Balancing Benefits and Risks of Immortal Data Participants’ Views of Open Consent in the Personal Genome Project; Hastings Center Report, 12/17/15

Oscar A. Zarate, Julia Green Brody, Phil Brown, Monica D. Ramirez-Andreotta, Laura Perovich andJacob Matz, Hastings Center Report; Balancing Benefits and Risks of Immortal Data: Participants’ Views of Open Consent in the Personal Genome Project:

"Abstract

An individual's health, genetic, or environmental-exposure data, placed in an online repository, creates a valuable shared resource that can accelerate biomedical research and even open opportunities for crowd-sourcing discoveries by members of the public. But these data become “immortalized” in ways that may create lasting risk as well as benefit. Once shared on the Internet, the data are difficult or impossible to redact, and identities may be revealed by a process called data linkage, in which online data sets are matched to each other. Reidentification (re-ID), the process of associating an individual's name with data that were considered deidentified, poses risks such as insurance or employment discrimination, social stigma, and breach of the promises often made in informed-consent documents. At the same time, re-ID poses risks to researchers and indeed to the future of science, should re-ID end up undermining the trust and participation of potential research participants.

The ethical challenges of online data sharing are heightened as so-called big data becomes an increasingly important research tool and driver of new research structures. Big data is shifting research to include large numbers of researchers and institutions as well as large numbers of participants providing diverse types of data, so the participants’ consent relationship is no longer with a person or even a research institution. In addition, consent is further transformed because big data analysis often begins with descriptive inquiry and generation of a hypothesis, and the research questions cannot be clearly defined at the outset and may be unforeseeable over the long term. In this article, we consider how expanded data sharing poses new challenges, illustrated by genomics and the transition to new models of consent. We draw on the experiences of participants in an open data platform—the Personal Genome Project—to allow study participants to contribute their voices to inform ethical consent practices and protocol reviews for big-data research."

Sharing Health Data Online; New York Times, 2/16/16

[Letter to the Editor] Julia Brody, New York Times; Sharing Health Data Online:

"Doctors and scientists have an ethical duty to explain to patients the implications of online data sharing, and to explain them well. In our recent study, we interviewed participants in the Personal Genome Project and found that when researchers are completely open about the risks and benefits of making their genetic and health data public, participants were often willing to consent because they wanted to help advance science.

It is up to scientists, then, to make good on their promise to accelerate discovery in the treatment and prevention of diseases, by ensuring that patient data is properly stored and managed so that other researchers can use it.

At the same time, more needs to be done to minimize the risks, like privacy violations, through better data security and legal protections for study participants.

JULIA BRODY"