A group of authors at the University of Oklahoma have retracted a 2013 paper on ethics training after the university found that the data they used couldn’t be shared publicly.
Here’s the notice for “Improving Case-Based Ethics Training: How Modeling Behaviors and Forecasting Influence Effectiveness:”
The authors have advised the Co-Editors of Science and Engineering Ethics that the article noted above must be withdrawn from publication. The University of Oklahoma’s Institutional Review Board conducted a review of the study after online publication had occurred, concluding that, for administrative reasons, the data could not be used outside of reporting to the granting agency. They deferred judgment on whether the publication should be retracted to the Provost’s office. The Provost’s office held that publication of an article requires authors to make the data publicly available and hence recommended retraction.
The paper has been cited once, according to Thomson Scientific’s Web of Knowledge.
We asked the authors for more details, and Shane Connelly responded:
This was an IRB-approved paper-pencil study investigating how certain features of ethics case studies influence knowledge and application of case study principles to new ethical scenarios. The study was part of a larger training course and participants consented to allow us to use their data from the study at the end of the course. Several administrative issues influenced our Institutional Review Board’s decision to not allow the data from this study to be used for research purposes. One of these had to do with the fact that some of the course instructors were not listed as key study personnel and they handed out and collected the study materials and informed consent forms. Even though they did not have any other involvement in the study, we recognized this oversight. Additionally, we implemented two minor changes to study materials, including dropping two items and renumbering 8 items, and did not obtain re-approval for these changes. Lastly, through this review process, we became aware that roughly half of the informed consent forms (ICFs) were not on file. Although we kept a clear record of who consented and who did not through the use of a training checklist, we recognized this was a data storage lapse. We worked with our IRB to fix these problems and have better processes in place to prevent similar issues from occurring in the future. Although the senior editor for the journal did not think that these issues warranted retraction of our paper, our university’s decision that we could not share the data publicly influenced our decision to voluntarily retract the article.
This is a subtle case, as the disagreement between the editor and the university demonstrates. We’d be curious to hear what Retraction Watch readers think.
Hat tip: Ken Pimple
This research group, headed by Michael D. Mumford, has an excellent record of high-quality research. It’s too bad that problems with paperwork required the retraction. If I had been involved with this decision, I would have encouraged the Oklahoma authorities to consult with the HHS Office for Human Research Protections (OHRP – http://www.hhs.gov/ohrp/). There might have been a less drastic measure than retraction.
Was the decision to retract, in part, made because of the fact that the course instructors were not listed as authors (based on the description above, it seems to me that they should not have merited authorship) or because no acknowledgment was made to their contributions to the paper? Assuming the latter, that matter, as well as the other IRB-related issues, could have been easily handled by a detailed correction. After all, and with respect to the other issues, this strikes me as minimal risk research and the lapses mentioned seem relatively minor and largely administrative in scope. I suspect that there is something more to this story.
The fact that half the consent forms were lost is a big deal and they should lose the paper for it, no ifs, ands or buts. It’s a hard lesson to learn, but it will help prevent worse problems in the future.
The other issues (who should have been a key person, and getting approval for every change, even if minor) are real issues, and they are emphasized in IRB training at my institution, and the IRB is right to flex their muscles on this because even though this was a minimal risk study, the next one might not be. But it is very unfortunate to lose a paper over what looks on the surface like administrative nitpicking.
There is a big difference between failing to obtain consent or doing so inappropriately in a way that misleads the subject about the nature of the study, and having the PI lose some of the consent forms (i.e., losing consent documentation). Failing to obtain consent or doing so inappropriately is a big deal. My reading of the case is that the problem with the study in question was with the failure to retain consent documentation; not with the failure to obtain proper consent. Presumably, those subjects (Ss) gave their verbal consent AND then read and signed that consent form in which they understood that they were free to withdraw from the study at any time, for any reason and with no penalty or cost to them (this is standard language in consent forms) and that this consent process was active throughout the study. From a human Ss’ protection point of view, which is supposed to be the sole mission of IRBs, losing some consent forms after the study has been carried out IS a very minor issue. Of course, from a legal point of view (see PJTV’s post) losing such documentation has the potential of being problematic if, for whatever reason, Ss decide to sue the PI and university. But, again, this was a minimal risk study. Were there even any adverse effects reported? I doubt it.
Yes, the IRB was not informed about what appears to be minor, inconsequential changes to the protocol and, yes, there is the issue of key personnel whose role was either not listed or was unclear in the protocol. And there is probably more to this story that we do not know, but the question for me is whether the IRB would have still approved this study if the committee would have been properly apprised of these issues. If the answer is yes and these PIs have never been cited for IRB violations (see Ken Pimple’s post), then, what exactly is the university’s rationale for asking for a retraction? I am not saying that no corrective action should have been taken against the PIs, but retracting an otherwise ethically conducted study? In the absence of other relevant information, I view the university’s actions as completely inappropriate in this case.
Retraction does seem severe.
Presumably, they could have got their participants to reaffirm for the record that they had indeed consented.
It’s possible that the technicalities are beyond me because they’re outside my field, but is institutional (re)validation necessary for them to change the numbering on forms and/or to *not* gather data? (I appreciate that, in some trials, certain answers might be critical to measuring certain effects, but it doesn’t sound like that’s the case here.)
The worst offence seems to be the non-registration of key study personnel, who were, in practice, peripheral. (I’m not at all downplaying the importance of vetting, but they were aware of its importance too, and sought and secured approval of all of their central personnel; it feels like some kind of reminder/warning would have sufficed.)
On a conceptual level, two of these problems are minor and I do feel some sympathy with the investigators. The issue for the IRB was that they are responsible for ethical oversight of the study. In order to fulfill their obligations for overseeing the conduct of the study (in terms of ethical principles and regulations), they have to know what is going on with it. In this situation they discovered: 1) some people were involved in carrying out portions of the study and IRB was not aware of this; 2) the investigators changed the data collection forms without IRB’s knowledge; and 3) the investigators lost the records demonstrating that they had obtained informed consent from the study participants. (The last one is actually pretty serious.) It may not have been at all feasible to track these people down and ask them to re-consent. But anyway, these multiple issues suggest from the IRB’s viewpoint that the investigators do not have reliable processes for remaining within the regulations and following ethical principles. Who’s working on the study? What questions do the participants have to answer? Did they really consent? The IRB has to take some action to correct this in a way that gets the investigators’ attention. The IRB/university needed to respond with something serious and perhaps had few other options. This time it does not appear anyone was harmed (or their rights violated) but it might not be that way the next time.
Responding to Miquel, the retraction was not based on not listing the course instructors as authors but rather because the investigators did not let the IRB know that they were involved in conducting the study. Contributions to the paper or questions of authorship had nothing to do with it.
The issue of people being listed as key people should be clarified. If it was only a matter of issuing and receiving forms, then they should not be listed. If those people had to give substantial guidance or clarifications in the process, then it is right that they are listed as they could eg influence the outcome of a survey.
However, the approach by Oklahoma University – described as emphasis on paperwork by one of the respondents – indeed gives the impression that the institution wants to be sure that all is right from a legal point of view. I presume that the university as employer of those involved can be sued. This reflects the big influence of the legal framework in the Anglo-Saxon world. Would this has happened in the Hispanic world or Asian countries? I venture to doubt this. What is then wisdom? It would at least justify the Oklahoma authorities within the American context.
Does anyone else see the irony in that a well respected husband/wife research team who specialize in ethical decision making CHOSE, er rather “recognize”, that they did not follow proper institutional IRB protocols yet cite “administrative reasons” for retracting the paper? To add insult, defenders such as Pimple and Roig, see this as no big deal. Well it IS a big deal.
Issue One: The Mumford group knowingly dismissed their institutional IRB protocols, made 2 changes to the study materials, rearranged 8 questions, can’t produce IRB consent forms, and still published the paper. WOW. I’ve updated IRB forms in the past and it’s no big deal. Inconvenient to wait a week for approval? Yes, but it is my ethical obligation to follow protocols.
Issue Two: By dismissing this incident as no big deal with a wave of the hand, this group (Pimple & Roig too) are sending a negative message that if no one gets hurt, what’s the big deal? This is a bad and dangerous precedent to set in a lab or research group. I have too many graduate students come to my office stating that they want to do conduct responsible research yet their PI dismisses it. Case in point here.
Issue Three: The Mumford group needs to “own” up to this mistake. They made the unethical decision to publish with perhaps inaccurate data (given the changes they made), and to not follow proper protocols. I expected the group to at least demonstrate some sort of mea culpa by stating that everyone would learn from this oversight, that the PIs would be more diligent in their project management – how hard is it to collect paper? – , and the graduate students would value the institutional process of IRB, no matter how “trivial” or cumbersome.
Perhaps the Mumford Group can write a case study on THEIR “sense making” ethical decision making about this research project.
M. Marie, I will simply repeat my position “I am not saying that no corrective action should have been taken against the PIs, but retracting an otherwise ethically conducted study? In the absence of other relevant information, I view the university’s actions as completely inappropriate in this case”.
Moreover, and given the facts as described above, I think an argument can be made that the greater ethical lapse in this case lies with the forcing of these authors to retract their paper.