SEMINAR: Research Ethics in the Era of Personalized Medicine: Updating Science�s Contract with Society

It has become a familiar refrain that completing the sequence of the human genome promises increased capacity to diagnose and treat disease and in so doing substantially improve the quality of life for millions (if not billions) of people. The vision includes the development of high quality tests that better identify the risk of disease onset, supplemented by an expansive medicine cabinet stocked with drugs that can be prescribed with the assurance that they will help (and not hurt) the patient who takes them. Whether this new paradigm is called tailored therapeutics, personalized medicine, or evidence-based medicine, the technologies now under development aim to not only fundamentally alter the way health and disease are defined, but how they are identified, diagnosed, prevented, treated and cured.

Critical to these advances is the need to conduct high quality research involving human subjects. For decades science and ethics have enjoyed an allegiance reflected in a common set of ethical principles and procedures guiding the conduct of research with human subjects. Some of these principles place emphasis on prioritizing avoiding harm or not harming (for example, the principle of non-maleficence and the principle of precaution), whereas others prioritize freedom and liberty (for example, the principles of respect for persons, respect for autonomy and the principle of free inquiry). This presentation revisits these principles – particularly the principles that support a cautious approach to science - and proposes a reframing the longstanding (but underappreciated) ‘social contract’ between science and society to accommodate advances in genome science.

This presentation is based on a paper prepared by my colleague Mildred Cho and I, that has been submitted for publication to Public Health Genomics.