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Hindu norms on human experimentation
Published in Joseph Tham, Alberto García Gómez, Mirko Daniel Garasic, Cross-Cultural and Religious Critiques of Informed Consent, 2021
The central case of human experimentation is as follows. Researchers for pharmaceutical companies develop chemical compounds that could be used to treat diseases. These compounds begin life as trade secrets, and at some point, if they have promise, they are patented. A patent is a legal monopoly on the compound. Having a patent is not enough to be able to market a compound, however. Before a compound can be marketed, the pharmaceutical company must prove, according to certain standards, to the drug regulatory agencies that the compound is relatively safe if used a certain way and relatively effective for the condition being treated. If the proof is sufficient, the agency may permit the company to market the compound for the intended use. If the agency approves the compound for marketing, it requires the company to label the compound to inform doctors and patients of the identity of the disease it treats and the nature, risks and benefits of the compound. Once labelled, the compound has legal status as a drug. The exclusive approval to market the drug combined with the patent gives the pharmaceutical company complete control over the market for the drug for the patent period.
Ethical considerations
Published in Hung N. Winn, Frank A. Chervenak, Roberto Romero, Clinical Maternal-Fetal Medicine Online, 2021
Frank A. Chervenak, Laurence B. McCullough
The history of human experimentation appears to be coincident with the history of medicine. Concern about the scientific and ethical quality of research with human subjects begins to emerge in eighteenth-century medical ethics. One of major figures of that period, Dr. John Gregory (1724–1773) of Scotland, wrote the first modern medical ethics in the English language (24). He developed a research ethics to address the potential abuse of patients in the Royal Infirmary of Edinburgh by younger physicians anxious to establish their reputations. These physicians would pronounce Infirmary patients incurable, not to abandon them (which was the common practice), but to justify introducing experimental medicines into patient care.
Investigating links between diet and health outcomes
Published in Geoffrey P. Webb, Nutrition, 2019
I have classified human experimentation into three categories: short-term experiments, clinical trials and field trials. The decision about which category a study belongs in depends upon factors like whether or not the subjects are suffering from an illness, the size and duration of the study, whether the subjects are in a hospital setting or free-living, the nature of the intervention and whether the subjects are expected to gain therapeutic benefits from the intervention being tested.
Updating cut-off values of severity scoring systems for community-acquired pneumonia to orchestrate more predictive accuracy
Published in Annals of Medicine, 2023
Qi Guo, Hai-yan Li, Wei-dong Song, Ming Li, Xiao-ke Chen, Hui Liu, Hong-lin Peng, Hai-qiong Yu, Nian Liu, Yan-hong Li, Zhong-dong Lü, Li-hua Liang, Qing-zhou Zhao, Mei Jiang
These studies were performed according to the principles of human experimentation guidelines of the United States Department of Health and Human Services. Our report was based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Patients suffering from CAP were cared for by respiratory physicians and intensivists in accordance with the IDSA/ATS guidelines [3] and the Surviving Sepsis Campaign guidelines [18,19]. PSI class ≥ IV, IDSA/ATS minor criteria ≥3, or CURB-65 score ≥3 was warranted a transfer to respiratory intensive care unit. Antibiotic regimens for the empirical treatment were prescribed based on the guidelines, and then adjusted in the light of subsequently cultured pathogens. All patients clinically stable and afebrile were discharged home [3].
Impact of cochlear implantation on the function of the three semicircular canals
Published in International Journal of Audiology, 2020
Joost J. A. Stultiens, Hieke W. Kieft, Emmanuel A. M. Mylanus, Ronald J. E. Pennings, Lotte Terwoert, Andy J. Beynon
All patients who underwent (routine) vestibular testing before and after receiving a CI at our hospital between 2010 and 2017 were selected. Patients younger than 7 years of age and patients with definite preoperative areflexia in the operated ear were excluded. The former because VOR gain is highly dependent on age below 6 years of age and intra-individual VOR gain variability appears to be relatively high below 7 years of age (Wiener-Vacher and Wiener 2017). In patients undergoing (sequential) bilateral implantation, only data regarding the first implantation were considered. All data were retrospectively collected from patients’ medical records. The procedures in this investigation were in accordance with legislation (the Medical Research Involving Human Subjects Act) and ethical standards on human experimentation in the Netherlands.
Ethical approval and informed consent reporting in ASEAN journals: a systematic review
Published in Current Medical Research and Opinion, 2019
Junjira Laothavorn, Pantipa Wongwai, Shyam Prakash Dumre, Panida Kongjam, Kesara Na-Bangchang, Juntra Karbwang
Scientific publication has long been seen as a way for a researcher to disseminate their knowledge to the scientific community, encouraging constructive competition which may lead to further new discoveries, while giving due acknowledgement to the labors of the researcher as well as prestige1. Due to past atrocities conducted in the name of science, such as the Tuskegee research and the Nazi human experimentation, great emphasis has been placed on evaluating the scientific and ethical validity of a proposed study2,3. While a clear and transparent recounting of the methodology used in a study is indispensable to the scientific community in evaluating the applicability and scientific validity of a study as well as in ensuring its reproducibility, there is usually very little information contained in an article with which one can evaluate the ethical validity of a study.