There is increasing concern that current informed consent models linnet the ability of patients to exercise their preferences for data sharing. In th context of healthcare data, this is particularly complicated because informed consent for care may include provisions for allowing data to be shared for research, as long as the use complies with state and federal laws. Some authors have declared that it is impractical to implement a system for tiered informed consent in which patients can indicate their preferences for whom they want to share their data with and for what types of research. The wide dissemination of electronic health record systems and derived clinical data warehouses has created an abundant pool of data that can be used in certain types of research. Clinical data warehouses could be used to store patient preferences and this would create an opportunity to verify whether tiered informed consent is indeed impractical. As patients start getting familiar with patient portals, itis possible to use them to elicit preferences. In this study, we will implement an electronic tiered informed consent system and evaluate it in a single center, single blinded randomized controlled trial. Specifically, we will develop iCONCUR (informed CONsent for Clinical record Use in Research), a software system to assist with patient informed consent of clinical data sharing for research. The system includes: a. A look-up registry for patients to inspect which studies used which parts of their data. b. A tiered informed consent option for patients to selectively opt-out partially or entirely from data sharing. Additionally, we will estimate financial costs of implementing a scalable system. We will also collect data on patient, provider, researcher, and institutional satisfaction. For this study, we will use an academic internal medicine clinic that treats patients a high proportion of ethnic minorities as the setting. The open-source software developed for this study will be made freely available. The results from our study will help elucidate whether the current consent for care forms are adequately capturing patient preferences.

Public Health Relevance

There is increasing concern that current informed consent processes do not allow patients to fully express their preferences for clinical data sharing. We will build and conduct a preliminary evaluation of a system designed to assist patients in selecting their preferences for use of their clinical data in research, such as which data can be shared, with whom, and for what purposes.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Specialized Center--Cooperative Agreements (U54)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1-HDM-B (90))
Program Officer
Larkin, Jennie E
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California San Diego
Internal Medicine/Medicine
Schools of Medicine
La Jolla
United States
Zip Code
Groat, Danielle; Grando, Maria Adela; Soni, Hiral et al. (2017) Self-Management Behaviors in Adults on Insulin Pump Therapy. J Diabetes Sci Technol 11:233-239
Eguchi, Akiko; Lazaro, Raul G; Wang, Jiaohong et al. (2017) Extracellular vesicles released by hepatocytes from gastric infusion model of alcoholic liver disease contain a MicroRNA barcode that can be detected in blood. Hepatology 65:475-490
Weng, Wei-Hung; Wagholikar, Kavishwar B; McCray, Alexa T et al. (2017) Medical subdomain classification of clinical notes using a machine learning-based natural language processing approach. BMC Med Inform Decis Mak 17:155
Doan, Son; Ritchart, Amanda; Perry, Nicholas et al. (2017) How Do You #relax When You're #stressed? A Content Analysis and Infodemiology Study of Stress-Related Tweets. JMIR Public Health Surveill 3:e35
Wang, Shuang; Jiang, Xiaoqian; Singh, Siddharth et al. (2017) Genome privacy: challenges, technical approaches to mitigate risk, and ethical considerations in the United States. Ann N Y Acad Sci 1387:73-83
Chen, Feng; Wang, Shuang; Jiang, Xiaoqian et al. (2017) PRINCESS: Privacy-protecting Rare disease International Network Collaboration via Encryption through Software guard extensionS. Bioinformatics 33:871-878
Spahn, Philipp N; Bath, Tyler; Weiss, Ryan J et al. (2017) PinAPL-Py: A comprehensive web-application for the analysis of CRISPR/Cas9 screens. Sci Rep 7:15854
Grando, Maria Adela; Groat, Danielle; Soni, Hiral et al. (2017) Characterization of Exercise and Alcohol Self-Management Behaviors of Type 1 Diabetes Patients on Insulin Pump Therapy. J Diabetes Sci Technol 11:240-246
Dulai, Parambir S; Singh, Siddharth; Jiang, Xiaoqian et al. (2016) The Real-World Effectiveness and Safety of Vedolizumab for Moderate-Severe Crohn's Disease: Results From the US VICTORY Consortium. Am J Gastroenterol 111:1147-55
Komenaka, Ian K; Nodora, Jesse N; Madlensky, Lisa et al. (2016) Participation of low-income women in genetic cancer risk assessment and BRCA 1/2 testing: the experience of a safety-net institution. J Community Genet 7:177-83

Showing the most recent 10 out of 164 publications