{"id":3333,"date":"2018-06-19T21:37:25","date_gmt":"2018-06-19T20:37:25","guid":{"rendered":"https:\/\/blogs.bmj.com\/medical-ethics\/?p=3333"},"modified":"2018-06-25T00:25:04","modified_gmt":"2018-06-24T23:25:04","slug":"guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/medical-ethics\/2018\/06\/19\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\/","title":{"rendered":"Guest Post: pathology incidental findings in the Genotype-Tissue Expression (GTEx) project"},"content":{"rendered":"<p><em><strong>Authors: Nicole C. Lockhart, Carol J. Weil, Latarsha J. Carithers, Susan E. Koester, A. Roger Little, Simona Volpi, Helen M. Moore, Benjamin E. Berkman<\/strong><\/em><\/p>\n<p><em><strong>Paper:<\/strong><\/em> <a href=\"http:\/\/jme.bmj.com\/content\/early\/2018\/06\/14\/medethics-2017-104691\"><em><cite class=\"highwire-cite highwire-cite-highwire-article highwire-citation-bmjj-title clearfix\">Development of a consensus approach for return of pathology incidental findings in the Genotype-Tissue Expression (GTEx) project<\/cite><\/em><\/a><\/p>\n<p>In 2010, the US National Institutes of Health (NIH) launched a research program called Genotype-Tissue Expression or <a href=\"https:\/\/www.genome.gov\/27543767\/genotypetissue-expression-project-gtex\/\">GTEx<\/a>. The goal of GTEx was to create a resource that researchers could use to study how inherited changes in genes lead to common disease. To do this, GTEx researchers collected samples of about 30 different organs and tissues from almost 1000 deceased donors. A board-certified pathologist examined a small piece of every organ or tissue sample before genetic analysis. Occasionally, the pathologist would notice evidence of a disease in the donor\u2019s sample that was not part of the donor\u2019s medical history. Since these pathology results were unexpected and not part of the original purpose of the research study, we called them \u201cpathology incidental findings.\u201d Importantly, some GTEx research donors were also organ or tissue donors. We were confronted with the question of whether our pathology incidental findings could be medically significant to transplant recipients. And, if so, whether the benefits of making information about such findings available to the medical provider for the transplant recipient outweighed any potential harm.<\/p>\n<p>We had not anticipated these questions at the start of the project and therefore we had not planned how to handle such findings. We consulted with the NIH Department of Bioethics to determine a path forward. While the ethics of returning incidental genetic and genomic research findings has been debated widely for many years, disclosing <em>pathology<\/em> incidental findings has not been well explored.\u00a0 Furthermore, in GTEx, the medical provider and transplant recipient would have no prior expectation or knowledge about the donor\u2019s research participation. So, we considered whether we should provide the pathology incidental findings based on an ethical \u201cduty to rescue\u201d the transplant recipient.\u00a0 We considered three questions to decide whether a duty to rescue required the return of GTEx pathology incidental findings:<\/p>\n<ol>\n<li>Were the pathology findings of sufficient clinical significance that they would provide significant benefit or prevent a significant harm?<\/li>\n<li>Was GTEx in a unique position to provide the information?<\/li>\n<li>Would providing the information pose unreasonable burdens or harms to GTEx or others?<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>Question #1:<\/p>\n<p>GTEx pathologists identified 12 cases of cancer in the first 479 GTEx donors. The GTEx pathologists were most concerned about 3 of the 12 cases because they involved either a blood cancer or a cancer with the potential to spread aggressively in transplant recipients. By the time the pathology findings were discovered, any planned organ transplant from the same donor would already have occurred.\u00a0 The removal of transplanted organs would be unlikely given the difficulty of finding new healthy organs.\u00a0 Nevertheless, providing this information could allow increased monitoring, screening, or changes in treatment.\u00a0 We asked some transplant surgeons their opinions and they said they would want to know about such findings. Also, the return of pathology incidental findings could lead to additional safety testing for banked tissue before transplantation or to a decision to discard those tissues.\u00a0 The consensus was that this small subset of cases had sufficient clinical significance to warrant communication with medical providers.<\/p>\n<p>&nbsp;<\/p>\n<p>Question #2:<\/p>\n<p>GTEx was in a unique position to return the pathology incidental findings because its analysis went beyond the typical assessment performed before transplantation. GTEx studied samples from organs not used for transplant that would not normally be examined.\u00a0 Moreover, because GTEx excluded participants with a known history of cancer, potential cancers identified by GTEx pathology analysis would not be included in the donor\u2019s medical history and transplant teams would be unaware of the possible medical risk. Thus, GTEx pathology incidental findings would not have been otherwise available.<\/p>\n<p>&nbsp;<\/p>\n<p>Question #3:<\/p>\n<p>Finally, the number of cases that would qualify for reporting based on clinical significance appeared to be quite low.\u00a0 Thus, a decision to return medically significant pathology incidental findings would not impose insurmountable burdens on GTEx investigators or project staff. \u00a0We concluded that the potential clinical benefits of returning the pathology incidental findings outweighed any risks or harms from disclosure of this information.<\/p>\n<p>We developed a plan for secondary review and return of confirmed pathology incidental findings. Our experience demonstrates the feasibility of developing an ethically defensible and practical strategy for returning such findings. Due to privacy protections, we do not know the identity of the transplant recipients and cannot assess the outcome or clinical impact of providing pathology incidental findings. Research uses of organ and tissue samples from deceased donors are increasingly common in cancer and other fields and our experience suggests that researchers should anticipate this ethical problem. We hope that future research will explore further the utility of returning pathology incidental findings to clinicians caring for transplant recipients.<\/p>\n<p><em>The opinions expressed herein are the authors\u2019 own and do not represent the official views of the NIH, any of the component Institutes, or the Department of Health and Human Services.<\/em><!--TrendMD v2.4.8--><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Authors: Nicole C. Lockhart, Carol J. Weil, Latarsha J. Carithers, Susan E. Koester, A. Roger Little, Simona Volpi, Helen M. Moore, Benjamin E. Berkman Paper: Development of a consensus approach for return of pathology incidental findings in the Genotype-Tissue Expression (GTEx) project In 2010, the US National Institutes of Health (NIH) launched a research program [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/medical-ethics\/2018\/06\/19\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3333","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Guest Post: pathology incidental findings in the Genotype-Tissue Expression (GTEx) project - Journal of Medical Ethics blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/blogs.bmj.com\/medical-ethics\/2018\/06\/19\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Guest Post: pathology incidental findings in the Genotype-Tissue Expression (GTEx) project - Journal of Medical Ethics blog\" \/>\n<meta property=\"og:description\" content=\"Authors: Nicole C. 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Berkman Paper: Development of a consensus approach for return of pathology incidental findings in the Genotype-Tissue Expression (GTEx) project In 2010, the US National Institutes of Health (NIH) launched a research program [...]Read More...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/blogs.bmj.com\/medical-ethics\/2018\/06\/19\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\/\" \/>\n<meta property=\"og:site_name\" content=\"Journal of Medical Ethics blog\" \/>\n<meta property=\"article:published_time\" content=\"2018-06-19T20:37:25+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2018-06-24T23:25:04+00:00\" \/>\n<meta name=\"author\" content=\"BMJ\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"BMJ\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/\"},\"author\":{\"name\":\"BMJ\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#\\\/schema\\\/person\\\/ba3da426ed20e8f1d933ca367d8216fe\"},\"headline\":\"Guest Post: pathology incidental findings in the Genotype-Tissue Expression (GTEx) project\",\"datePublished\":\"2018-06-19T20:37:25+00:00\",\"dateModified\":\"2018-06-24T23:25:04+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/\"},\"wordCount\":844,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/#organization\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/\",\"url\":\"https:\\\/\\\/blogs.bmj.com\\\/medical-ethics\\\/2018\\\/06\\\/19\\\/guest-post-pathology-incidental-findings-in-the-genotype-tissue-expression-gtex-project\\\/\",\"name\":\"Guest Post: pathology incidental findings in the Genotype-Tissue Expression (GTEx) project - 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