A Scenario: Dr. Green, of Large University, oversees a number of research regulatory areas as Associate Vice President for Research. These roles include serving as the Research Integrity Officer (RIO). Dr. Green regularly reviews Institutional Review Board (IRB) minutes and on this day notices a report of a death of a research subject in a Phase II clinical trial of a new cancer drug Large University has patented. What elevates Dr. Green's concern is the statement in the IRB minutes that the consent form in the deceased subject's research file was not signed. The minutes state that the IRB will investigate the matter further. Vice President Green calls the IRB chair and asks to be kept informed. The next day the IRB chair calls Dr. Green to report that there is also a discrepancy between the information in the deceased patient's clinical file (age, time since original diagnosis, previous therapy) and the information listed on the research intake form for that patient, signed by one of the research nurses for the drug trial. There are also several instances where records completed by the same nurse for follow-up visits to monitor health after conclusion of therapy do not include the subjects' initials as required by the protocol.
While fictionalized, this scenario is based on an actual case and is representative of complex problems RIOs have to confront. In this case, urgent review is required under both the regulations protecting human research participants (45 CFR 46) and those covering possible misconduct in research (42 CFR 93). How should the institution organize this review so that handling the case in one venue does not compromise the handling of it in the other? Who does what? In what order?
Because RIOs are often at or near the apogee of the research regulatory structure of their institutions (having titles like that of Dr. Green), it often falls to them to conduct the regulatory triage in cases such as this one. Almost none of them has had any prior training in how to do it.
A Short History of the Position of RIO
Since 1989, every research institution that receives U. S. Public Health Service (PHS) funding has had to assure the Office of Research Integrity (ORI/OPHS/DHHS) that it has policies and procedures conforming to 42 CFR 93 for investigating allegations of Misconduct in Research, defined as fabrication or falsification of research data, or plagiarism (Price, 1994). These policies and procedures are generally administered by an institutional official who has become known as the Research Integrity Officer (RIO).
When the federal misconduct regulations were first promulgated, the position of RIO was not defined--or even mentioned--in either the PHS or the parallel National Science Foundation (NSF) regulations. That has not changed in the intervening 20 years. The RIO remains neither defined nor mentioned in the second generation regulations (42 CFR 93 and 45 CFR 689). Rather, the RIO's position and role have developed and evolved as a matter of necessity. ORI, concerned about the frequent mishandling of cases at research institutions, wanted a single liaison on whom it could rely. As it had already successfully advocated for the creation of similar positions for intramural research at NIH, OR/ wanted RIOs at extramural institutions as well. At the research universities and institutes, misconduct allegations were typically handled at first by the vice president or chancellor for research, or a provost. As it became clear that misconduct cases were often highly complex and time-consuming, the administration of institutional misconduct procedures has become a specialized role assigned to one person, the RIO. Today, the RIO is usually a fairly senior official, typically an assistant or associate vice president or provost.
The RIO's Role and Responsibility
The role of the RIO is complex, exacting, and unique. There is no closely analogous position in the higher education academy. Some university attorneys refer to the RIO's role as "quasi-judicial," but, in fact, the RIO functions variously as prosecutor, judge, mediator, counselor, teacher, and regulatory manager. In the course of handling an allegation of misconduct in research, the RIO may be responsible for completing the following duties, among others: providing notice to respondents and providing all those involved in a case with notice of their rights and obligations under the procedures, conducting or participating in investigative interviews, sequestering data, conducting preliminary forensic analysis of questioned data and documents, selecting and training inquiry and investigative panels, drafting or reviewing inquiry or investigative panel reports, negotiating the regulatory matrix within research institutions, and serving as a liaison to federal oversight agencies. The RIO may also be responsible for triaging and managing particularly complex or difficult cases that involve more than one regulatory area (e.g., research misconduct, research involving human participants, and financial conflict of interest), assuring that the right steps are taken in the right order, protecting whistleblowers from retaliation, or addressing other exigent circumstances that require special handling and immediate notification of OR/or other oversight agencies (see 42 CFR 93.318).
A Critical Problem for RIOs: Impetus for the RIO Boot Camps
RIOs are rarely trained by their institutions. There has typically been only one RIO per institution at any given time. The predecessor RIO has sometimes left the position in the aftermath of a case that has gone awry or as the result of cumulative frustration, so there may be no knowledgeable person at the institution left to train the new RIO. Until now, no professional association or government agency has provided any training. Initial survey data, collected through the RIO Boot Camps, suggest that RIOs stay on the job an average of five years. When the small group of RIOs with 10 or more years of service is factored out, the average is about three years. In either case, it is a short time to gain the experience requisite to learn this complex job, particularly because research misconduct occurs with relatively low frequency and, therefore, many RIOs have handled few cases. Further, and partially because of the way the position developed and evolved, institutional policies and procedures do not always provide the RIOs the authority necessary to fulfill their duties optimally.
Because careers are at stake and many allegations of research misconduct grow out of heated disputes among colleagues, misconduct cases are usually tendentious and often litigious. Serious errors by RIOs in handling such cases can and do end up in the press and in the courts, and in the worst cases lead to millions of dollars in costs, public embarrassment and internal upheaval for their institutions. When RIOs seriously mishandle cases, it can lead to the end of their careers. Mishandled cases also create a problem for ORI as well as for the institutions. OR/must rely on the adequacy of the cases made and findings relayed from the institutions for its oversight work and possible additional findings. The initial work done by the RIOs and their institutions makes it possible for PHS to make findings of research misconduct and to sustain those findings if the respondent appeals under 42 CFR 93.
This, in short, is the impetus for the ORI-sponsored in-service training program for RIOs--the RIO Boot Camp. RIOs are thrown into a critical, high-risk job for which they typically have had no training and for which there is no training model, or body of clearly applicable theory or methods. The first goal of the RIO Boot Camp program, then, is to create well-trained RIOs for research institutions. The second goal is to create, through the RIOs, better institutional policies and procedures for handling allegations, including the building of institutional teams supporting the RIO. Consequently, in 2006, ORI launched the RIO Boot Camp program to train RIOs and to professionalize their roles. Over the course of the seven RIO Boot Camps held to date, a third goal has emerged: providing a web resource to give RIOs centralized access to sample documents, policies and procedures, and technical material targeted to their needs (http://rioresource.org/).
Needs Assessment and Backwards Planning for the RIO Boot Camp
Scientist-Investigators from the Division of Investigative Oversight (DIO) at ORI and the first author (a consultant to ORI who served as a university RIO for 11 years) designed the RIO Boot Camp curriculum. Lack of a pre-existing training model or curriculum for training RIOs, and very little information about who the institutional RIOs were in terms of background and experience, posed a challenging problem. A decision was made to design the RIO Boot Camp curriculum backwards from the outcomes desired--a competent and professionalized corps of RIOs--and to determine what kind of program was needed to get there (Wiggins & McTighe, 2005).
An initial, informal needs assessment (conducted by talking with first generation RIO peers) revealed that almost none of the RIOs had any training for the job. They appeared to have inconsistent legal and logistical support at their institutions (in some cases very little). RIOs were also isolated. Discussion with approximately 30 RIOs at the first boot camps revealed that most had never talked with another RIO, much less seen other RIOs' work, and so they had no opportunity to learn from their peers' successes and errors. Nor did they usually seek advice from ORI in the handling of cases, sometimes viewing that office as a potentially hostile oversight agency. In short, many were flying blind into the storm with no navigational aids.
To provide the research community information about who RIOs were, and to arm new RIOs with information about "the RIO experience," a video was created, entitled...