In the light of rapid developments in the clinical applications of genetics, updated guidelines on the ethical and legal issues facing healthcare professionals in this complex area have been published.
The nature of genetic information means that test results often have potential implications for family members as well as patients, leaving many clinicians uncertain about how best to balance the interests of all. A new report, Consent and confidentiality in clinical genetic practice: Guidance on genetic testing and sharing genetic information, explores the legal environment created by the Data Protection Act 1998, the Human Tissue Act 2004 and recent developments in statutory and professional guidance. Included in the guidance are worked examples, based on real cases illustrating how complex situations can be dealt with in practice. A key focus of the report is to illustrate how the family can be important in what otherwise might seem to be individual decisions.
Key recommendations include:
- Family history and clinical information are shared between relevant health professionals if appropriate to the health care needs of family members.
- Risks of disease are communicated to relevant family members (via an agreed route such as the general practitioner, genetic services or the patient). Such communication is particularly important where there may be potential to modify a genetic condition through medical intervention.
- The approach to obtaining consent is robust and transparent, so that patients are informed in general terms about how their sample (and the information derived from it) might be used. Apart from use for relatives, this might also include using remnants of the sample for quality assurance or incorporating test results into national data sets.
- The guidance identifies a list of key topics that should be discussed as part of the consent process for genetic testing. It suggests that those obtaining consent should explicitly address:
the benefits that might result to relatives from genetic investigations;
a recommendation that relevant information be shared with relatives;
the possibility of uncertain or unexpected findings from genetic testing and how these might be managed; and
the possibility of future testing to resolve current uncertainty.
In short, whilst the guidance is a little sketchy, it does provide a framework together with worked clinical examples which will be useful both to health care professionals and their patients.