Biomedical subjects

Sarah J L Edwards

Publications and source records attributed to Sarah J L Edwards.

4 recordsLinked to original sources

PubMed2006

Restricted treatments, inducements, and research participation.

In this paper, I support the claim that placing certain restrictions on public access to possible new treatments is morally problematic under some exceptional circumstances. Very ill patients may find that all available standard treatments are unacceptable, either because they are ineffective or have serious adverse effects, and these patients may understandably be desperate to try something new even if this means stepping into the unknown. Faced with certain death, it is rational to want to try something new and to chance a dire outcome. Restricting possible new treatments to research trials may put these treatments scientifically, geographically or economically out of reach of these patients. For those who can get access, research restrictions could weaken, though not necessarily eliminate, the value of consent participants of such trials are able to give. Some participants may therefore be exploited for scientific purposes in the name of public interest. There are nonetheless compelling reasons for keeping some restrictive regulation in this area.

Clinical Trials as Topic↗

PubMed2005

Research participation and the right to withdraw.

Most ethics committees which review research protocols insist that potential research participants reserve unconditional or absolute 'right' of withdrawal at any time and without giving any reason. In this paper, I examine what consent means for research participation and a sense of commitment in relation to this right to withdraw. I suggest that, once consent has been given (and here I am excluding incompetent minors and adults), participants should not necessarily have unconditional or absolute rights to withdraw. This does not imply that there should be a complete absence of rights, or, indeed, an abandonment of the right to withdraw. The point of this paper is to show that the supposed unconditional or absolute nature of these rights may be self-defeating and so fail to respect the autonomy of participants. In addition, and on a more positive note, I suggest that, attaching certain conditions on the right to withdraw, may better respect the autonomy of these participants by underlining the idea that autonomy is more than mere whim or indifference to the fate of others. On the contrary, research staff are currently unable to 'push' participants, who may merely have logistical difficulties unrelated to the research itself, but who really want to stay the course, for fear of coercing them. Furthermore, researchers now try to 'screen out' people they think may be unreliable to protect the science of the study and so groups at risk of dropping out may be unfairly denied access to research treatments. I conclude that on-going negotiation between the relevant parties could be on balance the only truly acceptable way forward but concede certain important limitations to take into account.

Clinical Trials as Topic↗

PubMed2004

The impact of describing clinical trial treatments as new or standard.

Concern has been expressed over a possible widespread belief amongst patients in trials, that a new treatment is better than the standard, despite the lack of evidence of such superiority. A sample of the general public (N = 130) read a leaflet describing a hypothetical trial comparing two similar treatments for either arthritis or back-pain. Half read that both treatments were standard and generally available; half that one was new and available only within the trial. Participants rated any preference for one or the other treatment, gave written reasons, and indicated their willingness to enter the randomized trial. Fifteen participants subsequently talked through their answers. Most participants expressed no preference for either treatment when both were described as standard. When one was new more people with the arthritis (but not the back-pain) scenario expressed a preference (chi2 = 5.44, P = 0.031). Importantly, this was not more likely to be for the new treatment. Rationally, those who preferred a freely available treatment were less likely to participate in the trial (chi2 = 23.3, P < 0.001). The mere description of a trial treatment as new was insufficient to engender a preference for it over a standard treatment, although it may contribute to preference under certain additional circumstances.

Adolescent↗

PubMed2004

Research ethics committees: differences and moral judgement.

Many people argue that disagreements and inconsistencies between Research Ethics Committees are morally problematic and there has been much effort to 'harmonise' their judgements. Some inconsistencies are bad because they are due to irrationality, or carelessness, or the operation of conflicting interests, an so should be reduced or removed. Other inconsistencies, we argue, are not bad and should be left or even encouraged. In this paper we examine three arguments to reject the view that we should strive for complete consistency between committees. The first argument is that differences in judgement are not necessarily incompatible with ideas of justice for patients who are potential participants of research reviewed by different committees. We call this 'the justice argument.' The second argument is that such committees do not have access to a single moral truth, to which their judgement is supposed to correspond. We call this the 'moral pluralism argument.' The third argument is that the process of ethics committee review is also morally relevant and not solely the outcome. We call this the 'due process argument.' While we fall short of establishing exactly how much variation and on what substantive issues would ethical permissible, we show that it is largely inevitable and that a certain amount of variation could be seen as a desirable part of the institution of medical research.

Consensus↗