FDA is committed to safeguarding the rights and welfare of all human beings who participate as subjects in research. The RIHSC reviews all research involving human subjects conducted, supported, or funded, in whole or in part, by FDA, to ensure that the research complies with applicable laws and ethical research standards.
What kind of members serve on an IRB?
Ideally, IRBs are made up of members from diverse backgrounds. Diversity assures a complete and thorough review of the research activities from a variety of perspectives.
We are seeking community members with different kinds of backgrounds than our current members. Some examples would be educators, members of the clergy, laborers, and previous government employees who have not worked in public health agencies.
RIHSC membership currently has scientists, health care professionals, social scientists, and regulatory counsel.
What are the qualifications RIHSC is seeking in a Public Member?
Although not required, it may be beneficial to have experience in:
Community members who volunteer to be a public member for RIHSC may not be affiliated with FDA or be an immediate family member of a person affiliated with FDA.
What are the responsibilities of a public member of RIHSC?
The public members on a rotating basis will be asked to:
The public members will be modestly compensated for performing committee duties.
If you know of interested individuals who are not affiliated with the FDA or a part of the immediate family of a person affiliated with FDA, please encourage him/her to send a resume or CV to the RIHSC Program Management Staff via email at RIHSC@fda.hhs.gov.]]>
|Date||Mon 24 Oct — Tue 25 Oct|
The Center for Bioethics and Nanoethics is proud to announce this conference featuring two prominent scholars of bioethics:
Ruth Faden will lecture on “Ethical Issues in the Zika Virus Vaccine Trials and Pregnancy”
Tom L. Beauchamp will close the conference by giving the first K.E. Loegstrup Lecture: “A Defense of Universal Principles and Common Morality”.
Researchers from Aarhus University will open interdisciplinary discussions on informed consent in biomedical trials and on the four principles of biomedical ethics in Beauchamp and Childress’ seminal book.
(Press Release via ISSCR)
Washington, D.C.; 12 May 2016 – The International Society for Stem Cell Research (ISSCR), the world’s largest professional organization of stem cell scientists, today released newly updated guidelines for stem cell research and the development of new clinical therapies. The new guidance comes at a time when rapidly evolving technologies like gene editing in human embryos and emerging areas of stem cell discovery and its applications are providing unprecedented opportunities to understand human biology and disease, but also raising questions that have social and ethical implications. The guidelines build on widely shared principles in science that call for rigor, oversight, and transparency in all areas of practice. Adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based.
“The field of stem cell research is growing at a rapid pace, with scientists and physicians developing new therapies that can help patients around the world who suffer from a wide variety of conditions,” said Sean J. Morrison, Ph.D., ISSCR president and director of the Children’s Medical Center Research Institute at UT Southwestern. “These guidelines are essential to protect the integrity of the research and to assure that stem cell treatments are safe and effective,” he said.
The ISSCR developed earlier sets of guidelines that are widely followed by researchers and institutions around the world (Guidelines for the Conduct of Human Embryonic Stem Cell Research, 2006;Guidelines for the Clinical Translation of Stem Cells, 2008). The 2016 guidelines update and expand those topic areas and bring all guidance together under common principles of research integrity, patient welfare, respect for research subjects, transparency, and social justice. At their core, the new guidelines preserve the imperative for a specialized oversight process for research involving human embryos, in recognition of the unique sensitivities surrounding such research. Responding to advances in science, the guidelines encompass a broader and more expansive scope of research and clinical endeavor than before, imposing rigor on all stages of the research, addressing the cost of regenerative medicine products, and highlighting the need for accurate and effective public communication.
“By addressing ethical uncertainties, articulating standards, and protecting patients and the public interest, these guidelines provide a path for rapid advances in stem cell biology and medicine,” said Jonathan Kimmelman, Ph.D., ISSCR Guidelines Update Task Force chair, and associate professor of Biomedical Ethics at McGill University. “Science moves quickly, and we recognize the guidelines are a living document that will undergo ongoing review, interpretation, and revision in order to support the community,” he said.
The new guidelines address several issues not included in previous versions; they:
“The public recognizes that stem cell research holds promise for treating diseases and disorders affecting millions of people around the world,” said George Q. Daley, M.D., Ph.D., member of the ISSCR Guidelines Update Steering Committee and professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School. “We remain steadfast in our commitment that only safe and effective treatments based on proven science should be marketed to patients,” he said.
The new guidelines were developed by an international task force of 25 experts in stem cell science, clinical research, and bioethics, from 9 countries, with review and feedback from 85 external individuals and organizations. A list of task force members may be found along with the guidelines on ISSCR’s website: 2016 Guidelines for Stem Cell Research and Clinical Translation (isscr.org/guidelines2016).
Several articles published today provide additional information about aspects of the new ISSCR guidance and the task force discussions:
About the International Society for Stem Cell Research; The International Society for Stem Cell Research (ISSCR) is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application. Learn more at isscr.org.
Anne Nicholas | Senior Communications Manager
International Society for Stem Cell Research
January 15, 2014
Johns Hopkins Berman Institute of Bioethics
Leah Ramsay 202.642.9640, email@example.com
Brigham and Women’s Hospital
Lori J. Schroth 617.525.6374, firstname.lastname@example.org
It’s the health care holy grail: higher quality care at lower cost, and there are a growing number of accountable care organizations (ACOs) in the United States aiming to achieve it, in part by influencing where patients receive care. This carries risk to patient well-being and choice, but medical ethicists at Johns Hopkins and Brigham and Women’s say ACOs can ethically influence referrals, under certain conditions.
Writing in The New England Journal of Medicine, the experts assert, “ACOs can influence referrals in an ethical manner that simultaneously enhances choice and improves patient outcomes if they consider three basic issues: transparency, appropriate metrics, and the right incentives.”
In ACOs, physicians and other providers assume responsibility for patients’ health outcomes and expenditures, and can earn financial bonuses by meeting specific quality measures while spending less than a benchmark. This is meant to encourage reducing unnecessary tests or increasing high value ones, explains Matthew DeCamp, co-author of the article, an assistant professor at Johns Hopkins Berman Institute of Bioethics and Division of General Internal Medicine. For example, he says, a traditional fee-for-service payment system may not discourage repeating diagnostic tests, such as X-rays, at both the primary care office and the specialist’s office; under the ACO model however, an incentive exists to communicate, coordinate, and not repeat such tests.
“Influence over referrals must be done in ways that preserve physicians’ primary duties to their patients’ well-being and the inherent value of choice,” DeCamp says.
The authors raise the specter of the managed care model of the 1990s that was plagued with issues, including ethically problematic “gag rule” contracts, some of which prevented physicians from referring specialists outside the organization. “We need to learn from the mistakes of managed care. Transparency about why and how referrals are being influenced is arguably the most fundamental ethical consideration,” says Lisa Lehmann, DeCamp’s co-author, the Director of Department of Medicine Bioethics Program at Brigham and Women’s Hospital.
The authors emphasize that the process of creating preferred referral lists is itself important, as there may be tension between choice and the ACO’s quality and cost goals.
“Ethically, it’s not just about telling patients and physicians about preferred referral lists, but also about basing these lists on more than cost and hard medical outcomes,” says DeCamp. “As a physician, I want to be sure my patient sees a cardiologist who prescribes the right medicines and doesn’t do unnecessary tests, but I also want to be sensitive to other values of interest to my patient, such as scheduling convenience, racial or cultural concordance, or communication style.” The authors suggest that these factors should also be considered when influencing referrals.
“Ideally, we should be engaging physicians and patients in the process of choosing criteria to evaluate specialists. This will help preserve the value of patient choice and the ACO’s commitment to cost and quality, while also engendering trust in the organization,” Lehmann adds.
Further, the authors propose that providing data on how specialists perform according to these criteria could provide enough incentive to influence the referral. According to Lehmann, “Providing physicians and patients with referral lists based on appropriate metrics could be incentive enough” to achieve patients’, physicians’, and ACOs’ shared goal of high value care. DeCamp and Lehmann do not say that financial incentives are inherently unethical, but should be employed only after nonfinancial options like information sharing and organizational recognition are tried, and patients must be informed.
“In the existing system it is unclear how much choice patients really have and whether referral practices are truly in their best interest. ACOs have an opportunity to develop referral systems based on transparency, appropriately chosen metrics, and carefully employed incentives. This could make health care not just more effective, but more ethical,” DeCamp says.
(Reposted via Johns Hopkins HUB)
‘The virus is winning hands down’ keynote speaker Michael Osterholm says, urges more action, investment in vaccine research
By Jackie Powder and Maryalice Yakutchik
The swiftly moving Ebola epidemic presents an immense challenge to unprepared national and global health systems, infectious disease expert Michael Osterholm said at an Ebola symposium Tuesday at the Johns Hopkins Bloomberg School of Public Health.
Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, is one of the leading public spokesmen on the Ebola epidemic, which has killed more than 4,300 in West Africa. Although he has reviewed hundreds of published papers on Ebola and briefs top government officials on the epidemic’s spread, Osterholm readily admits that he knows less today about the Ebola virus than he did nine months ago.
“Let’s acknowledge we’re making this up as we go and we have to become more comfortable with uncertainty,” said Osterholm, the keynote speaker at the event, titled “Dean’s Symposium on Ebola: Crisis, Context and Response.”
In addition to Osterholm’s keynote, the symposium included five presentations and two multidisciplinary panels and featured experts in microbiology, public health, bioethics, and emergency medicine. Topics discussed included a lack of coordination and leadership at the global level, an overview of experimental medical counter measures for Ebola, and the complex ethical decisions that need to be made in real-time.
Speakers acknowledged severe shortages in the affected countries—Liberia, Guinea, and Sierra Leone—of trained healthcare workers and vital supplies (including gloves and masks) because of a frustrating lack of logistical support.
Ebola was discovered in 1976 in central Africa, and past outbreaks have been contained, but the current outbreak has seen the disease move for the first time ever from remote areas into urban centers. Osterholm cautioned that the epidemic could become more widespread as seasonal workers move east from the affected regions into more populous parts of the continent—such as Kinshasa, capital of the Democratic Republic of Congo and home to more than nine million people.
At this stage in the epidemic, Osterholm said, the Ebola virus has the upper hand and the global health community is playing catch-up.
“The virus is operating on virus time and the rest of us are operating on bureaucracy and program time, and the virus is winning hands down,” Osterholm told an audience of 350 in Sommer Hall and more than 2,500 following the live webcast.
Johns Hopkins University President Ronald J. Daniels, who joined School of Public Health Dean Michael J. Klag in kicking off the symposium, noted that throughout its history, Johns Hopkins has been a leader in helping the world better understand public health crises—from the 1919 flu epidemic to polio to smallpox to HIV/AIDS—and shaping effective responses.
“Now,” Daniels said, “as the numbers of reported Ebola cases mount and the death toll rises; as nations and communities across West Africa struggle to meet the basic health care needs of populations in addition to managing acute care for Ebola patients; as we consider the daunting implications for the global populations if this outbreak is not met with an effective and sustainable international response; we are acutely aware of Hopkins’ obligation to marshal our intellectual bounty as the world community wrestles with this unpredictable and growing epidemic.
“With our deep ties to communities across the African continent, and our expertise in basic science, clinical practice, public health, and international public policy,” he added, “we are well-positioned to ignite ideas around best practices, and, most importantly, turn those ideas into action.”
As the Ebola crisis continues to unfold, Osterholm said he sees “lots of unexpecteds ahead of us.” He said he is convinced that a vaccine is the only hope of containing the outbreak but characterized the U.S. investment in vaccine research as “a drop in the bucket.”
“There’s a big disconnect between the work to get us there and getting it into somebody in Africa,” said Osterholm, at one point calling the Ebola outbreak “[The World Health Organization’s] 9/11.”
Trish Perl, a professor of medicine and infectious diseases at the Johns Hopkins schools of Medicine and Public Health, said there are relatively simple things that can be done now to decrease mortality in West Africa. Data suggest aggressive intravenous hydration, replacing electrolytes, and managing nausea and fever are relatively inexpensive measures that can be part of the bundle of care.
“We are talking about failures of infection control,” Perl said. “This is not sexy. It’s like learning to drive. How can we learn how to drive down this road a little better?”
The half-day symposium was organized by Andrew Pekosz, an associate professor in molecular microbiology and immunology and a leading expert on the basic biology of influenza and other emerging virus infections. An archived version of the event (in two parts) can be viewed below. A full agenda can be viewed online.
More information at www.jhsph.edu]]>
Her address entitled “Moral Sources for Collaborative, Practice-Based Ethics: A Transformation for Education and Practice” will focus on achieving social justice, improving access, and making full use of all professions to improve the health of society.
On August 5, 2014 9am EDT/USA click on this link to join the live webinar: https://connect.johnshopkins.edu/hsre/
Health systems research is increasingly being funded by international donors and conducted in low and middle-income countries but little conceptual work has been done to clarify the field’s ethical dimensions. This is problematic because health systems research has distinctive features relative to clinical research that may restrict the applicability of existing ethical guidance. This webinar will ask: What makes health systems research different from clinical research? What are the key ethical issues in externally-funded health systems research in low and middle-income countries? And do they deserve special consideration in, for example, project design and ethics review?
Join us for a lively moderated discussion where you can hear more about:
This webinar is organized by the Health Systems Global Thematic Working Group on Health Systems Research Ethics in collaboration with the Johns Hopkins Health Systems Program, The Johns Hopkins Berman Institute of Bioethics, Future Health Systems consortium, and Fogarty African Bioethics Training Program.
To find out more about/join this group, please contact Bridget Pratt at email@example.com.
Register for the webinar
On August 5, 2014 9am EST/USA click on this link to join the live webinar: https://connect.johnshopkins.edu/hsre/]]>
Monday, July 28, 2014 7:00 – 8:00 pm (EDT)
This webinar is free and open to all. Register online.]]>