RLO: ACCE Framework

• Introduction
• Analytical Validity
• Clinical Validity
• Gene-Environment Activity
• Clinical Utility
• Ethical, Social & Legal Issues
• Assessment

Ethical, Legal & Social Issues

This domain is perhaps the most difficult to address as it is wide ranging.  It is a question that we have to keep reminding ourselves and ask about at every stage.

What issues could this include?

From an individual's perspective it is vital for them to know that the test will be accurate and will provide the information that is wanted, and that that information will be useful in determining their clinical care.  This will help people to know whether or not they wish to take a genetic test.  For society, it is important that genetic tests are evaluated properly in order to maintain public confidence in the procedures.  In addition, people react negatively when they feel that science is being conducted 'behind their back' even if it is for their ultimate benefit.  A transparent evaluative process will add to that feeling of confidence.  Also, health professionals and policy makers need to be aware of the public's concerns, such as potential discrimination based on their test results, in order to best use these tests in the context of clinical care.