Institutional Review Board Crisis Response Review: FINAL REPORT, November 2089

After extensive investigation, the new members of the Board hereby present our analysis of the issues leading to the summary dismissal of our predecessors. We hope that our report will also be of use to the team investigating accusations that the actions of our predecessors caused a number of preventable local outbreaks.

We have unanimously concluded that our predecessors acted ethically at the beginning of the global crisis, especially given the confusion and communication breakdowns of the time. The first local application to conduct research on biospecimens derived from victims of the outbreak (#IRB-2072-H-267) was submitted as part of the Global Health Organisation’s Infection Control Consortium effort, and as such focused on understanding the basic biology of the disease; approval was granted at an emergency meeting of the Board. The research conducted locally under the auspices of this IRB approval contributed directly to the much-celebrated success of the ICC.

Our consensus opinion is that the expedited approval of the next related application, #IRB-2075-H-023 – which focused on vaccine development and testing – was also appropriate. We were not able to locate hard evidence of any exchange of this rapid approval for early access to said vaccine, as has been alleged.

Most of us agree on the ethical validity of the next related approval, IRB-2077-H-688. Progress in global efforts to manage the outbreak had by this time reduced its impact from outright panic to extremely heightened vigilance, and biomedical labs around the world were returning to their pre-crisis fields of research. IRB-2077-H-688 involved testing novel orthopedic devices on victims of the outbreak. The Principal Investigator made a compelling case that conventional preliminary testing of such devices on traditional (i.e. static) cadavers is inadequate, and successfully argued that tests on what were believed at the time to be merely ambulatory cadavers would provide much stronger validation of her experimental device’s superior performance compared to existing knee replacement technology. She was demonstrably correct in this assertion, although we believe that the Board could have done more to foresee and prevent the problems caused by improving the mobility of the test subjects.

Dr. Hutch has since retired to the Cayman Islands, and declined to be interviewed about her interactions with the IRB. The class action suit brought by the parents of her late graduate students has been settled out of court.

We could not reach consensus on the validity of the Board’s approval of the next contentious submission, IRB-2081-IH-003. It must be remembered that some members of the Board, as well as many of the returning evacuees from the Faculties deemed non-essential to Crisis Management efforts, were deeply traumatized, and in the latter case also strongly motivated by the grant funding offered as part of the Interim Government’s “Rebuild and Recover” Plan. In defence of our predecessors, the application in question promised tangible anti-terror and international trade benefits as a result of improved airport design; the use of infected individuals to empirically observe pedestrian behaviour and preferences at the most instinctive level was, at the time, novel, and the promised benefits of this research are now beginning to be realised to some extent. However, extension of this principle to the purely commercial sector, under the auspices of approval #IRB-2083-IH-051, did, in our unanimous opinion and despite the protestations of lobbyists hired by domestic and Swedish mega-retailers, cross an ethical line. Nevertheless, to blame our predecessors directly for the local outbreak caused by the failure of one outlet’s staff to thoroughly clear their wardrobe section of test subjects prior to re-opening the store to the public is, in our view, unfair.

The background to the scandal that launched the current investigation is well known. To summarise, the volume of post-outbreak-related submissions received by the IRB increased ten-fold from 2082-2087, and the exchange of financial and other favours for some approval certificates is a matter of record. As a result of successful campaigning by a number of groups representing the rights of infected individuals and (since last year) the Cured community, all approvals granted after #IRB-2083-IH-272 have (in our opinion correctly) now been rescinded, and all work on these projects has ceased to the best of our knowledge. However, the Interim Constitution does not allow for the results of the 2088 election, widely believed to have been influenced by the use of infected individuals to assist with the winning party’s candidate selection process, to be overturned. An analysis of the extent of the contribution made by former members of the IRB to the long-term impacts, positive and negative, of laws enacted by the Interim Government is beyond the scope of the current investigation; history can be the only judge.

In conclusion, examining the extenuating circumstances leading to the public relations challenges currently facing the University does offer some degree of insight into how the breakdown of the IRB system occurred. However, the exact point at which intervention in the Board’s activities from University officials could have prevented these issues is as grey an area as is the point at which the approved research became unethical.

As the IRB begins to accept new applications again, we would like to take this opportunity to unanimously and enthusiastically endorse the recommendations recently published by Snow et al. (Nature, 2089) to further our understanding of the recent outbreak primarily through the use of (traditional) model organisms.

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