Consent has been the cornerstone of personal data privacy regime. This notion is premised on the liberal tenets of individual autonomy, freedom of choice and rationality. More important, consent is only meaningful if data subjects are fully informed and parties are of equal bargaining power. Under orthodox framework, it is believed that privacy can be waived by consent.
The above concern is particularly pertinent to citizen science in health and medical research, in which the nature of research is often data intensive with serious implication for individual’s privacy and other interests. Although there is no standard definition for citizen science, it includes generally the gathering and volunteering of data by non-professionals, the participation of non-experts in analysis and scientific experimentation, and public input into research and project. Citizens become experimenters, stakeholders, purveyors of data, research participants or even partners. Consent from citizen scientists is indispensable as it is a constitutive element for self-determination and self-empowerment for participants. Furthermore, consent from data subjects determines the responsibility and accountability of data users. Yet with the advancement of data mining and big data technologies, risks and harm of subsequent data use may not be known at the time of data collection. Progress of research often extends beyond the existing data. Namely, researchers of existing team or even third parties can match data sets to re-identify individuals. Furthermore, big data technology use and transfer of data for other unforeseen purposes maybe outside the control of the original research team. In other words, consent becomes problematic in citizen science in big data era. The model that one can fully specify the terms in notice and consent has become an illusion.
Is consent still valid? Should it still be one of the critical criteria in citizen science health research which are collaborative and contributory by nature? With a focus on the issue of consent and privacy protection, this study will analyze not only the traditional informed consent model but also the alternative models of “open consent”, “portable consent,” “dynamic consent,” and “meta consent.” Facing the challenges that big data and citizen science pose to personal data protection and privacy, this paper explores the legal, social and ethical concerns behind the concept of consent. It argues that we need to move beyond the consent paradigm and take into account a much broader context of harm and risk assessment. Ultimately, what lies behind consent are the entailing values of autonomy, fairness and propriety in the name of research.'Vulnerable Subjects: Why Does Informed Consent Matter?' by Michele Goodwin in (2016) 44 Journal of Law, Medicine and Ethics comments
Most literature captures human experiments as either acceptable or unacceptable; good or bad; ethical or non-ethical. However, might there be finer degrees to distinguish medical experimentation from either being permissible or utterly unethical? Does informed consent convey different meanings depending on who invokes the term and the status of the human research subjects? When do researchers really know that consent is informed? Is a signature enough? This Essay unpacks important questions and concerns, including considering what human research subjects are entitled to know before, during, and after agreeing to participate in clinical trials. These matters gain further urgency in the wake of controversies involving the use of fetal tissue in human research. What can policymakers, lawyers, researchers, and doctors learn from the past to inform ethical research and medical practices in the wake of demands for fetal tissue research and the historic exploitation of vulnerable populations, including racial minorities, children, and the elderly in medical research?
This Essay makes three contributions. First, it offers a historical analysis and descriptive account of medical experiments conducted on individuals without informed consent of the human research subjects. Second, through the case studies highlighted, it illuminates how race, class, and status continue to impact decision-making with regard to unethical research. That is, the status of the research subject too often plays a role or influences whether the patient will be treated with dignity, respected, and able to give informed consent. Too frequently if a human research subject is a child, ethnic minority, or poor, she is more likely to be violated in a research study. As the case studies demonstrated, often vulnerable subjects are denied clear medical information and unable to grant informed consent. Third, this Essay queries the role of law and ethics to bring about change.