scholarly journals 155 Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study

2015 ◽  
Vol 21 (3) ◽  
pp. 155-163 ◽  
Author(s):  
H. Mansour ◽  
N. Zaki ◽  
R. Abdelhai ◽  
N. Sabry ◽  
H. Silverman ◽  
...  
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Therapeutic Misconception ◽  
Research Participants

Readability of Informed Consent Forms: Analysis and Recommendations for Development of Consent Forms for Use with Communities with Limited or Low Literacy

2016 ◽  
Author(s):  
Miraida Morales ◽  
Sarah Barriage
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Measurement Tool ◽  
Low Literacy ◽  
Consent Forms ◽  
Early Readers ◽  
Research With Children ◽  
Consentement Éclairé

This poster presents a pilot study that analyzed a small corpus of informed consent forms used in research with children, adolescents, and adult early readers using Coh-Metrix, a readability measurement tool. Recommendations for increasing readability of consent forms in order to improve the informed consent process are also provided. Cette affiche présente une étude pilote qui a analysé un corpus restreint de formulaires de consentement éclairé utilisés dans la recherche avec les enfants, les adolescents et les lecteurs précoces adultes,  utilisant Coh-Metrix, un outil de mesure de la lisibilité. Nous fournissons également des recommandations pour augmenter la lisibilité des formulaires de consentement afin d'améliorer le processus de consentement éclairé.

scholarly journals Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

2017 ◽  
Vol 4 ◽  
pp. 233339361773201 ◽  
Author(s):  
Lika Nusbaum ◽  
Brenda Douglas ◽  
Karla Damus ◽  
Michael Paasche-Orlow ◽  
Neenah Estrella-Luna
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Staff ◽  
Research Participants ◽  
Risks And Benefits ◽  
Successful Communication ◽  
Communication Practices ◽  
And Training

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research.

Checklist to improve informed consent process in pediatric surgery: A pilot study

2017 ◽  
Vol 52 (5) ◽  
pp. 859-863 ◽  
Author(s):  
Mohammed Firdouse ◽  
Amy Wajchendler ◽  
Martin Koyle ◽  
Annie Fecteau
Keyword(s):  
Informed Consent ◽  
Pilot Study ◽  
Pediatric Surgery ◽  
Informed Consent Process ◽  
Consent Process

scholarly journals An evaluation of the process of informed consent: views from research participants and staff

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lydia O’ Sullivan ◽  
Laura Feeney ◽  
Rachel K. Crowley ◽  
Prasanth Sukumar ◽  
Eilish McAuliffe ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Study ◽  
Contextual Factors ◽  
Informed Consent Process ◽  
Small Sample ◽  
Consent Process ◽  
Online Research ◽  
Research Staff ◽  
Research Participants ◽  
The Impact

Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. Methods Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. Results Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. Conclusions Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques. Trial Registration Not applicable

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.

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