Keywords Patient informed consent, rese...

Patient informed consent, research in ethics, participant informed consent document
Talia Isaacs, Jamie Murdoch, Zsófia Demjén, Fiona Stevenson
Obtaining informed consent (IC) is an ethical imperative, signifying participants' understanding of the conditions and implications of research participation. One setting where the stakes for understanding are high is randomized controlled trials (RCTs), which test the effectiveness and safety of medical interventions. However, the use of legalese and medicalese in ethical forms coupled with the need to explain RCT-related concepts (e.g. randomization) can increase patients' cognitive load when reading text...
October 13, 2020: Health (London)
Marie Uecker, Benno M Ure, Jens Dingemann
INTRODUCTION:  According to the Declaration of Helsinki, medical research and new therapeutic interventions involving human subjects require prior informed consent and ethical approval. In 2010, 46% of pediatric surgical publications lacked documentation of ethical approval and 84% lacked documentation of informed parental consent with lowest rates of ethical adherence found in articles concerning novel methods. The aim of this study was to investigate whether adherence to ethical standards has improved in pediatric surgical publications...
August 20, 2020: European Journal of Pediatric Surgery
Heidi Hopkins, Quique Bassat, Clare Ir Chandler, John A Crump, Nicholas A Feasey, Rashida A Ferrand, Katharina Kranzer, David G Lalloo, Mayfong Mayxay, Paul N Newton, David Mabey
INTRODUCTION: Fever commonly leads to healthcare seeking and hospital admission in sub-Saharan Africa and Asia. There is only limited guidance for clinicians managing non-malarial fevers, which often results in inappropriate treatment for patients. Furthermore, there is little evidence for estimates of disease burden, or to guide empirical therapy, control measures, resource allocation, prioritisation of clinical diagnostics or antimicrobial stewardship. The Febrile Illness Evaluation in a Broad Range of Endemicities (FIEBRE) study seeks to address these information gaps...
July 21, 2020: BMJ Open
Ludovica De Panfilis, Paolo Giorgi Rossi, Elisa Mazzini, Luca Pistolesi, Luca Ghirotto, Antonio Noto, Sandra Cuocolo, Massimo Costantini
INTRODUCTION: Advance directives are legal documents which individuals draw up to declare their treatment preferences and to appoint well-informed proxies to safeguard patient autonomy in critical situations when that individual is temporarily or no longer able to communicate these preferences. On December 22, 2017, the Italian Parliament approved the first law on end of life ("Provisions for informed consent and advance directives" L.219/2017), after a heated public and political debate lasting almost twenty years...
June 30, 2020: Journal of Pain and Symptom Management
Andrea G Jaramillo Vélez, Margarita Aguas Compaired, Montserrat Granados Plaza, Eduardo L Mariño, Pilar Modamio
BACKGROUND AND PURPOSE: Clinical trials (CTs) aimed at vulnerable groups such as patients with mental disorders create ethical complexity. The Patient Information Sheet (PIS) should provide all the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the Informed Consent Form (ICF). The objective was to assess the quality of PIS/ICFs from a Hospital Neurology Service (NS)...
June 28, 2020: European Journal of Neurology
Violeta Argudo-Portal, Miquel Domènech
BACKGROUND: Human-based biobanks have been presented as intermediary agents between donors/participants, the scientific community, the healthcare system, and patients. The objective of this systematic review was to contribute with an updated thematic synthesis in Spanish of the international literature (2011-2018) regarding ethical, legal, and social issues on contemporary biobanks. METHODS: A scoping review and thematic analysis were carried out on biobanks' ethical, legal, and social issues...
June 25, 2020: Revista Española de Salud Pública
Dickens Akena, Aggrey Semeere, Philippa Kadama, Emanuel Mwesiga, David Basangwa, Juliet Nakku, Noeline Nakasujja
INTRODUCTION: Psychotic disorders significantly contribute to high morbidity and mortality. In high-income countries, the predictors of mortality, relapse and barriers to care among patients with first episode psychoses (FEP) have been studied as a means of tailoring interventions to improve patient outcomes. However, little has been done to document relapse rates and their predictors in patients with FEP in low resourced, high disease burdened sub-Saharan Africa. OBJECTIVE: We shall estimate the rates of relapse of psychotic symptoms and the factors that predict them in patients with FEP over 4 years...
June 7, 2020: BMJ Open
Pierre Mermet-Bouvier, Matthew D Whalen
Beyond what are characterized as Special Populations in U.S. FDA regulatory considerations is vulnerability of patient populations in a broader context of international guidance. Such a review suggests a rich appreciation for the diversity of patients. Vulnerable patients' status and the associated patient protections are of growing interest in the clinical research environment. To participate in the current developments and reflections, we selected 12 international & recognized core documents that are discussing human research protections and identify all references to them pertinent to Vulnerables...
January 27, 2020: Therapeutic Innovation & Regulatory Science
Nicolaj Jersild Holm, Tom Møller, Lis Adamsen, Line Trine Dalsgaard, Fin Biering-Sorensen, Lone Helle Schou
INTRODUCTION: Spinal cord injury (SCI) predisposes those who suffer from it to physical inactivity and weight gain; consequently, death due to cardiovascular diseases is more frequent among people with SCI than in the general population. The literature documents a consensus about an interdisciplinary multimodal approach for the prevention and treatment of cardiovascular risk factors including overweight and obesity in people with SCI, focusing on diet, physical activity (PA) and behavioural interventions...
December 31, 2019: BMJ Open
M Skeen, C Eksteen, M Pepper
The publicity around stem cell therapy has given many persons who have sustained a devastating injury such as spinal cord injury (SCI) the hope of achieving partial or full recovery from their injuries. Several phase I and II clinical trials are being conducted owing to positive results obtained in animal models. While safety during the trials has been demonstrated, clinical efficacy in the outcome of ethically approved trials is still lacking. Many persons affected by SCI are, however, desperate for a cure and are lured into undergoing stem cell therapy by marketing campaigns and information readily available on the internet...
September 10, 2019: South African Medical Journal
Jeffrey Peppercorn, Eric Campbell, Steve Isakoff, Nora K Horick, Julia Rabin, Katharine Quain, Lecia V Sequist, Aditya Bardia, Deborah Collyar, Fay Hlubocky, Debra Mathews
BACKGROUND: Oncology research increasingly involves biospecimen collection and data sharing. Ethical challenges emerge when researchers seek to use archived biospecimens for purposes that were not well defined in the original informed consent document (ICD). We sought to inform ongoing policy debates by assessing patient views on these issues. MATERIALS AND METHODS: We administered a cross-sectional self-administered survey to patients with cancer at an academic medical center...
September 6, 2019: Oncologist
Lothar E van Hoogdalem, Claire Siemes, Pieternella J Lugtenburg, Jan J V Busschbach, Sohal Y Ismail
INTRODUCTION: There is a lot of speculation about why and how patients decide to use invasive treatment in an advanced stage of cancer, but the body of research is limited. The present longitudinal qualitative and quantitative study reflects real-life practice of pixantrone use and aims to collect data on patients' considerations for, expectations of and experiences with pixantrone and trajectories in their quality-of-life (QoL) values in a Dutch clinical setting. Hence, two questions emerge...
May 22, 2019: BMJ Open
Miras Mugazov, Yermek Turgunov, Dinar Kaliyeva, Dmitriy Matyushko, Zhandos Koishibayev, Dinara Omertayeva, Aidyn Nurbekov, Leyla Koishibayeva, Asylkhan Alibekov
AIM: The purpose of this study was to determine the level of significance of markers in the development of intra-abdominal hypertension in patients with acute surgical diseases of the abdominal cavity. METHODS: The authors surveyed 100 patients who were monitored at the Regional Clinical Hospital, Karaganda. The criterion for inclusion in the study was the informed consent of patients to participate in the study, the presence of acute surgical pathology, and the monitoring of intra-abdominal pressure over time...
April 30, 2019: Open Access Macedonian Journal of Medical Sciences
Pierre Mallia
Background: Authors have to be aware of the ethical stages in writing a scientific paper in order to be cognizant of what is required of them as researchers. The research ethics committee concerns itself with patient protection and therefore looks closely not only at the protocol, but also at the informed consent process and data protection issues. Conversely the publishers has ethical issues of their own relating to their reputation in publishing ethically sound and justified studies...
April 2019: Saudi Journal of Anaesthesia
Jorie M Colbert-Getz, Katie Lappe, Michael Northrup, Danielle Roussel
Phenomenon: There is an abundance of literature on Entrustable Professional Activities (EPAs) in theory, but there are few studies on the EPAs in practice for undergraduate clinical education. In addition, little is known about the degree to which the EPAs are or are not aligned with physician assessors' performance schemas of the clerkship student. Investigating the degree to which physician assessors' performance schemas are already aligned with the activities described by the EPAs is critical for effective workplace assessment design...
August 2019: Teaching and Learning in Medicine
Mila Petrova, Stephen Barclay
BACKGROUND: The red tape and delays around research ethics and governance approvals frequently frustrate researchers yet, as the lesser of two evils, are largely accepted as unavoidable. Here we quantify aspects of the research ethics and governance approvals for one interview- and questionnaire-based study conducted in England which used the National Health Service (NHS) procedures and the electronic Integrated Research Application System (IRAS). We demonstrate the enormous impact of existing approvals processes on costs of studies, including opportunity costs to focus on the substantive research, and suggest directions for radical system change...
January 25, 2019: BMC Medical Ethics
Noor Al Mortadi, Omar F Khabour, Karem H Alzoubi
Background: Research that involves dental pulp stem cells (DPSCs) is growing rapidly. DPSCs can be used for the treatment of craniofacial bone abnormalities and tooth repair. The procedure requires a donation of sound teeth, which might be associated with ethical and moral issues. The purpose of this study was to understand the attitudes and awareness of patients with respect to the donation of their teeth to research. Patients and methods: This study involved 500 patients recruited from Dental Care and Dental Teaching Center in Irbid during May 2017-July 2017...
2018: Clinical, Cosmetic and Investigational Dentistry
Miguel Ángel Celis, José Halabe, Oscar Arrieta, Rubén Burgos, Carlos Campillo, Manuel De la Llata, Judith Domínguez, Sergio Islas, Luis Jasso-Gutiérrez, Alberto Lifshitz, Mucio Moreno, Ricardo Plancarte-Sánchez, Alejandro Reyes-Sánchez, Guillermo Ruiz-Argüelles, Antonio Soda, Emma Verástegui, Julio Sotelo
Informed consent is an indispensable element to obtain adequate patient participation either in research protocols or in therapeutic design. The Committee of Ethics and Transparency in the Physician-Industry Relationship (CETREMI) of the National Academy of Medicine developed several recommendations for informed consent to be documented.
2018: Gaceta Médica de México
Padmaja A Marathe, Raakhi K Tripathi, Yashashri C Shetty, Sunil S Kuyare, Sandhya K Kamat, Urmila M Thatte
Objective: In view of dearth of information in national and international guidelines on payment practices in research, the present study was done to find out payments for participation allowed by 3 Ethics committees (ECs) and reasons for payment. Method: This was a retrospective observational study which analysed research proposals reviewed by 2 institutional and 1 non-institutional ECs over a period of 2 years. The permission of ECs was obtained and confidentiality of data was maintained...
April 2018: Perspectives in Clinical Research
Hussein Algahtani, Mohammed Bajunaid, Bader Shirah
Understanding the historical foundations of ethics in human research are key to illuminating future human research and clinical trials. This paper gives an overview of the most remarkable unethical human research and how past misconducts helped develop ethical guidelines on human experimentation such as The Nuremberg Code 1947 following WWII. Unethical research in the field of neuroscience also proved to be incredibly distressing. Participants were often left with life-long cognitive disabilities. This emphasizes the importance of implicating strict rules and ethical guidelines in neuroscience research that protect participants and respects their dignity...
May 2018: Neurological Sciences
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