Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (“the Regulations”). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as “relative” had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.
Competing interests: None declared.
MDW led the design, obtained funding, supervised the analysis, and wrote the first draft of the paper. EA conducted the analysis and contributed to writing the paper. Both authors approved the final version. MDW is the guarantor for this paper. The National Research Ethics Service funded this analysis but had no role in designing or conducting the study, writing of the paper or the decision to submit.
Provenance and Peer review: Not commissioned; externally peer reviewed.
Read the full text or download the PDF:
Other content recommended for you
- What do research ethics committees say about applications to conduct research involving children?
- Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project
- Strategies to enhance recruitment and consent to intensive care studies: a qualitative study with researchers and patient–public involvement contributors
- The effect of the neonatal Continuous Negative Extrathoracic Pressure (CNEP) trial enquiries on research in the UK
- Registration audit of clinical trials given a favourable opinion by UK research ethics committees
- Do research ethics committees identify process errors in applications for ethical approval?
- Clinical trials of contraceptive agents in those under 16 years of age: Are they necessary, ethical or legal?
- Healthcare professionals’ understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey
- Consent for emergency care research: the Mental Capacity Act 2005
- Protocol for a double-blind placebo-controlled trial to evaluate the efficacy of probiotics in reducing antibiotics for infection in care home residents: the Probiotics to Reduce Infections iN CarE home reSidentS (PRINCESS) trial