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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/

Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues (Papers: Anna Harding, et al | 2011)0

Posted by Admin in on July 17, 2018
 

Abstract

Background: When conducting research with American Indian tribes, informed consent beyond conventional institutional review board (IRB) review is needed because of the potential for adverse consequences at a community or governmental level that are unrecognized by academic researchers.

Objectives: In this article, we review sovereignty, research ethics, and data-sharing considerations when doing community-based participatory health–related or natural-resource–related research with American Indian nations and present a model material and data-sharing agreement that meets tribal and university requirements.

Discussion: Only tribal nations themselves can identify potential adverse outcomes, and they can do this only if they understand the assumptions and methods of the proposed research. Tribes must be truly equal partners in study design, data collection, interpretation, and publication. Advances in protection of intellectual property rights (IPR) are also applicable to IRB reviews, as are principles of sovereignty and indigenous rights, all of which affect data ownership and control.

Conclusions: Academic researchers engaged in tribal projects should become familiar with all three areas: sovereignty, ethics and informed consent, and IPR. We recommend developing an agreement with tribal partners that reflects both health-related IRB and natural-resource–related IPR considerations.

Keywords: American Indian, data sharing, informed consent, intellectual property, IRB, research ethics, sovereignty, tribal

Harding A, Harper B, Stone D, O’Neill C, Berger P, et al. (2011) Conducting Research with Tribal Communities: Sovereignty, Ethics, and Data-Sharing Issues. Environmental Health Perspectives.  120: 6–10. pmid:21890450
Publisher (Open Access): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3261947/

Moving Forward on Consent Practices in Australia (Papers: Rebekah E. McWhirter & Lisa Eckstein | 2018))0

Posted by Admin in on July 15, 2018
 

Abstract
Allowing persons to make an informed choice about their participation in research is a pre-eminent ethical and legal requirement. Almost universally, this requirement has been addressed through the provision of written patient information sheets and consent forms. Researchers and others have raised concerns about the extent to which such forms—particularly given their frequent lengthiness and complexity—provide participants with the tools and knowledge necessary for autonomous decision-making. Concerns are especially pronounced for certain participant groups, such as persons with low literacy and Indigenous persons. Multimedia strategies have the potential to usefully supplement current consent practices in Australia; however, information is needed about the need for supplementary consent practices, along with drivers for and barriers against adoption. This study initiates the required evidence base through an audit of informed consent practices for medical research in the Australian state of Tasmania to assess the need for, and current uptake of, supplementary consent strategies. Drivers for and barriers against adoption of multimedia consent practices were explored in detail through interviews with key stakeholders, including researchers, HREC chairs and members, and research participants, including Indigenous participants.

Keywords
Informed consent, Research ethics, Multimedia consent, Consent apps

McWhirter, RE and Eckstein, L (2018) Moving Forward on Consent Practices in Australia. Journal of Bioethical Inquiry. Published online: 12 March 2018 https://doi.org/10.1007/s11673-018-9843-z

National Statement on Ethical Conduct in Human Research (2007) – Updated with new link to July 2018 update0

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://nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018

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