The U.S. Department of Health and Human Services has announced proposed revisions to modernize federal regulations governing the protection of research participants’ rights and welfare. The newly proposed regulations have many positive features that will improve the informed consent process through transparency and stricter requirements to protect participant privacy and enhance informed consent.
For the first time in 20 years the U.S. Department of Health and Human Services has proposed changes to Federal Regulations governing protections for people who participate in research. Any changes will have a substantial impact on the conduct and Institutional Review Board (IRB) approval of social-behavioral research–especially in terms of how IRBs will interpret criteria for “minimal risk” research and expedited review.
A new study using Facebook data to study “emotional contagion,” and the ensuingbacklash of its publication offers the opportunity to examine several ethical principles in research. One of the pillars of ethically conducted research is balancing the risks to the individual participants against the potential benefits to society or scientific knowledge. While the study’s effects were quite small, the authors argue that “given the massive scale of social networks such as Facebook, even small effects can have large aggregated consequences.” However, participants were not allowed to give informed consent, which constitutes a risk of the research and the major source of the backlash.