In everyday life, social media is a connecting tool, allowing users from every corner of the earth to gather and keep up to date with one another. According to a Pew Survey, 72% of adults in 2019 were connected via social media. It’s no wonder clinical research has taken to social platforms as a method to recruit and retain participants for upcoming trials in their area. Thousands of potential participants can be reached via targeted ad, or from word-of-mouth about related groups.
Luke Gelinas, IRB Chairperson at Advarra, dissects what social media’s role in clinical research looks like in his articles Should Social Media Be Part of Your Research Toolbox? and Differentiating “Public” and “Private” Internet Spaces in IRB Review.
Even though social media usage is growing in many demographics around the world and it may be a useful tool to recruit participants, study staff still need to be aware of the ethical norms when interacting with potential participants. The responsibility is shared between Institutional Review Boards (IRBs), sponsors and sites to ensure research participants are protected and kept confidential on a platform.
Once online, researchers need to take the step to mitigate any risk of sensitive information about a participant being shared in a public space, as well as minimize interacting with a user in a way that would let the user’s friends or followers conclude they are involved in a clinical research study. Establishing this trust in the beginning when recruiting participants will also need to happen as they work on retaining participants.
Creating online groups or forums poses many benefits for current participants of a study. Giving participants a space to connect and discuss their experiences will minimize participants’ isolation as they move through the study. Online groups or forums acting as participant communities are especially helpful for participants who are contemplating on leaving a study due to lack of follow-up. Keeping participants engaged will likely boost their chances of completing the study, minimizing dropout rates. Staff can also reduce participant drop out by monitoring forums for potentially problematic communication, such as study misinformation spreading.
Additionally, study staff can also build digital rapport with participants. Feeling connected to a study staff member is just as important as feeling connected to other participants in a study. Having an online presence will help participants feel at ease when asking questions or looking for clarification on a study. Providing clarification on any participant questions will also promote retention in the trial.
As best practice, study staff involved in an online group or forum should work to prevent undue influence and misconception, as well as study unblinding. Examples of undue influence or study unblinding could be a participant believing they are receiving the placebo and withdraw due to that, and a participant revealing symptoms and experience of taking a product on an online forum.
Differentiating Public vs. Private
Even with the added benefits of an online community of support from fellow participants and study staff, users need to be aware of the difference between public and private internet spaces, and what that means in terms of researchers using the given information. A Common Rule exemption criteria states “research uses of identifiable private information” (including information found online) are exempt from typical Common Rule protections, such as full board or expedited IRB review, if some information is “publicly available” (45 CFR 46.104[i]). IRBs are responsible for defining if these spaces are public or private and ensure adequate protections for postings in groups.
Gelinas identifies three different categories of online information:
- Online information with no prerequisites for viewing. Information must not be gated by creating a username or password, or have any special features, such as having a health condition. This category contains the most “public” information.
- Online information requiring joining or logging into a platform, but not requiring any special features beyond this.
- Online information requiring a user to both log into a platform and affirm the user has special features. This category contains the most “private” information.
It can be helpful to think through which internet spaces are “public” versus which are “private” and whether the Common Rule exemption criteria above applies. If a site is working with multiple IRBs, keep in mind each IRB may have different ideas as to what is considered “public” or “private.” Determining these categories ahead of time will save your site time and ultimately make it easier for participants to understand which online group or forum may be more susceptible to usage of public information.