Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts

2002 ◽  
Vol 30 (3) ◽  
pp. 390-402 ◽  
Author(s):  
Mark Barnes ◽  
Patrik S. Florencio
Keyword(s):  
Conflicts Of Interest ◽  
Medical Center ◽  
Human Subjects ◽  
The United States ◽  
Human Subjects Research ◽  
Human Research ◽  
University Of Oklahoma ◽  
Financial Conflicts Of Interest ◽  
Oklahoma Health ◽  
The University

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and Johns Hopkins University.At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board (IRB) — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration (FDA) a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center.

scholarly journals Conflicts of Interest in International Human Drug Research and the Insufficiency of International Protections

2006 ◽  
Vol 32 (2-3) ◽  
pp. 351-364 ◽  
Author(s):  
Robert Gatter
Keyword(s):  
Drug Research ◽  
Conflicts Of Interest ◽  
Human Subjects ◽  
Private Investment ◽  
Pharmaceutical Products ◽  
Pharmaceutical Companies ◽  
Human Subjects Research ◽  
Drug Companies ◽  
The World ◽  
Financial Conflicts Of Interest

The world relies largely on private firms for the development of new medicine, and the system is efficient. Driven by the incentive to profit from sales of new pharmaceuticals, drug companies risk millions of dollars and years of work to shepherd basic scientific discoveries through laboratory and human testing in the hope of developing a marketable drug. For example, it is estimated that in 2002 alone, pharmaceutical companies invested $45 billion the development of new medicine worldwide.While the profit incentive generates such enormous private investment in human drug development, it also encourages firms to pose inappropriate risks to the safety of human subjects when speeding a new drug to the market. The risks posed by financial conflicts of interest associated with human subjects research on new pharmaceutical products are notable examples, both in the U.S. and internationally.

scholarly journals The WxChallenge: Forecasting Competition, Educational Tool, and Agent of Cultural Change

2013 ◽  
Vol 94 (10) ◽  
pp. 1501-1506 ◽  
Author(s):  
Bradley G. Illston ◽  
Jeffrey B. Basara ◽  
Christopher Weiss ◽  
Mike Voss
Keyword(s):  
Cultural Change ◽  
State Of The Art ◽  
Learning Experience ◽  
The United States ◽  
Higher Learning ◽  
Educational Tool ◽  
Web Interfaces ◽  
Wind Speeds ◽  
University Of Oklahoma ◽  
The University

The WxChallenge, a project developed at the University of Oklahoma, brings a state-of-the-art, fun, and exciting forecast contest to participants at colleges and universities across North America. The challenge is to forecast the maximum and minimum temperatures, precipitation, and maximum wind speeds for select locations across the United States over a 24-h prediction period. The WxChallenge is open to all undergraduate and graduate students, as well as higher-education faculty, staff, and alumni. Through the use of World Wide Web interfaces accessible by personal computers, tablet computer, and smartphones, the WxChallenge provides a state-of-the-art portal to aid participants in submitting forecasts and alleviate many of the administrative issues (e.g., tracking and scoring) faced by local managers and professors. Since its inception in 2006, 110 universities have participated in the contest and it has been utilized as part of the curricula for 140 classroom courses at various institutions. The inherently challenging nature of the WxChallenge has encouraged its adoption as an educational tool. As its popularity has grown, professors have seen the utility of the Wx-Challenge as a teaching aid and it has become an instructional resource of many meteorological classes at institutions for higher learning. In addition to evidence of educational impacts, the competition has already begun to leave a cultural and social mark on the meteorological learning experience.

Commentary: An African Perspective on the Doha Round Negotiations

2005 ◽  
Vol 5 (4) ◽  
pp. 1850076
Author(s):  
Kwame Bawuah-Edusei
Keyword(s):  
Medical Center ◽  
The United States ◽  
University Hospital ◽  
Community Leader ◽  
Washington Dc ◽  
Medical Sciences ◽  
Energy Company ◽  
Army Hospital ◽  
Howard University ◽  
The University

An African commentary on the Doha Development Round. Kwame Bawuah-Edusei is Ambassador of Ghana to Switzerland and Austria and Permanent Representative of Ghana to the UN offices and international organizations in Geneva, including the WTO. He obtained his MD degree in 1982 at the University of Science and Technology, School of Medical Sciences, Kumasi Ghana, worked in Ghana for two years, and later studied in the United States. He specialized in Family Medicine at Howard University Hospital, Washington DC, and worked as a physician for the Dewitt Army Hospital in Fort Belvoir, Virginia. He subsequently practiced at Educe Medical Center in Alexandria, Virginia. During this period he was active in promoting business in his native Ghana and extensively involved in humanitarian work in the deprived Northern part of his country. He became a community leader in North America and was instrumental in institutionalizing democracy in Ghana. He became a Director of the EO group, an energy Company, and President of Educe Incorporated in Ghana.

Functional Limitations of Patients with End-Stage Ankle Arthrosis

2005 ◽  
Vol 26 (7) ◽  
pp. 537-539 ◽  
Author(s):  
Julie Agel ◽  
J. Chris Coetzee ◽  
Bruce J. Sangeorzan ◽  
Matthew M. Roberts ◽  
Sigvard T. Hansen
Keyword(s):  
Medical Center ◽  
Functional Limitations ◽  
Population Sample ◽  
Operative Management ◽  
The United States ◽  
University Of Minnesota ◽  
Previous Trauma ◽  
End Stage ◽  
The University ◽  
Foot Fractures

Background: Arthritis and other rheumatic conditions are the leading causes of disability among adults in the United States. The purpose of this report was to describe the self-reported functional limitations of a group of patients with end-stage ankle arthrosis. Method: Patients who presented for operative management of end-stage ankle arthrosis at the University of Minnesota and Harborview Medical Center completed a Musculoskeletal Functional Assessment (MFA) as part of their preoperative clinical evaluation. Data from patients evaluated during the time period April, 1995, through May, 2004, were used for this project. Results: Four hundred and twenty-six patients with the diagnosis of end-stage ankle arthrosis completed baseline questionnaires. Six of the 426 patients received care on both ankles during the time of this project. The average age of patients at the time of completion of the questionnaire was 56.7 years. There were 241 men and 185 women. The primary underlying causes identified by the treating surgeon at the time of surgery were primary osteoarthritis with no known prior trauma (66), previous trauma (tibial fracture, foot fractures, or ankle ligamentous disruption) (296), rheumatoid arthritis (24), no known cause (21), and a variety of diseases or infections (19). In all domains, the patients with end-stage ankle arthrosis showed statistically significant differences from a general population sample. Conclusions: The effects of ankle arthritis as demonstrated by this data are severe. Most of these patients were severely limited in function. Without a data-driven understanding of the limitations the patients have, it is difficult to make an effective argument for focused research to solve the problems. Without understanding the patients' needs, it is impossible to assess the effect of treatment. The information in this paper provides a baseline understanding of effect of the current functional limitations of patients with end-stage ankle arthrosis.

Risks, Benefits, and Conflicts of Interest in Human Research: Ethical Evolution in the Changing World of Science

2000 ◽  
Vol 28 (4) ◽  
pp. 330-331 ◽  
Author(s):  
Greg Koski
Keyword(s):  
Conflicts Of Interest ◽  
Human Subjects ◽  
Scientific Discovery ◽  
Ethical Conduct ◽  
Technological Advancement ◽  
Research Environment ◽  
Human Research ◽  
National System ◽  
New Challenges ◽  
Protection Of Human Subjects

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe.

scholarly journals Determinants of antimicrobial use practices among veterinary clinicians at The University of Tennessee Veterinary Medical Center

2017 ◽  
Author(s):  
John Eddie Ekakoro ◽  
Chika C Okafor
Keyword(s):  
Antimicrobial Stewardship ◽  
Medical Center ◽  
Human Subjects ◽  
Antimicrobial Use ◽  
Antimicrobial Drugs ◽  
University Of Tennessee ◽  
Modifiable Factors ◽  
Cumulative Logit ◽  
The University ◽  
Antimicrobial Prescription

Background. Antimicrobial drugs in veterinary medical practice are primarily prescribed for the purposes of maintaining or improving health and increasing productivity. However, their value is being eroded by antimicrobial resistance (AMR). Indiscriminate use of antimicrobial drugs is suggested as one of the modifiable factors contributing to the development of AMR. To reduce indiscriminate use and to improve antimicrobial use, veterinary practices are encouraged to adopt good stewardship practices. Therefore, the objectives of this study were: to identify factors influencing clinician decisions to begin using antimicrobials as well as the choice of antimicrobials used at The University of Tennessee Veterinary Medical Center (UTVMC); to evaluate the practices, perceptions, opinions and concerns of veterinary clinicians at UTVMC concerning antimicrobial use, antimicrobial stewardship, and AMR. Methods. This study’s protocol was approved by the University of Tennessee Knoxville IRB for the Protection of Human Subjects in Research. Survey software was used to send a questionnaire to 121 eligible participants, where all were UTVMC faculty with clinical appointments and house officers. Cumulative logit models were fitted to investigate associations between categorical explanatory variables and ordinal response variables. Results. A response rate of 51.24% was achieved. Of the 62 respondents, 47 (75.81%) reported that bacteriological culture and antimicrobial susceptibility test results were extremely important in their antimicrobial prescription decision-making. Thirty-two (51.61%) respondents believed antimicrobials are being over-prescribed. The cephalosporin class was the most preferred antimicrobial class, while the lincosamide class was the least preferred. From the multivariable cumulative logit model, year of graduation from veterinary school (P = 0.034) and clinicians’ primary patient load (P = 0.009) were significantly associated with clinicians’ degree of concern about AMR. Conclusions and clinical relevance. The findings suggest a need for more awareness about AMR among veterinary clinicians. Improvements in antimicrobial stewardship are needed, especially among veterinary clinicians who graduated after 1999. Educational practices that target modification of antimicrobial prescription practices of veterinary clinicians would likely improve a Good Stewardship Practice (GSP) mindset. GSP is important in prolonging the efficacy of currently available antimicrobial drugs.

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