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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) NIH must better protect research from foreign influence, federal watchdog says – STAT (Lev Facher | September 2019)0

Posted by Admin in on October 13, 2019
 

WASHINGTON — Foreign governments and corporations could profit from American academic institutions’ failure to safeguard taxpayer-funded biomedical research, according to a set of new reports from a federal watchdog.

Even though this is a US centric item, its points about institution conflicts of interest and overseas funding are very relevant to Australasia.  It also makes some good comments about pharmacology research.

The reports, issued by the Department of Health and Human Services inspector general, show that 54% of research institutions funded by the National Institutes of Health — some 1,013 universities and academic centers — failed to publish financial conflict-of-interest policies online. In 2018, according to the report, the NIH conducted just three audits to determine grantee institutions’ own efforts to safeguard their research — down from 28 in 2012.
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“The concern, generally speaking, is whether financial interests threaten or distort the use of NIH funds for their intended research purpose or the results of that scientific research,” Erin Bliss, an assistant HHS inspector general, said in an interview. “There are also concerns around the diversion of intellectual property, which could be an economic or a national security risk, and the potential for distortion or inappropriate influence of funding decisions.”
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Pay-to-Participate Trials and Vulnerabilities in Research Ethics Oversight – JAMA Network (Holly Fernandez Lynch, et al | September 2019)0

Posted by Admin in on October 2, 2019
 

Faced with the prospect of death or debilitating disease, patients and their families may be willing to try almost any treatment. A number of systems exist to help prevent this understandable desperation from resulting in serious harm, including standards of medical professionalism, requirements for product approval by the US Food and Drug Administration (FDA), and oversight of research by institutional review boards (IRBs). There are gaps in this safety net, however, that become particularly evident in the context of clinical trials that require patients to pay to participate. Although these trials may sometimes satisfy the standards of ethical research, the research oversight system in the United States is not sufficiently robust to ensure that this will always be the case.

Pay-to-Participate Trials
Clinical research is typically funded by governments, charitable foundations, and private companies. Built into this traditional funding system are review mechanisms intended to select for high-priority, high-quality studies. These mechanisms can often prevent the initiation of low-value studies, but they may also limit innovation by prioritizing incremental progress over bold ideas or deprioritizing research with little commercial promise. Inevitably, limited resources may force funders to forgo important studies.

One response is to seek out alternative funding sources, including study participants. Short of fraud protections, there is no legal prohibition against asking patients to pay to participate in research. The FDA explicitly permits charging for investigational products under certain circumstances, while regulations governing research consent simply call for disclosure of any “additional costs” that may result from participation.

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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

Access the good practice guide

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.

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