Emma Angell

An analysis of decision letters by research ethics committees: the ethics/scientific quality boundary examined

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.

Do research ethics committees identify process errors in applications for ethical approval

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.

Is 'inconsistency' in research ethics committee decision-making really a problem? An empirical investigation and reflection

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.

Research involving adults who lack capacity: how have research ethics committees interpreted the requirements?

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.

What do research ethics committees say about applications to conduct research involving children

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, scientific design and confidentiality. RECs focused on childrens 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.

What do research ethics committees say about applications to do cancer trials

This is the author’s final draft of the paper published as Lancet Oncology, 2008, 9 (8), pp. 700-701. The final published version is available at http://www.sciencedirect.com/science/journal/14702045. DOI: 10.1016/S1470-2045(08)70184-0

Research involving storage and use of human tissue: how did the Human Tissue Act 2004 affect decisions by research ethics committees?

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.

Asthma management in British South Asian children: an application of the candidacy framework to a qualitative understanding of barriers to effective and accessible asthma care

BackgroundIn the UK, people of South Asian origin with asthma experience excess morbidity, with hospitalisation rates three times those of the majority White population and evidence suggests that South Asian children with asthma are more likely to suffer uncontrolled symptoms and hospital admissions with acute asthma compared to White British children. This paper draws on data from The Management and Interventions for Asthma (MIA) study to identify the operation of barriers to optimal care and good asthma control for South Asian children.MethodsThe MIA study followed a multi-phase, iterative, participatory design, underpinned by the socio-ecological model. Findings presented here are from face-to face, semi-structured interviews with South Asian (Indian, Pakistani and Bangladeshi origin) parents and carers of a child with asthma (n = 49). Interviews were conducted in English or relevant South Asian languages using specially trained community facilitators. Data were transcribed verbatim and analysed according to the principles of interpretive thematic analysis, facilitated by the use of NVivo.ResultsSeven dimensions of candidacy are identified: identification of candidacy; navigation; the permeability of asthma services; appearances at health services; adjudications; offers and resistance and operating conditions in the local production of candidacy. The analysis demonstrates several ways in which a potential lack of alignment between the priorities and competencies of British South Asian families and the organization of health services combine to create vulnerabilities and difficulties in effectively managing childhood asthma.ConclusionsHealthcare systems have a responsibility to develop services that are sensitive and appropriate to the needs of their communities. In South Asian communities, further efforts are required to raise awareness of symptoms and effectively communicate how, when and where to seek help for children. There is a need for improved diagnosis and consistent, effectively communicated information, especially regarding medication. Parents made several suggestions for improving services: presentations about asthma at easily accessible community venues; an advice centre or telephone helpline to answer queries; opportunities for sharing experiences with other families; having information provided in South Asian languages; longer GP appointments; extended use of asthma nurses; and better education for healthcare professionals to ensure consistency of care and advice.

Tackling health inequalities: socio-demographic data could play a bigger role

Health inequalities are a cause for significant concern across the globe; in the UK, the gap in disability-free life expectancy between the richest and poorest is around 17 years. General practitioners (GPs) have an importantrole to play in tackling inequalities, through delivering services that meet the needs of their local population, and engaging in preventative work, not just with patients who regularly consult, but also with harder to reach groups.

Style Matters: An Analysis of 100 Research Ethics Committee Decision Letters

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.