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

Resource Library

Research Ethics MonthlyAbout Us

ResourcesHuman research ethics

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)0

Posted by Admin in on September 11, 2019
 

Analysis of 30 leading institutions found that just 17% of study results had been posted online as required by EU rules.

Failing to post the results of a clinical trial is not only a technical breach, it is a waste of resources, places an unwarranted burden on volunteers, is a waste of resources and is a public health issue.  Does your institution follow-up to check if results have been reported?  Is action taken if it hasn’t?

Many of Europe’s major research universities are ignoring rules that require them to make public the results of clinical trials.

A report published on 30 April found that the results of only 162 of 940 clinical trials (17%) that were due to be published by 1 April had been posted on the European Union’s trials register. The 30 universities surveyed are those that sponsor the most clinical trials in the EU. Fourteen of these institutions had failed to publish a single results summary.

If three high-performing UK universities are excluded from the figures, the results of just 7% of the trials were made public on time. Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds.

Read the rest of this discussion piece

Study pulls back curtain on contracts between Coca-Cola and the researchers it funds – STAT (Andrew Josep | May 2019)0

Posted by Admin in on September 6, 2019
 

When it funds scientific research, Coca-Cola includes a provision in its contracts with academic institutions that allows the beverage giant to pull its funding for a study at any point, according to a group of researchers who obtained several such agreements.

The policies could pressure recipients of the funding to pursue research that dovetails with Coca-Cola’s goals out of fear of having their project canceled, the researchers said in a paper published Tuesday, though they added that they found no example of that occurring.

The paper, which was published in the Journal of Public Health Policy, comes amid increasing scrutiny of the food and beverage industry’s funding of and influence over academic research. The industry has taken a number of steps to improve transparency and safeguard the independence of studies it sponsors. Notably, Coca-Cola in 2015 started listing on its website the institutions and researchers it funded and the following year outlined principles that would guide its support for scientific research.

Read the rest of this discussion piece

Data sharing and how it can benefit your scientific career – Nature (Gabriel Popkin | May 2019)0

Posted by Admin in on September 5, 2019
 

Open science can lead to greater collaboration, increased confidence in findings and goodwill between researchers.

Ecologist Thomas Crowther knew that scientists had already collected a vast amount of field data on forests worldwide. But almost all of those data were sequestered in researchers’ notebooks or personal computers, making them unavailable to the wider scientific community. In 2012, Crowther, then a postdoctoral researcher at Yale University in New Haven, Connecticut, began to e-mail and cold-call researchers to request their data. He started to assemble an inventory, now hosted by the Global Forest Biodiversity Initiative, an international research collaboration, that contains data on more than 1 million locations. Data are stored in CSV files (plain-text files that contain a list of data) on servers at Crowther’s present laboratory at the Swiss Federal Institute of Technology in Zurich and on those of a collaborator at Purdue University in West Lafayette, Indiana; he hopes to outsource database storage to a third-party organization with expertise in archiving and access.

After years of courting and cajoling, Crowther has persuaded about half of the data owners to make their data public. The other half, he laments, say that they support open data in principle, but have specific reasons for keeping their data sets private. Mainly, he explains, they want to use their data to conduct and publish their own studies.

Crowther’s database challenges reflect the current state of science: partly open, partly closed, and with unclear and inconsistent policies and expectations on data sharing that are still in flux. High-level bodies such as the US National Academies of Sciences, Engineering, and Medicine and the European Commission have called for science to become more open and endorsed a set of data-management standards known as the FAIR (findable, accessible, interoperable and reusable) principles. Government funding agencies in the United States, Europe and Australia require researchers to devise plans for data management and, in some cases, data sharing; some private funders also require them. Many journals, including Nature, have adopted policies that encourage or require authors to make data available. A plethora of open-access repositories host data sets from almost all fields, and scientists have been publicly criticized by colleagues for not sharing data.

Read the rest of this discussion piece

Enhancing ethics review of social and behavioral research: developing a review template in Ethiopia (Papers: Liya Wassie, et al | August 2019)0

Posted by Admin in on September 1, 2019
 

Abstract

Background:
Africa is increasingly becoming an important region for health research, mainly due to its heavy burden of disease, socioeconomic challenges, and inadequate health facilities. Regulatory capacities, in terms of ethical review processes, are also generally weak. The ethical assessment of social and behavioral research is relatively neglected compared to the review of biomedical and clinical studies, which led us to develop an ethics review assessment tool for use in the review of social and behavioral research in Ethiopia, which could potentially be of value in low- and middle-income settings.

Methods:
Initially, we did a comprehensive literature review on principles, guidelines, and practices of research ethics, on social and behavioral studies, from which we extracted query terms to explore the opinions of selected key informants and focus groups in Ethiopia. The discussants and informants were selected using a convenience sampling method to evaluate an ethics review template, which integrated issues that commonly arise in social and behavioral studies. Finally, we directly solicited opinions from the discussants about the desirability, feasibility, acceptability, and relevance of the ethics review assessment tool and used the resulting data to refine our initial draft.

Results and conclusion:
Although the same basic ethics principles govern all research studies, social and behavioral research have some disciplinary particularities that may require reviewers to exercise a different orientation of ethical attention in some cases. Using a qualitative approach, we developed a review assessment tool that could potentially be useful to raise awareness, focus attention, and strengthen the review of social and behavioral studies by ethics review committees, particularly in settings without a long-standing tradition of reviewing such research. This process also exposed some areas where further capacity building and discussion of ethical issues may be necessary among stakeholders in the review of social and behavioral research.

Keywords
Behavioral, social, qualitative, biomedical research, ethics review, low and middle income

Liya Wassie, Senkenesh Gebre-Mariam, Geremew Terekegne et al. (2019) Enhancing ethics review of social and behavioural research: Developing a review template in Ethiopia. Research Ethics 15(4) 1–23.
Publisher (Open Access): https://journals.sagepub.com/doi/full/10.1177/1747016119865731

0