PAID MESSAGE
Social media can be a valuable tool for researchers to connect with and recruit potential clinical trial participants. However, US regulations and regulatory guidance do not currently provide specific information on the use of social media clinical trial recruitment strategies. In this blog, we’ll explore how existing regulations might be applied to establish best practices in using social media for research participant recruitment and engagement.
Defining the Scope of Social Media
“Social media” can be defined as interactive platforms for electronic communications, used by groups of people to create, share, and exchange information. These platforms are typically internet-based and allow users to interact with other users through a website or mobile application.
Examples of social media usage in clinical trials include:
- Facebook and Twitter advertising campaigns to recruit participants
- A phone application (i.e., iPhone, iPad, or an Android platform-based phone) that users download on their phones and use as an electronic diary
- A Pinterest board where a clinical trial site can “pin” news articles, blog postings, and enrolling clinical trials
- A Facebook page for the study
Although the forums and types of social media are distinct, the review by the institutional review board (IRB) is based on the same fundamental principles and regulatory requirements that govern review of traditional recruitment materials.
Regulatory Basis
An IRB has “the authority to approve, require modifications in, or disapprove all research activities” covered by IRB regulations (21 CFR 56.109; 45 CFR 46.109). In addition, an IRB is required to ensure that appropriate safeguards exist to protect the rights and welfare of research participants (21 CFR 56.107(a); 21 CFR 56.111; 45 CFR 46.109).
To fulfill these responsibilities, FDA guidance indicates that the IRB is expected to review the methods and material that investigators propose to use to recruit participants, as recruitment is considered the beginning of the informed consent process for participants. The IRB must review advertising material to ensure that it is not unduly influencing and does not promise a certainty of cure beyond what is outlined in the informed consent form (ICF) and protocol.
These regulatory requirements and expectations may present a challenge to the IRB when asked to review campaigns where complex risk and/or benefit information is communicated to the potential participant. Applying current regulatory tenets to the realm of social media requires flexibility and sensitivity to the nuts and bolts of social media platforms and how they function.
Review Standards
As noted in the FDA information sheet Recruiting Study Subjects, the IRB should review the information contained in an advertisement and the mode of its communication. Generally, the following types of material should be reviewed:
Recruitment
- Any direct advertising using social network ads, display ads, banner ads, rich media ads, paid search ads, and in-text ads
- Any free-form listing of study-specific information including but not limited to a study description, contact information, and compensation designed to recruit participants
- Any study-specific websites or posts designed to recruit participants
- Any study results published or disseminated with an intent to create interest in new research opportunities
Communications
- Any study- or site-specific websites or social media intended to serve as support for enrolled participants
- Any communications intended for study retention or advertising for future studies
Interactions
- Any study or site-specific websites or social media that allow for user-generated content
- Any requests for the provision of identifiable private information (e.g., health) from potential or current participants
- Any protocol study tools (applications or software) used to collect data for the research (e.g., an app that captures glucose or blood pressure readings, an app that interfaces with an implanted device, etc.)
IRBs may have varying policies regarding how this information should be submitted for review (e.g., final text and graphics). Researchers should consult with the IRB of record to ensure they understand IRB requirements.
Review should be undertaken in accordance with the guidelines set out in FDA guidance and the IRB’s written procedures. In addition to the standard guidelines, the IRB should account for any unique issues that may be unduly influential or raise privacy issues based on the proposed activity and the technology being used. For example, IRBs could legitimately raise concerns about using an open Facebook group to recruit, given that posts made to the page by interested parties could be viewed by others on the platform, resulting in potential inadvertent disclosures of sensitive health information.
Interactive Social Media Programs
One of the most difficult parts in a social media program is managing interaction with participants. Where an investigator, sponsor, or participant will interact with another participant (ge., through a Facebook page or an online message board), a written management/communication plan is advisable. The plan serves two prongs:
- Sponsor/Site– Development of a plan allows a sponsor/site to define the nature, frequency, and scope of social media interactions, and ensure the rights and welfare of research participants are protected.
- IRB– The IRB can use the plan to evaluate the social media program and ensure it is not unduly influential or coercive. Additionally, where social media will be used for the retention of participants, the IRB can ensure the information given to participants is in accordance with the regulations, and appropriate safeguards exist to protect the rights and welfare of research participants.
Conclusion
IRBs must consider a number of factors in developing review standards for social media and guidelines for social media plans. Existing guidance and regulations provide a good starting point for researchers and IRB to collaborate in ensuring social media recruitment strategies are ethical and appropriate. Want to learn more about using social media in clinical trials? Watch Advarra’s webinar “Social Media for Research Recruitment: Ethical and Practical Aspects.”
Author: Luke Gelinas, PhD, IRB Chair Director, Advarra
