Academic journal article Journal of Research Administration

Training the Research Integrity Officers (RIO): The Federally Funded "RIO Boot Camps" Backward Design to Train for the Future

Academic journal article Journal of Research Administration

Training the Research Integrity Officers (RIO): The Federally Funded "RIO Boot Camps" Backward Design to Train for the Future

Article excerpt

Introduction

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. …

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