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Since its creation in 1990, the Ethical, Legal and Social Implications (ELSI) Research Program has funded hundreds of research projects, conferences, and other activities-through grants and contracts. This has resulted in many peer reviewed journal articles, books, newsletters, websites, television and radio programs and educational materials. Many of these products are included in this database (updates are still in progress). However, there are likely to be a number of publications missing, particularly those affiliated with older grants.

Overview

The ELSI Publications and Products Database organizes the publications for all ELSI projects and activities by the last name of the principle investigator (PI). Each entry also includes, and can be searched by:

  • A specific topic - or search term - related to an ELSI issue, (i.e., discrimination, genetic testing or privacy)
  • The name of the author
  • The name of the journal
  • The type of grant (i.e., education, research or conference).
  • The grant number.
  • The name of the principal investigator.

Note: To see ALL publications, click on the Search button below without typing anything into the search fields. (Please be aware that publications with multiple authors may be associated with more than one project and will appear on the comprehensive list for each relevant project.)

Missing publication? Many of these products are included in this database (updates are still in progress). However, there are likely to be a number of publications missing, particularly those affiliated with older grants. If you know of an ELSI funded product that is not currently listed in this database, please submit a request to add it.


Topical Bibliographic Resource on DNA Identification

An annotated listing of  publications and other products from research supported by the ELSI program on issues related to using DNA for identification purposes in a wide range of settings.

  • Overview

    The ELSI Publications and Products Database organizes the publications for all ELSI projects and activities by the last name of the principle investigator (PI). Each entry also includes, and can be searched by:

    • A specific topic - or search term - related to an ELSI issue, (i.e., discrimination, genetic testing or privacy)
    • The name of the author
    • The name of the journal
    • The type of grant (i.e., education, research or conference).
    • The grant number.
    • The name of the principal investigator.

    Note: To see ALL publications, click on the Search button below without typing anything into the search fields. (Please be aware that publications with multiple authors may be associated with more than one project and will appear on the comprehensive list for each relevant project.)

    Missing publication? Many of these products are included in this database (updates are still in progress). However, there are likely to be a number of publications missing, particularly those affiliated with older grants. If you know of an ELSI funded product that is not currently listed in this database, please submit a request to add it.


    Topical Bibliographic Resource on DNA Identification

    An annotated listing of  publications and other products from research supported by the ELSI program on issues related to using DNA for identification purposes in a wide range of settings.

BURKE, Wylie - Center for Genomics and Healthcare Equality [P50 HG003374]

Genomic research is rapidly expanding our knowledge about the genetic contributors to health and disease. A broad range of health benefits will flow from this research, including tests to predict disease risk and guide drug use, innovative therapies, and improved understanding of the interactions between genetic and environmental contributors to health. However, the specific benefits will vary for different diseases and populations, influenced by the nature of the genetic and non-genetic contributors, and the availability and safety of therapeutic options. The likelihood of benefit for a particular individual or group will also be influenced by social, political and economic factors such as access to health care, meaning attached to genetic risk information, and cost and acceptability of specific interventions. In particular, medically underserved and marginalized populations may experience greater barriers to receiving benefit from genomic health applications, with the potential for genomics to exacerbate existing health disparities. In this renewal application of the Center for Genomics and Healthcare Equality, we will build on our existing work to develop methods for enhancing the benefits of genomic translation, with particular attention to the use of genomic technology to address population health and health disparities. The specific aims of our center are to: (1) Characterize the range of challenges and opportunities in the translation process from genomic discovery to health benefit with an emphasis on targeting benefits for medically underserved populations; (2) Develop methods to build and evaluate university - community and interdisciplinary partnerships, including deliberative processes and strategies to identify common ground; (3) Develop tools to assist decision-making about the clinical use and reimbursement of genomic health applications; (4) Provide training opportunities to encourage the participation of researchers from underrepresented minorities in the Center's research agenda and other ELSI research; (5) Stimulate collaborative partnerships that result in additional funded research addressing these and related questions. PUBLIC HEALTH RELEVANCE: This project will provide information and tools for researchers, clinicians, community members and policymakers, in order to improve the scope of benefits from genomic health research.

Laberge, A.-M., Psaty, B. M., Hindorff, L. A. & Burke, W. Use of Factor V Leiden genetic testing in practice and impact on management. Genet. Med. 11, 750–6 (2009).

[PubMed Central]
Journal Article

Laberge, A.-M. & Burke, W. Clinical and public health implications of emerging genetic technologies. Semin. Nephrol. 30, 185–94 (2010).

[PubMed Central]
Journal Article

Lemke, A. A., Smith, M. E., Wolf, W. A. & Trinidad, S. B. Broad data sharing in genetic research: views of institutional review board professionals. IRB Ethics Hum. Res. 33, 1–5 (2011).

[PubMed Central]
Journal Article

Meacham, M. C., Starks, H., Burke, W. & Edwards, K. Researcher perspectives on disclosure of incidental findings in genetic research. J. Empir. Res. Hum. Res. Ethics 5, 31–41 (2010).

[PubMed Central]
Journal Article

McGuire, A. L., Evans, B. J., Caulfield, T. & Burke, W. Science and regulation. Regulating direct-to-consumer personal genome testing. Science (80-. ). 330, 181–2 (2010).

[PubMed]
Journal Article

McGuire, A. L. et al. Ethical and practical challenges of sharing data from genome-wide association studies: the eMERGE Consortium experience. Genome Res. 21, 1001–7 (2011).

[PubMed Central]
Journal Article

BURKE, Wylie - Genomic Health Care and the Medically Underserved [P50 HG003374]

Genomic research is rapidly producing new opportunities for understanding disease biology, and promises to enhance health care and health outcomes significantly through improved strategies for prediction and prevention, targeted drug treatment, and innovative molecular-based therapies. As with other seminal developments in biomedicine and technology, successful clinical translation requires a careful evaluation of the benefits and harms of specific interventions, in order to encourage uses that improve health outcomes and minimize applications that cause harm or accelerate health care expenditures without commensurate benefit. This challenge is matched by the need to reduce health care disparities. A major concern in the era of genomic health care is to insure that the medically underserved can benefit fully from genome technology, while at the same time not experiencing additional disparities due to genetic discrimination. Yet these groups often experience significant barriers to health care, including limited access to services and culturally inappropriate care. In addition, minority groups may view genomic health care with suspicion, because of historic associations between genetics and racism or because genetic science is viewed as threatening core cultural values. These perceptions, which challenge the acceptability of clinical uses of genetics, need to be taken into account in determining the benefits and appropriate uses of genomic technology. This Center of Excellence in ELSI Research will be dedicated to addressing two overarching themes accompanying the clinical integration of genomics: the need to define criteria for clinical integration that lead to clinically and socially appropriate applications of genomic health care; and the need for a translational pathway that incorporates the goal of reducing health care disparities among the medically underserved. A major product will be the identification and assessment of policy options for addressing these challenges. The specific aims of the Center are to: 1) Identify strategies for assessing the clinical utility of a range of different genomic applications to health care; 2) Assess the implications of different genomic health care applications for medically underserved populations; 3) Describe policy options for the clinical integration of genomes into health care, and their implications for addressing health and health care disparities; 4) Engage ELSI researchers and genetic scientists in on_going conversations about the interacting contributions of the environment, social structural factors, and genetics to health outcomes; 5) Provide training opportunities to encourage the participation of researchers from underrepresented minorities in the Center's research agenda and other ELSI research; and 6) Stimulate collaborative partnerships that result in additional funded research addressing these and related questions.

Burke W, Zimmern R. Moving Beyond ACCE: An Expanded Framework for Genetic Test Evaluation. A Paper for the United Kingdom Genetic Testing Network. 2007.

[PHG Foundation]
Journal Article
Fullerton SM, Knerr S, Burke W . Finding a place for genomics in health disparities research. Public Health Genomics, 15 (3-4):156-63. 2012. [PubMed] Journal Article

Tarini B, Burke W, Wilfond B. Waiving informed consent in newborn screening research: balancing social value and respect. Am J Med Genet, 148(1):23-30. 2008.

[PubMed]
Journal Article
Woods B, Veenstra D, Hawkins N . Prioritizing pharmacogenetic research: a value of information analysis of CYP2D6 testing to guide breast cancer treatment. Value Health, 14 (8):989-1001. 2011. [PubMed] Journal Article

Yu J-H, Goering S, Fullerton M. Race Based Medicine and Justice as Recognition: Exploring the Phenomenon of BiDil. Cambridge Quarterly of Health Care Ethics, 2008. [PubMed]

[PubMed]
Journal Article

Paradies YC, Montoya MJ, Fullerton SM. Racialized Genetics and the Study of Complex Diseases: the thrifty genotype revisited. Perspectives in Biology and Medicine, 50(2):203-227. 2007.

[PubMed]
Journal Article

Burke W, Press N. Genetics as a tool to improve cancer outcomes: ethics and policy. Nat Rev Cancer, 6(6):476-82. 2006.

[PubMed]
Journal Article

Burke W, Holland S, Kuszler P, Starks H, Press N. Translational genomics: Seeking a shared vision of benefit. Am J Bioeth, 8:54-6. 2008.

[PubMed]
Journal Article

Fryer-Edwards K, Fullerton SM. Relationships with test-tubes: where's the reciprocity? American Journal of Bioethics, 6(6):36-38. 2006

[PubMed]
Journal Article

Shields AE, Burke W, Levy DE. The use of available genetic tests among minority-serving physicians in the US. Genet Med, 10:404-14. 2008.

[PubMed]
Journal Article

Veenstra DL, Burke W. Pharmacogenomics and public health. Public Health Genom, 2008. [PubMed]

[PubMed Central]
Journal Article

BURKE, Wylie - Guiding Clinicians in Genetic Assessment of Cancer Risk [R01 HG001085]

The overall goals of this project are to develop relevant, evidence-based clinical practice guidelines for genetic testing for BRCA1/2 through a consensus process involving community care practitioners and oncologists, and to evaluate the effect of the guidelines on clinical practice. The project will convene a Guidelines Group. Educational materials will be developed based on the guidelines, to aid clinicians in pedigree assessment, interpretation of the risks and benefits of BRCA1/2 testing, and use of cancer surveillance or other individuals with increased cancer risk. Educational seminars based on these materials will be presented to community physicians. These materials will be assessed using standardized patient encounters.

Spanier B.W.M., Bruno M.J., Burke W., et al. "Genetic testing." New Engl J Med. 348(11): 1066-1066 March 13, 2003.

Journal Article

BURNS, Joan - Partnership for Genetic Services [R25 HG001692]

This program will develop a model project, aimed at increasing the likelihood that persons affected by genetic conditions receive quality family-centered and culturally sensitive medical care. This will be accomplished by: 1) implementing a model for the program in conjunction with three regions of the Council of Regional Networks for Genetic Services (CORN) and evaluating the effectiveness of the model's design: 2) identifying and defining key components of a consumer perspective on quality genetic services: 3) integrating 30 genetics consumer educators in classes at approximately 15 medical schools, internship and residency programs, representing approximately 5,000 students: 4) bringing together 20 genetics consumer educators and clinical genetics providers with PCPs and managed care administrators at four, managed care pilot organizations - representing approximately 14,000 primary care providers to enhance genetic services to the approximately 768,000 plan members who receive their care within these settings: and 5) developing, employing and evaluating multimedia educational materials for genetic consumer educators to use in support of case-based learning interventions with medical students and primary care providers.

Davidson M., David K., Hsu N., Pollin T., Weiss J., Wilker N., Wilson M. "Consumer Perspectives on Genetic Testing: Lessons Learned." Genetics and Public Health in the 21st Century. Khoury M.J., Burke W., Thomson E.J., eds. Oxford University Press, New York, 579-602.

Book

Wilker, N.L., M.E. Davidson, C. Holmes et al. Report to NYLCare Health Plans Medical Affairs Department: Opportunities to Enhance NYLCare's Genetics Service Delivery System. June 1998. 26pp.

Book

CABURNAY, Charlene - Black Newspaper Coverage of Genetics and its Implications for African Americans [R03 HG005025]

The Human Genome Project and the International HapMap Project have produced significant resources for understanding the genetic bases for health and disease, including identifying genetic variations, genetic mutations, and genomic functions. The interpretation and reporting of findings from these resources have direct and immediate implications for researchers, the news media, and the general public. Knowledge gaps and low health literacy limit how well many people understand health and genetic information and can therefore influence their decisions and actions. Compared to other racial and ethnic population subgroups, African Americans are more likely to have limited and or inaccurate health information and lower levels of health literacy. With increasing and complex genetic information, recommendations, and products being reported to the public, the news media play an important role in reporting and interpreting new discoveries from genetic studies. Although recent studies have explored media reporting of genetic information and public perceptions of those reports, no studies have examined such coverage or its effects in media outlets specifically serving minority populations. Currently, Black newspapers reach a large proportion of the U.S. Black population-estimates range from 6 to 15 million African Americans in total circulation-and are the most trusted media source for health information among African Americans. This application proposes the first national study of news coverage of genetics in a national sample of Black newspapers plus experimental testing of three African American-centric approaches to reporting on genetics. The study consists of two parts: (1) describing differences between African American and general population newspapers in reporting genetics-related information; and (2) conducting a randomized experiment to determine which characteristics of news stories about genetics are most appealing to and understood by African American adults. First, using an existing database of 17,172 health stories we created from 24 Black newspapers and 12 general population papers published from 2003-2008, we will identify and content analyze all genetics-related health stories (n=370) and use this information to characterize current newspaper coverage of genetics. Second, in a randomized experiment, 296 African Americans ages =21 years will read mock news headlines and news articles about genetic risk that apply findings from prior studies of culturally based health communication in African Americans. The study will test effects of: (A) headlines using the term "family history" vs. "genetics"; (B) news reports that include personal stories ("narratives") vs. none; and (C) news reports that include local and race-specific information vs. none. By characterizing current journalistic practices in Black newspapers and identifying optimal strategies for presenting genetics-related information to African American audiences, this study takes the first step toward improving understanding and enhancing perceptions of genetics and genetic research among African Americans. PUBLIC HEALTH RELEVANCE - This two-part exploratory study uses a current and one-of-a-kind database of health stories from Black and general population newspapers to characterize current coverage of genetics-related health news stories, and improves upon this coverage by identifying characteristics of genetics-related stories that maximize interest, comprehension, and trust in those stories by African Americans exposed to this coverage.

Charlene Caburnay, Patricia Babb, Kimberly Kaphingst, Jessica Roberts, Suchitra Rath . Characteristics of genetics-related news content in Black weekly newspapers. Public Health Genomics, 17 (1):S7-15. 2014. [PubMed] Journal Article

CALLAHAN, Daniel - The Genetic Prism: Understanding Health and Responsibility [R13 HG000432]

This project is designed to support a conference on the implications for our understanding of health and moral responsibility of the Genome Project. The purpose of the conference will be to better anticipate the cultural impact that knowledge generated by the Genome Project will have on society. The conference will be held on the campus of the University of California, Berkeley in March or April of 1991. It will draw together speakers from the fields of medicine and genetics, philosophy, history, and the social sciences. The four major themes of the conference will encompass: cultural understandings of diseases and illness, moral responsibility, the political implications of genetic classifications, and the moral imperative to seek a cure for disease in general and genetic disease in particular. The program will be open to the public but will particularly be aimed at the researchers and others involved in the Genome Project in Northern California and the Bay Area. A conference report designed for wide circulation will help to assure wide distribution of the conference results.

Boyle, P.J. et al. "Genetic Grammar: Health, Illness, and the Human Genome Project." Hastings Center Report. 1992; Special Supplement 22(4): S1.

[PubMed]
Journal Article

CALLAHAN, Daniel - Ethical Priorities in for Clinical Uses of Genome Research [R01 HG000418]

This study will focus on setting priorities in the screening, testing, counseling, and treatment of pre-symptomatic and contingent genetic conditions. Under the assumption that unlimited resources will not be immediately available for smoothly introducing genome research into the clinical arena, this project will develop an ethically sound set of priorities to guide this process. In order to structure the introduction of novel technologies in ways appropriate to individual and societal notions of health and well-being, The Hastings Center will develop, analyze, and assess strategies for responding to these practical concerns. We are asking: What clinical priorities, if any should be established from information arising out of genetic research? Should there be any relative priority among disease groups and population served? and What should be the relative priority of clinical resources directed toward genetics compared to other clinical endeavors? To provide a context for these efforts, the Center will also formulate a theory of the goals of medicine designed to accommodate changing understandings of genetic health and simultaneously point to priorities that can direct rational implementation of clinical services.

Boyle, P.J. et al. "Public Priorities for Genetic Services." Hastings Center Report. May-June 1995; 25(3, Special Supplement).

[PubMed]
Journal Article

Wilfond, B.S. and K. Nolan. "National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Lessons from Cystic Fibrosis." JAMA. December 1993; 270(24): 2948-2954.

[PubMed]
Journal Article
Wilfond BS . Screening policy for cystic fibrosis. The role of evidence. Hastings Cent Rep, 25 (3):S21-3. 1995. [PubMed] Journal Article

Silverman, P. H. Commerce and genetic diagnostics. Hastings Cent. Rep. 25, S15–8 (1995).

[PubMed]
Journal Article
Boyle P . Shaping priorities in genetic medicine. Hastings Cent Rep, 25 (3):52-8. 1995. [PubMed] Journal Article
Clayton EW . The dispersion of genetic technologies and the law. Hastings Cent Rep, 25 (3):S13-5. 1995. [PubMed] Journal Article

Tauer, C. A. (1995). Human growth hormone. A case study in treatment priorities. The Hastings Center Report, 25(3), S18–20. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/7649735

[PubMed]
Journal Article

Press, N. & Browner, C. H. Risk, autonomy, and responsibility. Informed consent for prenatal testing. Hastings Cent. Rep. 25, S9–12 (1995).

[PubMed]
Journal Article

Nolan, K. Commentary: how do we think about the ethics of human germ-line genetic therapy? J. Med. Philos. 16, 613–9 (1991).

[PubMed]
Journal Article

CAMPBELL, Eric - Academic Industry Relationships in Genetics [R01 GM074915]

The purpose of the proposed investigation is to explore the phenomenon of Academic-Industry Relationships (AIRs) in the life-sciences, with an emphasis in the field of genetics. This study seeks to update previous work and explore how the prevalence and magnitude of AIRs have changed over the last two decades. Qualitative data from focus groups and personal interviews with investigators in research intensive medical schools and teaching hospitals will be used to refine existing and develop new survey items and hypotheses. The quantitative data will involve an anonymous mailed survey of a random sample of up to 3,000 faculty researchers in genetics, other basic life sciences, and clinical departments. Survey responses will be analyzed to show how individual, departmental, institutional, and national policies and characteristics affect the propensity, scale, length, and type of industry affiliation, including research, consulting, licensing, equity, training, and gift relationships. Results will be disseminated through publications in peer-reviewed journals and presentations at scientific meetings.

DesRoches, C. M., et al. (2010). "Activities, productivity, and compensation of men and women in the life sciences." Acad Med 85(4): 631-639. [PubMed]

[PubMed]
Journal Article
Zinner DE, Campbell EG . Life-science research within US academic medical centers. JAMA, 302 (9):969-76. 2009. [PubMed] Journal Article
Zinner DE, Bolcic-Jankovic D, Clarridge B, Blumenthal D, Campbell EG . Participation of academic scientists in relationships with industry. Health Aff (Millwood), 28 (6):1814-25. 2009. [PubMed] Journal Article

CAMPBELL, Eric - Data Sharing and Data Withholding in Genetics [R01 HG006281]

The overall purpose of this grant is to explore the nature, extent and consequences of data-sharing and data- withholding in academic genetics and the other life sciences. The specific aims are: (1) to empirically examine the frequency of various forms of the data sharing and withholding in genetics and the other life sciences and to compare these findings with the results from 2000; (2) to examine factors that are associated with data sharing and withholding in genetics and the other life sciences and to compare these findings with the results from 2000; (3) to explore using survey data to the functioning of existing federal policies related to data sharing and withholding in the life sciences. Our investigative team has significant experience conducting studies of science policy in general and data-sharing and withholding in particular. The study will employ qualitative and quantitative methods. The qualitative methods will include focus groups and individual interviews which will be used primarily to inform the revision of existing survey items and the development of new ones. The quantitative component will involve a large national survey of 3000 academic life scientists chosen to adequately represent both genetics researchers and other life scientists. The survey of scientists will provide data on the frequency of data-sharing and withholding behaviors, attitudes towards these behaviors and the factors that are associated with such attitudes and behaviors. The analyses will use univariate, bivariate and multivariate methods test several hypotheses as well as explore the changes the frequency of data-sharing and withholding behaviors and attitudes since our previous ELSI funded study in 2000. Results from this research will be disseminated in publications in scientific journals as well as presentations at scientific meetings and will be used to inform government policies. PUBLIC HEALTH RELEVANCE: Openness in data sharing (defining data to include the full range of research results, including materials useful for future investigation) is, or perhaps was, a major ideal in the conduct of academic science. Failure to share data is believed to have negative effects on the efficiency of science, the accuracy of the scientific record, the development of new scientific fields and on the education of the next generation of scientists. The results of this study are intended to inform institutional and national policies and procedures designed to limit data-withholding in the life sciences.

Arias JJ, Pham-Kanter G, Gonzalez R, Campbell EG. Trust, vulnerable populations, and genetic data sharing. J Law Biosci. 2015;2(3):747-753. Published 2015 Oct 29. doi:10.1093/jlb/lsv044

[PubMed Central]
Journal Article

Zinner DE, Pham-Kanter G, Campbell EG. The Changing Nature of Scientific Sharing and Withholding in Academic Life Sciences Research: Trends From National Surveys in 2000 and 2013. Acad Med. 2016;91(3):433-40.

[PubMed Central]
Journal Article

Arias JJ, Pham-Kanter G, Campbell EG. The growth and gaps of genetic data sharing policies in the United States. J Law Biosci. 2014;2(1):56-68. Published 2014 Dec 20. doi:10.1093/jlb/lsu032

[PubMed Central]
Journal Article

Pham-Kanter G, Zinner DE, Campbell EG. Codifying collegiality: recent developments in data sharing policy in the life sciences. PLoS One. 2014;9(9):e108451. Published 2014 Sep 26. doi:10.1371/journal.pone.0108451

[PLoS One]
Journal Article

CAPLAN, Arthur - Ethics, Values, Professional Responsibilities [R13 HG000433]

The centerpiece of this Center for Biomedical Ethics project is a meeting to be held in Minneapolis on April 19-20, 1991. The topic of the meeting is 'Genetics Counseling: Ethics, Values, and Professional Responsibilities'. The meeting will be an invitation only 'working conference' involving 12 experts from outside Minnesota and 5 Minnesotans who will meet, present papers and engage in discussions with an interdisciplinary and interprofessional group of approximately 210 scholars and professionals, the majority of whom are affiliated with the University of Minnesota. The objectives of the meeting are: to identify and critically assess current normative stances in genetic counseling; to examine the nature and adequacy of the norms of 'value neutrality' and 'non-directiveness' for genetic counseling practice; to help identify those issues in genetics counseling most likely to be affected by the human genome project; to present the best thinking about the ethical issues current in the field of genetics counseling to a 'core' group of individuals at the University of Minnesota so that they will be in a better position to undertake a more systematic inquiry into these issues under the aegis of a long-term systematic study of the area; and to produce a book of scholarly papers based on the conference which will help advance academic and public understanding of the ethical and value issues facing providers and patients in the area of genetic counseling.

Caplan, A.L. "Neutrality is Not Morality: The Ethics of Genetic Counseling." In: Prescribing Our Future, eds. Bartels et al. Hawthorne, NY: Aldine de Gruyter, 1993.

Book Chapter

Bartels, D.M.; B.S. LeRoy; and A.L. Caplan, eds. Prescribing Our Future: Ethical Challenges in Genetic Counseling. Hawthorne, NY: Aldine de Gruyter, 1993. 186p.

Book
LeRoy BS . When Theory Meets Practice: Challenges to the Field Genetic Counseling. In Bartels DB, LeRoy BS, Caplan AS Prescribing Our Future: Ethical Challenges in Genetic Counseling. Hawthorne, NY: Aldine de Gruyter. 186. 1993. Book Chapter

CAPPELLA, Joseph N. - Public Opinion Deliberation and Decision Making about Genetics Research [R01 HG004318]

How do ordinary Americans make sense of genetic research? How might they decide whether or not to participate in such research? The proposed study aims to address these questions, in a two-year panel study unfolding in three broad phases: —> an initial, general-population baseline survey of relevant knowledge, attitudes and opinions; —> a structured series of web-based group deliberations, whereby a random subset of survey participants meet three times over several months to respond to and discuss decision scenarios highlighting basic ethical and social issues implicated in genetics research; and —> a series of concluding public opinion surveys, gathered from participants in the deliberative groups as well as from a fresh sample of the U.S. population. Key goals of the project include: —> obtaining high-quality and representative public opinion data, of both a qualitative and quantitative nature, on beliefs and opinions about issues surrounding genetics research; —> constituting deliberative forums known to produce diverse, informed, and representative opinion; —> examining the changing nature of public opinion as it takes shape through public discourse and deliberation; —> testing the impact of information framing on opinions about uses of genetic data, privacy, data sharing, and on willingness to participate in research; and —> moving beyond conventional opinion-survey responses, by examining public decision making in the context of authentic choice scenarios related to participation in genetics research.

Kim SC, Cappella JN, Price V. Online discussion effects on intention to participate in genetic research: A longitudinal experimental study. Psychol Health. 2016;31(9):1025-46.

[PubMed Central]
Journal Article

CAPRON, Alexander Morgan - Genome Mapping: Implications for Health and Life Insurance [R01 HG000551]

This project will examine the moral basis of, and legal and policy framework for, health and life insurance in light of the increase that the HGP is expected to generate in genetic screening capacity to predict disease, disability, and premature death. A core group of 12 experts from ethics, law, regulation, business economics, actuary science, medicine, and genetics has been assembled. The group will first analyze the numerous unresolved issues in this field, and each member will prepare a paper on an aspect of the topic. Through a discussion of these and other sources of information and evaluation, the group will draft guidelines for the insurance industry and policy makers on the appropriate use of genetic screening in health and life insurance, balancing the needs of insurers with individual's interests in affordable insurance, right to privacy, etc. The research papers and guidelines will be presented and discussed at a national meeting, then modified and disseminated.

Capron, A.M. "Hedging Their Bets." Hastings Center Report. May-June 1993; 23(3): 30-32.

Journal Article

Capron, A.M. "Human Genome Research in an Interdependent World." Kennedy Institute of Ethics Journal. September 1991; 1(3): 247-251.

[PubMed]
Journal Article
Capron AM . Genetics and Insurance: Accessing and Using Private Information. Soc Philos Policy, 17 (2):235-75. 2000. Journal Article
Capron AM . At Law: Hedging Their Bets. Hastings Cent Rep, 23 (3):30-1. 1993. [Full Text] Journal Article

Capron, A.M. "Fashioning a Reasonable Interim Policy: Conclusions of the Insurance Project." p. 55-62, in Genetic Testing: Implications for Insurance. Chicago: Actuarial Foundation, 1998.

Book Chapter

CARROLL, Ann - A Model for State Policy on Genetic Testing/Screening [R01 HG001555]

The New York State Task Force on Life and the Law will analyze the appropriate role for state government in issues of genetics policy, identify specific issues involving genetic testing and screening most suited to legislation or regulation at the state level, and devise concrete recommendations for legislation and/or regulation to serve as a model for adoption by states nationwide. The project will be carried out by the Task Force's standing membership, which includes prominent physicians, nurses, bioethicists, lawyers, community advocates, and religious leaders, in conjunction with the Task Force's professional staff and a diverse group of specialist consultants. A Working Group, made up of selected Task Force members and consultants, will identify the issues raised by developments in genetic testing and screening most in need of prompt attention by state lawmakers and policy makers. In a series of meetings, the Task Force members and consultants will determine the goals that policy in these areas should seek to achieve, analyze the range of policy vehicles available to realize those goals, and formulate specific recommendations for state legislation and regulation.

The New York State Task Force on Life and the Law . Genetic Testing and Screening in the Age of Genomic Medicine. New York, NY: The New York State Task Force on Life and the Law 411. 2000. Book

Carroll A.M., Coleman C.H. "Closing the gaps in genetics legislation and policy: A report by the New York State Task Force on Life and the Law." Genetic Testing. December 2001; 5(4): 275-280.

[PubMed]
Journal Article

CASKEY, C. Thomas - National Study Conference on Genetics, Religion, and Ethics [Y01 HG020003]

This project will assemble persons of diverse religious commitments to study the religious and ethical implications of genome research. Four regional inter-disciplinary study groups will produce preparatory papers for an international, ecumenical conference, in March 1992. The papers will be supplemented by several addresses with respondents, interpretations of case studies on recent genetic research, and by presentations on diverse religious points of view. Topics addressed include: the impact of prevailing theologies of human life and new knowledge of molecular biology; modifying human nature by genetic manipulation; defining the limits of scientific inquiry and technology; religious organizations as educators on genetics; the role of women in science and the impact of the genome project on reproductive decisions; and concerns about screening, confidentiality, and factors affecting genetic counseling. The corpus of addresses, reports, case studies and discussions will be published in book form.

Genetics, Religion and Ethics Project, The Institute of Religion and Baylor College of Medicine, the Texas Medical Center, Houston, Texas, June 1, 1992, "Summary Reflection Statement" Human Gene Therapy. October 1992; 3(5): 525-527.

Journal Article
J. Nelson . On the New Frontiers of Genetics and Religion. Grand Rapids, MI: Eerdmans Publishing Company 224. 1994. Book

CHANDRASEKHARAN, Subhashini - Intellectual Property and Access to Noninvasive Prenatal Genetic Testing [R01 HG007074]

The purpose of this study is to provide empirical data on effects of intellectual property (IP) and commercialization on clinical translation of noninvasive prenatal genetic testing (NIPT) and identify potential barriers to clinical adoption and patient access. Advances in technologies for genetic analysis of cell-free fetal DNA could make NIPT routine. Early clinical trials indicate that sequencing-based NIPT tests for chromosomal aneuploidies are more accurate than currently used noninvasive screening tests. A commercial NIPT test for Down Syndrome recently became available and tests for common genetic conditions are in prospect. It is still too early to know the clinical utility and cost effectiveness of these tests. Nevertheless, NIPT could significantly change the paradigm of prenatal testing and screening and potentially even lower costs. Intellectual property (IP) and commercialization promise to be important components in the emerging debate about when and how such technologies should enter clinical practice. IP could induce commercial investment in R&D, in regulatory approval, and in securing third-party payment. But exclusive IP rights could also hamper innovation, increase transaction costs for test developers and providers, and decrease patient access, especially if monopolies emerge. Indeed patents on foundational NIPT technologies have been exclusively licensed to companies, raising such concerns. The commercial landscape is quickly evolving and companies are already involved in patent litigation. The disposition of these patents could determine who can offer the tests and the business models that will prevail, which in turn can impact clinical adoption and patient access. The IP landscape for NIPT appears complex and is unclear. Few if any data are also available on stakeholders' views about effects of IP vs non-IP factors on clinical adoption, and patient access to NIPT.. This study will address these gaps with the following specific aims: 1) map IP relevant to NIPT and assess potential IP effects on development of new NIPT genetic tests; 2) identify and rank IP versus non-IP barriers to clinical adoption and patient access based on stakeholders' views; and 3) identify ethical and policy implications of potential barriers to patient access. A multidisciplinary team of researchers with expertise in genetics, IP law, health policy, bioethics, health economics, maternal and fetal medicine and health law will use established qualitative research methods combined with legal, ethical, and policy analysis. One outcome of this study will be a careful empirical analysis of whether and how IP can affect patient access to NIPT genetic testing. This analysis will be enabled by a publicly available IP and commercialization landscape for NIPT technologies that we will create. Another expected outcome is a forecast of barriers to clinical adoption and patient access ranked by stakeholders. A workshop at the conclusion of the study will include stakeholder representatives groups and experts from relevant domains to identify approaches and policy priorities for reducing barriers to clinical translation and promoting patient access to NIPT. PUBLIC HEALTH RELEVANCE: Noninvasive prenatal genetic tests could significantly impact public health by aiding reproductive decision- making, improving pregnancy management and neonatal health care. The proposed research will find and analyze empirical data on the effects of intellectual property (IP) and commercialization on development, clinical adoption and patient access to noninvasive prenatal genetic tests. This study will also identify and compare how non-IP barriers such as FDA regulation, reimbursement, and quality control of these tests, could affect patient access and clinical adoption. The results of this study will ground and enrich ongoing debates about implementation and clinical integration of noninvasive prenatal genetic tests.

Chandrasekharan, S., McGuire, A. L. & Van den Veyver, I. B. Do recent US Supreme Court rulings on patenting of genes and genetic diagnostics affect the practice of genetic screening and diagnosis in prenatal and reproductive care? Prenat. Diagn. 34, 921–6 (2014).

[PubMed]
Journal Article
Mozersky J, Ravitsky V, Rapp R, Michie M, Chandrasekharan S, Allyse M . Toward an Ethically Sensitive Implementation of Noninvasive Prenatal Screening in the Global Context.. Hastings Center Report, 47 (2):41-49. 2017. [PubMed] Journal Article

CHEDD, Graham - The Secret of Life [R25 HG000712]

The Secret of Life is a series of eight, 60-minute programs for PBS broadcast with extensive educational and outreach materials. The goal of the program is to make molecular biology intelligible to the audience, to demonstrate the extent to which it has transformed the biological and medical sciences, and to explore the pressing issues it raises. The materials will debunk tabloid images of laboratory-created monsters and headlines of miracle cancer cures, and bring subjects to life through tales of discovery, personal case studies, and engaging histories. The project aspires to prepare viewers to act as informed citizens in debates that demand the widest possible participation. It is a collaborative effort between the WGBH Educational Foundation, the British Broadcasting Corporation, the Chedd-Angier Production Company, and an international panel of scientific advisors.

WGBH, "The Secret of Life" (Video series -- 8 one hour programs for PBS broadcast.)

Video
Suzuki D, Levine J . The Secret of Life: Redesigning the Living World. New York, NY: W. H. Freeman & Company 280. 1998. Book

CHO, Mildred - Center for Integrating Ethics & Genetic Research [P50 HG003389]

The Center for Integration of Research on Genetics and Ethics (CIRGE) was established in 2004. The overall goal of CIRGE is the proactive identification and integration of ethical, legal and social considerations into the design and conduct of current and emerging genetic research. Our thematic focus is on genomics of behavioral traits. The aims of CIRGE in this renewal application are to: 1) Conduct interdisciplinary ELSI research that informs policy regarding the conduct and translation of research on the genomics of behavior; 2) Develop an anticipatory approach to integrate ethics, policy and research on the genomics of behavior by linking the process of research on the genomics of behavior with the ELSI research and policy agendas; and 3) Train interdisciplinary ELSI researchers who are fluent in genomics, ethics and policy. CIRGE will serve as a nexus between stakeholders and end-users of the research on the genomics of behavior, genome scientists, and the ELSI research community. We will create a forum for integrating ethical and social considerations into specific areas of genomic research through: 1) "prognostic" normative analyses that identify the values, principles and assumptions implicated by research, technology and their applications, 2) empirical analyses to map relevant genomic research and technology and identify stakeholders, 3) empirical analyses to assess relevant features of the ethical, legal or social context, such as how different stakeholders think genome information or technology will be used, should be used, is perceived, or who it might benefit or harm, 4) "diagnostic" normative analyses to assess whether and how genomic research and technology supports or undermines stakeholder values, and 5) feedback of normative and empirical ELSI findings into research and development priorities, design criteria or other requirements. These processes can inform the design and application of genome research to enhance benefit and utility to end-users and facilitate translation to clinical and non-medical uses. CIRGE's innovation will be in developing a process for coordinating ELSI research agendas around specific focus areas in genomic research, and for translating the ELSI research findings into design features of genomic research and technology. RELEVANCE: CIRGE's aims to facilitate the appropriate and ethical translation of research on the genomics of behavior in a way that serves the needs and values of end users and stakeholders, including patients, clinicians, and health policy makers.

Shirts, B. H. & Parker, L. S. Changing interpretations, stable genes: responsibilities of patients, professionals, and policy makers in the clinical interpretation of complex genetic information. Genet. Med. 10, 778–83 (2008).

[PubMed]
Journal Article

Tabor, H. K. & Cho, M. K. Ethical implications of array comparative genomic hybridization in complex phenotypes: points to consider in research. Genet. Med. 9, 626–631 (2007).

[PubMed]
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Ormond, K. E., Cirino, A. L., Helenowski, I. B., Chisholm, R. L. & Wolf, W. A. Assessing the understanding of biobank participants. Am. J. Med. Genet. Part A 149A, 188–98 (2009).

[PubMed]
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Ormond, K. E. et al. Information preferences of high literacy pregnant women regarding informed consent models for genetic carrier screening. Patient Educ. Couns. 75, 244–50 (2009).

[PubMed]
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Ohata, T., Tsuchiya, A., Watanabe, M., Sumida, T. & Takada, F. Physicians’ opinion for “new” genetic testing in Japan. J. Hum. Genet. 54, 203–8 (2009).

[PubMed]
Journal Article

Mouchawar, J. et al. Impact of direct-to-consumer advertising for hereditary breast cancer testing on genetic services at a managed care organization: A naturally-occurring experiment. Genet. Med. 7, 191–197 (2005).

[Nature]
Journal Article

Sankar, P., Cho, M. K. & Mountain, J. Race and ethnicity in genetic research. Am. J. Med. Genet. Part A 143A, 961–70 (2007).

[PubMed Central]
Journal Article

Singh, J., Illes, J., Lazzeroni, L. & Hallmayer, J. Trends in US autism research funding. J. Autism Dev. Disord. 39, 788–95 (2009).

[PubMed]
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Singh, J., Hallmayer, J. & Illes, J. Interacting and paradoxical forces in neuroscience and society. Nat. Rev. Neurosci. 8, 153–60 (2007).

[PubMed Central]
Journal Article

Greely, H. T. in Impact Behav. Sci. Crim. Law (Farahany, N. A.) 161–182 (Oxford University Press, 2009).

Book Chapter

Sankar P, Wolpe PR, Jones NL, Cho MK. How do women decide? Accepting or declining BRCA1/2 testing in a nationwide clinical sample in the United States. Community Genet, 9(2):78-86. 2006.

[PubMed]
Journal Article

Butte AJ. Kohane IS. Creation and implications of a phenome-genome network. Nature Biotechnology, 24(1):55-62. 2006.

[PubMed]
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Illes J, Blakemore C, Hansson M, Hensch T, Leshner A, Maestre G, Magistretti P, Quirion R, Strata P. International perspectives on engaging the public in neuroethics. Nature Reviews Neuroscience, 6(12):977-982. 2006

[PubMed Central]
Journal Article

McCormick, J. B., Owen-Smith, J. & Scott, C. T. Distribution of human embryonic stem cell lines: who, when, and where. Cell Stem Cell 4, 107–10 (2009).

[PubMed]
Journal Article

CHO, Mildred - Center for Integration of Research on Genetics and Ethics [P50 HG003389]

Modern genetic research gives us unprecedented ability to understand and manipulate fundamental biological processes. Our growing potential to understand and shape the world in genetic terms also seriously challenges basic beliefs and ethical norms. At the same time, values and norms affect the way genetic research is designed and conducted. Despite the significant ethical and societal implications of emerging genetic research, there are few venues for geneticists to participate in interdisciplinary research and to discuss these issues. The overall goal of this proposal is to create a Center for Integrating Ethics and Genetic Research (CIEGR) to develop and test new models of deliberative, interactive processes that integrate ethical, legal and social considerations into the design and conduct of current and emerging genetic research. CIEGR will achieve these goals through a number of innovative programs and products: 1) The Program for Integrated ELSI Research (PIER), which will identify and conduct research on ethical, legal and social issues, focusing on two areas of genetic research (human genetic variation and neuro- and behavioral- genetics), and develop educational materials and policy guidance; 2) a Benchside Consultation Program BCP) for genetic researchers seeking real-time consultation to anticipate and develop policy guidance to address ethical, legal or social issues that could arise from current or future research and that are not addressed by other institutional mechanisms; 3) a Training and Education Program that will train four postdoctoral scholars in both genetic and ELSI research, and use the ethical issues identified by PIER and BCP as the basis for producing educational materials for genetic and ELSI researchers. These will include two documentary training films on research ethics, issue briefs, policy guidance, and webcasts of a series of Interactive Dialogs. The new models will be widely adoptable and will enable unprecedented consideration of genetic research ethics issues among the research community and the public.

Austin MA, Hair MS, Fullerton SM . Research guidelines in the era of large-scale collaborations: an analysis of Genome-wide Association Study Consortia.. Am J Epidemiol, 175 (9):962-9. 2012. [PubMed] Journal Article

Scott, C. T., DeRouen, M. C. & Crawley, L. M. The Language of Hope: Therapeutic Intent in Stem-Cell Clinical Trials. AJOB Prim. Res. 1, 4–11 (2010).

[Taylor & Francis Online]
Journal Article
Cho M . Patently unpatentable: implications of the Myriad court decision on genetic diagnostics. Trends Biotechnol, 28 (11):548-51. 2010. [PubMed] Journal Article
Greely H, King J . The coming revolution in prenatal genetic testing. Professional ethics report : newsletter of the American Association for the Advancement of ScienceProf Ethics Rep, 23 (2):1-8. 2010. Journal Article
Wilcken B . Ethical issues in genetics. J Paediatr Child Health, 47 (9):668-71. 2011. [PubMed] Journal Article
Greely HT, Cho MK, Hogle LF, Satz DM . Thinking about the human neuron mouse. Am J Bioeth, 7 (5):27-40. 2007. [PubMed] Journal Article

Simon, B. M. & Scott, C. T. Unsettled expectations: how recent patent decisions affect biotech. Nat. Biotechnol. 29, 229–30 (2011).

[PubMed]
Journal Article
Greely HT . From Nuremberg to the Human Genome: The Rights of Human Research Participants. In Rubenfeld S Medicine After the Holocaust: From the Master Race to the Human Genome and Beyond. New York, NY: Palgrave Macmillan. 185-200. 2010. Book Chapter
Brown T, Murphy E . Through a scanner darkly: functional neuroimaging as evidence of a criminal defendant's past mental states. Stanford Law Rev, 62 (4):1119-1208. 2010. [PubMed] Journal Article

Allyse, M. A. et al. Best ethical practices for clinicians and laboratories in the provision of noninvasive prenatal testing. Prenat. Diagn. 33, 656–61 (2013).

[PubMed]
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Cho MK, Relman DA . Genetic technologies. Synthetic "life," ethics, national security, and public discourse. Science, 329 (5987):38-9. 2010. [PubMed] Journal Article

Allyse, M. & Michie, M. Not-so-incidental findings: the ACMG recommendations on the reporting of incidental findings in clinical whole genome and whole exome sequencing. Trends Biotechnol. 31, 439–41 (2013).

[PubMed Central]
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Cho M, Wolpert M . Not yet in sequence: Clinical, technical, ethical questions linger over personal genomics. Mod Healthc, 40 (47):24. 2010. [PubMed] Journal Article

McCormick, J. B., Boyce, A. M., Ladd, J. M. & Cho, M. Barriers to Considering Ethical and Societal Implications of Research: Perceptions of Life Scientists. AJOB Prim. Res. 3, 40–50 (2012).

[PubMed]
Journal Article
Valenzuela RK, Henderson MS, Walsh MH, Garrison NA, Kelch JT, Cohen-Barak O, Erickson DT, John Meaney F, Bruce Walsh J, Cheng KC, Ito S, Wakamatsu K, Frudakis T, Thomas M, Brilliant MH . Predicting phenotype from genotype: normal pigmentation. J Forensic Sci, 55 (2):315-22. 2010. [PubMed] Journal Article

Magnus, D. Translating stem cell research: challenges at the research frontier. J. Law, Med. Ethics 38, 267–76 (2010).

[PubMed]
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Brown T, Lowenberg K . Biobanks , Privacy , and the Subpoena Power. Stanf J Law Sci Policy, 1 88-101. 2009. [Full Text] Journal Article

Lee, S. S.-J. & Mudaliar, A. Medicine. Racing forward: the Genomics and Personalized Medicine Act. Science (80-. ). 323, 342 (2009).

[PubMed Central]
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Sayres, L. C. & Cho, M. K. Cell-free fetal nucleic acid testing: a review of the technology and its applications. Obstet. Gynecol. Surv. 66, 431–42 (2011).

[PubMed]
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Latchaw, M., Ormond, K., Smith, M., Richardson, J. & Wicklund, C. Health insurance coverage of genetic services in Illinois. Genet. Med. 12, 525–31 (2010).

[PubMed]
Journal Article

Sayres, L. C., Allyse, M., Norton, M. E. & Cho, M. K. Cell-free fetal DNA testing: a pilot study of obstetric healthcare provider attitudes toward clinical implementation. Prenat. Diagn. 31, 1070–6 (2011).

[PubMed]
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Ladd, J. M., Lappé, M. D., McCormick, J. B., Boyce, A. M. & Cho, M. K. The “how” and “whys” of research: life scientists’ views of accountability. J. Med. Ethics 35, 762–7 (2009).

[PubMed]
Journal Article
Caulfield T, Fullerton SM, Ali-Khan SE, Arbour L, Burchard EG, Cooper R, Hardy BJ, Harry S, Hyde-Lay R, Kahn J, Kittles R, Koenig B, Lee SSJ, Malinowski M, Ravitsky V, Sankar P, Scherer SW, Séguin B, Shickle D, Suarez-Kurtz G, Daar AS . Race and ancestry in biomedical research: exploring the challenges. Genome Med, 1 (1):8. 2009. [PubMed Central] Journal Article

Mitchell, P. B. et al. Predictive and diagnostic genetic testing in psychiatry. Clin. Lab. Med. 30, 829–46 (2010).

[PubMed]
Journal Article
Caulfield T, Scott C, Hyun I, Lovell-Badge R, Kato K, Zarzeczny A . Stem cell research policy and iPS cells. Nat Methods, 7 (1):28-33. 2010. [PubMed] Journal Article

Meslin, E. M. & Cho, M. K. Research ethics in the era of personalized medicine: updating science’s contract with society. Public Health Genomics 13, 378–84 (2010).

[PubMed Central]
Journal Article

CHO, Mildred - BRCA1/2 Testing: Patient Uptake and Treatment Choices [R01 HG001576]

This project is designed to examine factors associated with the uptake of BRCA1/2 genetic testing and patients' medical management choices after learning their test results. The project will study patients' actual testing and medical management decisions in clinical practice and will examine the role of practitioner attitudes in those decisions. Data will be collected through interviews with patients who are offered BRCA1/2 testing, and through questionnaires to their practitioners. The main goals of the project are: 1) to determine the characteristics of health care practitioners who are interested in or request the BRCA1/2 test, and to test the hypothesis that practitioner specialty, attitudes towards testing, and use of genetic counseling facilities are associated, and that these variables change over time; 2) to test the hypothesis that patient uptake of BRCA1/2 testing is associated with patient demographics, patient knowledge and concerns about testing, actual and perceived risk factors, physician characteristics, and the extent of the informed consent process; and 3) to examine the role of practitioner characteristics in patient medical management decisions after receiving BRCA1 testing.

Cho, M.K., P. Sankar, P.R. Wolpe and L. Godmilow. "Commercialization of BRCA1/2 Testing: Practitioner Awareness and use of a new genetic test." Am J Med Genet. 1999; 83: 157-163.

[PubMed]
Journal Article

Sankar, P., Wolpe, P. R., Jones, N. L. & Cho, M. How do women decide? Accepting or declining BRCA1/2 testing in a nationwide clinical sample in the United States. Community Genet. 9, 78–86 (2006).

[PubMed Central]
Journal Article

CHO, Mildred - Effects of Gene Patents on Genetic Testing And Research [R01 HG002034]

This project will use case studies and a survey, combining qualitative and quantitative approaches, to describe and analyze the effects of a particular class of patents (those that claim DNA sequences for use as a genetic test). The investigators will examine the effects on 1) provision of DNA-based genetic testing services, and 2) research and development of other genetic tests or therapies based on disease-gene associations at academic and commercial institutions. They will use the theory of anti-commons developed by Heller and Eisenberg as the basis for a theoretical framework for identifying circumstances under which patents act as incentives or disincentives to genetic testing research, commercialization, and clinical services. This research will build a model for explaining the impact of patenting on clinical practice, research and development. The analysis will inform public policy by indicated whether intellectual property policies or their implementation should be changed to encourage research and technology transfer, and if so, how.

Cho, M.K., Illangasekare S., Weaver M.A., Leonard D.G.B., Merz J.F. "Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services." Journal of Molecular Diagnostics. 2003; 1 (5): 3-8.

[PubMed]
Journal Article

Merz J.F., Leonard D.G.B., Kriss A.G., Cho M.K. "Industry opposes genomic legislation." Nature Biotechnology. 2002; 20(7): 657-657 (letter to the editor).

[PubMed]
Journal Article

Caulfield, T., Gold, E.R. and Cho, M.K. "Patenting human genetic material: Refocusing the debate." Nature Reviews Genetics. 2000; 1: 227-231.

[PubMed]
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Displaying 301 - 400 of 1985 publications.

Last updated: January 24, 2019