Classes of Activities in Clinical Laboratories: Practice, Research, or Else?

281 Classes of Activities in Clinical Laboratories: Practice, Research, or Else? This case about good laboratory practice for establishing a new molecular biology-based clinical diagnostic test of a particular cancer raises an important ethical issue concerning the boundary of practice and research. Before starting this commentary, we will first briefly sum up the two pathologists’ assertions about the test at issue (called “Test-X” here). Pathologist A insists that from his personal experience of research works on the assay of Test-X that was “established”, as he says, in another lab at his previous centre and his experience of clinical practice in the centre using it as a clinical diagnostic tool, Test-X is now a “proven” test with an established clinical validation, and therefore requires no further research works on it. Because any proven test requires a preliminary process of developing an in-house protocol based on standard guidelines to establish a sensitive, standardised assay in each lab, Test-X must also have this process, which requires patient samples but should not be considered as a research activity. Conversely, Pathologist B asserts that because all staff in their lab except Pathologist A do not know whether or not Test-X fulfils the validation requirements as a clinically trustworthy diagnostic tool, the process for the establishment and clinical validation of the assay in this facility will be investigational and therefore need to be classified as a “research” activity. Because of this, the establishment of the clinical validity of Test-X in their lab should be structured as a research project under a properly written formal protocol, and implemented after the process of ethics review and approval by the IRB before introducing it in clinical practice in their institution. Also, because Test-X is still experimental, the test results obtained from actual patient samples should not be returned to the patients in a same way as other proven lab results, and therefore they must not be charged for Test-X. Asian Bioethics Review September 2009 Volume 1, Issue 3 281–284 C A S E C O M M E N T A R Y C l a s s e s o f A c t i v i t i e s i n C l i n i c a l L a b o r a t o r i e s K e n j i M a t s u i a n d S h i m o n Ta s h i r o 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 3 282 Is It a Proven Practice? The main conflict between the two pathologists’ opinions lies in whether, and when, an innovative, experimental test should be placed in the category of clinical practice. Pathologist A regards Test-X as a proven test with a sufficient, trustworthy clinical validation because it has been used already in daily practice in his previous institution, at least. On the other hand, Pathologist B claims that because she and her other colleagues have no experience of using Test-X in clinical practice in their facility and do not know its clinical validation yet, Test-X is not a proven test, but an experimental, unproven method. However, both ways of thinking are problematic. What should be importantly taken into consideration when deciding if Test-X is a proven clinical diagnostic tool is not only whether it is established in the relevant two labs or not, but also how it is currently accepted in the whole medical community consisting of professionals of relevant fields. In the case description there is little information about how Test-X is currently accepted in other labs. However, if the clinical utility of Test-X in terms of interpretation of results and subsequent patient management is still under study in many other labs, we can hardly declare that Test-X is a proven diagnostic tool that can be immediately used in clinical practice. We think therefore...