umu.sePublications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Informed consent: study of quality of information given to participants in a clinical trial
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Social medicine.
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Psychiatry.
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Psychiatry.
1991 (English)In: BMJ. British Medical Journal, ISSN 0959-535X, E-ISSN 1756-1833, Vol. 303, no 6803, 610-613 p.Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To determine whether the participants in a clinical trial had perceived adequate information about the trial according to the guidelines of the Declaration of Helsinki. DESIGN: About 18 months after the end of a gynaecological clinical trial the participants received a questionnaire by post, which focused on the quality of the information given to them before entering the trial. Neither researchers nor participants were aware in advance that the trial would become the subject of this follow up investigation. SETTING: Eight different centres in Sweden. SUBJECTS: 43 women out of the 53 who completed the trial (mean (range) age 23 (16 to 35) years) returned the questionnaire. MAIN OUTCOME MEASURES: Adequacy of the information (based on requirements of the Declaration of Helsinki) to enable the following: understanding of the aims of the study; awareness of what participation meant; and awareness of the possibility of withdrawing from participation at any time. Motives for agreeing to participate, and a subjective evaluation of the given information were also recorded. RESULTS: All but one of the participants had been aware that they were taking part in a research project. Five women stated that they had not been aware that a second laparoscopy was performed only for research reasons. Seven women reported that they had not been aware of the meaning of participating in the project and 17 that they had had no information about the possibility of withdrawing from the study whenever they wanted. In the subjective rating 22 women considered the information given as good or very good. There was a systematic variation in the quality of the given information among the eight centres. CONCLUSION: Although all but one of the participants had been aware that they were taking part in a clinical trial, the quality of the information understood and recalled by participants varied, and in many cases clearly did not meet the guidelines of the Declaration of Helsinki. Variations among centres in participants' perception of information suggest that deficiencies in perception may be caused by informers rather than the participants.

Place, publisher, year, edition, pages
1991. Vol. 303, no 6803, 610-613 p.
Identifiers
URN: urn:nbn:se:umu:diva-36744PubMedID: 1932901OAI: oai:DiVA.org:umu-36744DiVA: diva2:356074
Available from: 2010-10-11 Created: 2010-10-11 Last updated: 2014-05-08Bibliographically approved

Open Access in DiVA

No full text

PubMed

Authority records BETA

Sandlund, MikaelDahlquist, GiselaJacobsson, Lars

Search in DiVA

By author/editor
Sandlund, MikaelDahlquist, GiselaJacobsson, Lars
By organisation
Social medicinePsychiatryPaediatrics
In the same journal
BMJ. British Medical Journal

Search outside of DiVA

GoogleGoogle Scholar

pubmed
urn-nbn

Altmetric score

pubmed
urn-nbn
Total: 49 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association-8th-edition
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf