If Canada´s pharmaceutical and biological regulation process is a mysterious "black box," then Dr. Janice Graham´s main research goal is to open it.

As Canada Research Chair in Bioethics, Graham is examining regulatory practices at Health Canada, and other international regulatory sites. By mapping the regulatory territory between scientific evidence and policy decisions, her research will show how Health Canada ensures the safety, quality and effectiveness of the therapeutic products that end up in clinical treatments or in tubes and bottles inside our medicine cabinets.

Therapeutic product regulation is a process most of us take for granted, but the need to examine regulation is more urgent than ever as new biologic and genetic therapies emerge, and as industry-sponsored research expands. "Regulation is a scientific, cultural and moral practice. It´s meant to protect people from undue harm, but the process is not always open or transparent; in fact it´s often seen as residing in a ´black box´", explains Graham. "Many of us assume there are safeguards, but what really happens when a new therapy is submitted for evaluation? What level of evidence is required to say it is effective? Why is it that drugs are recalled after they have been deemed safe by scientific teams? What does the intersection of science, industry and government policy look like and how confident can we be that our drugs are safe and effective?"

To answer these questions, she´s been working among Health Canada regulators, researchers and decision-makers, and also among the employees of pharmaceutical companies that bring these therapeutic products to market. Using her background in anthropology, epidemiology and geriatric medicine, she´s also looking at the wider socio-cultural issues surrounding the regulation of drugs.

Graham says she hopes to further the dialogues that have begun on open and transparent science and policy, the proper reporting of clinical trials, and the potential for conflicts of interest in the research community. "The primary goal of regulation is to protect public health", she says. "We must make sure that the process is better understood by everyone and that assurance of public health is an integral part of the process, to make certain people are protected once the therapy hits a wider market."

Graham joined the Department of Bioethics, part of Dalhousie´s Faculty of Medicine, in 2002. As a medical anthropologist, she is also cross-appointed to the Department of Sociology and Social Anthropology. In 2004 she received over $400,000 in funding from the Canada Foundation for Innovation and the Nova Scotia Research and Innovation Trust for a new Qualitative Research Commons and Studio (QuRCS), the only one of its kind in Canada. Opening in spring 2005, the QuRCS is a state-of-the-art multi-media ethnographic research facility that will support collaborations between international networks of researchers working on socio-cultural and bioethical issues. Recently, the Canadian Institutes of Health Research awarded Graham a $500,000 operating grant to enable continued work on regulatory practices.