The SRA Symposium - College of Medicine

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Papers Table 1 Total Number of Protocol Actions taken by the UHC IRB from 2000 through 2005 broken down by the Type of Review Year Number of Expedited Review Protocol Actions Number of Full Review Protocol Actions Total Number of Protocol Actions Annually 2000 1,055 674 1,729 2001 1,515 813 2,328 2002 1,525 1,053 2,578 2003 1,721 1,365 3,086 2004 1,658 1,392 3,050 2005* 1,517 1,606 3,123 Total 8,991 6,903 15,894 *annualized Table 2 Number of JCAHO Consent Form Discrepancies Found as a Function of the number of Documents Audited and Protocols Audited Year Discrepancies Consents Audited Consents Audited Percentage Protocols Audited Consents Audited Percentage 1999 19 106 17.9 % 81 23.5 % 2000 22 149 14.8 % 101 21.8 % 2001 14 129 10.9 % 108 13.0 % 2002 13 158 8.2 % 132 9.9 % 2003 7 158 4.4 % 137 5.1 % 2004 18 166 10.8 % 136 13.2 % 2005* 28* 180* 15.6 %* 144* 19.4%* Total 121 1046 11.6 % 839 14.4 % *annualized Table 3 UHC IRB Actions from January 2002 through March 2005 Broken down as Non- Compliance reviews versus Not Non-compliance reviews UHC IRB Actions from January 2002 through March 2005 Number Frequency Determination: Not an issue of non-compliance 4 .05 Determination: Non-serious non-compliance 26 .28 Determination: Serious non-compliance 5 .06 UHC IRB actions that did not involve potential compliance allegations 9,542 99.6 Total Number of Actions the IRB took during time period 9,577 n/a 76 2005 Symposium Proceedings Book
After A Day Of Infamy, December 7, 2003—What Regulatory Ethics Have Become at the National Institutes of Health by August 31, 2005 John J. Gillon, Jr., J.D., M.P.H. Senior Attorney Office of Petitions, U.S. Patent and Trademark Office,U.S. Department of Commerce Visiting Fellow, Center for Biomedical Ethics/University of Virginia Health System Serves pro bono on the Institutional Review Boards of Walter Reed Army Institute of Research, Walter Reed Army Medical Center, and the American Red Cross Biomedical Services 2921 Stanton Avenue Silver Spring, MD 20910-1218 Phone/FAX (301) 589-6527 john.gillon@starpower.net Authors’ Note The views presented are those of the author and do not represent the policy or opinion of the Government of the United States or any of its agencies. Comments from Society members are welcomed. Papers Abstract For the 17,500 employees of the National Institutes of Health there may have been a sense of unprovoked attack when they awoke to find that Los Angeles Times reporter David Willman had targeted their institution with allegations that conflicts of interest and their corrupting influences were standard operating procedure at the NIH. The Congressional and Inspector General investigations of these allegations demonstrated that fewer than 70 scientists—maybe fewer than 50—had violated ethics rules then in place. Yet, the newspaper’s indictment of the NIH staff was carried as a top story by news operations throughout the nation, even The Washington Post buried on page the vindication of the many thousands of dedicated women and men at the NIH. Why and how the staff and institutes of NIH came under—in the last half of the 20th Century—an unmeasured and almost wholly undefended attack is lucidly and elegantly discussed by Evan G. DeRenzo, Ph.D., in a recent article for the Kennedy Institute of Ethics Journal, and need and will not be re-examined here. Better now to reflect upon the substance of some of the changes that have taken place over the last decade—that is, to look at the regulations in the wake of legislation and the administration of former NIH Director, and Nobel Prize winner, Harold Varmus, M.D., and how those regulations have been changed twice in 2005 following the December 2003 L.A. Times allegations. Whether any of the feared mass exodus of scientific talent from the NIH occurs likely will have more to do with whether the monies and the freedoms to engage in challenging and state-of-the-art scientific research continue to be made available to NIH staff than what stocks NIH staffers can own and for whom they can consult. Introduction Flooded with 1,300 comments by employees and threats of high-level defections, the head of the National Institutes of Health agreed [on August 25, 2005,] to loosen some of the ethics rules he unveiled in February. * * * Congress prompted the new regulations after lawmakers discovered that dozens of scientists had not revealed income and other perks they received from for-profit companies, as required. (Emphasis supplied) -- The Washington Post, Friday, August 26, 2005 (Connolly 2005) 2005 Symposium Proceedings Book 77
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2005 Symposium Proceedings The SRA
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Dear Colleagues and Friends, Octobe
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Table of Contents Karen M. Wilson.
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Poster Abstracts
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Page 48 and 49: Papers Introduction Day by day soci
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Page 68 and 69: Papers The Utility of Gender, Race,
Page 70 and 71: Papers As a three hospital health c
Page 72 and 73: Papers References Amdur, R., Banker
Page 74 and 75: Papers • Dramatic Growth in Resea
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Papers Conclusion Defense mechanism
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Papers of Pennsylvania in 2000. In
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Papers for board members, reviewing
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Papers Focusing on “Development
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Papers Figure 1: Total UB Internal
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Papers Respondents’ evaluations o
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Papers 140 2005 Symposium Proceedin
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Papers Abstract “Best Practices
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Papers INSTITUTIONAL ERA PLANNING A
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Papers Typically, all interactions
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Papers Figure 2 There are nine pers
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Papers Using the innovation success
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Papers The second is the Botswana T
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Papers European and Federal Funding
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Papers As the majority of US Univer
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Papers Integrated Project Duration
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Papers Conclusion SRA is an interna
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Papers and in which disciplines. Th
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Papers Benefits of Working with Jun
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Papers Mentoring and Motivating: Br
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Papers Introduction Certification p
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Papers References Bratton, B. & Hil
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Papers Never let your sense of mora
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Papers Table 1 Research Attitudes -
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