Patient Recruitment: Regulatory & IRB Considerations of Social Media

Many questions remain regarding social media’s use for patient recruitment, particularly with regard to regulatory and IRB considerations. Though pharma marketers are breathlessly awaiting the twice-delayed FDA guidance on social media, this guidance will be of little use to the clinical research industry, which has unique regulatory constraints.

This informational void is further exacerbated by uncertainty about the expectations of IRBs. But these expectations recently got a bit clearer. Mitchell Parrish and Claire Carbary of Quorum Review IRB hosted a webinar to provide information on the regulatory and IRB considerations associated with using social media in clinical research.

The webinar addressed the use of social media in three aspects of research: recruitment, communication during the course of a study, and post-study communications. I’m just going to summarize the patient recruitment portion of the webinar, but the full video and slides are available for viewing on the Quorum website.

Mitchell Parrish led the patient recruitment portion of the webinar, using existing FDA and DHHS regulations to guide discussion of social media in patient recruitment. Specifically, Parrish relied on two particularly applicable FDA Information Sheets: Recruiting Study Subjects and A Guide to Informed Consent.

The session provided much-needed clarity with regard to social media and patient recruitment as well as one suggestion that I found surprising.

Though this webinar was a step in the right direction, many questions remain. IRBs have distinct policies, so there will undoubtedly be much variation in how they view social media. In fact, I know of at least one research site that was refused approval of patient recruitment tweets of any kind. So it is still extremely important that research professionals communicate with IRBs to understand each of their policies.

What is the IRB Assessing?

To expedite the review process, it’s helpful to understand exactly what the IRB is assessing when reviewing patient recruitment materials.

Though not written with social media in mind, the FDA Information Sheet Recruiting Study Subjects can be applied to social media. Using this information sheet, we can infer that the IRB needs to review social media recruitment materials to ensure that ads:

• Are not unduly coercive
• Do not promise or imply a favorable outcome of other benefits beyond what is contained in the protocol
• Do not communicate that the study product is safe or effective the the purposes under investigation
• Do not make claims that the study product is known to be equivalent or superior to any other study product
• Do not include language indicating that regulatory authorities, such as the FDA and IRB, have approved the research
• Do not cause therapeutic misconceptions (e.g. modify the word “treatment” with a word that does not imply a benefit or explain that a term like “new drug” means that the study product is investigational)
• Do not promise or imply free medical treatment when the intent is to say subjects will not be charged for participation in the investigation
• Do not emphasize payment
• Provide information limited to that which subjects need to determine their eligibility and interest
• Do not include statements that are generally misleading

FDA: What Requires IRB Review

The Recruiting Study Subjects Information Sheet also discusses which items require review.

Does Not Require Review

According to the FDA, the following items do not require review by your IRB:

• Communications intended to be seen or heard by health professionals (e.g. doctor-to-doctor letters)
• News stories
• Publicity intended for other audiences (e.g. financial page advertisements intended for prospective investors)

Does Require Review

Review is required for direct advertising to research subjects. In other words, review is required for advertising that is intended to be seen or heard by prospective research subjects. This guideline includes, but is not limited to, newspaper, radio, TV, bulletin boards, posters, and flyers.

Parrish used the example of a blog to apply this guideline to the social media realm. While a blog that is strictly a news story does not require review, a blog intended to recruit patients does require review. For instance, if the blog contains information about how to enroll in a trial, compensation for the trial, or contact information for the trial, clearly the intended audience is prospective patients. In this instance, the blog will require review.

IRB: What Requires Review

With a discussion of the FDA’s viewpoint in place, Parrish went on to discuss what requires review from the perspective of the IRB.

Does Not Require Review

The following items generally do not require review:

• Information about relevant research conducted outside the study, including information on websites, blogs, Facebook, and Twitter
• General tips and/or resources containing information that is generally accessible on the Internet. This includes copied information from or links to blogs, news articles or sources, websites, or other social media pages.
• Signs and symptoms of the underlying disease or condition
• Information, pictures, videos, links or other information posted by a research participant
• Websites that contain only the following information: study title, purpose of study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the study site for more information (e.g. clinicaltrials.gov)

Parrish emphasized the fourth item on this list, which addresses information posted by a research participant. Participants are free to share information about clinical trials as they please. For example, a research participant who has a Facebook page is free to post information about a clinical trial. That Facebook page does not require review.

Regarding the fifth item, Parrish notes that OHRP’s Guidance on Institutional Review Board Review of Clinical Trial Websites exempts particular kinds of clinical trials websites from review. Websites not requiring review must be limited to information about study title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the study site for more information. An example of a website not requiring review is clinicaltrials.gov.

Because of this guidance, we can infer that social media posts limited to the information outlined by OHRP may not require review.

Does Require Review

As stated previously, all forms of direct advertising require review. Direct advertising can take many forms and can be found on search engines, websites, Facebook, blogs, etc. Ad formats subject to review include display ads, rich media ads, search ads, in-text ads, social network ads, social network pages, blogs, tweets, and text messages.

Regardless of your communications medium or where it appears, any communication intended for consumption by prospective patients will require review.

Regarding social network ads, Parrish noted that some of these social network ads might raise questions in terms of invasiveness. A social network will track user interests with “cookies” and use those interests to serve users relevant ads on their page.

Personally, I don’t consider social media ads to be inherently more invasive than other forms of online advertising. You can hardly visit a website these days without being “cookied,” and therefore tracked. Certainly, websites will vary in their level of invasiveness, but I think that’s largely a function of individual website policies rather than website categories.

The primary difference between search engines and social media sites is not the level of invasiveness but the kind of invasiveness. Search engines tend to focus on tracking search-related information, while social media sites focus on tracking demographic and interest-related information. And it’s important to note that advertisers are only given access to this information in the aggregate, rather than on an individual user level.

Parrish also goes into detail about social network pages. For example, a study-specific Facebook page can be used for patient recruitment purposes. If you are using such a page to collect patient information, the IRB will have some additional considerations:

• Access or privacy settings of the page
• Is any protected health information (PHI) being recorded? Is a partial HIPAA waiver required? Are you using a pre-screening form?
• Confidentiality of the collected information?

Additional examples of items requiring review include:

• Blogs for a specific study containing direct advertising
• Posts on any blog containing direct advertising
• Tweets containing direct advertising
• Text messages containing direct advertising

Beyond IRB Review

As previously discussed, existing regulatory guidance provides direction on what patient recruitment communications require review. But the IRB may ponder additional issues specific to social media. These issues include:

• Sending promotional messages about a clinical trial without using the medium in ways typical of a common user. Is this an appropriate use of new mediums? Is it intrusive to potential participants?
• Soliciting in social network sites or Twitter groups, such as breast cancer support groups may seems intrusive and inappropriate to members of those groups
• Collecting or obtaining PHI from social network sites implicates privacy, confidentiality, and potentially HIPAA concerns. Such collection could be akin to collection of data via receptionist scripts. The FDA Information Sheet Recruiting Study Subjects provides guidance about questions IRBs should ask when reviewing “receptionist scripts.” These questions include:
  • What happens to personal information gathered?
  • Are the data gathered by a marketing company?
  • If so, are names/other information sold to others?

I was pleased that Parrish addressed the issue of spamming in the first two of these items. This practice is something I have witnessed several times on social media sites, and it does not serve patients or the clinical research industry well.

When you communicate with prospective patients via social media, it is important to consider whether your communication is appropriate for that medium and respectful of prospective patients. According to Parrish, this is an issue that the Quorum Board will ponder as well.

Parrish also noted that the IRB will likely have questions about how information is gathered, retained, stored, or shared for online patient recruitment campaigns.

Working With Your IRB

One of my major concerns about the use of social media for patient recruitment relates to the difficulty of conversing in a manner social media users expect given the constraints of our industry. Social media users are accustomed to interactive dialogue, which is difficult for research professionals to participate in if every social media post must be approved.

To my surprise, Parrish indicated that there might be room for more flexibility with regard to the approval process.

Clinical research professionals should work closely with the IRB before recruitment begins and provide parameters for what might be discussed via social media. If you work closely with the IRB up front, the IRB may be able to provide expedited review for social media posts during the course of enrollment. Alternatively, if your social media post is within the parameters that you and the IRB have agreed upon and the essence of that post is the same, you may not require additional review.

If other IRBs adopt similar policies, this flexibility would certainly make social media a more attractive recruitment option. The key is that research professionals communicate with IRBs early to determine their policies and map an appropriate recruitment plan.

Do you have experience with seeking IRB approval of social media posts? Do you have any thoughts on the information presented? Share your comments below.