As COVID research continues across the globe, many US institutions and researchers will find themselves considering collaborations with international partners. Andrea and Genevieve authored a bulletin for the AHLA’s Hospitals & Health Systems Practices group discussing areas of risk to address before entering into these relationships .  An alphabet soup of issues might arise: the GDPR, FCPA, EAR, COIs… mismanagement of which may lead to unintended and unknown consequences for researchers.

International Research Collaborations: Compliance Issues to Consider When Solving for Global Problems” (paywall may apply)   https://www.americanhealthlaw.org/content-library/publications/bulletins/ff252eaa-04a6-4c3a-ad7e-c1701cc1dbe2/International-Research- Collaborations-Compliance-I

 

We are living in unprecedented times- how often have you heard that in the past few months? The fact is, we truly are in uncharted territory. On a dime, our world turned from long commutes, in-person meetings and the occasional lunch with a colleague to stay at home orders, virtual learning and zoom overdrive. Research was no different- a quick and careful pivot was required not only to ensure continuity to critical ongoing research, but more importantly, to accommodate emerging and urgent research involving COVID-19.

Seemingly overnight, COVID-19 research emerged- ranging from studies aimed at understanding the myriad of symptoms of the virus and its outcomes to potential therapeutic agents and vaccine trials.  The entire world is focused on how to end the pandemic, and participation in research provides COVID patients with access to the limited pool of therapeutic candidates available. The complications of COVID-19 research are extensive and require thoughtful and careful analysis under a rapid timeline. A few items your site must consider if COVID-19 research is in your future:

  • Whether your site has the volume of COVID patients necessary to support a trial
  • How to safely consent a patient who is infected with COVID
  • How industry sponsors can monitor their studies at your site
  • How to assess what studies may be meaningful and appropriate for your patient population
  • What additional resources will your site require to conduct COVID-19 research in a compliant and safe manner, including PPE

The list continues and the complications are real, but COVID research is of utmost importance. In order to address the pandemic, the world needs an understanding of the virus and its transmission, potential therapies and vaccines- all of which require extensive, scientifically valid research on a global scale. Historically, research has had its moments of importance, but the focus on research has never felt more intense.  The daily headlines of vaccine trials entering Phase 3, early findings from small human trials and animal models are reported with an urgency never seen before.  The ability to provide access to such trials will continue to be a focus for many physicians for the foreseeable future. Reach out to deLemos & Wever if you would like to discuss how to participate in this critical area of research.