A Research Revolution: Genetic Testing Consumers Become Research (and Privacy) Guinea Pigs

INTRODUCTION ............................................................................. 574 I. BACKGROUND ..................................................................... 574 A. Regulation of Human Subject Research in the United States ... 575 1. Historical Examples of Abuse ....................................... 575 2. Current Laws ................................................................ 576 B. Human Genome Sequencing and Testing ............................... 578 1. Sequencing the Human Genome ................................. 578 2. Direct-to-Consumer Genetic Testing .......................... 579 II. ONLINE COMMUNITIES AS A SOURCE OF HUMAN SUBJECTS FOR GENETIC RESEARCH .......... 580 A. Research Arms of Direct-to-Consumer Genetic Testing Companies ............................................................................ 580 B. Non-Profit Research Consortiums ......................................... 581 III. GENETIC INFORMATION PRIVACY IN ONLINE RESEARCH COMMUNITIES ............................................. 582 A. Relevant Legislation ............................................................. 583 1. The Genetic Information Nondiscrimination Act of 2008 .............................................................................. 583 2. State Laws ..................................................................... 584 B. Privacy Policies, Terms of Service, and Informed Consent ....... 585 1. Direct-to-Consumer Genetic Testing Companies ....... 585 2. Non-Profit Research Consortiums ............................... 588 IV. PRIVACY VERSUS PUBLIC BENEFIT ........................................ 590 A. Privacy Concerns .................................................................. 590 1. Reidentification: The Loss of Anonymity .................... 590 2. Informed Consent and Autonomy ............................... 592 3. Genetic Discrimination ................................................ 593 B. Public Benefit: Promoting, Not Impeding, Genetic Research ... 593 C. Balancing Concerns .............................................................. 595