-
CCTS Director Robert Kimberly, MD, regarding general research updates related to COVID-19
- In the laboratory setting, complete essential research experiments that are underway but do not initiate new experiments. Observe social distancing, hand washing and other public health guidelines.
- In the clinical setting, essential visits can continue but new enrollment is on hold unless critical to patient health, related to COVID-19 or performed remotely—for example, the trial for Remdesivir has just begun. Determine what is essential vs. non-essential based on the health and well-being of the patient, and use the guidance of local leadership in making that call.
- The work paradigm has changed, and so has the learning paradigm: many learning activities are still happening remotely. Visit the CCTS Upcoming Events page for more.
- In the laboratory and clinical setting, the idea is to make the most of remote team meetings.
Additionally, an important to note for COVID-19 research:
- A COVID-19 enterprise biorepository and data registry initiative is moving forward quickly. This will coordinate and streamline the consenting process for anyone interested in conducting COVID-19-related research. Contact
This email address is being protected from spambots. You need JavaScript enabled to view it. for more information. - As part of this effort, the CCTS and Informatics Institute are working with 15 other academic centers to make patient clinical data available for COVID studies.
-
Adam McClintock, Director, Office of the Institution Review Board, UAB
- The Office of the IRB is still fully operational and working hard to help you! Information online is up-to-date, and you can reach out directly to
This email address is being protected from spambots. You need JavaScript enabled to view it. with any questions. - If a study can be done remotely it should be done remotely. If it must be done in person, procedures should be in place to reduce the opportunity for transmission of COVID-19. Ask, “Is this study visit necessary for the health and wellness of the participant?” If a study is transitioning to remote visits, submit an amendment to Adam McClintock Approval takes 24 hours. Any deviation or non-compliance stemming from COVID-19 changes should still be reported according to IRB policy.
- IRB’s priority has been on COVID-19 projects; other projects are not prohibited but are being prioritized appropriately.
- The Office of the IRB is still fully operational and working hard to help you! Information online is up-to-date, and you can reach out directly to
-
Cynthia Joiner, RN, PhD, Associate Vice Chair, Department of Medicine
- Communicate with your research team often, and track progress of the team.
- Stay current because things are changing RAPIDLY. Stay tuned to local changes like hospital and ambulatory guidelines, and also FDA and NIH guidance UAB hospital and ambulatory guidelines. (Websites to watch: NIH.gov, FDA.gov, UAB Office of Research COVID-19 Guidance, IRB Business Continuity Plan, UAB Medicine)
- For essential study visits: screen for COVID-19 on the phone 24 hours in advance, then screen again at the patient care area. Know the symptoms and steps of reporting suspected infection. Resource to consider: Clinical Research Unit on Jefferson Tower 15 is an available and appropriate patient care area.
- UAB Medicine’s policy regarding no visitors also applies to clinical trials. Try to limit this, though caregivers are allowed.
- Communicate with patients. This is a helpful website to share with them: https://www.uab.edu/news/coronavirus/patients
-
Paul Muntner, PhD, Associate Dean of Research, UAB School of Public Health
- The School of Public Health (SOPH) is working to continue regularly scheduled activities, continued communication and support for all faculty and students. Some research has halted, but remote work on things like data analysis, new or revised grants, online training, and dissertation progress continues.
- The Survey Research Unit is functioning remotely, and this has been key to collecting public health data at this time.
- SOPH is pulling together ideas for COVID public health research needs, coordinating all ideas to work in a concerted effort.
-
Lisa Schwiebert, PhD, Senior Associate Dean for Graduate and Postdoctoral Affairs
- Emphasizing focus on stress and personal wellness in a time of great stress is a high priority: take care of yourself! Mental health resources can be found here.
- Trainees and lab personnel not involved in crucial studies are encouraged to work on things easily done from home: reading literature, analyzing data, and staying connected with colleagues.
- It is expected that research mentors articulate a plan for their trainees and allow flexibility and curtail all studies that are not immediately necessary.
- Regarding the hiring freeze: only offers already on paper can go forward. International trainees are delayed based on federal policy until at least June 1st.
-
Discussion Questions & Answers
Here are a few of the questions that followed presentations:
- How will NIH and other sponsors address delays in research progress? Will they be issuing no-cost extensions? Sponsors and the NIH are amenable to changes that need to be made—developments are still in process but there is a clear understanding that flexibility is needed. In place already: no-cost, one year extensions for eligible grants that can be submitted through the Office of Sponsored Programs. Information coming soon: there may be reimbursements for additional costs incurred because of COVID, so every lab should keep track of added expenses in case the federal government provides some support.
- Is trainee funding secured? Yes, that is the current understanding, but you should connect with your program official to confirm and enforce that—every mechanism is different.
- How are we compensating clinical research participants who are now joining remotely? Greenphire is still the mechanism to use. New patients can be set up for Greenphire payments: contact Stephanie Mullins. Financial Affairs has clarified that there were some rejections of payment requests in the first few days of the Limited Business Operations but no other issues have occurred since some clarification on procedures has taken place.
- For COVID studies within UAB, are there guidelines in place? Guidelines for the processes behind working with COVID-19 patients are coming along quickly!
- Can you recruit remotely? Yes, as long as it doesn’t involve in-person contact and as long as future study visits can likewise be performed remotely.
- Advice for amending clinicaltrials.gov information? Work with the sponsor, and if it is a multi-site study include the other site(s), then communicate changes with patients and finally work on the changes needed on clinicaltrials.gov. Need help? Reach out to
This email address is being protected from spambots. You need JavaScript enabled to view it. . - How is essential vs. non-essential determined? Essential is anchored in honoring the best interest of the patients’ safety. Investigators work with leadership to determine this status.
- What if we go on lockdown? Or something changes? Those issues will be worked through according to what is safest for patients. Creative solutions may be considered; we will work together.
- Given everything going on, how do we maintain a research seat at the table? We have every opportunity to take the data and resources we have to make observations that will improve and increase knowledge surrounding COVID-19 biology, risk factors and opportunities.
- What is UAB policy on paying personnel who's services are no longer able to be applied to their work such as clinical trials coordinators and nurses enrolling patients in studies and registries? Melinda Cotten explained that she and Stephanie Mullins are drafting an institutional position statement to align with the federal government’s recently released 0MB M-20-17, "Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations," to provide agencies with additional flexibilities for grants assisting the response to COVID-19. The position statement will address that extramurally funded salaries and fringe may continue to be charged to grants and contracts (all sources unless specifically barred by a sponsor) under unexpected or extraordinary circumstances.
Click to access slides and video from the Forum. This important discussion will continue; similar virtual gatherings will be available in the coming days, and listed on the Upcoming Events page.
"The CCTS Forum provided a nice overview and clarification of essential, ongoing processes and projects around campus in light of the current limited business model. More importantly, it was reassuring to see leadership coming together to collaborate on addressing issues related to the COVID-19 pandemic."
– Zachary D. Wallen, Graduate Trainee in the Graduate Biomedical Sciences Program, UAB