ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Resource Library

Research Ethics MonthlyAbout Us

ResourcesResearch ethics committees

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

AAA Comments on Notice of Proposed Rule Making for IRBs (Papers: Rena Lederman & Lise Dobrin 2016)0

Posted by Admin in on June 22, 2016
 

Below are some excerpts from the 18-page comment submitted by the AAA to the Office of Human Research Protections on January 6, 2016, in response to the proposed changes in the “Common Rule”, the federal regulations that motivate the system of research ethics review that is implemented by IRBs. The AAA comment was authored on the AAA’s behalf by Rena Lederman (Princeton University) and Lise Dobrin (University of Virginia). An overview of the Notice of Proposed Rulemaking (NPRM) and the full text of the AAA’s response can be found here.

On the NPRM’s proposal to expand the definition of “human subject” to include even non-identified biospecimens:
The American Anthropological Association is in general accord with the principle of “autonomy” (or “respect for persons”) underlying this NPRM proposal to change the definition of Human Subject. Anthropologists and their study participants have objected to the reduction of biospecimens to “data” (i.e., values detachable from their sources); they have pointed out that blood, tissue samples and the like can come to stand for persons and be invested with specific social, cultural, and ritual values.

On the problematic omission of sociocultural anthropology’s signature methods from both the Common Rule and the proposed rule change:
Our first and most important general comment is that several of the proposed changes will deepen, rather than alleviate, ambiguity. This is especially true with respect to sociocultural anthropologists’ most characteristic research activity – “participant observation” (also referred to as “ethnographic fieldwork”, “fieldwork”, and similar terms) – which finds no place within the existing Common Rule at all. Insofar as the proposed changes likewise make no mention of participant observation, anthropologists and others who employ this approach—along with their IRBs—are left entirely in the dark. This situation promises to keep ethnographic field projects that rely on participant observation in “expedited” or “full board” categories when according to the logic behind the NPRM they should be “exempt” or “excluded”…

Lederman R & Dobrin L (2016) AAA Comments on Notice of Proposed Rule Making for IRBs. AAA Ethics Blog
http://ethics.americananthro.org/aaa-comments-on-notice-of-proposed-rule-making-for-irbs/

The AAA issued an update about the changes to the common rule on 23 May 2016. You can view the update here

The Ethics of Social Research with Children and Families in Young Lives: Practical Experiences (2009)0

Posted by Admin in on June 19, 2016
 

Preview: A great deal of attention is now paid to the ethics of social research. Research governance has expanded, and a burgeoning literature is emerging that describes the processes, practices and questions that arise in social research with children, families and communities. This paper outlines the approach taken to research ethics within Young Lives, a long-term study of childhood poverty in four developing countries. It describes some of the practical difficulties that Young Lives faces, and emphasises the importance of understanding local contexts in undertaking research with children and families in environments that are dynamic and may change rapidly from one year to the next, economically, environmentally and politically. The paper aims to contribute to current debates about research practices, the ethics of longitudinal research with children and research with communities in majority world contexts, in the spirit of shared enquiry and learning.

Morrow, V (2009) The Ethics of Social Research with Children and Families in Young Lives: Practical Experiences. http://www.younglives.org.uk/content/ethics-social-research-children-and-families-young-lives-practical-experiences

An Ethical Framework for the development and review of health research proposals involving humanitarian contexts, Enhanced Learning and Research for Humanitarian Action, Project Final Report0

Posted by Admin in on June 18, 2016
 

“The authors propose an ethical framework to 1) guide development of research designs and protocols intended for implementation in humanitarian crises and complex emergency contexts to help ensure their ethical viability, and 2) support ethical review of such protocols by independent ethical review bodies (REBs, IRBs), funders, and other organizations of interest, and 3) serve general educational purposes and enhance public understanding of the issues involved in and ethical principles guiding research in such settings. The framework is designed as a tool – offering a practical and easily implementable approach in which key ethical principles are considered in a clustered, hierarchical order. Implementation and assessment of the utility of this approach by researchers and by REBs/IRBs considering research protocols involving humanitarian crisis setting will guide further refinement of this ethical framework.”

Keywords: Evidence, Health, Principles & ethics, Research methodology

Agency: DFID – Department for International Development (UK), ELRHA – Enhancing Learning and Research for Humanitarian Assistance

Curry D, Waldman R & Caplan A (2014) An Ethical Framework for the development and review of health research proposals involving humanitarian contexts, Enhanced Learning and Research for Humanitarian Action, Project Final Report. http://www.alnap.org/resource/10687

Médecins Sans Frontières – Research Ethics Framework: Guidance Document0

Posted by Admin in on June 17, 2016
 

Introduction

“Médecins Sans Frontières (MSF) is one of the leading humanitarian medical organizations. The
foundational and animating values of MSF as a humanitarian medical organization are rooted in
ethics. It has a well-deserved reputation for its work in responding to humanitarian needs created by a
variety of health emergencies around the world. It is respected as an organization for its leadership
and moral authority in humanitarian affairs.

“Historically, research was not seen as core to the mission of MSF. However, it now initiates, sponsors
or participates in numerous research projects in multiple field sites. The results of MSF research have
had substantial impact on global health policy and provided benefits to populations served by MSF
and elsewhere. MSF has also shown leadership in operational research initiatives in the humanitarian
NGO sector. As a result, research has become increasingly integral to MSF activities, both in the field
and in global health advocacy.

“MSF has paid particular attention to ethical issues related to the research in which they engage. This is
manifested by the creation of an independent ethics review board (ERB) that evaluates all research
proposals involving MSF. This board chose to use an explicit framework to assess the ethical
dimensions of the research1. Since its adoption in 2003, the research ethics framework has served
well, as it has brought greater clarity to the expectations of both the ERB and MSF staff engaged in
research. The quality of the proposals submitted to the board has improved considerably over the
past decade…”

Médecins Sans Frontières (MSF) (2013) Research Ethics Framework: Guidance Document. MSF. http://fieldresearch.msf.org/msf/handle/10144/305288

0