Policy development lessons from two federal initiatives: protecting human research subjects and handling misconduct in science.

The authors compare and contrast two policy development exercises--one that resulted in the publication of a common federal policy for the protection of human research subjects, and the other that is under way to develop a government-wide common policy for addressing misconduct in science. The article offers some basic lessons derived from these interagency activities and may shed some light on the issues that institutions face in developing their own policies and procedures for handling allegations of misconduct in science. These lessons include, among others: lead from a position of authority; use smaller working groups to draft text or work out differences; never underestimate the time needed to elucidate where all the participants are coming from; garner support of key players; timing is everything; and when presented with lemons, make lemonade. Although the process is not yet finished, interagency work is developing concerning misconduct in science. The different participants agree in theory that coordination is desirable, but they can be understandably concerned that they might have to relinquish some of their autonomy in setting policies for activities supported by their agencies. Although it may seem that the federal government moves slowly, often there is much going on behind the scenes, and often that work can be as important as, if not more important than, the task at hand.