Learning from Informed Consent Litigation to Improve Practices: A Systematic Review

2021 ◽  
Author(s):  
Karine Giudici-Wach ◽  
Pierre Gillois ◽  
Thomas Remen ◽  
Frédérique Claudot
Keyword(s):  
Systematic Review ◽  
Informed Consent

scholarly journals 36 Ethical surgical informed consent in emergency obstetrics and gynecology: A systematic review

2021 ◽  
Vol 224 (6) ◽  
pp. S767
Author(s):  
K.E. Nixon ◽  
J.M. Traylor ◽  
M. Beestrum ◽  
L.P. King ◽  
M.P. Milad
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Obstetrics And Gynecology

scholarly journals How to effectively obtain informed consent in trauma patients: a systematic review

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Yen-Ko Lin ◽  
Kuan-Ting Liu ◽  
Chao-Wen Chen ◽  
Wei-Che Lee ◽  
Chia-Ju Lin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Trauma Patients

A Systematic Review Of The Food And Drug Administration’s ‘Exception From Informed Consent’ Pathway

2018 ◽  
Vol 37 (10) ◽  
pp. 1605-1614 ◽  
Author(s):  
William B. Feldman ◽  
Spencer Phillips Hey ◽  
Aaron S. Kesselheim
Keyword(s):  
Systematic Review ◽  
Informed Consent

Ethical approval and informed consent reporting in ASEAN journals: a systematic review

2019 ◽  
Vol 35 (12) ◽  
pp. 2179-2186
Author(s):  
Junjira Laothavorn ◽  
Pantipa Wongwai ◽  
Shyam Prakash Dumre ◽  
Panida Kongjam ◽  
Kesara Na-Bangchang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Ethical Approval

scholarly journals Information, consent and perceived coercion: patients' perspectives on electroconvulsive therapy

2005 ◽  
Vol 186 (1) ◽  
pp. 54-59 ◽  
Author(s):  
Dana S. Rose ◽  
Til H. Wykes ◽  
Jonathan P. Bindman ◽  
Pete S. Fleischmann
Keyword(s):  
Mental Health ◽  
Systematic Review ◽  
Informed Consent ◽  
Electroconvulsive Therapy ◽  
Common Law ◽  
Sufficient Information ◽  
Compulsory Treatment ◽  
Perceived Coercion ◽  
Mental Health Legislation ◽  
Health Legislation

BackgroundElectroconvulsive therapy (ECT) is a procedure that attracts special safeguards under common law for voluntary patients and under both current and proposed mental health legislation, for those receiving compulsory treatment.AimsTo review patients' views on issues of information, consent and perceived coercion.MethodSeventeen papers and reports were identified that dealt with patients' views on information and consent in relation to ECT; 134 ‘testimonies' or first-hand accounts were identified. The papers and reports were subjected to a descriptive systematic review. The testimony data were analysed qualitatively.ResultsApproximately half the patients reported that they had received sufficient information about ECT and side-effects. Approximately a third did not feel they had freely consented to ECTeven when they had signed a consent form. Clinician-led research evaluates these findings to mean that patients trust their doctors, whereas user-led work evaluates similar findings as showing inadequacies in informed consent.ConclusionNeither current nor proposed safeguards for patients are sufficient to ensure informed consent with respect to ECT, at least in England and Wales.

scholarly journals Implementation of Electronic Informed Consent in Biomedical Research and Stakeholders’ Perspectives: Systematic Review (Preprint)

2020 ◽  
Author(s):  
Evelien De Sutter ◽  
Drieda Zaçe ◽  
Stefania Boccia ◽  
Maria Luisa Di Pietro ◽  
David Geerts ◽  
...  
Keyword(s):  
Systematic Review ◽  
Mixed Methods ◽  
User Interface ◽  
Informed Consent ◽  
Systematic Reviews ◽  
Biomedical Research ◽  
Cross Sectional ◽  
Research Participants ◽  
Stakeholder Groups ◽  
Multiple Stakeholder

BACKGROUND Informed consent is one of the key elements in biomedical research. The introduction of electronic informed consent can be a way to overcome many challenges related to paper-based informed consent; however, its novel opportunities remain largely unfulfilled due to several barriers. OBJECTIVE We aimed to provide an overview of the ethical, legal, regulatory, and user interface perspectives of multiple stakeholder groups in order to assist responsible implementation of electronic informed consent in biomedical research. METHODS We conducted a systematic literature search using Web of Science (Core collection), PubMed, EMBASE, ACM Digital Library, and PsycARTICLES. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were used for reporting this work. We included empirical full-text studies focusing on the concept of electronic informed consent in biomedical research covering the ethical, legal, regulatory, and user interface domains. Studies written in English and published from January 2010 onward were selected. We explored perspectives of different stakeholder groups, in particular researchers, research participants, health authorities, and ethics committees. We critically appraised literature included in the systematic review using the Newcastle-Ottawa scale for cohort and cross-sectional studies, Critical Appraisal Skills Programme for qualitative studies, Mixed Methods Appraisal Tool for mixed methods studies, and Jadad tool for randomized controlled trials. RESULTS A total of 40 studies met our inclusion criteria. Overall, the studies were heterogeneous in the type of study design, population, intervention, research context, and the tools used. Most of the studies’ populations were research participants (ie, patients and healthy volunteers). The majority of studies addressed barriers to achieving adequate understanding when using electronic informed consent. Concerns shared by multiple stakeholder groups were related to the security and legal validity of an electronic informed consent platform and usability for specific groups of research participants. CONCLUSIONS Electronic informed consent has the potential to improve the informed consent process in biomedical research compared to the current paper-based consent. The ethical, legal, regulatory, and user interface perspectives outlined in this review might serve to enhance the future implementation of electronic informed consent. CLINICALTRIAL PROSPERO International Prospective Register of Systematic Reviews CRD42020158979; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=158979

scholarly journals Access to Medications and Medical Care After Participation in HIV Clinical Trials: A Systematic Review of Trial Protocols and Informed Consent Documents

2009 ◽  
Vol 10 (1) ◽  
pp. 13-24 ◽  
Author(s):  
Andrea L. Ciaranello ◽  
Rochelle P. Walensky ◽  
Paul E. Sax ◽  
Yuchiao Chang ◽  
Kenneth A. Freedberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Informed Consent ◽  
Medical Care ◽  
Trial Protocols ◽  
Hiv Clinical Trials
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