Technology and the FDA

What Can Human Subject Research Learn from the FDA’s Draft Guidance on Internet/Social Media?

Mitchell-Parrish-Picture-Blog-2The influence of social media on society is expressly evident and undeniable. Less obvious is social media’s influence on human subject research, whether biomedical or social behavioral. Despite this, social media’s use and applications within the human subject research arena continues to grow. This reality prompts Quorum Review IRB (Quorum) to keep its finger on the pulse of social media and to share its insight on the topic through webinars and articles. It also prompts Quorum to review changes in the regulatory environment that, while not directly pertinent to human subject research, helps anticipate how federal agencies intend to regulate the use of social media in human subject research.

The most recent example is the Food and Drug Administration’s (FDA) two draft guidance documents released on June 17, 2014:

This article focuses on the FDA’s draft guidance on platforms with character space limitations, which contains several recommendations that can help human subject researchers understand how to maintain compliance when using social media.

Overview

Media-and-iPad-smallerThe Draft Guidance on Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (the Guidance) delivers recommendations for drug and device companies that promote their products on social media platforms with character space limitations. In general, the Guidance makes clear that the FDA expects product advertising and messaging to comply with all applicable regulations related to advertising and labeling. This is irrespective of the constraints that may exist within the social media platform and may mean not using various forms of social media, such as Twitter, when promoting products with complex indications or serious risks.

Overview – Relevance to Human Subject Research

What the Guidance indirectly, but clearly, indicates is 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.

Communicating Benefit InformationTweet Media Icon

The Guidance gives three recommendations for communicating benefit information:

1) Benefit information should be accurate and non-misleading and should reveal material facts within each individual character-space-limited communication (e.g. each individual message or tweet).

2) Benefit information should be accompanied by risk information within each individual character-space-limited communication.

3) If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the company should reconsider using that platform for the intended promotional message.

Communicating Benefit Information – Relevance to Human Subject Research

The Guidance reiterates existing FDA requirements: benefit information must be accurate; non-misleading; and should communicate material facts. What is new is the Guidance states that such requirements indeed apply to product promotion through such media as Twitter.

What does this mean for human subject researchers? Implausible is the scenario where the FDA would apply advertising and labeling requirements to product promotion via social media, but not apply recruitment and advertising requirements to clinical trial recruitment via the same medium. Therefore, taking into account the FDA’s Recruitment Information Sheet, the following requirements, amongst others, exist for clinical trial advertising through social media: trial information must be accurate; non-misleading; and should communicate “information the prospective subjects need to determine their eligibility and interest.”

The Guidance also reiterates the existing requirement that benefit information must be accompanied by risk information. However, equating this requirement to human subject research is unnecessary. Unlike product promotion in general, a clinical trial advertisement is not required to contain the potential risks of the clinical trial. Such burden is left to the informed consent process outlined in the federal regulation 21 CFR §50, Subpart B. Therefore, while a product promoting Tweet must contain risk information within its 140 characters, a clinical trial advertising Tweet is off the hook.

Finally, the Guidance stresses that researchers must use an appropriate medium in which to promote a product, which may preclude using a character-space-limited communication such as Twitter. This recommendation holds true in human subject research as well. The FDA’s Recruitment Information Sheet states that the Institutional Review Board (IRB) should review an advertisement’s mode of communication as a factor in assessing the advertisement’s acceptability. With that in mind, researchers should indeed consider the appropriateness of the social media they use to recruit or advertise for their clinical trial.

Communicating Risk Information

The Guidance gives four recommendations for the communication of risk information:

1) Risk information should be presented together with benefit information within each individual character-space-limited communication (e.g., each individual message or tweet).

2) The content of risk information presented within each individual character-space-limited communication should, at a minimum, include the most serious risks associated with the product.

For drugs, the most serious risks may include all those in a boxed warning, those that are known to be fatal or life threatening, and all contraindications from the approved product labeling. For devices, the most serious risks may include each risk associated with a particular identifiable use or population.

3) A mechanism, such as a hyperlink, should be provided within each individual character-space-limited communication to allow direct access to a more complete discussion of risk information about the product.

Note that this hyperlink should link to a landing page devoted exclusively to risk information. This means the landing page should not, for example, also contain promotional information.

4) The prominence of risk information should be comparable to the benefit information within each individual character-space-limited communication, taking into consideration any formatting capabilities available on the specific Internet/social media platform.

Companies must utilize similar techniques to emphasize both benefit and risk information and significant risk information should receive highlighting.

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Communicating Risk Information – Relevance to Human Subject Research

As noted above, clinical trial advertisements are not required to contain the potential risks of the clinical trial. This information is appropriately communicated through informed consent. Therefore, the first two recommendations for communicating risk information are not helpful to human subject researchers. However, there is useful information to glean from recommendations three and four.

Recommendation three states that a character-space-limited communication should contain a hyperlink to a landing page with more complete risk information. For human subject research, this means it may be perfectly acceptable to send an advertising Tweet that contains a link to a clinical trial landing page.Unlike with a product promotion landing page, a recruitment landing page would not need to be exclusively dedicated to trial risk information. Instead, as supported in the FDA’s Recruitment Information Sheet, the page could focus on certain basic trial information: study title; purpose of the study; protocol summary; basic eligibility criteria; study site locations; and research site contact information.

Recommendation four discusses that the prominence of risk information should be comparable to the benefit information. In human subject research terms, this means, in the words of the Recruitment Information Sheet, examining a research advertisement’s “relative size of type” and “visual effects” that may improperly enhance certain information. For example, an advertisement circulated via social media should not emphasize payment and part of a Tweet should not read: “investigational NEW DRUG.” Such emphasis on payment could unduly influence a person’s decision to participate in a study and capitalizing “new drug” could lead potential participants to believe they will receive a product of proven worth.

Conclusion

The use of social media in human subject research, including that with character space limitations, is an evolving practice. Nonetheless, the pertinent regulations and guidance from both the FDA and Office for Human Research Protections (OHRP) remain unchanged. While unchanged, this does not mean they are obsolete. Their requirements and guidance must simply be applied to a new mode of communication. Certainly assisting in this application are, even if not on point, agency guidance documents aimed at something other than human subject research. The Guidance discussed in this article is no exception.

Finding Help With Social Media in Human Subjects Research

The use of social media in human subject research is a new and evolving practice with many potential pitfalls.  The key to navigating this new technology is to coordinate with a regulatory professional while planning the study protocol.  In particular, your IRB’s regulatory team should make themselves available as an early resource to help you avoid regulatory problems and study delays.

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