title: Methylation array data can simultaneously identify individuals and convey protected health information: an unrecognized ethical concern.
abstract: BACKGROUND
  Genome-wide methylation arrays are increasingly used tools in studies of complex medical disorders. Because of their expense and potential utility to the scientific community, current federal policy dictates that data from these arrays, like those from genome-wide genotyping arrays, be deposited in publicly available databases. Unlike the genotyping information, access to the expression data is not restricted. An underlying supposition in the current nonrestricted access to methylation data is the belief that protected health and personal identifying information cannot be simultaneously extracted from these arrays.
  
  
  RESULTS
  In this communication, we analyze methylation data from the Illumina HumanMethylation450 array and show that genotype at 1,069 highly informative loci, and both alcohol and smoking consumption information, can be derived from the array data.
  
  
  CONCLUSIONS
  We conclude that both potentially personally identifying information and substance-use histories can be simultaneously derived from methylation array data. Because access to genetic information about a database subject or one of their relatives is critical to the de-identification process, this risk of de-identification is limited at the current time. We propose that access to genome-wide methylation data be restricted to institutionally approved investigators who accede to data use agreements prohibiting re-identification.
authors: Department of Psychiatry, University of Iowa, Rm 2-126 MEB, 500 Newton Road, Iowa City, IA 52242 USA ; Behavioral Diagnostics Inc, 316 E. Court St, Iowa City, IA 52244 USA.
authors: Robert A
authors: RA
authors: Philibert
authors: Indiana University, Robert H. McKinney School of Law, 530 W. New York St, Indianapolis, IN 46202 USA.
authors: Nicolas
authors: N
authors: Terry
authors: Departments of Medical Education and Psychiatry, Texas Tech University Health Sciences Center, 3601 4th St, Lubbock, TX 79430 USA.
authors: Cheryl
authors: C
authors: Erwin
authors: Department of Psychiatry, University of Iowa, Rm 2-126 MEB, 500 Newton Road, Iowa City, IA 52242 USA.
authors: Winter J
authors: WJ
authors: Philibert
authors: Center for Family Research, University of Georgia, 1905 College Station Road, Athens, GA 30602 USA ; Department of Psychology, University of Georgia, 125 Baldwin St, Athens, GA 30602 USA.
authors: Steven Rh
authors: SR
authors: Beach
authors: Center for Family Research, University of Georgia, 1905 College Station Road, Athens, GA 30602 USA.
authors: Gene H
authors: GH
authors: Brody
keywords: Confidentiality; DNA methylation; Ethics; Genetics; Methylation array