University Research Ethics Committee Research Articles

Counselling for sight loss. Using Hermeneutic Single Case Efficacy Design methods to explore outcome and common factors

BackgroundSight loss can lead to depression, suicidal thoughts, social isolation and loneliness. Although there is growing recognition of the need to provide emotional support for people with sight loss, little is known about effective counselling interventions for this client group.AimsThe aim of this study was to contribute to an understanding of the nature of counselling for sight loss by carrying out a Hermeneutic Single Case Efficacy Design (HSCED) study in which the client was a 70-year-old woman who had experienced sudden and irreversible post-operative sight loss.MethodThe client received six sessions of counselling from a sight-impaired counsellor, working within a pluralistic framework informed by a common factors perspective. The client completed outcome and process measures at each session, and was interviewed at the end of therapy and at follow-up. All counselling sessions were recorded and transcribed. These data formed a rich case record, which was analysed by an inquiry team, using an HSCED procedure. Ethical approval was obtained from the University Research Ethics Committee to conduct this study, and the client engaged in an informed consent process at the beginning and end of her therapy.ResultsResults indicated that the client reported considerable benefit from the counselling she had received. The most important aspects of the therapy process were: feeling understood; being able to express emotions around the loss of sight; finding a new identity; identifying strategies for coping with fear, loss, dependency and other people’s perceptions; exploring the possibility of a future without sight; making sense of things, and finding ways to become more socially connected. These themes are discussed in relation to the development of a model of counselling for sight loss based on a common factors approach.ImplicationsThe findings of this study suggest that systematic case study research and a common factors perspective have the potential to deepen our understanding of issues presented by specific client groups.

A survey of student nurses' and midwives' experiences of learning to use electronic health record systems in practice

AimThe study aimed to investigate student nurses' and midwives' experiences of learning to use electronic health records (EHR) in practice. BackgroundGood record keeping and documentation are integral to nursing and midwifery practice. As EHRs become more widespread, student nurses and midwives need opportunities to access and learn how to use them in practice. MethodA survey of nursing and midwifery students was conducted using questionnaires (n = 215) and three focus groups: one with midwifery students (n = 6); one with mental health nursing students (n = 5) and one with adult nursing students (n = 6). The University research ethics committee approved the study. The questionnaire data were analysed using SPSS v19. The focus group data were analysed thematically following transcription. ResultsThe results presented relate to two themes: 1) Preparation for using EHRs and skills development; 2) Access to EHRs and involvement. Students had variable experiences in relation to opportunities to access and use EHRs, training on EHR systems used in practice and guidance from mentors. Some mentors had concerns about students' legitimacy to access EHRs and verification of students' EHR entries was a challenging issue in some areas. ConclusionTo promote opportunities for students to develop competence in using EHRs in practice, training on EHR systems in use, and clear processes for authorised access, are needed. Following the survey, the University and practice partners collaboratively established formalised EHR training for students with clear governance procedures for access and use.

The Ethics of Care in Biomedical Research Committees

Principle based decision making is most commonly used by Research Ethics Committees. Whilst useful and encouraging the agreement of members from diverse disciplines, principles may be used without consideration of the specific situation under discussion. It is argued that, were some members of the committee familiar with the concepts and application of the ethics of care, they could engage in debate when the universal principles are used without consideration of the specific nuances of the situation under discussion. An ‘eclectic’ theory is not advocated as, unless conversant with the intricacies of each of the theories amalgamated, one is apt to slur theories and arrive at a messy, relativistic hodgepodge which is able to be manipulated every which way. However, using more than one source on which to base ethical decisions ensures that the universal and objective approaches which currently dominate the realm of ethical decision making in medical research are modified. The authors, both members of a university research ethics committee, argue the value of considering other approaches to enable ethics committees to adopt a more holistic and comprehensive view of the research situation, the people involved and the role of research in general.

Research Ethics Review: Social Care and Social Science Research and the Mental Capacity Act 2005

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ‘appropriate body’ to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews the views of social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible.

Whose ethics, whose accountability? A debate about university research ethics committees

Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other hand, a sizeable body of literature has emerged criticising the work of RECs, as, among other things, overly bureaucratic and unresponsive to the needs of disciplines outside the biomedical sciences. This article adopts the format of a debate between a Chair of a university REC and a social science researcher as a vehicle for contrasting different perspectives on research ethics. The fictional debate allows for a productive discussion between the two sides, incorporating key insights from the recent literature and concludes with a synthesis that sketches out some ideas about how university RECs can be made more responsive and accountable.

A content analysis of magazine diets in relation to the Eatwell Plate

Background: Current predictions suggest that by 2050 over half of the adult population will be classified as obese (Foresight Report, 2007). The media is a known platform for nutrition education and research indicates that health magazines specifically are highly influential in terms of their impact on health and diet (Hill, 2006). Whilst studies have examined the influence of magazine advertising on food choice, none have analysed the nutritional content of magazine diets in relation to healthy eating guidelines, or their influence over healthy dietary behaviours. The aim of this study was to identify whether the diets published in magazines adhere to national healthy eating guidelines as depicted by the Eatwell Plate (Food Standards Agency, 2007). Methods: The 15 best selling diet and health magazines were identified from national sales data and purchased from a single retailer in December 2009, with the cost of each magazine noted. Inclusion criteria were defined as the presence of a health theme, target audience within 18–54 years and incorporation of a 7-day diet plan. Diet plans were analysed using content analysis. Food lists were devised and coded through a deductive approach by cross referencing against the Eatwell Plate and previous content analysis studies. Associated word lists to determine subconscious influence were devised and coded using inductive content analysis. Each diet was analysed for food or word references which were counted against the relevant codes. References were collated as a total across all magazines and presented as the number cited by category as a percentage of the total. Descriptive statistics were used to present the data. Ethical approval was gained from Leeds Metropolitan University Research Ethics Committee. Results: Ten magazines (seven women's; three men's) met the inclusion criteria, representing a full target age range and varied cost (£2.60–£3.95). In total 1155 food references and 266 word references were cited. Fruit and vegetables were referenced most frequently (37.7%), exceeding the Eatwell Plate recommendation (33.3%); carbohydrates were referenced poorly (20.5%), below the 33.3% recommendation; protein (22.3%) was above the 13% recommendation; dairy foods (13.5%) met the Eatwell Plate recommendation (13%). No magazine represented an accurate depiction of the Eatwell Plate model. The associated words attracting most references were for fluid (15%), fat (14.3%), protein (11.3%) and energy (10.5%) with protein referenced more often in men's magazines and calories more often in women's. Discussion: The lack of evidenced based and balanced dietary information in magazine diets was of concern and contradicted government health promotion strategies. The magazines promoted popular dietary trends as opposed to evidence based healthy eating guidance. The evident repetition of words relating to calories and fat does little to promote healthy dietary behaviours and little emphasis was placed on multi-component dietary and lifestyle approaches. Conclusion: The magazine diets did not meet the Eatwell Plate guidelines, highlighting the need for furthercollaboration between the media and health professionals in order to improve public understanding and help shape the future of public health in relation to obesity prevention.

The impact of weight loss competition in the workplace

Background: The workplace has been identified as an environment in which primary prevention and secondary weight management strategies can be promoted (DH, 2008). Workplace weight management programmes have had limited success showing minimal weight loss, poor recruitment and high attrition rates (Stunkard et al., 1989). Team weight loss competitions have proved more promising although studies are predominantly American and have had methodological limitations (Cohen et al., 1987; Stunkard et al., 1989). The current investigation was a pilot study to determine if team based competition (without incentive) was more effective than traditional workplace education and behavioural programmes in achieving weight loss. Methods: Two established self-help diet groups were recruited from separate office workplaces within Lancashire. Each group attended a Healthy Lifestyle Workshop led by the lead researcher consisting of two components; a structured workshop incorporating an interactive presentation of a balanced diet, weight loss techniques, exercise and behaviour change and a worksheet on which participants identified personal goals and individual objectives. One office was randomly assigned to complete this on an individual basis (Group A), and the remaining office was assigned to a team based competition intervention (Group B), through random allocation into two teams, and encouraged to compete against each other to achieve the greatest collective team weight loss. No winning incentive was provided. The lead researcher recorded baseline age, weight and body mass index (BMI) and subsequent weight, BMI weekly for 3 weeks using the same set of calibrated scales. Independent t-tests were used to compare the final percentage weight loss between competing and non-competing groups and differences in weight and BMI at baseline and 3 weeks. Ethical approval was gained from Leeds Metropolitan University Research Ethics Committee. Results: A total of 42 individuals participated in the study [Group A: n = 17 (seven male, 12 female); and Group B: n = 23 (5 male, 18 female)] There were no differences between groups for age [29(8) years (Group A) versus 31(9) years (Group B) P = 0.55], baseline weight [81(17.9) kg (Group A) versus 75.6(16.5) kg (Group B) P = 0.32] or BMI [27.9(6.7) kg m−2 (Group A) versus 27.1(5.3) kg m−2 (Group B) P = 0.69]. The competing group (Group B) achieved significantly greater percentage weight loss after 3 weeks than the group participating as individuals (Group A) [2.6 (2)% v 1.1(2.1)%, P = 0.025]. Discussion: Over a 3-week period, a team based weight-loss competition was found to have a more beneficial effect on weight-loss than traditional work place interventions and, provides new evidence to suggest that unlike incentive based programmes (Schuessier L et al., 2007) this can be achieved through competition alone. Methodological limitations prevent an understanding of the dynamics of the competitive effect on weight loss, although it is likely that the competitive element improves motivation to succeed. Limitations of this pilot study include small sample size and a short time scale compared to recommendations for weight management programmes. However, this study provides valuable preliminary data in this area. Conclusions: Team weight loss competitions should be considered in addition to educational and behavioural functions when designing an effective workplace programme and require fuller evaluation through adequately sized controlled trial to fully evaluate their long-term effect.

Assessment of nutritional knowledge of learning disability support workers

Background: People with Learning Disabilities (LD) are one of the most vulnerable groups in Britain (DOH, 2001). The Disability Rights Commission (2006) found that one in three people with LD are obese compared with one in five of the general population. As the learning disability population move from institutional care into community residences, nutrition is an increasingly important issue. Food is no longer prepared in kitchens by catering staff and clients are more dependent on support workers for the provision of their food. Several studies have examined nutritional education and the impact this has on service users although few have assessed the nutritional knowledge of learning disability support workers. The aim of this study was to assess the nutritional knowledge of learning disability support workers in the community setting. Methods: In this cross-sectional survey, managers of seven community homes within a locality of Manchester were approached and agreed for staff to participate in the study. In total 60 questionnaires were distributed. The questionnaire was adapted from a validated assessment tool (Pamenter and Wardle, 1999) with the addition of questions that assessed knowledge of the Eatwell plate, food groups and food labelling. Questionnaires were collected 2 weeks after distribution. All data were coded and analysed using SPSS 16 (SPSS Inc., Chicago, IL, USA). Descriptive statistics of incidence and % correct response were used to examine the data. Independent t-tests were used to compare differences between the answers of those who had received previous training and those who had not. Ethical approval was gained from Leeds Metropolitan University research ethics committee. Results: The response rate was 42% (n = 25) and of this group 44% (n = 11) had received previous nutrition training. The questionnaire revealed a lack of nutritional knowledge, the most notable of which was knowledge of the Eatwell plate (8% were aware of the plate model and 4% correctly stated all food groups); food portion sizes (36% correctly stated the portion size of fruit, vegetables and dairy foods and 32% the portion size of meat); food labelling (28% correctly stating the saturated fat content regarded as ‘high’). There was no statistical significant difference between the answers of those who had previous training and those who did not. Of respondents, 88% indicated that they would benefit from nutritional training and 48% did not feel confident with their current nutritional knowledge. Discussion: Lack of nutritional knowledge of key workers within the care setting is of concern. Service users frequently rely on their support workers for menu planning and food provision. Coronary heart disease is the second most common cause of death in people with LD and lack of knowledge of fat recommendations is an important area of focus for the future. Support workers themselves welcomed further input and the apparent lack of difference in nutritional knowledge between those who have received previous training compared to those without, suggests that this should be ongoing. Conclusions: The nutritional knowledge of learning disability support workers in the community setting is poor and nutritional education programmes are now required to develop the nutritional knowledge of staff and evaluate their subsequent impact on clients with learning disability.

Sensory processing ability and eating behaviour in children with autism

Background: During the past decade the prevalence of autistic spectrum disorders (ASD) has increased to 1% of the UK population. Anecdotal reports of children with ASD suggest they are atypical selective eaters who restrict their food intake based on idiosyncratic pre-requisites of texture and food presentation. Research has previously focused on the nutritional adequacy of such diets rather than underlying sensory processing capabilities that are known to be impaired in up to 90% of children with ASD (Leekham et al., 2007). Sensory processing skills, eating behaviour and parent-child relationships are intersecting aspects of ASD; and each play a role in achieving maximum potential in developing daily living skills. Previous research, relating sensory processing ability and eating behaviour, is limited. The aim of the study was to explore the relationship between sensory processing ability and eating behaviour in children with ASD. Methods: This analytical, exploratory study used purposive sampling, through approach of a parental support group for children with ASD in October 2009. Consent was sought from parents or guardians to complete two questionnaires; the validated Short Sensory Profile (SSP) and an eating behaviour questionnaire (EBQ) developed by the author and consisting of eight domains and four open questions. The domains of the EBQ were taste, texture, smell, behaviour, sound, environment, vision and touch. The domains were selected to reflect the SSP, and as a result of qualitative research from parental and specialist input and literature. Results of both questionnaires were statistically analysed using SPSS. Domains within each questionnaire were presented as mean (SD) and performance related data (SSP only) was presented as ‘typical performance’, ‘probable difference’ and ‘definite difference’ to indicate the degree of sensory processing difficulty (Dunn, 1999). Spearman Rank Correlation coefficient was used to explore correlations between domains within the two questionnaires. Ethical approval was gained from Leeds Metropolitan University Research Ethics Committee. Results: All parents (n = 20) participated in the study; completing questionnaires for 20 children (18 male, two female), mean age 10.8(2.6) years. Results of the SSP indicated that 71% of children in the study had sensory processing difficulties, of which auditory filtering (83%) and tactile sensitivity (68%) were ‘definite’ problem areas. Within the eating behaviour questionnaire, mealtime behaviour, vision, taste and smell were common areas that caused difficulty in daily life. Significant correlations between 20% of factors on the SSP and eating questionnaire were noted, the highest being SSP-taste/smell and EBQ taste (r = 0.9, P < 0.001) and SSP-taste/smell and EBQ vision (r = 0.9, P < 0.001). Discussion: This pilot study confirmed previous reports of sensory processing difficulties in children with autism (Tomcheck and Dunn, 2007) and provides preliminary data indicating a potential relationship between aspects of sensory processing ability and eating behaviour. Validation of the eating behaviour questionnaire is now required to establish a true link between these two areas and provide a sound basis for further longitudinal research that can accurately examine the impact of behaviour on eating in children with ASD and potential shifts in behaviour over time. Conclusion: This pilot study provides preliminary data linking sensory processing difficulty and eating behaviour and provides a basis for further research that supports effective and early interventions that improve quality of life, skills and prospects for those with ASD.

Problem or safeguard? Research ethics review in social care research and the Mental Capacity Act 2005

The Mental Capacity Act 2005 (HM Government, 2005) introduced safeguards to protect people who lack capacity from intrusive research. While these safeguards stemmed from predominantly medical ethical review concerns and developments aimed to protect people from physical and psychological damage and harm, the Act relates to all forms of research. The implications of the requirements of the Act for the conduct of social care research and the identification of helpful approaches or development of new knowledge concerning people who may lack capacity are, as yet, unknown. There are some concerns that the Act does not fully account for social research, does not recognise its importance to and differences from health‐related research, and may even hamper such research from taking place. This paper describes the findings and implications from a research project funded by the Social Care Institute for Excellence (SCIE) and the Department of Health that considered the impact of the Mental Capacity Act 2005 on the ethical scrutiny and development of social care research. The particular focus of the study was processes relating to university research ethics committees (URECs). The study was undertaken in two stages, beginning with an online survey of UREC policies and procedures and was followed by interviews with social care researchers working in areas in which people may lack capacity according to the terms of the Act. Recommendations for research ethics review are made that will be of importance to practitioners, policy‐makers and researchers.

Exploring determinants of acceptance of the pandemic influenza A (H1N1) 2009 vaccination in nurses

This study investigated the anticipated vaccination rate against pandemic human influenza A (H1N1) 2009 in the health care setting. Self-administered questionnaires were used to assess nurses' acceptance of vaccination against seasonal flu and H1N1. They were sent to nurses by post through various nurses' unions before initiation of the vaccination program. Only 13.3% of the respondents planned to receive the H1N1 vaccine, compared with 37.5% for the seasonal influenza vaccine. Vaccination against seasonal influenza in the preceding season strongly predicted the likelihood of H1N1 vaccination. The main reason cited for H1N1 vaccination was self-protection, and reasons for rejecting vaccination included possible side effects, ineffectiveness of the vaccine, and the mild nature of the disease. Personal contact with patients with H1N1 or severe acute respiratory syndrome at work did not significantly increase the likelihood of receiving the H1N1 vaccine. More than 40% of the respondents were undecided at the time of the survey. The promotion of vaccination against seasonal influenza may play a role in improving H1N1 vaccination coverage. Efforts are needed to address concerns about vaccination risk and to incorporate H1N1 vaccination in standard infection control practice with policy support.

Serum lead levels in childhood eczema

Conflict of interest: none declared. Atopic dermatitis (AD) is a distressing disease associated with pruritus, sleep disturbance and impaired quality of life.1 The incidence of eczema has been increasing in developed countries. Although pollution of air and food (e.g., with lead) has been considered as a possible culprit, these factors have never been investigated in Hong Kong. This study aimed to evaluate if clinical severity scores of AD were associated with abnormal serum lead levels. The clinical research ethics committee of the Chinese University of Hong Kong approved the study. We prospectively measured the serum lead levels in consecutive new patients aged > 1 month and selected existing patients requiring blood samples to be taken at the paediatric dermatology clinic of a university teaching hospital over an 8‐month period. AD was diagnosed according to the criteria of Hanifin and Rajka.2 Correlations between these levels, serum IgE levels as a marker of atopy, eosinophil counts, AD severity [Scoring Atopic Dermatitis (SCORAD) and Nottingham Eczema Severity Score (NESS)]3–5 and quality of life [Childrens’ Dermatology Life Quality Index; (CDLQI)]5 were also evaluated. NESS was used for children aged > 1 year and CDLQI on children aged ≥5 years. Dietary intake and use of traditional Chinese medicine were also evaluated. Lead levels were measured by inductively coupled plasma mass spectrometry (ICP‐MS).

Principled Ethics Review: Governance Arrangements for University Research Ethics Committees

This, the third seminar organised by the AREC university sector committee, included short presentations followed by parallel workshops. These proposed and explored basic principles for ethical review in the context of current models within the university REC sector. In this report, following an introduction, each of the speakers/workshop leaders summarizes their own perspective on the issues raised and discussed.

Reproducibility of an isokinetic eccentric muscle endurance task

Despite the widespread use of isokinetic eccentric muscle endurance protocols, no research has examined the absolute and relative reliability of such tests. The aim of this study was to examine the reliability of an isokinetic eccentric knee muscle endurance task. Fifteen healthy untrained males volunteered to take part in the study and written informed consent was obtained. The procedures received approval from the University Research Ethics Committee. Participants visited the laboratory on three separate occasions: 2 weeks before testing to familiarize them with the experimental procedures, and on two separate occasions, 2 weeks apart and at the same time of day. Isokinetic eccentric knee extension and flexion movements of the dominant limb were performed using a calibrated dynamometer (Biodex System 3). Range of motion during testing was set using voluntary maximal full extension (0 rad) to 1.57 rad of knee flexion and testing was conducted at 1.56 rad · s−1. Participants performed four maximal efforts to determine maximal peak torque. After 2 min rest, participants completed the all-out endurance test of 50 continuous eccentric repetitions. Data were gravity corrected and windowed to only include constant velocity periods. Repeated-measures analyses of variance were used to examine differences in maximal peak extension and flexion torque and the maximal torque measurement recorded during the endurance test. Absolute and relative reliability of the torque fatigue index, work fatigue index, and total work were assessed through calculation of intra-class correlation coefficients, coefficients of variation, and absolute 95% limits of agreement using the methods described by Bland and Altman (1986). Differences between the strength test and the endurance trial for peak torque were found to be non-significant for both quadriceps (323 vs. 323 N · m) and hamstrings (183 vs. 178 N · m). The intra-class correlation coefficients revealed significant (P<0.05) positive moderate to strong correlations (r=0.44–0.94) across repeated trials for all parameters except hamstring torque fatigue (P=0.11) and hamstring work fatigue index (P=0.08). Coefficients of variation ranged from 6% to 48% and were large for the work fatigue index and torque fatigue index but acceptable for total work for both the extensors and flexors. The 95% limits of agreement indicated systematic bias in repeated trials for both the work fatigue index and torque fatigue index for extensors and flexors, ranging from −3% to −10%, with less fatigue evident in the second test. There was also systematic bias for total work, with more work being performed during the second than the first test for both extensors and flexors. The random error was large for all variables and there was greater random error in the hamstrings compared with the quadriceps. Together with moderate to strong intra-class correlation coefficients and large coefficients of variation, the data suggest that there is small systematic bias in repeated eccentric muscle actions for both the quadriceps and hamstrings, although the random error was large despite habituation procedures. Therefore, data from an isokinetic eccentric muscle endurance task should be viewed with some caution even when participants receive considerable habituation before assessment.

Population-Attributable Risk of Suicide Conferred by Axis I Psychiatric Diagnoses in a Hong Kong Chinese Population

Population-Attributable Risk of Suicide Conferred by Axis I Psychiatric Diagnoses in a Hong Kong Chinese Population

Population-Attributable Risk of Suicide Conferred by Axis I Psychiatric Diagnoses in a Hong Kong Chinese Population

This study was conducted to determine the population-attributable risk (PAR) of completed suicide among Hong Kong Chinese with axis I psychiatric diagnoses. With a case-control psychological autopsy method, 150 suicide decedents aged 15-59 were compared for axis I psychiatric diagnoses and psychosocial variables with 150 randomly selected age- and gender-matched persons living in the community. In the presence of other, non-disease-related social risk factors (unemployment and unmanageable debt), past suicide attempt independently accounted for 44% of the PAR of suicide, followed by current major depressive disorder (27%), schizophrenia spectrum disorders (22%), and substance use disorder or pathological gambling (16%). Other diagnoses (such as anxiety and phobic disorders, dysthymia, adjustment disorders, and past major depressive episode) accounted for 24% of PAR. Psychiatric morbidity remains the major risk factor for suicide in Hong Kong despite well-developed psychiatric services. Mental health policy should be refined to target clinical groups at high risk of suicide.

Getting the usual treatment: research censorship and the dangerous offender

In the course of finishing dissertation research, this author encountered a wall of opposition from the Canadian penitentiary service and parole board to his proposal. For political reasons they opposed research on dangerous offenders from the perspective of ‘convict criminology’, concluding: ‘This proposal does not reflect CSC [Correctional Service of Canada] priorities and service objectives, and would result in disruption to institutional operations.’ For a period of two months, this criminologist was barred from all penitentiaries in Ontario and could not interview any prisoner. Complaints were made to Members of Parliament including the then‐Solicitor General of Canada, as well as the Office of the Correctional Investigator; even the University tried to censor the project. This article seeks to place this episode in the context of the historic marginalization to which critical and convict criminology have been subjected. It will document how the state controls the criminological research agenda and what happens when ‘voices from below’ want to have a say in penological research. Of related interest will be a discussion of how a university research ethics committee, in conjunction with the penitentiary service, tried to stop this project.

Ethics approval for research in medical education

The issue of obtaining ethics approval for research in medical education was recently raised in a letter to the editor. It asked questions about our editorial policy and our views. A review of 16 papers published under the heading ‘Research papers’ in the first 5 issues of volume 35 of this Journal (2001) revealed that only one paper stated that ethics approval had been obtained from a University Research Ethics Committee. One further team reported that their data collection was planned to comply with local regulations. The other 14 papers made no mention of ethical considerations. Is this good or bad? Is research in medical education exempt from the ethical considerations which govern other research involving human subjects? Should this Journal, which aims to stimulate and publish high quality research in medical education, offer guidance to researchers about when to seek ethical approval for their research? These are thorny questions which this editorial does not set out to answer. Rather, we hope to provoke a constructive debate which can be conducted via our letters page. It is clear that researchers have a responsibility to carry out research ethically.1 This means that among other things they should adequately inform potential participants of the nature of the research and its risks and benefits, and must not expose participants to unacceptable risks. In response to research assessment exercises and the imperative of obtaining grant-funded income, medical academics are pursuing research in greater quantity than ever before. Their ethics committees are finding their workloads increasing. Do we want to increase it further by suggesting that researchers in medical education must obtain ethics approval for much of their research? Yet at the same time we want to ensure that the investigative activities of medical educators, whether focused on research or ongoing programme evaluation, are conducted according to high ethical standards with due protection of the rights of participants. Arguably, it is ethically wrong not to evaluate educational interventions. We need to know the educational impact of our curricula to ensure that they are having the desired effects on our students. Medical schools demand this as part of their quality assurance procedures. There are a great variety of ways of evaluating curricula but it is generally accepted that the views of students as consumers of education should be sought as part of the process. It is difficult to see how students could be harmed by this process particularly if their responses remain confidential and care is taken not to request evaluation more frequently than necessary. When does evaluation become research? When do these students move from being consumers of education giving their opinions to becoming research subjects? Research aimed at producing generalisable results to be published in the refereed literature is another matter. These are the attributes that define the differences between evaluation and research and this is the kind of work which would find its way into the research section of this Journal and others like it. Why should this research be exempt from the same critical scrutiny expected of other research endeavours? Perhaps it is the type of ethics approval that needs consideration. Are biomedical ethics committees best equipped to deal with medical education proposals, or are such proposals likely to receive a more relevant appraisal at the hands of social and behavioural ethics committees? Perhaps a middle ground is possible. Rather than overburdening university ethics committees, faculties should appoint curriculum ethics committees. These could be composed of a range of faculty and an equal number of students representing each year of the curriculum. They would consider ethical issues relating to curricular research and evaluation such as aspects of confidentiality, and monitor the volume of evaluation activity to prevent overload and unreasonable demands being placed on students. They could also give advice on appropriate methodologies and approaches, on sampling strategies as alternatives to including whole year groups in all evaluations and on appropriate student support mechanisms. Your views on this issue are sought and those which significantly contribute to the debate will be published in our Letters to the Editor section. With thanks to Mark Chaput de Saintonge, who raised this issue in the first place.

Effects of Human Subjects Requirements on Classroom Research: Multidisciplinary Evidence

PROFESSORS WHO INCLUDE THEIR STUDENTS as subjects in classroom-based research projects typically must submit to a review by their university's research ethics committee (REC) even in cases which present only minimal risks, and when the investigation is intended for evaluation of teaching approaches only, and not for publication. Results of a web-based survey with 378 respondents indicate that the perceived costs of the review process may outweigh the perceived benefits to subjects. A logistic regression analysis identifies the time it takes to complete the review application, the time it takes to receive a response, and the necessity of revising a project as significant factors in respondents viewing the REC process as a barrier to research. Instituting policies of expedited review for minimal-risk classroom research and exempting evaluations that are not to be published, both of which are permitted under the current regulations, would decrease burdens on both researchers and REC members, and foster improvement of teaching.

The Epistemological Bias of Ethics Review

This article investigates the concerns of a university research ethics committee in rejecting an application to interview people diagnosed with a mental illness. The committee's concerns included the safety of participants and the author as the researcher, the author's lack of training and clinical expertise, her disclosure of a past diagnosis of mental illness, the need for provisions to handle any emergencies, and the need to screen potential participants to ensure they were well enough to give informed consent. These paternalistic and medically derived concerns reflect assumptions about mental illness that are challenged by first-person perspectives, social movements in mental health, and newly emerging work within postpsychiatry. The article proposes some ethical procedures for human research ethics committees to follow to counter the epistemological bias of the current ethics review framework, particularly as it serves to constrain qualitative inquiry and first-person perspectives in mental health research.