University of North Carolina Chapel Hill United States
Objectives
To obtain the opinions of IRB Chairs in the United States on the use of social media in clinical trials, IRB capacity to review social media, and adequacy of the current regulatory framework to review social media.
Method
A cross-sectional, 30 question electronic survey was distributed to IRB Chairs in the United States.
Results
A total of 463 individuals started the survey with 408 completed surveys, yielding a 15% response rate overall and an 88% completion rate. Preliminary analysis reveals the majority of respondents (68%) were from IRBs affiliated with an academic institution/medical center. Respondents reflected a range of experience levels on the IRB with 45% having more than 10 years’ experience, 32% having 5-10 years, and 23% less than 5 years. Within the overall sample, 27% of respondents had actually deliberated on a proposal using social media. The most common use of social media was subject recruitment. Only 13% of respondents reported receiving formal training in social media. Two-thirds of respondents (66%) felt “somewhat prepared” to review a proposal using social media. Among the areas identified as priorities for IRB training and policy development were protection of privacy and confidentiality on social media, how social media platforms share data, and questions regarding informed consent.
Specific to clinical trials, respondents felt social media could be “very useful” for disseminating research education, increasing public knowledge about FDA or sponsor activities, and recruiting study subjects. Most of the respondents had never heard of or knew of specific studies in which social media allowed for “coaching” of subjects on meeting study eligibility criteria, where subject privacy was breached through use of social media, or subjects learned how to unblind study material through social media posts. When asked about the potential effect of social media on clinical trial integrity, 26% said they were very concerned about social media use by enrolled subjects affecting trial integrity and 22% said they were very concerned about social media use by the public affecting clinical trial integrity.
Conclusion
This sample of IRB Chairs identified a number of potential challenges with the use of social media in human subjects research and specifically, clinical trials, including privacy protection and confidentiality. Despite these challenges, the respondents believed social media was useful for several clinical trial activities, that review of social media was not more difficult than review of other technologies, and close to half of respondents were not concerned that use of social media by subjects or the public may affect clinical trial integrity. This work provides a foundation upon which to develop future training programs and to identify the specific issues sponsors and researchers must address when proposing the use of social media within clinical trials.
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