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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Justice in Human Research Ethics (Papers: Ian Pieper and Colin Thomson | 2014)0

Posted by Admin in on October 1, 2018
 

Abstract
One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice — whether distributive or commutative — and what counts as a just distribution or exchange — are given different weight and meanings by different people.

In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified.

We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researchers on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

Keywords
Human Research, National Statement, Human Research Ethics, Distributive Justice

Pieper, I. & Thomson, C.J.H. (2013) Justice in Human Research Ethics. Monash Bioethics Review (2013) 31: 99.
Publisher: https://link.springer.com/article/10.1007/BF03351345#citeas

(US) NIH delays controversial clinical trials policy for some studies – Science (Jocelyn Kaiser | July 2018)0

Posted by Admin in on September 30, 2018
 

Basic brain and behavioral researchers will get more than a year to comply with a new U.S. policy that will treat many of their studies as clinical trials. The announcement from the National Institutes of Health (NIH) appears to defuse, for now, a yearlong controversy over whether basic research on humans should follow the same rules as studies testing drugs.

Update on an unpopular US plan to radically expand the definition of a clinical trial. While limited to the States at the moment, the change might ripple out to the rest of us.

Although research groups had hoped NIH would drop its plans to tag basic studies with humans as trials, they say they’re relieved they get more time to prepare and give the agency input. “It’s a positive step forward,” says Paula Skedsvold, executive director of the Federation of Associations in Behavioral & Brain Sciences in Washington, D.C.
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At issue is a recently revised definition of a clinical trial along with a set of rules in effect since January that are meant to increase the rigor and transparency of NIH-funded clinical trials. About a year ago, basic scientists who study human cognition—for example, using brain imaging with healthy volunteers—were alarmed to realize many of these studies fit the new clinical trial definition.
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Read the rest of this discussion piece

Research ethics versus ethical approval: A response to Tomaselli (Papers: Katie Fitzpatrick | 2017)0

Posted by Admin in on September 27, 2018
 

Keyan Tomaselli’s opinion piece provides a great deal of food for thought about a wide range of issues in research. I want to pick up here on one point he makes, which I think is worth further consideration: the issue of research ethics and approvals in ethnography. He notes that “bio-medical ethical models are imposed on anthropologists” and he raises concerns about how universities engage in the gate keeping of research approvals. This is an important point and one that might usefully be explored further in future issues of this journal. It seems to me that ethical approval has, indeed, been divorced from the academic field of research ethics, especially in qualitative research. As Tomaselli notes, we might question the right of “organisations [to] claim jurisdiction over the right of adult individuals or researchers to make their own respective choices”. I think we might also seek to uphold the rights of young people—not only adults—to make decisions about the kinds of research they engage in and how their voices are represented therein.

Ethical issues in ethnographic research are, indeed, complex, locally and culturally specific, and are difficult to regulate. Part of this difficulty lies in the fact that ethnographic research is, by definition, relational. Romero and Walker (2010, 209) observe that “some of the most prevalent methodological and ethical questions in contemporary ethnographic research concern whose voice is heard and how it is represented”. They note that “in theory and in practice, Institutional Review Boards require that the identity of individuals be protected and remain anonymous or at very least confidential” [sic] (223). Many ethnographers adhere to this approach because they are committed to protecting the identities of their participants, especially when the research concerns personal, legal, sexual or other sensitive materials. However, an assumption that people’s identities should and will be obscured in research representations is also problematic, especially when this decision is made prior to even entering the field.

Fitzpartrick, Katie. 2017. “ Research ethics versus ethical approval: A response to Tomaselli.” The Ethnograhic Edge  1, (1): 21– 33. http://dx.doi.org/10.14663/tee.v1i1.20
Publisher: http://dx.doi.org/10.14663/tee.v1i1.20

Indigenous Data Sovereignty: University Institutional Review Board Policies and Guidelines and Research with American Indian and Alaska Native Communities (Papers: Tennille L. Marley | 2018)0

Posted by Admin in on September 16, 2018
 

Abstract
American Indians, Alaska Native, and other Indigenous people throughout the world have undergone and continue to experience research abuses. Qualitative data such as intellectual property, Indigenous knowledge, interviews, cultural expressions including songs, oral histories/stories, ceremonies, dances, and other texts, images, and recordings are at risk of exploitation, appropriation, theft, and misrepresentation and threaten the cultural sovereignty of American Indians, Alaska Native, and other Indigenous people. These issues are potentially magnified with the increasing use of big data. Partly as a result of past and current research abuse, the Indigenous data sovereignty, the control, ownership, and governance of research and data, is growing. In this article, I discuss American Indian political sovereignty, cultural sovereignty, and Indigenous data sovereignty, with an emphasis on qualitative data sovereignty. In addition, I explore whether Arizona’s public universities—Northern Arizona University, Arizona State University, and University of Arizona—policies and guidelines support Indigenous data sovereignty and the extent to which they align with the Arizona Board of Regent’s tribal consultation policy that governs relations between the three Arizona universities and Arizona American Indian nations. Overall expectations, requirements, and processes do not go far enough in supporting Indigenous data sovereignty. Although each university has specific research policies that follow the Arizona Board of Regent’s tribal consultation policy, the university guidelines differ in scope in term of supporting Indigenous data sovereignty. In addition, none of the policies address qualitative data sharing, including those in big data sets. Based on the findings I make several recommendations for researchers, including supporting the Indigenous sovereignty movement and to reconsider big data use and past positions about qualitative data ownership and sharing with regard to American Indians, Alaska Native, and other Indigenous people.

Keywords Indigenous data sovereignty, American Indian and Alaska Native, Indigenous people, qualitative data

Marley, T. L. “Indigenous Data Sovereignty: University Institutional Review Board Policies and Guidelines and Research with American Indian and Alaska Native Communities.” American Behavioral Scientist 0(0): 0002764218799130.
Publisher: http://journals.sagepub.com/doi/abs/10.1177/0002764218799130#articleCitationDownloadContainer

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