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
Showing posts with label translation. Show all posts
Showing posts with label translation. Show all posts
Friday, November 28, 2008
Thursday, May 8, 2008
Translating ELSI – From a Conference at Case Western to the World
An exciting conference occurred last week in Cleveland, Ohio on the past, present, and future of research into the ethical, legal, and social implications genetics (so-called "ELSI" research). If the large number of interesting presentations at this conference is any indication, the field is flourishing. Although I saw relatively few presentations (I was only there for part of the conference), the discussions, the turnout, and the book of abstracts show the rigor and creative energy of a thriving, international group of scholars.
As part of a panel on Saturday morning (May 3rd), I presented a short talk entitled "PredictER: Indiana University's Experience in Translating Predictive Health Ethics Research into Practice". The presentation covered the work that we've been doing at the IU Center for Bioethics on the ethical and legal aspects of predictive health research. Other speakers in the same session described similar work under way in Kyoto, Japan and in Newfoundland, Canada. Genetics is truly a global field, and, thus, so is the project of examining the ethical, legal and social implications of the science and medicine. If we want to insure the ethical practice of genetic science and the equitable sharing of its benefits, the global participation exemplified by the work at this conference, must become a common feature in the investigation of the ELSI of predictive health research. – Peter H. Schwartz
As part of a panel on Saturday morning (May 3rd), I presented a short talk entitled "PredictER: Indiana University's Experience in Translating Predictive Health Ethics Research into Practice". The presentation covered the work that we've been doing at the IU Center for Bioethics on the ethical and legal aspects of predictive health research. Other speakers in the same session described similar work under way in Kyoto, Japan and in Newfoundland, Canada. Genetics is truly a global field, and, thus, so is the project of examining the ethical, legal and social implications of the science and medicine. If we want to insure the ethical practice of genetic science and the equitable sharing of its benefits, the global participation exemplified by the work at this conference, must become a common feature in the investigation of the ELSI of predictive health research. – Peter H. Schwartz
Tuesday, February 19, 2008
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.
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.
Friday, February 8, 2008
Genetic Research - Up to the Task? Educating Health Care Providers
In lively exchanges between bloggers from Gene Sherpas, Genetic Future, and Venture Beat, the ethical implications of private genetic testing and personalized medicine were explored and a number of issues were spotted (see comments from Steve Murphy, David P. Hamilton, and Daniel MacArthur). I find Steve Murphy’s compelling suggestion that physicians in clinical practice lack the time and interest to provide thoughtful guidance to patients on genetic testing and test interpretation both relevant to PredictER's program and worth further assessment.
Like nearly every other academic medical center in the United States, Indiana University (PredictER's home) is interested in determining what a large scale predictive health study would look like. More clearly, researchers are asking: what needs to be in place for a large study to successfully combine genetic information along with other health data and biographical information? To be sure, it could serve as a platform for researchers in almost any biomedical research field, but more to Steve’s point, is it practical or possible to role out a study of this kind in clinics and doctors offices? Is there enough interest and enough time for a primary care doctor to attend to this new type of information?
If there's a deficit of interest and time, this is the moment in which the life sciences community should work to develop both. This not so much a disagreement with Steve’s suggestion as a statement about the ultimate goals of predictive health--there is no doubt that the clinical world of primary care is already pressured to the point of precluding physicians from developing new interests or allotting additional time in their schedules, but balance this fact with the knowledge that the outcomes of predictive health remain to be measured. As the prevalence and usage of these tests increases, so will the understanding of how they are being used and interpreted. So, while many are interested in fostering new research platforms to identify targets for new tests, others (including PredictER) are interested in laying a foundation of ethics outreach, education, and assessment to guide the realization of translational science and personalized medicine. One strategy might be to engage busy, primary care doctors with incentives to pursue relevant continuing medical education prior to initiating fully integrated predictive health projects. To do so, one would need a flexible, responsive curriculum (perhaps an online learning module) available for any physician whose patients are or might be enrolled in a predictive health research study ... but what would issues and subjects would such a curriculum need to address? Here are a few that leap to mind:
- Structure of Predictive Health Studies
A bank containing genetic samples and future research projects drawing on this
- Longitudinal research: from Framingham to today
- Impact on Practice in Primary Care
Personalized medicine: prevention, prognosis, pharmacogenetics
- Ethical Issues
Informed Consent
Vulnerable populations
Confidentiality
Recontacting patients
Withdrawal
Return of genetic information
Selling genetic information
I'd be interested to see how PredictER Blog's readers would change this list. What do primary care physicians need to know? Any ideas?
Like nearly every other academic medical center in the United States, Indiana University (PredictER's home) is interested in determining what a large scale predictive health study would look like. More clearly, researchers are asking: what needs to be in place for a large study to successfully combine genetic information along with other health data and biographical information? To be sure, it could serve as a platform for researchers in almost any biomedical research field, but more to Steve’s point, is it practical or possible to role out a study of this kind in clinics and doctors offices? Is there enough interest and enough time for a primary care doctor to attend to this new type of information?
If there's a deficit of interest and time, this is the moment in which the life sciences community should work to develop both. This not so much a disagreement with Steve’s suggestion as a statement about the ultimate goals of predictive health--there is no doubt that the clinical world of primary care is already pressured to the point of precluding physicians from developing new interests or allotting additional time in their schedules, but balance this fact with the knowledge that the outcomes of predictive health remain to be measured. As the prevalence and usage of these tests increases, so will the understanding of how they are being used and interpreted. So, while many are interested in fostering new research platforms to identify targets for new tests, others (including PredictER) are interested in laying a foundation of ethics outreach, education, and assessment to guide the realization of translational science and personalized medicine. One strategy might be to engage busy, primary care doctors with incentives to pursue relevant continuing medical education prior to initiating fully integrated predictive health projects. To do so, one would need a flexible, responsive curriculum (perhaps an online learning module) available for any physician whose patients are or might be enrolled in a predictive health research study ... but what would issues and subjects would such a curriculum need to address? Here are a few that leap to mind:
- Structure of Predictive Health Studies
A bank containing genetic samples and future research projects drawing on this
- Longitudinal research: from Framingham to today
- Impact on Practice in Primary Care
Personalized medicine: prevention, prognosis, pharmacogenetics
- Ethical Issues
Informed Consent
Vulnerable populations
Confidentiality
Recontacting patients
Withdrawal
Return of genetic information
Selling genetic information
I'd be interested to see how PredictER Blog's readers would change this list. What do primary care physicians need to know? Any ideas?
Thursday, October 18, 2007
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:
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
Monday, September 10, 2007
Predicitive Health & Medical Education: Lost in Translation
When reflecting upon the greatest medical advancements in the last fifty years of medicine, certain broad and worthy categories come to mind. Imaging technology, drug design, and minimally invasive surgery have made great changes in how patients are treated. As a fourth year medical student, I routinely request a CT, suggest a regimen of Gleevac, or recommend a laproscopic procedure. All of these advances have made waves in the practice of medicine, public expectations, and medical education. Predictive health research, however, has not yet fully entered the medical school curriculum.
I doubt whether there is a single undergraduate who gains acceptance to medical school who cannot identify the names Watson or Crick or explain the basic function of DNA. By now, most students are also aware of the recent completion and publication of J. Craig Venter’s genome. Nevertheless, discussions with my peers suggest that medical students may not be fully prepared for the medical and ethical implications of recent genetic research. Predictive health research discoveries are taught, but the potential clinical applications are lost in translation--stuck somewhere on the path from the bench to the bedside . . . or, in my case, from the pages of the textbook to the patient.
For my generation of medical students, predictive health research has the potential to significantly change the practice of medicine. While programs like the Personal Genetics Education Project at Harvard are building interest in predictive health, and while the public is flooded by a confusing array of genetics news reports, what are medical schools doing to prepare future physicians for the predictive health revolution?
Medical students and educators should step up their efforts to join the conversation about the clinical promise and ethical issues of predictive health. We need to start thinking and talking about how we make use of the predictive tools we already have and how we will prepare for future tools. For example, how many of us are ready to explain to new parents the meaning of normal newborn screening results? Are we fully prepared to share the non-watered-down reasons for why we may want a fifty-year old man to get a colonoscopy? Are we ready to address the anxieties of a patient considering a genetic test to better determine her risk of breast cancer? Clearly, students and bloggers like Bertalan Meskó at ScienceRoll are doing their share to spread the word, but we should encourage our mentors and professors to join the discussion. What is the current state of predictive health, and where can we expect it to advance?
[Note: To encourage a public discussion of the ethical, legal and social implications of predictive health research, PredictER Blog will be inviting guest contributions from students, professionals, and interested members of the public. This post from Pat Barrett, a fourth year medical student at the Indiana University School of Medicine and a graduate student of the Indiana University School of Philosophy, is a fitting introduction to this new feature of PredictER Blog. -- J.O.]
I doubt whether there is a single undergraduate who gains acceptance to medical school who cannot identify the names Watson or Crick or explain the basic function of DNA. By now, most students are also aware of the recent completion and publication of J. Craig Venter’s genome. Nevertheless, discussions with my peers suggest that medical students may not be fully prepared for the medical and ethical implications of recent genetic research. Predictive health research discoveries are taught, but the potential clinical applications are lost in translation--stuck somewhere on the path from the bench to the bedside . . . or, in my case, from the pages of the textbook to the patient.
For my generation of medical students, predictive health research has the potential to significantly change the practice of medicine. While programs like the Personal Genetics Education Project at Harvard are building interest in predictive health, and while the public is flooded by a confusing array of genetics news reports, what are medical schools doing to prepare future physicians for the predictive health revolution?
Medical students and educators should step up their efforts to join the conversation about the clinical promise and ethical issues of predictive health. We need to start thinking and talking about how we make use of the predictive tools we already have and how we will prepare for future tools. For example, how many of us are ready to explain to new parents the meaning of normal newborn screening results? Are we fully prepared to share the non-watered-down reasons for why we may want a fifty-year old man to get a colonoscopy? Are we ready to address the anxieties of a patient considering a genetic test to better determine her risk of breast cancer? Clearly, students and bloggers like Bertalan Meskó at ScienceRoll are doing their share to spread the word, but we should encourage our mentors and professors to join the discussion. What is the current state of predictive health, and where can we expect it to advance?
[Note: To encourage a public discussion of the ethical, legal and social implications of predictive health research, PredictER Blog will be inviting guest contributions from students, professionals, and interested members of the public. This post from Pat Barrett, a fourth year medical student at the Indiana University School of Medicine and a graduate student of the Indiana University School of Philosophy, is a fitting introduction to this new feature of PredictER Blog. -- J.O.]
Friday, July 13, 2007
Recent Blogs on Predictive Health Topics: Gene Expression; The Daily Transcript; Eye on DNA ...
Medical Records
A top-down approach to genetic networks. July 5, 2007. From p-ter at Gene Expression.
Comments on data mining health records to correlate hereditary disorders.
==========
Reviewing ENCODE
ENCODE. July 4, 2007. From Alex Palazzo at The Daily Transcript. A summary and critique, for the general reader, of: “Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project”. Nature 447, 799-816 (14 June 2007) doi:10.1038/nature05874.
==========
Ownership and Genetic Information
One Big Happy Family Genome, July 7, 2007. From Hsien-Hsien Lei at Eye on DNA. Lei comments on the BMJ “Head-to-Head” feature: “Should families own genetic information?” BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030.AD.
==========
Translation
Towards a World without Genetic Diseases July 7, 2007. From Bertalan Meskó at ScienceRoll.
Mentions recent genetic research advances on muscular dystrophies and potential technologies to speed translation.
==========
Genetic Databases
Indian genetic database offers R&D advances, July 7, 2007. From Albin Paul at Microarray Blog. Describes the work of The Indian Genome Variation Consortium, including: “data on the genetic codes of over a 1,000 genes from among 15,000 individuals belonging to Indian sub-populations”.
A top-down approach to genetic networks. July 5, 2007. From p-ter at Gene Expression.
Comments on data mining health records to correlate hereditary disorders.
==========
Reviewing ENCODE
ENCODE. July 4, 2007. From Alex Palazzo at The Daily Transcript. A summary and critique, for the general reader, of: “Identification and analysis of functional elements in 1% of the human genome by the ENCODE pilot project”. Nature 447, 799-816 (14 June 2007) doi:10.1038/nature05874.
==========
Ownership and Genetic Information
One Big Happy Family Genome, July 7, 2007. From Hsien-Hsien Lei at Eye on DNA. Lei comments on the BMJ “Head-to-Head” feature: “Should families own genetic information?” BMJ 2007;335:22 (7 July), doi:10.1136/bmj.39252.386030.AD.
==========
Translation
Towards a World without Genetic Diseases July 7, 2007. From Bertalan Meskó at ScienceRoll.
Mentions recent genetic research advances on muscular dystrophies and potential technologies to speed translation.
==========
Genetic Databases
Indian genetic database offers R&D advances, July 7, 2007. From Albin Paul at Microarray Blog. Describes the work of The Indian Genome Variation Consortium, including: “data on the genetic codes of over a 1,000 genes from among 15,000 individuals belonging to Indian sub-populations”.
Thursday, July 12, 2007
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.]
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.]
Tuesday, July 3, 2007
Ethics and Regulation of Predictive Health Research: A New Translational Paradigm
PredictER at the Upcoming 9th Annual Meeting (October 18-21, 2007) of ASBH
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