Assessing the impact of the requirement for explicit consent in a hospital-based stroke study

Jackson, C., Crossland, L., Dennis, M., Wardlaw, J. and Sudlow, C. (2008) Assessing the impact of the requirement for explicit consent in a hospital-based stroke study. QJM: An International Journal of Medicine, 101 4: 281-289. doi:10.1093/qjmed/hcm152

Author Jackson, C.
Crossland, L.
Dennis, M.
Wardlaw, J.
Sudlow, C.
Title Assessing the impact of the requirement for explicit consent in a hospital-based stroke study
Journal name QJM: An International Journal of Medicine   Check publisher's open access policy
ISSN 1460-2725
Publication date 2008-04
Sub-type Article (original research)
DOI 10.1093/qjmed/hcm152
Volume 101
Issue 4
Start page 281
End page 289
Total pages 9
Place of publication Oxford, United Kingdom
Publisher Oxford University Press
Collection year 2012
Language eng
Formatted abstract
Background: Increasing regulation of medical research, in particular the requirement for explicit consent, may reduce the quantity and quality of clinical epidemiological research.

Aim: To assess the potential biases arising from the need for explicit consent in our hospital-based stroke research register.

Design: Comparison of patients enrolled into our stroke research register with those included in a concurrent clinical stroke audit that targeted the same population but did not require explicit consent.

Methods: We obtained the numbers of consenters, refusers and those from whom consent was not sought for various logistical reasons. We compared characteristics of participants (those eventually included in the research register) vs. non-participants.

Results: Of 1228 patients included in the stroke audit during an 18-month period, 1075 (88%) were also included in the research register, with higher participation among outpatients than inpatients. Only 1% of eligible patients refused involvement in any aspect of the research register. By far the largest number of non-participants was those from whom we could not seek consent for practical reasons. Comparison of baseline characteristics showed important differences between participants and non-participants that could affect outcome.

Very few patients refused inclusion in our research register, but the need for explicit consent reduced participation and introduced bias. An opt-out system avoiding the need for explicit patient consent for minimally intrusive clinical epidemiological studies would minimize bias and reduce the considerable time and costs associated with the consent process.
Keyword Observational research
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Discipline of General Practice Publications
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 12 times in Thomson Reuters Web of Science Article | Citations
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