Why we should not seek individual informed consent for participation in health services research

Abstract

Ethics committees now require that individuals give informed consent to much health services research, in the same way as for clinical research. This is misguided. Existing ethical guidelines do not help us decide how to seek consent in these cases, and have allowed managerial experimentation to remain largely unchecked. Inappropriate requirements for individual consent can institutionalise health inequalities and reduce access to services for vulnerable groups. This undermines the fundamental purpose of the National Health Service (NHS), and ignores our rights and duties as its members, explored here. Alternative forms of community consent should be actively pursued.A fter a half century of rapid technological development, much organisational change in the National Health Service (NHS) is now driven by the results of medical research. Clinical medical research has traditionally been concerned with the question of whether specific therapies are effective, and usually postpones the question of how best to organise their delivery in, say, rural, or urban populations. Health services research (HSR), on the other hand, looks at the needs and outcomes of populations in relation to health care delivery, considered both as a resource issue and an organisational problem. For example, a study of the effects of screening and treating a population for the sexually transmitted infection chlamydia 1 is HSR rather than clinical research. While overlapping with epidemiology, HSR is also concerned with the evaluation of new organisational structures or care pathways, which have not generally been the concern of clinical research. An example of this would be the evaluation of antenatal care by midwife teams, rather than "standard care". 2 3 Health service research then, covers research into organisational structures or care pathways that may influence outcomes at a population level-this may include the evaluation of screening programmes, new staffing structures, resiting of services or collaborative services, to give a few examples. It does not include the use of experimental medical treatments.The evaluation of health services through HSR requires information about the population as a whole. For example, to discover that death rates from cancer vary geographically will require access to information about patients diagnosed and their deaths, and often review of patients' NHS records. In the wake of the incorporation of the Human Rights Act into UK law, and the new Data Protection Act, there has been a rise in public concern to protect the privacy of individuals in health care law. This presents problems for the guardians and users of databases such as the cancer registries. The cancer registries have in the past collected basic personal information about individuals diagnosed, in order to enable health services and researchers to compare survival trends, as well as to detect new risks and enable their investigation. Thus death rates can be compared, 4 5 and new risks investigated-either through statistical means or through appro...

Designing and evaluating complex interventions to improve health care

“…Data protection legislation prevented researchers from accessing names and addresses of potential participants, so staff in each general practice had to generate the randomised mailings. This proved prohibitively expensive Estimate recruitment and retention rates The feasibility study showed that recruitment rates in the current ethical and legal framework might make a definitive trial difficult 27 Calculate sample sizes A small scale feasibility study in 3 general practices informed sample size calculation for a definitive trial using both cluster and individual randomisation based on rates of acceptance of screening have not been obtained during prior research with the target group, a feasibility study may be needed to model patient flow. Such studies also enable assessment of feasibility of the methods of randomisation including acceptability to participants and suitable level to avoid contamination effects.…”

Covert research and adult protection and safeguarding: an ethical dilemma?

“…However, where capacity is an issue, this may not be the case and safeguards are important to protect participants, although it can also be argued that there needs to be greater attention paid to facilitating the involvement of seldom heard groups in research, and promoting decision-making where possible (see Parker et al, 2011;. Cassell and Young (2002) would refine the focus of ethical review still further, arguing that informed consent is important in clinical research but misses the point in broader policy and practicebased health services research. They suggest, rather than individual informed consent, there needs to be an on-going contract of evaluation and development based on practice.…”

Towards a critical epidemiology approach for applied sexual health research

“…by failing to account for the impact of zero-hours contracts on ability to access services). This may lead to the development of interventions which are doomed to low impact or failure for the most vulnerable in society (Cassell and Young, 2002), increasing the deleterious effects of health inequalites.E.g.if zero-hours contracts do impact on sexual health service access then interventions to improve access which do not address or account for this, will do little to improve access for those negatively impacted in this way. Non-critical enquiry may also reinforce moral positions which are victim-blaming (Lupton, 1993).…”