Use of social media by research subjects: ethical and regulatory considerations for protecting human research subjects
Approved on October 19, 2022
The use of social media by research subjects to discuss their participation in research has been known since the beginning, but it has attracted increasing attention due to the increasing use of social media platforms. The availability of social media has made it much easier for research subjects to find and communicate with each other. The OHRP asked the SACHRP to review 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 participants in clinical trials. There were examples of research subjects who met and shared their experiences while participating in ongoing research before social media existed, such as AIDS activists in the 1980s, and other means of communication could still be used. However, social media provides an effective communication network, making it the easiest way for research subjects to communicate with each other.
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 that encompasses the many websites and applications available for people to create and share content or participate in social networking. Examples of social media are Facebook, Snapchat, Tik Tok, Twitter, LinkedIn and YouTube. This recommendation will not cover all possible interactions and uses of social media and their impact on conducting human research. There are many such issues that are outside the scope of this recommendation. Examples include posting study reviews on sites like Just Another Lab Rat or Yelp and using artificial intelligence technologies to gather real-world data from social media posts.
In the following paragraphs, the SACHRP gives its answers to the questions posed by the OHRP responsible for this recommendation.
- What are the main concerns when subjects use social media to discuss their experiences participating in ongoing research and to what extent do scientific concerns affect the protection of human research?
The SACHRP believes that the two main concerns about subjects' use of social media to discuss their experiences participating in ongoing research are largely related to subject safety and scientific validity. However, there are also potential benefits, including increased subject safety and scientific validity. These three topics will be discussed in turn.
Subject safety can be negatively impacted in several ways. Based on discussions of experiences or information in online discussions, subjects may respond to information in ways that place them at greater risk or negatively affect the likelihood of benefit. For example, information obtained through communication with other subjects on social media could theoretically:
- Influencing a study participant's decision to complete or leave the study when such a decision is not in their best interest.
- Providing misinformation about the potential benefits or side effects of the study drug.
- Lead to erroneous conclusions about a subject's treatment assignment and, therefore, influence a subject to seek other treatments, medications, or dietary supplements, or to discontinue the study.
- Leading a subject to provide personal information about himself without knowing how widely or to whom the information may be available, both in clinical research and in social behavior.
- Getting a subject to hide or not disclose information that makes them unfit to participate in the study, or not to disclose information about adverse events once recorded, in order not to be excluded from the study.
The scientific validity of a research study can also be negatively influenced in several ways by such communication. Subjects could theoretically:
- Identify the characteristics of different study group drugs and reveal yourself, which can lead to a variety of data integrity issues.
- Discuss your assumptions and conclusions with the study team, which can expose the study team to the study design.
- Discuss eligibility criteria so potential subjects can withhold or not disclose information that may prohibit their participation in the research.
- Share information about adverse events and discourage other individuals from reporting such events so that they are not excluded from the study.
- Be biased to inappropriately alter patient-reported results from what they would otherwise have said.
It may also be beneficial for subjects to use social media to discuss their experiences participating in ongoing research.
As mentioned above, there may be scenarios where subject safety can be improved. For example, subjects participating in online discussions may identify adverse events and subjects' experiences that were not recorded as part of the endpoints, or that the research team identified in part or in part through survey visits. In addition, participants may share methods of managing adverse events that are not included in the protocol because they are outside the relevant subject of the protocol.
Likewise, such communications may lead to findings that strengthen the validity of the research, e.g. B. Better identification of negative or positive impacts of the study article. For example, there may be enhanced reporting of patient-reported results.
Communication with subjects can also lead to better recruitment if potential subjects read encouraging posts on social media or if there seems to be a sense of community and positivity among research subjects discussing the research. These discussions can also lead to better recall when subjects feel part of a community.
Subjects may also feel a sense of altruism if discussions lead them to believe that they are helping to cure or alleviate an illness that ails them. They may also be more inclined to stay on the research if discussions lead them to believe they are likely to receive personal medical benefits.
- Are there types of studies where these concerns might be a bigger issue, and if so, why? Do different studies require different mitigation efforts?
As noted above, the SACHRP believes that the main concerns about subject communication while participating in a research study are negative implications for subject safety and scientific validity.
There are significant scientific validity concerns for blinded clinical trials with two or more arms, including placebo-controlled trials, because communication can lead subjects or research staff to identify which arm subjects are participating in. This can include any type of disease condition, involve studies in adults or children, and occur in small or large studies. One particular area where such concerns can arise is in rare disease trials, as patients or their parents are often well connected on social media before the trial begins.
These concerns are not limited to clinical research. Social behavior research may also be affected. For example, if there is a study of low-risk social behavior involving deception, debriefing about the type of deception and the rationale for its use usually occurs immediately after each subject's participation ends. In theory, a person undergoing the debriefing could post the facts about the deception, making it difficult or impossible to continue the research.
- Are there frameworks or tools that funding agencies, investigators, HRPP staff and IRBs can use to clarify and mitigate concerns raised by subjects' use of social media to share their experiences of participating in ongoing research? What are some examples of mitigation strategies used to address these concerns?
Funding agencies, investigators, HRPP officials, non-profit organizations such as CISCRP and IRBs can take a number of steps to address the issue of subjects using social media to discuss ongoing research. One approach would be to create and disseminate general training for research subjects and collaborators on the use of social media to discuss ongoing research, which could include a discussion of the pros and cons of using social media for this purpose and general suggestions. about how to do it, and that's how to do it right. For example, this education may address concerns about disclosure of a research study.
Education programs can also be created for specific research studies, either proactively or in response to starting an online discussion.
The survey consent process and consent forms can also be used to resolve the issue.
A more proactive approach could be to ask or ask participants not to discuss certain aspects of the study on social media, possibly including disclosing penalties for discussing certain topics, up to and including discontinuing participation. However, this should be a limited practice and should only be used when there is strong compelling justification such as: B. the inability to conduct the research. Those affected may see this as an interference with their autonomy and their right to gather information to promote their own health. Furthermore, it may give subjects the impression that researchers are secretive, which may cause subjects to view you with suspicion.
Several articles discuss possible solutions to this problem. Lynch and others. present a five-step “Social Media ADEPT” framework to help stakeholders address the issues that may arise from research subjects' use of social media to communicate about research participation. "ADEPT" is an acronym for:
Aassess when and how social media may pose risks to a study and plan accordingly,Ddesigning studies to minimize these risks,Eeducate participants about their responsibility to promote academic success and avoid harmful use of social media,PResolve issues by providing participants with alternative mechanisms for their concerns to be addressed andTIf necessary, perform additional steps.
The SACHRP recommends this approach to all interested parties. “Protecting Clinical Trial Participants and Trial Integrity in the Age of Social Media”https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31748.
McNair offers some possible solutions, including past risk assessments by sponsors and researchers about the possibility of social media discussions affecting research, pedagogical language in consent forms, and the use of moderated online forums 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/
- What specific regulatory issues are likely to arise when addressing these concerns or common mitigation strategies?
Mitigation is likely to consist of educational activities, which may include information on issues ranging from disclosure and how it affects scientific validity, to the possibility that the FDA or other agency may not approve the medical device. A stronger mitigation strategy could include bans on sharing certain information, which are discussed in Question 5 below. When considering mitigation strategies for subjects' use of social media to discuss participation in research, a number of regulatory issues may arise.
One is the subjects' right to receive relevant information and to give their informed consent to participate in research, which includes the specific right to withdraw from research at any time and for any reason. Data subjects can base such a decision on information obtained from social media, and it is within their regulatory right to do so, even if the justification is based on incorrect information. 45 CFR 46.111(a)(4); 45CFR 46.116.
Communication on social media can also change the risk-benefit balance of the research if participants take actions that put them at greater risk of harm, such as society through greater participation or compliance with protocol requirements. 45 CFR 46.111(a)(2).
The use of social media could theoretically lead to an unfair selection of research topics if certain groups of subjects drop out or remain in surveys based on information obtained through social media. 45 CFR 46.111(a)(3).
Finally, the use of social media can negatively or positively affect the integrity of the data security monitoring process during the study. 45 CFR 46.111(a)(6).
Similar concerns exist under FDA Rules 21 CFR 312 and 21 CFR 812, the Drug and Device Rules, respectively.
- Are there circumstances when it is appropriate for an investigator to condition participation in the study on an agreement not to share study information on social media? If so, what are the circumstances and what should an IRB consider when faced with such a proposal?
Such a condition would only be justified in a limited number of situations, as it involves a limitation of the autonomy of the subjects and the right to seek and consider information about participation in the research, both in the initial consent process and during continuous participation in the study. Such a limitation may be justified, for example, when study blinding is difficult, for example, when a study or control item has very prominent identifiers, such as taste, appearance or route of administration. Such a condition should be used rarely and only when it is necessary to conduct research. A similar consequence would be the use of deception in research, which is rarely used but is sometimes necessary for study design and validity.
However, there are other conditions imposed on research participants for their continued participation. For example, participants are often at risk of being excluded from a study if they become pregnant, participate in another research study, or take prohibited co-medications. However, such conditions are usually based on a direct impact on the security of the research object or the validity of the research results. In the case of using social media to discuss ongoing research, the link between topic safety and research validity is not as straightforward and is outweighed by the potential benefits of such discussions.
Another issue that needs to be clarified is whether the ban on sharing information on social networks is just a request or whether there are sanctions such as possible exclusion from the study. Regardless, such intentions must be communicated to the IRB for consideration during the IRB approval process.
- Are there circumstances when it is appropriate for an investigator to monitor participants' use of social media? If so, what are the circumstances and what should an IRB consider when faced with such a proposal? Should the data subject be informed that he may be under surveillance?
There may be circumstances where it is appropriate for an investigator to monitor subjects' use of social media, but the SACHRP believes that they should be used infrequently and only when there are significant potential negative impacts on subjects' safety or have scientific validity. This monitoring should be disclosed in the consent process. The IRB would need to consider subjects' privacy and subjects' ability to control the level of information necessary to protect their privacy. The IRB must also consider the potential risks and benefits to both subjects and research in such a proposal. It is worth noting that engaging the research team in social media communication can also lead to better research participation and retention.
However, such monitoring would be administratively burdensome and also difficult to carry out. There are many social media platforms, groups can be private with restricted access, and subjects can use pseudonyms. For these reasons, it may be impossible for a researcher or other party to effectively monitor participants' social media activity.
Alternatively, research contributors or others may be given the role of moderating a specific discussion on a social media platform that can identify problematic directions in conversations. In theory, this moderator could take actions such as: B. Correcting incorrect information posted and remembering the importance of data integrity.
- What unique considerations, if any, exist for terminating a subject's participation in a study because of their social media use?
The decision to terminate a subject's participation in a study because of social media use would have to be based on a 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 considered, it must be presented to the CEP and disclosed in the informed consent form.