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4 Regulatory Considerations for Using Social Media in Clinical Trial Patient Recruitment

Posted by Brook White on Thu, May 21, 2015 @ 10:56 AM

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kristin-headshotKristen Snipes, Project Director

Social and digital media can be powerful tools for recruiting clinical trial participants and speeding up enrollment; however, there are several regulatory as well as operational considerations you need to keep in mind.  Here are some important ones:

IRB Approval

IRB approvalSocial media and digital media can have a much more informal feel than traditional advertising venues, like a newspaper or radio ad. While most of us would ask someone else to review anything we wrote for a newspaper, most of us don’t ask anyone before we post something on Facebook or Twitter. From a regulatory perspective, however, these two activities are the same if they are being used for patient recruitment. If it is visible by potential patients, you should assume it will need IRB approval and plan accordingly.

Depending on the type and format of social and digital media you are using, you will need to give some thought to how you will present the information to an IRB. For example, if you are promoting a study through Google AdWords, you will need to be able to provide the text of the ad and a static view of the page to which the ad will direct traffic. For a Facebook ad, you will need to include the text used as well as any images and links that are included. A web page will require a visual of the page layout, text included as well as any links provided to the subjects.

Sponsor Perceptions and Approval

Make sure the study sponsor is on board both with what information will be shared in the recruitment process and how it will be shared.  Social media potentially has a very broad audience and once you’ve posted something you have much less controlled with how it will be shared and distributed than you do with traditional media.  Sponsors may be less comfortable with providing detailed study information through social media channels than they would, for example, a poster designed for doctors’ offices.  The information posted on Clinicaltrials.gov is a good starting point as it will contain information the sponsor is comfortable sharing externally. Use of web pages and other social media can raise questions about the ownership of data and the restriction of access in a public domain.

Use Caution with Patient Provided Information

warningIf you social or digital media plans include collection of patient information (even if there is a potential that patients will submit data), you need to be particularly careful.  Two important questions to ask are what information are you collecting and how will you use the information.  Avoid collecting anything subject to HIPAA and be careful that nothing they submit would require informed consent.  In some cases, you may find that a process that is less efficient is still the way to go.  For example, rather than collecting information through a web form that is then submitted to sites, you may want to direct the patient to contact a site directly or use a call center with appropriately trained personnel.  This plan will also require review and approval by IRBs.

Picking an Agency

Sometimes CROs and sponsors don’t have the necessary expertise in-house to set up a social or digital media campaign, so it makes sense to outsource some of these activities.  If this is the case, you will likely be better off using a recruitment vendor that offers social and digital media services than a traditional ad agency.  If you do go with an ad agency, make sure they have experience working in regulated industries.

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