Introduction The subjective assessment of the adequacy of informed consent for clinical
trials, and the potential difficulties associated with it, has led several studies to develop …

Objectives: To compare the quality of informed consent forms (ICF) for different trial phases,
funding sources, oncology subspecialties, disease settings, and intervention modalities …

Primary objective: To investigate the readability of informed consent forms (ICF) used at
TREAD Research, a private clinical trial research unit located in Tygerberg Hospital …

Background Ethically, informed consent regarding randomised controlled trials (RCTs)
should be understandable to patients. The patients can then give free consent or decline to …

Background Informed consent is one of the primary standards of ethical clinical research.
This study assessed the quality of the informed consent forms (ICF) utilized in medical …

Objective Information on the rights of subjects in clinical trials has become increasingly
complex and difficult to understand. This study evaluates whether a simple booklet which is …

Introduction Early phase cancer clinical trials have become increasingly complicated in
terms of patient selection and trial procedures—this is reflected in the increasing length of …

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Introduction Early phase cancer clinical trials have become increasingly complicated in
terms of patient selection and trial procedures—this is reflected in the increasing length of …

2 forms while ensuring regulatory compliance and the use of plainlanguage principles. 11
By 2009, the NCI had received feedback that its consent forms had grown too long and …