Nancy Kass Named Vice Provost for Graduate and Professional Education at Johns Hopkins

Nancy Kass, a distinguished scholar and leader in the fields of bioethics and health policy, will become Johns Hopkins University’s vice provost for graduate and professional education effective Sept. 1.

Nancy Kass

Kass is the current deputy director for public health at the Berman Institute for Bioethics and a professor of bioethics and public health at the Johns Hopkins University Bloomberg School of Public Health. She led the PhD concentration in bioethics and public health policy at the School of Public Health for 15 years.

As vice provost for graduate and professional education, Kass will help support JHU’s many graduate and professional programs in developing students and preparing them to launch impactful careers. She will succeed Kelly Gebo, vice provost for education, who will step down at the end of August to pursue a cross-university opportunity between Johns Hopkins and the Stanford University School of Medicine.

“Nancy brings extensive expertise in the study of bioethics and health policy to the provost’s office as well as a proven track record of fostering relationships across the university,” Provost Sunil Kumar said. “Her thoughtful leadership, renowned scholarship, and collaborative spirit make her ideally suited for this important position.”

Kass has dedicated her career to supporting bioethics research, practice, and education. In 2001, she became the first bioethicist to publish an ethics framework for public health. In 2009, she served on the World Health Organization Ethics Review Committee Secretariat in Geneva, Switzerland, where she worked with representatives from around the world to establish ethics guidelines. She is an elected member of the Institute of Medicine and a Fellow of the Hastings Center.

One of her proudest career accomplishments, Kass said, is her work on the Fogarty African Bioethics Training program, which establishes collaborative training partnerships with institutions in sub-Saharan Africa to support the development of ethics and bioethics research.

She said she looks forward to listening and learning in her new role, which has been refined to focus on graduate and professional education. Janet Schreck, assistant vice provost for education, will continue to share responsibilities related to undergraduate education.

“There are many philosophies of graduate education, and I can’t emphasize strongly enough the importance of thinking about both theoretical training and application of the knowledge and skills learned—I don’t think one can come at the expense of the other,” Kass said. “Being deliberate about how one’s work makes the world a better place is important, at least for certain fields.”

Kass received her Doctor of Science in health policy from the Bloomberg School in 1989 and completed a postdoctoral fellowship at Georgetown University’s Kennedy Institute of Ethics.

In her new role, she will implement and analyze graduate student surveys, facilitate greater diversity and inclusion efforts in graduate programs, work on a PhD alumni database to help the university stay connected with professional students following graduation, and collaborate closely with schools to identify cross-cutting goals and initiatives.

Additionally, she will continue her faculty and research work, including chairing the national Precision Medicine Internal Review Board and co-directing the Fogarty African Bioethics Training Program. She will also continue projects on consent and respect in research, and on developing ethics guidance for infectious disease outbreaks.

“One of the joys and luxuries of a university such as Johns Hopkins is that there are so many different kinds of programs training talented people to do so many different things,” Kass said. “I look forward to learning a tremendous amount from colleagues who are steeped in the graduate education mission from the many divisions.”

The 12th Annual Hopkins GIM Housestaff Research Awards National Competition

The Johns Hopkins University Division of General Internal Medicine invites you to submit your research abstract to:

The 12th Annual Hopkins GIM Housestaff Research Awards National Competition

Application Deadline: Monday, September 11, 2017

Hopkins GIM offers 6 awards to recognize outstanding house officers who have the potential to become leaders in GIM-related research in:

  • Medical education
  • Clinical epidemiology and prevention
  • Health services and outcomes research
  • Behavioral medicine and health disparities
  • Bioethics
  • Population health and health system transformation

Awards carry a cash prize of $500 each and an invitation to present your winning abstract to the Hopkins GIM faculty at a special divisional grand rounds. Travel and lodging in Baltimore will be covered.

Enter the competition by submitting online:

  • The application form including statement of interest
  • Your abstract summarizing a research project
  • Two letters of recommendation

All award application forms and details of the competition can be found at

http://www.hopkinsmedicine.org/gim/GIM_Res_Awards/HSRA2017.html

Please note:  Due to funding restrictions on federal grants related to the Awards Program, applicants must be citizens or noncitizen nationals of the United States or admitted for permanent residence by the time the awards are presented.

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

Pressing need for hard evidence of impact of drugs taken during pregnancy

The widely accepted principle that mums-to-be are a ‘vulnerable’ group unfairly excludes them from taking part in clinical studies, and perpetuates the knowledge void around the impact of drugs taken during pregnancy, conclude researchers online in the Journal of Medical Ethics.

There is a pressing need to break this vicious circle to gather hard evidence, because drugs such as antibiotics and treatments for asthma and nausea are increasingly being prescribed to, and taken by pregnant women, they emphasise.

And despite the use of ‘vulnerability’ as a reason to routinely exclude pregnant women from clinical studies, there is no universally accepted definition of this term, they argue.

In a bid to try and explore whether, and if so, to what extent, pregnant women really are vulnerable, the researchers looked for published evidence citing reasons for this presumption.

They used the ethical principles for research participants, set out in 2008 by Samia Hurst, as a working definition of vulnerability.

Out of 65 relevant studies, 13 were included in the final analysis. Four main themes emerged: informed consent (9 studies); susceptibility to coercion (7); heightened risk because of lack of scientific knowledge (7); and the vulnerability of the developing fetus (6).

Although informed consent could be compromised because of the need to weigh up the pros and cons not only for themselves, but also for their baby, particularly in the absence of evidence to inform their decision, “there is no immediately obvious reason to assume that pregnant women are incapacitated during pregnancy,” insist the authors.

There are other situations where few/no data make it very difficult to give truly informed consent: patients with orphan diseases or elderly patients, they say.

The idea that pregnant women would be subject to coercion because of their own and society’s desire to protect the developing fetus is rather paternalistic, and not really warranted, they suggest.

The vulnerability of the fetus is an issue, not only because the unborn child can’t speak for him/herself, but also because there isn’t enough scientific data on the potential impact of drugs taken during pregnancy, particularly new drugs, they explain.

“Nevertheless, there is no reason to assume that the vulnerability of the fetus renders pregnant women increasingly vulnerable in comparison with ordinary research subjects,” they write.

In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, drug authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Johns Hopkins Berman Institute of Bioethics, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

Of the 172 drugs approved by the US regulator, the FDA, between 2000 and 2010, nearly all (97%+) had an “undetermined” risk for pregnancy. And the average length of time to find out how safe drugs are in pregnancy is 27 years, they point out.

“There is a desperate need to shift the paradigm to protect pregnant women through research, not just from research,” they write.

The powers that be are starting to take this on board, recognising the scientific and ethical importance of including them in research. And now is the time to move the agenda forward, they suggest.

“With the recent emergence of the Zika crisis and the rapid pace of vaccine development, we have a crucial opportunity to demonstrate what proactive and intentional inclusion of pregnant women’s interests in the R&D agenda looks like,” they conclude.

Research: Vulnerability of pregnant women in clinical research doi 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’  doi 10.1136/medethics-2017-104446

Press Release: via The Journal of Medical Ethics, BMJ

With Stringent Oversight, Heritable Human Genome Editing Could Be Allowed

 

February 14, 2017

Via the National Academies:

WASHINGTON – Clinical trials for genome editing of the human germline – adding, removing, or replacing DNA base pairs in gametes or early embryos – could be permitted in the future, but only for serious conditions under stringent oversight, says a new report from the National Academy of Sciences and the National Academy of Medicine.  The report outlines several criteria that should be met before allowing germline editing clinical trials to go forward.  Genome editing has already entered clinical trials for non-heritable applications, but should be allowed only for treating or preventing diseases or disabilities at this time.

Summary of report recommendations

One-pager: Principles for the Governance of Human Genome Editing

Genome editing is not new.  But new powerful, precise, and less costly genome editing tools, such as CRISPR/Cas9, have led to an explosion of new research opportunities and potential clinical applications, both heritable and non-heritable, to address a wide range of human health issues.  Recognizing the promise and the concerns related to this technology, NAS and NAM appointed a study committee of international experts to examine the scientific, ethical, and governance issues surrounding human genome editing.

Human genome editing is already widely used in basic research and is in the early stages of development and trials for clinical applications that involve non-heritable (somatic) cells.  These therapies affect only the patient, not any offspring, and should continue for treatment and prevention of disease and disability, using the existing ethical norms and regulatory framework for development of gene therapy.  Oversight authorities should evaluate safety and efficacy of proposed somatic applications in the context of the risks and benefits of intended use.

However, there is significant public concern about the prospect of using these same techniques for so-called “enhancement” of human traits and capacities such as physical strength, or even for uses that are not possible, such as improving intelligence.  The report recommends that genome editing for enhancement should not be allowed at this time, and that broad public input and discussion should be solicited before allowing clinical trials for somatic genome editing for any purpose other than treating or preventing disease or disability.

“Human genome editing holds tremendous promise for understanding, treating, or preventing many devastating genetic diseases, and for improving treatment of many other illnesses,” said Alta Charo, co-chair of the study committee and Sheldon B. Lubar Distinguished Chair and Warren P. Knowles Professor of Law and Bioethics, University of Wisconsin-Madison.  “However, genome editing to enhance traits or abilities beyond ordinary health raises concerns about whether the benefits can outweigh the risks, and about fairness if available only to some people.”

Germline genome editing, in contrast, is contentious because genetic changes would be inherited by the next generation.  Many view germline editing as crossing an “ethically inviolable” line, the report says.  Concerns raised include spiritual objections to interfering with human reproduction to speculation about effects on social attitudes toward people with disabilities to possible risks to the health and safety of future children.  But germline genome editing could provide some parents who are carriers of genetic diseases with their best or most acceptable option for having genetically related children who are born free of these diseases.

Heritable germline editing is not ready to be tried in humans.  Much more research is needed before it could meet the appropriate risk and benefit standards for clinical trials.  The technology is advancing very rapidly, though, making heritable genome editing of early embryos, eggs, sperm, or precursor cells in the foreseeable future “a realistic possibility that deserves serious consideration,” the report says.  Although heritable germline genome editing trials must be approached with caution, the committee said, caution does not mean prohibition.

At present, heritable germline editing is not permissible in the United States, due to an ongoing prohibition on the U.S. Food and Drug Administration’s ability to use federal funds to review “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.”  A number of other countries have signed an international convention that prohibits germline modification.

If current restrictions are removed, and for countries where germline editing would already be permitted, the committee recommended stringent criteria that would need to be met before going forward with clinical trials.  They include: (1) absence of reasonable alternatives; (2) restriction to editing genes that have been convincingly demonstrated to cause or strongly predispose to a serious disease or condition; (3) credible pre-clinical and/or clinical data on risks and potential health benefits; (4) ongoing, rigorous oversight during clinical trials; (5) comprehensive plans for long-term multigenerational follow-up; and (6) continued reassessment of both health and societal benefits and risks, with wide-ranging, ongoing input from the public.

Policymaking surrounding human genome editing applications should incorporate public participation, and funding of genome editing research should include support to study the socio-political, ethical, and legal aspects and evaluate efforts to build public communication and engagement on these issues.

The report recommends a set of overarching principles that should be used by any nation in governing human genome editing research or applications.

  • Promote well-being – providing benefit and preventing harm to those affected
  • Transparency – openness and sharing of information in ways that are accessible and understandable to patients, their families, and other stakeholders
  • Due care – proceeding only when supported by sufficient and robust evidence
  • Responsible science – adhering to the highest standards of research in accordance with international and professional norms
  • Respect for persons – recognizing the personal dignity of all individuals and with respect for their decisions
  • Fairness – treating all cases alike, with an equitable distribution of risks and benefits
  • Transnational cooperation – committing to collaborative approaches for research and governance while respecting different cultural contexts.

“Genome editing research is very much an international endeavor, and all nations should ensure that any potential clinical applications reflect societal values and be subject to appropriate oversight and regulation,” said committee co-chair Richard Hynes, Howard Hughes Medical Institute Investigator and Daniel K. Ludwig Professor for Cancer Research, Massachusetts Institute of Technology.  “These overarching principles and the responsibilities that flow from them should be reflected in each nation’s scientific community and regulatory processes. Such international coordination would enhance consistency of regulation.”

The study was funded by the Defense Advanced Research Projects Agency, the Greenwall Foundation, the John D. and Catherine T. MacArthur Foundation, U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and the Wellcome Trust, with additional support from the National Academies’ Presidents’ Circle Fund and the National Academy of Sciences W.K. Kellogg Foundation Fund.  The National Academy of Sciences and the National Academy of Medicine are private, nonprofit institutions that, along with the National Academy of Engineering, provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine.  The Academies operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln.  For more information, visit www.national-academies.org.

#          #          #

NATIONAL ACADEMY OF SCIENCES
and
NATIONAL ACADEMY OF MEDICINE
 
Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations


Alta Charo1 (co-chair)
Sheldon B. Lubar Distinguished Chair and Warren P. Knowles Professor of Law and Bioethics
University of Wisconsin, Madison

Richard O. Hynes1,2 (co-chair)
Investigator
Howard Hughes Medical Institute, and
Daniel K. Ludwig Professor for Cancer Research
Massachusetts Institute of Technology, Cambridge

David W. Beier
Managing Director
Bay City Capital, San Francisco

Ellen Wright Clayton1
Craig Weaver Professor of Pediatrics, and
Professor of Law
Vanderbilt University, Nashville, Tenn.

Barry S. Coller1,2
David Rockefeller Professor of Medicine,
Physician in Chief, and Head
Allen and Frances Adler Laboratory of Blood and Vascular Biology
Rockefeller University, New York City

John H. Evans
Professor
University of California, San Diego

Juan Carlos Izpisua Belmonte
Professor
Gene Expression Laboratory
Salk Institute for Biological Studies, La Jolla, Calif.

Rudolf Jaenisch1,2
Professor of Biology
Massachusetts Institute of Technology, Cambridge

Jeffrey Kahn1
Andreas C. Dracopoulos Director
Johns Hopkins Berman Institute of Bioethics
Johns Hopkins University, Baltimore

Ephrat Levy-Lahad
Director
Fuld Family Department of Medical Genetics
Shaare Zedek Medical Center and
Faculty of Medicine
Hebrew University of Jerusalem, Jerusalem

Robin Lovell-Badge
Senior Group Leader
Laboratory of Stem Cell Biology and Developmental Genetics
The Francis Crick Institute, London

Gary Marchant
Regents’ Professor of Law
Arizona State University, Tempe

Jennifer Merchant
University Professor
Université de Paris II (Panthéon-Assas), Issy-les-Moulineaux, France

Luigi Naldini
Professor of Cell and Tissue Biology and of Gene and Cell Therapy
San Raffaele University, and
Director
San Raffaele Telethon Institute for Gene Therapy, Milan

Duanqing Pei
Professor and Director General
Guangzhou Institute of Biomedicine and Health
Chinese Academy of Sciences, Guangzhou, China

Matthew Porteus
Associate Professor of Pediatrics
Stanford School of Medicine, Stanford

Janet Rossant2
Senior Scientist and Chief of Research Emeritus
Hospital for Sick Children
University of Toronto, Toronto

Dietram A. Scheufele
John E. Ross Professor in Science Communication and Vilas Distinguished Achievement Professor
University of Wisconsin, Madison

Ismail Serageldin2
Founding Director
Bibliotheca Alexandrina, Alexandria, Egypt

Sharon Terry
President and CEO
Genetic Alliance
Washington, D.C.

Jonathan Weissman2
Professor
Department of Cellular and Molecular Pharmacology
University of California
San Francisco

Keith R. Yamamoto1,2
Vice Chancellor for Science Policy and Strategy
University of California
San Francisco

 

STAFF
Katie Bowman
Study Director

____________________________

1Member, National Academy of Medicine
2Member, National Academy of Sciences