Adherence to the ethical and legal guidelines can be problematic in any research. These difficulties are potentially compounded if the research involves adults who are lacking capacity to consent to their participation.
The National Research Ethics Service (NRES) have recently published an online toolkit to help researchers, members of research ethics committees, and institutional research managers to ensure that projects fit with the legal requirements (for example, adherence to the Mental Capacity Act in England and Wales). The toolkit was developed at the University of Leicester and is primarily the brainchild of Emma Angell and Mary Dixon-Woods, with input from Ainsley Newson at the University of Bristol and with a little help from me.
The toolkit is split into Clinical Trials Involving Medicinal Products (CTIMPs) and non-CTIMPs to reflect the fundamental differences in the structuring and administration of each type of activity. There is also a separate section on emergency research.
We would value your feedback on the toolkit – please feel free to post comments here.
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