1. Research involving adults lacking the capacity to consent Legal, ethical and practical issues Dr Mikey Dunn Senior Research Associate in Health and Social Care Ethics The Ethox Centre University of Oxford michael.dunn@ethox.ox.ac.uk

2. Outline of the workshop 1.A brief introduction: The ethical underpinnings of research involving adults lacking the capacity to consent 2.Specific legal and governance requirements 3.Case-based discussion of challenges in translating these requirements into individual project protocols 4.Open Q&A

3. Research involving adults lacking the capacity to consent 1. A brief introduction

4. Introduction All research involving human participants is subject to ethical review through a complex set of governance arrangements Research ethics committees can give approval for a study to go ahead, require amendments to be made, or give an unfavourable opinion What justifies the ethical review process process?

5. 3 arguments for research ethics governance 1.The libertarian argument (rights-based) a)The value of research participants autonomy and freedoms b)Places focus on the validity of consent c)If consent has been obtained, the research is ethically justified to proceed 2.The paternalistic argument (duty-based) a)The value of the researchers duties in relation to participants b)One duty would be to ensure that the participant is not exposed to a more than minimal risk of harm c)Participant autonomy can be over-ridden in order to fulfil this duty 3.The utilitarian argument (consequence-based) a)Emphasises the outcome of the research taking place b)Balances the benefits and harms to participants and people in the future c)Non-consensual research that harms participants might be permitted if it will lead to considerable future benefits

6. 3 arguments for research ethics governance Research ethics governance frameworks are founded in the paternalistic position, but also incorporate elements of the other two arguments The core principle of the Governance Arrangements for Research Ethics Committees (GAfREC) in England is to: protect the dignity, rights, safety and well-being of all actual or potential research participants Thus, research ethics review focuses on: 1.The quality of consent procedures 2.Whether appropriate protections are in place for participants 3.The quality of the science, and the likelihood for future benefits

7. Applying the arguments in relation to participants lacking the capacity to consent Involving children or adults who lack the capacity to give consent (LCC) to take part in a study cause problems for all of these requirements to be met 1.How are the rights of adults LCC to be reconciled within an autonomy based consent process? 2.What additional duties to protect adults LCC are required? 3.Can involving adults LCC still produce research that has useful and beneficial outcomes? Additional protections and procedures need to be put in place to justify inclusion of adults LCC

8. Two starting points 1.Different laws regulate different kinds of research involving adults LCC differently Separate governance arrangements are in place for different kinds of research Key distinction: clinical trials of investigational medicinal products (CTIMP) and non-CTIMP research Requirements are similar, but the process, legal foundations, and terminology are different

9. Two starting points

10. 2.All involvement of participants LCC requires the approval of an appropriate body Approval from a flagged REC operating within the National Research Ethics Service (NRES) is required Researchers should make arrangements with the NRES Central Allocation System (CAS) rather than through individual RECs University RECs are not appropriate bodies for approving research involving adults LCC NRES Committees that can approve research involving adults LCC: – NHS Mental Capacity Flagged Committees – National Social Care REC – 2 Ministry of Defence RECs (if remit extends to the proposed research)

11. Any questions thus far?