scholarly journals Attitudes About Informed Consent: An Exploratory Qualitative Analysis of UK Psychotherapy Trainees

2020 ◽  
Vol 11 ◽  
Author(s):  
Charlotte R. Blease ◽  
Tim Arnott ◽  
John M. Kelley ◽  
Gillian Proctor ◽  
Tobias Kube ◽  
...  
Keyword(s):  
Informed Consent ◽  
Qualitative Analysis ◽  
Psychotherapy Trainees

scholarly journals Informed Consent in Pediatric Oncology

2018 ◽  
Vol 25 (1) ◽  
pp. 107327481877372 ◽  
Author(s):  
Ghiath Alahmad
Keyword(s):  
Informed Consent ◽  
Qualitative Analysis ◽  
Pediatric Oncology ◽  
Ethical Issues ◽  
Informed Consent Process ◽  
Qualitative Studies ◽  
Psychological Status ◽  
Consent Process ◽  
Parental Distress ◽  
Ethical Challenges

Objective: Obtaining informed consent in pediatric cancer research can be subject to important ethical challenges because of the difficulty in distinguishing between care and research, which are interrelated. Pediatric oncologists also often conduct research, such as clinical trials, on their own patients, which may influence voluntary informed consent. This review aims to determine the ethical issues encountered in obtaining informed consent in pediatric oncology by identifying and summarizing the findings of existing qualitative studies on this topic. Methods: A systematic review of qualitative studies was conducted. Medline, Embase, CINAHL, and PubMed were searched using the following terms: (oncolog* or cancer or hematol* or haematol* or leuk* or malign* or neoplasm*) and (child* or adolescent* or minor* or young people or pediatr* or paediatr*) and ethic* or moral*) and (qualitative or interview). Other sources were also mined to identify all relevant studies. The data analysis method used was thematic analysis. Results: At the end of the search process, 2361 studies were identified. Duplicates were removed and irrelevant studies were excluded. After screening the full text of the remaining studies against our inclusion and exclusion criteria, 13 studies were included in the qualitative analysis. All studies were qualitative studies using semistructured and structured interviews, qualitative analysis of open-ended questions, and observation of informed consent conferences. Four themes were identified: parental comprehension of the trial and medical terms, influence of parental distress on decision-making, no offer of an alternative treatment, and influence of the doctor–parent relationship. Conclusion: Many ethical challenges affect the informed consent process. These challenges may include a lack of parental understanding, the potential influence of treating doctors, and vulnerability because of psychological status. All of these result in parents being unable to give well-informed and voluntary consent. Researchers are encouraged to adopt a stepwise approach during the informed consent process.

High-impact RCTs without prospective informed consent: a systematic review

2020 ◽  
Vol 68 (8) ◽  
pp. 1341-1348
Author(s):  
Roma Dhamanaskar ◽  
Jon F Merz
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Qualitative Analysis ◽  
English Language ◽  
High Impact ◽  
Emergency Situations ◽  
Randomized Controlled ◽  
Emergency Interventions ◽  
Cluster Randomized ◽  
Highly Cited

The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs.

scholarly journals Informed consent for whole genome sequencing: A qualitative analysis of participant expectations and perceptions of risks, benefits, and harms

2012 ◽  
Vol 158A (6) ◽  
pp. 1310-1319 ◽  
Author(s):  
Holly K. Tabor ◽  
Jacquie Stock ◽  
Tracy Brazg ◽  
Margaret J. McMillin ◽  
Karin M. Dent ◽  
...  
Keyword(s):  
Informed Consent ◽  
Qualitative Analysis ◽  
Whole Genome Sequencing ◽  
Genome Sequencing ◽  
Whole Genome

Tools and Resources: Web Sites of Interest

2001 ◽  
Vol 6 (2) ◽  
pp. 6-8
Author(s):  
Christopher R. Brigham
Keyword(s):  
Informed Consent ◽  
Physical Examination ◽  
Functional Status ◽  
Web Sites ◽  
Satisfaction Survey ◽  
High Quality ◽  
Diagnostic Studies ◽  
Physician Relationship ◽  
Complete History

Abstract The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Fifth Edition, explains that independent medical evaluations (IMEs) are not the same as impairment evaluations, and the evaluation must be designed to provide the data to answer the questions asked by the requesting client. This article continues discussions from the September/October issue of The Guides Newsletter and examines what occurs after the examinee arrives in the physician's office. First are orientation and obtaining informed consent, and the examinee must understand that there is no patient–physician relationship and the physician will not provide treatment bur rather will send a report to the client who requested the IME. Many physicians ask the examinee to complete a questionnaire and a series of pain inventories before the interview. Typical elements of a complete history are shown in a table. An equally detailed physical examination follows a meticulous history, and standardized forms for reporting these findings are useful. Pain and functional status inventories may supplement the evaluation, and the examining physician examines radiographic and diagnostic studies. The physician informs the interviewee when the evaluation is complete and, without discussing the findings, asks the examinee to complete a satisfaction survey and reviews the latter to identify and rectify any issues before the examinee leaves. A future article will discuss high-quality IME reports.

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