Research Ethics Approval Research Articles

Research ethics training, challenges, and suggested improvements across Europe: Radiography research ethics standards for Europe (RRESFE)

IntroductionThe Radiography Research Ethics Standards for Europe (RRESFE) project aimed to provide a cross-sectional view of the current state of radiography research ethics across Europe. This included investigating education and training in research ethics, and identifying the key challenges and potential improvements associated with using existing research ethics frameworks. MethodsThis cross-sectional online survey targeting radiography researchers in Europe was conducted between April 26 and July 12, 2021. Descriptive and analytical statistics were used to identify research ethics education and training trends. Content analysis of qualitative responses was employed to identify significant challenges and proposed improvements in research ethics frameworks of practice. ResultsThere were 232 responses received across 33 European countries. Most (n = 132; 57%) respondents had received some research ethics training; however, fewer participants had received training on safeguarding vulnerable patients (n = 72; 38%), diversity and inclusivity (n = 62; 33%), or research with healthy volunteers (n = 60; 32%). Training was associated with a greater perceived importance of the need for research ethics review (p = 0.031) and with the establishment of EQF Level 6 training (p = 0.038). The proportion of formally trained researchers also varied by region (p = <0.001). Time-to-ethics-approval was noted as the biggest challenge for professionals making research ethics applications. ConclusionEarly and universal integration of research-oriented teaching within the radiography education framework which emphasises research ethics is recommended. Additionally, study findings suggest research ethics committee application and approval processes could be further simplified and streamlined. Implications for practiceThe survey contributes to a growing body of knowledge surrounding the importance of education and training in research ethics for assuring a high standard of research outputs in Radiography and has identified hurdles to obtaining research ethics approval for further investigation and address.

Feasibility and efficacy of a remotely delivered fall prevention exercise program for community-dwelling older adults with cancer: Protocol for the STABLE trial

Falls are a major issue in older adults with cancer due to the effects of cancer and its treatments. Ample evidence in the general population of older adults has demonstrated the effectiveness of strength and balance training in reducing fall rates in older adults. However, data on effective fall prevention interventions in the oncology setting are lacking. The objective of this study is to evaluate the feasibility and efficacy of a remotely delivered, partially-supervised, resistance and balance training program on lower body strength, balance, and falls in community-dwelling older adults with cancer. The proposed study is an observer-blinded, parallel group (intervention group vs. control group) randomized controlled trial (ClinicalTrials.gov Identifier: NCT04518098). This study will recruit 74 eligible community-dwelling older adults with cancer from a comprehensive cancer centre. Intervention includes a remotely delivered exercise program for 3 months. Outcome measures include feasibility measures, lower body strength, balance, and fall rates. Research ethics approval has been granted by the Biomedical Research Ethics Boards of the University of Saskatchewan. If found effective, findings from this study will inform a subsequent, phase III definitive trial, with the ultimate goal to reduce falls and reduce impact on cancer treatment. Study findings will be disseminated through presentation at community level and scientific conferences, and in scientific journals.Trial registration: ClinicalTrials.gov identifier: NCT04518098

Protocol for an intervention development and pilot implementation evaluation study of an e-health solution to improve newborn care quality and survival in two low-resource settings, Malawi and Zimbabwe: Neotree

IntroductionEvery year 2.4 million deaths occur worldwide in babies younger than 28 days. Approximately 70% of these deaths occur in low-resource settings because of failure to implement evidence-based interventions. Digital...

Can screening for degenerative cervical myelopathy (SCREEN-DCM) be effectively undertaken based on signs, symptoms and known risk factors? Rationale and research protocol for a prospective, multicentre, observational study

IntroductionDegenerative cervical myelopathy (DCM) is the most common cause of spinal cord impairment. Unfortunately, the condition remains poorly recognised and underdiagnosed. To better identify patients, screening tests that target individuals...

O-091 From Family Planning to Fertility Planning - ‘FertPlan’ awareness amongst contraceptive healthcare providers and users

Abstract Study question Are women and healthcare professionals seeking or providing contraception aware of age-related decline in female fertility and information support regarding fertility awareness? Summary answer 89.9% of contraceptive users and 71% of providers stated lack of awareness regarding age and fertility emphasising website as the preferred information resource. What is known already The last 50 years has seen an upward trend in the age at which women are giving birth. The birth rate for women aged 35 to 39 has trebled since 1980 and is now at its highest ever level. Delaying childbearing may mean that some women will inevitably leave it too late and become childless involuntarily. Women are also seeking fertility treatment at older ages, however, success rates decrease dramatically with age. It is not clear whether women who delay their fertility are aware of the decline in fertility with age, and whether healthcare professionals discuss fertility planning with women. Study design, size, duration We conducted two independent anonymous questionnaire surveys of reproductive age women seeking contraception and healthcare professionals(HCP) providing contraception in the UK following research ethics approval, to determine their awareness of the age-related decline in fertility, information resource and potential barriers to provision of information. . This was a prospective study design conducted over a year period using an online questionnaire. A total of 249 participants completed the survey. Participants/materials, setting, methods 138 reproductive age women on contraception consented and participated in the study by completing the online questionnaire. Of these, 96.4% were of white origin,1.4% mixed ethnicity, 1.4% Asian origin and 0.7% Black. 111 HCP providing contraceptive advice in family planning clinics or in General practice completed the survey. Of these, 6 were allied healthcare professionals ie specialist nurses. Data was collated and analysed using percentages and descriptive statistics. Main results and the role of chance Of the total 138 female contraceptive users, 87 were aged 30-39 years whilst 35 were 40-45 years. 51.4% of women indicated no concern about their future fertility, whilst the remainder gave roughly uniformly distributed ratings of concern from unconcerned to highly concerned. However, one third of all women (31.1%) believed that age-related fertility decline occurred after 40 years. 89.9% of women felt fertility awareness and education is important. Of the total 111 HCP, ∼one in 10 HCP (11.7%) misconstrued the female age-related decline to begin from 40 years onwards. The contraceptive providers also were misinformed regarding age related decline in IVF success rate with 45% of them citing 40 years or over to be the age that contributed to decline in IVF success. Despite these figures, majority (71.2%) of HCP agreed there was lack of fertility awareness and 33.3% felt fertility education should be commenced as early as school age. 27% HCP always discussed future fertility whilst 33.3% discussed most of the times. The most commonly-stated barriers to providing information were lack of time, self-perceived lack of knowledge, and women not asking. 73.2% of reproductive age contraceptive users and 85.6% HCPs expressed website to be the most preferred option for information resource. Limitations, reasons for caution To the best of our knowledge, this is one of the first studies seeking fertility awareness amongst those practising family planning. As this was not a qualitative interview based study, the findings are open to interpretation and one must exercise caution. Wider implications of the findings This study highlights clear need for fertility education and awareness amongst contraceptive providers and users. By providing resources to inform, we may increase awareness and confidence amongst both groups thereby empowering women to make informed choices about their future fertility by integrating Fertility planning within Family Planning. Trial registration number Not applicable (IRAS 248991 and R&amp;D Ref 8999)

Technical recommendations for pragmatic randomized controlled trials of heat-sensitive moxibustion in community (Ⅱ): organization, implementation and follow-up visits

Based on the community research experience of heat-sensitive moxibustion, this study explained technical recommendations for pragmatic randomized controlled trials (pRCTs) of heat-sensitive moxibustion in community from 7 aspects: selection of community research sites, ethical approval and registration, patient recruitment, training of standard operating procedures, ensuring patient compliance, quality control of follow-up visits and patient safety, which aimed to reduce the difficulty of research execution and improve the quality of pRCTs implementation and follow-up visits of heat-sensitive moxibustion.

Gross and applied anatomy pedagogical approaches in occupational therapy education: protocol for a scoping review

IntroductionHistorically, dissection is considered the ‘gold standard’ for teaching foundational anatomy to student occupational therapists. However, many programmes no longer have access to gross anatomy laboratory resources, as it is...

Anticipated impacts of voluntary assisted dying legislation on nursing practice.

Background:The Voluntary Assisted Dying Act 2017 passed into law in Victoria, Australia, on the 29 November 2017. Internationally, nurses have been shown to be intimately involved in patient care throughout the voluntary assisted dying process. However, there is a paucity of research exploring Australian nurses’ perspectives on voluntary assisted dying and, in particular, how Victorian nurses anticipate the implementation of this ethically controversial legislation will impact their professional lives.Objectives:To explore Victorian nurses’ expectations of the ethical and practical impacts the voluntary assisted dying legislation will have on their professional lives.Research design:This qualitative study analysed nurses’ free text responses collected as part of a larger mixed methods online survey investigating staff views on the Voluntary Assisted Dying Act. Data were collected during the period between the passing of the voluntary assisted dying legislation and the start date and were analysed using inductive content analysis.Participants and research context:Free text survey responses were analysed from 1873 nurses employed across seven Victorian health services located in both metropolitan and regional areas of the state.Ethical considerations:The study obtained research ethics approval and all participants were informed of the voluntary and anonymous nature of their participation.Findings:This study identified three broad areas of Victorian nurses’ professional lives that they expected to be impacted by the implementation of voluntary assisted dying: professional identity, career development and workplace relationships.Conclusion:Participants anticipate diverse and nursing-specific impacts of the implementation of voluntary assisted dying in Victoria. Their insights can inform health services in jurisdictions considering or already implementing voluntary assisted dying, to develop policies, procedures and staff training programmes that safeguard the well-being and legal rights of their nursing staff.

Suicidal Ideation and Suicide Attempts Among Lesbian, Gay, Bisexual, Pansexual, Queer, and Asexual Youth: Differential Impacts of Sexual Orientation, Verbal, Physical, or Sexual Harassment or Assault, Conversion Practices, Family or Household Religiosity, and School Experience.

Purpose: This article examines factors associated with suicidal ideation and suicide attempts in the past 12 months among lesbian, gay, bisexual, pansexual, queer, asexual, or other non-heterosexual identifying youth (LGBQA+). Methods: A national Australian cross-sectional online survey was conducted involving 4370 cisgender LGBQA+ participants aged 14-21 years from September to October 2019. Multivariable logistic regression analyses were performed to examine significant factors associated with suicidal ideation and suicide attempts in the past 12 months. Research ethics approval for the WTI4 study was granted by the La Trobe University Human Research Ethics Committee and the ACON Research Ethics Review Committee. Results: Overall, 56.4% of participants reported suicidal ideation and 8.9% a suicide attempt in the past 12 months. Multivariable regression results show that participants aged younger than 18 years, lesbian (compared with gay) identifying, those living in rural or remote locations (compared with inner city), those reporting any verbal, physical, or sexual harassment or assault based on sexual orientation or gender identity, or who had a religious family or household, or had experienced conversion practices in the past 12 months reported higher levels of suicidal ideation or suicide attempts. Those who reported feeling part of their school reported lower levels of suicidal ideation and suicide attempts. Conclusion: High levels of suicidal ideation and suicide attempts among young LGBQA+ people in Australia highlight a need for the ongoing inclusion of LGBQA+ youth as a priority population for suicide prevention. The findings illustrate key factors associated with a greater risk of suicidality among young LGBQA+ people. These findings can be used to inform the provision of tailored support services, including culturally safe suicide prevention programs and efforts to address stigma, discrimination, and conversion practices.

Assessing the impact of mental health difficulties on young people’s daily lives: protocol for a scoping umbrella review of measurement instruments

IntroductionAn important consideration for determining the severity of mental health symptoms is their impact on youth’s daily lives. Those wishing to assess ‘life impact’ face several challenges: First, various measurement...

Non-erythropoiesis-stimulating agent, non-iron therapies for the management of anaemia: protocol for a scoping review

IntroductionPreoperative anaemia is associated with poor postoperative outcomes and is the strongest predictor of allogenic blood transfusion, which contributes further to patient morbidity. Emphasis has been placed on correcting anaemia...

Representation of women on editorial boards of ophthalmology journals: protocol for a cross-sectional study

IntroductionThere is a notable under-representation of women in leadership positions in ophthalmology despite the increasing number of women as ophthalmologists. Gender inequality in editorial boards of ophthalmology journals has not...

Critical illness-related cardiac arrest: Protocol for an investigation of the incidence and outcome of cardiac arrest within intensive care units in the United Kingdom.

Critical illness-related cardiac arrest (CIRCA) as a distinct entity is not well described epidemiologically. There is currently a knowledge gap regarding how many occur in the UK or the impact on patient outcome. The CIRCA study is a prospective multi-centre observational cohort study of patients in the United Kingdom experiencing a cardiac arrest while in a Critical Care Unit embedded in the Case Mix Programme and National Cardiac Arrest Audit. The duration of data collection is 12 months, with surviving patients and family members receiving questionnaire follow-up at 90 days, 180 days and 12 months. This paper describes the protocol for the CIRCA study which received favourable ethical opinion from South Central - Berkshire Research Ethics Committee and approval from the Health Research Authority. Study registration is on clinicaltrials.gov (NCT04219384).

South African healthcare workers' knowledge of dolutegravir's drug-drug interactions in the first year of its rollout: a cross-sectional online survey.

IntroductionIn December 2019, dolutegravir‐based treatment was recommended as first‐line antiretroviral therapy (ART) in South Africa. Dolutegravir has clinically significant interactions with several commonly used drugs, such as rifampicin, metformin and cation‐containing medicines. National guidelines detail these interactions and how to manage them. While previous international studies have shown low healthcare worker knowledge of drug–drug interactions, there is a paucity of information on antiretroviral interaction knowledge in the South African setting, where much ART is nurse‐led. The study aimed to determine this knowledge and to describe which variables were associated with gaps in knowledge.MethodsAn anonymous online survey of healthcare workers in the field of HIV was conducted in August/September 2020. The survey was designed, tested and piloted, and included sections on demographics, guideline access and training, interaction knowledge, counselling and the effect of COVID‐19. Dissemination was via e‐mail and social media (convenience sampling). Descriptive and inferential analysis was done using proportions and the 95% confidence interval to determine relationships between independent and dependent variables. Research ethics approval was obtained from the University of Cape Town's Human Research Ethics Committee (HREC Ref: 357/2020).Results and discussionIn total, 1950 survey responses were included in the analysis – 47.1% nurses, 35.8% doctors and 8.9% pharmacists. When asked whether they were aware that dolutegravir has interactions, 70% said yes, 13.9% said no and 16.1% did not answer. Knowledge of specific interactions and the dosing changes needed was low with a wide range between different drugs: 79.7% knew to double the dolutegravir dose with rifampicin, but with calcium, 5.1% picked both correct dosing options and 33.7% picked one of the two correct options. Access to guidelines and training were positively associated with drug interaction knowledge.ConclusionsThere are gaps in the awareness and knowledge of dolutegravir interactions and how to adjust dosing among South African healthcare workers.

Technology-based group exercise interventions for people living with dementia or mild cognitive impairment: a scoping review protocol

IntroductionMore than 50 million people worldwide are living with dementia in 2020, and this number is expected to double every 20 years. Physical exercise is a growing field in non-pharmacological...

Use of selective gut decontamination in critically ill children: protocol for the Paediatric Intensive Care and Infection Control (PICnIC) pilot study

IntroductionHealthcare-associated infections (HCAIs) are a major cause of morbidity and mortality in critically ill children. In critically ill adults, there are data that suggest the use of Selective Decontamination of...

Efficacy of N-acetylcysteine on idiopathic or postinfective non-cystic fibrosis bronchiectasis: a systematic review and meta-analysis protocol

IntroductionNon-cystic fibrosis (non-CF) bronchiectasis is a chronic pulmonary disorder that causes destruction and permanent dilatation of the airways, resulting in excessive sputum production, repeated infection and inflammation. A need for...

Identification of models, theoretical design and formal evaluation of integrated specialist community health service provision for the first 2000 days: a protocol for a scoping review

IntroductionThe first 2000 days of a child’s life (during pregnancy up to age 5 years) represent a critical period, in which early interventions reduce risk associated with developmental delay, disability...

Evaluation of an Experimental Web-based Educational Module on Opioid-related Occupational Safety Among Police Officers: Protocol for a Randomized Pragmatic Trial to Minimize Barriers to Overdose Response.

BackgroundAs drug-related morbidity and mortality continue to surge, police officers are on the front lines of the North American overdose (OD) crisis. Drug law enforcement shapes health risks among people who use drugs (PWUD), while also impacting the occupational health and wellness of officers. Effective interventions to align law enforcement practices with public health and occupational safety goals remain underresearched.ObjectiveThe Opioids and Police Safety Study (OPS) aims to shift police practices relating to PWUD. It adapts and evaluates the relative effectiveness of a curriculum that bundles content on public health promotion with occupational risk reduction (ORR) to supplement a web-based OD response and naloxone training platform (GetNaloxoneNow.org, or GNN). This novel approach has the potential to improve public health and occupational safety practices, including using naloxone to reverse ODs, referring PWUD to treatment and other supportive services, and avoiding syringe confiscation.MethodsThis longitudinal study uses a randomized pragmatic trial design. A sample of 300 active-duty police officers from select counties in Pennsylvania, Vermont, and New Hampshire with high OD fatality rates will be randomized (n=150 each) to either the experimental arm (GNN + OPS) or the control arm (GNN + COVID-19 ORR). A pre- and posttraining survey will be administered to all 300 officers, after which they will be administered quarterly surveys for 12 months. A subsample of police officers will also be qualitatively followed in a simultaneous embedded mixed-methods approach. Research ethics approval was obtained from the New York University Institutional Review Board.ResultsResults will provide an understanding of the experiences, knowledge, and perceptions of this sample of law enforcement personnel. Generalized linear models will be used to analyze differences in key behavioral outcomes between the participants in each of the 2 study arms and across multiple time points (anticipated minimum effect size to be detected, d=0.50). Findings will be disseminated widely, and the training products will be available nationally once the study is completed.ConclusionsThe OPS is the first study to longitudinally assess the impact of a web-based opioid-related ORR intervention for law enforcement in the U.S. Our randomized pragmatic clinical trial aims to remove barriers to life-saving police engagement with PWUD/people who inject drugs by focusing both on the safety of law enforcement and evidence-based and best practices for working with persons at risk of an opioid OD. Our simultaneous embedded mixed-methods approach will provide empirical evaluation of the diffusion of the naloxone-based response among law enforcement.Trial RegistrationClinicalTrail.gov NCT05008523; https://clinicaltrials.gov/show/NCT05008523International Registered Report Identifier (IRRID)DERR1-10.2196/33451

Incidence and risk factors of delirium in post-anaesthesia care unit

Post-anaesthesia care unit (PACU) delirium is a potentially preventable condition that results in a significant long-term effect. In a multicentre prospective cohort study, we investigate the incidence and risk factors of postoperative delirium in elderly patients undergoing major non-cardiac surgery. Patients were consented and recruited from 4 major hospitals in Singapore. Research ethics approval was obtained. Patients older than 65 years undergoing non-cardiac surgery >2 hours were recruited. Baseline perioperative data were collected. Preoperative baseline cognition was obtained. Patients were assessed in the post-anaesthesia care unit for delirium 30-60 minutes after arrival using the Nursing Delirium Screening Scale (Nu-DESC). Ninety-eight patients completed the study. Eleven patients (11.2%) had postoperative delirium. Patients who had PACU delirium were older (74.6±3.2 versus 70.6±4.4 years, P=0.005). Univariate analysis showed those who had PACU delirium are more likely to be ASA 3 (63.6% vs 31.0%, P=0.019), had estimated glomerular filtration rate (eGFR) of >60mL/min/1.73m2 (36.4% vs 10.6%, P=0.013), higher HbA1C value (7.8±1.2 vs 6.6±0.9, P=0.011), raised random blood glucose (10.0±5.0mmol/L vs 6.5±2.4mmol/L, P=0.0066), and moderate-severe depression (18.2% vs 1.1%, P=0.033). They are more likely to stay longer in hospital (median 8 days [range 4-18] vs 4 days [range 2-8], P=0.049). Raised random blood glucose is independently associated with increased PACU delirium on multivariate analysis.