Australian Human Research Ethics Committee Research Articles

An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia-Study Protocol.

Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14–19-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.

Human Research Ethics Committee Experiences and Views About Children's Participation in Research: Results From the MESSI Study.

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members' confidence to judge ethical research with children.

Australian human research ethics committee members' confidence in reviewing genomic research applications.

Human research ethics committees (HRECs) are evaluating increasing quantities of genomic research applications with complex ethical considerations. Genomic confidence is reportedly low amongst many non-genetics-experts; however, no studies have evaluated genomic confidence levels in HREC members specifically. This study used online surveys to explore genomic confidence levels, predictors of confidence, and genomics resource needs of members from 185 HRECs across Australia. Surveys were fully or partially completed by 145 members. All reported having postgraduate 94 (86%) and/or bachelor 15 (14%) degrees. Participants consisted mainly of researchers (n = 45, 33%) and lay members (n = 41, 30%), affiliated with either public health services (n = 73, 51%) or public universities (n = 31, 22%). Over half had served their HREC [Formula: see text]3 years. Fifty (44%) reviewed genomic studies [Formula: see text]3 times annually. Seventy (60%) had undertaken some form of genomic education. While most (94/103, 91%) had high genomic literacy based on familiarity with genomic terms, average genomic confidence scores (GCS) were moderate (5.7/10, n = 119). Simple linear regression showed that GCS was positively associated with years of HREC service, frequency of reviewing genomic applications, undertaking self-reported genomic education, and familiarity with genomic terms (p < 0.05 for all). Conversely, lay members and/or those relying on others when reviewing genomic studies had lower GCSs (p < 0.05 for both). Most members (n = 83, 76%) agreed further resources would be valuable when reviewing genomic research applications, and online courses and printed materials were preferred. In conclusion, even well-educated HREC members familiar with genomic terms lack genomic confidence, which could be enhanced with additional genomic education and/or resources.

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

In Australia, ethics committees across different states vary in application, requirement and process for the ethical review and approval for clinical research. This may lead to confusion and delays in the enablement of multicentre research projects. This study explores the effect of differing processes for Ethics and Governance in the establishment of the CovidSurg-Cancer study during the global COVID-19 pandemic. An anonymous, structured web-based questionnaire was designed using the Research Electronic Data Capture application (REDCap) platform to capture consultant surgeons, fellows, and trainees experience in the ethics application process. 'CovidSurg-Cancer' was an international multicentre collaborative study to assess the impact of COVID-19 on the outcomes of patients undergoing cancer surgery. The ethics process to set up this observational study was used as to explore the differing processes applied across Australia. The CovidSurg-Cancer study was successfully set up in 14 hospitals. Four hospitals approved the study directly as an audit. Of the remaining sites, 10 ethics applications underwent Human Research Ethics Committee review following which two (14%) were subsequently approved as an audit activity and eight hospitals (57%) were given formal ethical approval with waiver of consent. Ethics application acceptance from another Australian Human Research Ethics Committee was provided with six applications; however, only three were reciprocated without the requirement for further agreements. A third of (30%) respondents suggested that the details of the application pathway, process and documentation were unclear. Ethics processes are varied across Australia with considerable repetition. A centralized, harmonized application process would enhance collaborative research.

Successful containment to date of SARS ‐CoV‐2 transmission in the Northern Territory

Successful containment to date of <scp>SARS</scp> ‐CoV‐2 transmission in the Northern Territory

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

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...

Supporting Aboriginal Community Controlled Health Services to deliver alcohol care: protocol for a cluster randomised controlled trial

IntroductionIndigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms. In Australia, Aboriginal Community Controlled Health Services (ACCHSs) offer culturally accessible care to Aboriginal...

Facemask versus No Facemask in Preventing Viral Respiratory Infections During Hajj: A Cluster Randomised Open Label Trial

Background: This large-scale cluster-randomised controlled trial (cRCT) evaluated use of facemasks against laboratory-confirmed viral respiratory tract infections (vRTIs) and clinical respiratory infection (CRI) because previous studies have been inconclusive. Methods: An open label cRCT, conducted in Makkah compared the offer and use of 50 surgical facemasks worn over five days versus no facemasks among pilgrims. Cluster-randomisation was by accommodation tents stratified by country and gender. Tents were allocated to groups by coin-tossing. Neither participants nor recruiting investigators could be blinded to the intervention. Facemask use and respiratory symptoms were recorded daily and nasal/pharyngeal swabs were collected from symptomatic participants for detection of respiratory viruses. Clinical and laboratory data were analysed for facemask efficacy against laboratory-confirmed vRTIs and CRI. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12613001018707. Findings: From October 13 to 17 in 2013, October 2 to 6 in 2014, and September 22 to 26 in 2015, 7,687 adult participants from 318 tents were randomised to facemasks or no facemasks; 3,864 participants from 149 tents were assigned to the Facemask group and 3,823 participants from 169 tents to the Control group. In the Facemask arm, respectively 27% and 51% participants used facemasks daily and intermittently, 22% did not; in the Control arm, respectively 15% and 38% participants used facemasks daily and intermittently, 47% did not. Respiratory viruses were detected in 277 of 650 (43%) nasal/pharyngeal swabs from symptomatic pilgrims. In intention-to-treat analysis, facemask use was neither effective against laboratory-confirmed vRTIs (OR 1.35, 95% CI 0.88-2.07) nor against CRI (OR 1.1, 95% CI 0.88-1.39), not even in per-protocol analysis (OR 1.2, 95% CI 0.87-1.69; OR 1.3, 95% CI 0.99-1.83). Interpretation: Facemask use does not prevent clinical or laboratory-confirmed viral respiratory infections among Hajj pilgrims. Funding: Qatar National Research Fund (number: NPRP 6-1505-3-358). Declaration of Interest: Professor Robert Booy has received funding from Baxter, CSL, GSK, Merck, Novartis, Pfizer, Roche, Romark and Sanofi Pasteur for conducting this research, travel to conferences or consultancy work; all funding received is directed to research accounts at The Children’s Hospital at Westmead. Dr Harunor Rashid has received fees from Pfizer, Sanofi Pasteur and Novartis for consulting or serving on an advisory board. The other authors have no competing interests to declare. Ethical Approval: The trial has received approval from an Australian Human Research Ethics Committee (NSW HREC Ref: HREC/13/HNE/265), and the Joint Institutional Review Board (J-IRB) of Hamad Medical Corporation - Weill Cornell Medical College in Qatar (IRB Number: 13-00039).

The NICE-GUT trial protocol: a randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children

IntroductionDiarrhoeal disease is the second leading cause of death in children under 5 years globally, killing 525 000 annually. Australian Aboriginal and Torres Strait Islander (hereafter Aboriginal) children suffer a...

A developmental evaluation to enhance stakeholder engagement in a wide-scale interactive project disseminating quality improvement data: study protocol for a mixed-methods study

IntroductionBringing together continuous quality improvement (CQI) data from multiple health services offers opportunities to identify common improvement priorities and to develop interventions at various system levels to achieve large-scale improvement...

Fly in/fly out health workers: a barrier to quality in health care

The project sought to improve the quality of diabetes care in a small primary healthcare clinic in a remote Indigenous community in Australia’s Northern Territory. The project followed quality improvement methodology over a 9 month period and obtained ethical approval from the Central Australian Human Research Ethics Committee. It involved clinical and administrative staff of varying employment contracts – fly in/fly out (FIFO), agency locums and other short-term employees, as well as permanent staff.

The ethics of obtaining consent in labour for research

It is widely acknowledged that the pregnant population is a vulnerable and potentially disadvantaged one with regard to research. We sought to evaluate compliance with this concept by examining current Australian practices of obtaining consent for research during labour through the published literature and from Australian Human Research Ethics Committees (HRECs) as well as reviewing the relevant literature. We surveyed Australian HRECs requesting information about their opinions and/or practices surrounding the ethics of research consent during labour or birth. In addition, a literature search was performed to find randomised controlled trials (RCTs) involving interventions during labour in Australia in the last five years. Of the HREC respondents, 75% believed it to be ethical to obtain consent for research in labour, 87% would require additional expert assistance to approve, 57% felt the partner should be involved and all proposed research scenarios were thought to require protocol changes. Recent local RCTs reflected a variety of consent strategies, each having their limitations. An under-used but potentially useful strategy may be staged recruitment and consent. Despite the evidence supporting labour as a time requiring increased acuity for informed consent, there is little to suggest that this knowledge is being applied to current Australian HREC and RCT practices. We suggest that further practical guidelines be devised to aid researchers and human ethics committees.

Ethics Creep or Governance Creep?

Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

Contextualising Merit and Integrity within Human Research

The first consideration of any Australian Human Research Ethics Committee should be to satisfy itself that the project before them is worth undertaking. If the project does not add to the body of knowledge, if it does not improve social welfare or individual wellbeing then the use of human participants, their tissue or their data must be questioned. Sometimes, however, committees are criticised for appearing to adopt the role of scientific review committees. The intent of this paper is to provide researchers with an understanding of the ethical importance of demonstrating the merit of their research project and to help them develop protocols that show ethics committees that adequate attention has been paid to this central tenet in dealing ethically with human research participants. Any person proposing human research must be prepared to show that it is worthwhile. This paper will clarify the relationship between research merit and integrity, research ethics and the responsibilities of human research ethics committees.

An Australian Based Study on the Readability of HIV/AIDS and Type 2 Diabetes Clinical Trial Informed Consent Documents

The aims of this study were to measure the readability of Australian based informed consent documents and determine whether informed consent readability guidelines have been established by Australian human research ethics committees (HRECs). A total of 20 informed consent documents, 10 HIV/AIDS and 10 type 2 diabetes, were measured for readability using the Simple Measure of Gobbledygook (SMOG) and Gunning Fog Index (Fog). Published guidelines and policy statements of the two local HREC who approved the 20 clinical trials under study where examined to identify whether they had any formal policies/guidelines on the readability of informed consent documents. The two HRECs were contacted via e-mail to also determine whether they utilised any informal readability standards or “rules of thumb” that may not have been mentioned in the published documents. The HIV/AIDS and type 2 diabetes informed consent documents were, on average, written at a grade 13 reading level. Formal readability standards had not been established by the two local HRECs, however, they did verify the use of informal rules for assessing readability of informed consent documents. Based on Australian literacy data, the majority of informed consent documents were written well beyond the reading ability of many Australians. Unreadable informed consent documents may result in patients rejecting trial participation altogether or conversely may result in their participating in a trial with inadequate consent. Therefore, a step toward reducing the complexity of informed consent documents may be to implement objective readability assessments into the human research ethics application and review process.

Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs

To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research. Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007. Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research. In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair. Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Is the Australian HREC system sustainable?

In Australia, Human Research Ethics Committees (HRECs) have a vital role to play--as the primary institutional mechanism for ethical review of research--in protecting research participants, and promoting ethical research. Their ability to act effectively in this role is currently threatened by the limited support they receive and their burgeoning workloads. In this discussion paper, I trace some of the factors contributing to what I describe as a resource crisis in human research ethics. I suggest a review of the working of HRECs to canvas a range of alternatives which might serve to redress this crisis, so as to ensure the continued effectiveness of HRECs in protecting participants and promoting ethical research.