Research Ethics

The practical and ethical issues associated with obtaining informed consent from children and young people living in residential state care for their participation in a research study are explored in this paper. Research involving the participation of these young people has received comparatively limited attention in the social sciences: this is due to several reasons including the challenging methodological and ethical issues associated with undertaking such research. These can be categorized as the practical issues of gaining direct contact with these young people through gaining the consent of relevant gatekeepers and the process of gaining a favourable opinion from a research ethics committee. Whilst the principles of clarity and consistency of practice are key elements in the process of accessing consent to participate in research, flexibility and imagination are also important skills for the researcher when developing the appropriate protocols for research in an area of social policy which can be methodologically and ethically complex.

Informed by interviews conducted with members of a local research ethics committee (REC), this article reflects upon how RECs can act to improve the quality of patient consent to clinical trials. Two emergent narratives which trial participants have drawn upon to account for their experiences are explored: the narrative of the clinical trial itself and a narrative of individualized treatment. Informed consent requires participants to recognize that only the first of these narratives is relevant to the design, and their experience, of randomized controlled trials. Improving the clarity of patient information is argued to be a relevant, but insufficient, strategy for increasing patient familiarity with the methodology of clinical trials. In the concluding sections of the article, other approaches, and the role of RECs, are considered.

Disquiet about the research ethics review process has, historically, been anecdotal and often takes the form of ‘atrocity stories’ from researchers about the bureaucratic nature of the application process or inconsistency and capriciousness in decision-making. However, systematic evidence has often been lacking. We analysed 100 decision letters written by NHS research ethics committees (RECs). We found evidence of poor communication in the way in which REC decisions were conveyed to applicants. Typos and grammatical mistakes were found in almost 30% of letters; sometimes wording was impolite and demonstrated a lack of respect towards applicants; and there was often lack of clarity about the nature of a revision and whether the revision was compulsory or optional. The analysis provides messages for RECs about how they can improve their practices to establish a more cooperative relationship between researcher and committee through the careful use of language and attention to detail in decision letters.

The World Medical Association's ‘Declaration of Helsinki’ on Medical Research on Human Subjects is undergoing its sixth revision in its 44 years. The aim of this paper is to put the Declaration into an historical context, define and identify the core ethical principles, and illustrate how these are applied within the Declaration.

In this paper, the author shows how research ethics committees must deal with illegality in the research protocol. He defines their legal duty by reference to the 2001 Clinical Trials Directive, and especially in the key areas of insurance, indemnity and no-fault compensation. The author is critical of the current GAfREC and recent guidelines issued by the Royal College of Physicians. He concludes that new rules are needed to replace the 2001 edition of GAfREC.

This study appeared in full in the last issue of Research Ethics Review (2008; 4 (2): 68). MJ's research focuses on those patients with brain damage following trauma such as a road traffic accident. She wants to find out about their experiences of daily life once they have been discharged from hospital. She plans to use a phenomenological approach in which each participant will be asked to take part in a series of in-depth interviews, via email, over a period of about two years. These interviews will allow her to compare participants' experiences in different parts of the UK. MJ has a research partner in Auckland; the two of them are planning a similar series of interviews in New Zealand to allow for comparison between participants' experiences in the two countries.