Thursday, April 28, 2016

U of Maryland Scapegoats IRB and Researcher for PR Foul Up

The University of Maryland has released a report on the problematic December 2015 press release, which included unsubstantiated claims about the benefits of a sports drink based on chocolate milk. While the press release was indeed a disaster, the university report fails to hold to account the people most responsible. Instead, it makes matters worse by accusing the researcher and the IRB of transgressions they did not commit, and by recommending drastic changes that are unnecessary and burdensome.

Shielding the staff who wrote a bad press release

The university issued the press release on 22 December 2015. As reported by Jesse Singal among others, the press release purported to summarize findings from a scientific study by kinesiologist Jae Shim, but the study had not been published, or even submitted for publication. The best the university could produce was a junky PowerPoint file that suggested serious methodological problems (no control group) and, notes Singal, “serious statistical red flags.” As Singal writes, “What happened here happened only because the University of Maryland trampled upon very well-established norms about what it means to publish a press release about a ‘study’ on a dot-edu website.”

The untitled March 25, 2016, report on the incident was written by five professors: two psychologists, a geologist, a chemist, and a chemical engineer. The last, Denis Wirtz, is the vice provost for research at Johns Hopkins, while the rest are current or emeritus Maryland faculty.

Their report claims to offer “a detailed sequence of events beginning with the development of the proposal and ending with the release of the study results to the press.” In fact, it obscures the identity of the individuals and offices responsible for the press release behind the passive voice:

“By May 20, 2015, preparation for Press Release 1 was well underway …”

“July 15, 2015. Press Release 1 was issued by MIPS. Before the Press Release was issued, MIPS had shared drafts and a request for comments with MIPS staff, Fluid Motion, Dr. Shim, the communications staff of the School of Public Health, the communications staff of the A. James Clark School of Engineering, and the UMD Central Communications Office. Several revisions of drafts were prepared based on feedback from individuals in all of these units.”

Who had the idea to issue a press release? Who drafted it? The report castigates Professor Shim for the contents of the release, something that someone else wrote for him. Why not name the flack who did so? By concealing these details, the report obscures the parties most responsible for the fiasco and hinders future reforms.

Blaming the IRB—for what?

instead of focusing on the PR offices, the report seeks to impose blame on everyone, including the IRB.

According to the report,

The IRB reviews of both Phase 1 and Phase 2 IRB protocols were expedited. Expedited Review means that they were reviewed by the Director of the IRB. IRB staff, and the Chair of the IRB, but no other IRB Board members even though Dr. Shim indicated on his application that he wanted a Full Board review. The IRB staff determined that expedited review was appropriate because the risk for participants was considered to be very low.

And you know what? The risk to participants was very low! Some dozens of teenaged and young adult athletes without food allergies were given a widely used food and put through some widely used tests, at least some of which they were taking already. Yes, we can quibble about whether all the actual procedures were fully described on the protocol, and what we mean by intervention. But nowhere does the report suggest that the study put any subjects at risk.

So while the IRB worked pretty much as advertised, the report recommends upending the system of expedited review:

The IRB should review its current practice of expedited review and/or approval of a waiver of informed consent in cases in which the protocols involve an intervention with human subjects, even though the potential for harm is minimal, another entity will be collecting the data, the data are de-identified. and the PI is not directly involved with the subjects. Of particular importance is an assessment of the scientific merit of the proposal and whether the benefit gained is important enough to justify research on human subjects in general, but especially when the research involves un-consenting subjects and minors. This is an important issue both for projects involving service to industry and research designed to contribute to generalizable knowledge through publication in peer-reviewed journals and outlets.

The report makes no effort to imagine what restricting expedited review and waivers of consent would do to the thousands of other researchers at the university hoping to get their protocols cleared. While the federal government works to reduce the burden and delay associated with IRB review, the Maryland report seeks to increase them.

Redefining Conflict of Interest

The report is equally bizarre in its treatment of conflict of interest (COI).

As the report explains,

the UMCPF [University of Maryland College Park Foundation] received the first of three gifts from the Allied Milk Foundation which, during the course of these projects, totaled $200,000. Officials of Allied Milk Foundation, who are also associated with Fluid Motion and FQF [the recovery drinks], authorized the gifts. The gifts provided unrestricted funding for the benefit of Dr. Shim’s Neuromechanics Laboratory. Dr. Shim did not declare these gifts as a potential conflict of interest when he received them, when he submitted the Phase 2 application, nor in his applications to the IRB for continuing Phase 1 and Phase 2.

It continues:

The committee has found a concerning lack of understanding of the basic principles of conflict of interest (COI) in research at all levels of the process among those we interviewed (MIPS, administration, and faculty). The PI. as well as several others, expressed less concern for, and were perhaps less attentive to. the potential of a research COI in part because they felt that this project was in support of small business which is highly encouraged by the state and actively promoted by the university. When asked by the committee to explain why he had not declared a COI regarding the funding from the Allied Milk Foundation, Dr. Shim stated that since the money had not gone directly to him, but had been given to UMCPF to support his research, he did not consider the funding a COI.

In other words, Shim didn’t think he had a COI, and neither did anyone else the report authors interviewed. This might have been a hint that he had no COI.

He didn’t. University of Maryland Conflict of Interest policy, in place since 2003,

The term “conflict of interest” denotes situations in which members of the University community are in a position to gain financial advantage or personal benefit (broadly construed) arising from their University positions, either through outside professional activities or through their research, administrative, or educational actions or decisions at the University.

Typically, a conflict of interest would mean that a researcher has outside financial interests that will be affected by the research. According to the National Science Foundation, for instance, a significant financial interest does not include “salary, royalties or other remuneration from the applicant institution.” Since Shim’s only interested in the milk study seems to have been that it helped pay his university salary, I am not persuaded that he had a conflict of interest.

Rather than accept the commonly understood meaning of COI, the report authors seek to impose a new meaning, with any outside funding constituting a conflict. And they recommend imposing this meaning in the most burdensome way possible:

Mandatory, in-person training on the principles of what constitutes a conflict of interest (COI) in research and why it must be disclosed should be required for all faculty, staff, and graduate students working on funded research or service projects, including those funded by MIPS, the Vice President for Research, or elsewhere.

To be sure, the chocolate milk press release was a disaster, but it was the fault of over-eager PR flacks trying to maximize profits for the corporate university. That is not excuse to punish thousands of student, staff, and faculty researchers by making them sit through mandatory in-person training, forcing an inexpert IRB to assess the scientific merit of their proposals, and taking away their chance at expedited IRB review.

This is how overregulation happens. Embarrassed by a single incident, a university overreacts and imposes burdens on researchers campuswide.

Bring on the Bear Patrol!

No comments: