Research Ethics

The study reported in this paper explored the ethical requirements of social research participants, an area where there is still little empirical research, by interviewing people who had participated in one of five recent social research studies. The findings endorse the conceptualization of informed consent as a process rather than a one-off event. Four different dynamics of decision-making were followed by participants in terms of the timing of decisions to participate and the information on which they were based. Multiple information events were important, as was verbal as well as written information. Study participants reacted unfavourably to the idea of written consent. Although prior information was relevant to participant experience of the interview, what emerged more strongly as relevant was the behaviour of interviewers and the interviewing strategy used. The authors suggest that naturalistic, authentic approaches to information-giving are necessary, and that in scrutinizing them research ethics committees need to look not only at written information but also at verbal information giving, and how interviewer information-giving is supported by training and supervision. They suggest that committees also need to concern themselves more broadly with who will carry out interviews and the training, mentoring and monitoring in place to shape their conduct of interviews. In considering research instruments, research ethics committees need to consider not only whether interviewers will capture accurate and appropriate data but also whether they are likely to lead to a satisfactory interaction for participants. Given the impossibility of anticipating each individual participants information needs and their reaction to the interviewing strategy, the authors suggest that interviewers and participants need to be encouraged to negotiate the conduct of interviews jointly, and discuss how such negotiating roles might be supported.

The development of the internet and other communications technologies over the past decade have seen a corresponding growth in the development and use of technologically-based research methodologies. This paper explores issues arising from the new technology which impact on ethics committees and how these might be addressed. Whilst some ethical issues are comparable in both online and offline worlds there are some elements of the techno-research which require extra consideration. Although ethics guidelines can be found on the worldwide web the onus remains upon techno-researchers and ethics committee members to collaborate in deciding upon the ethical dilemmas and the rigour of proposed techno-research solutions.

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. (1) Principal investigators should build ‘true research teams’ where members of the team are meaningfully involved in decisions regarding the protocol and its implementation. (2)There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. (3) While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions (such as elaborated consent processes) and look for means to negotiate appropriate protections for those willing to participate. (4) In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. (5) Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist.

This study appeared in full in the last issue of Research Ethics Review (2007; 3 (2): 53). John Harris is investigating the effectiveness of a new regime for the treatment rheumatoid arthritis. His role involves asking patients to fill out a questionnaire that normally takes about 35 minutes to complete. The case study outlines three events: a patient whose eyesight is poor, another who cannot read and a receptionist who is discovered reading some of the completed questionnaires.

Obtaining a valid informed consent from an elderly person, especially when frail or with possible dementia, will initially involve the practical problem of assessing the ability to communicate. Only then can the assessment of decisionmaking capacities and the obtaining of informed consent for participation in research be progressed. Normal ageing does not impair communication or decision-making, but pathological status does, this may, or may not, be associated with the ageing process. Perceptual impairment may, in particular, interfere with the communication.

Once the subject appreciates and understands that he/she has the right to make a choice then it is important to ensure that he/she fully understands the decision he/she is being asked to make and can communicate and explain in his/her own words why a particular decision was made.

In this paper suggestions, based upon existing guidelines or texts, will be made as to how to improve communication with the elderly and the capabilities that the subject must demonstrate to show his capacity to make a decision will be discussed.

In December 2006 there was an amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004, the statutory instrument that translated the European directive into UK law. I will demonstrate how the European directive stifled much needed clinical research in urgent critical states whilst there is an international consensus that research in these situations be allowed. The amendments to the UK Medicines for Human Use (Clinical Trials) Regulations 2004 in allowing such exception have failed to preserve the high degree of respect and protection of the participants' interest as reflected in the spirit of the numerous guidelines, conventions and laws appertaining to the ethics of research in clinical emergencies.

This paper presents a review, conducted by the ethics working party of the European Forum for Good Clinical Practice, of the structures and functions of research ethics committees across the member states of the EU. The findings demonstrate widespread differences, and further working groups have been established to develop thinking across Europe, in respect of the training of REC members, ethics committee quality assurance and the involvement of vulnerable subjects in research. In practical terms the differences do not matter, but they should be recognized. The review itself is considered a dynamic document and will be updated every six months.

This paper describes the provisions of the Public Interest Disclosure Act 1998.

This paper reports on a recent symposium seminar series entitled ‘Governing genetic databases – collection, storage and use’ hosted by the Ethox Centre at the University of Oxford. It outlines the inadequacy of the current UK framework for governing genetic databases and biobanks and some of the implications of this. It then briefly describes and reflects on each of the five symposium papers.