Ethical Dilemma 1

Case study instructions

This is a group assignment. The class will be divided in three groups. Group 1 will be assigned to case study part 1, group 2 to case study part 2 and group 3 to case study part 3. Each group will assign a group leader who will be responsible for ensuring the participation in this assignments and posting of their answer. Each group will provide feedback to the other group responses.

Case Study Part 1

Eric Woodworth is an oncology nurse working in a clinical research center (CRC) at a large academic medical center. Dr. Philip Thomas is an oncologist and clinician researcher who conducted a trial in the CRC of a drug being evaluated for its safety and efficacy in alleviating the nausea and discomfort associated with cancer chemotherapy. Eric assisted on Dr. Thomas’s project in several ways. He attended to the patients’ routine clinical needs and administered their cancer chemotherapy by I.V. He also gave the patients participating in Dr. Thomas’ protocol oral doses of what may have been either the experimental drug or a placebo. The vials were numerically coded, so Eric did not know which he was providing. Finally, he interviewed patients concerning their symptoms, following a standardized questionnaire prepared by Dr. Thomas.

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.

Questions

  • 1. If you were Eric, what would you do at this point to address these concerns?
  • 2. Does Eric have a responsibility to take action toward correcting what he believes is an erroneous report?

Case Study Part 2

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 decided to approach the administrator of the medical center’s institutional review board (IRB). The IRB reviews the ethical and legal ramifications of proposed clinical research and its administrator would certainly be interested in his suspicions, he reasoned. 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.

Questions

  • How should one decide whether a suspicion of wrongdoing is sufficiently significant to warrant lodging a formal complaint?
  • What are some considerations Eric might take into account in weighing whether to lodge a formal complaint?
  • In your opinion, does Eric have sufficient cause to register a complaint with the Research Integrity Officer?
  • How would questionable research studies impact evidence-based practice?

Case Study Part 3

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 face­to­face 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.

Questions

  • Should the clinical importance of the research weigh in the decision to pursue the allegation?
  • Eric might have wrongly accused Dr. Thomas. What should the consequences of that error be, if any?
  • If misconduct is found/ruled out, what steps should the institution take?

Case study retrieved from https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/case_studies-2001.pdf

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