Research Ethics Committee Oversight Research Articles

Behind the scenes of research ethics committee oversight: a qualitative research study with committee chairs in the Middle East and North Africa region

BackgroundResearch cites shortcomings and challenges facing research ethics committees in many regions across the world including Arab countries. This paper presents findings from qualitative in-depth interviews with research ethics committee (REC) chairs to explore their views on the challenges they face in their work with the oversight of research involving human populations.MethodsVirtual in-depth interviews were conducted with chairs (n = 11) from both biomedical and/or social-behavioral research ethics committees in six countries, transcribed, coded and subject to thematic analysis for recurring themes.ResultsTwo sets of recurring themes impede the work of the committees and pose concerns for the quality of the research applications: (1) procedures and committee level challenges such as heavy workload, variations in member qualification, impeding bureaucratic procedures, member overwork, and intersecting socio-cultural values in the review process; (2) inconsistencies in the researchers’ competence in both applied research ethics and research methodology as revealed by their applications.ConclusionsNarratives of REC chairs are important to shed light on experiences and issues that are not captured in surveys, adding to the body of knowledge with implications for the region, and low- and middle-income countries (LMICs) in other parts of the world. International research collaborations could benefit from the findings.

Development and implementation of participant safety plans for international research with stigmatised populations

People who inject drugs with high-risk sharing practices have high rates of HIV transmission and face barriers to HIV care. Interventions to overcome these barriers are needed; however, stigmatisation of drug use and HIV infection leads to safety concerns during the planning and conduct of research on such interventions. In preparing to address concerns about safety and wellbeing of participants in an international research study, HIV Prevention Trials Network 074, we developed participant safety plans (PSPs) at each site to supplement local research ethics committee oversight, community engagement, and usual clinical trial procedures. The PSPs were informed by systematic local legal and policy assessments, and interviews with key stakeholders. After PSP refinement and implementation, we assessed social impacts at each study visit to ensure continued safety. Throughout the study, five participants reported a negative social impact, with three resulting from study participation. Future research with stigmatised populations should consider using and assessing this approach to enhance safety and welfare.

Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project.

Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue regulation. In the absence of harmonized regulation, there is considerable scope for national legal variation. This article analyzes the legislative frameworks that apply to biobanking activities to identify differences in legal requirements between the BioSHaRE-EU project countries: Finland, France, Germany, the Netherlands, Norway, and the United Kingdom. This article highlights the primary role of consent and accompanying governance mechanisms, such as research ethics committee oversight, which enable consent exemptions in the context of research. Our analysis identifies a complicated legal landscape, whereby broadly similar provisions are contained in varied sources of law in each jurisdiction. The challenge for researchers is locating the applicable legal provisions within each national legal framework.

Efficacy of Oviductal Flushing with PGE2, in Mares, in and Out of the Breeding Season

Reasons for performing studyThere are limited data surrounding the efficacy of oviductal flushing in restoring fertility in mares with repeated returns to oestrus.ObjectivesTo determine the conception and foaling rates in mares treated by laparoscopic topical application of prostaglandin E2 (PGE2) to the oviduct(s) in mares: i) in the breeding season (January–May), pre‐covering; ii) in the breeding season, post covering; and iii) out of the breeding season (June–December).Study designFollow‐up study.MethodsAnalysis of electronic patient records (EPRs) identified 29 mares that underwent oviductal flushing via laparoscopic surgery between 1 January 2008 and 12 October 2014. One mare underwent the procedure twice; once in the breeding season (pre‐covering) and once out of the breeding season. Follow‐up data were collected via EPRs and from Weatherbys (www.bloodstockreports.co.uk).ResultsThe procedure was used in 27 Thoroughbreds, one Warmblood and one Hanoverian. Mean age at the time of the procedure was 13.1 years (range 6–22 years). Mean duration barren prior to the procedure was 1.9 years (range 49 days–5.6 years). The mean time post flushing to the first positive ultrasound scan was 31 days, with average time post flushing to foaling of 367.6 days. Of the 29 horses, 55.2% (16/29) conceived successfully, with 87.5% of these confirmed to have produced a live foal. In the breeding season, 16 mares were treated; 10 pre‐covering, and 6 post covering with conception rates of 60.0% and 83.3%, respectively. Thirteen mares were treated out of the breeding season, with a 35.7% conception rate.ConclusionsOviductal flushing within the breeding season was more successful in this study than flushing performed out of the breeding season. Restoration of fertility in this study was lower than that previously reported and potential reasons for this include limited pre‐surgical diagnostic testing, differing prior pathologies or reasons for sub‐fertility, and case selection.Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Explicit owner informed consent for inclusion of animals in this study was not stated. Source of funding: C.E. Wylie is funded by the Margaret Giffen Trust. Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

Atrial fibrillation is a common equine arrhythmia. Quinidine alone, or with digoxin are common treatments. Studies on outcome in Warmblood populations in which duration of the AF is often unknown are limited. To identify the factors that are associated with the success of full treatment cardioversion with oral medication, and establish whether there are differences in these factors between institutions. Retrospective case series using patient records of Equine University Clinic of Utrecht University and Rossdales Equine Hospital, Newmarket. Forty-nine horses treated with quinidine were identified (29 Warmbloods, 20 Thorougbreds, 1 Anglo-Arabian). Details of signalment, history, duration physical examination and echocardiography including left atrial size and presence of mitral regurgitation were retrieved. Clinical details including mean weight, age and left atrial size were compared between clinics using independent samples t test. Association between variables and cardioconversion were evaluated in a backwards logistic regression using Akaike's information criterium (AIC) and odds ratios were calculated. Factors were sex, clinic, breed, mitral regurgitation, duration and poor performance. Covariates were age, weight and the size of the left atrium. Significance was set at 0.05. Fifty-one horses (mean age 8.8 s.d. 4.5 years) were treated with quinidine sulfate, 18 also received digoxin. Eighty per cent converted to sinus rhythm. In 8 horses the known duration was less than 3 months. The only factor associated with successful treatment was the use of digoxin in combination with quinidine sulfate (odds ratio 12.4; 95% CI 2.61 and 91.85 according to AIC analysis). In this retrospective case series, there is much potential for bias in the data; however, the use of digoxin in addition to quinidine was associated with improved conversion rates regardless of breed even though AF duration was unknown in most horses. Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Explicit owner informed consent for inclusion of animals in this study was not stated. None. Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

Yellow fat disease or steatitis is characterised by a local or general inflammation of fat tissue and is occasionally found in horses. Diagnosis is challenging because of the wide range of nonspecific clinical signs. To describe clinical signs, treatment, outcome and ultrasonographic findings in horses with steatitis. Retrospective study (January 2008 to January 2015). History, clinical signs, ultrasonographic findings, diagnosis, treatment and outcome were recorded. Twenty cases (18 horses, 2 donkeys; 9 mares, 9 stallions, 2 geldings) were retrieved from 13,707 patient records. Mean age was 1.6 (± 0.8) years (range 1 month-3.5 years). All cases appeared between October and February except for one (August). History included dullness, recumbency, decreased appetite and weight loss. Fever, ventral oedema, stiff/painful gait and painful neck were found. Low haematocrit, low vitamin E and selenium and increased levels of creatinine kinase and particularly lactate dehydrogenase were almost consistent findings. On ultrasound, ventral oedema was found. Subperitoneal, perirenal, mesenteric, coronary and caudal mediastinal fat showed homogenously increased echogenicity. Especially the subperitoneal fat was surrounded by oedema or free fluid. Increased amounts of abdominal, thoracic and pericardial fluid were often found. Fat biopsies were taken in the neck or from the retroperitoneal fat in the ventral flank. In all horses where fat biopsy was taken (n = 13), steatitis was confirmed. Treatment consisted of selenium and vitamin E (intra-muscular injection followed by oral treatment) supplementation and anti-inflammatory treatment (dexamethasone or prednisolone parenteral or oral) for at least 1-4 weeks. Fourteen animals (70%) survived. Full recovery took about 2-6 months. Yellow fat disease may be underdiagnosed because of the nonspecific clinical signs. Ultrasound was extremely helpful for making a diagnosis. Recovery was rather slow but was achieved in 70% of the animals. Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Explicit owner informed consent for inclusion of animals in this study was not stated. Ghent University (institutional). Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

The morphology of the dorsal (DCB) and ventral (VCB) nasal conchal bullae, including their cellulae, drainage and histology, are poorly described. The recent recognition that these bullae can become infected, causing chronic unilateral nasal discharge has stimulated interest in these structures. A more complete understanding of their anatomy would be useful in the diagnosis and treatment of their disorders. To document the structure, drainage and histology of the equine DCB and VCB. Descriptive. Fourteen fresh cadaveric horse heads, were transected sagittally midline and dissected to expose the nasal conchal bullae. The dimensions of each bulla, the number of drainage apertures, the number of cellulae and orientation of the septae were recorded. Representative samples were collected for histopathology. The mean lengths of the DCB and VCB were 77.7 mm (range 48-105 mm) and 57.1 mm (range 34-86 mm) respectively; equivalent to 13.8% and 10.2% of skull length, respectively. The mean widths of the DCB and VCB were 28.5 mm (range 21-35 mm) and 28.2 mm (range 13-41 mm) respectively; equivalent to 5.1% and 5% of skull length respectively. The median number of drainage apertures from the DCB and VCB were 2 and 1 respectively. The median number of cellulae within the DCB and VCB were 3 and 2, respectively. No communications were identified between the DCB and VCB and the adjacent paranasal sinuses. Histology revealed that the bullae consisted of ciliated, pseudostratified, columnar epithelium supported by a glandular submucosa often overlying turbinate bone and, variably, hyaline cartilage. The morphology of the equine nasal conchal bullae is quite variable. The DCB is generally a more complex structure than the VCB, containing more septae, cellulae and drainage apertures. This more detailed description of DCB and VCB anatomy will hopefully facilitate successful treatment of their disorders. Ethical animal research: Research ethics committee oversight not currently required by this conference: the study was performed on material obtained from an abattoir. None. Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

Rasping of sharp enamel points (SEPs) is the most common procedure performed at routine dental examinations; however, there is little evidence to prove the true clinical significance of SEPs [1]. Maxillary SEPs are thought to cause buccal ulceration and pain on external palpation of the cheeks. Mandibular SEPs are thought to cause lingual ulceration. To examine associations between the presence of SEPs on the cheek teeth rows and the presence of pain on palpation of the cheeks and buccal and/or lingual ulceration. Retrospective clinical case series. Clinical records of routine dental examination performed by 8 veterinary surgeons in a single first opinion practice were examined. Presence of SEPs, buccal and/or lingual ulceration and pain on palpation of the cheeks (externally) were recorded. Chi squared tests were used to examine whether horses exhibiting pain on palpation or oral ulceration were significantly more likely to have SEPs present. Prevalence of buccal SEPs was 84.8% and prevalence of lingual SEPs was 84.3%. Five hundred and forty-eight horses (6.0%) had signs of pain on palpation. Prevalence of buccal ulceration was 5.9%. In contrast, only 0.2% of horses had visible lingual ulceration. Buccal ulceration and pain on palpation were significantly associated with presence of buccal SEPs (P<0.001 for both). Lingual ulceration was not significantly associated with lingual SEPs (P<0.0001). Buccal SEPs are common and often result in pain and buccal ulceration. Routine rasping would appear to be justified. Lingual SEPs are common but rarely cause lingual ulceration. The value of routine rasping of lingual SEPs is therefore questionable. Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Explicit owner informed consent for inclusion of animals in this study was not stated. None. Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

Selective 5-HT4 receptor agonists such as prucalopride are used as human prokinetics, since activation of 5-HT4 receptors on intestinal cholinergic neurons facilitates acetylcholine release. 5-HT4 receptors, linked to adenylyl cyclase, act via generation of cAMP. None of the 4 in vitro studies on 5-HT in horses provided evidence for neuronal 5-HT4 receptors, but none used the protocol as described in human studies [1-4]. To investigate whether functional 5-HT4 receptors are present in the equine small intestine. In vitro organ bath set up, applying electrical field stimulation (EFS) in longitudinal and circular smooth muscle strips. Results were similar in both muscle layers. In the presence of 0.3 mmol/l NG-Nitro-L-arginine methyl ester and 0.3 μmol/l apamine, excluding effects of the inhibitory transmitters NO and ATP, EFS induced voltage-dependent on-contractions; these were neurogenic as they were abolished by 3 μmol/l tetrodotoxin. At a voltage inducing 50% of the maximal amplitude, the submaximal EFS-induced contractions were cholinergic as atropine (1 μmol/l) abolished them. Prucalopride (0.3 μmol/l) did not increase the amplitude of these submaximal EFS-induced contractions. Even in the presence of the nonselective phosphodiesterase inhibitor IBMX, previously shown to enhance the effect of neuronal 5-HT4 receptors by inhibiting breakdown of their 2nd messenger cAMP [5], prucalopride (3 μmol/l) had no influence. Also 5-HT (10 μmol/l), a full agonist at 5-HT4 receptors, tested in the presence of methysergide and granisetron to exclude interaction with other 5-HT receptor subtypes, did not enhance EFS-induced submaximal contractions. There is no evidence for presence of 5-HT4 receptors on the cholinergic neurons of the equine small intestine. These results question the application of 5-HT4 prokinetic drugs in horses. Ethical animal research: Research ethics committee oversight not currently required by this conference: the study was performed on material collected at an abattoir. Sources of funding: None. Competing interests: None declared.

Ethmoidal Infection with Aspergillus spp. in 3 Horses: Successful Treatment by Transendoscopic Removal of Mycotic Plaques Alone or in Combination with Systemic Itraconazole

Reasons for performing studyEthmoidal infection with Aspergillus spp. is rarely reported in horses. Three horses suffering from unilateral infection with Aspergillus spp. of the ethmoid with varying underlying conditions are described.Study designCase series.MethodsDiagnosis was made by endoscopy of the ethmoid (presence of white mycotic plaques on a layer of thick yellow mucus) and confirmed by fungal culture (A. fumigatus) and/or cytology. Clinical details and outcome were obtained from the medical records and by contacting owners.ResultsHorse 1 and 2 had a progressive ethmoid haematoma (PEH) and had been treated for over 5 months with repeated formalin injections (one horse after initial surgical debulking of the PEH that also invaded the maxillary and sphenopalatine sinuses) before the infection with Aspergillus was diagnosed. The third horse, presented with poor performance and nasal discharge, had congenitally abnormal anatomy of the right dorsal nasal passage and right ethmoids. In the 2 horses with PEH the mycotic plaques were removed transendoscopically successfully. After 6 weeks the infection was no longer present at endoscopy in both horses (follow‐up endoscopy: Horse 1 no relapse &gt;16 months and Horse 2 no relapse &gt;7 months). In the third horse, it was not possible to remove all mycotic plaques, therefore systemic treatment with itraconazole (3 mg/kg bwt q. 12 h for 8 weeks orally) was started. After 8 weeks, the clinical signs had resolved and endoscopy showed that the Aspergillus infection had cleared (follow‐up: no relapse &gt;14 months). No side effects were seen with systemic itraconazole treatment.ConclusionsIn horses with underlying ethmoidal conditions, secondary infection with Aspergillus spp. may occur. Transendoscopic removal of the mycotic plaques alone may be successful and if this approach is not feasible or unsuccessful, systemic treatment with itraconazole can be considered.Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Owners gave informed consent for their horses' inclusion in the study. Source of funding: Utrecht University. Competing interests: None declared.

The Effect of Three Different Shoeing Conditions on Tendon Strain in the Thoroughbred Forelimb

Reasons for performing studyPrevious studies show the effect of toe or heel wedges on tendon strain but there is little understanding of the effect of other shoe types.ObjectivesTo quantify the effect of different shoeing conditions on the strain in the superficial digital flexor tendon (SDFT), deep digital flexor tendon (DDFT), distal check ligament (ALDDFT) and suspensory ligament (SL).Study designControlled experimental study.MethodsTwelve equine cadaver forelimbs were loaded onto a force plate mimicking stance phase. Markers were placed proximally and distally in each tendon structure and tracked using a motion capture system and strain was calculated. Tendon strain was determined for the following conditions: barefoot, glue on heart bar and aluminium racing plates with and without packing material. Data were analysed using a mixed effects model.ResultsSignificant variation in strain was observed between tendons. The DDFT had the lowest strain, then the ALDDFT, SDFT and SL. Glue on heart bar shoes significantly increased SDFT and SL strain compared to barefoot for the same leg force. Aluminium racing plates without packing material increased ALDDFT and SDFT strain and with packing material increased ALDDFT and SL.ConclusionsShoe selection should be based on minimising strain in the tendon with greatest injury risk. Aluminium racing plates with packing material may be most appropriate for the majority of racehorses as they do not significantly increase SDFT strain.Ethical animal research: Research ethics committee oversight not currently required by this conference: the study was performed on material obtained from an abattoir. Source of funding: The authors would like to thank the Horserace Betting Levy Board for their support of this project. Competing interests: None declared. Acknowledgements: We thank Peter Day, Carl Bettison, Chris Pardoe, Marianna Biggi and Emily Sparkes.

Evaluation of Dexamethasone for the Prevention of Post Operative Ileus

Reasons for performing studyInflammation is key in the development of post operative ileus in rodents, with a similar pathogenesis likely occurring in other species. Dexamethasone reduces inflammation and therefore could help reduce post operative ileus in the horse.ObjectivesTo determine if dexamethasone reduces post operative ileus in horses with small intestinal disease, and assess the effect on incisional health and short‐term survival.Study designRetrospective case series.MethodsFifteen horses that underwent small intestinal resection and anastomosis were given 0.1 mg/kg bwt dexamethasone intravenously during surgery (DEX). Data from a comparable number of horses that did not receive dexamethasone (NoDEX) was collected retrospectively and sequentially. Horses were matched for the type of resection performed. Fisher's Exact and Student's t tests were used for data analysis.ResultsThere was no significant difference in the amount of nasogastric reflux (litres) (DEX 8.06 ± 17.12, NoDEX 10.02 ± 24.03, P = 0.39) produced or in the number of horses that produced nasogastric reflux post operatively. There was no difference in survival to discharge. The severity of incisional discharge/infection was significantly different between groups when scored 0–3 (0 being no discharge and 3 being severe discharge/infection), (P = 0.01), in favour of DEX (2/15 horses affected) vs. NoDEX (7/15).ConclusionsDexamethasone did not appear to have a beneficial effect on the incidence of post‐operative ileus. Administration of a single dose of dexamethasone does not appear to have a detrimental effect on short‐term survival or on incisional complications.Ethical animal research: Research ethics committee oversight not currently required by this conference: procedures were performed as part of clinical investigations. Explicit owner informed consent for participation in this study was not stated. Source of funding: None. Competing interests: None declared.

Clinical Research Abstracts of the British Equine Veterinary Association Congress 2015.

Transcranial magnetic stimulation (TMS) is an electrophysiological technique used to elicit motor evoked potentials (MMEPs) to evaluate the functional integrity of the descending motor fibres in the spinal cord. Successful application of the technique was reported in horses with spinal cord compression. However, limited data are available on the correlation of TMS with histopathological changes. To determine sensitivity of TMS for assessing the integrity of the spinal cord in horses with compressive lesions of the spinal cord. Case series. The study was conducted on 6 horses with spinal ataxia grade III-V/V admitted to the Faculty of Veterinary Medicine, Ghent University. The horses underwent TMS, radiography of the cervical or thoracolumbar vertebral column, and myelography (4/6). All horses were subjected to euthanasia and the spinal cord examined histopathologically. In 5/6 horses MMEPs with abnormal onset latencies in both extensor carpi radialis muscles and cranial tibialis muscles were recorded, suggesting a cervical spinal cord lesion. Radiography revealed cervical vertebral malformation (4/5) with cervical vertebral canal stenosis (3/5) and tumour/osteomyelitis (1/5). In 1/6 horse MMEPs with normal onset latencies in extensor carpi radialis muscles and prolonged onset latencies in tibialis cranialis muscles were recorded, suggesting a thoracolumbar spinal cord lesion. Radiography revealed deformation of the 7th and 8th thoracic vertebrae. Myelography showed reduction in dural diameter and dorsal contrast column (4/4). Histopathological examination of the spinal cord confirmed compressive type lesions in all 6 horses with degenerative changes in the white matter of all funiculi, ballooning of myelin sheets, swollen axons, loss of axons and astroglial activation. In this case series abnormal function of descending motor pathways as registered by TMS showed 100% sensitivity with the histopathological characteristics of compressive lesions in the spinal cord, but the number of horses is limited and further research is warranted. Ethical animal research: Research ethics committee oversight not currently required by this conference: the study was performed on material collected during clinical procedures. Explicit owner informed consent for participation in this study was not stated. Not applicable. Competing interests: None declared.

A Retrospective Study of Sagittal Plane Slab Fractures of the Third Carpal Bone in Racing Thoroughbred Horses

Reasons for performing studySagittal plane slab fractures of the third carpal bone are a recognised injury in the racehorse. One study [1] reported 32 horses with sagittal fractures, 69% raced again. Surgical management appeared beneficial, with all horses that underwent inter‐fragmentary compression racing again.ObjectivesTo document the success rate following sagittal slab fracture of the third carpal bone in UK‐based racehorses, and to compare conservative and surgical management.Study designRetrospective study.MethodsInclusion criteria were Thoroughbred racehorses with a simple sagittal slab fracture of the third carpal bone. Exclusion criteria were comminuted fractures, radial carpal bone fractures and short incomplete linear lucencies. Fractures were classified as complete, incomplete or uncertain. Time from injury to next race was recorded. Success rates were compared by Fisher's exact test.ResultsForty horses were identified. Two were subjected to euthanasia and 3 have &lt;6 months follow‐up. Eleven were managed nonsurgically of which 4 (36%) were complete (5 uncertain) and 7 (64%) raced, 154–508 days following injury (median 242 days). Twenty‐seven horses underwent surgery to place a single 3.5 mm (n = 26) or 4.5 mm (n = 1) lag screw under arthroscopic guidance, of which 18 (67%) were complete. Thirteen (48%) raced again 147–711 days following surgery (median 256 days) P = 0.48. Of 23 horses with complete fractures 13 (57%) raced again, compared with 5/15 (33%) horses with incomplete fractures P = 0.2. Of horses with complete fractures, 10/18 (55%) underwent surgery and raced again compared to 3/4 (75%) horses managed conservatively P = 0.62.ConclusionsThe results confirm that the prognosis for athletic function is favourable but do not suggest that surgery is beneficial, or necessary for complete fractures. The numbers managed conservatively are small and it was not clear radiographically if the fracture was complete in 5/11 horses.Ethical animal research: Research ethics committee oversight not currently required by this conference: retrospective study of clinical records. Explicit owner informed consent for inclusion of animals in this study was not stated. Source of funding: None. Competing interests: None declared.

An In Vitro Investigation of the Effect of Curve Running on Equine Distal Limb Tendon Strain

Reasons for performing studyHorses run on curves during training and competition, and are often trotted in circles to assist lameness diagnosis. The effects of moving on a curve on tendon strain in the distal limb are not known.ObjectivesTo investigate the effect of curve running on the tendons and ligaments of the equine distal limb.Study designControlled experimental study.MethodsCadaver forelimbs from 6 Thoroughbred horses were loaded on a forceplate using a hydraulic ram. Limbs were loaded to 17–33 N/kg on a flat surface and with medial and lateral wooden wedges under the hoof to simulate curve running with the limb being on the inside and outside of a curve, respectively. Tendon length was measured for the superficial and deep digital flexor tendons (SDFT and DDFT), accessory ligament of the DDFT (ALDDFT), the suspensory ligament body (SL) and the medial and lateral suspensory ligament branches (SBM and SBL) using motion capture. A mixed effects model was used for data analysis.ResultsUnder most loading conditions SL was under most strain and DDFT least. For a medial 15° wedge SDFT was under 0.4% greater load than SL (P = 0.04). SBM was under 0.48% greater strain than SBL with a lateral 20° wedge (P = 0.01), and SBL was under 1.37% greater strain than SBM with a medial 20° wedge (P&lt;0.01).ConclusionsCurve running leads to increasing and asymmetrical strain on the suspensory ligament branches. This difference is unlikely to be sufficient to cause injury, but may assist lameness diagnosis.Ethical animal research: Research ethics committee oversight not currently required by this conference: the study was performed on material collected at an abattoir. Source of funding: R. Parkes is undertaking a PhD funded by the Horserace Betting Levy Board. Competing interests: None declared.

The Research Ethics Committee is Not the Enemy: Oversight of Community-Based Participatory Research

Researchers conducting community-based participatory research (CBPR) often complain about research ethics committee (REC) oversight of their research. RECs may contribute to researchers' frustrations by seemingly focusing on form over substance and by failing to communicate effectively with researchers about their mission and their specific concerns. UCSF CBPR researchers presented their views of the UCSF REC's review of its tobacco use study in "It's Like Tuskegee in Reverse: A Case Study of Ethical Tensions in Institutional Review Board Review of Community-Based Participatory Research." This article builds on that case study by providing some perspectives from the REC side, identifying how the researchers and the REC came to be at odds, and seeking to bridge the gap between the CBPR and REC worlds. In particular, the article explores the different perspectives on who are human subjects under the federal regulations in CBPR research, who counts as the community, and the purpose of REC oversight. It offers concrete suggestions for improving the relationship between CBPR researchers and RECs.