Full Disclosure of Data Sharing in Human Research Encourages Patient Participation

Participation in human research may improve with full disclosure and increased transparency of the risks of participating in publically shared, big-data research projects, according to a recent study published in The Hastings Center Report.1

This study examined the experiences of participants in the Personal Genome Project, which is an open data platform. These experiences could contribute to ethical consent practices and protocol review in big data research.

Participants in the Personal Genome Project were interviewed to better understand their views on consent. The Personal Genome Project was established in 2005 by researchers at Harvard Medical School in Boston, Massachusetts.

The primary goal of the Personal Genome Project is to sequence the genomes of 100 000 people to create a shared, public resource containing participants' genetic and health data. This resource could promote science and health research breakthroughs.

Informed consent is increasingly challenging as research projects using big data often rely on many researchers across multiple institutions. In addition, many research questions that will rely on big-data resources are unforeseeable. Finally, the risk of re-identification would breach the original consent agreement and could cause employment and insurance discrimination.

This study found the open consent model of the Personal Genome Project, whereby participants are fully aware of the risks of re-identification, promoted participation. It also suggests changing requirements such that researchers would have to obtain consent from patients prior to using discarded blood and tissue samples for research.

These results may affect Common Rule revisions proposed by the United States federal government.

“This is a great opportunity to revisit ethics in human research. These revisions are going to affect thousands of people and millions of dollars in research, so it's important that the government gets it right,” said Julia Brody, PhD, executive director of Silent Spring Institute in Newton, Massachusetts, and a co-author of the study.

“Right now, every time you walk into a clinic or a hospital for a blood test or a biopsy, scientists can take your anonymous samples and use them for research without your permission,” stated Brody. “Now that new technologies could potentially link those samples back to you, it makes sense to ask patients for their permission.”

As part of open consent, all possible risks are described, including re-identification. “You can't just say it's unlikely to happen. You need to be more forthcoming and say it's a possibility. That kind of transparency improves participants' trust in scientists, and that's vital to research in the long run,” said Brody.

This study was limited by the narrow demographic of the Personal Genome Project. Future research examining a more diverse demographic would validate this study's results.


1. Zarate OA, Green JB, Brown P, Ramirez-Andreotta MD, Perovich L, Matz J. Balancing benefits and risks of immortal data: participants' views of open consent in the Personal Genome Project. Hastings Cent Rep. 2016;46(1):36-45.

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