The clinical investigator as target

Abstract

Misconduct in scientific research has been given increasing attention during the past two decades. Whether charges of misconduct, misconduct itself, or public concern about it have been on the rise is unclear, but actions taken by professional and medical organizations, universities, and government evidence a reaction to the increased attention. The purpose here is not to review specific instances of alleged fraud or other research misconduct; rather, the goals are to acquaint clinical investigators with the extent to which they are in an exposed (and precarious) position and to suggest how to improve their position. The word target in the title is used deliberately. When the United States Attorney (the federal district prosecutor) names a person as a target of an investigation, it means the U.S. Attorney’s Office has received allegations of criminal conduct, has decided to present the case to a grand jury to secure an indictment, and has already sent or will send to the target a letter offering that person the opportunity to go before the grand jury. If the target accepts, he or she will be asked questions under oath without counsel present. Counsel may remain outside the grand jury room and the individual may consult counsel with respect to taking the Fifth Amendment and making other difficult decisions. Although research misconduct proceedings in a university or other institution are not criminal in nature, the objective here is to suggest that once the charges have surfaced the investigator may indeed feel like the target of a criminal investigation. Much of what follows is based on matters that came to light as the result of activities of a congressional subcommittee and the National Cancer Institute (NCI) that led to charges of scientific misconduct in connection with the National Surgical Adjuvant Breast and Bowel Project (NSABP) being brought against University of Pittsburgh faculty members. Three faculty members are now under investigation by the federal Office of Research Integrity (ORI) because of the alleged misconduct.