Finding a “New Normal” in Clinical Research

Meghan Hosely
June 2nd, 2020

For much of 2020, COVID-19 has rocked much of what society deems “normal,” and it has been no different in the clinical research world. Protocols are paused (or even halted altogether), research staff are working remotely, and many protocol-related activities that took place in person are now substituted for electronic alternatives. As always, there are a lot of moving pieces when it comes to conducting research, but ensuring participant safety and data integrity during this time has provided additional challenges.

Even with the current changes in place, research is critical to providing information contributing to the mental, social, and physical health of the community, and it’s important to keep moving forward. While conducting quality research, addressing how research is done needs to be thoughtful and mindful of the safety of principal investigators (PIs), staff, and participants.

What Does Restarting Research Look Like?

All stakeholders need to be involved and on the same page to ensure restarting research protocols moves forward in a meaningful and efficient way. Communication is key to making sure everyone understands the various moving parts. Working together ensures research continues smoothly and without hitting barriers. Understanding changes in policy structures or changes in process flows will help everyone understand the process fully, furthering effective communication.

Additionally, staff will have to work together to facilitate and communicate a plan with stakeholders – whether that’s to hospital care staff, research staff, compliance personnel, and institutional review boards (IRB) or institutional biosafety committees (IBC). Each stakeholder will bring new restraints, constraints, and resource considerations that may be implemented across an institution (such as social distancing measures), or specific to a single department and it is important to understand these in order to ensure the mission in supporting research is fulfilled.

The time given to conduct research may also look a little different. Staff may be redirected to clinical work, or local IRBs might be overloaded and unable to help sites take on new studies. Establishing procedures for assessing feasibility of studies and risk assessments will help sites identify what studies are doable in the restart phase versus what studies might be too challenging or cannot start at this particular time.

While day-to-day tasks may have changed during COVID-19, the foundation of clinical research has not. Advancing medicine and science is pivotal, as is keeping the safety and well-being of participants in mind. It’s the “how” that is changing – for example, the processes put in place to ensure participants’ safety, or the amount of documentation required may look different.

Keep Research Moving Forward

There is a lot to consider when continuing on with protocols. While it may seem overwhelming at first, and even so after communication between stakeholders is initiated, sites can and will have the ability to flourish in this new realm. The goal of restarting research is allowing sites the ability to grow and conduct solid research, rather than putting in policies and procedures for research staff to “make it work” for the time being.