Question

How would you address the ethical issues in this case, and what choice would you make? Explain what you believe to be the main ethical issue, the relevant facts, values involved, as well as alternative courses of action that could be taken. And explain the reasons why you made the choice you do for this case.

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Article: Trimming Data

Nabilah Deen

Joaquin was hired as a senior researcher for a medical research facility. His department has been developing a new medical device to detect HIV faster and cheaper, and the facility has promised investors a prototype would be ready in a year. However, the preliminary results have been somewhat disappointing as only 60% of the case samples have tested positive for HIV, whereas the expected sensitivity was aimed at 80%. Product development had been extended for another six months, but additional funding is needed to continue the project.

Concerned about the low true positives detected in HIV cases, senior managers decide to convene with their scientific advisors (who are under non-disclosure agreement) to determine if 60% is sufficient, if the study is adequately powered, and if there is a better way to evaluate the data. Before the meeting, Joaquin’s boss asks him to trim the data by reporting results only from certain samples, and filter out samples with low yields through observations made during meta-analysis of the clinical data.

Joaquin is uncomfortable with trimming, and argues with his boss that the scientific advisory board (SAB) should see all of their analyses, unfiltered and filtered, because it’s valuable information that could be telling them something about disease stage or test performance. His boss states that as long as they don’t lie about the numbers, there’s no harm in filtering. Joaquin counters they should show a flowchart of the numbers they started with, clinical metadata groupings, analysis methods and filtering steps so that all the information is laid out openly. In this way, the SAB has the opportunity to ask about the methods used to achieve their receiver operating curves, and better understand the clinical cohort subclassification applied to the analysis.

The more they argue over the discussion, the more his boss is unwilling to relent. Joaquin knows that the scientific advisors will expect to see sensitivity and specificity data, ROC curves, false positives and false negatives, and figures of all unfiltered data. While the device is on its way of determining positive HIV results, it is not there yet, so he understands his boss’s reluctance to share the information. How should Joaquin and his boss address this problem?

Nabilah Deen was a 2014-2015 Hackworth Fellow in Engineering Ethics at the Markkula Center for Applied Ethics at Santa Clara University.

August 2015

Answer 1

Joaquin should go to his boss's boss and present the results and go with a third-party witness.

Joaquin can also go directly to the company lawyer or ombudsman or a similar unbiased third party. there are serious ethical questions that override any issues of seniority or chain of command, especially since this deal with a serious issue, HIV

Joaquin must also record all findings as they were originally reported and documented and put a copy in safekeeping.

Joaquin should also document all discussions with his boss, especially those to do with filtering the results, and ensure the information is witnessed and signed off by a third party to ensure its validity and credibility.

Joaquin should not make the presentation to the advisors if he disagrees with them.

Joaquin might want to elect to retain legal advice to protect his position.

Joaquin might want to approach human resources and or a union official to alert them to the problem.

Joaquin should not talk to anyone about the findings or the attempt by his boss to filter them.

Joaquin must keep records and copies and ensure there is a witness when he is discussing the research, the findings, the report, and the presentation.