History Of Medical Research Research Articles

Review: Medical Films, Ethics and Euthanasia in Nazi Germany: The History of Medical Research and Teaching Films of the Reich Office for Educational Films/Reich Institute for Films in Science and Education, 1933-1945

1University of Toronto (Emeritus), #811, 21 Mayfair Ave., Toronto, Canada M5N‐2N5 Medical Films, Ethics and Euthanasia in Nazi Germany: The History of Medical Research and Teaching Films of the Reich Office for Educational Films/Reich Institute for Films in Science and Education, 1933–1945 Ulf Schmidt Husum, Germany Matthiesen Verlag 2002 394 Paperback€56

Review: Medical Films, Ethics and Euthanasia in Nazi Germany: The History of Medical Research and Teaching Films of the Reich Office for Educational Films/Reich Institute for Films in Science and Education, 1933-1945

Review: Medical Films, Ethics and Euthanasia in Nazi Germany: The History of Medical Research and Teaching Films of the Reich Office for Educational Films/Reich Institute for Films in Science and Education, 1933-1945

Ethics in the Design and Conduct of Clinical Trials

The history of medicine reveals the need for clinical research. All too frequently, interventions thought to be safe and effective by clinicians prove to be otherwise. The current emphasis on “evidence-based medicine” enunciates the need for carefully obtained data from carefully conducted clinical research; yet the history of medical research in general, and clinical research in particular, has been an unfortunate and littered one in which some physician-scientists have undermined the rights and interests of the participants. While some of the most frequently cited examples of unethical research are clearly egregious, such as the dangerous experimentation on unwilling concentration camp prisoners by Nazi physicians, others are more subtle and involve the misuse of commonly employed, rigorous methods of study design such as randomization and use of placebos. While underrecognition of these issues may be the norm, recent headlines demonstrate that ethical issues associated with certain types of study designs can animate substantial debate. Witness, for example, the controversy over the use of placebo controls in trials aimed at decreasing vertical transmission of human immunodeficiency virus infection (1). Regardless of whether such ethical issues are overt or subtle, it is critical that persons designing, sponsoring, overseeing, conducting, reviewing, and reading the results of clinical research understand these issues so as to ensure that all persons who agree to participate in research are adequately protected.

Informed Consent in Clinical Trials of in Vitro Diagnostic Devices: Perspectives from the FDA and Manufacturers

The need for informed consent from human subjects whose specimens are used in in vitro diagnostic studies is sometimes questioned. This is especially the case if the research carries only minimal risk to the subject. However, the process of obtaining informed consent recognizes the autonomy of the human subject to decide whether to participate in research regardless of whether there are risks. In this opinion, we will discuss the history of ethics in medical research and how this relates to federal regulations governing informed consent (see Table 1⇓ ). View this table: Table 1. FDA law and regulations addressing informed consent. Human participants in biomedical research contribute tremendously to our overall societal good. Unfortunately, the history of medical research is checkered with several unethical studies. For example, past atrocities, such as those described at the Doctor’s Trial at Nuremberg, Germany (1) and in the syphilis study at Tuskegee, Alabama (2), showed no respect for the autonomy of human research participants. These and other unethical studies have influenced the rules governing modern biomedical research. The basic principles underlying the current US federal regulations for human biomedical research can be traced to three landmark documents. The first document was the Nuremberg Code (3), formulated for the Doctor’s Trial at Nuremberg in 1947 and later adopted by the American Medical Association. The first of the 10 principles of the Nuremberg Code is “The voluntary consent of the human subject is absolutely essential”. Although the entire Nuremberg Code has not been formally adopted as law by any nation, its basic requirement for informed consent is a universal standard expressed in both international law (4) and international ethical guidelines for conducting human biomedical research (5). This document is often cited as the most important in the history of the ethics of medical research. The second salient document is the … [↵][1]bAddress correspondence to this author at: Ortho-Clinical Diagnostics, 1001 US Hwy 202, Raritan, NJ 08869. Fax 908-218-8822; e-mail RMcCorma{at}OCDUS.JNJ.com. [1]: #xref-corresp-2-1

New approaches to vaccines against tuberculosis: where we stand and where we want to go. Introductory remarks to the symposium.

The discovery of the tubercle bacillus, Mycobacterium tuberculosis, by Robert Koch in 1882, was a great moment in the history of medical research. The description of the bacterium was the ¢rst step in overcoming one of the most devastating epidemics, that of tuberculosis. In 1907 the `Robert Koch Foundation to Fight Tuberculosis' was founded and Robert Koch was the ¢rst scientist to receive a grant from the foundation for his research activities. In his speech of thanks to one of the patrons he made the following comments (in German):The general public is already convinced that tuberculosis is an avertable disease and people have learned to avoid infection better than was previously the case. Since the public awareness of this fact, the mortality rate of tuberculosis has been greatly reduced in all civilised countries and the indications that this disease will be completely wiped out are increasing. This is the moment to take up arms on all fronts. Unfortunately, these words still hold true 90 years later. Among infectious diseases, tuberculosis is responsible for the greatest number of deaths. Each year 54 million people are infected with M. tuberculosis, 7 million develop clinical diseases and 3 million people die of tuberculosis. BCG is currently the only available vaccine against tuberculosis and is widely administered within the WHO Expanded Programme for Immunization. It is generally accepted that the BCG vaccine can prevent death from disseminated tuberculosis in children, but its e¤cacy in preventing pulmonary tuberculosis in adults is extremely doubtful (trials of e¤cacy ranging from 0% in India to 77% in UK). Due to this insu¤cient e¤cacy and because the vaccine interferes with skin test screening, thwarting a discrimination between a BCG vaccination and an infection of M. tuberculosis, the BCG vaccination is not recommended for general use in many countries. The tool which has been adopted by the WHO as the main strategy for the global control of tuberculosis, but which requires that drug therapy be carefully supervised to assure compliance, is the `Directly Observed Treatment Short-course' (DOTS). Unfortunately this chemotherapy is relatively expensive, has signi¢cant side eiects, and a cure requires more than six months of DOTS. In areas of the world

New approaches to vaccines against tuberculosis: where we stand and where we want to go: Introductory remarks to the symposium

The discovery of the tubercle bacillus, Mycobacterium tuberculosis , by Robert Koch in 1882, was a great moment in the history of medical research. The description of the bacterium was the first step in overcoming one of the most devastating epidemics, that of tuberculosis. In 1907 the ‘Robert Koch Foundation to Fight Tuberculosis’ was founded and Robert Koch was the first scientist to receive a grant from the foundation for his research activities. In his speech of thanks to one of the patrons he made the following comments (in German): The general public is already convinced that tuberculosis is an avertable disease and people have learned to avoid infection better than was previously the case. Since the public awareness of this fact, the mortality rate of tuberculosis has been greatly reduced in all civilised countries and the indications that this disease will be completely wiped out are increasing. This is the moment to take up arms on all fronts. Unfortunately, these words still hold true 90 years later. Among infectious diseases, tuberculosis is responsible for the greatest number of deaths. Each year …

Clinical Trials in Australia

Australia has a strong history of medical research. Regulatory mechanisms relating to the conduct of clinical trials were established approximately 30 years ago; since then, the legislation and procedures have undergone a number of changes. Much of the impetus for those changes has come from the medical research community seeking greater involvement in pharmaceutical research and development. The effect of the changes has been a decrease in regulatory agency involvement and a marked increase in the number of clinical trials being conducted. Australia is currently considering its position regarding adoption of the International Conference on Harmonization Good Clinical Practice (ICH GCP) Guideline.

The Patient-Physician Relationship: Covenant or Contract?

The Patient-Physician Relationship: Covenant or Contract?

Ethical Issues in Prehospital Research

The atrocities committed by Nazi physicians and scientists, in the name of furthering medical science, is an appalling page of the history of medical research. In the wake of World War II, the scientific community strived to develop regulations to guard against future abuses in medical research. However, a particularly sobering thought is that the atrocities in Germany were being carried out in a country that had specific regulations for protecting human research subjects: Nazi Germany was the only European country to have such regulations. A more in-depth look at these regulations reveals institutional or department heads were held accountable, but not the individual researcher. The lesson from this analysis is clear: individual investigators must bear the responsibility of conducting ethical research. Governmental regulations and Institutional Review Boards never can replace investigators who are advocates for the protection of human subjects.The purpose of this paper is to address issues broadly regarding ethics and prehospital research, with a focus on the topic of informed consent.

The post-concussional syndrome then and now.

The post-concussional syndrome (PCS) is a relatively common and potentially devastating condition. It may follow what seem to be quite trivial closed head injuries, as well as more obviously severe cases. Despite a considerable volume of clinical and research publications in the past 25 years, which generally point towards an organic basis to the condition, the PCS seems to remain largely overlooked or under-diagnosed in this country. This paper presents a summary of the history of medical research and controversy relating to concussion and the PCS. Evidence in support of the organic aetiology of the PCS is summarised.

The atrial natriuretic factor: its physiology and biochemistry.

In the history of medical research, few advances have been more rapid — in all aspects — than those in the research on the atrial natriuretic factor since the original observation by de Bold et al. in 1981 of the marked natriuresis, diuresis, and vasorelaxation following the i. v. administration of crude atrial extracts. The atrial factor responsible for these findings has been isolated and sequenced, the cDNA coding for ANF has been cloned, and the gene has been localized on the chromosomal map. Most of its biological activities have been determined, and these clearly provide a balance to the activities of the reninangiotensin system. Many points remain to be elucidated, such as the role of ANF in patients with essential hypertension with congestive heart failure; the participation of ventricular ANF in pathological states such as hypertension and congestive heart failure; the interplay of ANF and angiotensin II in brain regions involved in the regulation of sodium, water, and blood pressure such as the AV3V region and the subfornical organ; the role of ANF in the ciliary bodies of the eyes; the relationship of particulate guanylate cyclase stimulation and adenylate cyclase inhibition with vasorelaxation; the neuromodulatory role of ANF in neural transmission; and many others. Fundamental questions remain to be answered and offer a field for innovative researches.

Responsibilities of Coauthors

Letters and Corrections1 December 1983Responsibilities of CoauthorsKANTI R. RAI, M.D.KANTI R. RAI, M.D.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-99-6-884_3 SectionsAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail ExcerptTo the editor: The Darsee affair has been a sad chapter in the history of medical research. The two letters (1, 2) of "retraction" in the August 1983 issue of theAnnalsare even sadder reading. Darsee's coauthors for the two articles published in theAnnalsin 1980 and 1978, respectively, have written these letters apparently to apologize to theAnnalsand its readers. But if read carefully, the apology is not for the inconvenience caused by the coauthors' failure in their responsibility to ensure accuracy of data, but for any embarrassment and inconvenience that might result from "our investigation...

ReviewDie Gesunde und Kranke Wirbelsäule in Röntgenbild und Klinik. (The spine in health and disease; radiological and clinical aspects.) By SchmorlG. (died 1932) and JunghannsH., pp.270 text; pp.43 references; (419 illus.), 4th edition, 1957 (Georg Thieme, Stuttgart).

In 1925 Professor Schmorl, a morbid anatomist, embarked upon systematic research to correlate the radiographic features of the vertebral column with the naked eye appearances and microscopic findings. Rare and interesting conditions had been studied before, but the common everyday appearances were taken for granted. Within five years Schmorl had dissected, X-rayed, photographed, examined macro- and microscopically, catalogued and studied 10,000 complete spines obtained from consecutive post-mortems. By any standard this must be regarded as a tour de force seldom equalled in the history of medical research. In 1932 the results were published in the first edition of the text-book under review.

The work of Paul Ehrlich and his position in the history of medical research.

The work of Paul Ehrlich and his position in the history of medical research.