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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Two-thirds of researchers report ‘pressure to cite’ in Nature poll – Nature (Dalmeet Singh Chawla | October 2019)0

Posted by Admin in on October 7, 2019
 

Readers say they have been asked to reference seemingly superfluous studies after peer review.

An online poll answered by more than 4,300 Nature readers suggests that most researchers have felt pressured by peer reviewers to cite studies in their papers that seem unnecessary.

Readers were asked, ‘Have you ever felt pressured by peer reviewers to cite seemingly superfluous studies in your work?’, to which 66% responded ‘yes’ and 34% said ‘no’ (see ‘Coercive citation?’).

The poll accompanied a news story last month, which revealed that the Dutch publisher Elsevier had found a small proportion of academics reviewing papers for its journals were exploiting the review process by asking authors to reference the reviewers’ own papers in exchange for a positive report.

Read the rest of this discussion piece

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

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Disclosure of interests and management of conflicts of interest (NHMRC An Australian Code (2018) good practice guide | August 2019)0

Posted by Admin in on October 1, 2019
 

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

Contents

1. Introduction 1

2. Disclosure of interests 2
2.1 What interests should be disclosed? 2
2.2 What is a conflict of interest? 3
2.3 Identifying and managing conflicts of interest 3

3. Responsibilities of institutions 4
3.1 Develop and promote institutional policy 4
3.2 Provide training for researchers 4
3.3 Manage institutional interests 5

4. Responsibilities of researchers 5
4.1 Disclose interests and comply with relevant policies 5
4.2 Engage in relevant training 6

5. Resolution of disputes 6

6. Breaches of the Code 6

Additional resources 6

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