Research Ethics

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.

Complementary and alternative medicine (CAM) research presents unique problems for research ethics committees which must be considered in some detail. Applying conventional research techniques to CAM raises a number of issues which ethics committees may find challenging. CAM is widely available and this will have a substantial effect on any proposed research strategy as so many individuals will have pre-existing opinions about these treatments. Whilst many complementary therapies may eventually be ‘validated’ by appropriate clinical trial methodologies other research methods could be more appropriate in the early stages of a research strategy, particularly in view of the widespread availability in both the public and private sectors. Safety, efficacy, cost-effectiveness and patient preference also need evaluation; and these cannot be adequately assessed through double blind randomised placebo controlled trials. If the research question is clear, then thoughtful and often innovative evaluative processes can be designed to answer the socially and clinically relevant issues posed by this area of medicine. There are a number of agencies and organizations available to offer advice to ethics committees in this newly emerging field of CAM research including CAM Strategy Research and Development (CAM STRAND), the Foundation for Integrated Health (FIH) and the Research Council for Complementary Medicine (RCCM).

The current practice for UK Research Ethics Committees is to invite researchers to attend meetings at which their applications are to be considered and the National Research Ethics Service strongly recommends researchers to attend. There are no available data, however, to substantiate the value of researchers' attendance and particularly on the extent to which their attendance may influence the initial decision of the committee. This study attempts to address whether it is in the researchers' interest to commit substantial time and resource to attend a REC meeting through using the REC decision on the research proposal as the main outcome measure.

There is always a debate around consent in the context of research. Given the expansion of different approaches to qualitative research within dementia care, there is increasing consideration around consent in this context; particularly in research concerning the experiences of living with dementia and the care of persons with dementia. Specifically there is a drive to directly involve persons with dementia as they offer specific expertise concerning living with dementia. Additionally, capacity legislation strengthens the case for ensuring that persons with dementia are actively enabled to make their own decisions for as long as possible. This paper discusses an approach and method that can enable more persons who are living with dementia to participate in some types of research should they want to. Currently, most researchers rely on an extension of the traditional competency-based informed consent method and/or proxy consent or assent. However, related to the development of so-called person-centred and participatory research in dementia, there are now a number of academic publications on approaches and practical methods of ‘inclusionary’ consent. This paper considers the broader contextual influences on inclusionary consent and outlines the key aspects of such approaches based on the development of one specific method for including persons with dementia in consent processes. The method is based on the premise that, for persons with a dementia, informed consent becomes increasingly redundant and consequently exclusionary to them as persons. And even where capacity is said to no longer exist, persons with dementia are often able to make choices and make known their preferences about participating in research where the consent process is made specifically dementia-sensitive. Ethics committees can facilitate researchers both by supporting them when they need to and want to include persons with dementia in gerontological research and by challenging them to ensure that participation is genuine and starts with process consent.

This study appeared in full in the last issue of Research Ethics Review (2008; 4 (1): 30). AJ has been commissioned to investigate ways to improve access to health services by homeless people living on the streets. She plans to use a series of focus groups to survey homeless people's views and experiences and has formed links with a number of voluntary organizations that provide services for street dwellers. She has been advised that to help empower homeless people to make changes in their lives, those who take part in projects are usually offered a small sum, £5.00, as a way of indicating that their time is considered valuable. It has been recommended that AJ does the same.

The temptation in clinical research to sacrifice the interests, the health, and sometimes even the lives of research subjects to the advancement of the interests of science and society, and to the advancement of researchers' own careers, is a hardy weed which can grow anywhere. Pursuant to a commendable EU Directive a new law, the Medicines for Human Use (Clinical Trials) Regulations 2004 was brought into effect in the UK. That law makes it illegal for anyone to start a clinical trial unless a Research Ethics Committee has expressed a favourable opinion upon its protocol. It gives to Research Ethics Committee members the legal power, and imposes upon them the legal duty, to protect research subjects from those who have strong financial and other temptations to mistreat them. The new law specifies what standard of protection the Research Ethics Committee members shall insist upon. The Royal College of Physicians, which has been reluctant to declare its own conflicting interests, in 2007 issued some guidelines which it hopes Research Ethics Committee members will follow. Those Guidelines on the practice of ethics committees in medical research with human participants urge Research Ethics Committee members to express a favourable opinion of clinical trials which they believe, for example, do not give to research subjects the protection the new law demands. But Research Ethics Committee members have a clear legal duty not to follow any course of conduct calculated to subvert the excellent and necessary 2004 law.

This article challenges the assumption inherent in many ethics codes that duties only arise when the project is sufficiently advanced that a formal research proposal can be put before an ethics committee for approval. Certain social science methodologies do not lend themselves to a simple demarcation between the preparation and the implementation of the research. It is therefore imperative that consideration is given to researchers' ethical duties prior to formal review. The problem of demarcation and of defining a duty are explored in the particular context of a potential research project involving research on taxi-drivers' experiences of crime and the strategies that they employ to avoid victimisation. Two key issues emerge. First, in what circumstances, if any, can information supplied during this gestation period be used as ‘research data’? Secondly, there are concerns about the researcher's identity and role at this stage. These issues, and others, need to be the subject of further consideration by the relevant bodies so that researchers receive meaningful guidance on the duty prior to ethics review.

Qualitative data typically contain multiple identifiable characteristics about people, places and events, in the unique voice of each participant. This short report considers sensitivity and security of audio-recordings, drawing attention to a lack of guidelines for researchers on the preservation or destruction of such data. The authors urge debate on this issue, with due consideration to both ethics and scientific rigour.

Informed consent is crucial in most research but written consent is not without its drawbacks. Written consent serves to protect the researcher more than it serves to protect the participant and this can present a barrier to their relationship. In certain circumstances it can undermine the trust important in research. For ‘simple’ studies, where treatments are largely interchangeable or where consent is implied, written consent can be considered not only to be unnecessary, but actually harmful. Research ethics committees should consider removing the requirement for written consent in these studies.