Regulating Human Subjects Research in the Information Age: Data Mining on Social Networking Sites

In the 1970s, the Department of Health, Education & Welfare promulgated the first regulations governing research with human subjects. Currently, the Department of Health and Human Services regulates both biomedical and behavioral research with human subjects through 45 C.F.R. § 46, but these regulations have not been revised to address the advances in technology that have changed the ways in which human subjects research is conducted in the 21st century. One of these advances includes researchers’ use of the Internet for various research purposes, including recruiting subjects for their studies, as well as mining data on social networking sites. The issue of data mining on social networking sites for research purposes is becoming more important as researchers in a number of academic fields are collecting research data in this manner. The question of whether such research involves “human subjects” as the term is defined in 45 C.F.R. §46 is important because the answer dictates whether or not such research is subject to federal regulation and oversight. The U.S. Department of Health and Human Services’ Office for Human Research Protections (OHRP) has previously acknowledged an increased use of the Internet for research purposes, but it has not published any guidance about how the Office understands the issue (nor have any applicable specific regulations been promulgated). Such guidance, and particularly guidance that addresses the use of social networking sites for research purposes, is becoming increasingly more important as researchers are expanding beyond just Facebook and MySpace to recruit research participants and collect data. Furthermore, new social networking sites such as PatientsLikeMe.com are changing the ways in which both behavioral and biomedical researchers recruit and interact with study participants. This article identifies three key research activities that any new guidance that the OHRP publishes about Internet research should address: (1) the use of the Internet (including social networking sites) to recruit subjects; (2) the use of the Internet to collect personal information via direct interaction with site users; and (3) the collection of personal information from the Internet for research purposes without direct interaction with the owner of the information, i.e. data mining. It further explores recent case law that says that there is no reasonable expectation of privacy with respect to information posted on social networking sites, and discusses the history of privacy in the federal regulations governing research with human subjects. This article concludes that in light of the changes in online social networking and resulting changes in expectations of privacy, as well as the consideration that the Department of Health and Human Services is giving to revising 45 C.F.R. § 46, guidance – or even new regulations – should be drafted that address these key research activities. It furthermore suggests language that would inform researchers and research institutions whether each of these key research activities is subject to the regulations governing research with human subjects.