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Patient informed consent, research in ethics, participant informed consent document

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
Behrooz Astaneh, Parisa Khani
Researchers should strictly consider the participants' rights. They are required to document such protections as an ethical approval of the study proposal, the obtaining "informed consent", the authors' "conflict of interests", and the source of "financial support" in the published articles. The purpose of this study was to assess the frequency of reporting ethical issues in human subject articles published in Iranian medical journals during 2009-2013. In this cross-sectional study, we randomly reviewed 1460 human subject articles published in Iranian medical journals during 2009-2013 in two Persian and English language groups...
November 10, 2017: Science and Engineering Ethics
Peter Doshi, Peter Hur, Mark Jones, Husam Albarmawi, Tom Jefferson, Daniel J Morgan, Patricia A Spears, John H Powers
Importance: Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials...
October 1, 2017: JAMA Internal Medicine
Amrita Sil, Nilay Kanti Das
Consenting to participate in a clinical research study after being properly and correctly informed upholds the basic ethical principle of "autonomy" in human research. The informed consent is a process by which the physician sensitizes the patient about the nature, procedures, risks benefits, treatment schedules, etc of the study in a language that is non-technical and understandable by the study participant. Informed consent document (ICD) has got two parts: the 'Subject Information Sheet' and the 'Informed Consent Form' (ICF); and they have to be approved by the Institutional Ethics Committee (IEC) before administration...
July 2017: Indian Journal of Dermatology
Heidrun Lingner, Ines Aumann, Margarethe Wacker, Michael Kreuter, Reiner Leidl, J-Matthias Graf von der Schulenburg, Tobias Welte
Reliable current information is needed for daily patient care and the health system, but comprehensive data, especially from primary care, are scarce and/or hard to access. The BeoNet Register-Database (BNR) aims to depict quality of medical care in Germany using routine data and with no additional documentation or costs for GPs. Registry design, data structure and database use will be demonstrated using chronic obstructive lung disease (COPD) as an example. The BNR is moving through pilot- and roll-out phases...
July 11, 2017: Das Gesundheitswesen
H Bleiberg, G Decoster, A de Gramont, P Rougier, A Sobrero, A Benson, B Chibaudel, J Y Douillard, C Eng, C Fuchs, M Fujii, R Labianca, A K Larsen, E Mitchell, H J Schmoll, D Sprumont, J Zalcberg
Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Susanne Voelter-Mahlknecht, Jan M Stratil, Rainer Kaluscha, Gert Krischak, Monika A Rieger
INTRODUCTION: Rehabilitation measures for patients in the working age primarily aim at maintaining employability, restoring fitness for work or timely return to work (RTW). To facilitate RTW after long sick leave in Germany, both rehabilitation physicians' knowledge about the patients' workplace and communication between the rehabilitation physician and the occupational physician need to be improved. This research will record the experiences and attitudes of occupational physicians, rehabilitation physicians and general practitioners, as well as of rehabilitation patients, to indicate barriers and possibilities for improvement concerning the intersection between workplace and rehabilitation institution...
April 26, 2017: BMJ Open
Scott Lamont, Cameron Stewart, Mary Chiarella
INTRODUCTION: Healthcare practitioners have a legal, ethical and professional obligation to obtain patient consent for all healthcare treatments. There is increasing evidence which suggests dissonance and variation in practice in assessment of decision-making capacity and consent processes. AIMS: This study explores healthcare practitioners' knowledge and practices of assessing decision-making capacity and obtaining patient consent to treatment in the acute generalist setting...
January 1, 2017: Nursing Ethics
Amrita Mukherjee, Alicia A Livinski, Joseph Millum, Steffany Chamut, Shahdokht Boroumand, Timothy J Iafolla, Margo R Adesanya, Bruce A Dye
BACKGROUND: Ethics in health care and research is based on the fundamental principle of informed consent. However, informed consent in geriatric dentistry is not well documented. Poor health, cognitive decline, and the passive nature of many geriatric patients complicate this issue. METHODS: The authors completed this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The authors searched the PubMed (MEDLINE), Web of Science, PsycINFO, and Cochrane Library databases...
April 2017: Journal of the American Dental Association
Li Du, Blake Murdoch, Carina Chiu, Timothy Caulfield
The protection of confidential research data is of key importance to clinical patient safety research. A review of selected Canadian and American case law indicates that although the relationship between researcher and participant has not been recognized as privileged, court-ordered disclosure of confidential research information seems to be a rare occurrence. In this review, we examine how confidentiality issues are presented in informed consent form templates and in relevant research ethics policies. We find an agreement among research policy documents that all information gathered should be treated as confidential, unless otherwise required by law...
November 2, 2016: Journal of Patient Safety
Pruthak C Shah, Ashwin K Panchasara, Manish J Barvaliya, C B Tripathi
INTRODUCTION: Application form of research work is an essential requirement which is required to be submitted along with the research proposal to the Ethics Committee (EC). AIM: To check the completeness and to find the errors in application forms submitted to the EC of a tertiary care hospital. MATERIALS AND METHODS: The application forms of research projects submitted to the Institutional Review Board (IRB), Government Medical College, Bhavnagar, Gujarat, India from January 2014 to June 2015 were analysed for completeness and errors, with respect to the following - type of study, information about study investigators, sample size, study participants, title of the studies, signatures of all investigators, regulatory approval, recruitment procedure, compensation to study participants, informed consent process, information about sponsor, declaration of conflict of interest, plans for storage and maintenance of data, patient information sheet, informed consent forms and study related documents...
September 2016: Journal of Clinical and Diagnostic Research: JCDR
Kate M Sahan, Keith M Channon, Robin P Choudhury, Rajesh K Kharbanda, Regent Lee, Mark Sheehan
Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties...
April 2016: European Journal of Cardiovascular Medicine
Stefano Savonitto, Teresa Coppola, Paola Braglia, Alfonso Ciccone
The principle of patient information, awareness and documented consent for the participation in clinical trials is a cornerstone in the modern ethics of clinical research. However, this procedure is seldom applicable in the critically ill patient who becomes suddenly incapable of fully evaluating the risk vs benefit of the alternative therapeutic options. This issue becomes particularly problematic in those conditions where the benefit of any intervention is highly time-dependent, such as acute myocardial infarction, stroke, cardiac arrest, polytrauma and other similar conditions...
May 2016: Giornale Italiano di Cardiologia
Elena Villamañán, Margarita Ruano, Enma Fernández-de Uzquiano, Paz Lavilla, Diana González, Mercedes Freire, Carmen Sobrino, Alicia Herrero
Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients...
May 1, 2016: Farmacia Hospitalaria
Montserrat Busquets, Jordi Caïs
BACKGROUND: The relationship between healthcare professionals and patients in the Spanish health sector has undergone dramatic change. One aspect of this is that the use of informed consent has become a key factor in the delivery of adequate healthcare. But although a certain period of time has already passed since informed consent started to be used, in Spain there is still doubt about how adequately informed consent is being used. OBJECTIVES: (a) To look at how patients understand the notion and purpose of informed consent, and (b) how the informed consent is applied - the way patients receive such information affects their level of participation and decision making during the time they receive medical care...
June 2017: Nursing Ethics
Denise L Buchner, Sean M Bagshaw, Peter Dodek, Alan J Forster, Robert A Fowler, François Lamontagne, Alexis F Turgeon, Melissa Potestio, Henry T Stelfox
INTRODUCTION: The transfer of patient care between the intensive care unit (ICU) and the hospital ward is associated with increased risk of medical error and adverse events. This study will describe patient transfer from ICU to hospital ward by documenting (1) patient, family and provider experiences related to ICU transfer, (2) communication between stakeholders involved in ICU transfer, (3) adverse events that follow ICU transfer and (4) opportunities to improve ICU to hospital ward transfer...
2015: BMJ Open
(no author information available yet)
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (a) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (b) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (c) appropriate guidelines for the selection of human subjects for participation in such research and (d) the nature and definition of informed consent in various research settings...
2014: Journal of the American College of Dentists
Rieke van der Graaf, Hendrik Koffijberg, Diederick E Grobbee, Esther de Hoop, Karel G M Moons, Ghislaine J M W van Thiel, G Ardine de Wit, Johannes J M van Delden
OBJECTIVES: The Ottawa Statement is the first guidance document for the ethical and scientific conduct of cluster-randomized trials (CRTs). However, not all recommendations are straightforward to implement. In this paper we will reflect in particular on the recommendation on identifying human research subjects and the issue to what extent the randomization process should be disclosed if there is a risk of contamination. STUDY DESIGN AND SETTING: The Ottawa Statement was thoroughly evaluated within a multidisciplinary research team, consisting amongst others of epidemiologists and ethicists...
September 2015: Journal of Clinical Epidemiology
Nathan J Smischney, James A Onigkeit, Richard F Hinds, Wayne T Nicholson
BACKGROUND: U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention...
2015: Journal of Clinical Ethics
Konstadina Griva, Nandakumar Mooppil, Eric Khoo, Vanessa Yin Woan Lee, Augustine Wee Cheng Kang, Stanton P Newman
INTRODUCTION: Diabetes mellitus (DM) is the most common cause of end-stage renal disease (ESRD). Patients with diabetes on dialysis have worse clinical outcomes and increased psychological burden. The need to manage the combined treatment demands for both conditions is particularly challenging yet there is paucity of data of the barriers preventing optimal management to combined therapy for diabetes and kidney failure. The study aims to explore needs of patients and develop an intervention to enable people with diabetes and ESRD to better manage both their conditions...
2015: BMJ Open
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