ArticleBMJ (Clinical research ed.)2005
Bias from requiring explicit consent from all participants in observational research: prospective, population based study.
Article in BMJ (Clinical research ed.), 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- "Let's get the best quality research we can": public awareness and acceptance of consent to use existing data in health research: a systematic review and qualitative study.BMC medical research methodology · 2013Pooled it
- [External validity of clinical trials for treatment of dementia with ginkgo biloba extracts].Zeitschrift fur Gerontologie und Geriatrie · 2008Pooled it
- Trial
- You are how you recruit: a cohort and randomized controlled trial of recruitment strategies.BMC medical research methodology · 2014Trial
- Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real-World Data: The INVESTED-Medicare Linkage Study.Clinical pharmacology and therapeutics · 2026Article
- Requirement for written informed consent and selection bias in a chart-review prostate cancer study.American journal of epidemiology · 2026Article
- Review
- Converting from face-to-face to postal follow-up and its effects on participant retention, response rates and errors: lessons from the EQUAL study in the UK.BMC medical research methodology · 2022Article
- Article
- Parental opinions regarding consent for observational research of no or minimal risk in the pediatric intensive care unit.Journal of intensive care · 2019Article
- Article
- The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication.Pharmacoepidemiology and drug safety · 2016Article
- Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research.JMIR medical informatics · 2016Article
- Investigating Respondents and Nonrespondents of a Postal Breast Cancer Questionnaire Survey Regarding Differences in Age, Medical Conditions, and Therapy.Breast care (Basel, Switzerland) · 2016Article
- Vasectomy and the risk of prostate cancer: a meta-analysis of cohort studies.International journal of clinical and experimental medicine · 2015Article
- Gay and Bisexual Men's Perceptions of the Donation and Use of Human Biological Samples for Research: A Qualitative Study.PloS one · 2015Article
- Waiver of consent in noninterventional, observational emergency research: the PROMMTT experience.The journal of trauma and acute care surgery · 2013Article
- LINKING SURVEY AND ADMINISTRATIVE RECORDS: MECHANISMS OF CONSENT.Sociological methods & research · 2012Article
- Management of anaphylaxis in schools: Evaluation of an epinephrine auto-injector (EpiPen®) use by school personnel and comparison of two approaches of soliciting participation.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2012Article
- Coordination and management of multicenter clinical studies in trauma: Experience from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study.Resuscitation · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the differences between adults who consent to participate in observational research, and those who do not.
designProspective, population based cohort study.
settingPrimary and secondary care throughout Scotland.
participants187 adults (aged > or = 16 years) resident in Scotland at the time of their first diagnosis of a brain arteriovenous malformation in 1999-2002.
interventionPostal consent form sent via participants' general practitioner.
main outcome measuresDifferences between consenters and non-consenters in demographic and clinical features at first presentation, and outcome during follow-up.
results111 adults (59%) consented to participate in the study. These consenters were not significantly different from non-consenters in age, sex, or socioeconomic status at first presentation. However, consenters were significantly more likely than non-consenters to present alive and independent, and with a seizure. During follow-up, consenters were significantly more likely to receive interventional treatment. Although consenters' survival was significantly better, they were more likely to have a seizure during follow-up. Presentation with intracranial haemorrhage conferred a higher risk of subsequent haemorrhage when the whole cohort was analysed, but not when it was restricted to consenters.
conclusionsWe have found differences between adults who consent to participate in observational records-based research and those who do not, or cannot, consent. Blanket requirements for explicit consent for the use of individuals' identifiable data can bias disease registers, epidemiological studies, and health services research.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.