Stephen Humphreys

Does Student Research Require a Lower Standard of Ethical Scrutiny

Recognizing that students are fundamentally engaged in a process of learning and self-development, ethical review of sub-doctoral student research should be proportionate to that objective. A students tutor has the pedagogical role and an ethics committee should not interfere with that relationship other than to seek to avoid harms unforeseen by either the student or tutor. Underpowered or other statistically or methodologically flawed sub-doctoral research should not however, in general, be regarded as ethically concerning. With the proviso that no subject is harmed the student can be allowed to learn such lessons as their mistakes may afford them.

The Sociology of Bioethics: The ‘is’ and the ‘Ought’

A selection of recent sociological literature dealing with bioethics, concentrating particularly on its interface with research ethics, is reviewed to reveal that the two disciplines of bioethics and sociology have tendencies to approach subject matters from opposed perspectives. These differences in approach have now been generally recognized, accepted and accommodated by proponents of both disciplines. A turning point in the relationship between the two disciplines may have been reached which augers greater mutual respect, appreciation and even learning.

Drip-Feeding: How the Pharmaceutical Industry Influences Research Ethics Committees

Whilst research ethics committees (RECs) exist to represent societys interests by placing appropriate checks on the economic power of ‘big pharma’, the political sphere is here seen to have generally acquiesced to economic interests and allowed industry to influence how it is regulated. RECs are accordingly urged to remain vigilant about the prospects of their being the subject of hidden influences.

Ethics Committee Membership Selection: A Moral Preference Tool

How the diversity of membership of research ethics committees is arrived at has, to date, largely been fairly arbitrary. However, a tool to help determine ones moral preference is now available and it is introduced here as, arguably, having the potential to assist with ensuring a more meaningful diversity amongst an ethics committees membership. The tool is seen to be easily applied – but, it is argued, may be conceived on at least two false premises. Firstly, despite different theories of ethics, none can be proved to give the ‘right’ answer other than in its own terms. Secondly, if there is an ethical hierarchy, as the model suggests, then ethical diversity must become redundant for the possibility of achieving ethical excellence.

Is it Time to Return to the ‘Gold Standard’ of Self-Experimentation?

The novel nature of certain investigational medicinal products may indicate that someone particularly knowledgeable about the risks involved should be the ‘first-in-man’ subject. Such self-experimentation has a noble and ethical heritage, and whilst its practice has declined of late it is perhaps timely to reconsider this situation.

Research ethics committees: The ineligibles

Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.

Finding New People to Join the REC: Discussion

This study appeared in full in the last issue of Research Ethics Review (2009; 5 (4): 159). There are three vacancies on the REC; one member has retired and left the area, a second has resigned because of pressures at work, and the third left because he was unable to attend the meetings. A fourth member will shortly be unavailable for several months because she is about to have her first baby. The days agenda begins with a discussion about how to attract new members. SG suggests that maybe members of the public should be invited to observe a meeting. DL feels that he can recommend two individuals who would be interested.

The Equality Act, 2010

The Equality Act 2010 brings the concept of indirect discrimination to discrimination on the grounds of religion or belief. This has real potential to require a change in practice in certain types of clinical trials of which relevant ethics committees should be aware.

The Body Mass Index — Just Who Does it Include?

Whilst I do not know exactly why it is that in phase I clinical trials of investigational medicinal entities investigators might want their subjects to be obese individuals, I doubt that it is because they are perceived as less troublesome than their slimmer volunteers. It is however a puzzling fact that in most phase I trials the inclusion criteria favour healthy volunteers who have a ‘BMI [body mass index] of between 18 and 32’ or who can regard themselves as within the tolerance suggested by ‘You must not be over or under weight for your height’. Such criteria are problematic for several reasons. The body mass index is a statistical measurement which compares a person’s weight and height. A ‘healthy volunteer’ with a BMI below 18.5 would generally be regarded as both oxymoronic and ‘underweight’. Someone with a BMI above 25 on the other hand would be considered ‘overweight’, and it is clearly difficult to see how either an underor an overweight individual could be considered as of a healthy weight. Cognitive dissonance struggles with such a concept. A BMI of 30 or above classifies one as obese; having a BMI above 35 suggests one is ‘grossly obese’ so that even for routine elective surgery, such a patient may need to discuss their options with the anaesthetist. Above 40 and one is ‘bariatric’ or ‘morbidly obese’ and may well need hoists to help mobilise. At the other end of the scale, anything below 18.5 is also generally regarded as distinctly unhealthy: a score below 17.5 in fact might well indicate anorexia, and 15 is usually taken as at the upper limit of ‘starvation’. As for a point of reference, a BMI of 18 became, after much debate and controversy, the minimum acceptable for catwalk models after Madrid fashion week decided, during 2006, to ban underweight models from its shows. To use, without any of the same intensity of discussion, the same minima for ‘healthy volunteers’ as was used in an industry notorious for its unhealthy workforce, strikes at least this author as troubling.

Ethical Issues in Conducting Clinical Trials of Investigational Medicinal Products (CTIMP): Discussion

This study appeared in full in the last issue of Research Ethics Review (2009; 5(1): 26). SB, a 21-year-old healthy male, volunteered to take part in a phase I randomized, double-blind, placebo-controlled drug interaction study. The trial compound was a CNS-active drug currently under development for a range of CNS indications. The trial–which was not ‘first in class’ or ‘first in man’ –comprised two residential seven-day study periods with a washout period in between. Three days after the end of the first study period the volunteer developed an acute, severe psychosis that warranted hospitalization.