Informed Consent, the Ethical Cornerstone of Medical Intervention, Especially within the Conduct of Clinical Trials

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Beran RG ◽  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Young Person ◽  
Medical Intervention ◽  
Undue Influence ◽  
Novel Approach ◽  
Consent Document ◽  
Ultimate Responsibility ◽  
Trial Coordinator ◽  
University Science

Introduction: This paper outlines and explains a new approach to informed consent, especially within clinical trials. Background: Autonomy implies the patient has control for what happens to his/her body. There is a problem with lack of equipoise between clinician and patient, especially when the clinician, conducting a trial, is also the patient’s physician. Beran et al adopted a novel approach to informed consent, especially within clinical trials. The patient is introduced to the trial coordinator who assumes responsibility of discussing the nature, risks and benefits of the trial. If the patient accepts and signs the informed consent document, with the coordinator, the doctor counter-signs it, offering the opportunity to ask further questions, criticize the process and feel confident that the decision was correct. Discussion: Where the investigator is also the patient’s treating clinician, it must be recognized that there might be a perception of potential coercion, asking a patient to join a trial. The practice employed a trial coordinator, a recent university, science graduate, a young person with less influence over the patient. Patients completed the bulk of the informed consent with the trial coordinator, given every opportunity to decline inclusion into a trial. With the trial coordinator, being responsible for discussing the elements of the trial, there is a reduced potential for undue influence, with ultimate respect for autonomy and selfdetermination. This procedure offers a novel approach to gain informed consent for inclusion in clinical trials with the doctor retaining ultimate responsibility, for informed consent, and countersigning the consent document.

scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

scholarly journals Involuntary Consent: Conditioning Access to Health Care on Participation in Clinical Trials

2016 ◽  
Vol 44 (3) ◽  
pp. 445-461 ◽  
Author(s):  
Ruqaiijah A. Yearby
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Informed Consent ◽  
Impact Assessment ◽  
Economically Disadvantaged ◽  
Access To Health Care ◽  
Assessment Tool ◽  
Respect For Persons ◽  
Undue Influence ◽  
Access To Health

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle.

scholarly journals Facilitating The Informed Consent Process Using Teleconsent: A Study Protocol (Preprint)

2018 ◽  
Author(s):  
Saif Khairat ◽  
Paige Ottmar ◽  
Christina Smith ◽  
Betsy Sleath ◽  
Brandon Welch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
South Carolina ◽  
Informed Consent ◽  
Rural Communities ◽  
Clinical Research ◽  
Phase 1 ◽  
Informed Consent Process ◽  
Consent Process ◽  
University Of South Carolina ◽  
Novel Approach

BACKGROUND Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants--particularly minorities and participants from rural communities. OBJECTIVE The objective of this study is to utilize telemedicine to improve the informed consent process for the clinical trials and studies. METHODS This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina (MUSC) and the University of North Carolina at Chapel Hill (UNC), in order to compare results both within and across institutions. RESULTS Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. CONCLUSIONS In this paper, we present a novel approach to conducting the informed consent using a new telemedicine modality namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. The aim of this research is to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants.

scholarly journals Assessment of Parents’/Guardians’ Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia

2018 ◽  
Vol 13 (3) ◽  
pp. 247-257
Author(s):  
Ezequiel B. Ossemane ◽  
Troy D. Moon ◽  
Jahit Sacarlal ◽  
Esperança Sevene ◽  
Darlene Kenga ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Study ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Voluntary Participation ◽  
Research Protocol ◽  
Full Understanding ◽  
Consent Document ◽  
Informed Consent Document ◽  
High Degree

Participants’ understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study’s aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study’s informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans’ informed, voluntary participation in clinical trials.

scholarly journals Advanced consent for participation in acute care randomised control trials: protocol for a scoping review

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039172
Author(s):  
Naomi Niznick ◽  
Ronda Lun ◽  
Brian Dewar ◽  
Dar Dowlatshahi ◽  
Michel Shamy
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Scoping Review ◽  
English Language ◽  
Grey Literature ◽  
Primary Data ◽  
Future Research ◽  
Substitute Decision Maker ◽  
Novel Approach ◽  
Randomised Control Trials

IntroductionInformed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will map and synthesise the literature on the use of advanced consent for participation and enrolment in randomised control trials for emergency conditions.Methods and analysisGuided by Arksey and O'Malley’s scoping review methodology framework, we will search electronic databases (Medline, Embase, Web of Science and the Cochrane Register of Clinical Trials), the grey literature sources and reference lists of relevant studies. Eligible studies will include English language articles that discuss, examine or employ the use of advanced consent for enrolment in randomised control trials, specifically related to emergency conditions or emergency treatment. Diverse types of articles will be eligible for inclusion, including peer-reviewed qualitative and quantitative studies such as randomised control trials, observational studies, surveys, systematic reviews, as well as narrative reviews and ethics papers. Studies will be screened by two independent reviewers to determine eligibility for inclusion. Data on bibliographic information, study characteristics and methodology, and reported results, specifically author disposition, will be extracted and described using qualitative analysis.Ethics and disseminationFormal ethics review is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication. The findings of this study will help identify knowledge gaps that may guide areas for future research and may aid in the design of future clinical trials using advanced consent.

Do patients participating in oncology clinical trials understand the informed consent form? A Brown University Oncology Research Group study.

2012 ◽  
Vol 30 (34_suppl) ◽  
pp. 23-23
Author(s):  
Andrew Schumacher ◽  
Carolyn Bartley ◽  
Anne Kaplan ◽  
Benjamin Murphy ◽  
Howard Safran ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Research Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Participants ◽  
Oncology Research ◽  
Consent Document ◽  
Oncology Clinical Trials ◽  
Informed Consent Document

23 Background: The informed consent process is used to provide research participants information that includes the purpose and procedures of the research study, risks, benefits, potential alternatives and that participation is voluntary. The goal of informed consent to is to provide this information in language that is understandable to the research participant. The aim of this study is to evaluate whether research participants in adult hematology/oncology clinical trials understand the information presented during the informed consent process. Methods: Patients receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy were eligible to participate in this study. After informed consent was obtained, research participants are given a 14-question test. The questions evaluate whether patients understand the following elements on the informed consent related to their oncology treatment study: The purpose and procedures of the research study, risks, benefits, potential alternatives, research related injury compensation, study contact information, measures used to protect confidentiality, and that participation is voluntary. The possible answers to each question are disagree, unsure, and agree. Results: This study was initiated in June 2012. Eleven patients enrolled on this study within the first month. Participants include those on cooperative group studies, pharmaceutical industry trials and investigator initiated trials. The average length of the informed consent document exceeded 20 pages. An initial analysis of data is planned after the study has been open for six months. Conclusions: Informed consents are becoming increasingly lengthy and complex. Much of the language added is regulatory and legal in nature and used to protect the institutions conducting the research. This study will assess the readability of the informed consent and whether patients participating in oncology research trials understand the essential elements of the informed consent document. The first data analysis will be December 2012.

Cyber-Situational Awarenss in Clinical Trials Using Wearable Device Technology

2021 ◽  
Vol 10 (1) ◽  
pp. 33-36
Author(s):  
Elizabeth A. Johnson ◽  
Jane M. Carrington
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Best Practices ◽  
Situational Awareness ◽  
Implantable Devices ◽  
Wearable Device ◽  
Sleep Habits ◽  
Privacy Issues ◽  
Trial Participants ◽  
Device Technology

It is estimated 1 in 3 clinical trials utilize a wearable device to gather real-time participant data, including sleep habits, telemetry, and physical activity. While wearable technologies (including smart watches, USBs, and implantable devices) have been revolutionary in their ability to provide a higher precision and accuracy to data acquisition external to the research milieu, there is hesitancy among providers and participants alike given security concerns, perception of cyber-related threats, and meaning attributed to privacy issues. The purpose of this research is to define cyber-situational awareness (CSA) as it pertains to clinical trials, evaluate its current measurement, and describe best practices for research investigators and trial participants to enhance protections in the digital age. This paper reviews integrated elements of CSA within the process of informed consent when wearable devices are implemented for trial procedures. Evaluation of CSA as part of informed consent allows the research site to support the participant in knowledge gaps surrounding the technology while also providing feedback to the trial sponsor as to technology improvements to enhance usability and wearability of the device.

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