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Members of Congress Join Push To Include Pregnant Women In Medical Research
Friday, January 27, 2012
FOR IMMEDIATE RELEASE
Johns Hopkins Berman Institute of Bioethics Media Contact: Leah Ramsay, 410-614-5381; Lramsay@jhu.edu
Thirty-six members of Congress have joined the Second Wave
Consortium, a group of concerned physicians, scientists and bioethicists in
urging Health and Human Services (HHS) Secretary
Kathleen Sebelius to ensure the inclusion of pregnant women in federally
funded medical research.
“Pregnancy poses a unique set of health care concerns due to hormonal
and metabolic changes,” says Ruth Faden, Ph.D., M.P.H., director of the Johns
Hopkins Berman Institute of
Bioethics and co-founder of Second Wave.
“It is vital that we learn more about how a pregnant body reacts to
treatment, for the welfare both of women and newborns,” she adds.
The letter, sent by Congress on Wednesday follows up on a letter sent
by Second Wave in October. Representatives
Nita M. Lowey (D-N.Y.) and Rosa DeLauro (D-Conn.) led the campaign among their
colleagues to sign and send the second letter.
Both legislators are veterans of the movement to expand medical research
to better address women’s health. They were involved in the “first wave” effort
in the late 1980s and early 1990s to make clinical trials more inclusive of
women.
“Over 500,000 women in the United States face serious medical illness
while pregnant, but we have a paucity of information on how to safely and
effectively treat them,” according to Second Wave’s initial letter to Sebelius.
Second Wave’s letter also notes that current regulations make
researchers hesitant to include pregnant women in studies, and thus physicians
reluctant to prescribe them medications due to lack of safety and efficacy
data. Pregnant patients are then left to shoulder the risks of unproven
treatments, or suffer untreated “at a substantial cost to the health of both
women and their newborns,” the letter says.
The Consortium was formed after the Second Wave Workshop
in April, 2009, co-sponsored by Faden, Margaret Little, Ph.D., Director of the
Kennedy Institute of Ethics at Georgetown University and Anne Lyerly, Associate
Director of the Center for Bioethics at the University of North Carolina,
Chapel Hill.
NEW MEDIA RELATIONS OFFICER AT THE BERMAN INSTITUTE OF BIOETHICS
Friday, January 06, 2012
FOR IMMEDIATE RELEASE
Johns Hopkins Berman Institute of Bioethics
Media Contact: Leah Ramsay 410-614-5381; cell: 202-642-9640 Lramsay@jhu.edu
Leah Ramsay has joined the Johns Hopkins Berman Institute of
Bioethics as a science writer to manage communications and news media relations.
She comes to Johns Hopkins from Washington, DC, where she worked in multimedia
and nonprofit communications for more than a decade.
Most recently, Ramsay handled media and public relations for the
advocacy organization DC Vote. Previously she worked on the other side of the
media aisle, in documentary production for National Geographic, the Smithsonian
Channel and Discovery Networks, and as a writer online for
DC Style and
Metromix.com.
A graduate of the Catholic University of America with a degree in
Media Studies, Ramsay also worked with prominent independent filmmakers in
Washington, helping to produce
Yoo-Hoo, Mrs. Goldbergwith
Aviva Kempner and interning with Charles Guggenheim on his final film,
Berga:
Soldiers of Another War. This independent film production experience
included fundraising, skills she will use at the Berman Institute.
In addition, Ramsay will work with faculty members to share their
research news internally and externally, as well as contribute to social media
and Web-based communications.
About the Johns Hopkins Berman Institute of
Bioethics One of the largest centers of its kind in the world, the Johns
Hopkins Berman Institute of Bioethics is the home for collaborative scholarship
and teaching on the ethics of clinical practice, public health and biomedical
science at Johns Hopkins University. Since 1995, the Institute has worked with
governmental agencies, nongovernmental organizations and private sector organizations
to address and resolve ethical issues. Institute faculty members represent such
disciplines as medicine, nursing, law, philosophy, public health and the social
sciences. Their work helps anticipate and inform debates on complex moral
challenges, discern ethically acceptable alternatives in medical, scientific
and public health policy and help to prepare the next generation of
bioethicists. More information is available at www.bioethicsinstitute.org.
Ethical Issues Raised in Addressing the Needs of People With Serious Mental Disorders in Complex Emergencies
Friday, January 06, 2012
Ethical Issues Raised in Addressing the Needs of People With Serious Mental Disorders in Complex Emergencies
Recent manmade and natural disasters highlight weaknesses in the public health systems designed to protect populations from harm and minimize disruption of the social and built environments. Emergency planning and response efforts have, as a result, focused largely on ensuring populations' physical well-being during and after a disaster. Many public health authorities including the World Health Organization, have recognized the importance of addressing both mental and physical health concerns in emergency plans. Individuals with mental disorders represent a notable proportion of the overall population, and anticipating their needs is critical to comprehensive emergency planning and response efforts. Because people with serious mental disorders historically have been stigmatized, and many individuals with mental disorders may be unable to care for themselves, ethical guidance may be of assistance to those engaged in emergency planning and response. This article considers several broad categories of ethical issues that arise during emergencies for people with serious mental disorders and offers recommendations for ways in which emergency planners and other stakeholders can begin to address these ethical challenges.
Dementia is a leading cause of death in the United States. This article outlines the current understanding of advanced dementia and identifies research priorities for the next decade. Research over the past 25 years has largely focused on describing the experience of patients with advanced dementia. This work has delineated abundant opportunities for improvement, including greater recognition of advanced dementia as a terminal illness, better treatment of distressing symptoms, increased access to hospice and palliative care services, and less use of costly and aggressive treatments that may be of limited clinical benefit. Addressing those opportunities must be the overarching objective for the field in the coming decade. Priority areas include designing and testing interventions that promote high-quality, goal-directed care; health policy research to identify strategies that incentivize cost-effective and evidence-based care; implementation studies of promising interventions and policies; and further development of disease-specific outcome measures. There is great need and opportunity to improve outcomes, contain expenditures, reduce disparities, and better coordinate care for the millions of persons in the United States who have advanced dementia.
Extremely premature infants face multiple acute and chronic life-threatening conditions. In addition, the treatments to ameliorate or cure these conditions often entail pain and discomfort. Integrating palliative care from the moment that extremely premature labor is diagnosed offers families and clinicians support through the process of defining goals of care and making decisions about life support. For both the extremely premature infant who dies soon after birth and the extremely premature infant who experiences multiple complications over weeks and months in the neonatal intensive care unit, palliative care can maintain a focus on infant comfort and family support. This article highlights the ways in which palliative care can be incorporated into intensive care for all critically ill infants.
Presidential Commission Calls For Better Oversight of Human Subjects Research
Thursday, December 15, 2011
Johns Hopkins Berman Institute of Bioethics
Media Contact: Leah Ramsay
410-614-5381; cell: 202-642-9640 Lramsay@jhu.edu
Dec. 15, 2011
FOR IMMEDIATE RELEASE
PRESIDENTIAL COMMISSION CALLS FOR BETTER OVERSIGHT OF HUMAN SUBJECTS RESEARCH
The Presidential Commission for the Study of Bioethical Issues released its report “Moral Science: Protecting Participants in Human Subjects Research” today, recommending changes to better protect research volunteers.
Primary among the Commission’s recommendations was to organize and make public the data on federally-funded human subject research. The Commission reports that in Fiscal Year 2010 the government funded over 55,000 projects involving human subjects across 18 agencies and departments, but was unable to readily access comprehensive information about this type of research.
“The Commission’s work in mapping the type of research supported by the federal government is unprecedented and was an important initial step in conducting its work,” says Jeremy Sugarman, M.D., M.P.H., M.A., Senior Advisor to the Commission and the Deputy Director for Medicine at the Johns Hopkins Berman Institute of Bioethics.
President Barack Obama requested the report in response to the discovery in October 2010 that, from 1946 to 1948, the U.S. Public Health Service conducted experiments in Guatemala that intentionally exposed thousands of people to sexually-transmitted diseases. President Obama asked the Commission to “determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government,” as well as to conduct a thorough investigation of the experiments in Guatemala. The findings of the historical investigation were published in September 2011 in the report “Ethically Impossible - STD Research in Guate mala 1946 to 1948.” (For more information, see http://bioethics.gov/cms/sites/default/files/Ethically-Impossible_PCSBI.pdf )
“Although serious human rights abuses like the Guatemala and human radiation experiments are unlikely to occur today, the government must continue to be held accountable for the ethics of the research it funds on human subjects,” says Ruth Faden, Ph.D., Director of the Johns Hopkins Berman Institute of Bioethics and chair of the Presidential Advisory Committee on the Human Radiation Experiments, which led to the first Presidential apology for unethical human subjects research by President Clinton in 1995. “The government can’t be held accountable for what it can’t count, which is why this report’s findings that there are major gaps in the extent and nature of the landscape of federally funded human research is of singular importance,” Faden adds.
The Commission also made recommendations regarding compensation for injuries sustained during research, the appropriate design of research and the need for education about the ethical underpinnings of the current regulations.
“The Commission's recommendations for a publicly-accessible database of federally funded human subjects research is an important acknowledgment of the real lesson from Guatemala, which is that transparency and oversight are essential to the acceptable conduct of medical research,” notes Dan O’Connor, Ph.D., a faculty member at the Johns Hopkins Berman Institute of Bioethics who specializes in the history of medicine and bioethics.
The Commission also recommended that the federal government take steps to assess the effectiveness of the current systems used to protect human subjects. Sugarman notes that “such assessments will be essential going forward so that we can continue to improve how valuable research is conducted while maximally attending to the rights and welfare of those who volunteer to participate as research subjects.”
FOR COMMENT from Sugarman, Faden or O'Connor, contact Leah Ramsay at 410-614-5381; cell 202-642-9640; Lramsay@jhu.edu
Institute of Medicine Committee Chaired By Johns Hopkins Bioethicist Calls For an End to Most Research on Chimpanzees
Thursday, December 15, 2011
December 15, 2011
Johns Hopkins Berman Institute of Bioethics
Media Contact: Leah Ramsay, 202-642-9640; c: 202-642-9640
Lramsay@jhu.edu
FOR IMMEDIATE RELEASE
INSTITUTE OF MEDICINE COMMITTEE CHAIRED BY JOHNS HOPKINS BIOETHICIST CALLS FOR AN END TO MOST RESEARCH ON CHIMPANZEES
Washington - In a report released today on the use of chimpanzees in biomedical and behavioral research, the Institute of Medicine (IOM) of the National Academies of Science called for a dramatic shift away from federally-funded experimentation on humanity's closest relative in the animal kingdom.
The report, titled "The Use of Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity," concludes that scientific advances now provide effective alternatives to the use of chimpanzees, and that "most current use of chimpanzees for biomedical research is unnecessary." The IOM conducted a study of the use of the animals in research in collaboration with the National Research Council and at the request of the National Institutes of Health (NIH), which has financed the majority of federally supported experimentation with chimps."
We were charged with determining if chimpanzees are necessary for the success of current and future research, and we set a high bar for determining that necessity with uniform criteria," said the IOM committee chair Jeffrey Kahn, Ph.D., M.P.H., Deputy Director of the Johns Hopkins Berman Institute of Bioethics. "In almost all cases, we found that research on chimpanzees was not necessary."
The committee stopped short of recommending an end to all research on chimpanzees, finding sufficient cause for continued work in three specific areas:
1. Comparative studies of chimpanzee and human brain function
2. Studies, in the short term, on monoclonal antibodies which precisely target viruses and bacteria, until recombinant technologies can fully replace the chimpanzee
3. Development of a prophylactic Hepatitis C vaccine, an issue which evenly split the committee over whether a challenge study is necessary in such vaccine development since such research could not ethically be performed in humans. The Hepatitis C virus only infects humans and chimpanzees.
The United States and Gabon are the only the only countries known to allow invasive research on chimpanzees. Though the European Union has an exception for using chimpanzees in the event of 'a serious pandemic,' no EU nation keeps chimpanzees in captivity or conducts research on them.
"The IOM's recommendations bring us closer to the ethically correct policy of not allowing any invasive research on chimpanzees," said Ruth Faden, Ph.D., Director of the Johns Hopkins Berman Institute of Bioethics. "With these new criteria, the government can begin phasing out its support of this research," Faden added.
Kahn, the only bioethicist on the Committee, noted the challenge of chimpanzee research. "Chimpanzees are attractive research subjects for the same reason that conducting research on them is ethically troubling," he said. "They are humans' closest genetic relative, with immune systems that are nearly indistinguishable from ours," Kahn added. "However, this close relationship also creates a high moral cost, which the Committee agrees must be factored into the assessment of the necessity of any research involving chimpanzees."
FOR COMMENT from Kahn or Faden, contact Leah Ramsay at
INSTITUTE OF MEDICINE COMMITTEE CHAIRED BY JOHNS HOPKINS BIOETHICIST TO REPORT ON THE USE OF CHIMPS IN MEDICAL RESEARCH
WHAT: The Institute of Medicine of the National Academies will hold a public briefing to release its report, "The Use of Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity." The committee releasing the report is chaired by Jeffery Kahn, Ph.D., Deputy Director for Policy and Administration at the Johns Hopkins Berman Institute of Bioethics.
WHEN: December 15, 2011, 11:00 a.m. - 12:00 p.m.
WHERE: Institute of Medicine
Keck Center, Room 100
500 Fifth St. NW
Washington, DC
AVAILABILITY:
Kahn will be in Washington, DC, December 12-16 and be available to speak with news media after the briefing Thursday and on Friday, December 16th, from 8:30 – 10:30 a.m. and 2:00 – 5:00 p.m.
Hilary Bok, Ph.D., Henry R. Luce Professor of Bioethics and Moral & Political Theory at the Johns Hopkins Berman Institute of Bioethics, will comment on the report after its release. See the Berman Institute's online bulletin: http://bioethicsbulletin.org/.
Ruth Faden, Ph.D., Director of the Johns Hopkins Berman Institute of Bioethics, will be available for comment on the report after 11:00 a.m. Thursday, December 15.
NEWS MEDIA CONTACT: Leah Ramsay at 410-614-5381; cell 202-642-9640
Lramsay@jhu.edu
Bioethicist Ruth Faden To Receive Lifetime Achievement Award from PRIM&R
Friday, December 02, 2011
Johns Hopkins Berman Institute of Bioethics
Media Contact: Leah Ramsay, 202-642-9640; Lramsay@jhu.edu
December 2, 2011
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FOR IMMEDIATE RELEASE FRIDAY, DECEMBER 2
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BIOETHICIST RUTH FADEN TO RECEIVE LIFETIME ACHIEVEMENT AWARD FROM PRIM&R
Ruth Faden, Ph.D., MPH, founding director of the Johns Hopkins Berman Institute of Bioethics, is a co-recipient with her husband, bioethicist Tom L. Beauchamp, Ph.D., of the Lifetime Achievement Award for Excellence in Research Ethics from Public Responsibility In Medicine and Research (PRIM&R).
The award, to be presented December 3 at the 2011 Advancing Ethical Research (AER) Conferenceat the Gaylord Hotel in National Harbor, MD, is given for work that "has embodied a unique and profound commitment to advancing research ethics." Past recipients include Jay Katz (2001), Charles McCarthy (2003), Robert Levine (2005) and Al Jonsen (2009). "Ruth and Tom are respected leaders, visionary thinkers, and role models to us all,” said Joan Rachlin, PRIM&R's executive director. “Those in the bioethics field have already benefited, and will continue to benefit, from their individual and collective wisdom and experience," she added.
In addition to her leadership of the Berman Institute since 1995, Faden is the Philip Franklin Wagley Professor of Biomedical Ethics; Professor, Department of Health Policy and Management, the Johns Hopkins University Bloomberg School of Public Health; and Professor, Department of Medicine, the Johns Hopkins University School of Medicine. “I am thrilled to be a recipient of this award,” said Faden, who taught what is believed to be the first public health ethics course in the country. “It is an extraordinary honor, and extraordinary to be sharing it with my husband. Scholarship on the ethics of research is one of the core strengths of the Berman Institute, and if my work is worthy of recognition it is because I have such wonderfully talented colleagues,” she added.
Among their extensive collaborative work and individual achievements, Faden and Beauchamp co-authored
A History and Theory of Informed Consent (Oxford University Press, 1986), which is still widely regarded as the most authoritative and comprehensive canon on informed consent. In October 2011, Faden was honored with a Lifetime Achievement Award from the American Society for Bioethics and Humanities for her work on social justice issues in health policy.
“I can think of no more fitting recipients of the PRIM&R Lifetime Achievement Award than Ruth Faden and Tom Beauchamp,” noted Jeffery Kahn, Ph.D., who joined BI as Deputy Director for Policy and Administration earlier this year and was formerly director of the bioethics program at the University of Minnesota medical school. “Their scholarship in the ethics of research on human subjects is the most important of the last thirty years, and a testament to the power of collaboration by two scholars of immense individual talent and insight.” Kahn said their “seminal book on informed consent is as fresh and relevant today as it was when it was published in 1986, and is but one example of their landmark contributions to our field."
The mission of the Johns Hopkins Berman Institute of Bioethics is to conduct advanced scholarship on the ethics of clinical practice, biomedical science and public health, both locally and globally, and to engage students, trainees, the public, and policy-makers in serious discourse about these issues. Established in 1995, the Berman Institute is now one of the largest centers of its kind in the world, featuring more than 30 core and affiliated faculty from the Johns Hopkins School of Medicine, School of Nursing, Bloomberg School of Public Health, and the Krieger School of Arts and Sciences. Faculty work collaboratively on scholarship and teaching in the Institute’s five areas of focus: biomedical research and discovery, ethics of clinical practice, public health ethics and health policy, research ethics, and global health ethics and research.
Participants' Perceptions of Research Benefits in an African Genetic Epidemiology Study
ABSTRACT
Background: Both the Council for International Organization of Medical Sciences and the Helsinki Declaration emphasize that the potential benefits of research should outweigh potential harms; consequently, some work has been conducted on participants' perception of benefits in therapeutic research. However, there appears to be very little work conducted with participants who have joined non-therapeutic research. This work was done to evaluate participants' perception of benefits in a genetic epidemiological study by examining their perception of the potential benefits of enrollment.
Methods: In-depth interviews lasting between 45 and 60 minutes were conducted with a convenient sample of 25 ill patients and 25 healthy accompanying relatives enrolled in a genetic epidemiological study of tuberculosis. Recorded interviews were transcribed and analyzed using content analysis.
Results: Participants perceived that research was beneficial and some of the benefits included the generation of new knowledge, finding the cause of diseases, as well as the control, eradication and prevention of disease. Some thought that research was risky whilst others thought that the benefits outweighed the risks.
Conclusion: Participants perceived research to be beneficial and most of them thought that, though it was risky, the benefits outweighed the risks. It is our view that researchers need to give serious consideration to participant's perception of benefits in designing their consent forms, to see to the fulfillment of achievable goals.
In an unusual move, an international coalition of flu researchers agreed last week to a hiatus on work surrounding a highly contagious, mammal-adapted version of the avian influenza virus. Research on transmissible H5N1 flu will halt, and two manuscripts describing how to modify the virus won’t be published, at least not yet.
The voluntary pause came a few weeks after an American advisory panel recommended censoring the research in the name of security. So it raises an interesting question — is some research just too dangerous to pursue? Not just for the scientists conducting it, but for the public in a post-9/11 world?
...
“There are always concerns about misuse of the products of research,” said Jeffrey Kahn, deputy director of the Berman Institute of Bioethics at Johns Hopkins University. “Think about nanotechnology as another example, or genetically modified food. We like the benefits of these new technologies, but we always worry about he misuse, the misapplication, or the unintended consequences. The trick is, how do we oversee and prevent problematic outcomes, while still realizing the benefits of the technology?”
human subjects protections and the meaning of ‘what happened in Guatemala’
By Dan O’Connor, PhD
Earlier today, President Obama’s bioethics commission released, “Moral Science“, their report on protections for human research subjects. The report was inspired by historian Susan Reverby’s expose of a 1940s research study, funded by the US government, which saw the deliberate infection of prisoners in Guatemala with syphillis. The question the report seeks to answer is, essentially,
could this happen again?
To this, commission Chair, Prof Amy Gutmann, responds: “The Commission is confident that what happened in Guatemala in the 1940s could not happen today.”
This is perhaps unsurprising, given the vast changes that have taken place in human subjects research protections since the 1940s. The 1950s saw the growth of internal hospital oversight committees, as well as the emergence of the ‘gold standard’ clinical trial – both of which developments placed constraints on the unfettered freedom of the physician researcher. The 1960s, of course, saw the first stirrings of public scandal around human experimentation – most obviously in Henry Beecher’s classic list of unethical research studies – and the federal government’s linking of funding to the existence of Institutional Review Boards. The 1970s saw the greatest scandals – Tuskegee, Willowbrook, DepoProvera – and a concerted legislative effort to regulate the conduct of research and the ethics which guide it. This culminated, in this truncated history at least, in the publication of the
Belmont Report and the enshrinement of the holy trinity of informed consent, risk/benefit balance and fair subject selection in federal regulations regarding human subjects research. Since
Belmont, ‘research ethics’ has emerged as a professional speciality within the law and public health and, most obviously, within bioethics itself. The regulatory apparatus that now surrounds human subjects research in the United States is vast, encompassing tens of thousands of lawyers, nurses, ethicists, physicians, pharmacists, community representatives, consent form specialists and compliance officers. Indeed, it would be
verysurprising if the president’s bioethics commission had come to any other conclusion than that to which they came.
In an unprecedented move yesterday the US Secretary of Health and Human Services, Kathleen Sebelius, invoked her authority to override the recommendations of the Food and Drug Administration (FDA) and denied approval for the Plan B “morning-after pill” contraceptive to be made available to women of any age without a prescription.
FDA Commissioner Margaret Hamburg, MD, issued a press release laying out her disagreement but legally mandated compliance with Sebelius’ decision, creating a rare public conflict between government officials in what is usually an arcane bureaucratic process.
Renee Boss, MD, MHS, a faculty member at the Johns Hopkins Berman Institute of Bioethics, said the facts support Hamburg and the FDA’s position. “Nearly half of all girls in the US report that they have had sexual intercourse by age 17, with a higher rate among girls who are depressed, abuse drugs or alcohol, have poor relationships with their parents or who have limited supervision,” Boss said. “Of those girls under 17 who are sexually active, nearly one-third do not use any form of contraception, a number significantly higher than for older women,” she added.
Boss also noted the inequity of the regulation affecting only girls, and the long-lasting negative impact of a teenage pregnancy. “Boys who have unprotected sex may be able to avoid the consequences of unwanted pregnancy –girls cannot. Girls who become pregnant as adolescents are more likely to drop out of school, to become pregnant again as adolescents, and to live in a cycle of poverty,” Boss said.
In her press release Sebelius cited the need for “enough evidence to show that those who use this medicine can understand the label and use the product appropriately.” That evidence was not supplied to her satisfaction. “The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use,” Sebelius said.
Boss, however, said there is lack of evidence that girls under 17 cannot understand the labeling. “There are no data to support the claim that girls under 17 years old will not be able to administer the medication as directed,” Boss said. “Plan B has been shown to be safe for girls as young as 11 years old. Disregarding scientific evidence in the name of politics and paternalism is a practice that should not be tolerated. The $50 price tag that comes with Plan B is already a barrier enough.”
The health status of elected officials is in the news again. Gov. Chris Christie of New Jersey is the latest name to be mentioned as a potential republican candidate for president, but along with the enthusiasm are murmurs about whether his weight is a liability.
As Eugene Robinson outlines in his recent op-ed in the Washington Post, obesity is bad for individual health as well as health care costs, and the negative effects are multiplied as the proportion of Americans who are obese increases to epidemic proportions. However, leaping from those facts to assertions about whether the Governor is a “fit” candidate or how he ought to get serious about losing weight doesn’t do much to address the public health issues or enlighten the debate about fitness for high office. And it begs the bigger questions. Discussion of the medical fitness of candidates is nothing new. Dick Cheney’s longstanding challenges with heart disease raised concerns over the course of his political career, and controversy over disease past and present have dogged candidates from Richard Nixon to Thomas Eagleton to Paul Tsongas. Gov. Christie’s case carries an added dimension in that whatever his known health issues may be, there are perceptions that someone clearly overweight is inherently less healthy than someone who appears more fit. Looks can be deceiving, however–high blood pressure, dangerous cholesterol levels, or susceptibility to cancer are invisible.
There is a clear and reasonably uncontroversial basis for a simple theory of justice that all nations/cultures can accept. This is grounded a few core values about human development and is expressed in theUniversal Declaration of Human Rights, the Millenium Development Goals, and other founding documents of the United Nations. This conception emphasizes several key values:
equal worth of all persons
value of freedom
value of democracy and self-determination
the injustice of hunger, lack of education, lack of healthcare
the injustice of capricious arrest and state violence (illegality)
A study says clinical trial forms that run 20-plus pages are difficult to understand, and that medical liability fears may be prompting too many warnings.
Despite years of guidelines urging simpler and easier-to-understand informed-consent documents, the forms given to clinical trial participants remain too long and use language that is too complex.A review of 124 informed-consent documents used in 21 HIV clinical trials sponsored by the National Institutes of Health's Division of AIDS found that the forms were typically written above the ninth-grade level and ran longer than 22 pages. The findings were published online July 6 in the Journal of General Internal Medicine(www.ncbi.nlm.nih.gov/pubmed/21748435/).
"Very few people are going to sit down and read a document that's that long, and the goal is to have people understand," said Nancy Kass, ScD, lead author of the study. "The whole reason for putting [informed consent] in writing is with the belief that someone will read it. The longer it is, the less likely people are to read it all the way through, and then you have defeated your own purpose."
In 1998, the National Cancer Institute recommended that consent forms be written at an eighth-grade level. The institute also advised that forms be shortened, with further details provided through information sheets and explanatory videos. Most institutional review boards also recommend that consent forms be written at or below the eighth-grade level, as measured by the Flesch-Kincaid readability test.
Shorter, more readable forms are especially important when providing informed consent to participants with poor health literacy skills, said Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics in Baltimore.
Kass and her colleagues studied 21 "template" forms used in multisite trials, and they were typically shorter -- 16.8 pages long -- and more readable, scoring at the 8.7-grade level. But by the time 103 trial sites around the world were done making changes to these template forms, they ran nearly 24 pages and had a 9.4-grade level readability score.
Faculty research scientist Joseph Ali named one of Baltimore's "10 People to Watch Under 30"
~
theb
Joseph Ali, coordinator of the Berman Institute's
Fogarty African Bioethics Training Program, is featured in the tabloid's second annual "10 People to Watch Under 30." The 29-year-old resident of northeast Baltimore has been with the institute since 2007.
"I am drawn to doing something that's concrete, that's improving other people around me," Ali told the
b. "And to do that in an environment where I'm constantly learning."
Core faculty members Jeremy Sugarman and Steven Goodman are among
various experts quoted in the Feb. 12 article "Risk
and Reward in Utero," about the ethical challenges presented by a
clinical trial comparing the effectiveness of fetal surgery to treat
spina bifida, versus surgery after birth.
Much of the response to the shootings in Tucson, Ariz., has already shifted to debate over whether hateful political talk should be blamed or absolved. It would seem a needless discussion in the country where Revolutionary War planter Charles Lynch's name became a synonym for taking the law into your own hands.
But the shootings do point out the need for another, urgent discussion, and it is entirely apolitical. Even more clearly than in other high-profile cases of assaults by young men, accounts of Jared Loughner's prior behavior strongly suggest that he was psychotic — not just "wacky," but having a definable, treatable mental illness.
No one can make a diagnosis from a few details in a newspaper article — it is hard enough in person — but an outline of the possibility emerges. A young person (the peak age for onset of schizophrenia and manic-depressive illness is in the late teens and early 20s) gradually becomes more withdrawn, suspicious of others, and frankly, starts to say things that don't make sense. The New York Times quotes his response to a straightforward classroom math question as, "How can you deny math instead of accepting it?"...
Deputy director quoted in today's issue of
Science Magazine Dec. 3, 2010
Jeremy Sugarman, deputy director for medicine at the Berman Institute, says HIV prevention scientists are ready to grapple with the ethical challenges faced by the promising and surprising AIDS prevention
pill in the Pre-Exposure Prophylaxis Initiative (iPrEx) study.
The Second Wave Initiative, working toward the responsible inclusion of pregnant women in medical research, is seeking help in getting support/signatures from members of congress for a letter to DHHS Secretary Sebelius expressing concern at the lack of attention to improving guidance on research with pregnant women.
To learn more and offer your assistance -- click here
DEADLINE: JANUARY 9!
Bioethics Intensives
The Johns Hopkins Berman Institute of Bioethics announces a new summer educational program. You’re invited to join us for several week-long summer courses in bioethics. More information about course offerings can be found here.
A report issued yesterday by a committee of the Institute of Medicine held that most research on chimpanzees is unnecessary, and set forth stringent guidelines for any future federally funded research:
“1. The knowledge gained must be necessary to advance the public’s health;
2. There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed on human subjects; and
3. The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments or in natural habitats.”
Specifically, while the committee did not rule out the possibility that the treatment, prevention, or control of some future disease might require research on chimpanzees, the use of chimpanzees might be warranted in only two forms of ongoing research. First, while the development of future monoclonal antibodies will not require the use of chimpanzees, “there may be a limited number of monoclonal antibodies already in the developmental pipeline that may require the continued use of chimpanzees.” Second, the committee was evenly divided on the question whether the use of chimpanzees was necessary for the development of a prophylactic Hepatitis C vaccine. In all other cases, the committee held that present biomedical research on chimpanzees is unnecessary, and that the National Institutes of Health should not support it.
The committee held that behavioral research should be performed only when the following two criteria are met:
“1. Studies provide otherwise
unattainable insight into comparative genomics, normal and abnormal behavior, mental health, emotion, or cognition; and
2. All experiments are performed on acquiescent animals, using techniques that are minimally invasive, and in a manner that minimizes pain and distress.”
Institute of Medicine Committee Chaired By Berman Institute Deputy Director, Jeff Kahn, Calls For an End to Most Research on Chimpanzees
In a report released today on the use of chimpanzees in biomedical and behavioral research, the Institute of Medicine (IOM) of the National Academies of Science called for a dramatic shift away from federally-funded experimentation on humanity’s closest relative in the animal kingdom.
The report, titled “The Use of Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity,” concludes that scientific advances now provide effective alternatives to the use of chimpanzees, and that “most current use of chimpanzees for biomedical research is unnecessary.” The IOM conducted a study of the use of the animals in research in collaboration with the National Research Council and at the request of the National Institutes of Health (NIH), which has financed the majority of federally supported experimentation with chimps.”
We were charged with determining if chimpanzees are necessary for the success of current and future research, and we set a high bar for determining that necessity with uniform criteria,” said the IOM committee chair Jeffrey Kahn, Ph.D., M.P.H., Deputy Director of the Johns Hopkins Berman Institute of Bioethics. “In almost all cases, we found that research on chimpanzees was not necessary.”
The committee stopped short of recommending an end to all research on chimpanzees, finding sufficient cause for continued work in three specific areas:
1. Comparative studies of chimpanzee and human brain function
2. Studies, in the short term, on monoclonal antibodies which precisely target viruses and bacteria, until recombinant technologies can fully replace the chimpanzee
3. Development of a prophylactic Hepatitis C vaccine, an issue which evenly split the committee over whether a challenge study is necessary in such vaccine development since such research could not ethically be performed in humans. The Hepatitis C virus only infects humans and chimpanzees.
The United States and Gabon are the only the only countries known to allow invasive research on chimpanzees. Though the European Union has an exception for using chimpanzees in the event of ‘a serious pandemic,’ no EU nation keeps chimpanzees in captivity or conducts research on them.
“The IOM’s recommendations bring us closer to the ethically correct policy of not allowing any invasive research on chimpanzees,” said Ruth Faden, Ph.D., Director of the Johns Hopkins Berman Institute of Bioethics. “With these new criteria, the government can begin phasing out its support of this research,” Faden added.
Kahn, the only bioethicist on the Committee, noted the challenge of chimpanzee research. “Chimpanzees are attractive research subjects for the same reason that conducting research on them is ethically troubling,” he said. “They are humans’ closest genetic relative, with immune systems that are nearly indistinguishable from ours,” Kahn added. “However, this close relationship also creates a high moral cost, which the Committee agrees must be factored into the assessment of the necessity of any research involving chimpanzees.”
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Jeremy Sugarman
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