“The Federal Register is surely not everybody’s bedtime reading. It is where the US Government formally publishes certain official documents, including advance notice of its intention to make rules that implement Executive policies. For social science researchers, one of the most important of these has long been the so-called Common Rule, introduced in 1981 and revised in 1991. This is the legal basis for the whole system of US ethical regulation through Institutional Review Boards. Although nominally confined to US institutions, it has had a much wider reach, since any country involved in scientific collaboration with US scholars has had to adopt a similar regulatory model. The new revisions to the Common Rule, described in a ‘notice of proposed rulemaking’ published in September 2015, are, then, likely to have global implications.
In practice, the present regime’s international impact has been uneven in the social sciences, because few institutions have relevant collaborative relationships with US researchers. Major European countries like France, Italy and Germany have seen very limited regulatory developments, mainly in their health sectors and in a few elite institutions open to US influence. The UK, Ireland and the Nordic countries have, however, been strongly affected by the US model. The extensive deregulation of social science research anticipated by the notice is, then, as much a challenge to their regulators as to those in the USA.
The implementation of the Common Rule has been increasingly criticized. As the history of ethical regulation has become better understood, its origins are seen to lie less in a desire to protect human subjects than to transfer litigation risk from the Federal government to universities and to defuse a political panic over accounts of historic biomedical research misdemeanors – some of which look less scandalous when properly contextualized. The system has been widely criticized, as much by biomedical scientists as by social scientists, for its costs, complexity, and conservatism. Many critics claim that it has created a self-serving bureaucracy and facilitated institutional practices that have less to do with ethics than with liability and reputation management. Its brakes on biomedical innovation have measurable costs in lives lost. There are less measurable costs in the systematic ignorance about social conditions created by the regulators’ resistance to qualitative methods that are difficult to control. Although attempts have been made at Federal level to press IRBs to be more accepting of flexible and emergent research methods and designs, these have had only a limited impact.”