The rapidly evolving federal, state, and local policies regarding COVID-19 are impacting every walk of life in the United States and around the world. Companies, as well as academic and government researchers, have pivoted their focus on vaccines and possible treatments for the novel coronavirus.
Health and research organizations are trying to keep up with rapidly changing policies and procedures, while still providing patient care in real time. Resources at medical facilities are being activated and redirected to respond to the increase in testing and treating patients.
Research organizations and sponsors are evaluating protocols to determine which ones may be paused, altered, or continued. A phase three clinical trial investigating a diabetes drug has been put on hold in order to protect patients and workers, according to the sponsor.1 Some universities have issued “urgent ramp-down of on-site, in-person research activities”2 or are downright “suspending all non-critical on-campus research activities.”3 Investigators are encouraged to check with their organizations’ research offices and sponsors for the latest information regarding trials in which they are involved.
Organizations must address several critical issues as they develop their policies, but the most important is the health and safety of patients and staff. Organizational review boards, research offices, laboratories and environmental health and safety committees must work together to provide guidance to investigators and research teams. These are some of the considerations in developing a policy:
- Flexibility — The situation is changing rapidly, as are federal, state, and local mandates regarding the mobility of the public. In communicating with staff, it is important that they recognize and acknowledge the fluidity of the situation, and that policies may be revised in response.
- Continuity plans — Policies should consider continuity or contingency plans to protect the integrity of ongoing research. In some cases, disaster plans can be consulted for guidance in this situation.
- Communication with patients — Investigators and research offices will need a plan for communicating with patients and human subjects. Some organizations are waiving IRB review of these urgent communications.
- Reporting study deviations — IRBs will likely require reporting of study deviations, or have modified policies for doing so. Check with your IRB.
- Remote work contingencies — With many non-critical staff working from home, policies should address the use of video conferencing for IRB and other meetings, remote access and security of HIPAA-protected data, and so on.
- Telemedicine — Researchers may want to consider the use of telemedicine technologies to conduct study visits.
The rapidly changing landscape, the urgency and scale of response, and the impact on health care organizations is making this an unprecedented situation for everyone. Protecting the physical and emotional health of workers and patients should be at the center of our attention as we navigate uncharted territory.
Below are some resources for investigators who are conducting NIH-funded research:
National Institutes of Health
Global Impact on Clinical Trials