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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Research with, not about, communities – Ethical guidance towards empowerment in collaborative research, a report for the TRUST project – TRUST (Kate Chatfield, et al | July 2018)0

Posted by Admin in on August 28, 2018
 

Executive Summary and Introduction
Community engagement is an ethical imperative (a ‘must’) for researchers operating globally. Research participants, their local communities and research partners in international locations should be equal stakeholders1 in the pursuit of research-related gains.2,3

Great TRUST paper about a more respectful approach to research with communities. We have included links to a treasure trove of papers, reports, blog posts and news items on matters around the topics discussed in this paper.

In the 1990s, community engagement became prominent as the new guiding light of public health efforts. Involving communities in research and health-improvement programs led to better results than government-led programs alone.4 At the same time, the emerging need to protect indigenous communities in genetic research led Canadian Charles Weijer to demand a fifth principle in bioethics5,6: protection for communities.7 The individualistic nature of existing research ethics principles, stemming from US origins with its traditional emphasis upon individual autonomy was thus questioned. Asian and African ethicists added their voices to highlight the importance of respect for communities, as well as individuals.8,9
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This report provides guidance on community engagement in research from the perspective of the four TRUST values: fairness, respect, care and honesty.
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These values were identified by a global group of experts as the cornerstones of equitable research partnerships between high-income country (HIC) and low- and middle-income country (LMIC) research partners in any discipline10. The group included representatives from two vulnerable populations that carry a high burden of research: Kenyan sex workers and San indigenous peoples of Southern Africa. The guidance is suitable for all who support vulnerable populations involved in research projects, including civil society organisations, whether or not they are carrying out the research projects themselves.
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Chatfield, K. et al. (2018) Research with, not about, communities – Ethical guidance towards empowerment in collaborative research, a report for the TRUST project.  http://trust-project.eu/wp-content/uploads/2018/07/TRUST-Community-Participation-in-Research-Final.pdf

A survey on data reproducibility and the effect of publication process on the ethical reporting of laboratory research (Papers: Delphine R Boulbes, et al | 2018)0

Posted by Admin in on August 24, 2018
 

Abstract

Purpose: The successful translation of laboratory research into effective therapies is dependent upon the validity of peer-reviewed publications. However, several publications in recent years suggested that published scientific findings could only be reproduced 11-45% of the time. Multiple surveys attempted to elucidate the fundamental causes of data irreproducibility and underscored potential solutions; more robust experimental designs, better statistics, and better mentorship. However, no prior survey has addressed the role of the review and publication process on honest reporting. Experimental Design: We developed an anonymous online survey intended for trainees involved in bench research. The survey included questions related to mentoring/career development, research practice, integrity and transparency, and how the pressure to publish, and the publication process itself influence their reporting practices. Results: Responses to questions related to mentoring and training practices were largely positive, although an average of ~25% didn’t seem to receive optimal mentoring. 39.2% revealed having been pressured by a principle investigator or collaborator to produce “positive” data. 62.8% admitted that the pressure to publish influences the way they report data. The majority of respondents did not believe that extensive revisions significantly improved the manuscript while adding to the cost and time invested. Conclusions: This survey indicates that trainees believe that the pressure to publish impacts honest reporting, mostly emanating from our system of rewards and advancement. The publication process itself impacts faculty and trainees and appears to influence a shift in their ethics from honest reporting (“negative data”) to selective reporting, data falsification, or even fabrication.

Boulbes, D. R., et al. (2018). “A survey on data reproducibility and the effect of publication process on the ethical reporting of laboratory research.” Clinical Cancer Research.
http://clincancerres.aacrjournals.org/content/early/2018/04/11/1078-0432.CCR-18-0227

Disgraced trachea surgeon – and six co-authors – found responsible for misconduct – Science (Alison Abbott | June 2018)0

Posted by Admin in on August 18, 2018
 

Studies co-authored by Paolo Macchiarini misrepresented patients’ conditions, according to the Karolinska Institute.

The Karolinska Institute in Stockholm has declared seven researchers responsible for scientific misconduct in a case involving six research articles co-authored by disgraced thoracic surgeon Paolo Macchiarini.

We included links to the earlier reporting about the horrendous Paolo Macchiarini story

It says that Macchiarini, who transplanted synthetic windpipes into three patients at the Karolinska University Hospital between 2011 and 2013, held the ultimate responsibility for the papers. The institute’s investigation found that the studies included “fabricated and distorted descriptions of the patients’ conditions”, and lacked the justification that the patients were given the treatment as a last resort. The experimental surgery failed.
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The president of the Karolinska Institute, Ole Petter Ottersen, has called for the papers to be retracted. The outcome overturns a 2015 decision from an investigation under the previous president, which stated that Macchiarini had not committed misconduct in these papers.
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(US) FDA’s revolving door: Companies often hire agency staffers who managed their successful drug reviews – Science (Charles Piller | July 2018)0

Posted by Admin in on August 4, 2018
 

The Food and Drug Administration (FDA) says its rules, along with federal laws, stop employees from improperly cashing in on their government service. But how adequate are those revolving door controls? Science has found that much like outside advisers, regular employees at the agency, headquartered in Silver Spring, Maryland, often reap later rewards—jobs or consulting work—from the makers of the drugs they previously regulated.

FDA staffers play a pivotal role in drug approvals, presenting evidence to the agency’s advisory panels and influencing or making approval decisions. They are free to move to jobs in pharma, and many do; in a 2016 study in The BMJ, researchers examined the job histories of 55 FDA staff who had conducted drug reviews over a 9-year period in the hematologyoncology field. They found that 15 of the 26 employees who left the agency later worked or consulted for the biopharmaceutical industry.

FDA’s safeguards are supposed to keep the prospect of industry employment from affecting employees’ decisions while at the agency, and to discourage them from exploiting relationships with former colleagues after they depart. For example, former high-level employees can’t appear before the agency on the precise issues they regulated—sometimes permanently, in other cases for a year or two.

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