Article Text
PDF
Abstract
Objectives: To study the consent process experienced by participants who are enrolled in a molecular genetic research study that aims to find new genetic mutations responsible for an apparently inherited disorder.
Design: Semi-structured interviews and analysis/description of main themes.
Participants: 78 members of 52 families who had been recruited to a molecular genetic study.
Results: People were well informed about the goals, risks and benefits of the genetic research study but could not remember the consent process. They had mostly been recruited to take part by trusted clinicians or their relatives but had little memory of, or concern about signing consent forms. Families appeared to regard the research as a continuation of their, or their relatives’, clinical care.
Conclusions: Ethical review should be more flexible in its attitude to consent forms and written information sheets for some sorts of research. For rare genetic disease studies where research has been discussed fully within the clinical setting then the consent obtained at that time could suffice rather than needing extra consent at a later stage. However, clinician-researchers will need to ensure that their duty of care extends for the duration of the research and beyond.
- documented consent
- research ethics
- genetic research
- rare diseases
Statistics from Altmetric.com
Footnotes
Competing interests: MP is Chair of the Genetic Interest Group. FLR is the Principal Investigator for the GOLD study.
↵i The consent form and information sheet for families participating in the research study of the genetics causes of learning disability (GOLD) can be accessed at: http://goldstudy.cimr.cam.ac.uk/consentforms.htm.
Ethics approval: The study was approved by the London multi-centre Research Ethics Committee.
Other content recommended for you
- Collection, storage and use of blood samples for future research: views of Egyptian patients expressed in a cross-sectional survey
- Ethics of genetic testing and research in sport: a position statement from the Australian Institute of Sport
- Effect of ethnicity, gender and drug use history on achieving high rates of affirmative informed consent for genetics research: impact of sharing with a national repository
- An investigation of patients’ motivations for their participation in genetics-related research
- Advances in identification of genes involved in autosomal recessive intellectual disability: a brief review
- Informed consent, participation in, and withdrawal from a population based cohort study involving genetic analysis
- Offering fragile X syndrome carrier screening: a prospective mixed-methods observational study comparing carrier screening of pregnant and non-pregnant women in the general population
- Ethical aspects of research into Alzheimer disease. A European Delphi Study focused on genetic and non-genetic research
- Pathogenic variants in the healthy elderly: unique ethical and practical challenges
- From the periphery to centre stage: de novo single nucleotide variants play a key role in human genetic disease