Principles

Allowable Activities

Operational Plan Template

Operational Plan Undergraduates

Human Subject Research Guidance

Updated 07/01/20

Lab and Space Considerations for Code Yellow

Roles and Responsibilities for Code Yellow

Enhanced Cleaning and Disinfection Protocols

Telephone Scripts for HSR

What You Can Expect During A Study Visit

COVID Testing for Human Subjects Research that Screen Positive for COVID-19


Resumption of Research FAQs

Added 7/30/20: My research protocol does not allow for there to be a remote COVID-19 screening 24 hours in advance of an in-person study visit. For example, the research participants are enrolled in the study when they present for emergency care. Can an exception be granted to the R2Ops HSR 24 hour remote COVID screening requirements?

Yes, it is possible and would requires that screening to be conducted as soon as feasible. Please contact Cindy Joiner, PhD, MPH, RN with details, who then will the seek approval in consultation with the R2Ops HSR task force (205-903-6362, This email address is being protected from spambots. You need JavaScript enabled to view it.).

Added 7/24/20: If a research participant screens positive for COVID-19, gets tested by UAB, and tests positive for COVID, can the participant later be re-tested for re-entry into research by UAB? Who will arrange the re-testing?

Yes, the participant can be re-tested for re-entry by UAB. The research team can complete the COVID test request form for retesting after at least (1) 14 days have passed since the original COVID RNA test and (2) 8 days of being COVID symptom-free.

Added 7/16/20: Is there a list of procedures that are considered aerosolizing in healthcare setting (aerosol generating procedures, “AGPs")?

UAB refers to the CDC guidance and FAQs as they relate to AGPs. There are several FAQs posted by the CDC which address common AGPs which are found here. Also note that outside of medical procedures, certain other protocols associated with research may be associated with the generation of aerosols (e.g., exercise physiology). If you are uncertain about a specific procedure or protocol, please contact Cindy Joiner, PhD, MPH, RN with questions (205-903-6362, This email address is being protected from spambots. You need JavaScript enabled to view it.)

Added 7/16/20: If I am conducting research that is invasive (surgery) or is associated with the generation of aerosols, what PPE is required?

Per the CDC guidance of July 9, 2020 for personnel working in facilities located in areas with moderate to substantial community transmission, personnel in these higher risk situations should wear an N95 or higher respirator, gloves, isolation gowns, and face shields or goggles. The guidance changes regularly so it is important to check the CDC website frequently.

What are the expectations for R2Ops plans as they relate to work that is done at another institution on behalf of UAB such as in the situation in a subcontract (i.e., under the jurisdiction of another institution including their personnel, IRB, IACUC or oversight)?

UAB R2Ops plans are not intended to cover research conducted for UAB by another institution. Therefore, research resumption at another entity or institution should follow the research resumption policies of that institution. An example would be a subcontract from UAB to another institution. However, if UAB researchers are involved in research conducted remotely, that research does need to be included in school approved R2Ops plans.

The human subjects R2Ops guidance requires COVID testing within 4 days of research study visits involving an invasive procedure. Do research study visits involving procedures such as phlebotomy or lumbar punctures require COVID testing?

No—COVID testing is not required prior to research study visits involving phlebotomy and lumbar punctures unless the research participant screens positive for COVID-19. Please contact Cindy Joiner, PhD, MPH, RN with questions (205-903-6362, This email address is being protected from spambots. You need JavaScript enabled to view it.).

When may external industry monitors return to campus for in-person visits?

No definitive date has been set for University-wide return of monitors while in Phase Yellow. In circumstances where a monitoring visit must be conducted in person, an exemption request may be submitted to Mark Marchant in the CTAO at This email address is being protected from spambots. You need JavaScript enabled to view it.. The request should outline the reason for the in person visit (rather than remote) in addition to the safety procedures the site plans to follow to minimize contact throughout the visit.

Is there a way for external industry monitors to access IMPACT (EHR) remotely without being on campus to enable review of source documentation?

The Coordinator Instructions for the Research Monitor Access Process to IMPACT has been modified which outlines the steps needed to provide a token to monitors to gain remote access to a defined patient list for viewing purposes only. You may find the modified instructions on the CTAO site.

Who pays for the COVID-19 testing required for human subjects research participation?

There are a number of mechanisms by which a participant may have his/her COVID-19 test covered to forego any out of pocket cost which includes one’s insurance, Jefferson County Department of Health, the CARES Act, FEMA, and others. Your research coordinator may be able to provide you with additional information.

Are floor plans required for every space in which human subjects research visits occur, including in those where clinical visits have already been occurring (such as TKC)?

Yes, floor plans are required for each separate space where your human subject research visits may be conducted. If that space includes areas within an already utilized patient-care area of the Health System such as The Kirklin Clinic or Whitaker Clinic, please consult with administration in that area for layouts of the space to enable safe research operations.

When we resume research and interact with research participants outside of UAB, for example in the community or at a nursing home or day care center, what procedures do we follow?

The R2Ops plan that will cover a research area (however that is defined by the School, Dept, or other unit) would include requirements applicable to the space regardless of location (internal or external to UAB). For example If a specific location where research will take place (a nursing home for instance) has certain stipulations for engaging with their residents, one would need to include those in the research resumption plan. The same requirements would apply if a PI is collaborating (or planning to collaborate) with researchers in another area of campus.

If a participant screens positive for COVID-19, are there potential trial options (outpatient or inpatient) that are available to him/her?

Yes, there are a number of both inpatient and outpatient COVID trials being conducted on campus. You may consult the trial search tool located here or inquire with the Division of Infectious Diseases to determine the recruitment status of them. 

Screening of research participants-who does the screening, when and where does it occur, and what process should be followed if the participant tests positive?

This is covered in detail in the R2Ops Human Subjects Research guidance document: https://www.uab.edu/coronavirus/images/documents/reentry/r2ops-human-subjects-research.pdf

How is the resumption of research planning coordinated in space that houses investigators and research programs from multiple labs/departments/schools?

Typically one or more individuals have building management as part of their responsibilities. These individuals should communicate with floor or building occupants to coordinate R2Ops plans regarding signage, traffic flow in hallways and stairways, hygiene practices for common spaces such as meeting or break rooms and other aspects of building management.

Where can I find the resumption of research (R2Ops) template?

Enter the search term “UAB R2Ops” into your browser. On the landing page you will see a box entitled R2Ops Operational Plan Template. Click on the Learn More button to find the template.

Can undergraduates involved in research return to laboratories?

Yes, but the undergraduate researcher must be included in the PI’s resumption of research plan that has been approved by the PI’s Chair and Dean. The student must also complete the COVID 19 Basic Safety and Awareness Course, and the UAB Healthcheck.

Please note: CAS undergrads will not be allowed to return to research in CAS laboratories but are allowed to return to non-CAS labs with the stipulation above.

When or how often do I need to update my R2Ops plans?

R2Ops plans should be updated when there are changes in personnel, room density, work shifts, screening protocols, or the use of PPE and disinfecting protocols for PI labs (wet or dry or clinical). Likewise, R2Ops plans should also be updated when there are changes in the use of common areas (hallways, core facilities, restrooms) that impact the individual R2Ops plans for a lab.

Should screening precautions be taken with community members who are not patients, but are engaged in research studies?

Yes, any non-UAB employees who are participating in the conduct of research should be managed with the same level of precaution in terms of screening for COVID-related symptoms.

Who determines a change of code for a building, floor, or room?

Changes in the color code (orange, yellow, green) and phases will be made on a university-wide basis, not by building, floor, or room. The decision will be made by the COVID Incident Command Executive Committee.