At times, Eric tried to guess, based on their responses, which patients were getting the placebo, and which were getting the real drug. In fact, he did not observe much difference in any of his patients and was convinced that the experimental drug was ineffective. He conveyed his opinion to Dr. Thomas, who merely shrugged and said, "We'll see."
After Eric's role in this protocol concluded, he was quickly engaged in other responsibilities. Meanwhile, Dr. Thomas compiled and analyzed the data that Eric collected and wrote up the results. Months passed, and the research ultimately was published in a well-known oncology journal. Eric was curious to read the results of this project, particularly since he was to be acknowledged for his contributions to the effort. Upon locating a copy of the journal, Eric read with astonishment Dr. Thomas's conclusion that the experimental compound was highly effective in alleviating the physical distress precipitated by chemotherapy. Eric read the article closely and decided that Dr. Thomas's recounting of the survey results was inaccurate, describing alleviations of discomfort that Eric never observed or recorded.
Eric wondered what he should do in response. He hesitated to tell his supervisor, the head CRC nurse, because they did not have a very good relationship. Although Eric thought of himself as assertive and conscientious -- never hesitating to point out ideas for improving the operations within the CRC -- he understood that his boss viewed him more as a thorn in her side. He reported his concerns to her, nonetheless, figuring that, at worst, she would discount his report as another in a long list of complaints. As he predicted, his supervisor advised Eric that it would be in his best interest to focus on his current responsibilities and to stop looking for problems. That earlier project was so subjective, she added, that differing opinions on the results were not surprising in any case. Eric indeed recognized a certain subjective quality to the study, having wondered at times if he was recording patient reports consistently.
One day, when crossing the medical center complex, Eric ran into Dr. Thomas and expressed his surprise at the paper's findings. Dr. Thomas stated that once the survey results were decoded, a significant difference between patients receiving the placebo and the experimental drug became evident. Eric then stated that he would be fascinated to learn which patients were getting the drug and which weren't; he asked if he could take a look at the completed surveys now that they were unblinded. Acting hurried, Dr. Thomas stated that they had been sent to storage and that it would be too much trouble to retrieve them. He then dashed off. This behavior seemed suspicious to Eric and made him inclined to believe that some deliberate misrepresentation had taken place.
Eric tried on several more occasions to get the survey data from Dr. Thomas, without success. Knowing his supervisor was unsympathetic to his concerns, and upon the advice of a trusted colleague, he decided to approach the administrator of the medical center's institutional review board (IRE). The IRE reviews the ethical and legal ramifications of proposed clinical research and its administrator would certainly be interested in his suspicions, he reasoned.
Upon meeting with the IRB administrator, Eric explained his belief that Dr. Thomas had misrepresented the findings of his research. In response, the IRB administrator informed Eric that complaints of that nature should be taken to Dr. Holly Baird, the associate vice president for research and the institutional Research Integrity Officer. The IRB administrator counseled Eric that he should not take his concerns any further, though, unless he were fairly certain of them. His allegations seemed to be based on sketchy recollections of data collected long ago, she said, adding that, in her opinion, he did not have sufficient basis for a complaint.
After the conversation, Eric pondered different ways to handle this situation. One approach would be to lodge an anonymous complaint with Dr. Baird and simply let events run their course. Alternatively, he could present his concerns in person, but rather than focus on the inaccuracy of Dr. Thomas's work, he would simply assert a right to access the surveys. Both approaches seemed loaded with pitfalls.
In the end, Eric approached Dr. Baird with the observation that Dr. Thomas's findings seemed inconsistent with Eric's knowledge of the surveys. He framed his concern as much as possible as an observation of fact, without suggesting that any deliberate misrepresentation had taken place. Eric was also quick to note that he repeatedly tried to access the original surveys without success.
Dr. Baird listened to Eric's report and told him that because he had questioned the integrity of Dr. Thomas' research, the institution would be compelled to explore the legitimacy of Eric's statements. This initial phase is termed an "inquiry" she said and would involve an initial review to determine whether a formal investigation would need to take place. Although the complaint might be resolved after reviewing the original survey instruments, it is possible, she explained, that an investigation might ensue, at which point Eric might need to become involved. Eric suddenly felt very queasy. Reflecting upon the prospect of having a face-to-face confrontation with Dr. Thomas, Eric wished that he had never raised the issue at all. The drug in question wasn't even that important, he thought. It's not as though patients would be harmed by it, he considered, wondering why should he take the risk of becoming further involved.