What do cancer patients and members of ethical review boards in Norway consider important elements of informed consent documents?

O Berger, K Sand, I Johansen, JH Loge… - AJOB Empirical …, 2014 - Taylor & Francis
Background: The length and content of informed consent documents (ICDs) in clinical trials
have increased in recent decades. In Norway, Regional Committees for Medical and Health …

[HTML][HTML] The length of consent documents in oncological trials is doubled in twenty years

O Berger, BH Grønberg, K Sand, S Kaasa, JH Loge - Annals of Oncology, 2009 - Elsevier
Background The aim of the study was to investigate whether the length of informed consent
documents (ICDs) for oncological trials have increased from 1987 to 2007 and analyze the …

Informed consent documents for cancer research: Textual and contextual factors of relevance for understanding

K Sand - 2012 - ntnuopen.ntnu.no
Participation in medical research must be completely voluntary, and a patient's or healthy
volunteers' decision to take part must be documented through an informed consent …

Identifying essential information to support patient decision‐making regarding participation in cancer clinical trials: A Delphi study

CY Kao, S Aranda, M Krishnasamy… - European journal of …, 2018 - Wiley Online Library
Purposes This research set out to contribute to ongoing efforts to improve the quality of
informed consent information provided to patients by specifically focusing on establishing …

[HTML][HTML] Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials

C Reinert, L Kremmler, S Burock, U Bogdahn… - European Journal of …, 2014 - Elsevier
Introduction In randomised controlled trials (RCTs), patient informed consent documents are
an essential cornerstone of the study flow. However, these documents are often oversized in …

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

A Schumacher, C Bartley, A Kaplan, B Murphy… - 2012 - ascopubs.org
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 …

The quality of informed consent forms for oncology clinical trials

WY Cheung, GR Pond, RJ Heslegrave… - Journal of Clinical …, 2008 - ascopubs.org
6544 Background: Informed consent forms (ICF) play an integral role in the consent process
for clinical trials (CT) by serving as a guide for discussion between the research team and …

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent …

V Sanchini, M Reni, G Calori, E Riva… - Journal of medical …, 2014 - jme.bmj.com
We explored the comprehension of the informed consent in 77 cancer patients previously
enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at …

Views of clinical trial participants on the readability and their understanding of informed consent documents

R Sommers, C Van Staden, F Steffens - AJOB Empirical Bioethics, 2017 - Taylor & Francis
Background: One of the ethical imperatives for a valid consent process in clinical medication
trials is that the process be guided by and recorded in an informed consent document (ICD) …

Improvement of informed consent and the quality of consent documents

M Jefford, R Moore - The lancet oncology, 2008 - thelancet.com
Guidelines on informed consent intend to protect patients and promote ethical research
conduct. To give informed consent, individuals should understand the purpose, process …