Professor Nancy Kass joins Ingrid Burger, left, and Summer Johnson, right, on graduation day in May 2007. The newly minted PhDs were enrolled in the Johns Hopkins PhD program in Bioethics and Health Policy. 
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Experts Provide Model Language to Help Clinical Researchers Disclose Financial Conflicts of Interests Facing a wide range of practices on how financial conflicts of interest are disclosed to potential clinical research participants, experts at Johns Hopkins University, Duke University, and Wake Forest University have published new language designed to help clinical researchers better disclose their financial interests in research. Featured in the January 2007 issue of IRB: Ethics and Human Research, the new language is designed to provide guidance for researchers seeking to properly disclose the types of financial interests most commonly found in clinical research.
“There is near-universal agreement about the need for clinical researchers to disclose financial interests to research participants, but until now there has been little guidance available on exactly how to do it,” said principal investigator Jeremy Sugarman, M.D., the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics. “Our team looked beyond the need for disclosure. We researched how it should be done. Using an empirically-based approach, we have helped create the right tools to do the right thing. The new language is a model for others to use, test, and improve upon.”
Developed as part of an ongoing, $3 million-dollar project called the Conflict of Interest Notification Study (COINS), the new disclosure statements are designed to be used in written materials provided to potential research participants before giving their informed consent. “If you are thinking about participating in a clinical research trial, you should understand what you are getting yourself into, and that includes any financial interests involved,” said Kevin Weinfurt, Ph.D., deputy director of the Center for Clinical and Genetic Economics at the Duke Clinical Research Institute. “We also recognized that people vary in their informational needs. So to provide adequate disclosure to all people, we included a core statement in the new disclosure language that’s to be made available to everyone. We then added an explicit invitation for potential research participants to ask for more detail.” After extensive focus group testing and multiple rounds of review by representatives of Institutional Review Boards, the COINS project team has unveiled the following generic disclosure for situations in which a financial interest exists but does not present a measurable risk to a research participant. The person leading this medical research study might benefit financially from this study. The Institutional Review Board and a committee at ABC University have reviewed the possibility of a financial benefit. They believe that the possible financial benefit to the person leading the research is not likely to affect your safety and/or the scientific quality of the study. If you would like more information, please ask the researchers or the study coordinator. The new model language also includes specific language for situations in which there may be risks to participants. The team categorized this additional language by the nine types of financial interests most commonly encountered in clinical research, including: - Salary support
- Money received outside of the study
- Per capita payments
- Finders’ fees restricted to research uses
- Unrestricted finders’ fees
- Researchers holding a patent
- Universities holding a patent
- Researchers owning equity
- University owning equity “The determination of risk to potential research participants can be complex, and varies by research institution. Individual institutions using the new language may want to modify key phrases to suit their purposes,” said Jeremy Sugarman. “This is language that can help these institutions craft better written materials. It can also help serve as a model for how to accurately phrase disclosure in discussions with potential research participants. It could even be expanded and presented in other formats, such as stand-alone pamphlets or videos about clinical research.”
“The COINS project is about providing a framework for establishing sound policy and practices for the disclosure of conflicts of interest in clinical research,” said Kevin Weinfurt. “Toward that end, we have developed something practical: working disclosure language. We hope that others will want to use the new language as a template to further refine the options for appropriate disclosure, and ultimately, minimize potential risks to research subjects.”
The Conflict of Interest Notification Study (COINS) was initiated to establish a framework for developing policy and practices for disclosing conflicts of interest in research. The $3 million dollar, five-year study is funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. The new disclosure language for researchers’ use was developed through the use of focus group testing, cognitive pre-testing to evaluate participants’ understanding, and numerous, subsequent expert panel reviews and revisions. New Paper Outlining Ethical Challenges for Radiology Researchers Named “Best of 2006” by Journal of the American College of Radiology
A new paper containing suggestions for radiology researchers to anticipate and resolve ethical challenges they may face while conducting research on human subjects has been named “Best of 2006” by the editorial board of the Journal of the American College of Radiology. Entitled “Ethical Conduct of Radiology Research With Human Subjects,” the award-winning paper was published in the December 2006 issue of the journal. The paper is authored by Ingrid Burger, a graduate student at the Johns Hopkins Bloomberg School of Public Health. Nancy Kass, ScD, deputy director of public health for the Johns Hopkins Berman Institute of Bioethics, served as co-author. The paper won in the category of Human Subjects Research and Policy. The citation for the article is Burger I, Kass N. Ethical Conduct of Radiology Research With Human Participants. Journal of the American College of Radiology. Dec; 3: 932-939 (2006) Joseph Carrese, M.D., MPH, New Chair of Hopkins Bayview Ethics Committee, Launches Clinical Ethics Web Site
Posted November 20, 2006 Joseph Carrese, M.D., MPH, the Institute’s director of the Program on Ethics in Clinical Practice and its first Blaustein Scholar in the Ethics of Clinical Practice, has just launched Clinical Ethics Corner, an educational Web site for medical professionals at the Hopkins Bayview Medical Center. The site was designed in consultation with the Hopkins Bayview Ethics Committee, which recently named Dr. Carrese as its chair. The site includes Medical Center policies, clinical ethics consultation information, and external Web resources on clinical ethics. Dr. Carrese is an associate professor of medicine and vice chair of Institutional Review Board #5 at Hopkins Bayview, and a core faculty member of the Johns Hopkins Berman Institute of Bioethics. In his new role as chair, Joseph Carrese succeeds another core faculty member from the Institute, Thomas Finucane, M.D., who led the Hopkins Bayview Ethics Committee for 12 years. As director of the Program on Ethics in Clinical Practice, Dr. Carrese studies the "epidemiology" of ethical issues that emerge in the daily practice of medicine in various clinical settings. He also participates with colleagues in designing, implementing and evaluating educational curricula for residents addressing ethical issues in clinical practice. More information on the program is available at Program on Ethics in Clinical Practice.
Announcing the “Grounds for Discussion” Lecture Series As a service to the community, the Johns Hopkins Berman Institute of Bioethics is pleased to present the first-ever “Grounds for Discussion” lecture series. The first lecture in this special series is entitled "Do Medical Ethics Get Scrubbed? What Doctors Don't Know, and How it Affects You." Members of the greater Baltimore community are invited to attend all three thought-provoking evenings with some of the brightest minds in higher education. "Grounds for Discussion" Schedule Nov. 14, 2006 Do Medical Ethics Get Scrubbed? What Doctors Don't Know, and How it Affects You Dec. 5, 2006 Scientists Can Watch Your Mind, Maybe Even Read it. Now What? Jan. 23, 2007 Why You Should Care About Research on Humans in Developing Countries Each event will be held at the Evergreen Coffee House at 501 West Cold Spring Lane in Baltimore, Maryland. Please RSVP to Stephanie Davis at stdavis@jhsph.edu or 410-516-8570. View the official invitation. | |
Institute’s Deputy Director of Medicine to Co-Lead New Committee on Embryonic Stem Cell Research Oversight
Posted October 25, 2006 A new committee charged with ensuring that all human stem cell experiments conducted at Johns Hopkins University are safe will be co-led by Jeremy Sugarman, MD, MPH, MA, the Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Berman Institute of Bioethics at Johns Hopkins. The other co-leader will be Carol Greider, Ph.D., the Daniel Nathans Professor and director of molecular biology and genetics in the Institute of Basic Biomedical Sciences and recent winner of the Lasker Award. The new Embryonic Stem Cell Research Oversight (ESCRO) committee will be modeled on guidelines set forth in 2005 by the National Academies, and will be similar to institutional review boards that oversee the safety of human subjects in research. Scheduled to begin a review of protocols in January of 2007, the ESCRO committee will work in tandem with the Stem Cell Resource Center, a new "one-stop shop" at Johns Hopkins to preserve, create, supply and test high-quality stem cell lines for researchers. More information on the new center is available at http://www.hopkinsmedicine.org/ice/index.html.
BBI names new communications director
July 19, 2006 - The Berman Institute of Bioethics at Johns Hopkins today announced plans for a sweeping overhaul of its communications efforts. The first order of business is to "re-imagine" the institute's overall look and feel, starting with a new web site. Ed Bodensiek, former head of the public affairs office for JA Worldwide, has been named to lead the effort. Ed plans to work with faculty, staff, and other Johns Hopkins Institution stakeholders to craft the institute's new strategy and tactics, most of which will be implemented in 2007.
Members of the media seeking assistance with background, access to faculty expertise, or general support for bioethics-related stories are encouraged to contact the communications office at 410-516-8523 or ebodensiek@jhu.edu. Deputy Director of Medicine for Berman Institute of Bioethics Named to New State Stem Cell Research Commission
Adapted from The JHU Gazette, July 10, 2006 Jeremy Sugarman, deputy director of the Berman Institute of Bioethics and the Harvey M. Meyerhoff Professor of Bioethics and Medicine,  is one of three faculty members from Johns Hopkins named to the 15-member Maryland Stem Cell Research Commission, according to Maryland Gov. Robert Ehrlich. Speaking at the university’s East Baltimore campus on July 6, 2006, the governor and senior representatives from the Maryland Technology Development Corporation (TEDCO) announced that Johns Hopkins was chosen to name three of 15 members of the new commission. The governor, Maryland attorney general, president of the Senate, speaker of the House of Delegates, and the University System of Maryland were each asked to name the remaining commission members. The commissioners, whose initial terms began on July 1, 2006, will establish criteria, standards and requirements to ensure that stem cell research financed by the newly established $15 million Maryland Stem Cell Research Fund complies with state law. Managed by TEDCO, the fund’s purpose is to promote stem cell research and cures through grants and loans to both public and private entities. The other commission members from Hopkins are Diane Griffin, professor of immunology and microbiology at the School of Public Health, and Murray Sachs, director of the Biomedical Engineering Department at the School of Medicine. Jeremy Sugarman has an appointment in the Johns Hopkins Bloomberg School of Public Health. For more information on the new commission, visit http://www.marylandtedco.org/_media/pdf/StemCellCommission7-6-06.pdf Nation’s Largest Foundation Devoted Exclusively to Health Care Asks Core Faculty Member Cynda Rushton to Help Craft National Voice of Nursing The Berman Institute of Bioethics is pleased to announce that one of its core faculty members, Cynda H. Rushton, DNSc, RN, FAAN, and Associate Professor at the Johns Hopkins School of Nursing, has been named a Robert Wood Executive Nurse Fellowship. Awarded by the Robert Wood Johnson Foundation, the nation's largest foundation devoted exclusively to health and health care, the fellowship is considered one of the highest-level leadership development programs designed for nurses in executive positions. With the nation’s health care system facing unprecedented change, the voice of nursing is increasingly needed. To help address some of the nation’s most urgent health care challenges, each year 20 nurses are asked to participate in the exclusive, three-year fellowship program. “Nurses must play a pivotal role in leading the redesign and success of health care, now and in the future,” said Dr. Cynda Rushton. Dr. Rushton added that she was honored to have such an intensive opportunity to develop critical leadership skills, as well as work with a nationally recognized team of coaches and instructors drawn from all sectors of the economy. Direction and technical assistance for the fellowship is provided by the Center for the Health Professions at the University of California, San Francisco. For more information, visit the fellowship’s home page. Dr. Sugarman Awarded Membership in ASCI May 1, 2006 Congratulations to Jeremy Sugarman, MD, MPH, MA, who has recently been named a member of the American Society for Clinical Investigation (ASCI). Established in 1908, ASCI is one of the nation's oldest and most respected medical honor societies, comprising more than 2,800 physician-scientists from all medical specialties. Members are elected to the Society for outstanding scholarly achievement in biomedical research, and many of the Society’s senior members are widely recognized leaders in academic medicine. Dr. Sugarman is the Harvey M. Meyerhoff Professor of Bioethics and Medicine and Deputy Director for Medicine at the Berman Institute of Bioethics of the Johns Hopkins University. His work concentrates on informed consent, research ethics, and the ethical issues associated with emerging technologies. He is the author of over 100 papers published in peer-reviewed journals, has edited or co-edited four books, and is on the editorial boards of Accountability in Research, the American Journal of Bioethics, Clinical Trials, and Theoretical Medicine and Bioethics. Dr Sugarman is a Fellow of the American Association for the Advancement of Science, the American College of Physicians, and the Hastings Center. The ASCI is dedicated to the advancement of research that extends understanding and improves the treatment of human diseases, and members are committed to mentoring future generations of physician-scientists. The ASCI considers the nominations of several hundred physician-scientists from the United States and abroad each year, and elects up to 80 new members annually for their significant research accomplishments. New Office Address The Berman Institute of Bioethics's main administrative, development, and research office has moved. The new address for the institute is as follows. The Berman Institute of Bioethics
100 North Charles Street
Suite 740
Baltimore, MD 21201 Telephone: 410-516-8500
Fax : 410-516-8504
E-mail: bioethic@jhsph.edu Please check individual faculty listings under “People” for each faculty member’s address and phone number. A number of faculty are located on the East Baltimore medical campus in the Institute’s old location, where we often hold seminars and events. First Fellows in Ethics in Clinical Practice We are delighted to announce the appointments of the first two scholars in the Ethics in Clinical Practice. Dr. Joseph Carrese will be the first Blaustein Scholar and Dr. Margaret Moon will be the first Freeman Scholar. Both Drs. Carrese and Moon have a strong background in the Ethics of Clinical Practice. Specifically, Dr. Carrese received formal training in ethics at the University of Washington and has been active in clinical ethics in several settings including at Bayview. Dr. Moon completed training at the MacLean Center at the University of Chicago and has done subsequent work in clinical ethics.
Research Ethics Consulting Service The Office for Research Subjects (ORS) is pleased to announce the creation of a new Research Ethics Consulting Service. The service is available without charge to faculty, staff, and students of JHSPH (students are welcome to use the consulting service for their dissertation research, but they must access the service along with their faculty advisors, who serve as PI for their projects). The goal of the consulting service is to help raise awareness of, and to assist investigators in resolving issues of ethics in human subjects research. The service is intended to assist JHSPH investigators in East Baltimore and abroad when considering ethics challenges that arise in the design, conduct, or analysis of their research projects with human subjects. Faculty, staff, and students can contact the service to talk through challenges relating, for example, to appropriate interventions to provide in studies; confidentiality in recruitment; alternative means of informed consent; or how to respond when an unforeseen event occurs during data collection. The service is not designed to "pre-review" submission to the CHR nor to review or rewrite consent documents. Requests for consultations may be submitted through the "Help Desk" system on the https:\\help.jhsph.edu\helpdesk website. Go to the "MyTools" menu at the top of the page, click on "Help Desk" and then click on "Research Ethics Consulting" under the heading "Departmental Services". A summary of the consultation will be made part of the CHR file for the study, if a file already exists. The service is staffed by Drs. Holly Taylor and Nancy Kass, both faculty of the Department of Health Policy and Management and the Berman Institute of Bioethics. Drs. Taylor and Kass serve as the ethics members of the
JHSPH CHRs. Questions and/or problems with accessing the site should be addressed to Information Systems. |
