Human Subject Research Reboot FAQ
Is new enrollment for observational trials allowed after June 1?
Yes, observational human subjects research studies will be allowed to begin new enrollment starting June 1, 2020.
Will COVID-19 tests be available for researchers?
Currently mass testing (both PCR tests for coronavirus and serological tests for antibody status) is not available for non-symptomatic research staff. Instead, 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. (A similar health screening tool is being developed for students. Further information will be shared when that is available.)
When is a person considered "exposed" and requiring quarantine?
The “exposed” definition relies on public health determination of a significant exposure that occurs in the community (see CDC resource) and there are specific modifications that we apply for determining significant exposures that occur in the healthcare setting. Household exposures are the highest risk, but other close contacts are also considered exposed: more than 5 minutes within 6 feet of an infected person without wearing a mask is the basic definition with some nuances for healthcare.
Certain spaces do not allow for six feet of separation (elevators, restrooms, clinic rooms). What is the guidance for using these spaces?
Spaces like elevators and restrooms should be used by one person at a time with the exception of people who need assistance. If it cannot be avoided that several individuals have to work in clinic rooms that have less space than 250 - 300 square feet per person, everyone involved should wear surgical procedure masks, gloves and eye protection, and treat each other as if they have COVID-19 but are asymptomatic.
What should we do if our study procedures require touching study subjects?
If your study required you to be within six feet of a study subject, you must 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.
What if we need to escort a study participant to the lab in an elevator?
If people need assistance, more than one person can travel in an elevator if they both wear face masks, respect each others' personal space and wash their hands before and after touching high-touch surfaces.
Should we only be physically coming to the medical center if necessary?
If you can perform study procedures remotely, we encourage you to do so. Please talk with your RSRB/IRB to see if you need to modify your protocol.
Could clinical research teams who need space but not necessarily clinic facilities use conference spaces in the Saunders Research Building?
Conference spaces should not be used for research surveys at this time as cleaning procedures would be cumbersome.
After June 1, will research involving COVID-19 patients be separated in space from non-COVID-19 patients?
Yes, we are working on designating specific areas for research visits with COVID-19-positive subjects. At present, the Clinical Research Center has a separate area (including a separate entrance) for studies with COVID-19-positive subjects and the Vaccine Trial and Evaluations Unit also has a separate area. We are working on other spaces as the need arises.
How can I get surgical procedure masks?
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, email firstname.lastname@example.org if you work on the medical campus or Greg Meyer (email@example.com) if you work on the river campus.
Can I get N95 masks for special circumstances (in person visits with at-risk study participants, collecting biospecimens from subjects, etc.)?
N95 masks are only required for high risk procedures in clinical areas and need to be reserved for those procedures only.
Can the medical center assist in purchasing thermometers for staff to use at home?
Thermometers for home use may be purchased through the hospital store or pharmacy. Touchless infrared thermometers will be made available to research departments and centers.
How can I switch to performing research visits remotely?
Contact your study sponsor and the reviewing IRB to discuss how best to move forward with performing remote research visits, when possible. Given that we expect this to be a temporary situation, a protocol modification may not be necessary. Sponsors may grant protocol waivers to conduct research in this manner and IRBs may allow for missed assessments and missed visits to be documented and submitted as protocol deviations as this is a required change to research to eliminate apparent hazards to research subjects. The most important aspect is to discuss these issues with both parties. For those studies where WIRB is serving as the IRB of record, please see the guidance on study modifications and documentation.
What technology and facilities are available to conduct remote visits with study subjects and/or study monitors?
Telephone conferencing and Zoom can be used to communicate with subjects, depending upon the subject’s resources. Zoom can be used for meetings with monitors and to enable monitor review of source documents. It is critical for the University of Rochester and URMC’s meeting hosts to ensure their Zoom settings are configured to prevent unwanted attendees or content from disrupting the meeting. The URMC version of Zoom is HIPAA compliant, but not the River Campus version. Please read the Zoom page carefully, and log in using your URMC login. Additional guidance on how to secure your Zoom meeting is available. If you are new to utilizing Zoom, the Office for Faculty Development’s ‘Introduction to URMC Zoom and Telemedicine’ recording is also available.
If it is not feasible to use Zoom for monitoring in a particular study, eRecord access may be an option in some circumstances. Please request eRecord access. Note: this form requires signatures of the PI, department program administrator or the administrator’s designee. Typical processing time is two weeks, subject to resource prioritization during the COVID-19 emergency. If you have questions, please email Kathleen_tranelli@urmc.rochester.edu.
Can oral investigational drug be shipped directly to a study participant?
Upon documented sponsor approval, the Investigational Drug Services may ship oral investigational agents directly to patients. After approval by the study sponsor and the IRB, you may consider shipping multiple treatment cycles to study patients or dispensing multiple treatment cycles to patients who are able to initially return to the treatment site, if feasible based on supply availability and protocol requirements. Please document these decisions and any communication with sponsors and/or CROs and study subjects, and continue to follow good documentation processes for drug management and accountability.