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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(Australia) Unauthorised survey asked students to rate Chinese people out of seven – Sydney Morning Herald (Nick Bonyhady | September 2019)0

Posted by Admin in on October 13, 2019
 

An unauthorised survey delivered to students at the University of Sydney under the university’s official logo asked them to rate the attractiveness and intelligence of Chinese people out of seven.

It is interesting this story doesn’t mention the National Statement (2007 updated 2018), the Australian Code (2018) or research misconduct though this may be encapsulated by the reference to suspension and investigation. The reported questions raise concerns as to the merit of the work, respect, justice and the troubling spectre of the alt-right.

The survey was delivered by both paid and volunteer pollsters to students voting in student representative council elections at the university this week. It claimed to be “approved in principle by the University of Sydney’s ethics committee” and “endorsed by the political science department.”
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A University of Sydney spokeswoman said the university had “very strong concerns” about the content of the survey, which it was not aware of until contacted by the Herald on Wednesday, and how it was delivered.
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“An initial inquiry indicates ethics approval was not obtained for the study and our logo has been used without permission,” the spokeswoman said. “We are formally contacting the staff and student involved today to advise them the matter may be subject to disciplinary proceedings.”
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Read the rest of this news story

How to Boost Racial, Ethnic and Gender Diversity in Clinical Research (Report – Syneos: September 2019)0

Posted by Admin in on October 6, 2019
 

Why All Stakeholders Must OWN The Mission
Healthcare transformations take time—and the time lag has consequences.

While this item and the accompanying report are decidedly US-centric, the issues are fundamental and global.  AHRECS Consultant Nik Zeps will be part of a panel discussion at the clinical oncology meeting in Adelaide in November 2019 debating this for the Cancer Council Victoria.

It has been 25 years since Congress passed the National Institutes of Health Revitalization Act requiring federally funded clinical research programs to prioritize inclusion of women and minorities. Since then, both the NIH and the Food and Drug Administration have mounted numerous initiatives, including regulatory guidance aimed at shoring up the law’s intent.
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Despite parallel efforts by biopharmaceutical innovators, the demographics of clinical trials today still do not reflect the racial, ethnic or gender diversity of target patient populations around the world. This is true for trial subjects, of whom an estimated 83 percent are white. And it’s true for the race/ethnicity/gender representation of investigators at many trial sites as well.

As advanced health systems around the world enter an era of genomic and precision medicine, lack of diversity across the clinical research landscape is a daunting obstacle.

Access this discussion piece and report

Payment of participants in research: information for researchers, HRECs and other ethics review bodies (NHMRC | September 2019)0

Posted by Admin in on October 3, 2019
 

Purpose and scope
This document is designed to provide information for researchers and reviewers of research to assist in decision-making about when payment of participants in research is ethically acceptable.

The approach taken in this document rests on the assumption that participation in research is desirable and a benefit to both the scientific community and the community at-large. This information also takes into account three core ethical principles of the National Statement on Ethical Conduct in Human Research 2007 (updated 2018) (National Statement): respect, beneficence and justice. Respect requires recognition that participation in research is voluntary and based on sufficient information about, and an adequate understanding of, both the proposed research and the implications of participating in it. Beneficence requires that the potential benefits of the research must justify the risks of participation. Justice requires that the benefits and burdens of research must be shared equitably and that opportunities for participation in research not be unjustly denied to those who are eligible for participation.

The payment models and options presented in this document are intended to reflect what may be reasonable and justifiable in the context of a specific research project, not what is required or expected. It remains the remit of Human Research Ethics Committees (HRECs) and other ethics review bodies to determine whether, for each research project, payment is ethically appropriate and, if so, whether the type/s and amount/s of payment proposed are optimal or acceptable.

The information in this document is not intended to replace or override guidance provided in the National Statement and should be understood as providing additional information to assist those designing and reviewing human research.

Contents

Purpose and scope 1

Explanation of key terms 1

Guidance statements 2

Context and explanation 3

Considerations for researchers and reviewers 5

Resources 6

Appendix 1: Examples of payment models 7

Appendix 2: Case studies 8

Access the guidance document

Management of Data and Information in Research (NHMRC An Australian Code (2018) good practice guide | June 2019)0

Posted by Admin in on September 29, 2019
 

A guide supporting the Australian Code for the Responsible Conduct of Research

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1. Introduction 1

2. Responsibilities of institutions 1
2.1 Provision of training for researchers 2
..2.2 Ownership, stewardship and control of research data and primary materials 2
2.3 Storage, retention and disposal 3
2.4 Safety, security and confidentiality 3
2.5 Access by interested parties 4
2.6 Facilities 4

3. Responsibilities of researchers 4
3.1 Retention and publication 6
3.2 Managing confidential and other sensitive information 7
3.3 Acknowledging the use of others’ data 7
3.4 Engagement with relevant training 7

4. Breaches of the Code 7

Additional Resources 8

Access the good practice guide

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