COVID-19 Guidance for Clinical Research

Research Continuity Guidance

The Office of the Vice President for Research has additional guidance on research continuity.

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The School of Medicine (SOM) leadership has been working closely with the Medical Center to develop COVID-19 guidance for the management of clinical research activities.

Human Subject Research

Effective 03/16/20, For all human subject research studies that involve direct subject contact, and that provide little or no potential benefit to subjects – human subject direct contact (face to face) must be paused until further notice in recognition of the COVID-19 pandemic. This directive is being made to decrease exposure for our staff, faculty and learners as well as research subjects. All other aspects of the research that do not involve direct human subject contact may be continued.

It is anticipated that certain types of human subject research will be allowed to continue.  These include (but are not limited to):

  1. FDA regulated clinical research that has the potential for direct health benefit to subjects.
  2. Interventional/treatment trials that have the potential for direct health benefit to subjects.
  3. Studies that do not meet the criteria of # 1 and # 2 above and that have no physical or direct subject contact. These are studies done via mail, phone, online, etc. or could be those involving things like review of medical records/ archival data/ public data sets or studies that are in the status of data analysis.

We recognize that this request will significantly impact your research on multiple levels. Guidance as to how to manage research delays and sponsor requirements as well as other research questions can be found at the website: https://research.virginia.edu/ResearchContinuity. Please visit the website frequently as we will be making daily updates. It is the responsibility of the Principal Investigator/Project leader to notify subjects as needed.

If you have questions about your particular study (including assessing health benefit), please direct these questions to the Research Deans or to the SOM Clinical Research email: uvaclinicaltrials@virginia.edu.

For other questions about SOM-specific research needs, facilities and grants and contracts, please see this site, which will be updated as needed https://med.virginia.edu/office-for-research/covid-19/

Research visits conducted in UVA Medical Center Ambulatory Care areas

At this time, an action plan is in place for research visits that are scheduled to take place in any UVA Medical Center ambulatory clinic.  .

Effective 03/11/20, for all research visits that will occur in a UVA Medical Center Ambulatory Care area, it is REQUIRED that the research subject first check in with Medical Center Registration to ensure compliance with the new COVID-19 screening policy.  Examples of UVA Medical Center Ambulatory Care areas include, but are not limited to, ambulatory clinics within ECCC, Primary Care, the West Complex, Fontaine, Culpeper, Zions Crossroads, Augusta, UVA Imaging, Clinical Labs, etc.

For information on the screening policy and for additional information, visit the Coronavirus Resource Page.  Please refer to this page often for the most up to date information.

Research visits conducted in UVA Academic areas

Updated 3/27/20

Effective 03/13/20, Clinical research teams are REQUIRED to screen all research subjects seen in non-Medical Center (academic) areas.  As a reminder, examples of non-Medical Center locations include, but are not limited to, the Collins Wing CRU, the Fontaine CRU, Memorial Gymnasium, Snyder, etc.

Please complete this screening questionnaire for research subjects seen in non-Medical Center areas.

You MUST ask your subject the screening questions at the following times:

The day before the subject’s scheduled research visit.

AND

When the subject arrives for their scheduled research visit.

The screening is considered POSITIVE if…

Question #1 is “YES” and the subject has any of the following symptoms: Cough, Shortness of Breath, or Fever (from Question #2).

OR

Question #3 is “YES” and the subject has any of the following symptoms: Cough, Shortness of Breath, or Fever (from Question #2).

For a POSITIVE screening please provide the research subject with the following guidance:

  • Contact your primary care physician via telephone or email immediately.
  • If you do not have a primary care physician, you may call the VDH hotline at 1-877-ASK-VDH3 (877.275.8343).

For information on the screening policy and for additional information, visit the Coronavirus Resource Page.  Please refer to this page often for the most up to date information.

Study monitoring visits

Until further notice, study monitors should not travel to UVA to conduct monitoring visits.  Monitors are able to review source data in Epic remotely via EpicCare Link.

To request remote Epic access for your monitor, please click here.

For studies for which source data is not recorded in Epic, please work directly with your monitor to develop a plan to provide them with the information they need to monitor remotely.

Research Concierge at UVA Health Science Library

This service has been cancelled until further notice.

FAQ

There is a list of FAQs that you can reference to address your questions (https://research.virginia.edu/human-research-protection-program/COVID19FAQs).

Collins Wing Clinical Research Unit

Operation status: Modified

Open only to studies that provide potential for direct health benefit to subjects

Fontaine Clinical Research Unit

Operation status: Modified

Open only to studies that provide potential for direct health benefit to subjects