Genome Ethics, Law & Policy

SSJC

Science and Society Journal Club

The Duke Institute for Genome Sciences & Policy (IGSP) journal club examines the relationship between science & society. It provides a forum for Duke staff, undergraduates, graduate students, postdocs, and faculty members to freely discuss and share opinions on issues at the intersection of science and policymaking. It also offers a venue for graduate students in scientific programs considering careers in law, ethics, policy, or similar fields to develop their interests by thinking about current issues and identifying future avenues for development.

Coordinators: Subhashini Chandrasekharan and Lane Baldwin

The 2012-2013 series of SSJC began in September 2012.  The schedule is below.  Unless otherwise indicated, the Journal Club will take place on the third Friday of each month, from 11:30am-12:30pm, in 100 North Bldg.  Please note that this is a different location from previous semesters. 

6/28/2013 Liz Cirulli, Ph.D, Duke University Center for Human Genome Variation

Topic: TBD

4/26/2013 Brian Hare, Ph.D and Evan MacLean, Ph.D, of the Duke University Canine Cognition Center, and Misha Angrist, Ph.D, of the Duke Institute for Genome Sciences and Policy

Topic: Genes, Brains, and Games: Studying Man's Best Friend

Speaker Bios: Dr. Brian Hare is associate professor of evolutionary anthropology at Duke University in North Carolina and a member of the Center for Cognitive Neuroscience, which is a division of the Duke Institute for Brain Sciences. He received his Ph.D. from Harvard University, founded the Hominoid Psychology Research Group while at the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and subsequently founded the Duke Canine Cognition Center when arriving at Duke University. He recently published The New York Times Bestselling book The Genius of Dogs with his wife Vanessa Woods. He is also the founder and Chief Scientific Officer of the citizen science company Dognition.com.

Evan MacLean is a Senior Research Scientist at Duke University and Co-Director of the Duke Canine Cognition Center. He received his Ph.D. in Evolutionary Anthropology from Duke University in 2012. His research investigates animal cognition with an emphasis on studies of domestic dogs and primates. His current work explores the relationship between individual differences in cognition and temperament and success in various working dogs roles.

Misha Angrist is an Assistant Professor at Duke University’s Institute for Genome Sciences and Policy where he teaches genetics/genomics and their concomitant policy issues. He also teaches science writing at Duke’s Sanford School of Public Policy. Angrist was the fourth participant in Harvard geneticist George Church's Personal Genome Project; he has had his entire genome sequenced twice and made public. He chronicled this experience in his book, Here is a Human Being: At the Dawn of Personal Genomics (Harper, 2010). His dog Django was genotyped, found to be a Rottweiler-Chow mix, and confirmed to be utterly awesome.

Suggested Readings:

Hare B and Woods V. The genius of dogs: how dogs are smarter than you think. Dutton: New York, NY. February, 2013. First chapter available to members of the Duke community here.

Hare B and Woods V. Why dogs are smarter than cats. The Wall Street Journal, February 3, 2013. Available here.

Rimbault M and Ostrander EA. So many doggone traits: mapping genetics of multiple phenotypes in the domestic dog. Human Molecular Genetics 2012, 1: R52-R57. Available to members of the Duke community here.

Hare B and Tomasello M. Human-like social skills in dogs? TRENDS in Cognitive Science 2005, 9: 439-444. Available to members of the Duke community here.

Supplementary Readings:

Browse: www.dognition.com

Barsh G and Anderson L. Detecting Selection. Nature 2013, 495: 325-326. Available to members of the Duke community here.

Cyranoski D. Pet Project. Nature 2010, 466: 1036-1038. Available to members of the Duke community here.

3/29/2013 (11-12 in North 100)*: Stephanie Chen, Duke University Undergraduate

Note, this is a change from the regular time

Topic:Show me the money: Battles of inventorship

Speaker Bio: Stephanie Chen is a sophomore undergraduate at Duke University majoring in public policy. She is currently working on an independent study with Professor Robert Cook-Deegan studying the early history of recombinant DNA technology and the issue of inventorship and authorship in academia, a project that she started as an IGSP summer fellow last summer. After completing her undergraduate degree, Stephanie hopes to pursue a graduate degree in the history of science and ultimately a career in science policy.

Suggested Readings:

Duccor, P. Coauthorship and Coinventorship. Science 2000, 289:873-875.Available to members of the Duke community here.

Resis, R. Inventor Rights: Chou v. The University of Chicago et al. Available to members of the Duke community here

McConathy E. Inventorship: A significant effect on Ownership and Validity of an Invention. The Licensing Journal 2006. Available to members of the Duke community here.

2/22/2013 (12:30-1:30 in North Building 246)* Sara Katsanis, MS, Associate in Research, Duke University Institute for Genome Sciences and Policy

*Note, this is a change from the regular time and location

Topic: Why does the government want my DNA?

Speaker Bio: Sara H. Katsanis is an Associate in Research in the Genome Ethics, Law and Policy Center at Duke University. Her research focuses on policy options for genetic testing applications in medicine and law enforcement and how genetic technologies affect individuals. She has explored direct-to-consumer genetic testing, pharmacogenetics drug labeling, familial searching of CODIS, and surreptitious collection of DNA. She is also delving into policy options for the applications of kinship analyses to identify victims of human trafficking and adoption fraud.
Katsanis received a MS in Medical Genetics from Brunel University in 1997 having completed her research thesis at Imperial College School of Medicine at St. Mary's in London, UK. From 1998-2002, she worked in Houston, TX, first as a DNA Analyst in the forensic laboratory at the Harris County Medical Examiner's Office, then as an Associate Scientist managing the genotyping facility at Lexicon Genetics, Inc. In 2002, she joined Johns Hopkins University in Baltimore, MD as Laboratory Manager for the DNA Diagnostic Laboratory, responsible for oversight and supervision of clinical diagnostic testing. In 2006, Katsanis began working with the Genetics & Public Policy Center within the Berman Institute of Bioethics at Johns Hopkins in Washington, DC. She contributed to the Center's efforts to address legal, ethics, and policy issues related to human reproductive genetic technologies, genetic testing quality and oversight, and public engagement in genetic testing and research.

Suggested Readings:

An Assessment of DNA Testing for African Refugees. Available here.

New portable DNA screener to debut this summer. Available here.

2/1/2013 (*12:30-1:30 in 100 North*) Lauren Sayers and Ashwin Agarwal, students at Duke University Medical School

Topic: Commercialization of Non-invasive prenatal genetic testing

Speaker Bios:Ashwin Agarwal is a current student at the Duke University School of Medicine. He graduated from Duke University in 2012 with a primary major in Biology, a secondary major in Neuroscience, and a certificate in Genome Sciences and Policy from the Duke Institute of Genome Sciences and Policy. He recently worked on a project for a non-profit health advocacy organization as part of his certificate program to create a comprehensive review of the the history, technological platforms, ethical and social concerns, and clinical implementation and validity of the major non-invasive prenatal genetic testing companies in or entering the US market. His research interests include the emerging NIPT technology landscape and clinical implementation strategies of involved stakeholders, and hopes to pursue a clinical and research career in medicine.

Lauren Sayres currently attends the Duke University School of Medicine. She earned her B.A. in Human Biology with a minor in Ethics in Society from Stanford University in 2010. Following graduation, she was awarded a two-year post-baccalaureate research fellowship position at the Center for Integration of Research on Genetics and Ethics, an NIH-funded Center of Excellence within the Stanford Center for Biomedical Ethics. In this capacity, she conducted several empirical studies on stakeholder interest and sociotechnical analysis of nascent non-invasive prenatal genetic technologies. Her research interests continue to include prenatal diagnosis and related ethical, legal, and social issues, and she ultimately hopes to pursue a clinical and research career in obstetrics and gynecology and particularly maternal-fetal medicine.

Suggested Readings:

Prenatal diagnosis using cell-free fetal nucleic acids in maternal blood. Available here.

Benn P and Chapman A. Ethical challenges in providing noninvasive prenatal diagnosis. Current Opinion in Obstetrics and Gynecology 2010, 22:128-134. Available here.

12/21/2012 Charmaine Royal, PhD, Associate Professor in Genome Sciences and the Department of African and African American Studies, Duke University

Topic:The Human Heredity and Health in Africa (H3Africa) Initiative- The H3Africa Initiative is funded by the National Institutes of Health and the Wellcome Trust to enhance research on genomic and environmental contributors to diseases in African populations and build capacity for African researchers to lead such research. This session will feature a discussion of the goals, opportunities, challenges, and implications of the H3Africa initiative.

Speaker Bio:Charmaine Royal is an Associate Research Professor in the Institute for Genome Sciences & Policy and the Department of African & African American Studies. Her research, scholarship, and teaching focus primarily on ethical, psychosocial, and societal issues at the intersection of genetics/genomics and concepts of “race,” ancestry, and ethnicity. She serves on numerous national and international professional committees and boards, including the Independent Expert Committee for the Human Heredity and Health in Africa (H3Africa) Initiative. She received a master’s in genetic counseling and a doctorate in human genetics from Howard University, and completed postgraduate training in bioethics and ELSI (ethical, legal, and social implications) research at the National Human Genome Research Institute, National Institutes of Health.

Suggested Readings:

The H3Africa website (http://h3africa.org/) provides a wealth of information related to the initiative. Feel free to peruse the site. Specific items to guide the session include:

 

11/16/2012 Jessie Tenenbaum, Ph.D., Associate Director for Bioinformatics, DTMI Biomedical Informatics Core, Duke University

Topic: Big Data in biomedical research: examples, issues, and implications

Speaker Bio: Dr. Tenenbaum is the Associate Director for Bioinformatics for the Duke Translational Medicine Institute's Biomedical Informatics Core (BIC) where her research focuses on infrastructure and standards to enable research collaboration and integrative data analysis. After earning her bachelor’s degree in biology from Harvard University in 1996, with a focus on computer science, Dr. Tenenbaum worked as a program manager at Microsoft Corporation in Redmond, WA for six years. In 2002, she returned to academia and received her PhD in Biomedical Informatics in 2007 from Stanford University. Her doctoral research focused on integration and analysis of disparate “-omic” scale datasets, and mining publicly available data for insights into human disease. Other research interests include genomics, biomarkers, personalized medicine, systems biology, and computer-human interaction.

Dr. Tenenbaum coordinates informatics activities related to the MURDOCK Study, the BIC, and the informatics community around Duke. She is Principal Investigator for the MURDOCK Integrated Data Repository (MIDR), a standards-compliant integrated data repository for clinical, omic, biobanking, and consent data as well as experimental and protocol metadata. An internationally recognized expert in translational bioinformatics, Dr. Tenenbaum is the Scientific Program Committee Chair for the American Medical Informatics Association's 2013 Summit on Translational Bioinformatics to be held in San Francisco, CA in March 2013.

Suggested Readings:

Schadt EE. The changing privacy landscape in the era of big data. Mol Syst
Biol. 2012 Sep 11;8:612. doi: 10.1038/msb.2012.47. PubMed PMID: 22968446; PubMed
Central PMCID: PMC3472686.

Birney E. The making of ENCODE: Lessons for big-data projects. Nature. 2012
Sep 6;489(7414):49-51. doi: 10.1038/489049a. PubMed PMID: 22955613.

McCarty CA, Chisholm RL, Chute CG, Kullo IJ, Jarvik GP, Larson EB, Li R, Masys
DR, Ritchie MD, Roden DM, Struewing JP, Wolf WA; eMERGE Team. The eMERGE Network:
a consortium of biorepositories linked to electronic medical records data for
conducting genomic studies. BMC Med Genomics. 2011 Jan 26;4:13. PubMed PMID:
21269473; PubMed Central PMCID: PMC3038887.

10/19/2012 Mollie Minear, Ph.D., Post-Doctoral Fellow in Genome Ethics, Law, and Policy at Duke University.

Topic: The bias against women in research: How do we correct this, and should we?

Spreaker Bio: Mollie Minear, Ph.D. is a postdoctoral associate in the Center for Public Genomics in the IGSP. She defended her Ph.D from the University Program in Genetics and Genomics at Duke University in Spring 2012, and her dissertation research examined the genetic basis of a disease of the eye. Although she has a long standing interest in human genetics, Mollie is transitioning away from the lab into genetic ethics and policy research. A recent article in PNAS about faculty hiring biases against women triggered the idea to discuss this important issue in the SSJC; this study is one of the suggested readings for our discussion.

Readings:

Jagsi, R., K. A. Griffith, A. Stewart, D. Sambuco, R. DeCastro, and P. A. Ubel. "Gender Differences in the Salaries of Physician Researchers." JAMA 307, no. 22 (Jun 13 2012): 2410-7.

Moss-Racusin, C. A., J. F. Dovidio, V. L. Brescoll, M. J. Graham, and J. Handelsman. "Science Faculty's Subtle Gender Biases Favor Male Students." Proc Natl Acad Sci U S A 109, no. 41 (Oct 9 2012): 16474-9.

Association of Women in Science Fact Sheets: http://awis.org/displaycommon.cfm?an=1&subarticlenbr=519

"Breaking the bias against women in science": http://www.nytimes.com/roomfordebate/2012/09/30/breaking-the-bias-against-women-in-science

9/21/2012 David Adams, Ph.D., Associate Professor of Medicine at Duke University

Topic: The Valley of Death in anticancer drug development

Speaker Bio: David Adams is an Associate Professor of Medicine in the Division of Medical Oncology.  He received his BA in chemistry and English from the University of Iowa and PhD in biochemistry from the University of Nebraska.  Following eleven years working on anticancer drug discovery and development for the Burroughs Wellcome Company (now GlaxoSmithKline), Dr. Adams joined the research team of Dr. O. Michael Colvin then Director of the Duke Comprehensive Cancer Center in 1996.  He has continued his anticancer translational research, which is currently focused on development of a drug for pancreatic cancer and on providing preclinical evaluation of drug combinations for hematologic malignancies.  In addition to laboratory research, Dr. Adams is interested in science and technology policy especially as it applies to anticancer drug development and our inability to translate advances in understanding cancer biology to effective new therapies for cancer patients.

Readings:

Adams, D. (2012) The Valley of Death in anticancer drug development - a re-assessment. Trends in Pharmacological Sciences 33, 172-180

Scannell, J.W., et al. (2012) Diagnosing the decline in pharmaceutical R&D efficiency. Nat. Rev. Drug Discov. 11, 191-200

Anonymous (2011) Crossing over the Valley of Death. FasterCures http://www.fastercures.org/documents/file/Valley%20of%20Death%20-%20Translational%20Research(1).pdf

Begley, S., and Carmichael, M. (2010) DESPERATELY SEEKING CURES. (Cover story). Newsweek 155, 38-42

6/15/2012 Sarah Timberlake, B.S.N., Duke University

Topic: Practical challenges in Clinical Implementation of Pharmacogenetic Testing

Speaker Bio: Sarah Timberlake is a recent graduate of the Duke Accelerated Bachelor of Science in Nursing program. She also holds a BS in Microbiology from NC State University and the Certificate in Core Public Health Concepts from UNC. Prior to her career shift into nursing, she worked as an analyst-level scientist for 8 years NC State, Duke, and the biotech industry in labs focused on cardiology, asthma, and vaccines. Her scientific interests include infectious disease, public health, and genomic and personalized medicine, the last of which was inspired by the Institute for Genome Sciences and Policy here at Duke and the new Genomics and Personalized Medicine course offered through the School of Nursing. Starting in July she will put her skills to work for the Infection Control Unit at Duke Hospital, and plans to eventually return to graduate school to further develop her scientific career.

Readings:

Optional readings to skim for background:
Pharmacogenomics FAQ: http://www.nigms.nih.gov/Research/FeaturedPrograms/PGRN/Background/pgrn_faq.htm

Review on Clinical Implementation of Pharmacogenomics: Scott SA. (2011). Personalizing medicine with clinical pharmacogenomics. Genetics in Medicine, 3(12):987-95. doi:10.1097/GIM.0b013e318238b38c

Paper on Warfarin PGx: Meckley, et al. (2010). A policy model to evaluate the benefits, risks, and costs of warfarin pharmacogenomic testing. Pharmacoeconomics 28(1): 61-74.

Review Paper on IL28B PGx: Clark, PJ & Thompson, AJ. (2012). Host genomics and HCV treatment response. Journal of Gastroenterology and Hepatology, 27, 212-222. doi:10.1111/j.1440-1746.2011.06918.x

 

5/18/2012 Stephanie Holmer, Ph.D. Candidate, Duke University

Topic: The H5N1 controversy

Speaker Bio:

Stephanie Holmer is a graduate student in the Department of Cell Biology. Her dissertation research focuses on the pulmonary immune response to an opportunistic fungal pathogen, Cryptococcus neoformans. After completing her Ph.D., Stephanie hopes to pursue a career in global health and/or science policy. She is especially interested in the issues surrounding infectious disease, especially related to both global health and bioterrorism concerns.

Readings:

A brief summary of the controversy: http://www.npr.org/blogs/health/2011/11/17/142453447/bird-flu-research-rattles-bioterrorism-field

Science policy article on the issue: http://www.sciencemag.org/content/335/6070/802.full

Additional audio and video resources:

Four minute audio from NPR: http://www.npr.org/blogs/health/2012/05/09/151870671/first-of-controversial-bird-flu-studies-is-published
The ASM panel discussion (very good, but 1 hr long): http://www.microbeworld.org/index.php?option=com_content&view=article&id=1140

 

4/20/2012 Maynard Olson, Ph.D., Visiting Professor to IGSP

Topic: The Predictive Capacity of Personal Genome Sequencing

Speaker Bio:

Maynard Olson­­ is a Visiting Professor this semester at the IGSP.  His home institution is the University of Washington, where he is Professor Emeritus of Medicine and Genome Sciences.  In recent years, Olson’s major research interest has been in natural genetic variation in humans and bacteria.  In addition to numerous research articles on these topics, he has written a review on “Human Genetic Individuality,” which will appear in the 2012 Annual Reviews of Genomics and Human Genetics.  Last year, Olson served—along with Duke faculty members David Goldstein and Charmaine Royal—on a National Research Council Committee that issued a report in December, 2011, entitled “Toward Precision Medicine:  Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease.”  Olson has been active in genome research for over 30 years, a period during which he developed a number of tools used in the Human Genome Project.  He also participated in policy development as an advisor to the NIH, DOE, NRC, and U. S. Congress.

Readings: Roberts NJ, Vogelstein JT, Parmigiani G, Kinzler KW, Vogelstein B, et al. 2012. The Predictive Capacity of Personal Genome Sequencing. Science Translational Medicine. e-published ahead of print (available to members of the Duke University community here)

3/16/2012 Discussion of "alternative scientific careers"

Topic: Non-laboratory career paths for the scientifically-minded

Panel description: Interested in science but not sure that a career in the laboratory is for you? Join us at this special meeting of the SSJC to discuss non-laboratory careers for those interested in science and scientific issues. Attendees to the SSJC will include individuals pursuing career paths in fields at the intersection of science and policy, law, ethics, history, and more.  Join us for a friendly discussion of the possibilites for "alternative" careers in science!

The members of the panel, and their current institutional and industry affiliations are:

-Cristina Kapustij, National Human Genome Research Institute (NHGRI), Public Policy
-Ashton Powell, North Carolina School of Science and Math (NCSSM), Education/ Research
-Robert Cook-Deegan, Duke Institute for Genome Sciences & Policy, Education/Research/Academia/Bioethics/Public Policy
-Misha Angrist, Duke Institute for Genome Sciences & Policy, Education/Research/Academia/Science Writing
-Subhashini Chandrasekharan, Duke Institute for Genome Sciences & Policy, Education/Research/Academia/Bioethics
-Kathryn Maxson, Duke Institute for Genome Sciences & Policy, Education/Research/Academia/History of Science

Readings: None. 

2/17/2012 Subhashini Chandrasekharan

Topic: Noninvasive Prenatal Genetic Testing: Does Clinical Translation Face New Challenges?

Speaker Bio: Subhashini (Shubha) Chandrasekharan, Ph.D., is a Senior Research Associate at the IGSP.  Her current research includes empirical studies of intellectual property on innovation and access to genetic/genomic technologies, including noninvasive prenatal genetic diagnostics.  In 2009, Shubha was awarded an R03 grant by the National Human Genome Research Institute (NHGRI) to examine whether, and to what extent, patents will impact the development of emerging genomic diagnostics and clinical whole genome sequencing services.  Her broad research interests include ethical, legal and social issues surrounding proprietary protection and commercialization of biomedical technologies, and particularly the effects of intellectual property on innovation and access to biomedical products and services. She is also studying how IP and commercialization can influence access to biomedical products such as childhood vaccines in developing countries.  Shubha has been actively involved in both mentoring students and ethics training activities, and is one of the coordinators of the IGSP Science and Society Journal Club.

Readings:

Greely, HT. (2011). Get ready for the flood of fetal gene screening. Nature 269(20 Jan 2011): 289-291. Available to members of the Duke University community here.

Supplementary Readings and Resources

CommonHealth, Reform and Reality: an informative website on relevant issues

Benn, PA & Chapman, AR. (2009). Practical and Ethical Considerations of Noninvasive Prenatal Diagnosis. JAMA 301(20): 2154-2156.  Available to members of the Duke University community here.

deJong, A, et al.  (2010). Non-invasive prenatal testing: ethical issues explored. European Journal of Human Genetics 18: 272-277.  Available to members of the Duke University community here. 

If you are interested in running a Journal Club meeting during either the Spring or Fall of 2012, please contact one of the coordinators via email. The Science and Society Journal Club welcomes session leaders of all ages and disciplines.

Past Meetings of Science and Society Journal Club

Below please find an archive of past meetings of the Science and Society Journal Club.

Fall 2011 Meetings

12/16/2011 Rachel Mills

Topic: Role of Genetic Counselors in Direct-to-Consumer Genetic Testing

Speaker Bio: Rachel Mills is a Clinical Research Coordinator in the IGSP who works with Dr. Susanne Haga. Rachel is a also Certified Genetic Counselor and completed her Masters in Genetic Counseling at UNC-Greensboro in 2008. Research interests include uses of genomic testing, public knowledge of genetics, and genetics education.

Readings:

Roberts, ME, Riegert-Johnson, DL, & Thomas, B. (2011) Self Diagnosis of Lynch Syndrome Using Direct to Consumer Genetic Testing: A Case Study. Journal of Genetic Counseling 20:327-329.  Available to members of the Duke University Community here.

Wade, C & Wilfond, B. (2006) Ethical and Clinical Practice Considerations for Genetic Counselors Related to Direct-to-Consumer Marketing of Genetic Tests. American Journal of Medical Genetics 142C: 284-292.  Available to members of the Duke University Community here.

McGuire, A & Burke, W. (2011) Health System Implications of Direct-to-Consumer Personal Genome Testing. Public Health Genomics 14: 53-58.  Available to members of the Duke University Community here.

11/18/2011 Joyce Kim

Topic: Forensic uses of DNA databases

Speaker Bio: Joyce is currently a research assistant at the Institute for Genome Sciences & Policy.  She graduated from Duke (Trinity 2011) with a B.A. in International Comparative Studies, a minor in History, and a certificate in Genome Sciences & Policy. She explored issues surrounding DNA technologies in criminal investigations during the Spring 2011 Genome Sciences & Policy Senior Capstone course.  Joyce plans to attend law school to study science law and policy.

Readings:

Gershaw C.J., Schweighardt A.J., Rourke L.C., and Wallace M.M.  Forensic utilization of familial searches in DNA databases.  Forensic Sci Int Genet.  2011 5(1): 16-20.  Available to members of the Duke University community here.

Dresser, R.  Families and Forensic DNA Profiles.  Hastings Center Report.  41(3): May-June 2011. Available to members of the Duke University community here.

10/28/2011 Robert Mitchell (CIEMAS 2120, 11:30 AM- 12:30 PM)

Note: This is on the fourth Friday of October, in a different room from regularly scheduled meetings.)

Topic: Genomics, Biobanks, and the Trade-Secret Model

Speaker Bio: Robert Mitchell is Associate Professor in English, Director of the Center for Interdisciplinary Studies in Science and Cultural Theory, Affiliated Faculty in Women’s Studies, and a Faculty member of the Institute for Genome Sciences and Policy at Duke University. His past research has focused on late eighteenth- and early nineteenth-century intersections between science and literature, as well as more contemporary relationships among biological materials, economics, and information processing technologies. His published work includes Tissue Economies: Blood, Organs and Cell Lines in Late Capitalism (Duke UP, 2006) and the co-authored DVD-ROM Biofutures: Owning Body Parts and Information (U of Pennsylvania P, 2008). His current work focuses on the social and economic dimensions of large-scale biobanks.

Readings:

Recent editorial:

Mitchell R et al. "Genomics, Biobanks, and the Trade-Secret Model."  2011 Science 332(15 Apr 2011): 309-310. Available to the Duke University community here.

Comments on this editorial, and the responses:

Matsuura JH. "Trade-Secret Model: Privacy Rights."  2011 Science 333(16 Sept 2011): 1574-1576.  Available to the Duke University community here.

9/9/2011 Robert Cook-Deegan (11:00 AM- 12:00 PM)

Topic: The Myriad/BRCA Patent Lawsuit

Speaker Bio: Dr. Robert Cook-Deegan is director of the IGSP Center for Genome Ethics, Law, and Policy (GELP) and Research Professor of Public Policy, Biology, and Medicine. He is also a Professor in the Genome Focus cluster for Fall 2011. Please see his full faculty page for more details.

Readings and subject background: The "Myriad" or "BRCA" patent lawsuit deals broadly with the subject of patents on DNA. More specifically, it concerns the validity of patents held by Myriad Genetics on genes responsible for inherited susceptibility to breast and ovarian cancers. The company made headlines when it raced to find the genes now called BRCA1 and BRCA2 and, later, when it used its intellectual property to dominate the American genetic testing market for those genes.

In 2008, the case was brought against Myriad Genetics and the United States Patent and Trademark Office (USPTO) by a group of more than twenty plaintiffs. Coordinated and argued by the American Civil Liberties Union (ACLU) and the Public Patent Foundation, the Myriad case is being anxiously followed and hotly debated by scholars, scientists, lawyers, and many others. For a detailed history of the case, please see the briefing page on the subject developed by the IGSP Center for Genome Ethics, Law, and Policy.

For the Journal Club, suggested readings are the recent (late August 2011) petitions for a panel rehearing of the most recent ruling in the case, a July 29th decision handed down by the United States Court of Appeals for the Federal Circuit (CAFC). The CAFC was formed by federal statute in 1982 and hears appeals of patent cases from all U.S. District courts. Both plaintiffs and defendants petitioned for rehearing, the former on August 25th and the latter on August 29th. Also suggested is Dr. Cook-Deegan's invited editorial on the July 29th ruling, which appeared in the August 5th, 2011 edition of The Cancer Letter.

Spring 2011 Meetings

6/17/2011 Misha Angrist

Topic: "It's My Own Business!"

Speaker Bio: Misha Angrist is an Assistant Professor at the IGSP. His doctoral and postdoctoral work was in human genetics, and he was formerly a board-eligible genetic counselor. He received an MFA in writing and literature from the Bennington Writing Seminars, and his fiction and nonfiction have appeared in numerous literary journals – he has been nominated for the Pushcart Prize. He blogs once in a while at http://blogs.plos.org/genomeboy/, and tweets often @MishaAngrist.

Readings:

Friend SH, Ideker T. Point: Are we prepared for the future doctor visit? Nat Biotechnol. 2011 Mar;29(3):215-8. Available to members of the Duke community here.

Terry SF, Terry PF. Power to the people: participant ownership of clinical trial data. Sci Transl Med. 2011 Feb 9;3(69):69cm3. Available to members of the Duke community here.

5/20/2011 Lauren Dame

Topic: "Should individual research results be returned to participants in genetic research studies? If so, when and how?"

Speaker Bio: Lauren Dame is the Associate Director for Genome Ethics, Law and Policy. She teaches "Bioethics" and "Genetics & the Law" at Duke Law School. Ms. Dame received her A.B. in Human Biology from Stanford University, her J.D. from Harvard Law School, and her M.P.H. from Harvard School of Public Health. She has served as a Visiting Lecturer in Law at Yale Law School, an associate at the law firm of Covington & Burling, and Staff Attorney for Public Citizen's Health Research Group in Washington, D.C. Her areas of interest include bioethics, genetics, human subjects research, healthcare policy, and the effects of technology on privacy. From September 2002 to December 2003, she was the Chair of North Carolina's State Task Force on Genetics and Public Health.

Readings:

Articles:

L. M. Beskow, W. Burke, Offering individual genetic research results: Context matters. Sci. Transl. Med. 2, 38cm20 (2010). Available to members of the Duke University community here.

Ethical and Practical Guidelines for Reporting Genetic Research Results to Study Participants: Updated Guidelines From a National Heart, Lung, and Blood Institute Working Group; Circulation: Cardiovascular Genetics 2010; 3; 574-580. Free online version available here.

Blog posts:

It's My Genome: Should researchers be obliged to return genetic data to research participants? Genomics Law Report.

Is there an obligation to return genetic data to participants? Kaiser responds to 23andMe TEDMED Criticism. Genomics Law Report.

Summary of a public survey:

Public expectations for return of results from large-cohort genetic research (2008). Genetics & Public Policy Center, Johns Hopkins University. Available online here.

4/22/2011 Michele Easter

Topic: "Warriors, Orchids, and Sluts: On the Implications of Behavioral and Psychiatric Genetics"

Speaker Bio: Michele is a postdoctoral associate for Genome Ethics, Law & Policy. Her degree is in Sociology and her research focuses on public understanding of genetic involvement in psychiatric and behavioral disorders. For her dissertation, she interviewed 50 women diagnosed with anorexia or bulimia nervosa about their views on eating disorder causation and the idea of genetic involvement. She is interested in the broad societal impact of genetic and brain-based understandings of human behavior, including whether and how such understandings do (or should) affect perceptions of individual and societal responsibility. Her next project is likely to address perceptions of genetic influence on violence. Before graduate school, she worked for several years on ethical, legal, and social implications (ELSI) research with an interdisciplinary team at UNC-Chapel Hill.

Readings:
Parens, E. (2004). "Genetic differences and human identities. On why talking about behavioral genetics is important and difficult." Hastings Cent Rep 34(1): S4-35 [1-32 – please read 1-7 (top), 23-24]  Available online here.
Yong, E. (2010). "Dangerous DNA: The truth about the 'warrior gene'." New Scientist (2755).  Available to members of the Duke University community here.

3/18/2011 David Parker

Topic: "Exome sequencing and functional testing of genetic variants: a better approach to studying human genetic disorders?"

Background: To date, the sequencing of human genomes and subsequent genome wide association studies have had a disappointingly small impact on our understanding of complex human genetic disorders. This is largely due to the difficulty interpreting the functional significance of individual base changes found in the human genome, the majority of which arise in DNA that does not encode protein. This problem is driving a shift toward a more targeted approach: sequencing the portion of the genome that is transcribed and translated into proteins (the exome). The principal advantage of this experimental design is that variants present in coding regions of DNA are far easier to interpret than non-coding changes. However, to be truly informative variants found via exome sequencing must be coupled to functional allelic data in vivo using model systems (i.e. determining what effect a mutation has on the function of the protein). Functional testing is a time consuming and expensive venture. This journal club will discuss questions surrounding this new approach to genomic medicine, such as:

Is exome sequencing a better use of public funds than a whole genome approach, which has in the past received the majority of funding?

This approach can be used to diagnose very young individuals (including prenatally), which generates a host of social and ethical issues, including:

What are the consequences when functional testing results in ambiguous data?
How do we address incidental findings in minor patients and/or siblings of affected individuals?

Speaker Bio: Dave is currently a postdoc in the Center For Human Disease Modeling at Duke University studying the genetics and cell biology of pleiotropic human diseases. His research focuses on the ciliopathies, an overlapping set of individually rare genetic syndromes arising from the dysfunction of cilia. Cilia are organelles that play a multitude of important roles in the development and homeostasis of vertebrates. His current work addresses the genetic basis of phenotypic variability in complex disease traits and the mechanistic defect of disorders that exhibit both structural and progressive features. Prior to arriving at Duke, Dave received a BSc in Biochemistry from Manchester University, England and a PhD from the University of Michigan, where he studied signal regulated gene transcription using Drosophila as a model organism.

Readings:
Amy Maxmen, "Exome Sequencing Deciphers Rare Diseases," Cell, March 2011. Available to members of the Duke University community here.
Jamie K. Teer and James C. Mullikin, "Exome sequencing: the sweet spot before whole genomes," Human Molecular Genetics, August 2010.  Available online here.
Nicholas Katsanis, "From association to causality: the new frontier for complex traits," Genome Medicine, February 2009. Available online here.

2/18/2011 Kathryn Maxson

Topic: "Genomes for medical benefit: Are we getting the best possible return on public investment in the HGP?"

Speaker Bio: Kathryn is currently working as a research assistant for Genome Ethics, Law, and Policy, where her research focuses on the history of next-generation DNA sequencing technologies; modern and historical models of data sharing in genomics; and comparative analyses of DNA sequencing with other major technological developments of the late 20th and early 21st centuries, including personal computing and the Internet. Before coming to IGSP, Kathryn graduated from Duke (T'10) with a B.S. in Biology and minors in Chemistry and History. As an undergraduate she was a Faculty Scholar, and in her independent work explored issues of science education and science policy in the United States, with particular attention to post-Sputnik America. After working at Duke, she plans to attend graduate school and gain more advanced training in either science writing or the history of science.

Readings:
Stephen S. Hall, "Revolution Postponed," Scientific American, October 2010. Available to members of the Duke University community here.
Jon McClellan and Mary-Claire King, "Genetic Heterogeneity in Human Disease," Cell, April 16, 2010.  Available to members of the Duke University community here.
(optional reading) Eric D. Green, Mark S. Guyer, & National Human Genome Research Institute. "Charting a course for genomic medicine from base pairs to bedside" 2011 Nature 470 (10 Feb): 204-213.  Available to members of the Duke University community here.

1/28/2011 Cristina Kapustij

Topic: The NCAA's testing of its athletes for sickle cell trait

Speaker Bio: Cristina Kapustij, MS. Cristina is currently working as a policy analyst at IGSP's Genome Ethics, Law, and Policy, where her research focuses on issues of intellectual property, bio-security, technology access, and the history and policy implications of DNA sequencing, amongst other topics. Before coming to Duke, she earned her MS in Biotechnology from Georgetown University. In the fall of 2008, she was a Christine Mirzayan Fellow in Science and Technology Policy at the National Academies in Washington, DC. As a Fellow, she studied synthetic biology, direct-to-consumer genetic testing, and engaged in the analytical processes informing science and technology policy in the United States.

Readings:
Vence L. Bonham, J.D., George J. Dover, M.D., and Lawrence C. Brody, Ph.D."Screening Student Athletes for Sickle Cell Trait— A Social and Clinical Experiment," The New England Journal of Medicine, September 2010.  Available to members of the Duke University community here.
Rob Stein, "Sickle cell testing of athletes stirs discrimination fears," Washington Post, September 2010.  Available online here.

2010 Meetings

Friday, April 30, 12:00 -1:00 pm
The next Science and Society Journal Club meeting will be on the topic, "Signing up for the DNA draft: What should be the status of human tissue samples?" The discussion will be lead by Chris Heaney. The meeting will be held at a new location, RENCI Conference Room, Telcom Building (behind CIEMAS)

Background: Rebecca Skloot's book The Immortal Life of Henrietta Lacks, as well as the recent settlement of the Havasupai tribe's suit over alleged misuse of their blood samples in favor of tribal members, have both brought attention to the already hot topic of the status of human tissue samples used for research. The growing number and size of collections of tissue samples, the increasing power of technologies for genomic analysis, and the rising economic importance of biotechnology overlap with perpetual questions about how much or little people identify with their bodies and what kind of commerce, if any, in human biological material is appropriate. This journal club will discuss questions including and related to:

-How much say should patients and research participants have in what happens to excised tissue samples?

-If patients and research participants have different underlying assumptions about the relationship between research participants and excised tissue samples, how can researchers constructively interact with participants?

-If and when researchers, participants, and others involved in the collection and use of human tissue samples have conflicts over the use of samples, how should those conflicts be resolved, and how can courts and universities choose between the different values at stake when there are disputes over the tissue samples?

SUGGESTED READING:

-To see how one family thinks about cell lines derived from a parent's unknowingly shared tissue sample, see Chapter 32 of The Immortal Life of Henrietta Lacks. (attached)

-For a discussion some of the relevant court cases and discussion of how some individuals have participated in the tissue market, see Rebecca Skloot, "Taking the Least of You," New York Times Magazine, 2006, available here.

-For a review of the Havasupai case, see Amy Harmon, "Indian Tribe Wins Fight to Limit Research of Its DNA," New York Times, April 22, 2010, available here.

-For one view of the field by several academic experts, see A. Cambon-Thomsen et al, "Trends in Ethical and Legal Frameworks for the Use of Human Biobanks," Eu Respir. (attached)

-For one way to organize biobanks, see David E. Winickoff and Richard N. Winickoff, "The Charitable Trust as a Model for Genomic Biobanks," NEJM. (attached)

February 19th, 2010
The first Science and Society Journal Club of the semester will be held on Feb. 19 at noon in 100 North Building. The topic for discussion, lead by Sara Katsanis, IGSP Associate in Research, will be "Criminal DNA Database Expansions and Familial Searching".

To RSVP, please go to http://tinyurl.com/ye4omgw.

1) General Assembly of North Carolina, Session 2009, House Bill 1403
(Collect DNA Sample on Arrest)
2) "Dangerous Relations" Investigative Practice Journal (D Small)
3) "Genetic Surveillance for All" Slate Magazine (J Rosen)
4) "Debating DNA Collection", NIJ Journal (Berson)

Supplemental: The Evolution of DNA Databases: Expansion, Familial Search, and the Need for Reform (M Seringhaus)

Other Journal Club meetings will be held on March 19, April 16, and May 14 at noon in North Building room 100. Topics and discussion leaders to be announced. If you have ideas or would like to
volunteer, please contact Tomalei Vess at tomalei.vess@duke.edu.

2009 Meetings

The next meeting of the IGSP Science & Society Journal Club will be on Friday, December 11 at 12:00 p.m. in 100 North. Pizza will be served. Lisa Warner will lead the discussion regarding the intersection of genetics and athletic performance. Please read the following material before attending the meeting; Genetics of Athletic Performance , Genetically Transformed World Records and Cheating is so 1999 .

November 20th, 2009
Our guest lecturer will be Dr. Alex Rosenberg, R. Taylor Cole Professor of Philosophy, who will be discussing a chapter from his book, "Reality: The Rough Guide". Book excerpt is below. The topics will include the following:

1. Does an understanding of science commit you to "scientism" (including atheism and its corollary tenets)?

2. Should scientists stay in the closet about the implications of science for "the persistent questions" (e.g. Is there a God?) simply because it is politically favorable to do so?

3. Why is science so hard to market to the general public? Can it ever compete with religious claims about physical reality given its inherent disadvantages in capturing public interest?

Because these might be sensitive topics for some attendees, we would like for everyone to put forth their best effort to have a dispassionate academic debate about these issues. It will be very interesting to have biologists, science policy experts, and a philosopher of biology discuss these topics.

Reading material for this meeting can be found here.

October 23rd, 2009
The next meeting of the IGSP Science & Society Journal Club will be on Friday, October 23 at 12:00 p.m. in 100 North. Pizza will be served. Sayan Mukherjee, Shubha Chandrasekharan, and Stoyan Georgiev will be presenting Studies of genetic diversity in India: Implications for health and society. Please read the following material before attending the meeting; Population Structure and Eigenanalysis, Tracing India's Invisible Threads and Reconstructing Indian Population History.

Please email Shandra Robertson back if you are interested in participating.

March 20th, 2009
The next meeting of the IGSP Science & Society Journal Club will be on Friday, March 20th at 12:00 p.m. in 100 North. Pizza will be served. Matthew Cook will be presenting. Please read the following material before attending the meeting; Popularizing Science in 1879, Carl Sagan, an Astronomer Who Excelled at Popularizing Science, Is Dead at 62, and The Power of Words.

February 27th, 2009
The next meeting of the IGSP Science & Society Journal Club will be on Friday, February 27th at 12:00 p.m. in 100 North. Pizza will be served. Felipe Garcia will present on international scientific cooperation and regulating the spread of scientific knowledge and reagents. Reading materials can be downloaded here and here.

January 23rd, 2009
The next IGSP Science & Society Journal Club is scheduled for Friday, January 23rd at 12pm in 100 North. Audrey Howell is going to be leading a discussion the most important "Science & Society" issues for the next few years you can download the reading materials here and here. 

2008 Meetings

December 5th 2008
The next IGSP Science & Society Journal Club is scheduled for Friday, December 5th at 12pm in 100 North. Felipe Garcia is going to be leading a discussion on U.S. policies on human embryonic stem cells. You can download the reading for this week here. 

September 12th 2008
The next IGSP Science & Society Journal Club is scheduled for Friday, September 12th at 12pm in 100 North. Subha and Andreas are going to be leading a discussion on the dual use issue, how genomic information can be used for the both the benefit and detriment of society.  We'll be using one particular example as a starting point.  (Homer et al, attached).  The news article (also attached) provides a nice summary of the results and a discussion of the implications.

June 20th 2008
On Friday, June 20th at 12pm in 100 North. Patrick Lynch will be presenting, and there are two background articles which will be discussed at the meeting (Therapeutic Misconception and Beyond Informed Consent).

May 9th 2008
On Friday, May 9th 2008 at 12pm in 100 North, Bill English will be presenting on the topic of "Devaluing Science". Please make sure you read the review of a book called "The Honest Broker: Making Sense of Science in Policy and Politics" by Roger A. Pielke, Jr. (Cambridge, 2007). The other article, "The New Politics of Technology", is optional.

March 7th 2008
Presenter: Audrey Howell  
Where does science fit into politics - Is a Science Debate for Presidential candidates a good idea?

January 25th 2008
Presenter: Jeremy N.Block
History of Science Policy since WWII in the United States: Vannevar Bush and beyond.