This validation study was approved by the SHCS scientific board.
Each of the proposed validation steps was approved by at least 7/9 of the panel members.
The protocol for the multi-site validation study was approved by the respective committees for each jurisdiction.
Both Study 1 and the validation study were approved by the relevant regional ethics committees of the institutions involved, and all participants gave their written informed consent.
The study protocol for collection and use of data from our external validation cohort was approved by the research ethics boards at Sunnybrook Health Sciences Centre and Women's College Hospital in Toronto and the Conjoint Health Research Ethics Board at the University of Calgary.
This prospective clinical validation study was approved by the ethics committee of the Klinikum rechts der Isar, Technische Universität München, Germany and was performed according to the ethical standards of the Declaration of Helsinki.
The validation study design was approved by the Ethics Committee of the 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine (i.e. Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, Guangdong Province, China (Approved No.2008GL-09).
The collection and analysis of the validation cohort samples was approved by the University of Michigan internal review board and written informed consent was obtained from all patients.
The transcultural translation and validation research protocol was approved by Emory University Institutional Review Board, Atlanta, USA, and by the Nepal Health Research Council, Kathmandu, Nepal.
The external validation study protocol was approved by the Institutional Review Boards and written informed consent was obtained from all patients.
Moreover, laboratory tests that are used in other areas of medicine, such as those intended for cancer screening, still require a considerable amount of development and validation before they can be approved by the FDA and used clinically [ 4].
