NIHR Emergency Care Incubator Forum – 12 April 2022

Consent in Research in an Emergency Setting, keynote talk by Victoria Shepherd

References

Articles

Davies, H., Shakur, H., Padkin, A., et al. (2014). Guide to the design and review of emergency research when it is proposed that consent and consultation be waived. Emergency Medicine Journal 31:794-795. http://dx.doi.org/10.1136/emermed-2014-203675

Shahzad, A., Kemp, I., Mars, C. et al. (2014). Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. The Lancet 384(9957), 1849-1858. https://doi.org/10.1016/S0140-6736(14)60924-7

Shepherd, V. (2020) An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent. Trials 21. https://doi.org/10.1186/s13063-020-04406-y

Shepherd, V., Hood, K., Wood, F. (2022). Unpacking the Black Box of Horrendousness: A Qualitative Exploration of the Barriers and Facilitators to Conducting Trials Involving Adults Lacking Capacity to Consent. [Preprint] https://doi.org/10.21203/rs.3.rs-1180306/v1

Other Resources 

Adults with Incapacity (Scotland) Act 2000 

Capacity and Consent Research website 

CONSULT Study

Deferred consent in Emergency Research-A patient video

Good Clinical Practice Network 4.1 INVESTIGATOR 

HRB-TMRN WEBINAR with Heidi Gardner, Victoria Shepherd, Fran Sherratt and Shaun Treweek – Serving the under-served better: lessons learnt from efforts to widen inclusion in trial populations

Mental Capacity Act 2005 (England + Wales) 

MRC-NIHR Trials Methodology Research Partnership (TMRP) website

NHS Health Research Authority. Applying a proportionate approach to the process of seeking consent 

NHS Health Research Authority. Confidentiality Advisory Group

NHS Health Research Authority. Research in Emergency Settings 

NIHR. Improving inclusion of under-served groups in clinical research: Guidance from INCLUDE project

The Medicines for Human Use (Clinical Trials) Regulations 2004

UKRI & NHS Health Research Authority. Is my study research? 

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