Conflict-of-Interest.net

In light of an impending roll out at my university (the University of Montreal) of a new conflict of interest process — including completion of an annual and punctual declaration form, supported by a new informational website and training program — its interesting to reflect on the challenges that institutions face when aiming to upgrade their conflict of interest policies and procedures.

The following story from the University of Texas — New Disclosure Policy Delayed at UT System — points to the challenge of striking a balance between too much and too little disclosure. Transparency in declaring an interest as part of a regular process of identifying and managing COI is clearly a good thing. Its important that members of the university be helped to recognise when a particular interest may become a COI so that appropriate management procedures can be implemented. But its also important that policies and procedures are sufficiently clear about what is or is not a problematic COI, what needs to be disclosed (financial, non-financial, institutional), when, and to whom. Not every COI gets dealt with in the context of a regular annual disclosure; some we have to deal with in the classroom, “on the fly” in a departmental meeting or in a committee, or in our relations with students and colleagues (see my recent paper on the  management of unavoidable COI). Where COI are declared through a formal process, then the institution also has to ensure that there is the appropriate expertise in place on the part of those managing declarations to ensure that any disclosure is dealt with in a sensitive and respectful manner, and not treated by those involved as an accusation of misconduct.

The 3rd World Conference on Research Integrity is being held in Montréal this spring, May 5-8, and looks to be an amazing opportunity to see some of the leading international research on research integrity and conflicts of interest (programme). So if you’re in the Montreal area, an opportunity not to be missed!

My team and I are presenting the following papers:

May 6 16:45-18:15 —  Concurrent Session 9. Social and Philosophical Perspectives on Research Integrity

• A core principle of integrity: Overriding the threesome of research ethics, Charles Dupras, Université de Montréal

May 7 10:15-11:45 — Concurrent Session 14. Conflict of Interest

• Research conflict of interest: Flaws in professional codes of ethics, Charles Marsan & Maude Laliberté, Université de Montréal
• Conflict of interest policies for authors, peer reviewers and editors of bioethics journals, Zubin Master, Albany Medical College, USA; Kelly Werner, Albany Medical College; Elise Smith, Université de Montréal; David B. Resnik, National Institute of Environmental Health Sciences; Bryn Williams-Jones, Université de Montréal
• Developing a conflict of interest policy at the University of Montréal: Process and innovation, Elise Smith, Charles Marsan, Bryn Williams-Jones, Université de Montréal
• Managing conflicts of interest in research ethics review: Exploring ethical tools for Canadian Research Ethics Boards, Marie-Josée Potvin, Ghislaine Mathieu, Elise Smith, Bryn Williams-Jones, Université de Montréal

May 8 12:30-14:00– Concurrent Session 24. Issues Arising in Collaborations and Networks

• Governing dual-use research in Canada: A policy review, Bryn Williams-Jones, Catherine Olivier, Elise Smith, Université de Montréal

Here’s a very interesting story about David Healy and his take on the field of Psychiatry, and its all too close a relationship with the pharmaceutical industry: Psychiatrist Contends the Field Is ‘Committing Professional Suicide‘

See also these related stories (in French):

• Études biomédicales: la fraude responsable des deux tiers des rétractations
• Des auteurs-fantômes discréditent la recherche médicale

This story from April - Student union and Lakehead U. board at odds - got me thinking about how the term COI gets overused, and sometimes even misused. At issue was changes to Lakehead University’s COI bylaw for its board of governors; the critique being made by the University is that student representatives on the board were in a COI when discussing issues of student tuition.

What’s odd about this move is that it seems to assume that all members of the board are neutral with regards to all subjects. And so because students can’t be neutral about issues regarding students, then they probably shouldn’t be on the board. The problem, though, is that the very reason that students are and should be representatives on boards or committees of various sorts, is to represent student interest – they are explicitly not disinterested, nor should they be!

The COI scandal/saga at the American Journal of Bioethics – which broke in Feb 2012 – has taken some new and interesting twists in the last two months.

As William Heisel states so clearly in his blog of Aug 15, 2012 “The American Journal of Bioethics has published what has to be one of the longest corrections ever for an academic journal. And yet it manages to beg more questions than it answers.” Heisel is referring to an AJOB Editor’s note in Vol 12/8 that begins with the following: “The editors regret that the journal failed to include the following possible conflict of interest disclosures in the November 2010 issue of The American Journal of Bioethics” and goes on to list the various financial COI of the editorial board members. Yet, as commentators to Heisel’s blog entry rightly note, financial disclosure has important limits and the list of editors is incomplete.

Then, in a comment posted by Glenn McGee on the AJOB Facebook page Sept 25, we hear:

After all this time, the Bioethics page on Facebook is now going to be run by David Magnus at Stanford University, my successor as editor in chief of The American Journal of Bioethics, to whom I have also bequeathed bioethics.net, blog.bioethics.net and the AJOB LinkedIn pages. I’m moving on. I no longer wish to be framed as having any kind of conflict of interest as I pursue new ventures, and believe that these electronic elements I’ve been working on since 1994 should be joined with the print journal, AJOB, and edited out of one place. Thank you for reading all these forums and to all 870 who have joined this one, more than 10,000 who read weekly AJOB news, and the thousands who read my blog.bioethics.net entries for years. Look forward to great new things from the AJOB and bioethics.net group as they continue to provide the #1 source of bioethics information on the Internet and in the highest ranked bioethics journal by all metrics. Cheers!

In these various declarations and changes of editorial leadership, we see a journal and its editors trying to get their editorial house in order…and succeeding more or less. The skepticism by many in the bioethics community remains widespread and clearly has had a negative impact on the trust placed in the objectivity and credibility of the journal. Rebuilding this trust will take continued and sustained effort on the part of the journal editors and the publisher.

The problem of editorial ethics — and COI in particular — is one that, unfortunately, has still received insufficient attention. Yet the consequences of poor editorial ethics can be dramatic.

Selected resources

• Smith, E.; Potvin, M.-J. & Williams-Jones, B. (in press) “Medical Journals Need More Transparent and Accessible Policy Instruments on Editor Conflicts of Interest” Journal of Medical Ethics.
• Committee on Publication Ethics (COPE)

I’ve been reflecting for a while on the non-financial and unavoidable (but manageable) conflicts of interest that occur in the life of a university professor. Below are three case studies — built on personal experience — that explore some of the COI that professors face.

• Williams-Jones, B. “Reference Letters and Conflict of Interest: A Professor’s Dilemma” BioéthiqueOnline 2012, 1/10
• Williams-Jones, B. “University Textbooks: An Acceptable Conflict of Interest?” BioéthiqueOnline 2012, 1/9
• Williams-Jones, B. “Choosing Thesis Juries: The Costs of Taking a Strict Line on Conflicts of Interest” BioéthiqueOnline 2012, 1/6

With my team, I’ll also be working up a variety of other resources (articles, book reviews, commentaries) on COI which I hope to publish as a thematic issue of BioéthiqueOnline, sometime this coming Fall.I’ve been reflecting for a while on the non-financial and unavoidable (but manageable) conflicts of interest that occur in the life of a university professor. Below are three case studies — built on personal experience — that explore some of the COI that professors face.

• Williams-Jones, B. “Reference Letters and Conflict of Interest: A Professor’s Dilemma” BioéthiqueOnline 2012, 1/10
• Williams-Jones, B. “University Textbooks: An Acceptable Conflict of Interest?” BioéthiqueOnline 2012, 1/9
• Williams-Jones, B. “Choosing Thesis Juries: The Costs of Taking a Strict Line on Conflicts of Interest” BioéthiqueOnline 2012, 1/6

With my team, I’ll also be working up a variety of other resources (articles, book reviews, commentaries) on COI which I hope to publish as a thematic issue of BioéthiqueOnline, sometime this coming Fall.

For those in Montreal next week for the ACFAS conference (Palais de congres, May 7-12), I’d recommend catching a presentation by my student Charles Marsan, entitled “Des conflits d’intérêts en médecine vétérinaire?” (May 7, 9am, 523A). Here’s the video.

Charles did a dry run of his presentation last week at an internal team workshop, and did an excellent job in spelling out why COI is an understudied by incredibly important issue of the practice of veterinary medicine.

For those in Montreal next week for the ACFAS conference (Palais de congres, May 7-12), I’d recommend catching a presentation by my student Charles Marsan, entitled “Des conflits d’intérêts en médecine vétérinaire?” (May 7, 9am, 523A). Here’s the video.

Charles did a dry run of his presentation last week at an internal team workshop, and did an excellent job in spelling out why COI is an understudied by incredibly important issue of the practice of veterinary medicine.

The following story — Conflict of interest policy shifts responsibility to U. — caught my attention. With a change of policy by the NIH, faculty at US universities are now required to declare to their institution, financial interests of more than $5000, so any COI can be managed. What is interesting, though, is not the financial threshold (which as I’ve noted in the past, is problematic), but the ongoing problem of identifying when there is a COI, and who should be responsible for such determinations.

As noted in the article,

“People do have conflicts of interest, and it’s not the end of the world,” said Janet Blume, associate dean of the faculty. All Brown professors are required to file a conflict of interest form with the University every year, now listing potential conflicts of interest amounting to $5,000 or more.

All well and good, but what financial sources fit into this requirement? Is it just direct contracts from industry, or can other funders create financial COI that should be declared, and then managed? If so, how are professors, acting in good faith, to know? What is their responsibility to do “due diligence” and investigate all sources of potential funding?

Professor of Economics Ross Levine offered an example of the complexities of conflict of interest in research funding. Levine received a $30,000 grant from the Charles G. Koch Charitable Foundation for research he is conducting on changes in competitive banking policies in 2009. The Koch brothers, founders of a group of charities that have given hundreds of millions of dollars to conservative organizations and causes, contacted Levine around 2006 after visiting campus, Levine said. They expressed interest in his research, which seeks to understand implications of increased competition among banks in the 1970s and 80s in terms of economic growth, distribution of income and racial discrimination, he said.

…

None of the money from the Koch brothers is personally benefiting Levine, he said. The money has been allocated to hiring research assistants through an account Brown set up for Levine’s research. Levine has also used funding from several other sources to hire graduate and undergraduate students to assist on the same research, he said.

…

Levine said he is “uncomfortable” with the fact he did not know about the Koch brothers’ politics before accepting their grant. “I wish this wasn’t the case,” he said. He said he acknowledges the Koch brothers as a funding source on all papers related to the research, because “it’s the reality.” At the same time, he said he recognizes the complexity of questions surrounding the ethics of accepting funds from outside sources. “I can’t be responsible for screening all of the money that comes to Brown that somehow affects my research, because it comes from such a huge number of sources,” he said.

The following story — Conflict of interest policy shifts responsibility to U. — caught my attention. With a change of policy by the NIH, faculty at US universities are now required to declare to their institution, financial interests of more than $5000, so any COI can be managed. What is interesting, though, is not the financial threshold (which as I’ve noted in the past, is problematic), but the ongoing problem of identifying when there is a COI, and who should be responsible for such determinations.

As noted in the article,

“People do have conflicts of interest, and it’s not the end of the world,” said Janet Blume, associate dean of the faculty. All Brown professors are required to file a conflict of interest form with the University every year, now listing potential conflicts of interest amounting to $5,000 or more.

All well and good, but what financial sources fit into this requirement? Is it just direct contracts from industry, or can other funders create financial COI that should be declared, and then managed? If so, how are professors, acting in good faith, to know? What is their responsibility to do “due diligence” and investigate all sources of potential funding?

Professor of Economics Ross Levine offered an example of the complexities of conflict of interest in research funding. Levine received a $30,000 grant from the Charles G. Koch Charitable Foundation for research he is conducting on changes in competitive banking policies in 2009. The Koch brothers, founders of a group of charities that have given hundreds of millions of dollars to conservative organizations and causes, contacted Levine around 2006 after visiting campus, Levine said. They expressed interest in his research, which seeks to understand implications of increased competition among banks in the 1970s and 80s in terms of economic growth, distribution of income and racial discrimination, he said.

…

None of the money from the Koch brothers is personally benefiting Levine, he said. The money has been allocated to hiring research assistants through an account Brown set up for Levine’s research. Levine has also used funding from several other sources to hire graduate and undergraduate students to assist on the same research, he said.

…

Levine said he is “uncomfortable” with the fact he did not know about the Koch brothers’ politics before accepting their grant. “I wish this wasn’t the case,” he said. He said he acknowledges the Koch brothers as a funding source on all papers related to the research, because “it’s the reality.” At the same time, he said he recognizes the complexity of questions surrounding the ethics of accepting funds from outside sources. “I can’t be responsible for screening all of the money that comes to Brown that somehow affects my research, because it comes from such a huge number of sources,” he said.

An interesting case study in the Journal of Bioethical Inquiry, by Sarah Winch and Michael Sinnott, entitled “Toward a Sociology of Conflict of Interest in Medical Research“, inspired three members of my team and I to write responses, which have just been published in the same journal. The case of Dr B is an interesting exploration of the challenges facing researchers who, in good faith, try to identify and manage COI, but encounter significant difficulties when they don’t have the necessary knowledge and institutional support.

1. Smith, E. (in press) “Towards a postmodernist view of conflict of interest” Journal of Bioethical Inquiry. (Online First: March 20 2012)
   
2. Mathieu, G. & Williams-Jones, B. (in press) “Managing Conflicts of Interest Should Begin with Dialogue and Education, not Punitive Measures” Journal of Bioethical Inquiry. (Online First: March 20 2012)
   
3. Potvin, M.-J. (in press) “The Strange case of Dr B and Mr Hide: Ethical sensitivity as a means to reflect upon one’s actions in managing COI” Journal of Bioethical Inquiry. (Online First: March 2o 2012)

Chris MacDonald at the Business Ethics Blog has an interesting analysis on the costs of COI, and in particular, why its problematic not only being in a COI, but putting someone else in a COI: The True Cost of Conflict of Interest