Emma Angell | University of Leicester (original) (raw)

Papers by Emma Angell

Abstract There has been longstanding interest in the consistency of decisions made by research et... more Abstract There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority.

Archives of Disease in …, Jan 1, 2010

Objective: To identify issues raised by research ethics committees (RECs) in letters about applic... more Objective: To identify issues raised by research ethics committees (RECs) in letters about applications to conduct research involving children.

Methods: Analysis of 80 provisional and unfavourable opinion decision letters written by RECs in response to applications to conduct research involving child participants.

Results: RECs were most likely to be concerned about issues relating to consent, recruitment, care and protection of participants, scientifi c design and confi dentiality. RECs focused on children’s status as “vulnerable”. They sought to ensure that children would be protected, that appropriate written language would be used to communicate with children and that an appropriate person would give consent for children to participate.

Implications: Researchers should be attentive to issues of potential vulnerability when preparing applications. REC letters may be improved by giving clear and explicit reasons for their opinions.

Background: Little is known about the types of issues research ethics committees (RECs) raise in ... more Background: Little is known about the types of issues research ethics committees (RECs) raise in their letters about research involving the storage and use of human tissue.

Aims: To classify the issues that appear to trouble RECs and to identify how the implementation of the Human Tissue (HT) Act in September 2006 might have affected REC decisions.

Methods: 100 letters relating to applications about research use of human tissue were randomly selected from the National Research Ethics Service database, of which half were issued before the implementation of the HT Act and half post-implementation. Ethical issues raised by RECs were classified with a coding scheme developed using ethnographic content analysis.

Results: Many letters raised issues about informed consent, including specific concerns about the information to be provided to participants about the taking, using and storing of their tissue samples. However, RECs appeared to be less likely to raise concerns about informed consent to use or store tissue after the HT Act, and there was some evidence that RECs were more comfortable allowing archived tissue samples to be used without additional patient consent after the HT Act than before.

Conclusions: In the wake of the HT Act, RECs do not appear to be more cautious about approving research to use or store tissue without consent when responding to applications for ethical approval. The HT Act has provided clarity and authority to RECs and may indeed facilitate the process of gaining ethical approval for tissue-based research.

Two separate regulatory regimes govern research with adults who lack capacity to consent in Engla... more Two separate regulatory regimes govern research with adults who lack capacity to consent in England and Wales: the Mental Capacity Act (MCA) 2005 and the Medicines for Human Use (Clinical Trials) Regulations 2004 (‘‘the Regulations’’). A service evaluation was conducted to investigate how research ethics committees (RECs) are interpreting the requirements. With the use of a coding scheme and qualitative software, a sample of REC decision letters where applicants indicated that their project involved adults who lacked mental capacity was analysed. The analysis focuses on 45 letters about projects covered by the MCA and 12 letters about projects covered by the Regulations. The legal requirements for involving incapacitated adults in research were not consistently interpreted correctly. Letters often lacked explicitness and clarity. Neither consent nor assent from third parties is a legally valid concept for purposes of the MCA, yet they were suggested or endorsed in 10 post-MCA letters, and there was evidence of confusion about the consultee processes. The correct terms were also not consistently used in relation to clinical trials. Inappropriate use of terms such as ‘‘relative’’ had the potential to exclude people eligible to be consulted. Unless the correct terms and legal concepts are used in research projects, there is potential for confusion and for exclusion of people who are eligible to be consulted about involvement of adults who lack capacity. Improved clarity, explicitness and accuracy are needed when submitting and reviewing applications for ethical review of research in this area.

Sociology of health …, Jan 1, 2009

Research ethics committees (RECs) are charged with adjudicating the ethical status of research pr... more Research ethics committees (RECs) are charged with adjudicating the ethical status of research projects, and determining the conditions necessary for such projects to proceed. Both because of their position in the research process and because of the controversial nature of ethical judgements, RECs’ views and decisions need to be accountable. In this paper we use techniques of discourse analysis to show how REC decision letters ‘do’ accountability. Using a sample of 260 letters from three datasets, we identify a range of discursive devices used in letters written by RECs. These include drawing attention to: the process behind the decision, including its collaborative nature; holding the applicants accountable, by implying that any decision made by the REC can be attributed to the performance of the applicants; referring to specialist expertise; and calling upon external authorities. These tactics ‘do’ accountability by showing that routines of ethical assessment have been enacted, by establishing the factuality of claims, and by managing questions of fault and blame attribution. They may, however, also risk undermining legitimacy by failing to acknowledge the inherent contestability of ethical decision making or the limited nature of the cultural authority accorded to RECs, and thus may appear as an illegitimate exercise of power.

We analysed research ethics committee (REC) letters. We found that RECs frequently identify proce... more We analysed research ethics committee (REC) letters. We found that RECs frequently identify process errors in applications from researchers that are not deemed ‘‘favourable’’ at first review. Errors include procedural violations (identified in 74% of all applications), missing information (68%), slip-ups (44%) and discrepancies (25%). Important questions arise about why the level of error identified by RECs is so high, and about how errors of different types should be handled.

Disquiet about the research ethics review process has, historically, been anecdotal and often tak... more 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.

Progress in …, Jan 1, 2008

Objectives: The performance of NHS research ethics committees (RECs) is of growing interest. It h... more Objectives: The performance of NHS research ethics committees (RECs) is of growing interest. It has been proposed that they confine themselves to ‘‘ethical’’ issues only and not concern themselves with the quality of the science. This study aimed to identify current practices of RECs in relation to scientific issues in research ethics applications.

Methods: Letters written by UK RECs expressing provisional or unfavourable opinions in response to submitted research applications were sampled from the research ethics database held by the Central Office for Research Ethics Committees. Ethnographic content analysis (ECA) was used to develop a coding framework. QSR N6 software was used to facilitate coding.

Results: ‘‘Scientific issues’’ were raised in 104 (74%) of the 141 letters in our sample. The present data suggest that RECs frequently considered scientific issues and that judgments of these often informed their decisions about approval of applications. Current processes of peer review seemed insufficient to reassure RECs about the scientific quality of applications they were asked to review.

Conclusions: This study provides evidence that scientific issues are frequently raised in letters to researchers and are often considered a quality problem by RECs. In the discussion, the authors reflect on how far issues of science can and should be distinguished from those of ethics and the policy implications.

Social Science & …, Jan 1, 2007

Research Ethics Committees (RECs) are increasingly institutionalised as a feature of research pra... more Research Ethics Committees (RECs) are increasingly institutionalised as a feature of research practice, but have remained strangely neglected by social scientists. In this paper, we argue that analysis of letters from RECs to researchers offers important insights into how RECs operate. We report a traditional content analysis and an ethnographic content analysis of 141 letters to researchers, together with an analysis of the organisational and institutional arrangements for RECs in the UK. We show that REC letters perform three important social functions. First, they define what is deemed by a REC to be ethical practice for any particular application, and confer authority on that definition. They do this actively, through comments on particular aspects of proposals, and passively, through silences about other aspects. Second, they provide an account of the work of the REC, and function as a form of institutional display. Third, they specify the nature of the relationship between the REC and the applicant, casting the applicant in a supplicant role and requiring forms of docility. Writing and reading REC letters require highly specific competences, and engage both parties in a Bourdieusian ‘‘game’’ that discourages challenges from researchers. The authority of RECs’ decisions derives not from their appeal to the moral superiority of any ethical position, but through their place in the organisational structure and the social positioning of the parties to the process thus implied. Letters are the critical point at which RECs act on researchers and their projects.

Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evid... more Research Ethics Committees (RECs) are frequently a focus of complaints from researchers, but evidence about the operation and decisions of RECs tends to be anecdotal. We conducted a systematic study to identify and compare the ethical issues raised in 54 letters to researchers about the same 18 applications submitted to three RECs over one year. The most common type of ethical trouble identified in REC letters related to informed consent, followed by scientific design and conduct, care and protection of research participants, confidentiality, recruitment and documentation. Community considerations were least frequently raised. There was evidence of variability in the ethical troubles identified and the remedies recommended. This analysis suggests that some principles may be more institutionalized than others, and offers some evidence of inconsistency between RECs. Inconsistency is often treated as evidence of incompetence and caprice, but a more sophisticated understanding of the role of RECs and their functioning is required.

Journal of Medical …, Jan 1, 2006

There has been longstanding interest in the consistency of decisions made by research ethics comm... more There has been longstanding interest in the consistency of decisions made by research ethics committees (RECs) in the UK, but most of the evidence has come from single studies submitted to multiple committees. A systematic comparison was carried out of the decisions made on 18 purposively selected applications, each of which was reviewed independently by three different RECs in a single strategic health authority. Decisions on 11 applications were consistent, but disparities were found among RECs on decisions on seven applications. An analysis of the agreement between decisions of RECs yielded an overall measure of agreement of k = 0.286 (95% confidence interval 20.06 to 0.73), indicating a level of agreement that, although probably better than chance, may be described as ‘‘slight’’. The small sample size limits the robustness of these findings. Further research on reasons for inconsistencies in decision making between RECs, and on the importance of such inconsistencies for a range of arguments, is needed.

Measurements of the relative Doppler power scattered by an embolus and the surrounding blood are ... more Measurements of the relative Doppler power scattered by an embolus and the surrounding blood are widely used to infer the composition of the embolus. For a given embolus, measured embolus-to-blood ratio (MEBR) is affected by the Doppler sample volume shape, the geometrical relationship between the sample volume and the vessel, and the embolus trajectory through the blood vessel. The likely magnitudes of such effects were quantified using a model that allowed calculation of theoretical values of MEBR as a function of the geometrical relationship between a blood vessel and a defined sample volume. Overall, the effects of embolus trajectory, likely insonation angles, and plausible vessel misalignments introduced uncertainties in MEBR values of approximately 10 to 12 dB for a given vessel size. In practice, the only operator-controlled factors are the position and orientation of the transcranial Doppler probe on the patients' heads. Probe positioning can significantly affect MEBR and suboptimal positioning may result in the reduced detection of emboli.

BMC Public …, Jan 1, 2006

Background Effective health protection requires systematised responses with clear accountabiliti... more Background
Effective health protection requires systematised responses with clear accountabilities. In England, Primary Care Trusts and the Health Protection Agency both have statutory responsibilities for health protection. A Memorandum of Understanding identifies responsibilities of both parties, but there is a potential lack of clarity about responsibility for specific health protection functions. We aimed to investigate professionals' perceptions of responsibility for different health protection functions, to inform future guidance for, and organisation of, health protection in England.

Methods
We sent a postal questionnaire to all health protection professionals in England from the following groups: (a) Directors of Public Health in Primary Care Trusts; (b) Directors of Health Protection Units within the Health Protection Agency; (c) Directors of Public Health in Strategic Health Authorities and; (d) Regional Directors of the Health Protection Agency

Results
The response rate exceeded 70%. Variations in perceptions of who should be, and who is, delivering health protection functions were observed within, and between, the professional groups (a)-(d). Concordance in views of which organisation should, and which does deliver was high (≥90%) for 6 of 18 health protection functions, but much lower (≤80%) for 6 other functions, including managing the implications of a case of meningitis out of hours, of landfill environmental contamination, vaccination in response to mumps outbreaks, nursing home infection control, monitoring sexually transmitted infections and immunisation training for primary care staff. The proportion of respondents reporting that they felt confident most or all of the time in the safe delivery of a health protection function was strongly correlated with the concordance (r = 0.65, P = 0.0038).

Conclusion
Whilst we studied professionals' perceptions, rather than actual responses to incidents, our study suggests that there are important areas of health protection where consistent understanding of responsibility for delivery is lacking. There are opportunities to clarify the responsibility for health protection in England, perhaps learning from the approaches used for those health protection functions where we found consistent perceptions of accountability.