On occasions, laws on consent are subject to modification, largely on account of being subject to common law rather than statute—for example, in the UK. Guideline publications such as the UK Department of Health Reference Guide to Consent for Examination or Treatment are intended to provide information for clinicians on when and how to apply current laws in everyday clinical situations. While the extent to which guidelines influence clinician behaviour depends on how much they are read and followed, what is (...) also relevant, and sometimes omitted from consideration, is discussion about underlying philosophical concepts.This paper analyses philosophical weaknesses relating to English laws on consent, the main focus of attention being applied ethics and the rights of adults with incapacity. It draws comparisons between the US and the UK, and advocates changes in English law in order to help rectify weaknesses in patient protection. Discussion includes references to Scottish law, and the use of advance directives, and it voices concerns about over-reliance on “best interests” determinations. The problem is partly one of logical analysis, and what can happen is that best interests determinations fail to show proper respect for adults lacking the capacity to consent to examination or treatment on their own behalf. This is fundamentally a matter of rights, and requires further investigation and appropriate legal remedies in order to respond to ethical deficiencies in English law as it now stands. (shrink)

A frequent feature of pharmaceutical research is the open label extension study, in which patients participating in double blind placebo controlled trials of new medications are invited, on completion of the initial trial, to take the study drug for some further period. Patients are openly given the active substance at this stage, regardless of their assignment in the initial trial. Investigators are typically reluctant to unblind the patients’ assignment at the point of entry into the open label phase, on the (...) grounds that this may introduce ascertainment bias in the main study.It is argued that patients invited to participate in open label extension studies cannot give a proper consent to such research unless they know to which arm of the main trial they were recruited. It is further argued that to recruit certain groups of patients from placebo controlled trials into open label extension studies may also be unethical for clinical reasons. (shrink)

When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A moral view which can (...) be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals. (shrink)

The same research proposal was submitted to 24 district health authority (DHA) research ethics committees in different parts of the country. The objective was to obtain permission for a multi-centre research project. The study of neonatal care in different types of unit (regional, subregional and district), required that four health authorities were approached in each of six widely separated health regions in England. Data were collected and compared concerning aspects of processing, including application forms, information required, timing and decision-making. The (...) key finding was that ethics committees received and processed the applications variably, reflecting individual factors and local problems. To improve consensus and facilitate multicentre studies, standard forms and instructions are suggested and the establishment of a national committee or advisory group advocated. (shrink)

The eclectic problem solving methodology used by the British Medical Association is described in this paper. It has grown from the daily need to respond to doctors’ practical queries and incorporates reference to law, traditional professional codes, and established BMA policies—all of which must be regularly assessed against the benchmark of contemporary societal expectations. The two Jehovah’s Witness scenarios are analysed, using this methodology and in both cases the four principles solution is found to concur with that of the BMA’s (...) approach. The author’s overall conclusion is that although the BMA resorts to a lengthier list of thins to consider, the solutions that emerge are often likely to coincide with the four principles approach. (shrink)