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A university investigator is in hot pursuit of a project
that received a mediumsized grant from the NIH. Her grant depends on the use of
reagents from an independent company. She has had a long and fruitful
relationship with the company—she has given several seminars at the company,
and her counterpart in the company has given several seminars at the
university. Also, the investigator has earned a few thousand dollars annually
from the company through consulting. She has signed a consultancy agreement
with the company without clearance from the university. Her agreement
relinquishes all her intellectual property rights regarding the subject of the
consultancy to the company. The investigator asked the university to sign a
material transfer agreement (MTA) so that she could start using the reagents.
The university refused because the MTA gave too many rights to intellectual
property to the company in exchange for the reagents. The university
investigator was anxious to start her project and make progress so that she
would be able to renew her grant. One day during her frequent seminars at the
company, she was asked to sign the MTA agreement, and she did. • What should
the university do? • What should the faculty member do? • What should the
company do?

In early 1990s, a university faculty member was
collaborating with a Danish company in a joint venture on a compound with a
view toward clinical trials within a year. The company has already submitted a
patent application on a portion of the project. In written correspondence
between the university faculty member and her counterpart at the Danish
company, both pledge full cooperation without mentioning anything about
intellectual property. A year later, the Danish company enlisted a U.S. company
to conduct certain experiments. The university and the Danish and U.S.
companies all entered into negotiation regarding intellectual property. The
negotiations failed, and the university ordered the faculty member to stop any
further collaboration. • What should the faculty member do? • What should the
university do? • What lessons are learned in this scenario?

A faculty member of a midwestern university has a
postdoctoral fellow who had been working for three years on one aspect of a new
drug that has just been approved by the FDA. The drug company pays the mentor
$5,000 per year in consulting fees. This year, the company is sponsoring a
threeday conference in San Francisco, all expenses paid. The conference brings
together approximately 15 scientists from around the country who are leaders in
research on this drug. Their job is to speak to 300 invited guests, physicians
who are potential prescribers of the drug. All the physicians’ expenses are
paid. The speakers will each receive a $3,000 honorarium. The faculty member
accepts the invitation, and the postdoctoral fellow hears about it by accident.
He informs his mentor that he has new data indicating that the drug may have
serious side effects. The mentor points out that the work is not yet published
and that she will deal only with the published data for now. • Under the terms
of the COI policies described above, is this a COI? • If the answer is yes,
what is the COI? What type is it? • Are there COIs in this case that are not
covered by the policies? • Is this a case of misconduct? • Should the mentor
have done anything differently up to the point that the postdoctoral fellow
told her about the new data? What should the mentor and postdoctoral fellow do
now?

A senior researcher in a major research university has two
grants from the NIH and research contracts from two different large
pharmaceutical companies. She also serves on the National Heart, Lung, and
Blood Institute Advisory Board and one of the FDA’s advisory panels. Her work
pertains to drugs that lower cholesterol. The FDA panel that she is on was
convened to decide whether to recommend the fi nal approval of a drug for
consumer use. The drug is manufactured by one of the two companies with which
she has a contract. However, the contract has nothing to do with this
particular drug. Prior to the deliberations, she disclosed her research
contract as a COI and proceeded to participate in the panel. She was one of
those who voted to recommend approval of the drug, but the recommendation would
have passed anyway, without her vote. • Is this really a COI case? Was it
necessary for the senior researcher to have disclosed her contract with the
company as a COI? • Should the FDA have allowed her to deliberate on this
panel? • Despite the fact that she was allowed to participate on the panel, do
you think she can deliberate without being unduly infl uenced by the contract
she holds? • Should universities encourage or discourage their researchers from
placing themselves in such positions?

A junior scientist at a university made a major discovery
for a new antibreast cancer drug. With the help of the university’s Offi ce of
Research Development, she applied for a patent and established an agreement
that splits the profi ts between her and the university. The new drug had the
potential for bringing in millions of dollars for both parties. Using venture
capital, the university formed a startup company. The junior scientist and her
department chair were on the board of directors. Other board members included
several university administrators and a few employees of the venture capital
company. The patent was awarded few years later. The startup company still has
not made a profi t, but it is very close to marketing the drug. The junior
scientist, while at a conference, heard that a researcher at another university
has come up with a drug very close in structure to hers, but one that is much
more effective and has fewer side effects. The inventor of the new drug plans
not to patent his drug but instead to place the information in the public
domain. A different group of venture capitalists formed a new company to
manufacture the drug as quickly as possible. The junior scientist, with
prodding from her venture capitalists, is now thinking about challenging the
new company with a lawsuit on the basis of patent infringement. The patent
battle could delay and may eventually prevent the new company from ever
producing the new drug. • What are the COIs in this case? Who has COIs? •
Because NIH funds have not been used for this research, should the NIH and
university COI policies be applied to this case? If so, what impact would these
policies have? • At this point in the case, what should the interested parties
do?

A member of an NIH study section was the primary reviewer of
a grant proposal submitted by a very close personal friend and colleague. The
extent of their relationship was well known among the close-knit research
community, and the primary reviewer chose not to recuse himself. He proceeded
to review the proposal and gave it his highest ranking. During the
deliberation, another member of the study section raised the issue of the
perception of COI. The chair of the study section and the reviewer in question rejected
the implications of the comments, pointing out that the member’s signature on
the COI declaration was suffi cient indication of his ability to make an
objective judgment. Additionally, the NIH scientifi c review administrator said
that study section members were obligated and expected to put personal
relationships aside as part of their commitment to an objective evaluation. The
study section proceeded with the overall approval of the grant proposal.
However, the administrator informed the chair of the study section that the
person who raised the issue concerning the COI has the right to go through the
formal appeal process. • Was the scientifi c review administrator justifi ed in
making the statement about expected objectivity? What should the policy be in
such circumstances? Should personal friendships ever be considered as a
disqualifi er for an objective review? • Should the member of the study section
in question have done anything differently? • Was the other member of the study
section justifi ed in bringing the subject of COI?

A university scientist/ethicist who is often cited by the
national media on issues related to research on human subjects is called by a
journalist from a major newspaper in a distant city. The journalist wants to
know what he thought of the letters just received from the FDA and Offi ce for
Human Research Protections warning his university about its continued and
frequent failure to comply with federal regulations. The letters in question
had been addressed to a university vice president, who happens to chair a
search committee formed three months ago to fi nd a top-level assistant on
research affairs. Two weeks ago the scientist/ethicist had applied, with many
others, for the job. • Is the COI fairly obvious here? Why or why not? Does it
fall under the umbrella of any COI policies? • What should the
scientist/ethicist do? Should he tell the journalist about his application?
Should he inform the vice president of the journalist’s request for his opinion?
Should he give the interview off the record or fi nd a reason not to give the
interview at all? • Is there any reason for the scientist/ethicist to consider
the university’s interests as more important than his own? The public’s right
to be informed as more important than his own interests?

A clinical researcher receives $3,200 per patient from a
drug company to enroll patients in a clinical trial of a new hypertension
medication. The money covers patient care costs and administrative costs for
the duration of the study and includes a $200 fi nder’s fee. After the initial
screening and enrollment, patients will make a total of eleven 15-minute offi
ce visits during the study. At each visit, nurses will take blood, record vital
signs, and ask them questions about their hypertension. The clinician will do a
physical exam. • Is this fi nancial arrangement a COI or apparent COI? • Should
it be prohibited? • During the informed consent process, should patients be
told about the clinician’s fi nancial interests?