Research involving adults lacking capacity to consent: the impact of research regulation on 'evidence biased' medicine.
Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals' exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a result of 'evidence biased' medicine.



This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs.



The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented.
South East Wales Trials Unit, Centre for Trials Research, College of Biomedical and Life Sciences, Cardiff University, Room 406, 4th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. ShepherdVL1@cardiff.ac.uk.
Victoria
V
Shepherd
D022126:Access to Information; D000328:Adult; D015982:Bias; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D003657:Decision Making; D004739:England; D026689:Ethical Analysis; D033161:Government Regulation; D054625:Healthcare Disparities; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D026706:Paternalism; D026684:Personal Autonomy; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D018570:Risk Assessment; D020458:Third-Party Consent; D035501:Uncertainty; D035862:Vulnerable Populations; D014852:Wales