Ramon Jones

by Ramon Jones

Human Subject Protection in the Age of Social Media

The power of communicating through social media is increasing rapidly: In 2017, Facebook reported 2.07 billion monthly active users, and Instagram and Twitter achieved all-time highs at 800 million and 330 million monthly active users respectively.

The ways in which the general public interacts with social media are unpredictable, and the communicative structure of social media is in constant flux. These changes have been paralleled by significant regulatory changes affecting internet usage. In March 2017, the Senate passed a vote to allow internet service providers to use and profit from user information without user consent. More recently, the Federal Communications Commission (FCC) voted to repeal “Net Neutrality” and deregulate the broadband industry.

Our internet landscape is changing, prompting necessary discussions on how sponsors should continue to work with IRBs to protect clinical research participants.

How Do Research Sponsors Use Social Media?

Most often, sponsors use social media platforms as recruitment and retention avenues. Sponsors may rely on social media to house materials that are intended to be seen by a study participant prior to enrollment, upon enrollment, or after enrollment closes. These include, for example, recruitment flyers, radio scripts, posters, participant cards, and website materials.  When reviewing such materials, Quorum Review IRB adheres to standards informed by Food and Drug Administration (FDA) guidance to ensure the following:

  • Prevention of therapeutic misconception: Quorum generally removes language that implies or promises potential benefit from a study, makes claims about the efficacy of an investigational product, or in other ways conflates research procedures with medical treatment.
  • Elimination of language that is unduly influencing: Though they are often subtle, unduly influencing statements can promote participation in a study by, for example, overemphasizing compensation or the quality of care to be delivered, or by promising other incentives such as free study product.

How Do Participants Use Social Media?

In contrast to sponsors, participants use social media on various platforms (Facebook, Twitter, Instagram, and chat rooms) in ways that are dynamic and unpredictable. When discussing their individual involvement in research, participants could increase the risk of unblinding a study and breaching confidentiality (their own and others’). Participants can also provide skewed reporting of benefits and/or adverse events or disseminate misinformation to the public in other ways.

How Does a Sponsor Build a Protective Social Media Management Plan?

The IRB, with guidance from the FDA and National Institutes of Health (NIH), is tasked with monitoring and minimizing the risks associated with social media use in clinical trials. This mitigation of risk is facilitated by requiring sponsors to compose a tool called the social media management plan. A detailed and concise social media management plan should address the following elements:

  • Management and monitoring: Identify who will provide oversight for use of social media content. Who will be responsible for answering questions regarding efficacy and safety? At what frequency will monitoring of user-generated content occur (i.e. hourly, daily, weekly)? Is there someone who can serve as the contact for clarification of content?
  • Advice from Quorum: A study physician or qualified study staff should answer user questions posed on social media. This safeguard prevents such risks as unqualified individuals providing information that could lead to harm.
  • Continuous monitoring is warranted because social media is continuously populated. Standard operating procedures for handling different types of comments and questions, including who can be contacted if problems arise, should be comprehensive and robust.
  • Maintenance: How will you resolve IT or technical issues? Is there a dedicated team for these issues? How will data gathered through social media be used, stored, and managed to ensure participant safety and data integrity?
  • Advice from Quorum: It is good practice to have technical staff available to remediate any issues that may arise, particularly those that might result in breaches of privacy or confidentiality, or that prevent the answering of user questions related to safety events.
  • Safety and data integrity: How will you handle inappropriate or misleading comments, or comments related to promise of therapeutic benefit? How will you monitor the accuracy and relevance of statements made about side effects?
  • Advice from Quorum: Misleading, inaccurate, or inappropriate comments could potentially unblind study groups, promulgate therapeutic misconception, raise false safety alarms, or violate the rights or reputations of study staff or other participants. You should monitor, hide, or delete such comments as necessary.

Social media platforms have provided clinical trial participants with a powerful public voice. Mitigating risks associated with this new frontier of clinical trial interaction will take time. Sponsors must be forward-thinking in their use of social media platforms and their establishment of social media management plans, and IRBs must be thorough in their reviews of such plans. Eliminating risk associated with user-generated social media content and promoting participant safety are the IRB’s primary objectives.

For more information about social media use in clinical trials check out IRB Review of the Use of Social Media in Research and Research 2.0: Embracing Social Media in Clinical Trials.


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