Administrators and the Responsible Conduct of Research
Case Study:
Janet's Suspicions

Janet's Suspicions

Professor Smith has made no secret of his consulting arrangement with Excellent Pharma Corp. He travels to Miami to meet with company scientists. Sometimes he is in Miami several days at a time, and frequently visits Excellent Pharma two or three times per month. Janet Jones, his department secretary, makes his travel arrangements Prof. Smith also makes no secret of the fact that the vacation he took to Paris this year and his new Porsche Boxter were made possible by the money he made in his consulting activities.

Last week he submitted a proposal to NIH on work closely related to the work he has been doing for Excellent Pharma. As Janet was preparing the proposal packet, she noticed that he checked "no" next to all the questions on the Conflict of Interest Disclosure. She is aware that faculty are permitted to consult with external entities one day per week. She also wonders how Prof. Smith can answer "no" to questions about whether he has any significant financial interest with a company that could benefit from the research. She was very uncomfortable with this and decided to ask Prof. Smith about the Disclosure. He took offense and said "How dare you question my integrity! This is none of your business, so just do as you are told and take the proposal to OSP to get signed." Janet is concerned as to what is the appropriate action to take without being penalized. If she reports Prof. Smith, she might get fired. Could she prove that Prof. Smith really did anything wrong? What if she reported the situation and she turned out to be wrong, or what if Professor Smith had a special arrangement that allows him to do so much consulting? But then, what if she is right and doesn't report the situation?

Case Discussion
Interests of the Affected Parties

Prof. Smith sees no problem in conducting his research at the university and consulting with Excellent Pharma on related work. After all, he would argue, the best way of getting drugs and other medical improvements to the market is to maintain close relationship with companies that can bring the results of research to the marketplace. In his view, the university rules are so restrictive that they would inhibit his work and destroy his collaboration with Excellent Pharma.

Janet Jones has the obvious interest of keeping her job and protecting herself. She also must be able to feel she can do her job while acting ethically herself and not being put in the position of helping other act unethically.

Dr. Alford has the right to expect that faculty in her department are acting ethically and in concert with university's and sponsor policies.

The university is the named grantee and is responsible for compliance with sponsor policies as well as enforcing it's own policies. It has the responsibility for ensuring that research conducted by its employees is done in an ethical manner and is free from the taint of any form of conflict of interest.

Ethical Issues

Janet Jones is troubled because she has this terrible feeling that she is helping Prof. Smith violate the university's policies as well as federal policy. By keeping silent she can protect her job. On the other hand, Prof. Smith told her a while ago that the money he made with Excellent Pharma paid for his Porsche and the trip to Paris. She also knows the time he spends in Miami far exceeds the one day per week the university allows faculty for consulting. She has quite a bit of information that indicates that Prof. Smith is violating university and federal policy and, in fact, is lying on his conflict of interest disclosureConflict of Interest Disclosure
The document completed by those having decision-making authority in proposing, performing, and reporting the work under sponsored projects.
. She is also distressed by Prof. Smith's defensive attitude.

Dr. Alford, the department Chair, depends on faculty being open and honest about their activities. The Conflict of Interest disclosure is the key element in faculty divulging relevant information. If, in the unusual case, a faculty member acts unethically and lies on the disclosure, the chair must be accessible to those who may have information that would address the situation. If the chair is closed to someone like Janet approaches her, then she is indirectly supporting Prof. Smith's unethical behavior. If, when approached, she blindly defends Prof. Smith out of "collegiality" or dismisses Janet's inquiry, then Dr. Alford is acting directly to assist Prof. Smith's inappropriate actions and violation of university and federal policy.

Consequences of Actions

Since Janet is a departmental secretary she could probably have a confidential talk with Dr. Lois Alford, the department chair. Janet could approach it in terms trying to understand the conflict of interest rules better. It would be inevitable that Prof. Smith's situation would be revealed, but Janet would feel better knowing she did not have to bear the burden of unresolved suspicions and the possibility of abetting unethical actions.

Dr. Alford's receptiveness and actions are crucial. First, by acting in a manner that does not demean or punish Janet, she would encourage professionalism among the departmental staff and send the message that ethical behavior is not only encouraged, but expected on the part of everyone in the department. Should Dr. Alford decide to dismiss Janet's inquiry, she would very likely make Janet an outcast in the department and make her continued employment, at best, extremely uncomfortable, and at worst impossible.

Not taking the appropriate action would also place the university in jeopardy. Federal agencies review compliance programs and would Prof. Smith's actions completely unacceptable. The university would also be subject to significant findings in it's A-133A-133, OMB Circular
Audits of States, Local Governments, and Non-Profit Organizations (06/24/1997) (includes revisions published in Federal Register 06/27/2003) – issued by the U.S. Office of Management and Budget.
audit if the auditors chose to review the conflict of interest policy and the implementing procedures.

Prof. Smith may not recognize it, but he is placing his entire research program in jeopardy. If he publishes his findings and it is later discovered that he had a serious conflict of interest and, even worse, that he acted to cover it up, professional journals and other publishers would be forced to retract the publications. This action would, without doubt, be discovered by or reported to NIH. Future funding would be unlikely and there is the possibility that the current sponsored projects could be terminated.

Obligations

Janet Jones needs to find a way to report her suspicions and ask the right questions. If the avenue is through the department chair, Dr. Alford has the obligation to be open and accessible, and then willing to take the appropriate action with regard to Prof. Smith. This would at the very least mean requiring a complete disclosure of his significant financial interests. This would also mean reporting those financial interests to the Conflict of Interest CommitteeConflict of Interest Committee
The body designated by the institution to review and manage or eliminate conflicts of interest.
in order that appropriate action can be taken to manage and/or eliminate the conflict. Dr. Alford and the university also have the obligation to take whatever action is necessary to protect Janet. She would be making a good faith inquiry and does not deserve to suffer negative consequences of any kind. In fact, the message should be conveyed that good faith inquiries are encouraged in the spirit of effective compliance and ethical administrative action.