4.3 Article

Regulatory compliance and readability of informed consent forms in industry-sponsored drug development clinical trials

相关参考文献

注意:仅列出部分参考文献,下载原文获取全部文献信息。
Article Ethics

Understanding the Use of Optimal Formatting and Plain Language When Presenting Key Information in Clinical Trials

Erin D. Solomon et al.

Summary: Researchers reported using formatting in 42% of their key information sections, and plain language in 63% of their key information sections. Perceived barriers included lack of knowledge, Institutional Review Board, other members of their team, and the burden associated with implementation. Education and training are required to increase adoption of the practices.

JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS (2022)

Article Medicine, General & Internal

Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices

Anne Wisgalla et al.

Summary: Inadequate understanding of informed consent is a serious problem in clinical research, with factors such as lengthy and hard-to-read documents, low readability, and therapeutic misconception contributing to the issue. Immediate action is needed to address these deficits.

BMJ OPEN (2022)

Article Oncology

Understanding Verbosity: Funding Source and the Length of Consent Forms for Cancer Clinical Trials

Quyen Duong et al.

Summary: Consent forms are important for cancer patients to decide on their participation in clinical trials, but wordiness may reduce their educational value. This study found that consent forms from pharmaceutical company trials had the highest median word count, and overall consent forms have become more verbose over time.

JOURNAL OF CANCER EDUCATION (2021)

Article Ethics

Informed Consent: What Must Be Disclosed and What Must Be Understood?

Joseph Millum et al.

Summary: Traditional view holds that understanding and disclosure are equally important in clinical research, but this paper argues that this view is mistaken, stating that the understanding and disclosure of information for participants are not necessarily linked, and whether participants give valid consent should be determined based on different grounds of invalid consent.

AMERICAN JOURNAL OF BIOETHICS (2021)

Review Medicine, Research & Experimental

The reality of informed consent: empirical studies on patient comprehension-systematic review

Tomasz Pietrzykowski et al.

Summary: Research indicates that patients' comprehension of fundamental informed consent components is limited, particularly in terms of placebo concepts, randomisation, safety issues, risks, and side effects. This lack of understanding may impact patients' genuine involvement in shared medical decision-making.

TRIALS (2021)

Editorial Material Oncology

Informed Consent 2021: The Terms and Conditions of the Research World

Philip J. Saylor

ONCOLOGIST (2021)

Article Medicine, Research & Experimental

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

Lydia O' Sullivan et al.

Summary: Research participants generally had positive experiences with the informed consent process, emphasizing the importance of having enough time and providing follow-up after the study. Most research staff felt confident facilitating informed consent discussions, but expressed concerns about the length and complexity of information leaflets, participants' understanding of the information, and time constraints. Adequate time allocation and consideration of Teach Back techniques are important for improving the informed consent process.

TRIALS (2021)

Review Anesthesiology

Exemption from informed consent: When it is possible in investigational product and drug trials?

Swati Verma

Summary: Obtaining informed consent is crucial in conducting investigational product trials or drug trials, but there are situations where it may not be practical or could impact the validity of the study data. This review aims to provide insight into when it is necessary to obtain informed consent and when it can be waived off, particularly considering factors like literacy or medical conditions of participants.

SAUDI JOURNAL OF ANAESTHESIA (2021)

Article Medicine, Research & Experimental

Institutional improvements in readability of written informed consent forms sustained post-revised Common Rule

Alison Caballero et al.

Summary: Obtaining informed consent is essential in human subjects' research. Informed consent forms contain a lot of information, and efforts should be made to optimize subjects' ability to read and understand them, especially for those with limited health literacy.

JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE (2021)

Review Medicine, General & Internal

A Modern History of Informed Consent and the Role of Key Information

Lydia A. Bazzano et al.

Summary: The concept of informed consent has evolved significantly, but the new key information section introduced in the 2017 revisions to the Common Rule lacks regulatory guidance, leading to concerns about compliance. Further research is needed to evaluate the effectiveness of the key information section in enhancing research participants' understanding of study details.

OCHSNER JOURNAL (2021)

Article Medical Informatics

Evaluation of Legal Legislation Compliance and Readability of Clinical Trial Informed Consent Forms

Buket Gungor et al.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2020)

Article Medicine, Research & Experimental

How are US institutions implementing the new key information requirement?

Jessica Mozersky et al.

JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE (2020)

Review Medicine, General & Internal

Revised Common Rule Changes to the Consent Process and Consent Form

Leah L. LeCompte et al.

OCHSNER JOURNAL (2020)

Review Medicine, General & Internal

Investigator Responsibilities in Clinical Research

Amy K. Feehan et al.

OCHSNER JOURNAL (2020)

Article Public, Environmental & Occupational Health

Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document

Vanessa W. Simonds et al.

JOURNAL OF RACIAL AND ETHNIC HEALTH DISPARITIES (2020)

Article Pharmacology & Pharmacy

Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers

Nut Koonrungsesomboon et al.

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2019)

Article Ethics

Consent for participating in clinical trials - Is it really informed?

Teodora Alexa-Stratulat et al.

DEVELOPING WORLD BIOETHICS (2018)

Article Oncology

A comparison of the quality of informed consent for phase I oncology trials over a 30-year period

Laeeq Malik et al.

CANCER CHEMOTHERAPY AND PHARMACOLOGY (2018)

Article Ethics

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

Amy Corneli et al.

JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS (2017)

Review Medicine, General & Internal

The Changing Face of Informed Consent

Christine Grady et al.

NEW ENGLAND JOURNAL OF MEDICINE (2017)

Article Education, Scientific Disciplines

Assessing Reading Levels of Health Information: Uses and Limitations of Flesch Formula

Pranay Jindal et al.

EDUCATION FOR HEALTH (2017)

Article Medicine, Research & Experimental

Improving readability of informed consents for research at an academic medical institution

Kristie B. Hadden et al.

JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE (2017)

Article Ethics

Examining Provisions Related to Consent in the Revised Common Rule

Jeremy Sugarman

AMERICAN JOURNAL OF BIOETHICS (2017)

Article Pharmacology & Pharmacy

Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study

Nut Koonrungsesomboon et al.

EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY (2016)

Article Ethics

Exceptions to the rule of informed consent for research with an intervention

Susanne Rebers et al.

BMC MEDICAL ETHICS (2016)

Article Psychiatry

Sense and readability: participant information sheets for research studies

Liam Ennis et al.

BRITISH JOURNAL OF PSYCHIATRY (2016)

Article Medicine, Research & Experimental

Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative

Jennifer Lentz et al.

CONTEMPORARY CLINICAL TRIALS (2016)

Review Ethics

Reading Level and Comprehension of Research Consent Forms: An Integrative Review

Gabriella Foe et al.

JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS (2016)

Review Public, Environmental & Occupational Health

Participants' understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis

Nguyen Thanh Tam et al.

BULLETIN OF THE WORLD HEALTH ORGANIZATION (2015)

Article Medicine, Research & Experimental

Informed consent in clinical research: Consensus recommendations for reform identified by an expert interview panel

Beverly H. Lorell et al.

CLINICAL TRIALS (2015)

Article Ethics

What Should Be Disclosed to Research Participants?

David Wendler

AMERICAN JOURNAL OF BIOETHICS (2013)

Article Public, Environmental & Occupational Health

Assessing readability formula differences with written health information materials: Application, results, and recommendations

Lih-Wern Wang et al.

RESEARCH IN SOCIAL & ADMINISTRATIVE PHARMACY (2013)

Article Medicine, General & Internal

What potential research participants want to know about research: a systematic review

Helen Michelle Kirkby et al.

BMJ OPEN (2012)

Article Medicine, Research & Experimental

Analysis of the compliance of informed consent documents with good clinical practice guideline

Biswa M. Padhy et al.

CONTEMPORARY CLINICAL TRIALS (2011)

Article Medicine, Research & Experimental

Do informed consent documents matter?

David B. Resnik

CONTEMPORARY CLINICAL TRIALS (2009)

Article Oncology

Consent documents for oncology trials: Does anybody read these things?

SM Sharp

AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS (2004)