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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Self-Determination in Health Research: An Alaska Native Example of Tribal Ownership and Research Regulation (Vanessa Y. Hiratsuka, et al | 2017)0

Posted by Admin in on July 17, 2018
 

Abstract

The idea of researchers building the trust of potential participants is sometimes viewed with caution (because of worry it will undermine the voluntary nature of participation) and scepticism (because of the time/resources required, that are needed to actually conduct the research). While such worries might seem reasonable, it is important to recognise: the historical experience of First Peoples and research has not been positive (and some of that ‘historical experience is fairly recent); Indigenous people are generally underrepresented in health research; and building trust is not only sound in terms of the ethical principle of Respect it’s likely to improve the usefulness of the results.

Alaska Native (AN) and American Indian (AI) people are underrepresented in health research, yet many decline to participate in studies due to past researcher misconduct. Southcentral Foundation (SCF), an Alaska Native-owned and operated health care organization, is transforming the relationship between researchers and the tribal community by making trust and accountability required features of health research in AN/AI communities. In 1998, SCF assumed ownership from the federal government of health services for AN/AI people in south central Alaska and transformed the health system into a relationship-based model of care. This change reimagines how researchers interact with tribal communities and established community oversight of all health research conducted with AN/AI people in the region. We describe the SCF research review process, which requires tribal approval of the research concept, full proposal, and dissemination products, as well as local institutional review board approval, and a researcher-signed contract. This review evaluates research through the lens of tribal principles, practices, and priorities. The SCF example provides a framework for other tribes and organizations seeking to reshape the future of health research in AN/AI communities.
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Keywords: community review, Alaska Native, tribal, ethics, Native American, research, research conduct, trust, accountability
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Hiratsuka, V. Y., Beans, J. A., Robinson, R. F., Shaw, J. L., Sylvester, I., & Dillard, D. A. (2017). Self-determination in health research: An Alaska Native example of Tribal ownership and research regulation. International Journal of Environmental Research and Public Health, 14(11), 1324. http://dx.doi.org/10.3390/ijerph14111324
Publisher (Open Access): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707963/

National Statement on Ethical Conduct in Human Research (2007) – Updated July 20180

Posted by Admin in on July 12, 2018
 

National Statement 2018 coverThe National Statement is the Australian national reference for human research. It was issued by the NHMRC and has been endorsed by the ARC and UA. The document articulates the four core principles of merit and integrity, beneficence, justice and respect for persons. Specific advice is provided with regard to benefits and risk, informed consent, privacy, methodologies and potential participant populations. Guidance is also provided with regard to the appointment and operation of human research ethics committees, the conduct of ethical reviews, and the responsibilities of institutions. Even though the document has not been enacted compliance with the National Statement is a strict condition of NHMRC and ARC funding.

Since 2014 a joint working group (including appointees from AHEC, the ARC and UA) have been conducting a rolling review of the National Statement. Dr Allen is involved in this rolling review.

In 2015-17 a joint drafting committee (including appointees from AHEC, the ARC and UA) drafted changes and addition to the chapters in Section 3 of the National Statement, as well as corresponding changes to Section 5 and the glossary Dr Allen, Prof Israel and Prof Thomson are involved in this rolling review.

Access – the PDF copy | the NS page

National Health and Medical Research Council, Australia (2007, updated 2018) National Statement on Ethical Conduct in Human Research. Available at: https://www.nhmrc.gov.au/_files_nhmrc/file/publications/national-statement-2018.pdf

Research ethics committees in the Pacific Islands: gaps and opportunities for health sector strengthening (Papers: Justin T Denholm, et al | 2017)0

Posted by Admin in on July 8, 2018
 

Abstract
There has been a range of developments in recent years to stimulate increasing public health research activity throughout the Pacific. Development of local capacity for ethics committee review and oversight is, however, frequently underdeveloped. This is reflected in the number of Pacific Island nations where ethics committees have not been established or where only informal processes exist for ethics review and oversight. This is problematic for the optimal development of relevant and culturally appropriate research, and building up local ethics committees should be part of continued research development in the Pacific. Three areas in which local ethics committees may add value are 1) offering better capacity to reflect local priorities, 2) providing broader benefits for research capacity building, and 3) assisting to strengthen systems beyond research ethics. This article considers benefits and challenges for ethics committees in the Pacific, and suggests directions for regional development to further strengthen public health research activity.

Keywords: research ethics, Pacific Islands, operational research, public health, ethics

J. T. Denholm, K. Bissell, K. Viney, A. M. Durand, H. L. Cash, C. Roseveare, O. E. Merilles, Jr., A. D. Harries and S. Biribo (2017) Research ethics committees in the Pacific Islands: gaps and opportunities for health sector strengthening. Public Health Action. 2017 Mar 21; 7(1): 6–9. Published online 2017 Mar 21. doi: 10.5588/pha.16.0076 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526493/

Open access

Europe’s biggest research fund cracks down on ‘ethics dumping’ – Nature (Linda Nordling | July 2018)0

Posted by Admin in on July 7, 2018
 

The practice of conducting ethically dubious research in foreign countries is under fresh scrutiny.

Ethics dumping — doing research deemed unethical in a scientist’s home country in a foreign setting with laxer ethical rules — will be rooted out in research funded by the European Union, officials announced last week.

A commendable move by the EU, which at least, in theory, is addressed by the provisions of national research ethics frameworks such as Australia’s National Statement, but peak research funding bodies should consider the merits a similarly clear statement in its funding criteria.

Applications to the EU’s €80-billion (US$93-billion) Horizon 2020 research fund will face fresh levels of scrutiny to make sure that research practices deemed unethical in Europe are not exported to other parts of the world. Wolfgang Burtscher, the European Commission’s deputy director-general for research, made the announcement at the European Parliament in Brussels on 29 June.
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Burtscher said that a new code of conduct developed to curb ethics dumping will soon be applied to all EU-funded research projects. That means applicants will be referred to the code when they submit their proposals, and ethics committees will use the document when considering grant applications.
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