Have you considered using social media to recruit participants into one of your clinical trials? Have you looked at the stream of posts on Facebook and wondered, could that help us find the right people for our study? If so, you’re not alone. In an earlier blog I looked at the growing interest in using social media platforms such as Facebook or Twitter to reach the right participants. But this remains new territory; despite the appeal of reaching out to Facebook’s 1.3 billion users or Twitter’s 230 million, regulatory agencies are still refining their guidance around participant recruitment through social media.
If you are considering a social media campaign to recruit participants, you may be wondering what a sponsor, a CRO, or a site should include in an IRB submission. I have found it’s always helpful to learn by example, and here I’d like to review a recent submission to Quorum that reflected a thoughtfully-prepared social media recruitment program.
What Does the IRB Review?
The essential submission criteria for online social media are the same as for print, radio, television, and Internet banner ads, but social media’s unique nature creates some additional requirements. As a reminder, for any recruitment campaign the IRB needs to review material that is specific to a study trial and directed at prospective or current participants.
At the same time, the IRB does not need to see information that discusses a condition generally, or that does not reference a particular study.
Our example: For this clinical trial the sponsor planned two main branches to its social media program: one would provide general information about the disease itself (the target condition was a little-known subset of a disease). The second branch would discuss the clinical trial. The sponsor’s design included extensive links between the two branches, and the submission to the IRB included information about both. In this case, the sponsor actually included more than was necessary, because the IRB focused only on the trial-specific side of the plan.
What to Include in an IRB Submission
The IRB needs to see everything a potential participant will see about a clinical trial. A social media program can complicate this part of the submission, as the program design can include page layouts and functions, texts of messages to be sent, statements about expectations, images that will appear, tags and hashtags, etc.
Our example: The submission included a thorough overview of the social media program. The packet included screen shots of pages, images to be used, and what text the sponsor would use in discussions or posts. The overview included text of privacy disclosures that would appear on the site, an important inclusion. All of this helped the IRB understand the context of how participants would interact with the site, and what they would see there.
A Social Media Management Plan
Much more than static radio or print ads, a social media program can create a dynamic interaction between researcher and a potential participant. The IRB needs to understand how the sponsor will handle the program after it launches, and how the sponsor will respond in these continuing interactions. A well-formulated management plan can reassure the IRB that the social media campaign will run appropriately. At Quorum, solid submissions have included:
- A rationale for using social media
- Discussions of privacy and confidentiality issues
- Policies for vetting communications
- Processes for handling user-generated content
Here’s how our example handled each:
Rationale: The sponsor described how it selected the two social media platforms it wanted to use. The sponsor had found that the patients they were seeking used those platforms more often than others. The background demonstrated to the IRB that the recruitment program could reach the right people.
Privacy and confidentiality: The sponsor submitted the guidance it would use on both platforms and outlined for the IRB the strengths and vulnerabilities of each platform it had selected. The sponsor also provided its internal management plans for protecting user confidentiality and privacy.
Vetting communications and handling user-generated content: The IRB will want to know how the sponsor plans to manage communications in the dynamic arena of social media. Two issues are of particular concern to the IRB here:
- Identifying what future content will require IRB review and approval and what will not
- How user generated content will be reviewed to determine if there is a participant rights or safety issue that must be addressed
In this case, the submitting sponsor revised some of its planned posts to match the IRB’s suggestions, and outlined how it would monitor public postings. The sponsor planned to check user posts daily for the first 60 days, and then multiple times a week after that. The sponsor stated clearly for all users what its policies would be.
Quorum’s IRB approved this sponsor’s plan, and the recruitment program has been online for many months. As more sponsors, CROs, and sites turn to social media as a recruiting tool, this example of a good submission might help you prepare yours. To learn more about social media and recruiting for clinical trials, view our recent Quorum Webinar.