What Do Cancer Patients and Members of Ethical Review Boards in Norway Consider Important Elements of Informed Consent Documents?

Ola Berger, Kari Sand, Ingunn Johansen, Jon Havard Loge, Stein Kaasa, Bjørn Henning Grønberg

Research output: Contribution to journalArticle

Abstract

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 Research Ethics (RECs) approve ICDs according to national and international guidelines. The aim of this study was to investigate how important members of these committees and cancer patients consider the information elements found in ICDs to be. Methods: Using the Delphi technique, an expert group developed a questionnaire for asking the participants how they rated the importance of 31 information elements, and whether they were familiar with or considered seven terms/phrases commonly used in ICDs difficult to understand. All 123 members of the Norwegian RECs and 200 consecutive cancer patients at the outpatient cancer clinic at St. Olavs Hospital, Trondheim University Hospital, received the questionnaire. Group comparisons were conducted using chi-squared and Fisher's exact tests. The statistical significance level was defined as p <.01 due to multiple comparisons. Results: The committee members (n = 81) and patients (n = 104) rated almost all (95%) of the information elements as important. Very few (4%) information elements were rated as not important. We did not find any significant differences in the rating of the elements between subgroups of patients, between subgroups of REC members, or between patients and REC members. The patients were not familiar with all terms commonly found in ICDs, and the REC members were not able to predict which terms the patients were familiar with. Patients rated the information elements as more important if they were familiar with the terms used in the respective elements. Conclusions: The participants rated almost all information elements important to include in ICDs, suggesting that ICDs cannot necessarily be shortened by leaving out information elements. Ensuring that patients understand all terms in an ICD appears to be a particularly important part of the informed consent process. © 2014

Original languageEnglish (US)
Pages (from-to)1-13
Number of pages13
JournalAJOB Empirical Bioethics
Volume5
Issue number4
DOIs
StatePublished - Jan 1 2014

Fingerprint

Ethical Review
Consent Forms
Norway
cancer
Research Ethics
research ethics
Neoplasms
Committee Membership
Delphi Technique
Informed Consent
Cancer Patients
questionnaire
statistical significance
Ambulatory Care Facilities
Group
Biomedical Research
rating
expert
Clinical Trials
Guidelines

Keywords

  • clinical research
  • consent forms
  • ethics
  • informed consent
  • patient education

ASJC Scopus subject areas

  • Health(social science)
  • Philosophy
  • Health Policy

Cite this

What Do Cancer Patients and Members of Ethical Review Boards in Norway Consider Important Elements of Informed Consent Documents? / Berger, Ola; Sand, Kari; Johansen, Ingunn; Loge, Jon Havard; Kaasa, Stein; Grønberg, Bjørn Henning.

In: AJOB Empirical Bioethics, Vol. 5, No. 4, 01.01.2014, p. 1-13.

Research output: Contribution to journalArticle

Berger, Ola ; Sand, Kari ; Johansen, Ingunn ; Loge, Jon Havard ; Kaasa, Stein ; Grønberg, Bjørn Henning. / What Do Cancer Patients and Members of Ethical Review Boards in Norway Consider Important Elements of Informed Consent Documents?. In: AJOB Empirical Bioethics. 2014 ; Vol. 5, No. 4. pp. 1-13.
@article{6df74d6dcf494f5eb66d1178d09acfa8,
title = "What Do Cancer Patients and Members of Ethical Review Boards in Norway Consider Important Elements of Informed Consent Documents?",
abstract = "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 Research Ethics (RECs) approve ICDs according to national and international guidelines. The aim of this study was to investigate how important members of these committees and cancer patients consider the information elements found in ICDs to be. Methods: Using the Delphi technique, an expert group developed a questionnaire for asking the participants how they rated the importance of 31 information elements, and whether they were familiar with or considered seven terms/phrases commonly used in ICDs difficult to understand. All 123 members of the Norwegian RECs and 200 consecutive cancer patients at the outpatient cancer clinic at St. Olavs Hospital, Trondheim University Hospital, received the questionnaire. Group comparisons were conducted using chi-squared and Fisher's exact tests. The statistical significance level was defined as p <.01 due to multiple comparisons. Results: The committee members (n = 81) and patients (n = 104) rated almost all (95{\%}) of the information elements as important. Very few (4{\%}) information elements were rated as not important. We did not find any significant differences in the rating of the elements between subgroups of patients, between subgroups of REC members, or between patients and REC members. The patients were not familiar with all terms commonly found in ICDs, and the REC members were not able to predict which terms the patients were familiar with. Patients rated the information elements as more important if they were familiar with the terms used in the respective elements. Conclusions: The participants rated almost all information elements important to include in ICDs, suggesting that ICDs cannot necessarily be shortened by leaving out information elements. Ensuring that patients understand all terms in an ICD appears to be a particularly important part of the informed consent process. {\circledC} 2014",
keywords = "clinical research, consent forms, ethics, informed consent, patient education",
author = "Ola Berger and Kari Sand and Ingunn Johansen and Loge, {Jon Havard} and Stein Kaasa and Gr{\o}nberg, {Bj{\o}rn Henning}",
year = "2014",
month = "1",
day = "1",
doi = "10.1080/23294515.2014.938199",
language = "English (US)",
volume = "5",
pages = "1--13",
journal = "AJOB Empirical Bioethics",
issn = "2329-4515",
publisher = "Taylor and Francis Ltd.",
number = "4",

}

TY - JOUR

T1 - What Do Cancer Patients and Members of Ethical Review Boards in Norway Consider Important Elements of Informed Consent Documents?

AU - Berger, Ola

AU - Sand, Kari

AU - Johansen, Ingunn

AU - Loge, Jon Havard

AU - Kaasa, Stein

AU - Grønberg, Bjørn Henning

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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 Research Ethics (RECs) approve ICDs according to national and international guidelines. The aim of this study was to investigate how important members of these committees and cancer patients consider the information elements found in ICDs to be. Methods: Using the Delphi technique, an expert group developed a questionnaire for asking the participants how they rated the importance of 31 information elements, and whether they were familiar with or considered seven terms/phrases commonly used in ICDs difficult to understand. All 123 members of the Norwegian RECs and 200 consecutive cancer patients at the outpatient cancer clinic at St. Olavs Hospital, Trondheim University Hospital, received the questionnaire. Group comparisons were conducted using chi-squared and Fisher's exact tests. The statistical significance level was defined as p <.01 due to multiple comparisons. Results: The committee members (n = 81) and patients (n = 104) rated almost all (95%) of the information elements as important. Very few (4%) information elements were rated as not important. We did not find any significant differences in the rating of the elements between subgroups of patients, between subgroups of REC members, or between patients and REC members. The patients were not familiar with all terms commonly found in ICDs, and the REC members were not able to predict which terms the patients were familiar with. Patients rated the information elements as more important if they were familiar with the terms used in the respective elements. Conclusions: The participants rated almost all information elements important to include in ICDs, suggesting that ICDs cannot necessarily be shortened by leaving out information elements. Ensuring that patients understand all terms in an ICD appears to be a particularly important part of the informed consent process. © 2014

AB - 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 Research Ethics (RECs) approve ICDs according to national and international guidelines. The aim of this study was to investigate how important members of these committees and cancer patients consider the information elements found in ICDs to be. Methods: Using the Delphi technique, an expert group developed a questionnaire for asking the participants how they rated the importance of 31 information elements, and whether they were familiar with or considered seven terms/phrases commonly used in ICDs difficult to understand. All 123 members of the Norwegian RECs and 200 consecutive cancer patients at the outpatient cancer clinic at St. Olavs Hospital, Trondheim University Hospital, received the questionnaire. Group comparisons were conducted using chi-squared and Fisher's exact tests. The statistical significance level was defined as p <.01 due to multiple comparisons. Results: The committee members (n = 81) and patients (n = 104) rated almost all (95%) of the information elements as important. Very few (4%) information elements were rated as not important. We did not find any significant differences in the rating of the elements between subgroups of patients, between subgroups of REC members, or between patients and REC members. The patients were not familiar with all terms commonly found in ICDs, and the REC members were not able to predict which terms the patients were familiar with. Patients rated the information elements as more important if they were familiar with the terms used in the respective elements. Conclusions: The participants rated almost all information elements important to include in ICDs, suggesting that ICDs cannot necessarily be shortened by leaving out information elements. Ensuring that patients understand all terms in an ICD appears to be a particularly important part of the informed consent process. © 2014

KW - clinical research

KW - consent forms

KW - ethics

KW - informed consent

KW - patient education

UR - http://www.scopus.com/inward/record.url?scp=84907373972&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84907373972&partnerID=8YFLogxK

U2 - 10.1080/23294515.2014.938199

DO - 10.1080/23294515.2014.938199

M3 - Article

AN - SCOPUS:84907373972

VL - 5

SP - 1

EP - 13

JO - AJOB Empirical Bioethics

JF - AJOB Empirical Bioethics

SN - 2329-4515

IS - 4

ER -