Asian Bioethics Review

A s i a n B i o e t h i c s R e v i e w S e p t e m b e r 2 0 0 9 Vo l u m e 1 , I s s u e 3 292 Ethical Issues of Good Laboratory Practice Beginning with a Hypothetical Story In the case presented, two pathologists (A and B) arrange a meeting with the Head of Department to discuss the establishment of a new molecular biologybased clinical test, which would be used to help in the diagnosis and management of a particular cancer. Pathologist A had done some work on the assay in another lab and has experience in using this test as a clinical diagnostic tool. However, Pathologist B is apprehensive and would like to see a proper clinical validation of the test performed at this facility before it is launched as a clinical test. From this setting, we unravel the ethical issues of good laboratory practice. Issues and Discussion Following completion of the genetic sequencing of the human genome, the integration of genetic technology into clinical and public health has been widely adopted internationally.1 Over the past years, the tool of genetic testing is used in clinical tests for diagnosing diseases, for example for the prevention of epidemics. In addition all kinds of clinical data from diverse populations in different countries are being collected to determine genetic contributors to specific disease and identifying which groups are more inclined to be affected.2 As a result, to better protect the rights of patients, issues regarding the variety of standards adopted within different laboratories had become noticed and needed to be considered when assessing the quality or accuracy of genetic testing.3 After all, the quality or utility of tests is directly affected by what standard is adopted. Recently, great effort has been taken by many international organisations to overcome the differences in laboratory practices of different countries, so as to assure the quality of testing, and to better protect the patient.4 In light of this policy trend, we reflect on the issues raised by the story above. C A S E C O M M E N T A R Y 292–298 Asian Bioethics Review September 2009 Volume 1, Issue 3 293 Is There a Need to Validate? To become an accepted method for treating patients or assist in diagnosing diseases, appropriate clinical data or statistics are critical for a clinical test to be adopted by medical practitioners to assess the status of patients’ health, make diagnostic judgments, formulate treatment procedures, and monitor the effects of treatment. In other words, a medical practitioner must be able to trust the test results in order to use them for follow-up clinical diagnosis. In the field of genetic testing for common genetic diseases, because the targeted groups usually exist across different regions, genetic testing is commonly available and verified by numerous laboratories. However, for rare conditions or diseases, specimen and patient referrals across national boundaries may be necessary. It is worth noting that the predictive values of a test are heavily dependent on the prevalence of the condition in the population being tested, and a test may be clinically valid when applied to individuals from a high risk population, but not so when applied to the general population.5 As elucidated in the World Medical Association’s (WMA) Statement on Genetics and Medicine,6 while the number and types of such tests and the diseases they detect increase, there are doubts about the reliability and limitations of such tests, the implications of testing and result disclosure. That is to say, sometimes the accuracy of genetic testing is indeterminate and the ability of physicians to interpret test results and counsel their patients is challenged by the proliferation of knowledge, thus requiring more analysis or validation studies especially those for rare genetic diseases, and in situations where cross-national or cross-regional cooperation is inevitable. Grounded in these facts, the validity and utility of testing shall be specifically taken into account when employing or adopting test methods. Clinical validation of a genetic test reflects its ability to correctly classify individuals according to their...