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Vitamin C and Cancer
Published in Qi Chen, Margreet C.M. Vissers, Cancer and Vitamin C, 2020
Channing Paller, Tami Tamashiro, Thomas Luechtefeld, Amy Gravell, Mark Levine
ClinicalTrials.gov, which is managed by the U.S. National Library of Medicine, is a database of publicly and privately funded clinical studies conducted in 206 countries. Information about each clinical trial is provided by the trial's sponsor or principal investigator. The ClinicalTrials.gov website became publicly available in February 2000, and the results database on the site containing information on study participants, adverse events, and outcomes became available in September 2008. Congress passed the Food and Drug Administration Amendments Act of 2007 that expanded clinical trial registration requirements to ClinicalTrials.gov, which required additional types of trials to be registered and required additional trial information, such as summary results. Due to the staggered implementation of registration requirements for ClinicalTrials.gov over the past two decades, not all clinical trials are included in the database, and information on trials is incomplete. Despite these limitations, ClinicalTrials.gov is still the largest trial registry in the world.
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Published in Gary Chan Kok Yew, Health Law and Medical Ethics in Singapore, 2020
The clinical trial must be supervised by a principal investigator who is a qualified practitioner (ie, a registered medical practitioner or dentist). Only the investigator or a person who is assisting and acting under the instructions of such investigator may treat or administer any investigational medicinal product of the trial to a subject of the trial.61
Researchers Experience Moral Distress Too!
Published in The American Journal of Bioethics, 2021
Toby Schonfeld, Cynthia M. A. Geppert
One possible explanation may apply if the PI is also the participant’s healthcare provider. The ethical tension between the dual roles of researcher and health care provider is increasingly recognized (Morain, Joffe, and Largent 2019). In that case, the PI may have difficulty separating roles—and, importantly, correlative responsibilities—when acting as clinician and when acting as researcher. In the former role, the healthcare provider’s obligation is to promote the patient’s welfare. If the healthcare provider believes that the patient would want information consistent with their health care preferences, regardless of its potential import, the provider might feel they should disclose it out of respect for the patient’s values. The researcher, however, does not have the participant’s welfare as the central organizing principle. Instead, fidelity to the research protocol as a mechanism to answer an important scientific question is the focus. True, the PI must monitor and act on the participant’s welfare during the course of the research in accordance with both the rules that govern and the values that ground human subjects research. Still, the end goal is not benefit to the individual participant. This difference in moral obligation is what may give rise to moral distress: standing by while the participant is not provided information the investigator believes the individual would want to know.
Guidelines for the standardized collection of blood-based biomarkers in psychiatry: Steps for laboratory validity – a consensus of the Biomarkers Task Force from the WFSBP
Published in The World Journal of Biological Psychiatry, 2019
Ana C. Andreazza, Isabelle Laksono, Brisa S. Fernandes, Catherine Toben, Piotr Lewczuk, Peter Riederer, Sidney H. Kennedy, Dimitrios Kapogiannis, Florence Thibaut, Manfred Gerlach, Carla Gallo, Yong-Ku Kim, Edna Grünblatt, Lakshmi Yatham, Michael Berk, Bernhard T. Baune
In general, the principal investigator (PI) will be required to design clinical studies in which risk of harm or discomfort to participants is minimised. Due to the inherently vulnerable nature of the subject population of persons with mental illnesses, in particular when dealing with child and adolescent populations, but, also in aged probands, particular attention needs to be paid to the design of clinical and epidemiological studies, especially to avoid increasing the risk of symptom provocation. These include, but are not limited to, case–control studies, placebo-controlled studies, washout studies and challenge studies.