Approved October 19, 2022
The use of social media by research subjects to discuss their participation in research has been noted since its inception, but has drawn increasing attention as a result of the steady growth of the use of social media platforms. The availability of social media has made it much easier for research subjects to find one another and communicate. OHRP has asked SACHRP to consider the implications for subject safety and data integrity related to the use of social media by research subjects to share and discuss their experiences and observations as clinical trial participants. There were examples of research subjects finding one another and communicating about their experiences while participating in ongoing research prior to the creation of social media, such as the AIDS activists in the 1980s, and other means of communication could still be used. However, social media provides an effective communication network, such that it has become the easiest way for research subjects to communicate with one another.
There are many potential benefits and advantages of subjects’ use of social media for such communication, as well as risks and disadvantages.
Social media is a broad term covering the many websites and applications available to people to create and share content or to participate in social networking. Examples of social media include Facebook, Snapchat, Tik Tok, Twitter, LinkedIn and YouTube. This recommendation will not cover all of the possible interactions and uses of social media and their effect on the conduct of human subject research. There are many such issues that are outside the scope of this recommendation. Examples include posting reviews of studies on websites such as “Just Another Lab Rat” or Yelp, and using Artificial Intelligence technology to capture real world data from social media postings.
In the following sections SACHRP provides its responses to the questions asked by OHRP in the charge for this recommendation.
- What are the primary concerns with subjects’ use of social media to discuss their experiences participating in ongoing research, and to what extent do scientific concerns impact human research protections?
SACHRP believes that the two primary concerns with subjects’ use of social media to discuss their experiences participating in ongoing research relate broadly to subject safety and scientific validity. However, there are also potential benefits, including increased subject safety and scientific validity. These three issues are discussed in order.
Subject Safety
Subject safety could be negatively impacted in several ways. Based on discussions of experience or information in online discussions, subjects may react to information in a manner that places them at greater risk, or negatively impacts the likelihood of benefit. For instance, information obtained by communicating with other subjects on social media could theoretically:
- Affect a subject’s decision to complete or drop out of study when such a decision is not in their best interest.
- Provide misinformation about the possible benefits or adverse effects of the study drug.
- Give rise to incorrect inferences about a subject’s treatment assignment, and therefore influence a subject to pursue other treatments, medications, or supplements, or exit the study.
- Lead a subject to provide personal information about themselves without realizing how broadly or to whom the information might become available, in both clinical and social-behavioral research.
- Lead a subject to conceal or fail to disclose information that would make them ineligible to participate in the research, or to fail to disclose adverse event information once they are enrolled so that they are not removed from the study.
Scientific Validity
The scientific validity of a research study could also be negatively impacted in several ways by such communication. Subjects theoretically might:
- Identify characteristics of the various study arm medications and unmask themselves, which could lead to a variety of problems with the integrity of the data.
- Discuss their assumptions and conclusions with the study staff, which could unmask the study staff as to the trial design.
- Discuss eligibility criteria, so that potential subjects can conceal or fail to disclose information that would disallow their participation in the research.
- Share adverse event information, thus discouraging other subjects from reporting such events so that they are not removed from the study.
- Be influenced to inappropriately alter patient reported outcomes from what they otherwise would have said.
Benefits
There can also be benefits to subjects’ use of social media to discuss their experiences participating in ongoing research.
As noted above, there may be scenarios in which the safety of subjects could be improved. For instance, subjects participating in online discussions may identify side effects and subject experiences that were not captured as part of the endpoints, or that research staff were partially or not completely identifying through the research visits. Further, subjects might share methods to treat adverse events that are not included in the protocol because they are outside of the relevant subject matter of the protocol.
Similarly, such communications may lead to the discoveries that strengthen the validity of the research, such as the improved identification of negative or positive effects of the study article. For instance, there could be enhanced reporting of patient reported outcomes.
Subject communication could also result in better recruitment if potential subjects read encouraging posts on social media, or if there appears to be a sense of community and positivity among the research subjects who are discussing the research. Such discussions may also result in better retention if subjects feel that they are part of a community.
Subjects may also feel a sense of altruism if the discussions lead them to believe that they are contributing to curing or mitigating a disease that affects them. They may also be more inclined to stay in the research if the discussions lead them to believe that they are likely to receive personal medical benefit.
- Are there types of trials for which these concerns might be more of a problem, and if so why? Are different mitigation efforts necessary for different trials?
As noted above, SACHRP believes that the most significant concerns with subjects communicating during participation in a research study are negative effects on subject safety and scientific validity.
A significant concern in regard to scientific validity is in blinded clinical trials with two or more arms, including placebo-controlled studies, because the communication could lead to subjects or research staff being able to discern which arm the subjects are on. This could include any type of disease state, include adult or pediatric studies, and could occur in small or large studies. A particular area where such concerns could arise is rare disease trials, as the patients or their parents are often well-connected in social media even before the study begins.
These concerns are not limited to clinical research. Social behavioral research could also be affected. For instance, if there is a low risk social behavioral study involving deception, the debrief on the type of deception and the rationale for its use normally occurs immediately upon the end of each subject’s participation. Theoretically, a subject who went through the debrief could post the facts about the deception, thereby making it difficult or infeasible to continue the research.
- Are there existing frameworks or tools that funding agencies, investigators, HRPP staff, and IRBs can use to illuminate and mitigate the concerns raised by subjects’ use of social media to discuss their experiences participating in ongoing research? What are some examples of mitigation strategies used to address these concerns?
Funding agencies, investigators, HRPP staff, non-profits such as CISCRP, and IRBs could take several steps to address the issue of subjects using social media to discuss ongoing research. One approach would be the creation and distribution of general education for research subjects and staff about the use of social media to discuss ongoing research, which could include discussion of the pros and cons of using social media for this purpose, and general suggestions on whether to, and is so, how to do it appropriately. For instance, such education could address the concerns with unblinding a research study.
Education programs could also be created for specific research studies, either proactively or in response to an online discussion beginning.
The consent process and consent forms for research could also be used to address the issue as well.
A more proactive approach could be to ask or require subjects to refrain from discussing certain aspects of the trial on social media, potentially including the disclosure of penalties for discussing certain issues, up to termination of participation. However, this should be a limited practice, and only used where there is a strong compelling rationale such as not being able to conduct the research. Subjects may view it as an infringement on their autonomy and their right to pursue the gathering of information to further their own health. Moreover, it could give subjects the impression that the researchers are being secretive, which could lead subjects to view it suspiciously.
Several papers address possible solutions to this issue. Lynch et al present a five step “Social Media ADEPT” framework to assist stakeholders in addressing the issues that can arise with research subjects’ use of social media to communicate about research participation. “ADEPT” is an acronym for:
Assess when and how social media are likely to pose risks for a study and plan accordingly, Design studies to minimize these risks, Educate participants about their responsibilities to promote study success and avoid harmful social media use, Preempt problems by offering alternative mechanisms for participants to have their concerns addressed, and Take additional steps if necessary.
SACHRP recommends this approach to all interested stakeholders. “Protecting Clinical Trial Participants and Study Integrity in the Age of Social Media,” https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31748.
McNair provides a few possible solutions, including prior risk assessments by sponsors and investigators of the possibility of discussions on social media affecting the research, educational language in consent forms, and the use of moderated online fora so that the content of the discussion can be controlled. “Clinical Trials and Social Media: Friends or Foes?,” https://www.wcgirb.com/insights/clinical-trials-and-social-media-friends-or-foes/
- Which specific regulatory issues are likely to arise when considering these concerns or common mitigation strategies?
Mitigation is most likely to consist of education activities, which can include information about issues such as unblinding and its effect on scientific validity, up to the possibility of FDA or another agency not approving the medical product. A stronger mitigation strategy could include prohibitions on sharing certain information, which is discussed below in question 5. Several regulatory issues can arise when considering mitigation strategies for subject use of social media to discuss research participation.
One is the right of research subjects to obtain relevant information and provide informed consent to participate in research, which includes the specific right to withdraw from the research at any time and for any reason. Subjects may base such a decision on information obtained on social media, and it is within their regulatory rights to do so, even if the reasoning is based on faulty information. 45 CFR 46.111(a)(4); 45 CFR 46.116.
Social media communications could also potentially change the risk-benefit ratio of the research if subjects take actions that put them at greater risk of harm, such as ignoring protocol requirements regarding concomitant medicines or timing of dosage. It is worth noting that the use of social media may also increase the potential benefit of the research to the participants and to society through increased participation or adherence to protocol requirements. 45 CFR 46.111(a)(2).
The use of social media could theoretically cause inequitable selection of research subjects if certain groups of subjects either drop out of the research or stay in the research due to information obtained through social media. 45 CFR 46.111(a)(3).
Finally, the use of social media could affect, either negatively or positively, the integrity of the process for monitoring data for safety during the course of the study. 45 CFR 46.111(a)(6).
Similar concerns exist under the FDA regulations 21 CFR 312 and 21 CFR 812, the drug and device regulations respectively.
- Are there circumstances where it is appropriate for an investigator to condition study participation on an agreement to refrain from sharing study information on social media? If so, what are the circumstances, and what should an IRB consider when encountering such a proposal?
Such a condition would only be warranted in a limited number of situations as it involves a limitation on the subjects’ autonomy and the right to seek out and consider information about research participation, both in the initial consent process and during ongoing participation in the study. For instance, such a limitation might be warranted when it is difficult to blind the study, for instance when a study article or control has very noticeable identifiers, such as taste, appearance, or mode of delivery. Such a condition should rarely be used, and only when it is necessary for the conduct of the research to be possible. A similar corollary would be the use of deception in research, which is rarely used but is sometimes necessary for study design and validity.
That said, there are other conditions imposed on research subjects for their continued participation. For instance, subjects often face removal from a study if they become pregnant, join another research study, or take prohibited co-medications. However, such conditions are usually based on a direct effect on the safety of the research subject or the validity of the research results. In the case of the use of social media to discuss ongoing research, the nexus to subject safety and research validity is not as direct and is counterbalanced by the potential benefits of such discussions.
Another issue that must be addressed is whether a prohibition on sharing information on social media is just a request, or if there will be penalties such as potential being removed from the study. Regardless of which it is, such intentions should be communicated to the IRB for consideration during the IRB approval process.
- Are there circumstances where it is appropriate for an investigator to monitor subjects’ use of social media? If so, what are the circumstances, and what should an IRB consider when encountering such a proposal? Should the subject be informed that they might be monitored?
There may be circumstances where it is appropriate for an investigator to monitor subjects’ use of social media, but SACHRP believes they should be rare and used only when there are significant potential negative effects on either subject safety or scientific validity. Any such monitoring should be disclosed in the consent process. The IRB would need to consider the privacy of the subjects and subjects’ ability to control the level of information necessary to protect their privacy. The IRB should also consider the potential risks and benefits, both to the subjects and the research, in such a proposal. It is worth noting that research staff involvement in social media communications might also provide enhanced participation and retention in the research.
However, such monitoring would be administratively burdensome and also difficult to perform. There are many social media platforms, groups can be private with limitations on entry, and subjects can use aliases. It may be impossible for a researcher or other party to effectively monitor subjects’ social media activities for these reasons.
Alternatively, research staff or other individuals could be given the role of moderating a dedicated social media platform discussion, who could identify troubling directions in the conversations. Theoretically, such a moderator could take actions such as the correction of posted misinformation and reminding subjects about the importance of the integrity of the data.
- What, if any, unique considerations exist surrounding ending a subject’s participation in a study on the basis of their use of social media?
The decision to end a subject’s participation in a study on the basis of their use of social media would need to be based on either risk to a subject’s health or the health of others, or the possibility of negatively affecting the validity of the research. If such a possibility is contemplated, it should be presented to the IRB and disclosed in the consent form.
References:
https://www.nature.com/articles/nm0314-231.pdf?origin=ppub
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31748
https://www.wcgirb.com/insights/clinical-trials-and-social-media-friends-or-foes/
