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Federal Commission Urges Government Initiatives on Sequencing Data Privacy, Consent Process

NEW YORK (GenomeWeb News) – An Obama Administration panel today released a dozen recommendations drafted to help create policies for securing whole-genome sequencing data, with the aim of protecting individual privacy without hampering the use of genome sequencing in research and medicine.

In its report, the Presidential Commission for the Study of Bioethical Issues advised federal and state governments to take steps to create a layer of baseline protections while promoting data access and sharing, to improve data security and access, to create a "fully informed" consent process, and to ensure that all citizens benefit from whole-genome sequencing, Commission Chair Amy Gutmann said yesterday.

The commission was charged with surveying the current state of whole-genome sequencing data privacy because the cost of sequencing has dropped to the point where what has so far been a cutting-edge research tool is now seeping into the clinical and consumer markets.

Guttman said in a call with reporters that the Privacy and Progress in Whole Genome Sequencing report is "proactive and forward-looking … It is not a response to a crisis, but the commission understands that if this issue is left unaddressed we could all feel the effects."

She added, "In order to make full use of whole-genome sequencing, which holds enormous promise for human health and medicine, we're going to have to figure out how to protect people's privacy, and avoid the harms that can come from the misuse of this very personal data."

The commission launched its effort to study whole-genome sequencing and data privacy earlier this year through a set of public meetings and conversations with stakeholders interested in genomic data-driven research, clinical medicine, and patient protection.

Since the commission undertook this subject, reports about the potential benefits of genome sequencing in clinical medicine and research have bled into mainstream US media outlets, suggesting that the public is becoming aware of its potential in treatment and in predictive medicine.

But concerns about data privacy have hovered over the genome sequencing field, because of the nature of genomic data. Genomic information can predict risk of illness, can have an impact on the relatives of patients, consumers, and research participants, and it is being studied more and more often by researchers who trawl through vast seas of data in search of meaningful links to diseases and genetic variants.

"Privacy is very different for whole-genome sequencing than it is for one genetic test, because it's not just you that you're learning about. ... It's also your family," Guttman said yesterday as she outlined some of the ethical issues related to genomic data privacy that the commission weighed .

"What does it mean that the data is sitting in a database somewhere? Will it impact your ability to get long-term care insurance or life insurance?" she asked.

"In many states in the US, someone could literally pick up your discarded coffee cup and send it in for whole-genome sequencing. It is not a fantasy to think about how in the future, without clear baseline privacy protections, people could use this [information] in ways that are really detrimental to the people whose genome sequencing they learn about," she said.

For these reasons, Gutmann said, the data from such science must be "respected and secured," and these "timely and proactive" recommendations represent an effort to "craft policies that are flexible enough to ensure progress and responsive enough to protect privacy."

Broadly, the commission's recommendations focus on oversight and data security-related measures to protect patient and research participant information, on development of a better consent process, and on ensuring that the public at large may reap the benefits of innovations stemming from genomic science and medicine.

The commission wants funders of whole-genome sequencing research and those managing sequencing databases to develop "clear policies" over who has access to genomic data and how that data may be used — policies that will promote data sharing by individuals who want to share their genomic information with clinicians and researchers.

The group also has urged federal and state governments to create and ensure "a consistent floor of privacy protections covering whole-genome sequence data regardless of how they were obtained." The aim is to protect individual privacy by prohibiting unauthorized genome sequencing without consent.

The panel also recommends that whole-genome sequence data should be kept secure, and that everyone who works with such information is guided by professional ethical standards related to privacy, and that they be held accountable to state and federal law and regulations that cover breaches and hacking of data security.

Research funders and policy makers also should make clear what the permissible uses are for whole-genome sequence data, and the data should be stripped of traditional identifiers whenever possible to protect people's identities, the commission said.

Federal agencies also should take steps to ensure that when third parties are entrusted with whole-genome sequence data that they are in compliance with the Health Insurance Portability and Accountability Act, or other relevant regulations.

The commission also advised that consent processes should be adopted that allow patients, research participants, and others to know who has access to their data and how that information might be used in the future. These processes also would ascertain how individuals would or would not like their data to be used when they provide their samples.

The Office for Human Research Protections in the Department of Health and Human Services also should "establish clear and consistent guidelines for informed consent forms," the commission advised. These forms should describe whole-genome sequencing and analysis; explain how data will or may be used; explain what controls individuals will have over how their information is used; define benefits and potential risks to those who provide their whole-genome sequence data; and explain what data and information, if any, might be returned to the individual.

Researchers, clinicians, and sequencing entities also must let individuals know that there may be incidental findings in the course of the genome sequencing, and the consent process should explain how these findings will be communicated to the individual, the commission recommended.

Funders of sequencing research also should support studies to evaluate different approaches to return incidental findings and other research results to patients, and they should study people's attitudes and preferences about how they would like such findings to be returned.

Research funders, clinical entities, and the commercial sector should take steps to facilitate the exchange of information between scientists and clinicians, while maintaining safeguards, so that sequencing data and health care data can be shared and compared to advance genomic medicine, the commission urged.

Policy makers also should promote opportunities for the public to benefit from sequencing research, and promote the development of new models for collaborative relationships between researchers and participants.

Lastly, the commission advised that the federal government make investments in whole-genome sequencing that will enable the broadest group of people possible to benefit from sequencing and genomic medicine.

"Research funded with taxpayer contributions should benefit all members of society," the commission stated. "To these ends, researchers should be vigilant about including individuals from all sectors of society in their studies, so that research findings can be translated widely into improved clinical care."

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