Skip to content

Increase the NIH Budget, Only With Reform Of Our Research Integrity Efforts

Today The Gates Institute ( http://gatesinstitute.org/ )and Johns Hopkins Bloomberg School of Public Health ( http://www.jhsph.edu/ ) continue to present the Forum on Public Health Advocacy:  http://gatesinstitute.org/event/high-level-forum-public-health-advocacy. This morning, Senator Ben Cardin of Maryland ( http://www.cardin.senate.gov/about/ben/ ; https://twitter.com/SenatorCardin ) urged for an increase in our NIH budget.

The observations shared in this blog indicate this must be accompanied by a change in our approach to research integrity and the management of biomedical research protocols.

In Research Integrity – Get It Right

It is vitally important to communicate objective and accurate information about known cases of research misconduct, including the management environment in which it occurs.  This knowledge is fundamental to our understanding of scientific misconduct, and thus to improving the integrity and ROI in our biomedical research.  It is also essential to education and training in Responsible Conduct in Research (http://www.nsf.gov/bfa/dias/policy/rcr.jsp https://www.citiprogram.org/index.cfm?pageID=418&id=72 ).

At PRIM&R’s Advancing Ethical Research Conference in 2010 (AER 2010) (1) the U.S. Deptartment of Health and Human Services, Office of Research Integrity (http://ori.hhs.gov/) presented several sessions.  In a session on research misconduct cases, Sandra Titus of the Office of Research Integrity presented information about Eric Poehlman’s work (2).  She stated several times that Poehlman “worked alone” while conducting his research.  That he worked alone when he was first at UVM during the time I was working with him (1988 – 1991+); that he worked alone while at University of Maryland, and he continued to work alone when he returned to UVM.  It is fair to say that this was a point Titus was intent on making and reinforcing.

Those who have worked on research protocols of this type know that it simply is not possible for one person to conduct such a study alone. Poehlman was not working alone when I worked with him, and he did not do so later. This does not mean that those who worked on Poehlman’s protocols were necessarily aware of, or intentionally took part in, misconduct .  It is, however, an important point to clarify in our effort to improve our understanding of research misconduct.

I attended the Office of Research Integrity’s Conference in April, 2013 (“ORI at 20” Conference; April 3rd to 5th 2013; Baltimore,MD) where I told Alan Price (who worked on the Poehlman case when he was at the ORI) about Titus’ AER 10 presentation.  That Titus stated repeatedly that Poehlman had worked alone.  I explained my view that this was not the case, and why I thought it was important to understanding Poehlman’s misconduct as well as for improving our Responsible Conduct in Research educational efforts.  Alan also felt that it was important to understand that Poehlman did not work alone, in fact he said he would talk to Titus about it.

Sandra Titus went on to present more inaccurate information at AER 2010 about Walter DeNino (who reported Eric Poehlman’s wrong doing through procedures then available at UVM).  She said DeNino later “applied to four medical schools, didn’t get into any of them, and went back to New York”.  The fact is Walter DeNino was admitted to, and graduated from, the University of Vermont College of Medicine in 2010.  Indeed, as Titus was telling the audience this, Dr. Walter DeNino had started the Integrated Cardiothoracic Surgery Training Program at the Medical University of South Carolina.

It is important to note that the ORI http://ori.hhs.gov/ is presenting information which is incorrect but easily available after a brief internet search, about one who reported one of the largest instances of biomedical research misconduct in the US.  I spoke with Sandra Titus at the Office of Research Integrity Conference in April of 2013.  She still did not know Walter DeNino had gone to medical school.  She said she had a phone conversation with DeNino after he applied to medical schools during which she thought he had told her he was not accepted to, and would not be attending, medical school.

(1) At the PRIM&R, AER 2010 Conference; Dec 6th – 8th, 2010, San Diego, CA; I presented my Research Integrity “Thesis” from UVM: Session C5; “Towards Ensuring Research Integrity: Appropriate Communication and Delegation of Responsibilities by the Principal Investigator”  http://www.slideshare.net/VHDavid .

(2) PRIM&R, AER 2010 Conference; Dec 6th – 8th, 2010, San Diego, CA;  D24  An Update from the Office of Research Integrity (ORI)  (RCR Track);  Tue 3:45 pm — 5 pm;  John Galland, Sandy Titus.

Next: “Why It Is Important To Get It Right. And To Fix It When It Is Not”

In Research Integrity: It’s One Thing

Call it Research Integrity, call it Responsible Conduct in Research, I like to just call it “Research”.  The Weekly Review Meeting of the Principal Investigator & Research Team is the cornerstone of conducting, and training for, responsible and effective biomedical research protocols.. (Please click to enlarge the image and read my Comment and Dr Fang’s reply.)

ResearchIntegrity,OneThing B

I began my work in the Cell Biology Ph.D. program at UVM in 1988.  I shared an office with Eric T. Poehlman, then a post–doc.  My observations of Eric Poehlman’s misconduct became part of the data I collected for my “Thesis” in this Cell Biology–turned–Research Integrity Ph.D. program.

20 years later I used this in a submission to PRIM&R for its annual Advancing Ethical Research Conference. emtoPRIM&R AERC09 Idea

I then presented my “Thesis” (for fullfillment of my own requirements for this Research Integrity “Ph.D”) at PRIM&R’s 2010 Advancing Ethical Research Conference:  “Towards Ensuring Research Integrity: Appropriate Communication and Delegation of Responsibilities by the Principal Investigator”    (http://www.slideshare.net/VHDavid)

David R. Van Houten   http://www.linkedin.com/in/davidvanhouten

The Science of the Research Protocol: Principal Investigator Meetings with the Research Team

Efforts towards improving integrity in biomedical research have often ignored the environmental, research protocol management aspects that provide the “opportunity” for misconduct (Adams and Pimple, Accountability in Research 12(3):225-240,2005).

> At times this has been an intentional oversight.

Not long after I began work in the Cell Biology Ph.D. program at the University of Vermont in 1988, it became evident that a Post—Doc with whom I was working, Eric T. Poehlman, was not following some basic practices vital to scientific research.  Some of these poor practices have not been addressed in the investigations and reviews of the misconduct for which Poehlman later plead guilty.  Nor have they been adequately dealt with in research integrity publications and communications in general.

The single biggest factor allowing for Poehlman’s data fabrication and falsification was the absence of weekly meetings of the Principal Investigator with the research team.  During meetings all staff, clinical and lab technicians, new scientists in training (graduate students) and those with more experience (post–docs, fellows, other faculty) participate in, and learn from, the regular review and discussion of the benchmarks of data collection and management.  I pushed to get these meetings organized, and when they did occur, it made it easier to detect and prevent Poehlman’s manipulation of data, and made it easier to recover original, unaltered data.  It also reduced the hours and stress involved in conducting the protocol.

This observation became part of the “data” I collected for my “thesis” in this Cell Biology Ph.D.–turned–Research Integrity Ph.D. program.  https://researchintegrity.wordpress.com/about/   I used this in a submission to PRIM&R for its annual Advancing Ethical Research Conference. emtoPRIM&R AERC09 Idea

This became a  workshop I presented with Greg Koski at the AER 2010 conference titled “Towards Ensuring Research Integrity: Appropriate Communication and Delegation of Responsibilities by the Principal Investigator”    (http://www.slideshare.net/VHDavid)

Research leaders need to recognize, and stop ignoring, the importance of following practices vital to conducting scientific protocols, such as regular meetings of research team members with the Principal Investigator.  As I found with Poehlman’s misconduct, following basic practices inherent in conducting scientific protocols is the most direct route to integrity in science.  This approach makes some resources that have been spent on improving research integrity, such as the ill—defined “Mentor” role, appear redundant.  It is one issue that suggests a need for a review of the work of the Office of Research Integrity, and the Responsible Conduct in Research field in general.

–David R. Van Houten,  Closter, NJ

________________________________________________________________________________
Note:  I have posted Comments on PI meetings on other sites.  You may read them, and their Replies, at the links below. DVH

–A  blog by Peter Murray-Rust http://blogs.ch.cam.ac.uk/pmr/2011/08/14/data-publication-some-replies/#comment-96507
–Science, “Live Chat, Are We Doing Science the Right Way?” 6 February 2013. http://news.sciencemag.org/sciencenow/2013/02/live-chat-are-we-doing-science-t.html#disqus_thread
_______________________________________________________________________________

The Science of the Collection and Publishing of Data

Observations on managing the research team during the collection of data.   I posted this on a blog by Peter Murray-Rust, a chemist, who writes on the value and methods of keeping knowledge open.  It is in a discussion on Publishing Data in scientific Journals.  David R. Van Houten
__________________________________

Thank you for the important blog article and comments. Publishing original data can be beneficial in many ways, all of which are probably not possible to predict at the time of publication. Having a record of original data gives insight into contemporary methodologies and knowledge that the full text paper may not reveal.

To add an observation, from one in biomedical research, on improving scientific integrity at an earlier in the scientific process, as data is being collected. I think research leaders in all disciplines should recognize the fundamental importance of weekly (at least) meetings of the research team with the Principal Investigator. During these meetings all staff, new scientists in training, & those with more experience, can learn from the regular review and discussion of the benchmarks of data collection & management.

The absence of these weekly meetings was, I believe, the single biggest factor allowing for the data fabrication and falsification that I observed 20 years ago as a PhD student. I pushed to get these meetings organized, and when they did occur, it made it easier to get the offender to stop and easier to “salvage” original data. I bring this up because it is one of the important “environmental” components that have been overlooked in the review and investigations of scientific misconduct as the RCR field has developed over the last 25 years.

Thank you to those in the informatics and publishing field for your work in making original data available along with the authors publication.

That’s this reader’s two cents/two pence.

  • pm286 says:

    Thanks,
    Good points – and certainly possible – in principle – to build data management into much PhD supervision. We do this in software with code review meetings.

The Compliance & Integrity Goal

As with all compliance and scientific integrity issues, progress can only occur when we keep in mind the goal is not to point to people, but to data/information, practices, and management methods that appear to need revision.

Observations of research integrity issues over 25 years indicates that, at times, this is not possible without also referring to the people involved.  This too often leads to a reluctance to review apparent mistakes, ineffective or poor practices.  This is a significant barrier which I have repeatedly observed prevents people from making changes to improve our biomedical research — even those in the Responsible Conduct of Research field.  Those who are committed to integrity in biomedical research (which should be everyone in the field) must focus on fixing the problem and not the blame.  This is vital to maintaining and improving the Return On Investment on the dollars we spend on biomedical research.

Biomedical Research Practices and Quality of Life

In discussions and reviews of the costs of scientific and biomedical research fraud, the most important and devastating consequence is rarely mentioned. (1)  Reports on the consequences of research fraud correctly raise the loss of public confidence in research; the effect on recruiting subjects for participation in clinical research studies (a primary factor in the money and time needed for clinical trials); effects on colleagues, students, post—docs and others on the research team (an effect I can personally verify); and the consequences for the department and institution where the misconduct occurs. (2)

–>Yet the most important impact is on those suffering from the disease states to which our biomedical research is devoted. Their quality and length of life is dependent on the basic day-to-day practices of the research team.

(1) Dahlberg, J.  The Costs of Research Misconduct.  Office of Research Integrity Newsletter, December 2009

(2)  It should be noted that federally—funded grants such as NIH are given to the grantee Institution or University not the researcher. Usually the Institution/University is responsible for Responsible Conduct in Research education programs.

Clinical Trial Patient Recruitment & Digital Marketing

Clinical Trial Patient Recruitment & Digital Marketing

Retraction Watch

Tracking retractions as a window into the scientific process

Just another WordPress.com site

Chaos Theory and Pharmacology

A blog dedicated to the study of complex relationships in pharmacology. “Journalism is printing what someone else does not want printed: everything else is public relations.” ― George Orwell | CC-0

Research Integrity

Observations of Scientific Misconduct, Basic Practices for Integrity & ROI in Biomedical Research http://www.linkedin.com/in/davidvanhouten

davidgimlett

A great WordPress.com site

THE SINGLE ONE IN THE GROUP

When you're the one who always has the crazy dating stories...

ORI UPDATES

Observations of Scientific Misconduct, Basic Practices for Integrity & ROI in Biomedical Research http://www.linkedin.com/in/davidvanhouten

HealthcareVistas - by Joseph Babaian

Discussing modern healthcare initiatives that improve outcomes, change lives, and create opportunity.

CFA

Taking Action to End Hunger & Homelessness

Nurses Advocating for Nurses

hcldr

Healthcare Leadership Blog

Medical Writing, Editing & Grantsmanship

Customized Customer Support for Biomedical Researchers

Ethics Beyond Compliance

Ethics training on demand

Emerging Technologies Librarian

PF Anderson's virtual explorations

Health Care Social Media

Monitoring The Pulse Of Health Care Social Media

Open Access Button

Push Button. Get Research. Make Progress.

Follow

Get every new post delivered to your Inbox.

Join 897 other followers

%d bloggers like this: