Community Roundtable, April 9: Biobanking 101: What are they and how can the public participate?

If you're in central Indiana this coming April, you might want to attend a community event on biobanks. PredictER's Eric M. Meslin will be directing a roundtable discussion on biobanks on April 9 from 11:30 a.m. to 1 p.m. at the Indiana Historical Society, 450 W. Ohio St.

This event is sponsored by The Fairbanks Institute for Healthy Communities and the Indiana Clinical and Translational Sciences Institute Community Health Engagement Program.

Eric M. Meslin, PhD, is director of IU Center for Bioethics and associate dean for bioethics at the IU School of Medicine. He also co-directs the IU Center for Law, Ethics and Applied Research in Health Information and directs the Indiana CTSI Bioethics and Subject Advocacy Program.

Parking is free and lunch will be provided. To register, visit redcap.uits.iu.edu/surveys/?s=g6M4FP.

For more information, see the event flier.

The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Eric M. Meslin, PhD. Nov. 14th, 2011

Join us Monday, November 14th at 3:00 p.m. for a presentation by Eric M. Meslin, The Next Ethical Problem in Translational Science: Crossing the "Policy Valley of Death". Location: Indiana University Center for Bioethics, 410 West 10th Street, Suite 3100, Indianapolis, IN.

This presentation will make the case that there are two gaps to be bridged in successful translational science, one between "the bench and the bedside" and another between the "lab and legislature." Without a sturdy bridge from the lab to the legislature, advances in translational science could be lost to the "policy valley of death."

Ethics and Health Information Technology: Kenneth W. Goodman, PhD

Join us on January 29th from 12 - 1 PM for Kenneth W. Goodman's discussion: "Ethics and Health Information Technology: New Challenges in Clinical Care and Research in a Pharmacogenomic World" [Flyer, 71 KB - PDF ]

In addition to being a widely recognized expert on the ethical issues of information technology, Goodman is co-director of the University of Miami’s Ethics Programs and founder and director of its Bioethics Program and Pan American Bioethics Initiative. The Ethics Programs have recently been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy, one of four such centers in the world and the only one in the United States.

Goodman notes, in an abstract for this presentation, that the intersection of ethics, computing, and medicine is transformative. He expects "this transformation will continue and acquire greater urgency in a post-genomic, evidence-based world, as digitized genetic data introduces new challenges for clinicians, researchers and policy makers."

This is truly a timely topic; so, join us in Room 1110 of the HITS Building, 410 W. 10th Street, Indianapolis, Indiana. - J.O.

Translational Medicine, Cancer and Biobanks: Predictive Health Ethics Events at IU

On December 1-2, 2008 the Indiana Health Industry Forum will present From Basics to Bench to Bedside: Emerging Trends and New Developments in Cancer Discovery, Diagnosis and Treatment. The purpose of this summit, the third in a series, is to examine the state of life sciences research in Indiana with a diverse range of individuals and institutions interested in cancer research, diagnosis and treatment. Of particular interest to those keen on predictive health is a panel discussion on December 2nd at 1:00 PM entitled “Tailored Therapeutics and Implications for Regulatory Endpoints.” Panelists include Jerome Yates, MD, MPH, National Vice President for Research at the American Cancer Society, Eric Meslin, PhD, Director of the Indiana University Center for Bioethics (IUCB), Lawrence Lesko, PhD, FCP, Director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research, and Silvana Borges, MD, Medical Officer for the Genomics Group of the same.
   
On December 4, 2008 the Indiana Clinical and Translational Sciences Institute and IU Simon Cancer Center are hosting a symposium entitled Biorepositories: Scientific, Technical and Ethical Considerations at the Cancer Research Institute on the Indiana University – Purdue University Indianapolis campus. IUCB Faculty Investigator Jennifer Girod, JD, PhD, RN, will be giving a talk on “Ethical and Legal Considerations in Biobanking.” Other presentations will address issues specific to the storage of biospecimens, the extraction and processing of RNA and DNA, tissue procurement, the impact of storage conditions on DNA, and the benefits of biorepositories to research.

On December 8- 9, 2008 the Indiana University School of Medicine will be holding an event that addresses the FDA in the 21st Century: Issues and Their Impact on Medical Technology. This event, which will focus on the future role of the FDA in a changing market, is part of the medical school’s Medical Technology Leadership Forum [Flyer - PDF]. IUCB Director Eric Meslin, PhD, will be moderating a morning session on December 9th specific to ethics and conflicts of interest with Ora Pescovitz, MD, President and CEO of Riley Hospital for Children and Elazar Edelman, MD, PhD, Director of the Harvard-MIT Biomedical Engineering Center. – Amy Lewis Gilbert

Genetic Testing and Personalized Drugs: PredictER at Spirit and Place

As part of the 2008 Spirit & Place Festival, a panel of experts from the Indiana University Center for Bioethics and the Indiana University School of Medicine will join together to illustrate the complex intersection of ethics, medicine and science. Dr. Eric M. Meslin, director of the Center for Bioethics; Dr. Kimberly A. Quaid, professor of medical and molecular genetics; and Dr. David Flockhart, chief of the division of clinical pharmacology, will present Imagining Our Medical Future: The Ethics of Predictive Genetic Testing and the Search for Personalized Drugs this Sunday, November 9th, 2:00-4:00 p.m. at the Indiana Medical History Museum, 3045 W. Vermont Street, Indianapolis. Free tours of the museum will be available both before and after the panel discussion. More information regarding the Spirit & Place Festival, which is runs now through November 16th, is available at www.spiritandplace.org - ALG

Genetics, Ethics, and Tasmania

If you're in the Indianapolis, Indiana area on November 10th, join us at the IU Center for Bioethics with Mark Stranger, Ph.D., from the University of Tasmania. Our guest will be delivering a talk on Genetics, Ethics and the Law Down Under: A Tasmanian Perspective from 3:00-4:00PM in the HITS Building, Suite 3100 [Flyer - PDF 74 KB]. Dr. Stranger, a sociologist with expertise in risk assessment, social change, biobanking and social research methodologies, is a Senior Research Fellow and Executive Director for the Centre for Law and Genetics at the University of Tasmania. He also manages the Centre’s multidisciplinary and international Biotechnology, Ethics, Law and Society Network.

This event will be convened by the Indiana University Center for Bioethics; IUPUI Consortium for Health Policy, Law and Bioethics; and the IUPUI Office of International Affairs. - ALG

Personalized Therapeutics at IU

In August 2008, the Indiana University Department of Medicine’s Division of Clinical Pharmacology began a new series of compelling seminars that may be of great interest to those involved in predictive health research ethics. The Personalized Therapeutics Seminar series commenced on August 5th with a presentation on the FDA’s Sentinel System for Post-market Drug Safety Surveillance given by Barbara Evans, J.D., Ph.D. from the Health Law and Policy Institute at the University of Houston Law Center. Additional speakers this fall, all from the Indiana University School of Medicine, have included Dr. Noah Hahn presenting on the Indiana University Cancer Biomarker Study, Dr. David Haas addressing PREGMED and the search for individualized pharmacotherapy in pregnancy, Dr. Zeruesenay speaking about emerging in vivo phenotyping methods and Dr. Tatiana Foroud addressing the results of whole genome association studies and how they may change our approach to medicine. The next seminar, entitled Personalized Therapeutics in Breast Cancer: A Model for Translating Pharmacogenomics, will be presented Dr. David Flockhart, Chief of the Division of Clinical Pharmacology, on September 9th. All seminars in this series are held on Tuesdays from 12:00pm – 1:00pm, in room W7120 on the 7th floor of the Wishard Myers Building.

For a complete schedule, please see: http://medicine.iupui.edu/clinpharm/PMG/PT_Seminars.asp [link edited 9-18-09]



Amy Lewis Gilbert

PredictER Year-End Review

Join us Monday afternoon (August 4th, 3-4pm) at the Center for Bioethics for a year-end review of PredictER's progress. PredictER's director, Eric M. Meslin, will share his assessment of the program's accomplishments and goals for the coming year. This is an excellent opportunity to learn about the services we provide to our constituents with an interest in predictive health research, medicine, and the associated ethical and legal issues. Refreshments will be served.

IU Center for Bioethics, 410 W 10th Street, Suite 3100. Indianapolis, IN 46202 | 317-278-4034

Biobanks for Breakfast

On April 25, 2008, a collection of community leaders, top medical researchers, and statewide biotech industry leaders met to discuss the bioethical and legal issues surrounding biobanks in Indiana. Biobanks are a growing resource in biotech research. They contain samples of human biological specimens and are often linked in varying degrees to the personal health and demographic information of the donor. Biobanks range from the very small disease specific collections of tissue to the very large national sponsored banks of several million specimens incorporating several different types of biological material from persons both healthy and with known disease. Ownership and commercial involvement are among the most difficult ethical issues in developing successful biobanks. The Bioethics for Breakfast group considered these issues along with Indiana’s role in future biobanking by asking attendees to think about the following questions:

- Are you willing to donate your DNA to a biobank for medical research?
- Are you comfortable allowing Indiana companies to profit by developing commercial products from your samples and donations?

Guest speakers at the event included:

David Flockhart, M.D., Ph.D. , Chief of the Division of Clinical Pharmacology at the Indiana University School of Medicine – Dr. Flockhart outlined the national and international status of biobanks.

Mervin C. Yoder, Jr., M.D., Richard and Pauline Klingler Professor: Department of Pediatrics, Indiana University School of Medicine – Dr. Yoder discussed the therapeutic use of biobank samples.

Andrew R. Klein, J.D., Paul E. Beam Professor of Law, Indiana University School of Law - Indianapolis – Prof. Klein led the group in discussion of the difficult ethical and legal issues.

The Bioethics for Breakfast series is co-sponsored by the Indiana University Center for Bioethics and the law firm of Sommer Barnard. – Patrick Barrett

Purdue Bioethics: Ethical Issues in Constructing and Using Biobanks

PredictER's Eric M. Meslin, PhD, Director, IU Center for Bioethics, will address the Purdue Bioethics lecture series this Wednesday, April 16th, from 6 to 7 pm. Meslin will provide an overview of the ethical issues in developing and using biobanks for genetic research. The Purdue lecture series (now in its second year) intends "to build opportunities for engagement between philosophy, policy, and science at a campus-wide level and to raise awareness of the ethical implications of biotechnological development for our environment both local and global". The current year's series focuses "on two central themes in bioethics: the ethical issues of climate change and those of issues in medical technologies". Read more about Meslin's lecture or to learn more about the series contact Jonathan Beever or Nicolae Morar at Purdue Bioethcs. Also see the international blog, BlogEthics Purdue.

MCI and Predictive Neuroimaging

Monday ( March 3, 2008) at the weekly PredictER meeting, Andrew Saykin, PsyD, Director, Indiana University Center for Neuroimaging, shared his work on the neuroimaging of Alzheimer's disease. Saykin's study of Alzheimer's began with a small cohort at Dartmouth. Except for the control population, most of participants in this research were diagnosed with MCI (Mild Cognitive Impairment). As his research developed his cohorts began to include individuals reporting memory complaints, but who were not yet diagnosed with MCI. Interestingly, Dr. Saykin has observed changes in the brain scans of both MCI patients and patients with memory complaints compared to his control. Today Saykin is working to build (and collaborate with) larger, more diverse cohorts—cohorts which are easier to find at research institutions, like the Indiana University School of Medicine, located in "sunny" Indianapolis. In addition to representing a more diverse demographic, these developing cohorts will also examine ways to identify, with new imaging technologies and genetic research tools, the earliest biomarkers of the disease. As with many predictive health research studies, the ultimate goal is to identify the disease early enough to develop therapeutic and preventative interventions.

Some of the ethical issues discussed include:

How much to tell research participants: Do participants want to know the results of every memory test and each neuroimaging procedure?

Should researchers be prepared to disclose this information even when a reliable interpretation of the risks is not available?

The value of this research to public health: At the moment and into the foreseeable future, the ability to diagnose the onset of Alzheimer's disease exceeds medicine’s ability to treat the disease … will early diagnostics result in inappropriate marketing of unproven interventions to at-risk individuals?

Will there be a way to protect individuals from wasted expense, discrimination and questionable experimental treatments while at the same time encouraging continued research to understand the disease?

To join us at a future PredictER meeting, check our Center's calendar to verify the time and topic: www.bioethics.iu.edu - calendar

The Genetics & Public Policy Center - Public Consultation Dates

The Genetics & Public Policy Center at Johns Hopkins University recently released the dates for its upcoming town hall discussions to "gather feedback from the public on their views related to a proposed large cohort study on the role of genes and environment in health". Meetings will be held March 8th (Kansas City, MO), April 5th (Phoenix, AZ), April 19th (Jackson, MS), April 24th (Portland, OR), and May 13th (Philadelphia, PA). These meetings follow similar meetings in the same cities last year. The scheduled "town hall" meetings are a part of the second stage in a two-year, $2 million pilot project funded by the National Human Genome Research Institute, "Making Every Voice Count: Public Consultation on Genetics, Environment, and Health". The results of last year's public consultations regarding the feasibility of a pediatric biobank were recently published in the American Journal of Medical Genetics:

Kaufman D, Geller G, Leroy L, Murphy J, Scott J, Hudson K. Ethical implications of including children in a large biobank for genetic-epidemiologic research: a qualitative study of public opinion. Am J Med Genet C Semin Med Genet. 2008 Feb 15;148(1):31-9. PMID:18189289

The Research Advocacy Network

Yesterday (Feb. 18), Elda Railey and Mary Lou Smith from the Research Advocacy Network (RAN) addressed the weekly PredictER meeting at the IU Center for Bioethics. RAN facilitates cooperation between research advocates (often disease survivors) and researchers. With access to the energy and resourcefulness of patient and research advocates, RAN accelerates the translation of clinical research. Researchers receive assistance with participant recruitment, public engagement, and patient and clinician education. In turn research advocates and patients have the pleasure of making a real difference in the progress of biomedical science, while also ensuring enhanced patient care in the future.

For readers interested in patient and research participant education, RAN provides print and electronic resources. Including a booklet for patients on the importance of tissue donation, a tutorial for advocates on the clinical trials process, and a training manual for advocates interested in genetic and genomic oncology research.

Also a guest at the PredictER meeting, Cynthia Burkhardt, a research site coordinator, discussed RAN’s collaboration with the Hoosier Oncology Group.

Visit the Research Advocacy Network website to download these and other RAN publications:

“Why is it important for me to consider donating my tissue for research: A booklet for prospective donors”. Research Advocacy Network, 2005. 12p.

Perlmutter, J. Understanding Clinical Trial Design: A Tutorial for Research Advocates.

Genomics in Cancer: An Advocate’s Guide and Training Manual. [Forward by Francis S. Collins, MD, PhD.] Research Advocacy Network, 120p. Research Advocacy Network, 52p.

Next at PredictER:

CANCELED - February 25 – 3:00 pm: Anna Maria Storniolo, M.D., (Director, Catherine Peachey Breast Cancer Prevention Program) will share the progress of the Mary Ellen Tissue Bank.

March 3 - 3:00 pm: Andrew J. Saykin, M.D., (Director, IU Center for Neuroimaging, IU School of Medicine): Neuroimaging, Cognition and Genetics in the Early Detection of Alzheimer's Disease.

If you are in the Indianapolis area and would like to attend, visit the Indiana University Center for Bioethics website for more information. - J.O.

Ethics Meetings at PredictER

PredictER holds a semi-regular weekly meeting to discuss the ethical, legal and social issues relevant to the latest predictive health research. These meetings frequently include presentations from distinguished guest speakers. Recent speakers have included:

Greg Sachs, M.D. - Chief of the Division of General Internal Medicine and Geriatrics, Department of Medicine, Indiana University School of Medicine.

Anantha Shekhar, M.D., Ph.D. - Associate Dean for Translational Research, Indiana University School of Medicine.

David W. Crabb, M.D. - Director of the Indiana Alcohol Research Center, Chair of the Department of Medicine, Indiana University School of Medicine.

Eric Wright, Ph.D. – Director, Center for Health Policy, Indiana University-Purdue University, Indianapolis.

Eleanor DeArman Kinney, J.D., M.P.H. - Hall Render Professor of Law, Co-director of the William S. and Christine S. Hall Center for Law and Health, Indiana University School of Law - Indianapolis.

Jim Wolf, M.S. - Director, Survey Research Center, Indiana University-Purdue University, Indianapolis.

Most recently, Jennifer Girod, J.D., Ph.D., R.N. (IU Center for Bioethics/Sommer Barnard, PC) introduced and moderated a discussion of PredictER’s developing agenda for predictive health policy research. Four domains for potential public policy research were identified: the growing life sciences research and development sector, predictive health information and the future of insurance underwriting, the use and misuse of modestly predictive health information in clinical settings (including patient understanding of risk and related professional liabilities), and the impact of genomic information on public health.

The schedule for the rest of the month includes:

February 18 – 3:00: Elda Railey, Cynthia Burkhardt and Mary Lou Smith from the Research Advocacy Network will present their current activities and will discuss the influence advocates have had on tissue banking.

February 25 – 3:00: Anna Maria Storniolo, M.D., (Director, Catherine Peachey Breast Cancer Prevention Program) will share the progress of the Mary Ellen Tissue Bank.

If you are in the Indianapolis area and would like to attend, visit the Indiana University Center for Bioethics website for more information. - J.O.

Engaging the Community in Predictive Health Research: Reporting on PredictER's November 2nd Expert Panel

Research and the Community

In most predictive health projects, researchers need to obtain human biological materials that can be stored for immediate or later use and then linked to detailed health information from medical records. Building biobanks and predictive health research projects requires a supportive public. To succeed researchers need a representative sample of willing participants, good state and institutional policy, and (of course) funding. (This research also benefits from highly motivated advocacy groups such as Susan G. Komen for the Cure.) In a few words, predictive health is one of the most community saturated forms of medical research to date.

Ethical Issues

The great good that will be accomplished by predictive health research, with its ability to forecast a person’s health future with reasonable probability, must be pursued with careful consideration. These studies raise ethical, legal, and social questions beyond the scope of the current paradigm of medical research. Very basic examples of these questions include: What do researchers do when they find that an individual tests positive for a gene or other biomarker that puts them at significant risk for a disease in the future? Can an individual’s biological material be used first to study one type of disease or treatment and then later another? What protections need to be in place to ensure that the sensitive information in an individual’s health record and genes does not result in employment or health insurance discrimination?

The Pace of Translation

While questions like these may seem very scary when rattled off one after the other, the truth is that predictive health is the future of medicine--a future that hopes to fulfill the ambitions of the human genome project, by providing an individual with a personalized assessment of risk and response to treatment. The human genome project succeeded in decoding a great deal of information, but what that information means for individuals with heart disease, a family history of cancer, or a smoking addiction, has not been answered. If current research succeeds, this information will be translated into real clinical applications in the not too distant future. Research looking to define these types of predictors is well underway at most universities--some, as exemplified by Emory's Predictive Health Initiative and the TGen (Translational Genomics) project in Arizona, have worked to establish comprehensive predictive health research programs. Meanwhile, as The Wall Street Journal recently reported many (up to 1,400) genetic tests are already available for individuals interested in assessing their risks for a number of diseases. Moreover, many specific predictive tests are already being used to chart treatment paradigms in hospital care.

PredictER Engaging the Community

Still, the fact that predictive health is occurring does not answer any of the concerns voiced earlier. These are concerns that the PredictER program at the IU Center for Bioethics is working to address. On November 2nd, PredictER convened a panel of 35 experts and community advocates to begin to give shape to many of these concerns and to explore ways to reach out to the community, build collaboration, and encourage research while protecting individual and public interests. While the panel of experts shared an understanding of the progress of predictive health, it took an entire day of brainstorming and discussion to reach consensus on what issues may be present with respect to engaging the community. In the end, it was clear that predictive health will require physicians, researchers, and the community to join in constructive, mutually beneficial work. In the near future a white paper will be published by the Center for Bioethics with a more detailed account of the November 2nd event. This paper will also introduce the next step in PredictER's community outreach mission--a plan to engage central Indiana community leaders and to listen to their concerns about the future of predictive health research. -- Patrick Barrett

PredictER at the ASBH Annual Meeting

If you are attending 9th Annual Meeting of the ASBH (American Society of Bioethics and Humanities) this weekend in Washington, D.C., do not miss presentations by PredictER's faculty and friends. Scott C. Denne, MD, Timothy Caulfield, LLM, Barbara J. Evans, PhD, JD, LLM, and Peter H. Schwartz, MD, PhD. will address the ethical, legal and social implications of predictive health research, focusing on the essentially collaborative and interdisciplinary nature of research on these issues in their panel session. The panel, Ethics and Regulation of Predictive Health Research: A New Translational Paradigm?, will discuss pediatric biobanks; informed consent; regulatory protections; and patient understanding of risk and genetic information. For a complete abstract, see the American Society for Bioethics and Humanities program description: Sunday, 21 October 2007 - 11:00 AM

Other panel sessions relevant to the ethics of predictive health research include:

- One Hundred Years of Eugenics: From the “Indiana Experiment” to the Human Genome Project. Friday, 19 October 2007: 10:30 AM-11:30 AM
- Who Controls Your DNA? Saturday, 20 October 2007: 10:30 AM-11:30 AM
- Identifiability in Genomic Research: Considerations of Privacy, Autonomy, and Social Identity. Sunday, 21 October 2007: 9:45 AM-10:45 AM

Research: Communicating Genetic Information; Event: CDC--Translational Genetic Research

In the Literature: Communicating Genetic Information

Gaff, CL, et al. Process and outcome in communication of genetic information within families: a systematic review. European Journal of Human Genetics. [advance online publication 4 July 2007]; doi: 10.1038/sj.ejhg.5201883. http://www.nature.com/ejhg/journal/vaop/ncurrent/abs/5201883a.html

. . . . To understand the process by which communication occurs as well as its outcomes, a systematic review of actual communication in families about genetic risk was conducted. Findings from 29 papers meeting the inclusion criteria were summarised and are presented narratively. . . .

Gilbar, R. Communicating genetic information in the family: the familial relationship as the forgotten factor. Journal of Medical Ethics 33 (7), 390-3 (Jul 2007). pmid/17601865; doi/10.1136/jme.2006.017467. http://jme.bmj.com/cgi/content/abstract/33/7/390

. . . . Based on a legal and bioethical analysis on the one hand, and an examination of empirical studies on the other, this paper advocates the adoption of a relational perception of autonomy, which, in the context of genetics, takes into account the effect that any decision-whether to disclose or not to disclose-will have on the familial relationship and the dynamics of the particular family. . . .

Seminar Announced: “Closing the Gap Between Human Genome Discoveries and Population Health”. CDC Genomics, July 26, 2007.

Public Health Genomics Seminar Series: Closing the Gap Between Human Genome Discoveries and Population Health. http://www.cdc.gov/genomics/events/special1.htm

Session 6: But how do we translate new genetic knowledge into practice? 1-3 pm, ENVISION-Koger Center, Williams Bld, Room 1802/05. Centers for Disase Control and Prevention.

"How do we actually translate guidelines into action?" – Speaker: Jon Kerner, NCI
"What is the role of professional organizations, consumers, oversight and regulation?" -- Speaker: Kathy Hudson, Genetics and Public Policy Center, Johns Hopkins University.

[PredictER Note: Slides and video-casts will be posted following the event.]