According to a recent report from the Pew Research Center on social media usage in the United States, 65 percent of all adults and 76 percent of adult Internet users spend time online on at least one social networking site. That\u2019s nearly a tenfold increase in the last decade. Given the vast public use of social media, it should come as no surprise that clinical researchers have come to view Facebook, Twitter and other social media as treasure troves of minable information and data. Amid the allure, there are risks involved, some perceived while others not, that can lead unprepared investigators to peril. Thus, these waters must be navigated with great care.Despite the prevalence of social media usage, clinical investigators and institutional review boards (IRBs) have provided little, if any, concrete guidance on the ethical use of social media and the Internet as research tools. The Code of Federal Regulations, which covers human subjects research, doesn\u2019t provide specific information concerning social media research; however, the issue has not gone unnoticed. An advisory committee to the U.S. Office for Human Research Protection provided some guidance, noting that the \u201cethical conduct of Internet research brings questions of scientific design into high relief authenticity of subject identity, assurance of comprehension of consent, and verification of data integrity can present significant challenges.\u201d There are other matters to be considered as well, including technical issues, privacy, and security.While social media and the Web\u2019s collective usefulness as a research tool is significant, there are inherent ethical issues concerning consent, voluntariness, scientific merit and confidentiality that have yet to be addressed by the greater clinical research community. In order to rectify these issues, the clinical research community must come together to create more extensive research guidelines for human subjects research involving social media.Some investigators with whom I have discussed these matters have taken the stance that gathering information from publicly available social media pages, such as Facebook, is akin to observing behavior in a public square, and as such, these types of protocols should be exempted from or fast tracked though IRB review. Unfortunately, the issues are not that simple: a Facebook user, even if his page is publically accessible, may consider his information and photos to be private. There is also a possibility that he or she may not want to be involved in any research studies.Many users simply don\u2019t understand the basic privacy implications that come with social media sites like Facebook, and users may exhibit signs of online disinhibition as they engage in behaviors and expression that may not be representative of the individual generally. Other users may view their social media accounts as extensions of their personal lives, acting or communicating as if in private, even if their accounts can be viewed publically. It is easy to assume that social media users assume or already understand the risks, but this is irrelevant in the face of the duty to provide informed consent. A patient\u2019s existing knowledge does not preempt a researcher\u2019s duty to manage the consent process; for example, clinicians on the receiving end of treatment must provide informed consent for interventions that they provide to patients. Understanding is just one part of the consent process, as is the participant receiving information regarding risks.Another aspect to be considered is that items or posts shared online may contain more information than the user is aware of. Even if a researcher gathers online information under the condition of user anonymity, some data\u2014even obscured photos\u2014may contain metadata such as dates, times and even geospatial information. Some files or photos may also feature information about the devices utilized for uploading, such as a phone number or other device identification. The content of information being gathered must also be considered. For example, if data gathered from a social media site for research has the potential to exposes a user to criminal liability, then appropriate measures must be taken to protect the subject.When researchers gather information online, they must ensure that the data doesn\u2019t unwillingly compromise a subject\u2019s identify, or potentially compromise them legally, financially, or socially. And it is not just large academic medical centers at play here. Some private and publicly traded companies conduct research using data posted or shared through their respective sites. Facebook is constantly studying human behavior through social networks. Google stores search data entered into its search engine on a regular basis. When paired with cookies, Google can then pass along that search data to help advertisers target users. This highlights the current ethical trend of Web-based privacy issues and a lack of transparency concerning information ownership, making it even more critical for researchers to establish strict guidelines on gathering Web data.The social media industry is ever changing and subject to minimal regulation. On the other hand, clinical research is extensively regulated, but the community has been slow when it comes to adapting to current research trends involving social networking technologies. The Web and social media in particular represent valuable research resources, but in order to use them in an ethical manner that protects users, both the clinical community and private sector must come together in order to establish a relevant set of guidelines. Until that\u2019s done, outstanding ethical dilemmas and their attendant risks will continue to burden social media users and research participants.