By Anne Meade, senior manager for website and social media
The process of developing federal regulations may be unfamiliar to those whose jobs require adherence. In this excerpt from People and Perspectives, Richard Klein, director of the Food and Drug Administration’s Patient Liaison Program in the Office of Health and Constituent Affairs, talks about being involved in the process of writing the Common Rule. As this was his first foray into writing regulations, at the beginning, Mr. Klein did not anticipate too much difficulty. He quickly realized that assembling a diverse group of people really presents an opportunity.
"When you get a [group] of people together, and everybody’s got different perspectives to take care of, you start to realize how flexible regulations really need to be."
While striving to adhere to regulations is likely a regular objective of many within the research ethics field, it may be difficult to think of regulations as flexible. Although lengthy and comprehensive, there certainly seems to be a feeling of "the regulations say you can do this or that," and that’s that. Mr. Klein explains, though, that regulations are written to allow flexibility in order to adjust for unexpected changes.
"[The regulations] are written in a very elegant way to allow flexibility, to allow things that nobody is foreseeing. Because…things pop up that nobody ever expected and you want the regulation to be able to be flexible enough to be stretched around that situation."
Mr. Klein explains that the process of gathering people together to discuss the regulations allows for conversations to occur and questions to be asked that might otherwise never come up. This dialogue allows for all viewpoints to be heard and considered, which is especially important when considering how to formulate regulations. These varied perspectives help account for problems before they occur, thus maintaining flexibility within the regulations in order to accommodate them.
Watch the full interview with Mr. Klein on People and Perspectives.
As flexibility in the federal regulations is an area of ongoing interest for the PRIM&R community, the 2015 Advancing Ethical Research (AER) Conference and the 2015 Social, Behavioral, and Educational Research (SBER) Conference both offer sessions on this topic. Registration for both conferences opens on June 10, 2015. Sign up here to be notified when registration begins.