Abstract

Human subject research in the United States has historically been governed by federal regulations attached to grant funding support. Through this regulatory reach, it has been possible to enforce standards of ethical treatment, built on the foundations of the Nuremberg Code, Declaration of Helsinki, and the Belmont Report, on the vast majority of research with human subjects in the United States. However, new research methods, such as citizen science, DIY biology, biohacking, and corporate research all pose challenges to the conventional approach, because they can be left ungoverned by these regulations. This requires us to think anew about how to ensure such research is conducted ethically. How can we think about ethical research in the absence of regulatorily required or universally shared norms?

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