Consent for Anesthesia Clinical Trials on the Day of Surgery

2016 ◽  
Vol 124 (6) ◽  
pp. 1246-1255 ◽  
Author(s):  
Glenn S. Murphy ◽  
Joseph W. Szokol ◽  
Michael J. Avram ◽  
Steven B. Greenberg ◽  
Torin D. Shear ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Research Participation ◽  
Study Groups ◽  
Low Risk ◽  
Consent Process ◽  
Median Score ◽  
Anesthesia Research ◽  
Strongly Agree ◽  
Question Survey

Abstract Background Opportunities for anesthesia research investigators to obtain consent for clinical trials are often restricted to the day of surgery, which may limit the ability of subjects to freely decide about research participation. The aim of this study was to determine whether subjects providing same-day informed consent for anesthesia research are comfortable doing so. Methods A 25-question survey was distributed to 200 subjects providing informed consent for one of two low-risk clinical trials. While consent on the day of surgery was permitted for both studies, a preadmission telephone call was required for one. The questionnaire was provided to each subject at the time of discharge from the hospital. The questions were structured to assess six domains relating to the consent process, and each question was graded on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Overall satisfaction with same-day consent was assessed using an 11-point scale with 0 = extremely dissatisfied and 10 = extremely satisfied. Results Completed questionnaires were received from 129 subjects. Median scores for satisfaction with the consent process were 9.5 to 10. Most respondents reported that the protocol was well explained and comprehended and that the setting in which consent was obtained was appropriate (median score of 5). Most patients strongly disagreed that they were anxious at the time of consent, felt obligated to participate, or had regrets about participation (median score of 1). Ten percent or less of subjects reported negative responses to any of the questions, and no differences were observed between the study groups. Conclusion More than 96% of subjects who provided same-day informed consent for low-risk research were satisfied with the consent process.

scholarly journals Parental perceptions of the informed consent process in pediatric oncology clinical trials

2013 ◽  
Vol 3 (11) ◽  
Author(s):  
Yvonne D Hastings ◽  
Natalie K Bradford ◽  
Liane R Lockwood ◽  
Robert S Ware ◽  
Jeanine Young
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Pediatric Oncology ◽  
Parental Perceptions ◽  
Informed Consent Process ◽  
Consent Process ◽  
Oncology Clinical Trials

Consent in gastrointestinal endoscopy: valid, informed and nurse-led

2019 ◽  
Vol 17 (5) ◽  
pp. 20-23
Author(s):  
Christine Metcalf
Keyword(s):  
Informed Consent ◽  
Gastrointestinal Endoscopy ◽  
High Volume ◽  
Mental Capacity ◽  
Low Risk ◽  
Therapeutic Interventions ◽  
Consent Process ◽  
Multi Stage ◽  
Potential Risks ◽  
To Receive

Gastrointestinal endoscopy is generally safe, but these diagnostic and therapeutic interventions come with potential risks and thus require written, valid and informed consent, except in emergencies. Informed consent requires patients to receive and discuss information on the benefits, risks and nature of the procedure, as well as any alternatives. To consent, a patient must have the mental capacity to understand the information and use it to make and communicate a decision. Consent is a multi-stage procedure, beginning when endoscopy is first proposed and continuing into the intervention, as patients can withdraw consent during the procedure, whether sedated or not. For high-volume, low-risk procedures, the consent process can be safely delegated to qualified endoscopy nurses, with sufficient and relevant training, knowledge and support from the trust. Nurses competencies and other elements of the consent process should be regularly audited.

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

scholarly journals Regulatory developments in the conduct of clinical trials in India

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Supreme Court ◽  
Large Scale ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Consent Process ◽  
Regulatory Institutions ◽  
Indian Supreme Court

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

How Informed Is Informed Consent?

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2556-2556
Author(s):  
Karl Desch ◽  
Jun Z. Li ◽  
Scott Kim ◽  
Naomi Laventhal ◽  
David Siemieniak ◽  
...  
Keyword(s):  
Informed Consent ◽  
Biomedical Research ◽  
Reading Time ◽  
Conflicts Of Interest ◽  
Clinical Care ◽  
Informed Consent Process ◽  
Low Risk ◽  
Consent Process ◽  
University Of Michigan ◽  
The University

Abstract Abstract 2556 The informed consent process is a critical component of human subject protection in biomedical research, with the goals of informing participants of the purpose of the study, as well as the likely risks, benefits and alternatives. The signed informed consent document (ICD) is a required legal disclosure which documents that the informed consent process has taken place and provides research subjects with comprehensive information about their role in a study. Despite efforts to optimize the ICD, only limited data are available regarding the utilization of these documents by participants in biomedical research. We measured the time taken by participants, in a genetic study of hematologic traits, to review a 2833 word online ICD prior to indicating consent. ICDs were generated utilizing standard templates provided by the University of Michigan IRB with the addition of a hyperlink at word 2254 of the ICD that read “If you are reading this form, please click on this sentence”. Identification of the hyperlink, as a proxy for thorough reading of the ICD, was recorded. The study was approved by the University of Michigan IRB (IRBMED# 2005-0080.) A total of 1209 subjects were recruited from the University of Michigan, Ann Arbor student population from 2/12/08 to 1/30/09. Age ranged from 14 to 35 years with a mean of 21. Standard reading speeds predicted a range of 567 to 850 seconds to read the full ICD text. The distribution of consent times was heterogeneous, heavily weighted toward times that would suggest little to no reading of the ICD. Twenty-eight percent of participants consented within ten seconds. Only 78 participants (6.4%) took longer than the minimum estimated reading time (566 seconds) to indicate consent. The hyperlink was identified by 2.2% of participants with a median reading time of 621 seconds, significantly longer than those who did not (52 seconds, p<3×10−11). Additionally, significant differences in consent time were noted for sex, age, and downloading of the ICD PDF file. Our results demonstrate that the majority of participants in this study (93.6%) provided consent without spending sufficient time to thoroughly read and comprehend the ICD. The 6.4% of participants with consent times greater than the minimum predicted ICD reading times is likely a significant overestimate of ICD comprehension since the consent interval recorded could also include time spent on other distracting activities. In conclusion, these observations imply that the consent by subjects to participate in this and many other low-risk studies is unlikely to have been as truly informed as originally intended by the investigators and the IRB. This lack of truly informed consent is also likely to extend beyond research studies, to include ICDs used for treatment in the routine clinical care setting. These data suggest that current ICDs, particularly for low-risk studies, may no longer serve the intended informed consent purpose and that ICD length and complexity should be reassessed. Disclosures: No relevant conflicts of interest to declare.

Entering a Clinical Trial: Is It Right For You?–A randomized study of the Clinical Trials Video and its impact on the informed consent process

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9072-9072
Author(s):  
S. Hitchcock-Bryan ◽  
B. Hoffner ◽  
S. Joffe ◽  
M. Powell ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Provider Communication ◽  
Patient Provider Communication ◽  
Source Of Information

9072 Background: In an effort to improve the informed consent process for subjects considering participation in a clinical trial, we created an educational video: “Entering a Clinical Trial: Is it Right for You?” In this randomized study, we assessed the effect of the video on patients’ understanding and perceptions of clinical trials. We also assessed patient satisfaction with the video and how the video impacted decision-making and patient-provider communication. Methods: We recruited 90 adults considering cancer clinical trials of whom 77 participated. After discussing the trial with the physician and reading the trial consent form, patients were randomized to receive (n=38) or not receive (n=39) the study video. Using a validated questionnaire, we interviewed subjects to assess objective understanding of the trial, our primary endpoint, and self-reported understanding of clinical trials. All subjects completed a second interview assessing secondary endpoints, including patient-provider communication, satisfaction with video, and decision-making. We used linear regression (two-sided tests) to conduct the primary analysis and the Wilcoxon rank-sum test and descriptive statistics to analyze the secondary aims. Results: Neither objective nor self-reported understanding of clinical trials differed between the two groups (Mean 86.5 vs. 87, p=0.75). 85% (61/72) indicated the video was an important source of information about clinical trials; 89% of those who watched the video with their family/friends (n=37) said the video helped loved ones better understand clinical trials; 73% indicated it helped their family accept their decision about participation. 81% (58/72) felt better prepared to discuss the trial with their physician after watching the video. Of those who found the video helpful with decision- making, 80% (21/26) were considering a trial for the first time compared with 19% (5/26) veterans who had previously participated in a clinical trial. Conclusions: The video did not measurably improve subjects’ understanding of their clinical trials. However, subjects reported that the video was an important source of information, helped them educate their families, and enhanced patient-provider communication. No significant financial relationships to disclose.

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