Alle Daten werden zusammen mit den Namen der Teilnehmer, d. h. nicht anonymisiert veröffentlicht. PGP was the first attempt to assemble a massive study of people willing to publicly share the DNA information from their entire genome as well as their medical history, biological samples, and even additional information like facial images. The Personal Genome Project. The views expressed in this article are those of the author alone and not the World Economic Forum. When conducting genomics research, two essential values of science research need to be balanced - the need to share data broadly to maximize its utility for ongoing scientific exploration, and the need to protect research participants' privacy. The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule establishes protections to maintain the confidentiality of patients' individually identifiable health information. Meredith Salisbury, Editorial Director/Senior Consultant, Bioscribe. Already, scientists are using PGP data to help pinpoint the genetic source of disease in other populations. How do we strike the proper balance between scientific progress and patient privacy? These certificates protect investigators and institutions from being compelled to disclose identifying information in any civil, criminal, or other proceeding at federal, state, and local levels. https://www.ucl.ac.uk/legal-services/ucl-general-data-protection-regulation-gdpr, https://www.ucl.ac.uk/legal-services/ucl-general-data-protection-regulation-gdpr/gdpr-frequently-asked-questions, http://data.consilium.europa.eu/doc/document/ST-5419-2016-INIT/en/pdf. Personal Genomes Project. Research. It has turned out to be an extraordinary success. Presently thousands of genomes have been completely sequenced. Yet while there are clear clinical benefits to the patient, this introduces new risks to patient privacy, and patients are potentially vulnerable to the misuse of their genetic information. Specimens collected in medical settings, like blood and tissue taken during biopsies, can serve as excellent sources of samples for genetics research. In addition to GINA, HIPAA protects patient privacy by restricting the sharing of patients' medical information. Die Ethik-Kommission der Harvard Medical School schrieb vor, dass die ersten Kandidaten einen Master-Abschluss in Genetik besitzen sollten oder über „gleichwertiges Verständnis der genetischen Forschung“ verfügen müssten, um alle Aspekte der Studie verstehen zu können. Enacted in 1966, the Freedom of Information Act (FOIA) was the first U.S. law to explicitly give citizens the right to access Federal documents upon request. Who, they wondered, would be nutty enough to release their personal genome sequence and medical data to the world? NHGRI is exploring the potential impact of a clear legal exemption of genomic information under FOIA that would not depend on the court's interpretation of genomic information as warranting privacy. More such projects are expected in the future. Whether an individual's genomic information is being used for research, clinical applications or other uses, it is important to ensure that the individual's privacy is respected. Ethnically, geographically, and linguistically identifiable populations present particular concerns with regard to privacy, stigmatization, and discrimination, since the ability to protect the privacy of these individuals or groups participating in the research is diminished. It was initiated by Harvard University's George M. Churchin 2005. The Personal Genome Project (PGP) is a long term, large cohort study which aims to sequence and publicize the complete genomes and medical records of 100,000 volunteers, in order to enable research into personal genomics and personalized medicine. Achieving the right balance is particularly challenging for genomic data since each person's DNA sequence is unique (with the exception of identical twins) and a DNA sample therefore can never be made truly anonymized. Events. Because PGP participants sign very broad consent forms—granting permission to reuse their data and to allow scientists virtually anywhere to contact them for follow-up studies —the data has become a gold standard for researchers who need a control group for their disease study or who need real-world trial data to test a new health-related algorithm. PGP-UK is a member of the Global Network of Personal Genome Projects (PGP), a … For further information about informed consent in genomics and guidance for researchers or IRB members, please see the Informed Consent for Genomics Research Resource. In addition, NIH issues Certificates of Confidentiality to enable NIH-funded researchers to limit access to research participant information held at grantee institutions. The Common Rule requires all federally funded research projects to obtain informed consent from each participant prior to their participation. Even though PGP hasn’t received nearly the funding it needs to sequence everyone who wants to take part, it has an impressive track record of inspiring others to launch similar projects. Yet a decade ago many of his peers thought PGP founder and genomics visionary George Church was betting on the wrong horse. Publication does not imply endorsement of views by the World Economic Forum. There is no federal law prohibiting surreptitious testing. The creation of DNA databases such as NDIS has spurred much controversy. More information on GINA is available here. Such critical insights will pave the way for more effective and more personalized medicine. This article is published in collaboration with Techonomy. In 2013, as required by the passage of the Genetic Information Nondiscrimination Act, the Privacy Rule was modified to establish that genetic information is health information protected by the Privacy Rule to the extent that such information is individually identifiable, and that HIPAA covered entities may not use or disclose protected health information that is genetic information for underwriting purposes. Google engagiert sich für Gen-Analyse-Projekt, Personal Genomes. CODIS is used to search the National DNA Index system (NDIS), a database populated by DNA profiles submitted by federal, state and local forensic laboratories to the FBI. There are no such restrictions on the use or disclosure of PHI that has been de-identified. Together, they showed that it was cool to be involved in genomics. The Genetic Information and Nondiscrimination Act of 2008 (GINA) protects the genetic privacy of the public, including research participants. Federal laws, like the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA) aim to strike that delicate balance. Most recently, in 2014 Congress passed a law requiring consent for the research use of blood spots from newborn screening. The Newborn Screening Saves Lives Reauthorization Act supports newborn screening programs across the United States and authorizes the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children. In the future, this data—as well as that from Open Humans and new PGP-inspired projects—will be instrumental in establishing the associations between variations in DNA and diseases. Das Personal Genome Project (PGP) plant die Veröffentlichung des vollständigen Genoms sowie der medizinischen Daten seiner Teilnehmer, um damit weitere Forschung im Bereich der Pharmakogenetik zu ermöglichen. Such information held by entities covered by HIPAA, such as a health care provider or insurance company, is defined as Protected Health Information (PHI) and there are limits on when and with whom PHI may be shared. We use cookies to improve your experience on our website. Learn more about GINA on the Genetic Discrimination page. By using our website you consent to all cookies in accordance with our updated Cookie Notice. Exemption six of FOIA allows the government to deny requests for information that, "... constitute a clearly unwarranted invasion of personal privacy," and NIH's interpretation is that the release of genomic information datasets in response to a FOIA request would be an unreasonable invasion of personal privacy.