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Precautions against spreading the coronavirus, including physical distancing and working from home, have transformed the work of academic research teams across the country. That’s especially the case for scholars who conduct behavioral research, like us: Danielle Arigo specializes in research promoting healthy behaviors like physical activity, Ilana Graetz studies medication adherence for women with breast cancer and Becca Krukowski conducts weight- and smoking-related research.
Such research focuses on understanding how people think, feel and act -- either in their usual circumstances or in response to introducing new variables, such as new settings, people or treatments. COVID-19 precautions have changed this work in myriad ways.
For example, many assessments that behavioral scientists have conducted face-to-face -- meant to objectively verify participant characteristics like weight, behaviors such as walking speed or activities in real-world contexts like grocery stores or fitness centers -- are not possible right now. Restrictions on in-person contact may limit confidence in measurement accuracy and validity. In many cases, such work has stopped until precautions are lifted and face-to-face visits resume.
Some pre-existing behavioral research has continued during this time, such as long-term observational studies or treatment trials. But changes to participants’ environments and social contact due to COVID-19 precautions are likely to shift their behavior from what was typical pre-pandemic. Consequently, we can’t assume participants’ current behaviors and experiences represent the usual, or that change over time is due to treatment effectiveness. Although randomized controlled trials can adjust for changes in temporal trends related to the pandemic, intervention effectiveness during this time may simply not be generalizable to non-pandemic times.
Institutional review boards and funding agencies’ guidance has generally been to not continue or start new research unless it is fully remote, considered essential or COVID-19 related. As a result, some behavioral researchers are debating whether to enroll new participants in ongoing research trials. When the trial has a treatment element, like Becca’s weight and smoking studies, it may make sense to enroll new participants; they may have more time and also be more motivated to participate in certain trials related to, say, research on smoking cessation treatments since smoking is a risk factor for COVID-19 severity. Also, learning effective coping strategies through participating in a behavioral intervention in areas like weight management during these particularly stressful times could set participants up for even greater success during less stressful ones.
In contrast, behaviors involving physical activity may be reduced due to stay-at-home orders, so enrolling new participants in research like Dani’s ongoing observational study of physical activity does not make sense. People who were previously enrolled may have very different patterns compared to those who enrolled mid-pandemic, and their data could not be combined to draw conclusions about the broader population.
New Approaches Required
Meanwhile, the COVID-19 pandemic is spurring universities, institutional review boards and investigators to update policies and procedures around consent, assessments and compensation. Here are our recommendations to other behavioral scientists for dealing with each area under the new conditions.
Informed consent processes. Without in-person enrollment, you will need to modify your consent process to allow for remote discussion and verification of consent. For studies with minimal risk, IRBs may allow for a verbal consent statement over the telephone or with an e-signature using Redcap or a similar platform. An alternative for remote consent is electronic signatures through companies such as DocuSign. Institutional review boards may require verification of who signed the form and collect additional identification, like a driver’s license photo, at the same time.
Of course, a low-tech option is sending consent documentation by mail. You can facilitate that by sending two copies of the consent form -- one for the participant and one to return to the research team -- as well as an addressed, stamped envelope, so the participant can easily return signed consent without going to the post office.
Assessment. For research with in-person interventions and assessments, you can transition to distance-based modalities -- videoconferencing, telephone calls, online questionnaires -- as long as they are sufficiently secure. Many interventions use digital tools that collect data remotely -- for example, researchers already collect many patient-reported outcomes using online surveys or mobile apps.
Other digital tools, however, can be more challenging, such as electronic pill boxes, physical activity monitors and smart scales. Participants already enrolled and using such devices can continue doing so in various ways. Such usage, however, can be a little more complicated with new participants, who may be wary of receiving devices by mail or may face technical challenges learning how to use such tools without in-person training.
For one of her studies, which requires particular caution as participants are breast cancer survivors, Ilana has mailed participants electronic pill boxes, encouraged those participants to wash their hands after handling the packages, and asked them to wait 24 to 72 hours before opening them. Her team has also created user guides to orient participants to the pill boxes and offer remote troubleshooting. If devices need to be returned to the investigative team, careful planning is required regarding device cleaning and safety so as to not require staff or participants to leave their homes to mail or receive the device. Nonetheless, many biological specimens, even those that normally could be collected remotely, will need to be discontinued in order to ensure research team safety.
Participant compensation. An electronic gift card is one remote compensation option that doesn’t require the staff or participants to use the postal system, potentially touch contaminated items or leave their homes. Some electronic gift cards allow small and unusual amounts, which may be necessary for certain protocols with frequent incentives in small amounts. Although some institutions don’t currently allow electronic gift cards, now would be a good opportunity to either change those policies or provide a suitable alternative.
Maintaining Team Communication Remotely
As investigators, you are probably also responsible for continuing to provide quality learning experiences and supervision for trainees and staff even when on-site work is prohibited. Although your time may be more limited now, holding virtual group meetings allows for professional and social connection, ongoing learning, and orientation to new research practices. You can use those meetings to share your process for thinking through the issues raised above as a way to teach trainees and staff how to make decisions and responsibly conduct research during times of upheaval.
For example, Dani recently devoted virtual meeting time to discussing the pros and cons of introducing follow-up data collection in her observational physical activity study as a way to examine changes pre- and mid-pandemic. You could also use meetings to encourage mutual support among team members, which could help them feel less alone in their challenges and bolster their motivation for research activities.
Although interruptions in data collection could have severe consequences for our research productivity as well as our ability to support trainees and to make meaningful scientific advancements, the COVID-19 pandemic is also compelling us to innovate. Technology-based research procedures may illuminate opportunities for disseminating interventions that may not have been previously attempted. Some researchers are also asking new questions about how people are managing physical distancing and how it changes their behaviors, beliefs, intentions, risk perceptions and so on. We will also be able to increase access to behavioral treatments among populations who aren’t typically included -- such as those in rural areas, military personnel and young adult populations who are highly mobile.
We are hopeful that changes in policies and procedures will have a positive and lasting impact on behavioral research. The pandemic has created significant challenges -- there will be many missed deadlines, studies with insufficient sample sizes and asterisks in manuscripts describing modifications to research methods. But we could, in fact, emerge stronger, more adaptable and more innovative.