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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

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.

Read the rest of this discussion piece

Checklists to Detect Potential Predatory Biomedical Journals: A Systematic Review (Papers: Samantha Cukier, et al | Preprint September 2019)0

Posted by Admin in on September 23, 2019
 

Abstract

Background:
We believe there is a large number of checklists to help authors detect predatory journals. It is uncertain whether these checklists contain similar content.

Purpose:
Perform a systematic review to identify checklists to detect potential predatory journals and to examine their content and measurement properties.

Data Sources:
MEDLINE, Embase, PsycINFO, ERIC, Web of Science and Library, Information Science & Technology Abstracts (January 2012 to November 2018), university library websites (January 2019), YouTube (January 2019).

Study Selection:
Original checklists used to detect potential predatory journals published in English, French or Portuguese, with instructions in point form, bullet form, tabular format or listed items, not including lists or guidance on recognizing “legitimate” or “trustworthy” journals.

Data Extraction:
Pairs of reviewers independently extracted study data and assessed checklist quality and a third reviewer resolved conflicts.

Data Synthesis:
Of 1528 records screened, 93 met our inclusion criteria. The majority of included checklists were in English (n = 90, 97%), could be completed in fewer than five minutes (n = 68, 73%), had an average of 11 items, which were not weighted (n = 91, 98%), did not include qualitative guidance (n = 78, 84%) or quantitative guidance (n = 91, 98%), were not evidence-based (n = 90, 97%) and covered a mean of four (of six) thematic categories. Only three met our criteria for being evidence-based.

Limitations:
Limited languages and years of publication, searching other media.

Conclusions:
There is a plethora of published checklists that may overwhelm authors looking to efficiently guard against publishing in predatory journals. The similarity in checklists could lead to the creation of evidence-based tools serving authors from all disciplines.

Cukier, S., Helal, L., Rice, D.B., Pupkaite, J., Ahmadzai, N., Wilson, M., Skidmore, B., Lalu, M., Moher, D. (Preprint 2019) Checklists to Detect Potential Predatory Biomedical Journals: A Systematic Review. medRxiv. 19005728; doi: https://doi.org/10.1101/19005728
Publisher: https://www.medrxiv.org/content/10.1101/19005728v1

(China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged (Papers: Katrina A. Bramstedt & Jun Xu | September 2019)0

Posted by Admin in on September 13, 2019
 

Abstract

Background
Organ donation and transplantation in China are ethically complex due to questionable informed consent and the use of prisoners as donors. Publishing works from China can be problematic. The objective of this study was to perform a 10-year follow up on Chinese journals active in donation and transplant publishing regarding the evolution of their publishing guidelines.

Methods
Eleven Chinese journals were analyzed for 7 properties: (1) ethics committee approval; (2) procedure consent; (3) publishing consent; (4) authorship criteria; (5) conflict of interest; (6) duplicate publication; and (7) data integrity. Results were compared with our 2008 study data. Additionally, open access status, impact factor, and MEDLINE-indexing were explored.

Results
Most journals heightened the ethical requirements for publishing, compared to the results of 2008. All 11 now require their published manuscripts to have data integrity. Ten of 11 require ethics committee approval and informed consent for the publication of research studies, whereas in the original study only 2 journals evidenced these requirements. Nine of 11 have criteria for authorship, require conflict of interest disclosure, and forbid duplicate publishing. None of the journals have a policy to exclude data that was obtained from unethical organ donation practices. Nine of 11 journals are MEDLINE-indexed but only 2 are open-access.

Conclusions
Most journals have improved their general ethical publishing requirements but none address unethical organ donation practices.

Keywords:
China; Informed consent; Organ donation; Publishing; Research ethics; Research integrity

Bramstedt, K. and Xu, J. (20019) (China) A 10-year follow up of publishing ethics in China: what is new and what is unchanged. Research Integrity and Peer Review 4(17) https://doi.org/10.1186/s41073-019-0077-3.
Publisher (Open Access): https://researchintegrityjournal.biomedcentral.com/articles/10.1186/s41073-019-0077-3

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