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

Robust and Prototypical Immune Responses Towards Influenza Vaccines in the High-Risk Group of Indigenous Australians

Aboriginal and Torres Strait Islander people, Australia's Indigenous peoples, make up three percent of the population of Australia. Like many other Indigenous peoples in colonised countries, they suffer the worst health and social status of any population group. Australian Indigenous people have a lower life expectancy (8.6 years lower for men and 7.8 years for women) compared with other Australians (ABS 2018a). The reasons for the poorer health outcomes are complex and include historical, political and social factors (AIHW 2015a). The health disparity has driven a high number of research projects with a focus on Australian Indigenous people or mainstream research projects where Australian Indigenous people are overrepresented. Given the uniqueness of Australian Indigenous cultures as well as the historical, political and social context, in 1998, the Aboriginal Health and Medical Research Council of New South Wales (AH&MRC) established an Australian Indigenous-specific human research ethics committee (HREC). The AH&MRC is the Indigenous peak health body of New South Wales. This presentation will outline the role and benefit of the AH&MRC HREC as a specialised HREC. The AH&MRC HREC is fully constituted and registered under the National Health and Medical Research Council (NHMRC). The NHMRC is the leading expert body in health and medical research in Australia and develops health research guidelines. The AH&MRC HREC is one of three AHRECs in Australia. The AH&MRC Ethics Committee not only guarantees that research is conducted ethically but also ensures research involving Indigenous people is undertaken in a culturally appropriate manner. One of the key elements required by the AH&MRC is that researchers consult Indigenous communities across all stages of the project from the design, implementation, analysis and write up. The AH&MRC HREC is essential, ensuring the research is of benefit to the Indigenous community in NSW and is conducted in a culturally safe manner. Key messages Specialised Indigenous human resarch ethics committees are vital to enuring research is culturally appropriate. Spscialised human resarch ethics committees can be of benefit for other disctinct populations.

In 2011, the Australian National Health and Medical Research Council (NHMRC) initiated an inquiry to determine whether there is a need for expanded ethical guidance in the form of a discrete guidance document for alcohol and other drug (AOD) research. An issues paper was developed to frame the inquiry. AOD researchers, Human Research Ethics Committees and others were invited to discuss whether there are distinctive ethical issues facing researchers and Human Research Ethics Committees in the AOD setting. Based on the public submissions, the NHMRC recommended that no AOD research-specific guidance is required. The inquiry and the NHMRC decision were not widely publicized, and we feel there is a need for further discussion. In order to do so, we have analysed the public inquiry submissions and described the central themes. Few submissions in the inquiry explicitly agreed AOD research warrants a specific guidance framework. Most were concerned that the NHMRC issues paper unfairly targeted people who use drugs as complex research participants. The inquiry highlights tensions around research governance and ethics review boards dealing with illicit and stigmatised behaviours. While we agree that a specific guidance framework for AOD research is not needed and could potentially be harmful and restrictive, we are concerned that the wholesale rejection of a guidance framework has closed the door to much needed debate. There remains, we argue, a need for alternative strategies and tools to support ethical research, inform and streamline institutional ethics approval, and engage and protect participants.

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Mindfulness-Based Online Intervention to Improve Quality of Life in Late-Stage Bipolar Disorder a Randomised Clinical Trial

To determine how familiar human research ethics committees (HRECs) are with the principles of natural justice and whether they apply these principles. A postal survey conducted between April and September 2002 of the Chairs of all HRECs registered with the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) in 2001. HRECs' reported familiarity with, and application of, three principles of natural justice: (1). the hearing rule, requiring a decision maker to allow a person affected by a decision to present his or her case; (2). the rule against bias, requiring a decision maker to be unbiased in the matter to be decided; and (3). the evidence rule, requiring that a decision be based on the evidence provided, and not irrelevant issues. From 201 Chairs of HRECs Australia-wide, we received 110 completed questionnaires (55% response rate). About 33% of respondents were very familiar with the principles of natural justice, and 25% completely unfamiliar. Most respondents felt that natural justice should be, and usually is, applied by HRECs. In cases of possible positive bias of an HREC member towards a research proposal, 70% of respondents said they would exclude the member from decision making. In cases of possible negative bias, 43% said they would exclude the HREC member. The degree of familiarity with principles of natural justice varies widely among Chairs of HRECs. While many respondents felt that HRECs usually apply natural justice, responses to questions about bias suggest that HRECs do not always exclude members with possible bias, contrary to NHMRC guidelines.

Effects of Fluoxetine on Functional Recovery after Acute Stroke (AFFINITY): A Randomised, Double-Blind, Placebo-Controlled Trial

Effectiveness of an Integrated Responsive Web Application for Cardiovascular Disease Management in Primary Care: 1 Year Multicenter, Open-Label Randomized Controlled Trial

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.

Reporting and publishing quality improvement projects.

Reduced Hepatitis C Incidence Associated with Rapid Treatment Scale-Up in Australian Prisons: Treatment-as-Prevention in the SToP-C Study

In reply: The National Health and Medical Research Council (NHMRC) welcomes Hayes and colleagues’1 commentary on its Relative to Opportunity (RTO) policy.2 Consideration of personal circumstances in peer review of track records is a challenging issue for grant applicants, assessors and NHMRC alike. Applicants vary enormously in their circumstances which can, in turn, affect their research productivity and career trajectory. NHMRC has long believed applicants should have the option to outline any circumstances they wish to be considered. The RTO policy applies to all grant schemes where track record is assessed. The policy has two components: career disruption (at least 90 days’ continuous full- or part-time absence due to pregnancy, illness, or caring responsibilities) and RTO considerations (any other circumstances, including shorter or discontinuous absences, affecting productivity).2 Assessors are instructed to consider both components in evaluating track records. Career disruptions also extend the period for which publications and other outputs are assessed and the eligibility for an Emerging Leadership Investigator Grant. Since 2019, career disruptions have been defined as continuous absences of at least 90 days to distinguish them from normal leave and because it proved difficult to validate claims of multiple short absences. This step aimed to reduce the burden for institutions, applicants and assessors. Similarly, limiting RTO information to a ten-year period recognises the challenges assessors face in adjusting track record scores for career interruptions, especially outside the review period. In 2021, after sector consultation, NHMRC piloted an expanded approach requiring all Investigator Grant applicants to describe their career context to inform track record assessment.3 Following positive feedback from applicants and assessors,4 this approach is being progressively extended to all NHMRC grant schemes involving track record assessment. Normalising consideration of career context may help to reduce the reported risks of listing RTO matters.5 No doubt the RTO policy can be further improved — the question is how, without increased burden on applicants and assessors or unintended consequences. The current policy is the outcome of extensive discussion by NHMRC's advisory committees. Consultation with the sector and other funders will continue as NHMRC monitors the policy's effectiveness to support the fair evaluation of all grant applications. Feedback and suggestions, as presented by Hayes and colleagues, are valuable contributions. No relevant disclosures.

Ageing research directions for Australia

The Australian NHMRC guidelines for alcohol consumption and their portrayal in the print media: a content analysis of Australian newspapers

The regulation of genomic data sharing in Australia is a confusing mix of common law, legislation, ethical guidelines, and codes of practice. Beyond privacy laws, which only apply to genomic data that meets the definition of personal information, the key regulatory lever is the National Health and Medical Research Council (NHMRC) National Statement for Ethical Conduct in Human Research (“National Statement”) (2007). Compliance with the National Statement is a requirement for institutions to apply to the NHMRC for funding, and includes—among other things—requirements for review of most genomic research by Human Research Ethics Committees. The sections of the National Statement specifying requirements for research with human genomic data are currently under review, including proposed new requirements addressing the return of genetic research findings and oversight of transfer agreements. Ensuring the willingness of Australians to donate their genomic information and participate in medical research will require clarification and harmonisation of the applicable regulatory framework, along with reforms to ensure that these regulations reflect the conditions necessary to promote ongoing public trust in researchers and institutions.