In my last blog I discussed, from a clinical research site perspective, some of the benefits that social media, particularly Facebook, can have for a developing site by increasing recruitment tool options, allowing new avenues for distribution of study-specific information and providing trial access to a previously untapped population of potential participants. Flow on effects for sponsors and industry correspondingly included, besides recruitment optimisation, identification of enrolment barriers, engagement of increasingly diverse groups involved in clinical trials research and highlighting trial and study design flaws.
Like any other business development venture though, without appreciation of legislation, regulations and site management due diligence the preservation of clinical trial integrity becomes threatened and liability concerns may arise. Therefore when a digital media initiative such as recruitment via a social media inclusive system is implemented, sites must prepare accordingly and ensure commitment to the development, implementation and ongoing maintenance of an integrated Quality Management System for social media usage. Commitment to these responsibilities will ensure site compliance with statutory legislation, regulations and guidelines that govern Human Research Standards.
Current Clinical Trial Regulations regarding Social Media (US/Australia)
The FDA Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, was published in January 2014. Importantly, as a reference this guide is clearly described as ‘for comment purposes only’. As Thomas, 2014 noted, this is hardly definitive, nor does it “create or confer any rights for or on any person and does not operate to bind FDA or the public.” The main points covered by the guide and as explored by Thomas include:
- That a company (or firm) is essentially responsible for communications and/or promotional advertisements on sites that are either owned, created, controlled, influenced, or operated by, or on behalf of that company. This includes websites, and Facebook pages that in this context are linked to recruitment campaigns.
- That under particular circumstances, a company may be responsible for publicity on third-party sites. From a site management perspective, any and all promotional materials and/or advertisements including text and images that relate to a clinical trial and recruitment for such a trial, must be endorsed prior to any use by the Sponsor. Subsequently after this initial sponsor approval, social media collateral must be submitted to the HREC/IRB for their approval.
- A company is responsible for any content or posts created by an employee or person who may be acting on behalf of the company to promote the companies services/product. Establishment and responsible site management governed by internal recruitment/advertisement operating procedures and social media policies allows a systematic approach to distribution of posts and advertisement sets, blogs, interactive conversations, complaints management and implementation of corrective actions.
For fixed or static promotional materials such as advertisement layouts on Facebook and study specific websites, there are no significant additions to current regulations within the guide. Fundamentally the FDA requires:
- That an Human Research Ethics Committee (HREC) or Institutional Review Board (IRB) review and have authority to approve, require modifications in, or disapprove all research activities covered by the IRB regulations
- That direct advertising for study subjects is considered to be the start of the informed consent and subject selection process and therefore all advertisements including social media’s should be reviewed and approved by the IRB as part of the package for initial review. That is submitted as static images, with all associated text included for specific review and appropriate approvals. For Facebook submissions, you will need to include the exact text used as well as all images and links that are included. A web page will require a visual of the page layout/s, including text as well as any links provided for the participants. It may be handy, and save time in the long run to discuss with your nominated HREC/IRB, prior to application to see if they have a preferred submission layout for social media advertisement designs and sets. If you work closely with your HREC/IRB from the outset they may be able to provide expedited review for social media posts during the course of enrolment.
- HREC’s and IRBs are to review the proposed advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol.
Basically the same requirements are recommended in Australia by the Therapeutic Goods Administration (TGA) with guidance provided by the Therapeutic Goods Advertising Code 2015. The code stipulates that an advertisement for therapeutic goods must (amongst other conditions):
- Comply with the statute and common law of the Commonwealth, States and Territories; and
- contain correct and balanced statements only and claims which the sponsor has already verified;
- they may not be likely to arouse unwarranted and unrealistic expectations of product effectiveness, or;
- mislead, or be likely to mislead, directly or by implication or through emphasis, comparisons, contrasts or omissions.
Specific national health authority regulations and industry standards provide wide ranging frameworks within which Pharmaceutical/Biotechnology companies should operate although there are numerous relevant omissions noted such as those surrounding control of social networking sites, sponsor monitoring requirements and source material verification processes. For clinical trial sites specifically, it is fair to say that besides standard privacy legislation, firm guidelines and best practice measures for social media governance are next to non-existent. In the absence of standard industry guidelines, all the stakeholders involved in social media recruitment should themselves, or be satisfied that a specialist vendor has, established internal standard operating procedures outlining acceptable practices and ethical standards required for social media recruitment and monitoring of digital recruitment operations. These standard operating procedures should detail corrective action responses in the event that these requirements are not met.
The US Privacy Rule protects all ‘individually identifiable health information’ held or transmitted by a covered entity. This health information includes:
- The individuals past, present or future physical or mental health or condition,
- The provision of health care to the individual or
- The past, present, or future payment for the provision of healthcare to the individual.
The basic principle of the rule is that health information may not be used or disclosed unless:
- The privacy rule permits
- The individual who is subject to the information authorises in writing
For research purposes the rule allows use of disclosure of protected health information without an individual’s authorisation provided prior obtainment of documentation that an alteration or waiver of an individual’s authorisation for the use or disclosure of this information for research purposes has been approved by a HREC/IRB.
With both of these privacy regulations (Australian and US) in mind and with reference to use of social media, it is imperative that sites do not collect or use protected health information without clearly obtaining informed consent first. Additonally those whose protected information has been collected should be afforded the opportunity to withdraw consent at any time. This can be enabled by sites by providing ‘opt-in’ and subsequent ‘opt-out’ informed consent disclaimers on digital platforms or study specific systems, creation and access for data collection policies and even custom designing systems where enquirers for clinical trial via social media have to provide consent before being able to actually progress through a screening process. Customers of a clinical trial site must always have the opportunity to contact management with complaints and quality improvements should be administered in response to these in case of a breach. With multiple levels of safeguards sites can ensure that those who inquire about a clinical trial can elect to either not have any of their information stored or know that if stored it is soundly protected and not misused.
If you are using Facebook for social media recruitment you must also consider the following:
- There are terms and policies, which may affect campaign performance and overall risk
- You cannot solely rely on your Facebook business account privacy settings. This only offers limited protection and additional information security systems need to be in place.
- Estimate, assess and manage risk throughout the lifecycle of the recruitment project, this means at least daily checks and response to correspondence.
- When commencing advertising online you must always consider the copyright and intellectual property implications of engaging with the public and others within the research industry
So what in fact needs review and approval in regards to creating a social media recruitment campaign? Quite simply we can can say that any ‘direct advertising’ requires review. We have discussed that this can be in the form of websites, Facebook, and blogs and the formats of these which are subject to review include display ads, social network ads, social network pages, text messages, emails and rich-text media.
In my point of view, through first-hand experience and with the consideration of the current literature, it seems reasonable that if data collected from enquiries generated via a Facebook trial recruitment advertisement, produced by a clinical trial site, that has been assessed and approved by both the sponsor and the HREC/IRB, and is:
- Obtained with consent;
- Is not misused, and;
- The privacy and confidentiality of our participants is maintained, and;
- Information security systems are in place, the result is not only are all the principles and regulations of GCP, Human Research Standards, HIPAA Privacy Rule and Australian Privacy Act compliance assured, we will find that in fact there is little to no difference between the ethical or legal compliance of social media and traditional media recruitment methods for studies, rather an obvious opportunity to create a new form of best practice.
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Therapeutic Goods Advertising Code 2015. Australian Government: Department of Health: Therapeutic Goods Administration.
Available via: https://www.comlaw.gov.au/Details/F2015L01787
Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. (Draft Guideance) U.S. Food and Drug Administration. 2014.
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Recruiting Study Subjects – Information Sheet. Guidance for Institutional Review Boards and Clinical Investigators. U.S. Food and Drug Administration. 2015.
Available via: https://www.fda.gov/RegulatoryInformation/Guidances/ucm126428.htm