Essential studies

**As of March 23: all in-person enrollment for Tier 2 essential studies have been temporarily suspended until further notice. In addition, we ask research teams to continue converting study activities to virtual or remote/tele visits as much as possible.  Please also prepare contingency planning in the case all in-person follow-up study activities are suspended for Tier 2 Essential Studies.** 

**As of April 13, laboratory building access has been restricted to personnel who have been identified as requiring access for essential research duties. Anyone requesting access to a laboratory building must submit the Lab Access Request Form for departmental approval.

Please review the IRB Policy titled “COVID-19 and Research at Duke” released on March 11, 2020, for further guidance on changes to research activities related to COVID-19. 


What do I do if I have an idea for a COVID-19 study? 

A COVID-19 study start-up checklist can be found here.

Duke requests that you submit all COVID-19 research studies, ideas, and proposal plans via the brief myRESEARCHhome survey. This helps track Duke’s response to COVID-19 and will get you quickly connected with the COVID-19 Leadership Task Force and additional resources you need to get your research going or your proposal submitted.  If you need help finding collaborators, contact the myRESEARCHnavigators team at myresearchnavigators@duke.edu . For assistance in planning operational aspects of your study, contact DOCR Outreach through docr-studyplanning@dm.duke.edu, and include your Clinical Research Unit leadership. 


What defines an essential study? 
An essential study is any study utilizing drugs, biologics, or devices that holds the prospect of direct benefit to the participant. Furthermore, any study involving therapeutic radiation would be considered essential. We have asked PI and CRUs to assess studies meeting this definition to identify those they believe must continue with in-person study activities due to the health and well-being of the participant. All other studies would be considered non-essential.  


What defines a Tier 1 Essential Clinical Research Study?
Tier 1 = High Potential Direct Benefit to Research Participants 

All clinical research protocols involving COVID-19 or clinical research protocols in which there is a high potential benefit for an individual’s survival or when alternative treatments are severely limited and there is a potentially serious or immediate harm for an individual without participation in the protocol. For example: 

  • Clinical research protocols involving treatments for acute, life-threatening health conditions (e.g., some treatment trials for cancers). 

  • Clinical research protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful. 


What defines a Tier 2 Essential Clinical Research Study? 
Tier 2= Moderate Potential Direct Benefit to Research Participants 

Clinical research protocols that provide moderate potential benefit for an individual’s health or well-being over time, which, if unavailable, may pose a long-term risk to the research participant. For example: 

  • Clinical research protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, diabetes, HIV, fatty liver disease, etc.). 

  • Clinical research protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants, including the risk of exposure of COVID-19. 


What defines a Tier 3 (non-essential) clinical research study? 
Non-essential studies are primarily observational or behavioral studies, surveys, focus groups, retrospective studies, archival data/sample-based research studies. Non-essential studies may also be interventional studies that are not viewed as so critical to the health and well-being of the participant that it is worth the risk to the research staff and Duke Health community. If a PI or CRU believes a non-essential study needs to continue with in-person study activities, they will need to request this permission from Susanna Naggie and Adrian Hernandez. We must balance the benefit to participants with risk to our research staff and the Duke Health community. 

Studies approved by the IRB as exempt do not meet the definition of an essential research study and must suspend any in-person activities. The PI should consider whether the activity can continue virtually or remotely, as well as other requirements described in this FAQ when deciding how to manage the study during this time. 


If my study is Tier 3 (non-essential), do I need to suspend my study? 
Not necessarily.  Any remote (not on DUHS or Duke premises) research activities that do not require in-person visits can continue for any study. Furthermore, we encourage PIs and study teams to use virtual study visits whenever possible. Duke has made several accommodations to make this easier (see Going Remote Section). Only research activities that must be conducted in-person for non-essential studies must be suspended to minimize the risk of exposure to COVID-19 for participants, staff, and the Duke Health community. 


If my study is a Tier 2 essential study, do I need to suspend enrollment? 
For studies that require in-person interaction, enrollment must be suspended at this time.  However, in-person follow-up visits may continue for Tier 2 essential studies as well as any research activities that can be done remotely. If all study activities can be done remotely (e.g. virtual consent and study visits), then you do not have to suspend enrollment.  Remote/virtual activities do not introduce risk of exposure to COVID-19 for either the participant or the study staff and may continue for any study. 


I run a biobanking study in which our staff interact with a lot of patients. Is such a study considered essential?  
A biobanking study would not be considered an essential study (see above). On Monday, March 16, the Duke School of Medicine Clinical Research Administration initiated the Essential Clinical Research Study Policy. At that time, all in-person clinical research study activities for non-essential studies have been temporarily suspended until further notice.  While other clinical research activities that can be done virtually or remotely will be able to continue, participant in-person visits will not be allowed.  

If your biobanking study uses only regular clinic visits and clinic providers, you may submit a request to keep your study open.  Such requests are submitted in writing to Dr. Susanna Naggie and will be decided on a case-by-case basis, dependent on the evolving nature of Duke’s response to the COVID-19 outbreak.