before they come into work, and we’ll screen you for symptoms the day of your visit. (We could add something like – Whenever possible, we escort you into the study rooms immediately).
- We are following meticulous infection control practices, including disinfection, wearing gloves, and hand washing.
- We are limiting the number of visitors accompanying people for their study visits, and have rearranged and/or removed furniture in our waiting areas to enforce strict social distancing practices.
- We’re also being careful about who we ask to come for in-person study visits, and when possible are using telephone or video conferencing to reduce the number of study subjects coming to our research areas at the same time.
We know that COVID-19 will be in our community for many months. We appreciate your continued participation in our study. Please ask if there is anything you are concerned about.