This post originally appeared on Bill of Health, the blog of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. To learn more about the collaboration between the Petrie-Flom Center and Harvard Catalyst on issues in clinical research ethics, visit their website.
Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!
But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?
There is a growing body of literature supporting social media’s effectiveness in recruiting research participants for everything from pediatric cancer research to depression prevention research to studies on smoking cessation. Social media has also shown promise at reaching historically hard-to-access populations, including gay Latino couples, young cancer survivors, and (as in the example above) sufferers of rare diseases. Since under-enrollment in clinical research is a major challenge, and because of the ubiquity and still-growing popularity of social media, social media has the potential to be an invaluable research recruitment tool.
But there has been little discussion to date of the ethical issues raised by recruiting via social media. There is no specific regulatory guidance on the practice and almost nothing in the bioethics literature to help investigators and IRBs navigate this unfamiliar terrain. Thus researchers may, understandably, under-utilize this powerful resource because of uncertainty over how best to assess the ethical aspects of recruitment using social media.
To address this potential obstacle, a working group composed of members from the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and Harvard Catalyst | The Harvard Clinical and Translational Science Center at Harvard Medical School has authored an open-access guidance document: “The Use of Social Media in Recruitment to Research: A Guide for Investigators and IRBs”. The document contains a number of detailed case studies as well as two practical checklists (one for investigators proposing and one for IRBs reviewing social media recruitment techniques). Key points include:
- Evaluating recruitment using social media does not require new ethical principles. It should be evaluated using the same considerations that guide review of other recruitment techniques.
- The most salient ethical considerations in this context are respect for social media users’ privacy and investigator transparency. These are not new considerations, but are specific components of the foundational principles of research ethics: respect for persons, beneficence, and justice.
- Social media recruitment techniques typically have strong corollaries with more traditional, offline recruitment methods. For example, approaching a patient support group over Facebook is in many ways analogous to approaching a patient support group in-person. Thus researchers seeking to utilize social media for recruitment purposes should imagine an analogous off-line recruitment scenario, consider how the off-line scenario would be assessed, and then try to identify differences in the online scenario that may require further scrutiny.
- Respect for privacy requires researchers to treat social media users’ sensitive personal information securely even if it has already been made publicly available online, and to take extra steps to protect vulnerable populations from privacy harms. Researchers should not always assume that social media users are well-informed about online privacy settings or privacy harms.
- Investigator transparency requires researchers to refrain from using deception to gain access to online communities with specific requirements for joining (e.g., having a certain illness). Transparency also requires studies to be described accurately and precludes researchers from lurking in private or semi-private online spaces without proactively disclosing why they are there.
- Investigators should certify compliance with website business rules or ‘terms of service’ to the IRB. In cases where investigators wish to pursue research strategies that conflict with a site’s rules, they should seek an exception from the moderator or authority connected to the site. In rare cases, when there is strong ethical imperative to pursue the research (and with input from institutional legal counsel), the IRB may consider whether to permit research that conflicts with a site’s terms of service.
- Online ‘friends’ of enrolled research participants may be eligible for particular studies and a promising recruitment pool for investigators. However, in approaching these individuals researchers must not disclose the health information of currently enrolled participants or their involvement in the research. Researchers may be best served asking the participant to approach members of her network on behalf of the study team.
- Online communication between participants carries risks for the scientific integrity of the research. Participants should be educated about the risk that certain communications (e.g., describing their experience in one arm of a study in great detail) may result in un-blinding. Researchers should provide the IRB with a communication plan as part of the protocol, including a description of how people will be contacted, responses to likely questions from participants, what types of participant communications the study team regards as risky, and how the research team will respond to these communications should they encounter them.
For more detail on these and related points, download the full guidelines.
Social media has the potential to serve as a powerful and perhaps transformative tool for clinical research recruitment. But if we are to effectively harness that potential in ways that maintain public trust, the research community must adapt and apply the foundational norms of research ethics to this new medium. We hope that this document will serve both as useful guidance and as the launch point for further discussion and development of this important topic.