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Ethics and the standards of prevention in HIV prevention trials
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Thursday, August 26, 2010
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Taking a hard look at successes and failures in HIV prevention research is essential. Accordingly, the excellent comprehensive review of randomized trials of interventions aimed at protecting from the sexual transmission of HIV that Padian et al. [1] recently reported in AIDS is a most welcomed addition to the literature. As pointed out in their review, although it is critical to applaud thesmall numerator of successful trials, it is also important to evaluate carefully the much larger denominator of trials that were ‘flat’.
On the basis of their review, the authors conclude that flat trials ‘are attributable, at least in part, to issues related to trial design, implementation, or both’ ([1], p. 631). The authors pay particular attention to the selection of the control arm. Although this issue is of profound importance from the perspective of trial design, it also raises fundamental ethical considerations, among others, related to both the need for equipoise among the arms of the trial as well as designing trials which promise to be informative. Such considerations should be useful in taking the lessons learned from this recent review forward into the HIV prevention arena. ...
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Genetics and Public Policy Center to study genetic researchers’ views on their work
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Thursday, August 26, 2010
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The National Human Genome Research Institute (NHGRI) has awarded the Genetics and Public Policy Center a two-year grant to examine the views and practices of genetic researchers who collect and study banked human DNA. The center will work in collaboration with the Institute for Public Health Genetics at the University of Washington.
A part of the Johns Hopkins Berman Institute of Bioethics, the Genetics and Public Policy Center (GPPC) was awarded the grant on Aug. 13 and has begun work on this new study. Headed by Dave Kaufman, the center’s director of research and statistics, the study will systematically measure the attitudes, preferences and actual practices of geneticistsaround issues of informed consent, data sharing, privacy and the return of research results to participants.
“The use of large genomic biobanks and the number of researchers who rely on them are increasing rapidly,” Kaufman said. “Understanding researchers’ views about the current landscape of biobank research will help policymakers and scientists as they design new studies and develop research guidelines.”
Kaufman added that considering perspectives of the human genetics community should help to both maximize the scientific benefits of biobanks and ensure that such work is conducted ethically.
This study will build on the GPPC’s Public Consultation Project, an ongoing investigation of public attitudes toward participation in population-wide genetic research to examine the role of genes and environment in human health.
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The burden of emergency department use for sickle-cell disease: An analysis of the national emergency department sample database
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Wednesday, August 25, 2010
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It is estimated that there are 100,000 people living with sickle-cell disease (SCD) in the United States [1]. The most common manifestation of SCD is vaso-occlusive crisis, which is characterized by intermittent, unexpected episodes of excruciating pain. As these episodes often come on suddenly, much of the care for these crises occurs within emergency departments (EDs). Several studies have examined ED use and costs for certain groups of patients with SCD [2–4]. For example, in 1997, Woods et al. [2] found that 85.7% of 7,202 hospital admissions for SCD in Illinois were for patients that came through the ED, and the total charges for sickle-cell admissions in Illinois were found to be $30 million a year. A recent study of healthcare use by children with SCD demonstrated that children insured by Medicaid had higher ED utilization than those with private insurance (57% vs. 45%) [5]. The purpose of our study was to provide national level estimates of ED utilization by SCD patients, which have not previously been available.
There were a total of 50,418 ED visits for patients with SCD sampled in the Nationwide Emergency Department Sample (NEDS) in 2006. This represents a national estimate of 232,381 ED visits. There were an estimated 188,194 (81%) adult ED visits and 44,188 (19%) pediatric (<18 years) visits. The characteristics of the sickle-related ED visits in 2006 is shown in Table I.
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The Ethical Review of Health Care Quality Improvement Initiatives: Findings from the Field
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Thursday, August 19, 2010
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Authors
Holly A. Taylor, Ph.D., M.P.H., Peter J. Pronovost, M.D., Ph.D., Ruth R. Faden, Ph.D., M.P.H., Nancy E. Kass, Sc.D., and Jeremy Sugarman, M.D., M.P.H., M.A.
Overview
Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assessment of the proposed QI initiative.
Downloads
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Berman Institute scholar calls for consistent regulation of direct-to-consumer genetic tests
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Wednesday, August 11, 2010
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 Commentary in Aug. 12 issue of Nature provides framework and concrete examples for F.D.A. to follow
An opinion piece by a legal scholar from the Johns Hopkins Berman Institute of Bioethics in this week’s issue of Nature calls for the Food and Drug Administration to regulate all health-related genetic tests — whether available directly to consumers or through a health care provider — using an approach that imposes requirements proportionate to a test’s level of risk.
“‘Direct to consumer’ is simply a delivery method that in itself provides no information about the quality of the test offered,” writes Gail Javitt, J.D., M.P.H., a research scholar at the Berman Institute. Instead of treating direct-to-consumer (DTC) genetic testing as a “special case,” Javitt argues that the F.D.A. should implement a regulatory framework that ensures the quality of all health-related genetic tests.
“Some genetic tests are likely to be comparable to pregnancy tests,” which the F.D.A. considers to be low-risk medical devices that consumers may purchase over the counter, according to Javitt. She adds that other genetic tests, such as those used to diagnose or guide decisions about the treatment of serious diseases, would be more appropriately offered through a health care practitioner.
Javitt also argues that more oversight is needed to ensure the clinical validity of some of the newer, more complex tests offered by clinical laboratories.
“In such a fast-changing landscape, striking the right balance between protecting the public and promoting innovation is crucial,” Javitt concludes. “To get it right, agencies must proceed in small steps, articulate clear goals and rationales for their proposed actions, and consider input from all those affected.”
Javitt’s article, “Assign regulation appropriate to the level of risk,” appears alongside another commentary in the same issue of Nature by Arthur Beaudet, a professor and chair of the Department of Molecular and Human Genetics at Baylor College, in Houston. His piece urges the F.D.A. to ban all DTC tests, but to not impose new regulations on clinical labs offering genetic testing through health care providers.
Both scholars agree that the evolving understanding of the significance of certain genetic markers — along with the rapid pace of research and discovery — make the results of genetic tests difficult for both doctors and the public to accurately interpret. The magazine says it published the expert commentaries in the wake of recent actions by the F.D.A. that signal the agency’s desire to increase oversight of laboratory-developed tests — in particular, those offered directly to consumers.
According to Javitt, the former law and policy director at the Berman Institute’s Genetics and Public Policy Center, about 30 companies worldwide offer more than 400 genetic tests direct to consumers. In May, the center published several charts listing DTC tests — sorted by company, disease and category.
Click here to access the charts online.
Media contact: Michael Pena
410-625-7872; mpena@jhsph.edu |
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Carlton Haywood Jr. awarded grant to study patients' opinions of 'opioid agreements'
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Friday, August 06, 2010
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 The Berman Institute’s
Carlton Haywood Jr. has been awarded $20,000 by the Blaustein Pain Research Fund to study how patients with sickle cell disease feel when caretakers ask them to agree to certain terms prior to receiving opioids for pain management.
Physicians around the country are increasingly asking patients with chronic, non-cancer pain to abide by “opioid agreements” or “opioid contracts” in the wake of growing scrutiny over prescribed narcotics. The excessive use of potentially addictive drugs such as OxyContin has placed intense pressure on doctors to practice caution when prescribing them.
But in reviewing published research on the use of opioid agreements, Haywood said none asked patients with chronic pain how they feel about the use of these documents. The studies also didn’t examine how being asked to sign such contracts might affect the amount of trust and respect that patients feel toward their caretakers.
“We are attempting to rectify this important gap,” says Haywood, an associate faculty member at the Johns Hopkins Berman Institute of Bioethics.“If these documents are to be utilized, we feel that their content should be informed by the perspective of the patients who ultimately will be asked to sign them and adhere to their rules.”
Although the development of research protocols has just begun, the grant money will be used to conduct exploratory, descriptive and qualitative research on three focus groups. Haywood and his team also plan to explore the possibility of differences in attitudes about opioid agreements due to patient gender—as well as do preliminary work on a questionnaire that can be used to gather more precise data in future research in this area.
The
Blaustein Pain Research Fund, housed at the Johns Hopkins University School of Medicine, awards grants through a committee consisting of pain researchers and faculty at the school.
Media Contact: Michael Pena
410-625-7872;
mpena@jhsph.edu
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Bioethicist's talks commemorate centennial of sickle cell disease
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Wednesday, August 04, 2010
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Carlton Haywood Jr., also a sickle cell patient, focuses on the role of race in the doctor-patient relationship
Carlton Haywood Jr., Ph.D., an associate faculty member of the Johns Hopkins Berman Institute of Bioethics, will mark the 100-year anniversary of the discovery of sickle cell anemia on Wednesday, Aug. 4, with a talk on the impact that race has had on the history of research and treatment of the inherited blood disorder.
In the United States, sickle cell anemia is mostly observed in African-Americans and Hispanics from the Caribbean and Central and South America. Research suggests that the minority status of the patients has sometimes had a negative impact on care. Haywood, who has sickle cell disease and is an assistant professor of hematology at the Johns Hopkins University School of Medicine, will speak at 8:45 a.m. at the annual convention of the National Medical Association in Orlando, Fla.
In addition to describing his perspective on the role of race in the history of the disease, Haywood plans to discuss how its “racialization” continues to affect sickle cell policy. The most common genetic condition detected by newborn blood screenings in the United States, sickle cell disease occurs in an estimated 1 in 500 African-Americans. About one in every 1,000 to 1,400 Hispanic-Americans is also diagnosed with the disease at birth, while among other racial and ethnic populations, cases are much more rare.
Sickle cell disease is caused by the inheritance of two defective genes — one from each parent who is a carrier — that cause red blood cells to lose their smooth, donut shape and become sharp and rigid. This occurs when hemoglobin releases the oxygen it delivers throughout the body. The cells then get stuck in blood vessels, depriving organs and tissue of oxygen, causing chronic anemia, periodic severe pain, and other life-threatening complications.
Because the “pain crises” can be sudden and excruciating, sometimes the most effective treatments during an emergency are powerful opiates such as morphine. Doctors are very cautious about administering potentially addictive drugs, and many sufferers who return repeatedly for pain relief are sometimes perceived as being addicts. Haywood says issues of race and other socioeconomic factors contribute to the mistrust and rifts in the physician-patient relationship that are common among this patient population.
Working with Mary Catherine Beach, M.D., M.P.H. , also on faculty at the Berman Institute, and other colleagues at Johns Hopkins University, Haywood has published several studies over the past year that seek to identify how trust can be engendered between caretakers and patients with sickle cell disease.
That relationship is the topic of another talk that Haywood will deliver in November at an international conference sponsored by the National Institutes of Health. The James B. Herrick Symposium: 100 Years of Sickle Cell Research will be held in Bethesda, Md., on Nov. 16 and 17.
The event will bring together scientists, practitioners, academics and students to discuss research, unresolved issues and the burdens of sickle cell disease around the world — while exploring the scientific way forward.
Media Contact: Michael Pena
410-625-7872;
mpena@jhsph.edu
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Beyond 'compliance'
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Monday, August 02, 2010
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Academic Medicine 85(8) August 2010
Abstract
Purpose: To contribute data to conceptual explorations of the role of institutional culture in promoting research ethics and integrity.
Method: The authors highlight relevant themes that emerged from a multimodal needs assessment conducted under the Johns Hopkins Clinical Translational Science Award regarding ethical issues encountered in the conduct of clinical and translational research. Qualitative and quantitative data were collected through a short survey targeting research staff, course evaluations from a research ethics and integrity education course attended primarily by faculty and fellows, a review of institutional policies on research ethics education, and in-depth interviews of key administrative officials.
Results: Major themes included the relative influence of regulatory compliance and relationships between research personnel at different levels of the organizational hierarchy on the responsible conduct of research. The majority of respondents (85%) expressed comfort with reporting suspected breaches in research integrity, but the others did not feel comfortable doing so for fear of professional repercussions. Respondents provided insight into factors in the research environment they felt were most helpful in fostering research integrity, particularly with respect to relationships and power differentials between individuals or groups.
Conclusions: Compliance with research regulations is only one of a number of important factors in an institution's ethical culture of research. Equally important are a clear articulation of the ethical reasoning that underlies the regulations, and efforts to redress power imbalances by encouraging open communication. Other ways of improving relationships among various members of the academic research team should be the focus of future investigations.
...Read More |
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Genetics and Public Policy Center Director to Lead Genetics Education Organization for Health Professionals
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Friday, July 30, 2010
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Washington—Joan Scott, director of the Genetics and Public Policy Center (GPPC), will leave Johns Hopkins University to become executive director of the National Coalition for Health Professional Education in Genetics (NCHPEG), effective Sept. 7.
Scott took over as head of the GPPC in 2009 when founder and then-director Kathy Hudson was tapped to become chief of staff to National Institutes of Health Director Francis Collins. The GPPC was founded in 2002 at Johns Hopkins—with support from The Pew Charitable Trusts—to fill an important niche in the science policy landscape, and to focus exclusively on public-policy issues raised by advances in human genetics.
Over the years, the GPPC, a core component of the Johns Hopkins Berman Institute of Bioethics, has become a prominent source of research and policy analysis on genetics.
“I’m very sad to leave the center,” said Scott, “but the important work of the GPPC will continue.” She added, “I am pleased that I will be able to continue to work with Dave Kaufman and other center faculty and staff on their research.”
Kaufman, the center’s director of research and statistics, along with Gail Javitt, the GPPC’s former law and policy director, and Gail Geller, a Berman Institute professor and leading scholar in ethics and genetics, have been named to a strategic planning committee that will develop recommendations about future initiatives for the center. Javitt, who will chair the group, is currently a research scholar at the Berman Institute.
“Under Joan’s leadership, the center has continued to win funding and collect new data about why people want their genetic information, and the attitudes of customers of genetic testing companies who purchased genetic risk profiles online,” Kaufman said.“Joan’s hard workhas set the stage for the center to move forward with its mission.”
Many GPPC research projects are generously supported by the National Human Genome Research Institute’s ELSI (ethical, legal and social implications) Program. Among them are an examination of issues related to direct-to-consumer genetic testing, and an assessment of public attitudes about the expected benefits of participating in genetic research. That study also looks at people’s perspectives on disclosing, receiving and using genetic information collected or discovered as part of a large cohort study.
Scott will continue to be involved in those projects. In addition, Kaufman will be starting new research to examine genetic researcher attitudes and practices about similar issues.
“Joan has been a wonderful leader for the GPPC,” said Ruth Faden, director of the Berman Institute. “Although we are sorry to see her leave, the research being done at the center to shed light on the interface between advances in genetics and health care is even more important today as new discoveries make their way into clinical practice.”
Faden added, “We are committed to making sure that work goes forward.”
For more information, contact Michael Pena at 410-625-7872 or mpena@jhsph.edu. |
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Assessing the Readability of Non-English-Language Consent Forms: The Case of Kiswahili for Research Conducted in Kenya
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Thursday, July 22, 2010
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A large body of literature supports the notion that the language used in informed consent forms is not comprehensible to most research participants. Creating comprehensible informed consent forms for international research presents a further challenge because they are generally written first in English and then translated into the local language. …the aim of this study is to measure and compare the text difficulty in 10 pairs of English informed consent forms and their translated Kiswahili forms. The results show that a readable English-language consent form does not necessarily result in a readable form once translated into Kiswahili.
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The Chronicle of Higher Education, 24 August 2010, By Sophia Li
 In the last days of July, the Food and Drug Administration gave the green light to a clinical trial that has been nearly a decade in the making. The federal agency approved a test of some of the first fruits of human-embryonic-stem-cell research, in a new therapy that could help patients recover from spinal-cord injury.
The trial will be the first to use embryonic stem cells in human beings. The plan was developed by the Geron Corporation, a drug company, which financed the development of the cells in a lab at the University of California at Irvine.
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Many people will be keeping tabs on the trial, says Debra J.H. Mathews, an assistant director of the Johns Hopkins University's bioethics institute. She believes the study will be under intense public scrutiny. If there are negative side effects in the clinical trial, it could influence financing and public support for the entire field,
"They are going to have to be very thoughtful about how they release data," says Ms. Mathews, comparing Geron's trial to an incident in one of gene therapy's first clinical tests. In 1999 a young man died because of complications in a trial testing the safety of a treatment for liver disease, and the fallout from the tragedy derailed further work in the field.
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Wednesday, August 25, 2010
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 Roles of CIA Physicians in Enhanced Interrogation and Torture of Detainees
Leonard S. Rubenstein, JD; BG (ret) Stephen N. Xenakis, MD
Secrecy has restricted scrutiny of the role of physicians and other medical personnel in the Central Intelligence Agency's (CIA’s) "enhanced" interrogation program, begun in 2002. The program, also labeled "physical and psychological pressure," was designed to "psychologically ‘dislocate’ the detainee, maximize his feelings of vulnerability and helplessness, and reduce or eliminate his will to resist" efforts to obtain intelligence.1-3(appendix F) In 2009, the Obama Administration released guidelines on enhanced interrogation written in 2003 and 2004 by the CIA Office of Medical Services (OMS).1-3(appendix F) The OMS guidelines, even in redacted form, and opinions from the US Department of Justice's (DOJ’s) Office of Legal Counsel show that CIA physicians, psychologists, and other health care personnel had important roles in enhanced interrogation.
Enhanced interrogation methods were applied in escalating fashion. Interrogators typically began by removing the detainee's clothes, limiting food, and depriving him of sleep through the use of stress positions. If this failed to produce intelligence, interrogators introduced "corrective" and "coercive" methods, including facialand abdominal slaps, dousing with cold water, stress positions and wall standing, confinement in a small or large box, and "walling" (throwing a detainee against a wall up to 20-30 times).4 If the detainee still did not provide information, interrogators could use waterboarding (simulated drowning).4 These methods have been recognized to constitute torture under international and domestic law by inflicting severe physical or mental pain or anguish on a person.
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Tuesday, August 10, 2010
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By Melinda Wenner Moyer
Slate Posted Friday, July 23, 2010, at 5:04 PM ET
 With all the hype about personalized medicine—one day, doctors will use patients' genomes to tailor treatments—one would hope that the medical community already had a decent grip on differences between the sexes. After all, saysTeresa Woodruff, a professor of obstetrics and gynecology at Northwestern University, "You really can't get to personalized medicine until you at least split the population in half." Unfortunately, that hasn't happened yet. Last month, Woodruff co-authored one of three related editorials in Nature illuminating the now decades-long sex bias in biomedicine, which leads doctors to preferentially study diseases and test drugs in males. It's a practice that not only puts women at risk, Woodruff argues, but also limits the scope of our scientific knowledge.
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Of course, this bias isn't malicious—just a little lazy. Because males don't have a menstrual cycle, their hormones do not fluctuate much over time, making them a more homogenous study population and ensuring that results are easier to analyze and interpret. There are also historical reasons for excluding women, particularly those in their child-bearing years. In the 1950s, the sedative thalidomide caused pregnant women to give birth to babies with missing limbs, and DES, an estrogenlike drug prescribed to prevent miscarriages, increased the risk that female babies would develop rare vaginal cancers later in life. When these findings came to light, clinicians and drug companies became cautious. "There was this worry: What about women who might get pregnant?" says Ruth Faden, executive director of the Johns Hopkins Berman Institute of Bioethics.
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Monday, July 26, 2010
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NY Times, July 21, 2010
The Food and Drug Administration on Wednesday orderedGlaxoSmithKline to stop enrolling people in a controversial clinical trial comparing diabetes drugs.
The F.D.A. also ordered GlaxoSmithKline, the British pharmaceutical giant, to inform the 1,324 people already testing the drugs that its product Avandia may increase heart risks.
The company said it would comply, but maintained Avandia was a safe option for some people with Type 2 diabetes. The F.D.A. notice said it was studying whether to take further action after most members of an advisory panel voted last week to withdraw Avandia from the market or severely restrict its use.
“This was the right thing for the F.D.A. to do now while we await the final decision,” Ruth R. Faden, Director of the Johns Hopkins Berman Institute of Bioethics, said on Wednesday, “This was one of our main recommendations,”
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Thursday, July 22, 2010
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American Medical News, July 19, 2010
By Christine Moyer
Experts say the 21st century holds even more promise for new vaccines.
Application of genetic engineering, an increased understanding of the immune system and new immunization delivery technologies have created what some call the golden age of vaccines.
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Research for the HPV vaccine, which was first licensed in 2006, began in the early 1990s, according to Douglas Lowy, MD, an HPV researcher for the National Cancer Institute. He said the NCI lab was the first to show that if a single HPV gene is expressed, it could self-assemble to create virus-like particles. GlaxoSmithKline's Cervarix vaccine and Merck's Gardasil are based on this development, he said.
Cervical cancer was considered a vaccine priority, in part, because of the high number of women diagnosed with the disease, Dr. Lowy added. The American Cancer Society estimated that 11,270 new cases of invasive cervical cancer were diagnosed in 2009. About a third of those women will likely die from the disease.
Underserved populations, particularly Hispanic and black females, are disproportionately affected because they often cannot afford cervical cancer screening.
"The HPV vaccine could be one way, in the long run, to try to address this disparity," Dr. Lowy said.
There are, however, some ethical concerns with the immunization, said Ruth Faden, PhD, MPH, director of Johns Hopkins Berman Institute of Bioethics in Baltimore. Faden said the HPV vaccine is too expensive for many poor nations to purchase. That means the people who need the vaccine the most often do not get it. ...
Research into the immune system factored into advancements made in the development of a cocaine vaccine that is being readied for national multisite study. Principal researcher Thomas R. Kosten, MD, chair and professor of psychiatry, neuroscience and pharmacology at Baylor College of Medicine in Houston, has been working on a cocaine vaccine for about 15 years. The vaccine provokes the body to make antibodies that bind to cocaine and prevent it from leaving the bloodstream. The result is an inability to experience the drug's euphoric effects.
The ethical question, according to Faden, of Johns Hopkins, is whether people who get the cocaine vaccine would start abusing another drug. She said such questions need to be addressed as vaccines for drug abuse are developed.
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Monday, July 19, 2010
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Paro the Robo-Seal Aims to Comfort the Elderly, But Is It Ethical?
Wall Street Journal, June 21, 2010
By Anne Tergesen and Miho Inada
 It might be the cuddliest medical device ever to cause an ethical quandary.
Five years ago, a Japanese robot manufacturer introduced Paro to the world. Built to resemble a baby harp seal—with a plush coat of antibacterial fur—Paro was hailed in Japan as a pioneer among socially interactive robots, one that would help lift the spirits of millions of elderly adults.
It never quite caught on. "It doesn't do much other than utter weird sounds like 'heeee' or 'huuuu,'" says Tomoko Iimura, whose adult day-care center in Tsukuba City keeps its Paro in a closet.
Now Paro has come to American shores, appearing in a handful of nursing homes and causing a stir in a way that fake seal pups rarely do.
Nursing-home workers and academics who study human-robot interaction are trying to figure out whether the $6,000 seal, cleared last fall by U.S. regulators as a Class 2 medical device (a category that includes powered wheelchairs) represents a disturbing turn in our treatment of the elderly or the best caregiving gadget since the Clapper.
"Some of our residents need more than we as human beings can provide," says Marleen Dean, activities manager at Vincentian Home, one of four facilities run by Pittsburgh-based Vincentian Collaborative System. Vincentian Collaborative recently used a $55,000 grant to purchase eight Paros and finds them especially comforting to patients with dementia. "We've tried soft teddy bears that talk and move. But they don't have the same effect."
Bill Thomas thinks it's inhumane to entrust the task of emotional support to a gadget.
"If you give me a robot that helps perform mundane tasks associated with caregiving, such as vacuuming or doing the dishes, I'm all for that," says Dr. Thomas, founder of the Green House Project, a campaign to make nursing homes smaller and more like regular houses. But "if we wind up with nursing homes full of baby-seal robots, the robots will be trying to fulfill the relationship piece of caregiving, while the humans are running around changing the beds and cooking the food."
In several countries, robots are starting to play a role in elder care. In Japan—where 22.3% of the population is over 65—robots handle such tasks as feeding patients and helping disabled people move their limbs. Also planned are wheelchairs with robot arms and robotic diet-and-exercise coaches.
... Read more
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Thursday, June 24, 2010
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Image:
Winfried Rothermal/AP
Instead of the usual required summer-reading book, this year’s incoming freshmen at the University of California, Berkeley, will get something quite different: a cotton swab on which they can, if they choose, send in a DNA sample. The university said it would analyze the samples, from inside students’ cheeks, for three genes that help regulate the ability to metabolize alcohol, lactose and folates.
Those genes were chosen not because they indicate serious health risks but because students with certain genetic markers may be able to lead healthier lives by drinking less, avoiding dairy products or eating more leafy green vegetables.
Berkeley’s program for the class of 2014 is the first mass genetic testing by a university. Jasper Rine, the professor of genetics who is leading the project, said it was designed to help students learn about personalized medicine and identify their own vulnerabilities.
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Thursday, May 20, 2010
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What if police could scan a suspect's brain to see if he was lying? Some companies claim the technology works, and it should be allowed as evidence at trial. Law professor Hank Greely explains the state of the technology and the ethical questions surrounding its use.
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Thursday, May 20, 2010
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New York Times, May 20, 2010
The genome pioneer J. Craig Venter has taken another step in his quest to create synthetic life by synthesizing an entire bacterial genome and using it to take over a cell.
Dr. Venter calls the result a “synthetic cell” and is presenting the research as a landmark achievement that will open the way to creating useful microbes from scratch to make products like vaccines and biofuels. At a press conference Thursday, Dr. Venter described the converted cell as “the first self-replicating species we’ve had on the planet whose parent is a computer.”
“This is an important step, we think, both scientifically and philosophically,” Dr. Venter said in an interview with the journal Science, which is publishing the research this week. “It’s certainly changed my views of definitions of life and of how life works.”
Other scientists agree that he has achieved a technical feat in synthesizing the largest piece of DNA so far — a million units in length — and in making it accurate enough to substitute for the cell’s own DNA.
But some regard this approach as unpromising because it will take years to design new organisms, and meanwhile progress toward making biofuels is already being achieved with conventional genetic engineering approaches in which existing organisms are modified a few genes at a time. ...
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Thursday, May 20, 2010
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Company plans to sell genetic testing kit at drugstores
By Rob Stein
Washington Post, 11 May 2010
Beginning Friday, shoppers in search of toothpaste, deodorant and laxatives at more than 6,000 drugstores across the nation will be able to pick up something new: a test to scan their genes for a propensity for Alzheimer's disease, breast cancer, diabetes and other ailments.
The test also claims to offer a window into the chances of becoming obese, developing psoriasis and going blind. For those thinking of starting a family, it could alert them to their risk of having a baby with cystic fibrosis, Tay-Sachs and other genetic disorders. The test also promises users insights into how caffeine, cholesterol-lowering drugs and blood thinners might affect them.
The over-the-counter test marks the first foray of personalized genomic medicine into the corner drugstore. The move is being welcomed by those who hope that deciphering the genetic code will launch a new era in biomedical science. ...
"It's the first widespread retail availability of genetic tests that are directed specifically at health issues," said Joan A. Scott, director of the Genetics and Public Policy Center at Johns Hopkins Berman Institute of Bioethics....
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Thursday, May 13, 2010
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Berman Institute of Bioethics Seminar Series: Speakers for Fall 2010 announced
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The lunchtime seminar series will resume in September 2010. Find out about all of our upcoming speakers
here.
The series will explore "
Who’s In and Who’s Out: Ethical Implications of the Construction of Groups in Clinical Care, Research & Public Health"
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The Ethical Review of Health Care Quality Improvement Initiatives: Findings from the Field
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Authors: Holly A. Taylor, Ph.D., M.P.H. , Peter J. Pronovost, M.D., Ph.D., Ruth R. Faden, Ph.D., M.P.H. , Nancy E. Kass, Sc.D. , and Jeremy Sugarman, M.D., M.P.H., M.A.
Overview
Questions have been raised about whether and how health care quality improvement (QI) initiatives ought to be reviewed to address possible ethical issues associated with them. These questions have focused primarily on whether some QI initiatives meet the regulatory criteria for human subject research and should therefore be regulated and reviewed as such. Based on surveys of health care system professionals conducting QI initiatives and hospital CEOs, this issue brief finds that QI initiatives are routinely reviewed by a variety of internal mechanisms prior to implementation, although rarely through an institutional review board or another independent body charged specifically with ethical oversight of QI initiatives. Further research, the authors say, is needed to achieve a better understanding of how review mechanisms for QI initiatives are structured, including information on who reviews these activities, how they are reviewed, and whether such processes include an ethical assessment of the proposed QI initiative.
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Berman Institute scholar calls for consistent regulation of direct-to-consumer genetic tests
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Commentary in Aug. 12 issue of Nature
provides framework and concrete examples for F.D.A. to follow
An opinion piece by a legal scholar from the
Johns Hopkins Berman Institute of Bioethics
in this week’s issue of
Nature
calls for the Food and Drug Administration to regulate all health-related genetic tests — whether available directly to consumers or through a health care provider — using an approach that imposes requirements proportionate to a test’s level of risk.
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Berman Institute's Carlton Haywood Jr. to study patients' opinions of
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The Berman Institute’s
Carlton Haywood Jr. has been awarded $20,000 by the Blaustein Pain Research Fund to study how patients with sickle cell disease feel when caretakers ask them to agree to certain terms prior to receiving opioids for pain management.
Physicians around the country are increasingly asking patients with chronic, non-cancer pain to abide by “opioid agreements” or “opioid contracts” in the wake of growing scrutiny over prescribed narcotics. The excessive use of potentially addictive drugs such as OxyContin has placed intense pressure on doctors to practice caution when prescribing them.
But in reviewing published research on the use of opioid agreements, Haywood said none asked patients with chronic pain how they feel about the use of these documents. The studies also didn’t examine how being asked to sign such contracts might affect the amount of trust and respect that patients feel toward their caretakers.
“We are attempting to rectify this important gap,” says Haywood, an associate faculty member at the Johns Hopkins Berman Institute of Bioethics.“If these documents are to be utilized, we feel that their content should be informed by the perspective of the patients who ultimately will be asked to sign them and adhere to their rules.”
Although the development of research protocols has just begun, the grant money will be used to conduct exploratory, descriptive and qualitative research on three focus groups. Haywood and his team also plan to explore the possibility of differences in attitudes about opioid agreements due to patient gender—as well as do preliminary work on a questionnaire that can be used to gather more precise data in future research in this area.
The
Blaustein Pain Research Fund, housed at the Johns Hopkins University School of Medicine, awards grants through a committee consisting of pain researchers and faculty at the school.
On a related note, Haywood was featured on the May 7 podcast of the
Bioethics Channel, a production of the Center for Practical Bioethics. Haywood's interview was titled,
"Pain Contracts: A Patient Perspective."
Media Contact: Michael Pena
410-625-7872;
mpena@jhsph.edu
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IRB: Ethics & Human Research 32 (4) July-August, 2010
