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Jacob Schuman - One of the best experts on this subject based on the ideXlab platform.
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beyond nuremberg a critique of informed consent in third world Human Subject Research
2012Co-Authors: Jacob SchumanAbstract:I. INTRODUCTION: FROM NUREMBERG TO KANO A. The Birth of Informed Consent B. Global Challenges to Informed Consent C. Proposal for a Critique of Informed Consent in Third World Research II. THE PRINCIPLE OF INFORMED CONSENT: THEORY, POLICY, AND ADVOCACY A. The Theoretical Bases of Informed Consent B. The FDA's Informed Consent Policies for Foreign Research C. The Advocacy for Informed Consent in Third World Research III. A CRITIQUE OF INFORMED CONSENT IN THIRD WORLD Human Subject Research A. A Contextualization of Third Worm Research B. A Critique of the Right to Informed Consent in Third Worm Research C. A Critique of the Possibility of Informed Consent in Third Worm Research IV. BEYOND INFORMED CONSENT: DISTRIBUTIVE JUSTICE IN THIRD WORLD Human Subject Research V. CONCLUSION: TOWARD A "KANO CODE". The hidden Yes in you is stronger than all Nos and Maybes that afflict you and your age like a disease--Friedrieh Nietzsehe (1) I. INTRODUCTION: FROM NUREMBERG TO KANO A. The Birth of lnformed Consent The principle of "informed consent" forms one of the "basic ethical protections for Research involving Human participants." (2) Informed consent requires that a Human Subject of scientific Research "willingly verif[y] his/her willingness to participate in a particular treatment, after having been informed of all aspects which are pertinent to that treatment and relevant to the Subject's participation." (3) Governments around the world have adopted a variety of regulations (4) that articulate and enforce this "oldest and most universally accepted ethical standard in Research." (5) In the United States, the Federal Food, Drug, and Cosmetic Act (FDC should be so situated as to be able to exercise free power of choice ... and should have sufficient knowledge and comprehension of the elements of the Subject matter involved as to enable him to make an understanding and enlightened decision. (17) Later international guidelines, such as the World Medical Association's 1964 "Declaration of Helsinki," (18) provided further direction for medical Researchers. Nevertheless, the Nuremberg Code "remains the most authoritative legal and ethical document governing international Research standards." (19) Supreme Court Justice William Brennan once remarked, "[t]he medical trials at Nuremberg in 1947 deeply impressed upon the world that experimentation with unknowing Human Subjects is morally and legally unacceptable." (20) B. Global Challenges to Informed Consent The globalization of the pharmaceutical industry, especially the clinical testing process for new drugs, (21) has undermined enforcement of the informed consent requirement. …
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beyond nuremberg a critique of informed consent in third world Human Subject Research
2011Co-Authors: Jacob SchumanAbstract:Concerns about the welfare of Human Subjects in developing countries have led activists, academics, and government officials in the United States to call for reinforcement of the informed consent requirement in Third World pharmaceutical Research. This paper offers a critical analysis of that approach. Although the assurance of experimental Subjects‟ voluntary participation in Third World clinical studies is certainly a laudable goal, a rights-based notion of autonomous consent ignores the actual context in which that consent takes place — a terrain defined by the absence of essential medical treatment, desperation for healthcare, and important cultural differences. These circumstances belie the notion of an inalienable and universal right to freely assent to medical experimentation. As an alternative, this paper proposes that advocates concerned about the interests of Human Subjects in developing countries address the distributive consequences of globalized pharmaceutical testing. This approach seeks to ensure that Third World citizens enjoy the benefits of the clinical trials conducted in their communities.
Leon F Burmeister - One of the best experts on this subject based on the ideXlab platform.
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racial differences in factors that influence the willingness to participate in medical Research studies
2002Co-Authors: Vickie L Shavers, Charles F Lynch, Leon F BurmeisterAbstract:PURPOSE: The relative absence of racial/ethnic minorities among medical Research Subjects is receiving considerable attention because of recent government mandates for their inclusion in all Human Subject Research. We examined racial differences in the prevalence of sociocultural barriers as a possible explanation for the underrepresentation of African Americans in medical Research studies. METHODS: During 1998‐1999, a total of 198 residents of the Detroit Primary Metropolitan Statistical Area (PMSA) participated in a survey that examined impediments to participation in medical Research studies. Chi square tests and logistic regression analyses were used to examine the association between race, issues related to trust of medical Researchers, and the willingness to participate in medical Research studies. RESULTS: Study results indicate that African Americans and whites differ in their willingness to participate in medical Research. Racial differences in the willingness to participate in a medical Research are primarily due to the lower level of trust of medical Research among African Americans. African American respondents were also somewhat less willing to participate if they attribute high importance to the race of the doctor when seeking routine medical care, believed that minorities bear most of the risks of medical Research, and if their knowledge of the Tuskegee Study resulted in less trust in medical Researchers. CONCLUSION: These data reiterate the need for medical Researchers to build trusting relationships with minority communities. Researchers can begin by acknowledging the previous medical abuse of minority Research participants, discussing their specific plans to assure the protection of study participants, and explaining the need for the participation of racial/ethnic minorities including studies that specifically target or that are likely to result in disproportionate representation of racial/ethnic minorities among study participants. Ann Epidemiol 2002;12:248‐256 . © 2002 Elsevier Science Inc. All rights reserved.
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factors that influence african americans willingness to participate in medical Research studies
2001Co-Authors: Vickie L Shavers, Charles F Lynch, Leon F BurmeisterAbstract:BACKGROUND. The underrepresentation of African-Americans among medical Research participants is receiving considerable attention because of recent government mandates for the inclusion of all racial/ethnic groups in Human Subject Research. Therefore, there is a need to determine factors that influence minority enrollment in medical Research studies. METHODS. Between 1998-1999, 91 African-American residents of the Detroit Primary Metropolitan Statistical Area participated in a mail and telephone survey designed to examine impediments to participation in medical Research studies. Chi-square tests and multiple logistic regression analyses were used to examine the association between race, issues related to trust in medical Researchers, and the willingness to participate in medical Research studies. RESULTS. African-American respondents were somewhat less willing to participate if they attributed high importance to the race of the physician when seeking routine medical care, believed that minorities or the poor bear most of the risks of medical Research, and, most especially, their knowledge of the Tuskegee Study resulted in less trust in medical Researchers. CONCLUSIONS. These data reiterate the need for medical Researchers to build trusting relations with African-Americans and to conduct Research in an ethical manner. This includes maximizing benefits, reducing risks, and assuring distributive justice to all medical Research study participants.
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why are african americans under represented in medical Research studies impediments to participation
1997Co-Authors: Vickie L Shavershornaday, Charles F Lynch, Leon F Burmeister, James C TornerAbstract:Abstract Objectives. In accordance with the NIH Revitalization Act of 1993, the National Institutes of Health and the Alcohol, Drug and Mental Health Administration require grant applicants and cooperative agreement participants to include minorities in Human Subject Research. In an environment characterized by diminishing Research dollars, this mandate has increased the pressure on investigators to determine factors that impede minority participation and to develop strategies to overcome these impediments. Methods. An extensive review of the literature was conducted to identify the factors possibly responsible for the low participation levels of African Americans in medical Research studies and to highlight areas for further Research. The items examined included the historical relationship between African Americans and medical Researchers and the attitudes, perceptions and beliefs of potential participants and Researchers as they relate to the low representation of African Americans in medical Research. ...
Karen Kensek - One of the best experts on this subject based on the ideXlab platform.
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absolute glare factor and relative glare factor based metric predicting and quantifying levels of daylight glare in office space
2016Co-Authors: Marc Schiler, Karen KensekAbstract:Abstract Extensive Human Subject Research was performed to develop a daylight glare analysis methodology that correlates the Absolute Glare Factor (AGF) and the Relative Glare Factor (RGF). Literature reviews compared existing luminance thresholds developed by different Research groups. More than 450 Subjective data and visual scenes have been collected and analyzed to develop a new method. A HDR image analysis tool was developed in MATLAB to calculate luminance values and detect potential glare sources in digitally captured glare scenes. It was determined that using the Human eye’s field of view (FOV) improves the discomfort glare evaluation performance. Luminance and glare ratio thresholds were defined in statistical analysis software. In addition to the newly defined luminance and contrast thresholds for different office task types, an AGF- and RGF-based glare equation was developed to evaluate and report perceived glare levels. AGF and RGF dominant zones were displayed on a scatter plot graph to visually explain which glare factor is more dominant to cause discomfort glare. This overall approach can help users to understand a cause of daylight glare and find solutions to avoid glare issues, which would ensure occupant’s visual comfort in buildings.
Won Oak Kim - One of the best experts on this subject based on the ideXlab platform.
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institutional review board irb and ethical issues in clinical Research
2012Co-Authors: Won Oak KimAbstract:Clinical Research has expanded tremendously in the past few decades and consequently there has been growing interest in the ethical guidelines that are being followed for the protection of Human Subjects. This review summarizes historical scandals and social responses chronologically from World War II to the Death of Ellen Roche (2001) to emphasize the lessons we must learn from history. International ethical guidelines for studies with Human Subjects are also briefly described in order to understand the circumstances of clinical Research. The tasks and responsibilities of the institutions and investigators in Human Subject Research to preserve the safety and welfare of Research Subjects are summarized. Next, several debated ethical issues and insights are arranged as controversial topics. This brief review and summary seeks to highlight important arguments and make suggestions to institutional review boards (IRBs) to contribute to the future evolution of ethics in clinical Research as we advance forward.
Marc Schiler - One of the best experts on this subject based on the ideXlab platform.
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absolute glare factor and relative glare factor based metric predicting and quantifying levels of daylight glare in office space
2016Co-Authors: Marc Schiler, Karen KensekAbstract:Abstract Extensive Human Subject Research was performed to develop a daylight glare analysis methodology that correlates the Absolute Glare Factor (AGF) and the Relative Glare Factor (RGF). Literature reviews compared existing luminance thresholds developed by different Research groups. More than 450 Subjective data and visual scenes have been collected and analyzed to develop a new method. A HDR image analysis tool was developed in MATLAB to calculate luminance values and detect potential glare sources in digitally captured glare scenes. It was determined that using the Human eye’s field of view (FOV) improves the discomfort glare evaluation performance. Luminance and glare ratio thresholds were defined in statistical analysis software. In addition to the newly defined luminance and contrast thresholds for different office task types, an AGF- and RGF-based glare equation was developed to evaluate and report perceived glare levels. AGF and RGF dominant zones were displayed on a scatter plot graph to visually explain which glare factor is more dominant to cause discomfort glare. This overall approach can help users to understand a cause of daylight glare and find solutions to avoid glare issues, which would ensure occupant’s visual comfort in buildings.