|Welcome to the first NIDDK Director's Update. This periodic electronic newsletter will bring you updates on NIH and NIDDK activities and events of interest and will include news of the latest policy developments at the NIH. Whenever possible, we will include internet links to web sites for more information. |
NIH Public Trust Initiative: As part of the NIH Public Trust Initiative, the NIH Director's Council of Public Representatives (COPR) will hold a workshop entitled: “Inviting Public Participation in Clinical Research: Building Trust through Partnerships” October 26th and 27th on the NIH campus. The workshop will include 50 invited public participants from the constituency community and 21 COPR members. The invitees and COPR members will identify opportunities to improve public participation and trust in medical research, with particular emphasis on clinical trials. The goal of the workshop will be to develop recommendations for the NIH Director and NIH partnering organizations for improving public participation and trust in the medical research process. Additional information on the COPR is available at http://copr.nih.gov/ . Additional information on public participation at the NIH is available at http://getinvolved.nih.gov/ . The NIH Public Trust Initiative (PTI) is a component of the NIH Roadmap for Medical Research. More information is available at http://nihroadmap.nih.gov/ .
NIH Policy on Conflict of Interest: On September 24th, NIH Deputy Director Raynard S. Kington, M.D., Ph.D., released a memorandum to NIH employees outlining a change in NIH policy regarding the management of conflict of interest. According to the memorandum, NIH will seek a one year moratorium on consulting with pharmaceutical and biotechnology companies for all NIH employees. In addition, NIH will pursue a permanent ban for all senior NIH staff on such activities. During the period of the proposed moratorium, appropriate interactions with industry will continue as such activities relate to official duty. During the time of the moratorium, NIH will complete a review of specific cases of conflict of interest, develop effective information systems to track outside activities, and develop more effective ethics training programs for staff before a final policy is put in place.
On June 22nd, NIH Director Elias A. Zerhouni, M.D., appeared before the United States House of Representatives, Committee on Energy and Commerce, Oversight and Investigations Subcommittee, to testify on NIH ethics concerns in the areas of consulting arrangements and outside awards. He stated at that time that he would seek a major reform of the ethics program at NIH by requesting restrictive rules and by seeking to increase the public availability of information related to outside activities with industry.
At a May 12th appearance before the same subcommittee, Dr. Zerhouni put forth four principles for change in the NIH ethics program: to enhance public trust in NIH by preventing conflicts of interest through the restriction of financial relationships that employees may have with outside organizations; to increase levels of transparency in the NIH ethics program by requiring much more internal as well as public disclosure of the details of financial relationships that employees have with outside organizations, including consulting arrangements and awards; to balance NIH's ability to recruit and retain the best scientific expertise while expediting the translation of research advances; and to establish effective monitoring and oversight of employee activities. The NIH is currently working to implement these changes.
Dr. Zerhouni's statement to the Committee on Energy and Commerce, Oversight and Investigations Subcommittee, is available on the NIH web site at http://www.nih.gov/about/director/062204zerhouni_COI.pdf .
More information on Conflict of Interest at the NIH is available at http://www.nih.gov/about/ethics_COI.htm .
NIH Public Access Initiative: On September 3rd, NIH released a notice in the NIH Guide to Grants and Contracts regarding NIH's plans to facilitate enhanced public access to NIH health-related research information. On September 17th, Elias A. Zerhouni, NIH Director, published a similar notice in the Federal Register. The purpose of the notice was to announce and to seek public comments regarding NIH's plans to facilitate enhanced public access to NIH health-related research information. The notice states that the NIH intends to request that its grantees and supported Principal Investigators provide the NIH with electronic copies of all final version manuscripts upon acceptance for publication if the research was supported in whole or in part by NIH funding. This would include all research grants, cooperative agreements, contracts, as well as National Research Service Award (NRSA) fellowships. NIH defines final manuscript as the author's version resulting after all modifications due to the peer review process. Submission of the electronic versions of final manuscripts will be monitored as part of the annual grant progress review and close-out process.
NIH will archive these manuscripts and any appropriate supplementary information in PubMed Central (PMC), NIH's digital repository for biomedical research, maintained by NIH's National Library of Medicine. The manuscripts will be made freely available to the public through PMC no later than six months after the publication of the research study manuscript. If the publisher requests, the author's final version manuscript of the publication will be replaced in the PMC archive by the final publisher's copy with an appropriate link to the publisher's electronic database.
The NIH encourages comments concerning its intentions to enhance public access to NIH-funded health-related research. Comments on short-term impacts and suggestions for mitigating these are especially welcome.
Comments must be received on or before November 16, 2004 . Comments should be directed to the following NIH web site: http://grants.nih.gov/grants/guide/public_access/add.htm
Comments may also be submitted via email to PublicAccess@nih.gov or by mail to
NIH Public Access Comments
National Institutes of Health
Office of Extramural Research
6705 Rockledge Drive , Room 350
Bethesda, Maryland 20892-7963
In response to the NIH notice, many outside organizations and individuals have published comments. For example, a recent editorial in The New England Journal of Medicine addressed the issue of Public Access and the NIH notice (Drazen, Jeffrey M., M.D., and Gregory D. Curfman, M.D. The New England Journal of Medicine, 351;13; 1343. September 23, 2004). Many other organizations have also commented publicly. An NIH Fact Sheet on the topic of Public Access contains links to some of these organizations' web sites:
For more information on the NIH Public Access Initiative: http://www.nih.gov/about/publicaccess/index.htm
To access the notice in the NIH Guide to Grants and Contracts: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html
To access the notice in the Federal Register: http://www.nih.gov/about/publicaccess/federalregister.pdf
NIH Roadmap Update: NIH Director Elias A. Zerhouni, M.D., will release a statement on September 30th about the status of the NIH Roadmap for Medical Research one year after its launch. In addition to the news statement, the NIH will post three information backgrounders to the NIH Roadmap web page – one for each of the three themes of the Roadmap: New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise. More information on the NIH Roadmap for Medical Research can be found at http://nihroadmap.nih.gov/ .
NIH Clinical Research Center Dedication: The dedication ceremony for the Mark O. Hatfield Clinical Research Center (CRC) took place on September 22nd within the atrium of the new facility, an extension of the existing Warren Grant Magnuson Clinical Center located in the center of the NIH campus in Bethesda, Maryland . Together, the two centers form the NIH Clinical Center complex, part of the NIH intramural science research program. The CRC will promote translational research and encourage interaction and collaboration among clinicians and researchers by housing inpatient units, day hospitals, and research labs in close proximity to each other. Researchers are currently moving into the CRC laboratories and the first patients are scheduled to transfer to the inpatient units in early December, 2004.
Speakers at the dedication ceremony included HHS Director Tommy G. Thompson; NIH Director Elias A. Zerhouni, M.D.; NIH Clinical Center Director John I. Gallin, M.D.; Tom Harkin, United States Senator from Iowa; Paul S. Sarbanes, United States Senator from Maryland; the Honorable “C.W.” Bill Young, Congressman from Florida; and former Senator from Oregon, the Honorable Mark O. Hatfield, who supported medical research throughout his congressional career. More information on the Mark O. Hatfield Clinical Research Center is available at http://www.cc.nih.gov/ccc/crc/ .
Strategic Plan for Obesity Research: On August 24th, Dr. Zerhouni announced the release of the final version of the Strategic Plan for NIH Obesity Research, a multi-dimensional research agenda to enhance both the development of new research in areas of greatest scientific opportunity and the coordination of obesity research across NIH. Emphasizing the importance of cross-cutting investigations, the plan calls for interdisciplinary research teams to bridge the study of behavioral and environmental causes of obesity with the study of genetic and biologic causes. Areas of interest will include behavioral and environmental approaches to modifying lifestyle to prevent or treat obesity; pharmacologic, surgical and other medical approaches to effectively and safely prevent or treat obesity; breaking the link between obesity and diseases such as type 2 diabetes, heart disease, and certain cancers; research on special populations at high risk for obesity, including children, ethnic minorities, women and older adults; translating basic science results into clinical research and then into community intervention studies; and disseminating research results to the public and health professionals.
An NIH news release on this report is available at http://www.nih.gov/news/pr/aug2004/niddk-24.htm .
The report is available on the web at http://obesityresearch.nih.gov/ .
Liver Disease Action Plan: The NIDDK Liver Diseases Research Branch is leading a trans-NIH initiative to develop an Action Plan for Liver Disease Research. This Action Plan will provide an overview of current research funding in liver disease, summarize challenges to advancing liver disease research, delineate the major needs for future research, and provide a tactical plan for meeting these needs. The Strategic Plan draws on the insights of experts from NIH, other federal agencies, and the external liver disease research and advocacy communities.
More information on the NIDDK Liver Disease Research Branch is available at http://www.niddk.nih.gov/fund/divisions/ddn/ldrb.htm
More information on the Action Plan for Liver Disease Research is available at http://www.niddk.nih.gov/fund/divisions/ddn/ldrb/ldrb_action_plan.htm
Departing NIDDK Council Members: The National Diabetes and Digestive and Kidney Diseases Advisory Council met September 22nd, on the NIH Campus in Bethesda, Maryland. This was the parting council meeting for four NIDDK Advisory Council members. Mr. David Baldridge is the Director of the National Indian Project Center in Albuquerque, New Mexico. Dr. Jose F. Caro is Vice President, Endocrine Research and Clinical Investigations, at Eli Lilly in Indianapolis, Indiana. Dr. Carolyn J. Kelly is Professor of Medicine, Division of Nephrology-Hypertension, at the University of California, San Diego. Dr. Vicki Ratner is President and Founder of the Interstitial Cystitis Association in Los Gatos, California. The NIDDK thanks each of the members for their four years of service to NIH and NIDDK as advisory council members.
New NIDDK Staff Appointments: NIDDK welcomes several new members to the staff.
Joining the Division of Diabetes, Endocrinology, and Metabolic Diseases:
- Dr. Olivier Blondel comes to NIDDK from Human Genome Sciences, Inc., where he was a Senior Scientist in the Department of Preclinical Development, and designed integrated functional genomics screening programs for diabetes and obesity therapeutics and for the discovery of new secreted factors with growth-inhibitory and anti-angiogenic properties. Dr. Blondel will manage the bone endocrinology program and will contribute genomics expertise to the management of the Beta Cell Biology Consortium and the Diabetes Genome Anatomy Project.
- Dr. Lisa Spain was an Associate Professor in the Immunology Department of the American Red Cross Holland Lab, and Adjunct Associate Professor of Immunology at George Washington University Medical School . Dr. Spain will be managing research on the autoimmune process in type I diabetes and will serve as an advisor to TrialNet relevant to autoimmune interventions.
- Dr. Karen Teff comes to the NIDDK from the Monell Chemical Senses Center and the University of Pennsylvania where she was Associate Director for Patient-Oriented Research of the Penn Diabetes Center and Associate Program Director at the Pen GCRC. She will manage research portfolios on the neurobiology of appetite regulation, metabolic alterations in HIV, hypoglycemia, and glucose sensors.
Joining the Division of Digestive Diseases and Nutrition:
- Dr. Edward Doo is a hepatologist and gastroenterologist who joined the Liver Diseases Research Branch of DDN in June 2004. Before joining the NIDDK, he worked for two years as a transplant hepatologist at California Pacific Medical Center in San Francisco. From 1996 to 2002 he trained in hepatology in the intramural NIDDK Liver Diseases Section.
- Rebecca Torrance, a former Army nurse, joins DDN as a Clinical Trials Specialist, assisting with multi-center trials, most notably with the Data and Safety Monitoring Boards (DSMBs). She is a master's prepared nurse with experience in medical management, including outcomes management, population health analysis, and utilization review and management. She has research experience as a principal investigator, co-investigator, and project manager.
Joining the Division of Kidney, Urologic, and Hematologic Diseases:
- Dr. Mark Geanacopoulos joins the KUH staff as a technical writer. He came to the NIH in 1993 and joined the Laboratory of Molecular Biology at the National Cancer Institute. But an interest in science communications led him to journalistic work and a career in science writing. His journalistic work includes contributions to the educational outreach efforts of the American Academy for the Advancement of Science.
Joining the Review Branch:
- Dr. Carol Goter-Robinson joins the Review Branch as a Scientific Review Administrator. Her early research in the areas of immunotoxicology and human cytotoxic T cell maturation in the Department of Molecular Microbiology and Immunology at Johns Hopkins University, at the U.S. Food and Drug Administration, and at the University of Maryland School of Medicine led to her recent research in the area of protective immunity afforded by candidate tuberculosis DNA vaccines in a mouse model.
Joining the Office of Communications and Public Liaison:
- Ms. Marcia Vital joins the NIDDK as Deputy Director, Office of Communications and Public Liaison. She comes to the NIDDK from the NIH Office of the Director, Office of Communications and Public Liaison, where she was a press officer and science writer in the NIH News Media Branch. She has seven years of experience with NIH as a medical writer-editor, media relations specialist, press officer, and public information specialist.
Retirement of David Badman: After 30 years of service to the NIH and the NIDDK, Dr. David Badman, Director of the NIDDK Hematology Program and Deputy Director of the NIDDK KUH Division, will retire at the end of the 2004 calendar year. He joined the NIH in 1974 with a Ph.D. in zoology and graduate and teaching experience in basic biology. After completing the prestigious NIH Associates Program, Dr. Badman joined the NIDDK as the Director of the Hematology Program. During his 29 years at NIDDK, he led the Hematology Program through remarkable scientific growth and evolution. In addition, he fulfilled a number of other administrative roles for NIDDK, including his current position as Deputy Director of the KUH Division. Dr. Badman has received many awards and honors during his time at the NIDDK, including the NIH Award of Merit in 1983, the NIH Director's Award in 1993 and in 1999, and this year he was one of the first recipients of the new NIDDK Director's Awards. Dr. Badman will be much missed by his NIDDK colleagues, many of whom consider him a mentor and a friend.
I look forward to continued interaction with those of you who have an interest in the programs of NIDDK. Comments about this electronic newsletter can be directed to Betsy Singer, Public Liaison for NIDDK at Elizabeth_singer@nih.gov
Allen M. Spiegel, M.D., Director
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