Seeking Approval from Universities to Research the Views of Their Staff. Do Gatekeepers Provide a Barrier to Ethical Research?

2022 ◽  
pp. 155626462110683
Author(s):  
Katherine Christian ◽  
Carolyn Johnstone ◽  
Jo-ann Larkins ◽  
Wendy Wright
Keyword(s):  
Informed Consent ◽  
Research Ethics ◽  
Ethics Committee ◽  
University Staff ◽  
Institutional Approval ◽  
Human Research ◽  
Human Research Ethics ◽  
Risk Research ◽  
Case Basis

A “gatekeeper” controls access to an organization; “gatekeeper approval” is often needed before external research can take place within an organization. We explore the need for gatekeeper approval for research with university staff employing, as a case study, a project which collected data in Australia. This case study addresses known issues, seemingly rarely addressed in the literature. The Human Research Ethics Committee (HREC)'s requirement for approval from individual universities to approach their staff brought significant consequences, exacerbated by the lack of university procedures for such approvals. Simultaneously, since invitations could legitimately be distributed via other avenues, such approval was superfluous. We recommend the HREC's blanket requirement for institutional approval instead be considered on a case-by-case basis depending on the risk of the research, and perhaps waived for low-risk research where participants are able to provide informed consent, and that universities establish processes to deal with requests from external researchers.

Re: Variation in Human Research Ethics Committee and governance processes throughout Australia: a need for a uniform approach

2021 ◽  
Vol 91 (11) ◽  
pp. 2545-2545
Author(s):  
Guy Henry Morton Stanley ◽  
Ryckie George Wade ◽  
Sara Potts ◽  
Nichola Wilson ◽  
Michael Findlay
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Human Research ◽  
Research Ethics Committee ◽  
Uniform Approach ◽  
Human Research Ethics ◽  
Governance Processes

scholarly journals National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden

2015 ◽  
Vol 26 (7) ◽  
pp. 586-606 ◽  
Author(s):  
Bernard Gallagher ◽  
Anne H. Berman ◽  
Justyna Bieganski ◽  
Adele D. Jones ◽  
Liliana Foca ◽  
...  
Keyword(s):  
Great Britain ◽  
Research Ethics ◽  
Comparative Case Study ◽  
Human Research ◽  
Human Research Ethics ◽  
National Human

scholarly journals Understanding and responding to the cost and health impact of short-term health staffing in remote and rural Aboriginal and Torres Strait Islander community-controlled health services: a mixed methods study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e043902
Author(s):  
Michelle S Fitts ◽  
John Humphreys ◽  
Terry Dunbar ◽  
Lisa Bourke ◽  
Edward Mulholland ◽  
...  
Keyword(s):  
Health Services ◽  
Research Ethics ◽  
Primary Healthcare ◽  
Ethics Committee ◽  
Mixed Methods Study ◽  
Short Term ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
The Impact

IntroductionAccess to high-quality primary healthcare is limited for remote residents in Australia. Increasingly, remote health services are reliant on short-term or ‘fly-in, fly-out/drive-in, drive-out’ health workforce to deliver primary healthcare. A key strategy to achieving health service access equity, particularly evident in remote Australia, has been the development of Aboriginal Community Controlled Health Services (ACCHSs). This study aims to generate new knowledge about (1) the impact of short-term staffing in remote and rural ACCHSs on Aboriginal and Torres Strait Islander communities; (2) the potential mitigating effect of community control; and (3) effective, context-specific evidence-based retention strategies.Methods and analysisThis paper describes a 3-year, mixed methods study involving 12 ACCHSs across three states. The methods are situated within an evidence-based programme logic framework for rural and remote primary healthcare services. Quantitative data will be used to describe staffing stability and turnover, with multiple regression analyses to determine associations between independent variables (population size, geographical remoteness, resident staff turnover and socioeconomic status) and dependent variables related to patient care, service cost, quality and effectiveness. Qualitative assessment will include interviews and focus groups with clinical staff, clinic users, regionally-based retrieval staff and representatives of jurisdictional peak bodies for the ACCHS sector, to understand the impact of short-term staff on quality and continuity of patient care, as well as satisfaction and acceptability of services.Ethics and disseminationThe study has ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (project number DR03171), Central Australian Human Research Ethics Committee (CA-19-3493), Western Australian Aboriginal Health Ethics Committee (WAAHEC-938) and Far North Queensland Human Research Ethics Committee (HREC/2019/QCH/56393). Results will be disseminated through peer-reviewed journals, the project steering committee and community/stakeholder engagement activities to be determined by each ACCHS.

scholarly journals Why Did You Not Act on Our Suggestion? Regulatory and Growth-Oriented Opportunities During Ethical Review: A Case Study

SAGE Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. 215824402092058
Author(s):  
Sean G. Dicks ◽  
Ian J. Pieper ◽  
Holly L. Northam ◽  
Frank M. P. van Haren ◽  
Douglas P. Boer
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Ethical Review ◽  
Human Research Ethics ◽  
Apply Research ◽  
Differences Of Opinion ◽  
Research Plan ◽  
Conducting Research ◽  
Human Participants

In Australia, before conducting research with human participants, researchers must have their research plan reviewed by a Human Research Ethics Committee (HREC) to ensure that proposed methods meet ethical requirements and protect the welfare of participants. In addition, it has been proposed that HRECs can contribute to a novice researcher’s ethical mindfulness. To explore this suggestion, the current self-reflective case study examines the dialogue between a PhD candidate and the HREC that reviewed his proposed study of family bereavement in the context of the potential for organ donation. Findings suggest that when a respectful, problem-solving attitude is adopted by both parties, a learning environment evolves where diverse views, differences of opinion, and novel solutions are tolerated. In this context, the research plan is improved and the novice researcher’s ability to apply research ethics is developed. Simultaneously, members of the HREC gain practice in the identification of ethical dilemmas and the application of ethical principles that help resolve those dilemmas.

scholarly journals Identifying psychosocial characteristics that predict outcome to the UPLIFT programme for people with persistent back pain: protocol for a prospective cohort study

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028747
Author(s):  
Hayley Thomson ◽  
Kerrie Evans ◽  
Jonathon Dearness ◽  
John Kelley ◽  
Kylie Conway ◽  
...  
Keyword(s):  
Cohort Study ◽  
Back Pain ◽  
Research Ethics ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Ethics Committee ◽  
Prognostic Models ◽  
Psychosocial Characteristics ◽  
Human Research ◽  
Human Research Ethics

IntroductionPrognostic screening of people with low back pain (LBP) improves utilisation of primary healthcare resources. Whether this also applies to secondary healthcare remains unclear. Therefore, this study aims to develop prognostic models to determine at baseline which patients with persistent LBP are likely to have a good and poor outcome to a 5-week programme of combined education and exercise (‘UPLIFT’) delivered in a secondary healthcare setting.Methods and analysisA prospective cohort study of 246 people with persistent LBP will be conducted in a secondary healthcare outpatient setting. Patients will be recruited from a physiotherapy-led neurosurgical screening clinic. Demographic data, medical history and psychosocial characteristics will be recorded at baseline. Fear avoidance beliefs, pain self-efficacy, LBP treatment beliefs, pain catastrophising, perceived injustice, depression, anxiety and stress, disability level, pain intensity and interference, health status and social connectedness will be considered as potential prognostic variables, which will be assessed using self-reported questionnaires. Participants will attend the UPLIFT programme, consisting of weekly 90 min group sessions that combine interactive education sessions and a graded exercise programme. The outcome measure to identify good and poor outcome is the Global Rating of Change scale, assessed at completion of the UPLIFT programme and at 6 months follow-up. Multiple imputation analyses will be performed for missing values. Prognostic models will be developed using multivariable logistic regression analyses, with bootstrapping techniques for internal validation. We will calculate the explained variance of the models and the area under the receiver operating characteristic curve. Furthermore, we will determine whether participation in the UPLIFT programme is associated with changes in psychosocial characteristics.Ethics and disseminationGold Coast Health Service Human Research Ethics Committee (HREC/18/QGC/41) and the Griffith University Human Research Ethics Committee (GU Ref No: 2018/408) approved the study. Dissemination of findings will occur via peer-reviewed publications and conference presentations.Trial registration numberACTRN12618001525279.

scholarly journals The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032549 ◽  
Author(s):  
Bianca Fleur Middleton ◽  
Mark A Jones ◽  
Claire S Waddington ◽  
Margaret Danchin ◽  
Carly McCallum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Ethics Committee ◽  
Northern Territory ◽  
Rotavirus Vaccine ◽  
Additional Dose ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Indigenous Children

IntroductionRotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.Methods and analysisThis Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.Ethics, registration and disseminationEthics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.Trial registration numberNCT02941107; Pre-results.

scholarly journals Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017550
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
Sheau Huey Chen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Care Programme ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionChronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.Methods and analysisAn open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.Ethics and disseminationThe clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.Trial registration numberRegistered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

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