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Regenerative Medicine Ethics pp 107–128Cite as

Repositories for Sharing Human Data in Stem Cell Research

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Abstract

High-throughput biology is data intensive, and stem cell research is no exception to this trend. Funders often require scientists to share the data generated by high-throughput methods, because sharing speeds scientific discovery and increases the benefit of public investments in science. When human data are involved, the benefits of sharing must be balanced against the risks of inappropriately disclosing sensitive, personal information. Historically, scientists anonymized data to protect the interests of people whose data were shared. However, recent development of computational methods for re-identifying people from anonymous data and empirical demonstrations of re-identification have led many commentators to question whether anonymization still provides adequate protection for people whose data are included in shared databases. Because of disclosure concerns, data sharing repositories control who can access sensitive human data and what the approved users can do with those data. Stem cell researchers who create such repositories must develop governance mechanisms that prevent harm to individuals whose data they share.

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Notes

  1. 1.

    As of July, 2012, the Nucleic Acids Research online database catalog could be found at http://www.oxfordjournals.org/nar/database/a/.

  2. 2.

    For a comprehensive review of new repositories and databases for the biological sciences, see the January 2012 database supplement of Nucleic Acids Research (volume 40, issue D1), and for a discussion of the difficulties of creating, maintaining, and analyzing large data sets, see the February 2011 issue of Science.

  3. 3.

    One of the earliest and best-known standards for information sharing is MIAME—minimum information about a microarray experiment (Brazma et al. 2001). As microarray gene expression studies became a widely used source of genome-scale data in the life sciences, scientists discovered that much of the microarray data being generated were inaccessible or unusable by most of the interested scientific community. Microarray data accompanying publications were typically reported on the authors’ website, using a variety of formats. There was no consensus on what annotation was necessary, and the data often were not annotated. Data generally did not include indicators of reliability and quality. As the scientific community moved to create repositories for microarray data sharing (such as GEO and ArrayExpress), a consensus group was formed to suggest what types of information should be included in the repositories. The MIAME standards were the consensus group’s attempt to specify minimum information that must be included in a repository to make the data interpretable and usable to the broader scientific community. Since MIAME, other consensus groups have attempted to specify minimum information standards for other types of data.

  4. 4.

    Associations between a genetic or biochemical marker and a health outcome have been patentable in the United States for several decades. However, in 2012, the US Supreme Court held that a patent on a method of calibrating a drug’s dose by assessing levels of the drug’s metabolites in a person’s blood was not patentable because it was a law of nature (Mayo Collaborative Services v. Prometheus Laboratories, Inc. 2012). This case and others currently before the courts may substantially limit researchers’ and firms’ opportunities to patent correlations between biomarkers and health states or treatment outcomes. See, also, Noonan (this volume).

  5. 5.

    When the project involves an international collaboration, differences in national laws concerning data security and transfer, national security, and privacy can make research governance extremely difficult (Zink and Silman 2008).

  6. 6.

    Shortly after Dr. Watson’s genome sequence was published, Nyholt et al. published an article describing how one could infer Dr. Watson’s genetic risk for Alzheimer’s using linkage disequilibrium between genetic markers in the published sequence and the redacted portion of Dr. Watson’s genome (Nyholt et al. 2009). The Nyholt authors demonstrated that their method worked by using it to infer the Alzheimer’s risk alleles in Craig Venter’s published sequence. As a consequence of this work, Dr. Watson and the scientists who sequenced his genome redacted an additional two megabases of his sequence around genes associated with Alzheimer’s disease risk. Nyholt et al. point out that as the scientific community’s knowledge of genetic risk and linkage disequilibrium increases, it will become more difficult to protect a person from unwanted information disclosure by withholding a portion of her otherwise public genome.

  7. 7.

    In the United States, both the regulations for the protection of human participants in research (the “Common Rule,” codified at 45 CFR Part 46) and the Health Insurance Portability and Accountability Act’s Privacy Rule (codified at 45 CFR Parts 160 and 164) would place oversight and consent requirements on a repository that included explicit identifiers.

  8. 8.

    Sometimes, molecular analysis is conducted using leftover clinical specimens for which no consent for research was obtained or for which the purported consent constituted a one-line authorization to use excess tissue in research. Unconsented research on specimens originally collected for clinical treatment or diagnoses is allowed under the Common Rule. Institutions differ as to whether data from such studies may be deposited in a repository for broad data sharing. Some institutions require researchers to contact or recontact individuals and obtain consent for data sharing (Ludman et al. 2010).

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  1. University of Wisconsin, School of Law and School of Medicine and Public Health, Morgridge Institute for Research, Madison, WI, USA

    Pilar N. Ossorio Ph.D., J.D.

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  1. University of Wisconsin, Madison, Wisconsin, USA

    Linda F. Hogle

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Ossorio, P.N. (2014). Repositories for Sharing Human Data in Stem Cell Research. In: Hogle, L. (eds) Regenerative Medicine Ethics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9062-3_5

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