FDA Guidance on the Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic
NEW! 3/30/20 FDA Issues Updated Guidance on Clinical Trial Conduct During the COVID-19 Pandemic
On March 18, 2020, FDA issued “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic” to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic. On March 27, 2020, FDA amended the guidance to include an appendix to further explain those general considerations by providing answers to questions about conducting clinical trials that the Agency has received during the COVID-19 pandemic.
As of 3/18/20 FDA Issues Guidance on Clinical Trial Conduct During the COVID-19 Pandemic
The following FDA Guidance has been released regarding the conduct of clinical trials of Medical Products during the COVID-19 Pandemic. The guidance contains recommendations for how to continue existing IRB approved research under the FDA purview, when necessary, to minimize or eliminate immediate hazards or to protect the life and well being of research participants. The Human Subjects Office strongly encourages the study teams to consider the implications of reduced staffing, clinical\UIHC resources, and availability of study related materials (i.e. PPE, investigational product, etc) during this time and implement study measures consistent with the FDA regulatory guidance. New human subjects research detracting from hospital resources that may need to be directed to clinical care should be avoided.
Vice President for Research Issues a Statement on Research Slowdowns
As of 3/18/20 The Vice President for Research has also issued the following guidance earlier today regarding research activity rampdowns. FAQs and other resources for research involving human subjects, animal subjects, costs charged to sponsored projects, and more is available on our COVID-19 Information for Researchers webpage.
Iowa City VA Research conducted with VA ORD funds and the COVID-19 Pandemic
As of 3/18/20 The VA ORD (Office of Research and Development) has issued the following communication regarding ORD funded research during the COVID-19 pandemic.
ORD is placing an administrative hold on all non-critical, in-person, ORD-funded human research subject interactions. Please review the VA ORD FAQs for what to do if your study is impacted by this. In addition, ORD-funded Principal Investigators who find that they are unable to continue with their research during this time due to increased clinical demands should contact their ORD funding service for guidance at their earliest opportunity in accordance with the COVID-19 Administrative Hold Frequently Asked Questions.
Other COVID-19 Related Resources
- University of Iowa Coronavirus Information
- The Loop - University of Iowa Hospitals and Clinics (UIHC) FAQs for patients, clinical care, COVID updates.
- NIH Notice containing COVID updates for grant related purposes
- CDC COVID related updates
- Iowa Department of Public Health (IDPH) COVID related updates