Using a fingerprint recognition system in a vaccine trial to avoid misclassification.

PROBLEM: The potential for misidentification of trial participants, leading to misclassification, is a threat to the integrity of randomized controlled trials. The correct identification of study subjects in large trials over prolonged periods is of vital importance to those conducting clinical trials. Currently used means of identifying study participants, such as identity cards and records of name, address, name of household head and demographic characteristics, require large numbers of well-trained personnel, and still leave room for uncertainty. APPROACH: We used fingerprint recognition technology for the identification of trial participants. This technology is already widely used in security and commercial contexts but not so far in clinical trials. LOCAL SETTING: A phase 2 cholera vaccine trial in SonLa, Viet Nam. RELEVANT CHANGES: An optical sensor was used to scan fingerprints. The fingerprint template of each participant was used to verify his or her identity during each of eight follow-up visits. LESSONS LEARNED: A system consisting of a laptop computer and sensor is small in size, requires minimal training and on average six seconds for scanning and recognition. All participants' identities were verified in the trial. Fingerprint recognition should become the standard technology for identification of participants in field trials. Fears exist, however, regarding the potential for invasion of privacy. It will therefore be necessary to convince not only trial participants but also investigators that templates of fingerprints stored in databases are less likely to be subject to abuse than currently used information databases.