Institutional Review Board Oversight of Citizen Science Research Involving Human Subjects

In their target article, “The Rise of Citizen Science in Health and Biomedical Research,” Andrea Wiggins and John Wilbanks summarize some of the emerging ethical issues related to citizen science in biomedical research. Their aim is not to resolve ethical questions related to citizen science but to flag important issues for practitioners and stimulate further discussion and debate. One of these issues, namely, ethical review and oversight of citizen science projects involving human subjects, is becoming increasingly important as citizen science moves beyond disciplines like astronomy and ecology into areas of inquiry, such as medicine, nutrition, genomics, and psychology, which involve collection of private data or interventions with human participants.

In thinking about ethical review and oversight of citizen science research involving human subjects, I will follow Wiggins and Wilbanks’ lead by distinguishing between professional-driven and public-driven inquiry. Professional-driven inquiry does not normally raise the sorts of issues that are the focus of my commentary, because professional scientists are likely to work for institutions that provide ethical review and oversight of human subjects research (HSR), and they are likely to comply with those policies and procedures. To be sure, professional-driven inquiry raises some interesting and important issues, such promoting data quality and integrity, minimizing bias, managing conflicts of interest, and giving appropriate credit to citizens (see Resnik et al. 2015; Elliott and Rosenberg 2019; Rasmussen 2019; Smith et al. 2019; Wiggins and Wilbanks 2019), but these issues are not the focus on my commentary.

Instead, I will focus on ethical review and oversight of public-driven citizen science projects. These are projects that are initiated, designed, and conducted by citizens, either individually or in collaboration with other citizens. The health self-tracking projects described by Wiggins and Wilbanks fit into this category. Some of these involve individuals keeping track of their own health data over time, i.e. “N-1 studies.” Others, such as the Soylent Diet Self-Experimentation group, involve collaborations among individuals who are tracking and sharing their own data. Some health data companies, such as PatientsLikeMe and 23andMe, provide users with platforms to facilitate collaborations on observational research studies on health, ancestry, and genomics (Wiggins and Wilbanks 2019).

In professional-driven citizen inquiry, an institutional review board (IRB), or similar independent committee, would be responsible for reviewing and overseeing studies involving human subjects to ensure that investigators comply with federal and state regulations and protect the rights and welfare of participants. Independent review/oversight is an important principle for HSR because investigators have an inherent conflict of interest that compromise their ability to recognize and appreciate ethical concerns that may arise in HSR (Resnik 2018). In the US, federal regulations mandate IRB review and oversight of HSR. The major chief sources of regulatory oversight are the Common Rule (45 CFR 46), which applies to HSR funded or conducted by 16 different federal agencies, and the Food and Drug Administration (FDA) regulations (21 CFR 50 and 56), which apply to research for FDA-regulated products, such as drugs, biologics, and medical devices. Some states, such as California and Maryland, also have human research regulations (Resnik 2018). Most institutions apply the Common Rule to all HSR within their purview, regardless of the source of funding, to ensure that research participants receive equal protections (Resnik 2018).

In public-driven citizen inquiry, however, HSR probably does not receive IRB review and oversight for two reasons. First, if citizen scientists are not receiving federal funds for their HSR projects, are not testing an FDA-regulated product, and are not conducting research in California or Maryland, then it is likely that regulations will not apply to their research. Second, in the rare case that federal or state regulations apply to public-driven HSR, citizen-scientists may not be aware of them, due to the lack scientific education or training (Resnik 2019).

Should we be concerned if public-driven HSR does not receive IRB review and oversight? One might argue that there is no need for public-driven HSR to receive IRB review and oversight because it is not likely to cause significant harm to participants or violate their rights. IRB review is a burdensome and expensive form of oversight that public-driven HSR can do without.

While I am sympathetic to this argument, I think there are some reasons that citizen-scientists should consider seeking IRB review/oversight of their self-initiated HSR. First, although public-driven HSR is not likely to involve interventions, tests, or procedures that impose significant risks on participants, it raises some important human protection issues, such as informed consent, privacy and confidentiality, and sharing and control of research data (Wiggins and Wilbanks 2019). IRB review can help citizen scientists deal with these issues and ensure that participants are adequately protected. Second, most scientific journals require that manuscripts submitted for publication which report the results of HSR include information about ethics approval (Finlay and Fernandez 2008). Citizen scientists may find that they have difficulty publishing their research in professional journals if they do not obtain IRB approval.

However, I recognize that IRB review can be intimidating for citizens who are not familiar with this form of oversight or federal or state regulations. It can also be time-consuming and expensive, costing thousands of dollars per study (Western IRB 2018). Citizen scientists could address these problems by partnering with professional scientists, who can guide them through the approval process at their institutions and save them considerable money. In some cases, an IRB may determine that a citizen science project is “exempt” from the federal regulations because it only involves the collection of anonymous data or it includes adequate confidentiality protections for personally-identifiable data. In other cases, an IRB may decide that a citizen science project does not qualify as HSR because it is not a systematic investigation designed to produce generalizable knowledge (Resnik 2018). Although partnering with professional scientists to obtain IRB approval for HSR may take away some independence from citizen scientists, it can be a useful way of ensuring that human participants in their studies receive appropriate protections.