Guidance for Research Participants
Pausing Select Human Subject Research Studies at URMC
The health and safety of our community is of utmost importance to the University of Rochester Medical Center as we weather the evolving COVID-19 emergency together. To this end, we have paused select human subject research activities until further notice. This pause will not affect human subject research that includes therapies or procedures directly benefiting study subjects (e.g. clinical trials).
Frequently Asked Questions
Which human subject research studies will this affect?
Studies that involve contact with study subjects but have no direct benefit to the subject will be paused until further notice.
Which human subject research studies will not be paused?
Clinical trials testing drugs and devices that may benefit participants will continue through the COVID-19 emergency.
Will I be able to enroll in a clinical trial?
Enrollment in clinical trials will be placed on hold immediately, except where treatment during a clinical trial is medically necessary for patients, such as some oncology studies, device studies and clinical trials testing investigational drugs. Trials with drugs or devices will continue to enroll new subjects only if there are no other treatments available and the subjects would be placed at risk without treatment. Clinical trials with placebo arms will be placed on enrollment hold. If you are screening or have recently consented to participate in a clinical trial, please contact the study team.
Who should I contact to determine if my study is paused?
We are instructing all study teams to contact people currently enrolled in a study or scheduled to enroll in the near future. However, you may contact the study team using the phone number provided to you by the study team to determine if you should come in for your next study visit.
What should I do if I am receiving treatment?
If you are in treatment on a clinical trial, you may continue treatment, although the study visit schedule may change. When you come for your treatment, please be prepared to answer questions about your recent trips and health. This screening is intended to protect you, your family, and our healthcare workers, from coronavirus infection. If you are sick, have symptoms, or significant exposure to somebody who is infected with coronavirus, your visit may be rescheduled. We will do everything we can to maintain your treatment schedule.
What should I do if my next visit is a follow-up visit?
If you are having follow-up visits, we may reschedule or cancel these visits during the next 90 days. These are not treatment visits. A research team member will contact you to discuss these visits prior to your next visit.
We understand that you may have concerns about your participation in clinical trials. Please contact the study team for specific concerns. If you are experiencing adverse events, or have been diagnosed with COVID-19 infection, please contact your study team immediately using the 24-hour contact number in your consent form.
What should I expect if I come to URMC for a study treatment?
Call the day before you have a visit to answer the travel screening questions:
- Have you or your family members traveled in the last 14 days?
- Do you or anyone in your home have any of the following symptoms: cough, fever, shortness of breath?
- Have you or anyone in your family had any contact with a confirmed COVID-19 patient?
If you answer yes to these questions we may postpone your visit for at least 14 days. You should also talk to your healthcare professional.
When you arrive for your treatment you will be asked these questions again.
Can I participate in my study remotely?
You may be asked to participate in a study remotely by speaking with the study team by phone or through teleconferencing. Contact the study team to find out if this is an option.