15 NIH trainees and collaborators prohibited from publishing their data.

In 2016, the Director and Clinical Director of the NIDCD (National Institute on Deafness and Other Communication Disorders) within the NIH Intramural Research Program decided to terminate the employment of one of the institute’s senior faculty members, Dr. Allen Braun. The circumstances of this decision are murky, as the two directors, Dr. Andrew Griffith and Dr. Carter Van Waes, have declined to comment publicly on the matter and have refused to provide information on the situation to Dr. Braun’s trainees and collaborators, on the grounds that pending litigation prevents them from commenting. However, along with the termination of employment, they announced to the former trainees and collaborators that they are no longer permitted to publish any studies based on data that they collected at NIH with Dr. Braun. This is a complete publication ban on all data collected under Dr. Braun’s ethics protocol dating back to 1992. This is an extremely harsh prohibition that threatens to destroy careers, negate the contributions of hundreds of research participants, and waste literally millions of dollars of taxpayer money that funded the research.

The directors claim that there was an ongoing pattern of protocol violations that raise questions about the scientific integrity of the data. However, these claims have not been evaluated by any independent review body. The directors are involved in an ongoing wrongful termination suit with Dr. Braun, and their grounds for terminating him rest solely on the protocol violations that they are claiming. Therefore, they are in a position of conflict of interest for evaluating the severity of the protocol violations. To make a rather long story short, the dispute rests on whether or not the proper forms were used to verify participant eligibility for the studies. Eligibility was verified, through extensive formal procedures, but there is a disagreement on whether the procedures fully complied with the details specified in the ethics protocol. For comparison, the Marc Hauser scandal at Harvard involved outright scientific fraud and fabrication of data, testified to by former lab members. Harvard implemented an independent review process and evaluated each of Dr. Hauser’s projects individually, allowing several lab members and collaborators to publish their work that was deemed untainted by the issues brought forward in the investigation. This is standard procedure at Universities. But at NIH, the heart of biomedical research in the USA, no such procedures exist. The insitute directors seem to have unlimited and arbitrary power to use the ethics process punitively, to gain leverage in disputes such as these.

I was a postdoc at NIH from 2006 to 2010. These were some of the most scientifically satisfying years of my life. I got to build my skills and work with some of the most sophisticated equipment and most talented people in the world. In many respects, my postdoctoral experience at NIH was everything that it was supposed to be. I got to collect amazing, irreplaceable data, and I got to learn from the best and work with unparalleled resources. Most importantly, I got to publish several papers that established my scientific reputation and positioned me to move into a faculty position in 2010. So when I moved to my new institution after 4 years at NIH, my enthusiasm for the NIH postdoc experience was glowing. I received many inquiries about the experience from junior colleagues at my new institute, and I always recommended it highly. Until everything came crashing down suddenly six years later. Given the treatment that I and my colleagues have received from NIH in the past year, I can no longer recommend an NIH postdoctoral fellowship as a good career move for anyone. The system that allowed this horror story to take place seems simply too risky for any junior researcher to take, when there are many comparable opportunities available at Universities around the world. Universities that have a transparent system of accountability to resolve academic disputes, as opposed to the arbitrary and capricious system at NIH that allows institute officials unchecked power to inflict irreparable damage on a large body of scientific inquiry and on the careers of over a dozen junior researchers, based on unsubstantiated claims.

I am actually one of the lucky ones. The events that occurred in my postdoctoral lab in 2016, six years after my departure, are remote enough from my present situation that they will not destroy my career. The more recent trainees in the lab have had their entire body of work as trainees rendered unpublishable. Most of these trainees are women and visible minorities, and many of them are not permanent residents or citizens of the United States, making them especially vulnerable. The NIDCD leadership has shown no interest in protecting the careers of any of these trainees and collaborators who invested years of effort into collecting irreplaceable data. It has also swept away the contributions made by over a thousand research participants, many of whom suffer from serious health conditions and volunteered their time to participate in research that promised to make strides towards the improved treatment of those conditions. Furthermore, the publication ban results in an enormous waste of the taxpayer money and resources, several millions of dollars, that went into supporting the lab for 25 years.

There are a lot of details in this case, and there were indeed some protocol violations that occurred – no one is disputing that. But the seriousness and extent of the violations has been grossly exagerrated by the NIDCD leadership, and the scientific integrity of the lab’s data have been impugned without evidence. We are eager to defend the integrity of our data, to which we can amply attest with the help of full documentation, but we are not being given any forum in which to do so. What we are hearing is that Dr. Carter Van Waes’ decision to completely halt all publishing is final, and there is no possible appeal. This kind of arbitrary absolute decision making is shocking, an abuse of a position of power within the federal government, which seems to lack the capacity for independent research oversight found in most universities.

We will continue to fight this publication ban, and to present the fine details of the case in any forum in which we are permitted to. In the meantime, I would caution anyone considering a postdoctoral fellowship at NIH that these kinds of abuses are frequent (ours is not the only similar story by a longshot), and constitute a significant risk of training there.

Part 2 – Initial summary of the facts of the case

I will attempt to summarize the basic facts of the case, although my knowledge of them is limited due to the fact that the NIH leadership has refused to answer requests for more specific information. This is a shortened outline of our understanding of the key facts; documentation is available to support these statements.

The events concern the Language Section (LS) of the National Institute on Deafness and Other Communication Disorders (NIDCD), formerly headed by Dr. Allen Braun. All of the research involving human subjects within LS is under the IRB protocol 92-DC-0178. In March 2015, a volunteer newly consented to the protocol was mistaken for a previous participant with the same name, and the participant completed a research study, listed under the identity of the previous participant.

Dr. Braun discovered and reported this incident to the NIDCD Clinical Director, Dr. Carter Van Waes, following standard OHSRP procedure, and also filed a report with the IRB. On the basis of this single case, the NIDCD issued a termination memo to Dr. Braun, requesting his resignation, suspended all research on the protocol, and issued a moratorium on further publications from the protocol, which still stands today.

Following this, Dr. Braun reviewed the records of the LS and identified a systematic problem, in that 107 participants had been consented to research studies in the past several years without having had History and Physical (H&P) exams by a physician, which is a standard requirement of our protocol. In all cases, the participants were healthy volunteers, not patients, and all had previously participated in a study at NIH in other institutes within the previous 2 years, and had received an H&P clearing them for participation at that time. There was a systematic failure in standard operating procedure, in that staff within the LS had mistakenly believed that these participants did not require new H&Ps within the LS. Dr. Braun has admitted that this was a protocol violation, resulting from a failure of supervision on his part. However, in all cases involving MRI studies, these participants additionally completed MRI safety screening forms on the day of their MRI scans, and all were completed without incident. Thus, all scanning data were obtained using procedures that properly protected participant safety.

The NIDCD Clinical Director then engaged an external firm to conduct an audit of all records from the LS from the previous six years. The NIDCD leadership instructed the audit form in its procedures. The report confirmed the account of the 107 H&Ps, but also raised concerns about 467 other participant records, reaching the rather shocking conclusion that only 9% of the enrolled participants in the six-year period had been fully complied with the protocol. However, these contentions are incorrect, and the LS has presented extensive documentation demonstrating that fact to the leadership of the NIDCD. We have requested several times that an independent body review the case, but have gotten no response to these requests.

There are three categories for which the auditor’s report suggested non-compliance with protocol requirements. These are:

1) 107 cases where new H&Ps were not performed, because existing H&Ps were available, as described above. We acknowledge these to be genuine violations. At the IRB’s invitation, Dr. Braun submitted a remediation plan for how these cases could be reviewed and approved for publication, but the remediation plan was never addressed. The day before the IRB was scheduled to discuss the remediation plan, NIDCD terminated Dr. Brown’s appointment and instructed the IRB not to review the remediation plan.

2) 364 cases for which it is claimed that compliance with inclusion/exclusion criteria had not been documented. Extensive documentation has been provided to NIDCD leadership rebutting this assertion, and they never responded to it. Essentially, the claim is that telephone screening forms for these participants were not preserved, and therefore their eligibility for inclusion/exclusion cannot be determined. This is not the case. Eligibility and safety clearance was thoroughly documented when participants visited the NIH campus, according to the requirements of the protocol. Eligibility is determined through the H&P, and safety clearance is additionally determined through the use of an MRI safety screening form administered on the day of the scan. These practices are standard at NIH and in much of the extramural research world. The telephone screening is merely an initial screen used by lab staff when making first contact with potential participants. Crucially, it is a pre-consent document that seeks to avoid wasting participants’ time by identifying exclusionary factors before they visit the NIH. It is not part of the formal documentation of eligibility and there was no requirement in the protocol to preserve it. We can document the relevant requirements upon request.

3) 103 cases for which the H&Ps performed for healthy volunteers were rejected for not using the proper format, allegedly a standard Clinical Center form signed by the physician performing the H&P. However, this standard form is not in fact a requirement for H&Ps performed on healthy volunteers of outpatient research studies, and all of these cases did receive valid H&Ps in accordance with the requirements for the protocol.

These facts have been presented to the NIDCD leadership, the IRB who reviewed the protocol, and the OHSRP at NIH. I have received no response to my inquiries from these offices other than that all inquiries should go to Dr. Van Waes, the Clinical Director of NIDCD. Dr. Van Waes has responded to my requests for more information with a short form letter devoid of substantial information, and he has repeatedly ignored my requests for a telephone meeting. Essentially, the current state of affairs is that the publication moratorium stands indefinitely and there is no recourse or appeal process being offered. The publication ban affects virtually all data collected in Dr. Braun’s lab, including many data sets collected long before the period of review. In my own personal case, almost all of the relevant data comes from before the period of review.

It is not our intention to dispute the termination of Dr. Braun. He is engaged in his own process regarding that. While that process of litigation proceeds, over a dozen former trainees are currently left in limbo, unable to publish their studies, putting their scientific careers in jeopardy. The specific relief requested is to establish an independent body to review the procedures leading to the moratorium, and to make an impartial decision about whether the data collected by the LS is in fact either ethically or scientifically compromised to the point of precluding publication. It is essential that any such body not include or be unduly influenced by the NIDCD directors, Dr. Carter Van Waes, and Dr. Andrew Griffith, who we believe to have a vested interest and thus a conflict of interest in using a finding of data invalidity as a supporting factor in their decision to terminate Dr. Braun from his tenured position in the NIH IRP.


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