The application of the regulatory model of IRBs to research using big-data, particularly in the for-profit sector, raises a host of issues. I want to highlight three areas of concern where the regulatory framework of IRBs is challenged by this research: the power of the IRB, privacy, informed consent and the obligation of subjects to participate in research.
The practice of ethical and regulatory review of research involving human subjects has its roots in revelations of some very harmful research that came to light in the early 1970s. The Tuskeegee Syphilis Study is perhaps the most notable, in which a cohort of African American men from Alabama were denied treatment for syphilis with simple antibiotics over a period of over 20 years, resulting in many untimely deaths and the transmission of syphilis to their wives and children. Other studies that came to light involved infecting mental patients with hepatitis and injecting radioactive agents, all without consent, much less informed consent.