keyword
https://read.qxmd.com/read/34787769/controversies-between-regulations-of-research-ethics-and-protection-of-personal-data-informed-consent-at-a-cross-road
#21
JOURNAL ARTICLE
Eugenijus Gefenas, J Lekstutiene, V Lukaseviciene, M Hartlev, M Mourby, K Ó Cathaoir
This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of 'broad consent', which has been widely applied in the context of biobanking...
March 2022: Medicine, Health Care, and Philosophy
https://read.qxmd.com/read/34649840/prospective-feasibility-study-of-indigo-naturalis-ointment-for-chemotherapy-induced-oral-mucositis
#22
JOURNAL ARTICLE
Kenro Hirata, Yuka Yamada, Yasuo Hamamoto, Kazuyuki Tsunoda, Hiroshi Muramatsu, Sara Horie, Yasutaka Sukawa, Makoto Naganuma, Taneaki Nakagawa, Takanori Kanai
OBJECTIVES: Indigo naturalis, a herbal medicine effective against ulcerative colitis, exhibits anti-inflammatory effects and induces interleukin-22-mediated antimicrobial peptide production. Anti-inflammatory activity and the prevention of secondary infection are essential for the management of chemotherapy-induced oral mucositis (CIOM); therefore, we developed an indigo naturalis ointment to be administered topically for CIOM and evaluated its feasibility. METHODS: We performed a single-centre, open-label, prospective feasibility study from March 2017 to December 2018...
October 14, 2021: BMJ Supportive & Palliative Care
https://read.qxmd.com/read/33996432/assessing-the-topical-application-efficiency-of-two-biological-agents-in-managing-chemotherapy-induced-oral-mucositis-in-children-a-randomized-clinical-trial
#23
JOURNAL ARTICLE
Muaaz Alkhouli, Mohannad Laflouf, John C Comisi
BACKGROUND: oral mucositis is one of the most annoying complications of chemotherapy. This randomized clinical trial aimed to assess the efficiency of Aloe Vera and Olive Oil in managing chemotherapy-induced oral mucositis. METHODS: 36 children between 6 and 9 years and suffering from grade 3 or 4 oral mucositis, according to the World Health Organization (W.H.O.) scale, were enrolled in this clinical trial. Participants were separated into three groups to treat their mucositis using Aloe Vera, Olive Oil, or sodium bicarbonate...
July 2021: Journal of Oral Biology and Craniofacial Research
https://read.qxmd.com/read/33908353/placebo-control-in-covid-19-trials-a-missed-opportunity-for-international-guidance
#24
JOURNAL ARTICLE
Urban Wiesing, Hans-Jörg Ehni
Vaccines preventing Covid-19 have been approved in several countries. Is it still ethically acceptable to use placebo controls during the development of other vaccine options? If two of the most influential international guidelines of biomedical research are consulted, the Declaration of Helsinki and the CIOMS-guidelines, the answer is "no". We discuss the implications for ongoing vaccine research, and how placebo controls might be justified nevertheless. However, the ethical conflict remains highly problematic...
April 2021: Indian Journal of Medical Ethics
https://read.qxmd.com/read/33908349/covid-19-the-who-and-the-apparent-collapse-of-traditional-medical-research-ethics
#25
JOURNAL ARTICLE
Godfrey B Tangwa
On January 14, 2021, a WHO Ad Hoc expert group published an article in the highly influential The New England Journal of Medicine, titled: "Placebo-Controlled Trials of Covid-19 Vaccines - Why We Still Need Them" justifying the use of placebo in further trials of Covid-19 vaccines, even after purported efficacious vaccines have become available. Medical research involving human beings ought to conform strictly to principles, rules and procedures established since the Nuremberg Code (1947), especially as elaborated in the Declaration of Helsinki (2013) and the WHO/CIOMS Guidelines (2016)...
April 2021: Indian Journal of Medical Ethics
https://read.qxmd.com/read/33897255/how-do-healthcare-professionals-respond-to-ethical-challenges-regarding-information-management-a-review-of-empirical-studies
#26
JOURNAL ARTICLE
Cornelius Ewuoso, Susan Hall, Kris Dierickx
AIM: This study is a systematic review that aims to assess how healthcare professionals manage ethical challenges regarding information within the clinical context. METHOD AND MATERIALS: We carried out searches in PubMed, Google Scholar and Embase, using two search strings; searches generated 665 hits. After screening, 47 articles relevant to the study aim were selected for review. Seven articles were identified through snowballing, and 18 others were included following a system update in PubMed, bringing the total number of articles reviewed to 72...
April 5, 2021: Global Bioethics
https://read.qxmd.com/read/33854434/the-efficacy-of-heat-clearing-qingre-and-detoxifying-jiedu-traditional-chinese-medicine-gargle-for-chemotherapy-induced-oral-mucositis-a-systematic-review-and-meta-analysis
#27
JOURNAL ARTICLE
Zhixian Lin, Jiangfeng Chen, Sunya Han
Objective: Chemotherapy-induced oral mucositis (CIOM) is an extremely serious complication of cancer. In China, the heat-clearing (Qingre) and detoxifying (Jiedu) traditional Chinese medicine QRJD-TCM gargle has been widely used to treat CIOM. To date, no systematic evaluation has been conducted on the clinical efficacy of QRJD-TCM gargle in treating CIOM. The objective of this systematic review and meta-analysis was to evaluate the efficacy of QRJD-TCM gargle in the treatment of CIOM. Methods: Relevant randomized controlled trials (RCTs) comparing QRJD-TCM gargle with conventional Western medicine mouthwash (CWMM) for CIOM were confirmed by systematically searching PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Wanfang Database, and Sinomed until October 20, 2020...
2021: Frontiers in Pharmacology
https://read.qxmd.com/read/33565024/risk-management-for-the-21st-century-current-status-and-future-needs
#28
JOURNAL ARTICLE
Rania Mouchantaf, Doris Auth, Yola Moride, June Raine, Soon Young Han, Meredith Y Smith
Global adoption of risk management principles outlined in the International Conference on Harmonisation (ICH) E2E guideline and the Council for International Organizations of Medical Sciences (CIOMS) Working Group VI guidance introduced greater proactivity and consistency into the practice of pharmacovigilance and benefit-risk management throughout the lifecycle of a drug. However, following the release of these guidelines there have been important advances in the science and practice of risk minimisation itself, especially in terms of how risk minimisation measures (RMMs) are designed, implemented, disseminated and evaluated for effectiveness in real-world healthcare settings...
February 9, 2021: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/33226250/candesartan-induced-cholestatic-hepatitis-a-case-report
#29
JOURNAL ARTICLE
Benito Hermida Pérez, Marta Izquierdo Romero, Rosa García López
We present the case of a 55-year-old male that was admitted to our hospital for cholestatic hepatitis. Other causes of hepatitis were excluded with imaging, laboratory and serologic tests. A liver biopsy was performed, which was compatible with toxicity-induced hepatitis. Re-assessing the patient, he mentioned the start of treatment with candesartan cilexetil 3 weeks prior to the onset of the symptoms. Candesartan was withdrawn, with a progressive improvement in cholestasis and complete normalization of liver biochemistry at 6 months...
December 2020: Revista Española de Enfermedades Digestivas
https://read.qxmd.com/read/33174498/ethical-reflections-on-the-conduct-of-hiv-research-with-community-members-a-case-study
#30
JOURNAL ARTICLE
Brandon Brown, Jeff Taylor, Karine Dubé, Dario Kuzmanović, Yasmeen Long, Logan Marg
Some researchers continue to engage in "helicopter" or "parachute" research and do not ethically engage or collaborate with communities from which data are collected. This paper uses a case study to discuss the ethical issues arising from these research practices and the importance of increasing meaningful community involvement in research. Set in the context of research among older people living with HIV, the case study is followed by the perspectives of four research stakeholders. Through these perspectives, this paper demonstrates the ethical perils and harms that stem from research practices exemplified in the case...
November 11, 2020: Journal of Empirical Research on Human Research Ethics: JERHRE
https://read.qxmd.com/read/33034859/the-work-of-the-council-for-international-organizations-of-medical-sciences-cioms-in-global-pharmacovigilance
#31
EDITORIAL
Manal M Younus, Monika Zweygarth, Lembit Rägo, Mira Harrison-Woolrych
No abstract text is available yet for this article.
November 2020: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://read.qxmd.com/read/32981780/integrating-public-health-programs-and-research-after-the-malaria-vaccine-implementation-program-mvip-recommendations-for-next-steps
#32
JOURNAL ARTICLE
Rieke van der Graaf, Ruth Macklin, Annette Rid, Anant Bhan, Eugenijus Gefenas, Dirceu Greco, David Haerry, Samia Hurst, Alex John London, Rodolfo Saracci, Dominique Sprumont, Johannes J M van Delden
BACKGROUND: In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. METHODS: We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans...
September 24, 2020: Vaccine
https://read.qxmd.com/read/32852569/drug-induced-liver-injury-an-update
#33
REVIEW
Miren Garcia-Cortes, Mercedes Robles-Diaz, Camilla Stephens, Aida Ortega-Alonso, M Isabel Lucena, Raúl J Andrade
Drug induced liver injury (DILI) is a relatively rare hepatic condition in response to the use of medications, illegal drugs, herbal products or dietary supplements. It occurs in susceptible individuals through a combination of genetic and environmental risk factors believed to modify drug metabolism and/or excretion leading to a cascade of cellular events, including oxidative stress formation, apoptosis/necrosis, haptenization, immune response activation and a failure to adapt. The resultant liver damage can present with an array of phenotypes, which mimic almost every other liver disorder, and varies in severity from asymptomatic elevation of liver tests to fulminant hepatic failure...
October 2020: Archives of Toxicology
https://read.qxmd.com/read/32844466/comparison-of-laboratory-threshold-criteria-in-drug-induced-liver-injury-detection-algorithms-for-use-in-pharmacovigilance
#34
JOURNAL ARTICLE
Eng Hooi Tan, Zheng Jye Ling, Pei San Ang, Cynthia Sung, Yock Young Dan, Bee Choo Tai
PURPOSE: For the purpose of pharmacovigilance, we sought to determine the best performing laboratory threshold criteria to detect drug-induced liver injury (DILI) in the electronic medical records (EMR). METHODS: We compared three commonly used liver chemistry criteria from the DILI expert working group (DEWG), DILI network (DILIN), and Council for International Organizations of Medical Sciences (CIOMS), based on hospital EMR for years 2010 and 2011 (42 176 admissions), using independent medical record review...
November 2020: Pharmacoepidemiology and Drug Safety
https://read.qxmd.com/read/32782137/challenges-and-opportunities-for-clinical-pharmacogenetic-research-studies-in-resource-limited-settings-conclusions-from-the-council-for-international-organizations-of-medical-sciences-ibero-american-network-of-pharmacogenetics-and-pharmacogenomics-meeting
#35
JOURNAL ARTICLE
Eva Peñas-LLedó, Enrique Terán, Marta Sosa-Macías, Carlos Galaviz-Hernández, Jose-Pedro Gil, Sujit Nair, Shyam Diwakar, Isabel Hernández, Julio Lara-Riegos, Ronald Ramírez-Roa, Ignacio Verde, Eduardo Tarazona-Santos, Juan Molina-Guarneros, Graciela Moya, Lembit Rägo, Adrián LLerena
PURPOSE: The symposium Health and Medicines in Indigenous Populations of America was organized by the Council for International Organizations of Medical Sciences (CIOMS) Working Group on Clinical Research in Resource-Limited Settings (RLSs) and the Ibero-American Network of Pharmacogenetics and Pharmacogenomics (RIBEF). It was aimed to share and evaluate investigators' experiences on challenges and opportunities on clinical research and pharmacogenetics. METHODS: A total of 33 members from 22 countries participated in 2 sessions: RIBEF studies on population pharmacogenetics about the relationship between ancestry with relevant drug-related genetic polymorphisms and the relationship between genotype and phenotype in Native Americans (session 1) and case examples of clinical studies in RLSs from Asia (cancer), America (diabetes and women health), and Africa (malaria) in which the participants were asked to answer in free text their experiences on challenges and opportunities to solve the problems (session 2)...
August 8, 2020: Clinical Therapeutics
https://read.qxmd.com/read/32603785/meta-analysis-of-blinded-and-unblinded-studies-for-ongoing-aggregate-safety-monitoring-and-evaluation
#36
JOURNAL ARTICLE
Li-An Lin, Shuai Sammy Yuan, Nathan Li, Greg Ball
During the course of clinical development, ongoing aggregate safety monitoring and evaluation are needed to understand the evolving safety profile and to ensure effective risk-management strategies for medicinal products. CIOMS reports and global regulatory guidance (including from ICH, US FDA, and EMA) compel sponsors for assessment of safety based on aggregate data. To identify and characterize the risks of medicinal products at a program level in a more timely and informed manner, aggregate safety evaluations should combine all available information, including from ongoing blinded trials, completed unblinded trials, and other data sources...
June 27, 2020: Contemporary Clinical Trials
https://read.qxmd.com/read/32131975/immunization-stress-related-response-redefining-immunization-anxiety-related-reaction-as-an-adverse-event-following-immunization
#37
JOURNAL ARTICLE
Michael S Gold, Noni E MacDonald, C Meghan McMurtry, Madhava Ram Balakrishnan, Ulrich Heininger, Lisa Menning, Oleg Benes, Robert Pless, Patrick L F Zuber
The Council for the International Organizations of Medical Sciences (CIOMS) and WHO working group on pharmacovigilance defines five cause specific AEFI which includes an immunization anxiety-related reaction. Historically this term has been used to describe a range of symptoms and signs that may arise after immunization that are related to "anxiety" about the immunization. However, the term "anxiety" does not adequately capture all the elements of this cause specific AEFI. In 2015, the Global Advisory Committee for Vaccine Safety convened an expert working group with the purpose of redefining, preventing and managing this particular AEFI...
March 23, 2020: Vaccine
https://read.qxmd.com/read/32101488/efficacy-of-aloe-vera-use-for-prevention-of-chemotherapy-induced-oral-mucositis-in-children-with-acute-lymphoblastic-leukemia-a-randomized-controlled-clinical-trial
#38
JOURNAL ARTICLE
Muaaz Alkhouli, Mohannad Laflouf, Mazen Alhaddad
Oral mucositis can be caused by chemotherapy and can affect a patient's quality of life. Nowadays, to prevent chemotherapy-induced oral mucositis (CIOM) is a crucial point in palliative care centers. This trial aimed to assess the effectiveness of aloe-vera in that concept. The trial was accomplished at Hematology Department of Hospital of Children of Damascus University, Syria. Acute lymphoblastic leukemia (ALL) children were the population from which 26 children were enrolled in the study. They were aged between 3 and 6 years old and were randomly referred according to the intervention into two groups, Aloe-vera (AV) and sodium bicarbonate 5% (13 each)...
February 26, 2020: Comprehensive Child and Adolescent Nursing
https://read.qxmd.com/read/32073940/participants-written-informed-consent-in-low-risk-pragmatic-clinical-trials-with-medicines
#39
JOURNAL ARTICLE
Rafael Dal-Ré
<u>Introduction:</u> An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are those conducted resembling usual clinical practice that pose no or minimal incremental risk compared with normal clinical practice.<u>Areas covered:</u> This review addresses one important hurdle in the conduct of low-risk pRCTs: the need to seek participants' written informed consent.<u>Expert opinion:</u> The CIOMS ethical guidelines consider that any research that a) would not be feasible or practicable to carry out without the waiver or modification; b) has important social value; and c) poses no more than minimal risks to participants; and that is approved by the relevant research ethics committee, could be conducted without participants' consent...
February 19, 2020: Expert Review of Clinical Pharmacology
https://read.qxmd.com/read/32067405/prospective-evaluation-of-clinical-symptoms-of-chemotherapy-induced-oral-mucositis-in-adult-patients-with-acute-leukemia-a-preliminary-study
#40
JOURNAL ARTICLE
Yeon-Hee Lee, Junshik Hong, Inho Kim, Youngnim Choi, Hee-Kyung Park
OBJECTIVE: The objective of this study was to prospectively evaluate the clinical features of chemotherapy-induced oral mucositis (CIOM) in adult patients with acute leukemia and the aggravating factors for such symptoms. SUBJECTS: Thirty-seven prospective patients aged ≥19 years with acute leukemia undergoing chemotherapy were enrolled. Oral and clinical investigations were performed at baseline and on Day 14 after starting chemotherapy. The presence and severity of cancer-induced oral mucositis were demonstrated using the World Health Organization (WHO) scoring system...
February 2020: Clinical and Experimental Dental Research
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