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

What information and the extent of information research participants need in informed consent forms: a multi-country survey (Juntra Karbwang, et al | 2018)0

Posted by Admin in on October 7, 2018


The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research.

This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important).

Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making (mean score, ranging from 3.58 to 4.47). Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF (mean score = 4.47, 4.47, and 4.45, respectively).

Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF.

Consent forms, Informed consent, Disclosure, Information, Ethics, Research subjects

Karbwang, J., et al. (2018). “What information and the extent of information research participants need in informed consent forms: a multi-country survey.” BMC Medical Ethics 19(1): 79.
Publisher (Open Access):

A Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)0

Posted by Admin in on October 2, 2018

The most salient takeaway from the collapse of the MACH15 trial is that the conflicts of interest at its core are probably not as rare as we think.

LAST YEAR, the National Institute on Alcohol Abuse and Alcoholism, part of the federal National Institutes of Health, laid out plans for what is a rarity in the realm of public health: a high quality clinical trial. The “Moderate Alcohol and Cardiovascular Health Trial,” known as MACH15, was to be randomized so that some subjects would be selected to drink and some would not. It would follow participants “prospectively,” over time, not retrospectively. And in the end, the results were to be adjudicated by evaluators blinded to which subjects had been instructed to drink and which to abstain. The goal was an assessment of the effect of alcohol consumption on cardiovascular health.

This discussion piece highlights how unmanaged conflicts of interest can easily creep into work, even when it’s a banner project of a peak research funding and oversight body. Taken in retrospect you might wonder how they couldn’t see the mistakes they were making and how inevitable the consequences were, but it’s a ‘good’ case for highlighting that even enthusiastic correspondence can slide into a compromised space.

But last month, the National Institutes of Health took the unusual step of shutting down one of its own clinical trials — a $100 million dollar experiment gone wrong. The announcement followed an internal investigation, prompted by a dogged New York Times report, that uncovered inappropriate interactions between the alcohol industry (Anheuser-Busch InBev, Heineken, and others) and the NIAAA in the execution of MACH15.
By law, federal health agencies can receive funding from for-profit industry. But direct courting of funding, coordination, and collaboration on research design, and excessive communications are not permitted, and according to The Times and the findings of the NIH’s subsequent internal investigation, these violations occurred early and often during the development of the MACH15 trial. The NIH report concluded that the actions uncovered “calls into question the impartiality of the process and thus casts doubt that the scientific knowledge gained from the study would be actionable or believable.”

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Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines (Papers: Austin Carlisle, et al | September 2018)0

Posted by Admin in on October 1, 2018

Recent studies have highlighted the presence of disclosed and undisclosed financial conflicts of interest among authors of clinical practice guidelines.

We sought to determine to what extent urology guideline authors receive and report industry payments in accordance with the Physician Payment Sunshine Act.

Design, setting, and participants
We selected the 13 urology guidelines that were published by the American Urological Association (AUA) after disclosure was mandated by the Physician Payment Sunshine Act. Payments received by guideline authors were searched independently by two investigators using the Open Payments database.

Outcome measures and statistical analysis
Our primary outcome measure was the number of authors receiving payments from industry, stratified by amount thresholds. Our secondary outcome measure was the number of authors with accurate conflict of interest disclosure statements.

Results and limitations
We identified a total of 54 author disclosures. Thirty-two authors (59.3%) received at least one payment from industry. Twenty (37.0%) received >$10 000 and six (11.1%) received >$50 000. Median total payments were $578 (interquartile range $0–19 228). Twenty (37.0%) disclosure statements were inaccurate. Via Dollars for Docs, we identified $74 195.13 paid for drugs and devices directly related to guideline recommendations. We were limited in our ability to determine when authors began working on guideline panels, as this information was not provided, and by the lack of specificity in Dollars for Docs.

Many of the AUA guideline authors received payments from industry, some in excess of $50 000. A significant portion of disclosure statements were inaccurate, indicating a need for more stringent enforcement of the AUA disclosure policy.

Patient summary
Pharmaceutical company payments to doctors have been shown to influence how doctors treat patients. If these doctors are charged with making clinical recommendations to other doctors, in the form of clinical practice guidelines, the issue of industry payments becomes more severe. We found that many urologists on guideline panels receive money from industry and that a significant portion did not disclose all payments received.

Carlisle, A., et al. (2018). “Financial Conflicts of Interest Among Authors of Urology Clinical Practice Guidelines.” European Urology 74(3): 348-354.
Publisher (Open Access):

Let the Sun Shine into the Medical Ivory Tower – The Hastings Center (Adriane Fugh-Berman | September 2018)0

Posted by Admin in on September 25, 2018

In 2012, I coauthored a case report about the successful use of dietary supplements in treating a case of male infertility in the American Family Physician. Before it was published, I was surprised to receive a communication asking me to disclose the fact that I had written a textbook on dietary supplements. It had not occurred to me to disclose the publication of my then decade-old book, but I certainly should have, and I was impressed that the publication had actually checked up on me.

Would that more journals would follow AFP’s example. A joint New York Times and ProPublica investigation found that Jose Baselga, the chief medical officer at Memorial Sloan Kettering Cancer Center in New York, failed to disclose payments from pharmaceutical and health care companies in more than 100 articles he authored in medical journals. Between August 2013 (when Federal Open Payments disclosures began) and 2017, nine pharmaceutical and medical device companies paid Dr. Baselga almost $3.5 million.

Dr. Baselga has been on the board of directors of Bristol Myers Squibb and Varian medical systems, which sells radiation equipment to Memorial Sloan Kettering, among other clients. Dr. Baselga has been a consultant to Astra Zeneca, Eli Lilly, Novartis, and Roche/Genentech and an advisor to many pharmaceutical companies, diagnostics companies, and start-ups. He has presented favorable opinions about drugs made by companies that paid him– including drugs that other researchers found ineffective or unsafe. According to the Times article, Dr. Baselga called the results of a Roche trial of taselisib, a P13K inhibitor “incredibly exciting” at a meeting of the American Society of Clinical Oncology; Roche, the manufacturer, considered the drug so disappointing they scrapped further development.

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