For planned emergency research, the United States Food and Drug Administration (FDA) regulations governing research with humans provide for a narrow exception from informed consent for emergency research. To conduct this research, the regulations require that the community where the research is being conducted be informed about the research ahead of time. The community must also be given the opportunity to provide feedback on the study through community consultation. Historically, this has involved the research team engaging members of the community in face-to-face conversation. The recent COVID-19 pandemic complicates traditional models of community consultation. How should sites conducting planned emergency research approach community consultation in the time of COVID-19?
What Is Planned Emergency Research Involving an Exception From Informed Consent?
The FDA regulations permit IRBs to approve research without requiring that informed consent be obtained when specific conditions are met, including that individuals are in a life-threatening situation, no proven or satisfactory therapies exist, and the research holds the prospect of direct benefit for enrolled participants. In addition, informed consent must not be feasible, due to the participant being incapable of providing consent because of their medical condition and a legally authorized representative being unavailable within the window during which treatment should be initiated. Finally, the institutions conducting the research must have engaged in consultation with the community and public disclosure, and such efforts must be approved by the IRB.
What Is Community Consultation for Planned Emergency Research?
While ”public disclosure” generally involves informing the community about the study through a one-way transfer of information (from the research site to the community), ”community consultation” (CC) is a much more interactive activity. It involves conversation and dialogue with, and listening and learning from, members of the public.
FDA guidance emphasizes several key objectives of CC. These include showing respect for community members by informing them about the study, giving them an opportunity to provide meaningful input and express potential concerns to the research team and IRB before the study commences. The relevant community is defined in geographical terms: it involves the catchment area from which the hospital draws patients, with particular importance on reaching people who may be at risk for the condition being studied and thus more likely to be enrolled in the study.
CC and the Challenge of COVID-19
Historically, examples of CC activities include such things as the research team attending existing meetings or groups and giving an interactive presentation, or setting up a booth and speaking with people at fairs or sporting events. Unfortunately, due to the current pandemic, these types of face-to-face interactions may involve a high risk of viral transmission, and many states have placed restrictions on public gatherings. While the risks of in-person CC are contextual, and the decision about whether to conduct them is complex and multi-factorial, many sites may wish to pursue activities that minimize risks to the study team, community members, and public health.
A number of strategies for conducting remote CC are available and may fill this need. Such strategies leverage online platforms, social media, and other technologies to enable community member engagement while minimizing public health risks. Notably, nothing in the FDA regulations or guidance precludes such remote CC or using online platforms to satisfy CC obligations. While doing so may require flexibility and creativity, the following types of online activities may be considered.
Target Existing Online Meetings
Many groups that met in person before the pandemic may now have switched to virtual meetings using Zoom or other technologies. Such venues may support interactive discussion and engagement no less than at in-person meetings. Sites should consider contacting representatives from existing groups and enquiring into whether they are conducting online meetings that can accommodate CC presentations and discussion.
Convene Online Meetings
While it may sometimes be challenging to locate existing online groups, investigators may also take the initiative to convene their own online forums for CC purposes. This might involve inviting known community representatives and advertising the meeting to the public in community forums, public-facing websites and social media pages, and listservs.
Interview Community Leaders
One-on-one interviews with community leaders, such as the heads of local religious or activist groups, can be a legitimate way to gauge public perception and hear concerns through the eyes of respected community members. Such interviews can be conducted remotely using online platforms or by phone.
Conduct Online Surveys
Surveys are often used during CC to document community member views and preferences. Ideally, surveys should be made widely available and aim to capture a demographically representative slice of the catchment area. Ideally, survey respondents should have an opportunity to learn about the research and ask questions before being asked to complete the survey.
Fortunately, it is relatively easy for surveys to be coded into online platforms, such as RedCap or Qualtrics, to facilitate remote CC efforts. A link to the survey can typically be sent to individuals who participate in online CC meetings, forums, and interviews. The study team may also wish to make the link more widely available through social media or public-facing websites. Such links should be accompanied by educational materials that describe key study features, so community members can complete the survey with pertinent background knowledge in mind.
COVID-19 has raised operational and ethical challenges across the research spectrum, and planned emergency research is no exception. However, with sufficient creativity and persistence, remote community engagement may permit robust interaction with community members and accomplish respect for autonomy and the other aims of CC in a way that satisfies regulatory obligations and is mindful of public health.
Want to know more about planned emergency research? Watch our on-demand webinar Conducting Planned Emergency Research in the Era of sIRB.