Equipoise, Informed Consent and Clinical Research

2002 ◽  
Vol 11 (2) ◽  
pp. 22-23
Author(s):  
Lynne C. Brady Wagner
Keyword(s):  
Informed Consent ◽  
Clinical Research

Cancer patients’ awareness about clinical research in the era of social media and “fake news”: Preliminary results from ELPIS Study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24121-e24121
Author(s):  
Celeste Cagnazzo ◽  
Veronica Franchina ◽  
Giuseppe Toscano ◽  
Franca Fagioli ◽  
Tindara Franchina ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Cancer Patients ◽  
Experimental Therapy ◽  
Average Score ◽  
Trial Participation ◽  
Primary Role ◽  
Fake News ◽  
Patient Awareness ◽  
The Impact

e24121 Background: Barriers for low recruitment in clinical trials have been classified based on three main sources: physician, patient, system. A primary role is played by a low patient awareness, which often leads to a lack of confidence in science and a substantial inability to estimate the benefits deriving from trial participation, aggravated by the spread of fake news. A prospective observational study was conducted to investigate the views of cancer patients on aspects of clinical research, their expectations, the level of comprehensibility of informed consent and the impact of the fake news phenomenon. Methods: From January 2018, after Ethics Committees approval, the ELPIS study was initiated in 9 Italian Medical Oncology Units. After signing the informed consent, patients were asked to complete a questionnaire, consisting of a set of multiple choice and Likert-score questions. Results: As of January 2021, 115 patients were enrolled, with a balanced sex distribution and a prevalence of subjects older than 55-years (79.8%). Regarding the previous knowledge about clinical research, the average score was 3.9 (range 1-5). The vast majority of respondents (91.3%) had already started experimental therapy and many of them constantly used internet (65.2%) and social networks (34.8%). More than half (53.9%) stated the interview with the physician was sufficient for a full understanding of informed consent. In case of doubt, the majority seeked support in the clinician (39.1%) while very few (1.7%) relied on the web. The average score attributed to doctor-patient relationship was equal to 8.89 (range 1-10). Respondents were quite confident in their ability to independently search for information on their disease, discriminate fake news and identify reliable sites (average score 3.26, 3.27, 3.09 respectively, over a range of 1-5). The scores related to the presumed ability to understand the results of a clinical study and to actively collaborate to produce research were high (average score 4.72 and 4.39 over a range of 1-5). Conclusions: Preliminary data from our research show a good level of patient awareness and a fine ability to understand information, discerning real from fake news. Continuing and implementing the training initiatives of the population in the health sector will certainly contribute to further improvement, hopefully obtaining an even greater involvement of patients in the early phases of research.

113 Simplifying consent - Use of the novel integrated consent model in paediatric clinical research

2021 ◽  
Vol 26 (Supplement_1) ◽  
pp. e82-e84
Author(s):  
Frances Yeung ◽  
Saoirse Cameron ◽  
Sepideh Taheri
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Paediatric Population ◽  
Standards Of Care ◽  
Patient Recruitment ◽  
Clinical Equipoise ◽  
Inpatient Setting ◽  
Pragmatic Clinical Trials ◽  
Circle Of Care ◽  
Integrated Consent Model

Abstract Primary Subject area Hospital Paediatrics Background Obtaining informed consent from patients to participate in clinical research has traditionally been a cumbersome process, often requiring lengthy documentation and the involvement of trained research staff. Moreover, this process can be a burden to the patient/family. As a result, progress in paediatric research and enabling continual improvement in care has been slow. In the last decade, research ethicists have proposed a new “integrated consent model” (ICM) for obtaining informed consent for pragmatic clinical trials that compare standard-of-care interventions, where there is clinical equipoise. In most cases of ICM, only a brief discussion with verbal consent is required, along with a handout on study purpose, risks, benefits, and procedures. This allows for a more condensed consent process, which maximizes clarity and minimizes information overload. ICM also allows the patient/family to maintain prospective autonomy and decision-making, as compared with deferred or waived consent. The ICM model allows staff in the circle of care to obtain consent, which minimizes the stress of meeting an additional person. To our knowledge, ICM has not yet been used in the paediatric population. Objectives The objective of this abstract is to report on the utility of ICM in a non-randomized clinical trial carried out in the inpatient setting of a tertiary children’s hospital. Design/Methods We compared two widely accepted standards of care for maintaining peripheral intravenous catheter patency in a cohort of children, namely continuous infusion (“to keep the vein open” or TKVO) versus saline lock (SL). The ICM process was reviewed and approved by REB. Nurses in the circle of care received a study package that included an REB approved “consent script” to be read to the patient/family, a single page information sheet, and instructions on documenting the obtained verbal consent in the patient’s chart (Graphic 1). Results With ICM, 79% of participants were recruited into the trial by a nurse. Patient recruitment was completed 4 months ahead of the predicted schedule (Figure 1). Nursing, research, and medical staff were satisfied with ICM and found it easy to administer. ICM occurred smoothly and quickly for patients/families, with no interference with their medical care and practically no disruption to their daily schedule. Conclusion ICM is a practical alternative to laborious traditional consent models, is associated with higher patient recruitment rates, and is less burdensome for the patient/family. Paediatricians should be aware of the utility of this novel consent model.

Approach of the Clinical Research Nurse to Informed Consent

1985 ◽  
Vol 3 (1) ◽  
pp. 125-137
Author(s):  
Priscilla M. Brady ◽  
Jane E. McCue ◽  
Joseph S. Alpert
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Research Nurse

Protecting boundaries of consent in clinical research

2013 ◽  
Vol 21 (1) ◽  
pp. 16-27 ◽  
Author(s):  
Shirley T Bristol ◽  
Rodney W Hicks
Keyword(s):  
Quality Improvement ◽  
Informed Consent ◽  
Clinical Research ◽  
Patient Care ◽  
Current Practice ◽  
Informed Consent Process ◽  
Legal Requirements ◽  
Research Outcomes ◽  
Rigorous Research ◽  
Improving Patient Care

Successful clinical research outcomes are essential for improving patient care. Achieving this goal, however, implies an effective informed consent process for potential research participants. This article traces the development of ethical and legal requirements of informed consent and examines the effectiveness of past and current practice. The authors propose the use of innovative monitoring methodologies to improve outcomes while safeguarding consent relationships and activities. Additional rigorous research will help direct policy efforts at standardizing quality improvement processes.

scholarly journals Evidence-Based Strategies for Shortening Informed Consent Forms in Clinical Research

2017 ◽  
Vol 12 (1) ◽  
pp. 14-25 ◽  
Author(s):  
Amy Corneli ◽  
Emily Namey ◽  
Monique P. Mueller ◽  
Jenae Tharaldson ◽  
Steve Sortijas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Evidence Based ◽  
Online Surveys ◽  
Consent Forms ◽  
Modified Delphi ◽  
Key Stakeholders ◽  
Semistructured Interviews ◽  
Prevention Trials ◽  
Grouping Study

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants’ understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

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