Intrusive research
Intrusive research is the gathering of data from individuals through interviewing, observation, or surveying,[1] when consent is legally required, yet the test subjects don't have the capacity to give such consent due to mental illness or developmental disability. It is a legal issue addressed by the United Kingdom Mental Capacity Act 2005.
Intrusive research and UK's Mental Capacity Act
[edit]UK's Mental Capacity Act 2005 criminalizes intrusive research if it was carried out without securing the consent of the person involved, who has the mental capacity to make the decision.[2] It is also unlawful to involve a person lacking mental capacity without the approval of an "appropriate body".[3] The appropriate body pertains to the authority appointed by the Secretary of State in England and the National Assembly for Wales (e.g. Research Ethics Committee).[4][5] The Act also applies to non-interventional research such as observational research. The law provides the statutory framework and provisions for the participation of people without the capacity to give consent in intrusive research.[6]
The Act also applies to clinical trials of treatments and procedures, but doesn't apply to trials of medicinal products, for which there is a separate regulation (The Medicines for Human Use Regulations, 2004).
The Mental capacity Act code of practice, 2007, gives examples of intrusive research:
- Clinical research into new types of treatments (except clinical trials of medicines that are covered by separate regulations)
- Health or social care services research to evaluate the effectiveness of a policy intervention or service innovation.
- Research in other fields, (e.g. criminal justice, psychological studies, lifestyle or socioeconomic surveys)
- Research on tissue samples (i.e. tissue removed during surgical or diagnostic procedures)
- Research on health and other personal data collected from records.
- Observations, photography or videoing of humans.
Other usage
[edit]A broader conceptualization defines intrusive research as a method of data gathering that entails the participation of the investigator as opposed to non-participant observation.[7] It includes various types of interviews such as structured interview and in-depth interview.[7][8]
See also
[edit]References
[edit]- ^ "Intrusive research". oxfordreference.com. Oxford University Press. 18 February 2016. ISBN 978-0-19-179223-6.
- ^ bsd4. "Research involving adults lacking mental capacity — University of Leicester". www2.le.ac.uk. Retrieved 2019-10-15.
{{cite web}}
: CS1 maint: numeric names: authors list (link) - ^ Brindle, Nick; Branton, Tim; Stansfield, Alison; Zigmond, Tony (2013). A Clinician's Brief Guide to the Mental Capacity Act. London: RCPsych Publications. p. 62. ISBN 9781908020635.
- ^ "ed.ac.uk" (PDF).
- ^ Britain, Great (2005). Mental Capacity Act 2005: Chapter 9; Explanatory Notes. London: The Stationery Office. p. 18. ISBN 978-0-10-560905-6.
- ^ McLaughlin, Hugh (2009). Service-User Research in Health and Social Care. Los Angeles, CA: SAGE. p. 51. ISBN 9781847870711.
- ^ a b Kirby, Mark (2000). Sociology in Perspective. Oxford: Heinemann. pp. G-358. ISBN 0-435-33160-4.
- ^ Morris, Alan (2015). A Practical Introduction to In-depth Interviewing. Thousand Oaks, CA: SAGE. ISBN 978-1-4739-2698-1.