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

Resource Library

Research Ethics MonthlyAbout Us

ResourcesEthical review

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Evaluating ethics oversight during assessment of research integrity (Papers: Andrew Grey, et al | November 2019)0

Posted by Admin in on January 24, 2020
 

Abstract
We provide additional information relevant to our previous publication on the quality of reports of investigations of research integrity by academic institutions. Despite concerns being raised about ethical oversight of research published by a group of researchers, each of the four institutional investigations failed to determine and/or report whether ethics committee approval was obtained for the majority of publications assessed.

Grey, A., Bolland, M. & Avenell, A. (2019) Evaluating ethics oversight during assessment of research integrity. Research Integrity and Peer Review 4, 22 (2019). https://doi.org/10.1186/s41073-019-0082-6
Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0082-6

Google health-data scandal spooks researchers – Science (Heidi Ledford | November 2019)0

Posted by Admin in on January 12, 2020
 

Scientists fear the controversy over the Nightingale project will undermine trust in research.

Google and one of the largest health-care networks in the United States are embroiled in a data-privacy controversy that researchers fear could jeopardize public trust in data-sharing practices and, potentially, academic studies.

At issue is a project dubbed Nightingale that gives Google access to the health-care information, including names and other identifiable data, of tens of millions of people without their knowledge. The people were treated at facilities run by the health network Ascension, which is based in St Louis, Missouri.

Google says that Nightingale, first reported in The Wall Street Journal on 11 November, is meant to develop technology that would enable Ascension to deliver improved health care.

Read the rest of this discussion piece

Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)0

Posted by Admin in on January 7, 2020
 

Abstract
Comparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.

KEYWORDS:
Human subjects research; IRB (Institutional Review Board); informed consent; risk/benefit analysis

Macklin, R. & Natanson, C. (2019) Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error. Americaan Journal of Bioethics. 20(1):31-39. doi: 10.1080/15265161.2019.1687777.
Publisher: https://www.tandfonline.com/doi/full/10.1080/15265161.2019.1687777

Reasoning “Uncharted Territory”: Notions of Expertise Within Ethics Review Panels Assessing Research Use of Social Media (Papers: Chelsea Sellers, et al | February 2019 )0

Posted by Admin in on January 5, 2020
 

Abstract

Of late, AHRECS has been asked numerous times to conduct professional development for HREC members, and in-meeting briefings on online research.  But committee expertise on project designs is an important general point to make.  For example: If an HREC doesn’t have access to someone (or more than one) who has run a clinical trial or been involved in trials groups and trial management then they have insufficient expertise to review trials.  During the preparation of a meeting agenda, the Chair and Secretary should discuss the committee’s relevant expertise and needs.

The fast changing field of social media (SM) research presents unique challenges for research ethics committees (RECs). This article examines notions of experience and expertise in the context of REC members reviewing proposals for SM research and considers the role of the RECs in this area of review. We analyze 19 interviews with REC members to highlight that a lack of personal and professional experience of SM, compounded by a lack of institutional and professional guidelines, mean many REC members feel they do not possess sufficient expertise to review SM research. This view was supported by 14 interviews with SM researchers. REC members drew on strategies to overcome their lack of experience, although most SM researchers still found this problematic, to varying degrees. We recommend several steps to ensure REC expertise in SM research keeps pace of this fast-developing field, taking a pro-active, dialogic approach.

Keywords
social media, research ethics committee, ethics, experience, expertise

Samuel, G. N., Samuel, G. and Derrick, G. (2019). Civil society stakeholder views on forensic DNA phenotyping: balancing risks and benefits. Special Issue: Ethical Issues in Social Media Research
Publisher (Open Access): https://journals.sagepub.com/doi/pdf/10.1177/1556264619837088

0