Institution Bulletin vol 5, issue 1
As new technologies emerge, stakeholders must find ways to apply existing regulations and guidance to ensure appropriate IRB review and approval is obtained. This presents a huge challenge to independent and institutional review boards (IRBs) as they must develop their own written policies and procedures. This article focuses on the regulatory basis and considerations an IRB may want to contemplate when developing their own policies on reviewing social media recruitment and retention campaigns.
Defining the Scope of Social Media
Quorum Review has defined “social media” as “an interactive platform for electronic communications, used by groups of people to create, share, and exchange information.” Typically, these platforms are internet-based and allow users to interact with other users through a website or web application. Examples of social media usage in the context of 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 phone and use as an electronic diary;
- A Pinterest board where a clinical trial site can “pin” news articles, blog postings, and enrolling clinical trials; or,
- A Facebook “Fan” page for the study.
Although the forums and type of social media are distinct, the IRB’s review is based on the same fundamental principles and regulatory requirements.
An IRB has “the authority to approve, require modifications in, or disapprove all research activities,” covered by IRB regulations. In addition, an IRB is required to ensure that appropriate safeguards exist to protect the rights and welfare of research subjects. To fulfill these responsibilities, the IRB is expected to review the methods and material that investigators propose to use to recruit subjects. 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 document and protocol.
Although the FDA has issued draft guidance recently on social media and internet communications about medical products, this guidance is intended for the post-approval context instead of the research context. However, it can be useful in understanding the agency’s approach to the use of social media. As noted in a previous article by my colleague, Mitchell Parrish, the guidance titled Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices indicates that
…any recruitment of or advertising to research subjects through social media must still comply with applicable FDA regulations related to human subject research. This means adherence to 21 CFR §56 as explained in the FDA’s longstanding document titled, “Recruiting Study Subjects – Information Sheet, Guidance for Institutional Review Boards and Clinical Investigators” (Recruitment Information Sheet). This also means that some forms of social media, such as Twitter, may not be appropriate to advertise certain clinical trials that require the dissemination of more complex information.
This 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. However, the basic tenets set out in the current regulations and guidance remains the same and can be applied to emerging technologies.
As noted in the Recruiting Study Subjects – Information Sheet, the IRB should review the information contained in an advertisement and the mode of its communication. This can be a challenge with social media campaigns, as the sponsor or site may have to initially submit unfinished campaign materials, such as storyboards, mockups, or wireframes to depict social media interactions, social media pages, or websites for review as well as the final product. Generally, the following types of material should be reviewed:
- 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 publication or dissemination of study results with an intent to create interest in new research opportunities;
- Any study specific websites or social media intended to serve as support for enrolled participants; or
- Any communications intended for study retention or advertising for future studies;
- Any study or site specific websites or social media that allows for user generated content;
- Any requests for the provision of identifiable private information (e.g., health) from potential participants or participants; and
- 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.).
Quorum’s social media policy sets the minimum acceptable submission for review as a printable final draft. This final draft may comprise the text and graphics that will be used only and does not have to be the final composition.
Review should be undertaken in accordance with the guidelines set out in the Recruiting Study Subjects – Information Sheet and the IRB’s written procedures. In addition to the standard guidelines, the reviewer should try and account for any unique issues that may be unduly influential based on the proposed activity and the technology being used.
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 (i.e., through a Facebook “fan” page or an online message board), Quorum’s social media policy typically requires development of a written management/communication plan. The plan serves two prongs:
- Sponsor/site – development of a plan allows a sponsor/site to define the scope of the plan, set out specific procedures tailored to the nature and frequency of interaction, 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 coercive. Additionally, where social media will be used for 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.
IRBs need to consider a number of additional factors in developing review standards for social media and guidelines for social media plans. To help institutional boards in this effort, Quorum has developed a whitepaper describing many of the factors IRBs should consider.
 21 CFR 56.109; 45 CFR 46.109.
 21 CFR 56.107(a); 21 CFR 56.111; 45 CFR 46.109.