Srish Saini

2K19/BMBA/17
MBA (Business Analytics)
USME, DTU (East Campus)

Data Management & Ethics

Surprise Test 2
Case Study 2

Q1 What is a conflict of interest?

A conflict of interest is a situation in which financial or other personal considerations have

the potential to compromise or bias professional judgment and objectivity.

Q2 Why does a conflict-of-interest matter? Why should the university be concerned?

Conflicts of interest matter because they threaten the central ethical core in the scientific pursuit
of truth and undermine the public trust in science. Objectivity is the sine qua non of scientific
discovery. In addition, conflicts of interest in the clinical-research setting can be, and have
been, associated with injury and death of research participants. Recent headlines have called
attention to conflicts, particularly in clinical research, at many notable universities, causing
them to change their conflict-of-interest policies.

Q3 What types of conflicts of interest can you identify in this case?

1. There are many potential conflicts of interest in this case, both tangible and
intangible. The potential tangible, or financial, conflicts of interest are many:

2. The consulting fees for Dr. Roberts and Dr. Chung if they exceed the Westfield
University policy.

3. The combined 5% common stock for Dr. Roberts and her family.

4. The stock offered to Dr. Chung.

5. The equity owned by the IRB members.

6. The institutional conflict of interest between Arthrid and Westfield University.

There are also several actual and potential intangible conflicts of interest:

• A conflict of interest exists if Dr. Roberts recruits her own patients for the drug trial,
since Dr. Roberts would be acting both as her patientsâ clinician and as the research
investigator for the lupus trial.

• The publication restrictions between Arthrid and Dr. Roberts are an academic conflict
of interest.
Srish Saini
2K19/BMBA/17
MBA (Business Analytics)
USME, DTU (East Campus)

• There is a conflict of commitment/effort/obligation for Dr. Roberts because she is

spending time at Arthrid, but her major responsibility is to Westfield University.

• An academic conflict exists when Dr. Bonita requests the reagent from Dr. Roberts.
The secrecy commitment, made to benefit Arthrid, clearly prohibits Dr. Roberts from
sharing company proprietary secrets and reagents. This agreement was made without
the review of the university legal office or technology-transfer office. If Dr. Roberts
provides the reagent to Dr. Bonita, she violates the secrecy agreement. If Dr. Roberts
refuses his request, she may lose a colleague.

Q4 Should Westfield University Hospital undertake the clinical drug trial? If so, should
Dr. Roberts participate?

Westfield University should consider not undertaking the clinical drug trial, in order to
avoid an appearance of a conflict of interest, since Westfield University holds common
stock from Arthrid. Because Dr. Roberts will financially benefit from this clinical drug trial
if the new drug proves to be successful, she should consider not participating in the drug
trial, particularly as principal investigator. If the Westfield Hospital IRB reviews the Arthrid
protocol, members who have equity interests in Arthrid should recuse themselves from the
review of the study. Also, there is an institutional conflict of interest for the IRB. If
necessary, the Westfield Hospital IRB should consider having the protocol reviewed by an
outside IRB. To be sure, conscientious application of the scientific method and a
randomized controlled-trial design should be in place.

Q5 Does it matter if Dr. Roberts' financial interest in Arthrid consists of consulting fees,
or common stock (equity), or both?

Yes, equity interests are different from consulting fees since equity is dependent on the
success of the clinical studies and future marketing ventures whereas consulting fees are
predetermined and are independent of the testing of the new drug.

Q6 Should Dr. Roberts recommend to her patients that they enrol in the clinical trial if it
is carried out at Westfield University Hospital? What about elsewhere?

Dr. Roberts should not be involved in recruiting her patients, regardless of where the clinical
trial takes place. Or, if Dr. Roberts is involved, she should disclose her relationships with
Arthrid, and independent reviewers should monitor the trial.

Q7 Is Dr. Roberts being faithful to her obligation to provide an educational experience

for Dr. Chung?

Dr. Roberts appears to have a conflict of commitment/effort/obligation that is undermining

the educational experience for Dr. Chung. She is asking Dr. Chung to postpone his research
to comply with her interests, which are influenced by Arthrid.
Srish Saini
2K19/BMBA/17
MBA (Business Analytics)
USME, DTU (East Campus)

Q8 Is Dr. Roberts acting properly in the way she chooses to allocate her time? Is this in
violation of Westfield University Medical School policy?

Dr. Roberts is not acting properly in the way she chooses to allocate her time. She should
discuss her time allocation with her superior. Westfield University, along with many other
institutions, allows researchers to spend up to one day, or 20% of their time, at an outside
interest, and Dr. Roberts has exceeded that amount.

Q9 How should Dr. Roberts respond to Dr. Bonita's request for the reagent?

The secrecy covenant (non-disclosure agreement) in the Westfield-Arthrid contract prevents

Dr. Roberts from sharing the reagent with Dr. Bonita. Dr. Roberts should have consulted
with Westfield University’s legal department and/or the technology-transfer office before
committing to this restriction. In order to comply with the agreement, she made with
Arthrid, she may not share reagents with anyone. She will have to explain the covenant to
Dr. Bonita and apologize. This secrecy covenant would not have been permitted if funding
had come from the National Institutes of Health.

Q10 What are the implications of the Arthrid-Westfield non-disclosure agreement for
academic freedom?

The non-disclosure agreement compromises academic freedom, an important core value of

universities, to freely educate, discuss, publish, and share study results.