Dark Medicine: How the National Research Act Has Failed To
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
Henrietta Lacks Enhancing Cancer Research Act of 2019
G:\COMP\116\HENRIETTA LACKS ENHANCING CANCER RESEARCH ACT....XML Henrietta Lacks Enhancing Cancer Research Act of 2019 [Public Law 116–291] [This law has not been amended] øCurrency: This publication is a compilation of the text of Public Law 116–291. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https:// www.govinfo.gov/app/collection/comps/¿ øNote: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).¿ AN ACT To direct the Comptroller General of the United States to complete a study on barriers to participation in federally funded cancer clinical trials by popu- lations that have been traditionally underrepresented in such trials. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ‘‘Henrietta Lacks Enhancing Can- cer Research Act of 2019’’. SEC. 2. FINDINGS. Congress finds as follows: (1) Only a small percent of patients participate in cancer clinical trials, even though most express an interest in clinical research. -
Informed Consent and Shared Decision Making in EBM
3 Informed Consent and shared decision making in EBM 3.1 ‘Informed consent’ in regular medical practice ‘Consent’ as it is understood in the medical context has to be asked from the pa- tient and is the explicit agreement to waive a right to certain rules and norms which are normally expected in the treatment of other people and of ourselves as patients. Every surgical procedure would, without consent from the patient, be legally un- derstood as assault and battery and the physician could be prosecuted for perform- ing it. ‘Informed consent’ therefore in its most simple form means that the patient has received a good explanation about a medical procedure, understands what is happening to him or her and then can make an informed choice to accept or refuse, in the latter case the so called ‘informed refusal.167 In order to give ‘informed con- sent the patient has to be capable of understanding the information given by the physician. He or she must be competent to decide and to give consent voluntarily without being coerced by any means into giving consent.168 ‘Autonomy’ of the patient, hereby equated with ‘person’ plays the overarching role in ‘informed con- sent.’ A competent person who exercises autonomy will have the final say about their own life. ‘Autonomy’ itself is a contested term in the philosophy of science and interpretations therefore vary. According to Dworkin, “Liberty (positive or negative) ... dignity, integrity, individuality, independence, responsibility and self knowledge ... self assertion ... critical reflection ... freedom from obligation ... ab- sence of external causation ... and knowledge of one’s own interests.”169 all fall under the definition of autonomy. -
Presentation Abstracts
Eighth Annual Western Michigan University Medical Humanities Conference Conference Abstracts Hosted by the WMU Medical Humanities Workgroup and the Program in Medical Ethics, Humanities, and Law, Western Michigan University Homer Stryker M.D. School of Medicine September 13-14, 2018 Our Sponsors: Western Michigan University Homer Stryker M.D. School of Medicine, WMU Center for the Study of Ethics in Society, WMU Department of Philosophy Ethics After Error: Malpractice, Mistrust, and the Limits of Medical Moral Repair Ben Almassi, PhD Division of Arts & Letters Governors State University Abstract: One limitation of medical ethics modelled on ideal moral theory is its relative silence on the aftermath of medical error – that is, not just on the recognition and avoidance of injustice, wrongdoing, or other such failures of medical ethics, but how to respond given medical injustice or wrongdoing. Ideally, we would never do each other wrong; but given that inevitably we do, as fallible and imperfect agents we require non-ideal ethical guidance. For such non-ideal moral contexts, I suggest, Margaret Walker’s account of moral repair and reparative justice presents powerful hermeneutical and practical tools toward understanding and enacting what is needed to restore moral relationships and moral standing in the aftermath of injustice or wrongdoing, tools that might be usefully extended to medical ethics and error specifically. Where retributive justice aims to make injured parties whole and retributive justice aims to mete out punishment, reparative justice “involves the restoration or reconstruction of confidence, trust, and hope in the reality of shared moral standards and of our reliability in meeting and enforcing them.” Medical moral repair is not without its challenges, however, in both theory and practice: standard ways of holding medical professionals and institutions responsible for medical error and malpractice function retributively and/or restitutively, either giving benign inattention to patient-practitioner relational repair or impeding it. -
International Regulation of Human Subject Experimentation
04__LAUGHTON.DOC 5/27/2008 1:29:05 PM SOMEWHERE TO RUN, SOMEWHERE TO HIDE?: INTERNATIONAL REGULATION OF HUMAN SUBJECT EXPERIMENTATION ADAM H. LAUGHTON* INTRODUCTION The pharmaceutical industry is one of the most important players in the field of clinical research on human beings. Increasingly in recent years, “Big Pharma” in the United States and elsewhere has turned to foreign populations to test its new products. The purpose of this note is to examine how existing sources of quasi-legal and ethical regulation address the troublesome issues raised by this increase in international human experimentation. First, the note gives a brief history of human experimentation and its regulation, giving special focus to the events of the twentieth century that have most affected the development of the bioethics movement. Next, it describes and compares several instruments of international regulation of human subject experimentation. Finally, it examines some of the difficult ethical issues associated with international research on human subjects. In this discussion, the greatest amount of attention will be given to clinical trials performed by the pharmaceutical industry. Other types of international research on human subjects exist, but research by the pharmaceutical companies poses its own special regulatory and ethical problems. I. HISTORY AND BACKGROUND A. Pre-Nuremberg Though the Holocaust and the concurrent Nazi experimentation on prisoners and Jews1 brought unprecedented attention to Copyright © 2007 by Adam H. Laughton. * Adam H. Laughton is a J.D. candidate at Duke University School of Law and an Executive Editor of the Duke Journal of Comparative and International Law. He would like to thank his wife Ariel Bybee Laughton for her constant support in all of his academic endeavors. -
IRB Presentation
Institutional Review of Research Involving Human Participants IRB Presentation University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html 1 University of Central Florida Institutional Review Board Overview Sophia F. Dziegielewski, Ph.D., LCSW IRB Chair Michael G. Deichen, MD, MPH IRB Vice Chair IRB Office Staff: Joanne Muratori, MA, CIP, CIM Patria Davis, MSP, CIP Kamille Chaparro, BS Gillian Morien, BS 2 IRB Function The purpose of an IRB is to review research involving human subjects to ensure their rights and welfare are adequately protected. 3 The Role of the IRB Members Charged with safeguarding the rights and welfare of human subjects. Duties include reviewing protocols that involve the use of human subjects. Assist and guide researchers to help protect the rights of human subjects 4 Research Ethics Why Do Human Research Subjects Need Protection? Trigger Events • The Nazi Experiments • Tuskegee Syphilis Study • Milgram’s Studies • Rosenhan Studies • Laud Humprey’s 6 Trigger Events: “What we have learned from history…” Nazi experimentation on concentration camp prisoners Tuskeegee Syphilis Study Milgram Study 7 Do we have a right to use information gathered unethically? Prisoner of War camps in Asia and Europe: practiced mutilation surgery, tested antibiotics, affects of cold, injured people to study the healing process. Tuskegee Experiments: Physical Harm 1932 took 625 black males and studied the course of syphilis. 425 were diagnosed as having syphilis and the remainder were used as a control. In 1937 we discovered Penicillin but still did not give it to the men. -
Tuskegee and the Health of Black Men
Tuskegee and the Health of Black Men Marcella Alsan and Marianne Wanamaker April 2016 PRELIMINARY. COMMENTS WELCOME. Abstract JEL Codes: I25, O15 For forty years, the Tuskegee Study of Untreated Syphilis in the Negro Male passively monitored hundreds of adult black males with syphilis despite the availability of effective treatment. The study’s methods have become synonymous with exploitation and mistreatment by the medical community. We find that the historical disclosure of the study in 1972 is correlated with in- creases in medical mistrust and mortality and decreases in outpatient physician interactions for black men. Blacks possessing prior experience with the medical community, including veterans and women, appear to have been less affected by the disclosure. Our findings relate to a broader literature on how be- liefs are formed and the importance of trust for economic exchanges involving asymmetric information. We are grateful to William Collins, Joe Ferrie, Nathan Nunn, John Parman, Achyuta Adhvaryu, Arun Chandrasekhar, Martha Bailey, Rebecca Diamond, Claudia Goldin, Melanie Morten, Mark Duggan, Mark Cullen, Melissa Dell, Nancy Qian, Ran Abramitzky, Pascaline Dupas, Rema Hanna, Grant Miller and participants at NBER DAE, University of Tennessee, Vander- bilt Health Policy, Carnegie Mellon Applied Microeconomics, University of Copenhagen Economics, University of Pennsylvania Health Policy, ASSA 2016 Berkeley Population Center, University of Chicago Harris and Stanford Health Policy for constructive comments. We thank the CDC for providing access and to the administrators at the Atlanta and Stanford Census Research Data Centers for their help in navigating the restricted data. We thank Michael Sinkinson, Martha Bailey, Andrew Goodman-Bacon and Walker Hanlon for sharing data and methods. -
Duck and Cover: How Print Media, the U.S. Government, and Entertainment Culture Formedamerica's Understanding of the Atom
DUCK AND COVER: HOW PRINT MEDIA, THE U.S. GOVERNMENT, AND ENTERTAINMENT CULTURE FORMEDAMERICA’S UNDERSTANDING OF THE ATOM BOMB A thesis submitted in partial fulfillment of the requirements for the degree of Master of Arts By Daniel Patrick Wright B.A., University of Cincinnati, 2013 2015 Wright State University WRIGHT STATE UNIVERSITY GRADUATE SCHOOL May 5, 2015 I HEREBY RECOMMEND THAT THE THESIS PREPARED UNDER MY SUPERVISION BY Daniel Patrick Wright ENTITLED Duck and Cover: How Print Media, the U.S. Government and Entertainment Culture Formed America’s Understanding of the Atom Bomb BE ACCEPTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF Master of Arts ________________________________ Jonathan Winkler, Thesis Director ________________________________ Carol Herringer, Chair History Department Committee on College of Liberal Arts Final Examination ________________________________ Drew Swanson, Ph.D. ________________________________ Nancy Garner, Ph.D. ________________________________ Robert E. W. Fyffe, Ph.D. Vice President for Research and Dean of the Graduate School ABSTRACT Wright, Daniel Patrick. M.A. Department of History, Wright State University, 2015. Duck and Cover: How Print Media, the U.S. Government and Entertainment Culture Formed America’s Understanding of the Atom Bomb This research project will explore an overview of the different subsections of American post-war society that contributed to the American “atomic reality” in hopes of revealing how and why the American understanding of atomic weapons did not slowly evolve over the course of a generation, but instead materialize rapidly in the years following the bombing of Hiroshima and Nagasaki. By analyzing government sources and programs, print media sources such as newspapers and magazines, and the American entertainment culture of the 1940s and 1950s, this research project will answer exactly why and how the American public arrived at its understanding of the atom bomb. -
Hela's Ancestors
HELA’S ANCESTORS Teaching about Race and Science A guide to teaching with Rebecca Skloot’s The Immoral Life of Henrietta Lacks Mikaila Mariel Lemonik Arthur Rhode Island College Department of Sociology [email protected] Rebecca Skloot’s masterpiece of science writing, The Immoral Life of Henrietta Lacks (2009), tells the story of how American science developed the ability to culture and grow cell lines in science laboratories—and how this development is intimately tied to the story of one woman, her family, and their unfortunate experiences with racial and health care inequality in the United States. My goal in this Teaching Guide is to explore some of the ways in which Henrietta Lacks’s story emerges from a larger history in which people of color have been mistreated by the scientific establishment in so very many ways. While Skloot alludes to some of these issues, her book is better understood as a biography of the HeLa cell line—and thus, it is up to those of us who use the book in our classrooms to ensure that we teach the book not only as the story of one poor woman and her family’s suffering or as the story of the casualties of scientific progress but instead as a chronicle of one incident in a litany of incidents that make up the history of racial science in our nation. While there are many ways to approach these topics, this teaching guide will focus on three particular aspects of the history of race and science of relevance for teaching and learning in the context of The Immortal Life of Henrietta Lacks: (1) race, ethics, and experimentation in relation to the development of protections for human subjects in research; (2) the history of attempts to “scientize” racial inequality; and (3) race-based medical practice. -
THE ROLE of INSTITUTIONAL REVIEW BOARDS in AVIATION RESEARCH: IT's the LAW and IT MAKES SENSE Dr
THE ROLE OF INSTITUTIONAL REVIEW BOARDS IN AVIATION RESEARCH: IT'S THE LAW AND IT MAKES SENSE Dr. Earl S. Stein FAA, William J. Hughes Technical Center Atlantic City International Airport, New Jersey Research in medicine and social sciences often involves the participation of human participants, who under the rules in place today volunteer their time and understand both the benefits and risks associated with the research. This was not always the case. Rules, regulations, and laws currently require oversight by organizations referred to as Institutional Review Boards (IRBs). These boards exist to protect the participants, ensure their ethical treatment, and encourage good research. IRBs enhance the quality of research planning, and the IRB process should be part of every researcher's timeline for completion of his/her projects. example of the CIA's LSD research program. He was Research involves a systematic search for a reality given LSD without informed or any other consent; it that transcends our concepts as individuals. While led to depression and his suicide (Elliston, 2004). The philosophers will debate that there are many realities, US Army also experimented with LSD and a in science we attempt to narrow the options. In social psychoactive gas, quinuclindnyl benzilate (BZ), from science we usually state our conclusions in 1955 to 1975 at Edgewood Arsenal Maryland, on probabilistic terms, admitting that there is some soldier "volunteers", who were told they would chance we could be wrong. experience transitory discomfort and could terminate We base our conclusions on data gathered from the the experiment any time they wished but only with systematic study of some phenomenon such as the consent of the physician in charge (Edgewood behavior. -
United States Court of Appeals for the Ninth Circuit
Case: 13-36217, 03/14/2016, ID: 9899915, DktEntry: 34-1, Page 1 of 33 FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT GEORGE O. MITCHELL, No. 13-36217 Plaintiff-Appellant, DC No. v. 3:12 cv-05403 BHS STATE OF WASHINGTON; KELLY CUNNINGHAM, SCC Superintendent; DR. THOMAS BELL, OPINION Defendants-Appellees. Appeal from the United States District Court for the Western District of Washington Benjamin H. Settle, District Judge, Presiding Argued and Submitted April 6, 2015—Pasadena, California Filed March 14, 2016 Before: Dorothy W. Nelson, A. Wallace Tashima, and Richard R. Clifton, Circuit Judges. Opinion by Judge Tashima; Concurrence by Judge Clifton Case: 13-36217, 03/14/2016, ID: 9899915, DktEntry: 34-1, Page 2 of 33 2 MITCHELL V. STATE OF WASHINGTON SUMMARY* Prisoner Civil Rights The panel affirmed the district court’s summary judgment in an action brought pursuant to 42 U.S.C. § 1983 in which plaintiff, who is civilly committed as a sexually violent predator, alleged that defendants’ refusal to treat his Hepatitis C with interferon and ribavirin violated his right to reasonable medical care and that the consideration of race in the denial of this treatment violated the Equal Protection Clause. The panel first held the district court erred by finding that the damages claims against the state defendants were barred by the Eleventh Amendment. The panel held that even though plaintiff testified in his deposition that he was suing defendants only in their official capacities, his amended complaint clearly stated that he was suing defendants in both their official and personal capacities for damages and injunctive relief and the record demonstrated that plaintiff, acting pro se, did not understand the legal significance of bringing claims against defendants in their official versus personal capacities. -
Clinical Research Straight Talk
Clinical Research: Straight Talk about When Expectations Meet Reality Reina Hibbert, CCRC Regulatory Manager Phase 1 & RCC/Melanoma Clinical Trials Agenda Fundamentals ► The scientific method ► Phases of trials ► Basic evolution of trial structure ► History: Errors, Corrections and Successes Critical skills Identifying pressures The business of clinical research vs. the goals and outcomes Permission or forgiveness: how do you decide? Errors: embracing the chaos to find the opportunities Public perception The far-reaching effects of research outcomes 2 Fundamentals – The Scientific Method 3 Fundamentals – The Phases of Trials Approval Phases 2, 3 (and sometimes 4) Pilot and Phase 1 Pre-Clinical 4 Fundamentals – A History Lesson 5 Fundamentals - Historical Errors Ojanuga, D. (1993). The medical ethics of the'father of gynaecology', Dr J Marion Sims. Journal of medical ethics, 19(1), 28-31. 6 Fundamentals – Historical Errors 7 Brandt, A. M. (1978). Racism and research: the case of the Tuskegee Syphilis Study. Hastings center report, 8(6), 21-29. Fundamentals – Historical Errors 8 Spector-Bagdady, K., & Lombardo, P. A. (2013). “Something of an adventure”: postwar NIH research ethos and the Guatemala STD experiments. The Journal of Law, Medicine & Ethics, 41(3), 697-710. Fundamentals – Historical Errors Williams, P., & Wallace, D. (1989). Unit 731: Japan's secret biological 9 warfare in World War II (pp. 178-179). New York: Free Press. Fundamentals – Historical Errors 10 Annas, G. J., & Grodin, M. A. (1992). The Nazi doctors and the Nuremberg Code Human rights in human experimentation. Fundamentals – Historical Errors 11 Marks, J. (1979). The search for the" Manchurian candidate": The CIA and mind control (pp. -
Tuskegee Mixer Materials
Tuskegee Syphilis Study Mixer By Gretchen Kraig-Turner (with additions and revisions by Linda Christensen) Questions: 1. Find someone who supported the study. Who is it? Why did this person support the study? 2. Find someone who was hurt by the Tuskegee Study. Who is it? How was this person hurt? 3. Find someone who took action about the Tuskegee Study. Who is it? What did the person do? 4. Find someone who benefited from the Tuskegee Study. Who is it? How did this person benefit? 5. Find a doctor who was connected to the Tuskegee Study. Who is it? What was his connection to the study? 6. Find someone who was troubled by the Tuskegee Study. Who is it? What troubled this person? 7. Find someone who had to make a choice about their role in the study. Who was it? What choice did the person have to make? Jean Heller: After receiving a tip from whistleblower Peter Buxtun, who worked as an interviewer for the Public Health Service, Associated Press asked me to investigate Buxtun’s claims about an unethical medical study focused on African American men with syphilis. Although I wrote the story that eventually stopped the study, Peter Buxtun was the one who uncovered the story and investigated what he believed was an immoral study. On July 25, 1972, the Washington Evening Star newspaper ran my article on its front page: "Syphilis Patients Died Untreated." I wrote: For 40 years, the U.S. Public Health Service has conducted a study in which human guinea pigs, not given proper treatment, have died of syphilis and its side effects.