Guidance for Research Participants During COVID-19

Guidance for  Research Participants

March 20, 2020, 4:00 p.m. 

The University of Kentucky is Pausing Select Human Subject Research Studies  

The health and safety of our community is of paramount importance during the COVID-19 emergency. To this end, the University of  Kentucky Chandler  Medical Center will be temporarily pausing select human subject research activities.    

 We are instructing all study teams to contact  active study participants with information on  whether the  study has been delayed/paused or  temporarily changed  due to COVID-19 concerns.   Study staff  may prioritize calls based on studies involving treatments, visits, therapies, etc.   Be aware that study  payments or compensation owed may be delayed.       

  If your study staff have contacted you, follow their directions.     

  If you have questions or concerns,  contact the study team using the phone number provided to you. It  should be on the front page of the informed consent provided  when you joined the study.   

Which human subject research studies will this affect?   

Studies that involve  direct  contact with study  participant but  have no direct benefit to the  participant  will be paused until further notice.    

  Which human subject research studies  will not be paused?    

This pause may not affect  studies  with  medically necessary  treatments  or clinical trials with  important  benefits to participants.  The pause may not affect studies with no personal contact (such as online surveys and phone interviews).    

  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 the patient, such as some oncology studies and device studies or clinical trials with investigational drugs.  Generally, trials  with drugs or devices will  continue to enroll new  participants  only if there are no other treatments available and the  participants  would be placed at risk without treatment. Clinical trials with placebo  groups  will  likely  be placed on enrollment hold.  If you are screening or have recently consented to participate in a clinical trial, please contact the study team.   

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 have been exposed to somebody who is infected with coronavirus, your visit may be rescheduled.  The study team  will do everything  they  can to maintain your treatment schedule.   

  What should I do if my next visit is a follow up 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 coronavirus 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 UKMC  for a study treatment?   

Call  before visits  to  see if the visit will be rescheduled or  changed.  You may be  asked screening  questions such as:   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  the study team  may postpone your  visit.  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.