International Meeting for Autism Research (London, May 15-17, 2008): Balancing Accuracy and Anonymity of Biological Specimens in CADDRE, SEED

Friday, May 16, 2008

Champagne Terrace/Bordeaux (Novotel London West)

10:30 AM

G. B. Jensen , Biomedical Research and Informatics Center, Michigan State University, East Lansing, MI

P. A. Thompson , Biomedical Research and Informatics Center, Michigan State University, East Lansing, MI

A. E. A. Siddiqi , Biomedical Research and Informatics Center, Michigan State University, East Lansing, MI

J. E. Siebert , Radiology, Michigan State University, East Lansing, MI

J. D. Bonner , Biomedical and Research Informatics Center, Michigan State University, East Lansing, MI

S. Meyerer , School of Public Health, Johns Hopkins University, Baltimore, MD

M. F. Kuhn , Department of Radiology, Michigan State University, East Lansing, MI

K. L. Marable , Department of Radiology, Michigan State University, East Lansing, MI

S. J. Sharp , Department of Radiology, Michigan State University, East Lansing, MI

T. L. Holland , Department of Radiology, Michigan State University, East Lansing, MI

S. Chandan , School of Public Health, Johns Hopkins University, Baltimore, MD

H. Farzadegan , School of Public Health, Johns Hopkins University, Baltimore, MD

P. L. Reed , Biomedical Research and Informatics Center, Michigan State University, East Lansing, MI

M. H. Rahbar , Epidemiology, Biostatistics, University of Texas Medical School at Houston, Houston, TX

Background:
Protection against disclosure of personally identifiable information (PII) and maintenance of anonymity of study participants is an ethical and regulatory imperative for clinical research. The Center for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) information system (CIS), developed for the national Study to Explore Early Development (SEED), anonymizes participant biological specimens and tracks them throughout the study protocol.
Objectives:
–Accurately track participant biological samples throughout the study protocol
–Minimize exposure of PII
–Blind laboratory analysts to minimize risk of associating between sample genotypes and participant phenotypes
Methods:
The study sites collect and barcode participant specimens and send them to the laboratory, identified without PII. The courier’s tracking barcode is scanned into CIS, which tracks the package via link to the courier’s tracking system for study sites and laboratory. At the laboratory, a receiving clerk scans the courier’s barcode into CIS, records the initial condition of each sample, creates a record for each sample in the laboratory information system (LIS), links new laboratory IDs into CIS, replaces each CIS barcode with a laboratory barcode and discards the CIS barcode; thereby anonymizing the sample for all future steps. The laboratory assesses the samples and enters findings into the LIS, and CIS automatically retrieves sample assessment data using a secured Simple Object Access Protocol (SOAP) connection to the LIS. CIS imports the LIS internal specimen analysis data. Only CIS stores tracking data, PII, and associations between CIS and LIS data.
Results:
The specimen workflow design obviates the possibility of linking samples to phenotypes and adds a layer of protection against PII disclosure.
Conclusions:
The SEED study’s CIS tracks and maintains information on biosamples while preventing association of PII with genotypes outside of CIS.

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