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**Ethical Dilemmas in Research Integrity**

**Janet Brigham, PhD**

**Arthur B. Chausmer, MD, PhD**

**Kendall S. Fraiser, DVM, PhD, ACVP**

**Claire E. Gutkin, PhD, MPH, MS**

**Gailen D. Marshall, MD, PhD**

**Shawn Spilman**

**Harry W. Tyrer, PhD**

**Copyright 2004**

This publication was funded by the US Dept of Health and Human
Services, Office of Research Integrity.

**ISBN 0-9628976-5-0**

Contents

**Data Acquisition, Management, Sharing and Ownership** Independent
Confirmation of a Colleague\'s Results 6

Sharing Data Prior to Publication 7

Commercially Valuable Research Results 8

Results Based on Proprietary Data 9

Incidental Results and Transient Data 10

Confidential Information that Might Affect Others 11

Ownership of and Responsibility for

Research Materials 12

Data Integrity 13

Ownership of Data and Right of Use 14

**Mentor / Trainee Responsibilities**

Staff Attendance and Working Hours 16

Advisor\'s Ownership of Mentored Work 17

Rights to Mentored Research Concepts and Results 18

Inside Knowledge and Equality of Opportunity 19

Recruiting Outside Resources 20

Romantic Relationships 21

**Publication Practices and Responsible Authorship**

Use of Copyrighted Illustrations from Prior Publications 24

Attribution of Mentored Research 25

Simultaneous Publication in Different Venues 26

**Peer Review and Privileged Information**

Confidentiality of Material Being Reviewed 28

Protecting Information Provided Anonymously 29

Use of Anonymous Survey Data 30

**Collaborations**

Collaborators Who Become Competitors 32

Spouses as Collaborators 34

Collaborating on the Review Process 36

**Human Subject Research**

Minority Representation that Confounds Data Analysis 38

Informed Consent that Confounds Data Analysis 40

Unexpected Changes in Sample Demographics 42

Unexpected Abnormal Test Results 44

Ending a Study Early 45

Informed Consent for Saving Research Data 47

Appropriate Use of Test Data 48

Scope and Venue Issues for Informed Consent 49

Selecting a Control Group 50

Selecting a Clinical Trial Site 51

**Animal Subject Research**

Choice of Animal Subject 54

Animals Used to Monitor Other Animals 55

Source of Animal Tissue Used in Research 56

Changing a Research Protocol that Uses Animals 57

Use of Animals after Research Ends 58

Unexpected Death of Animal Subjects 59

Research Use of Tissue from Livestock 60

**Research Misconduct**

Appropriate Use of Commercial Software 62

Research Use of Commercial Publications 63

Research Impact of Changes to Guidelines 65

Padding a Budget 66

**Financial Conflicts of Interest**

Divulging Information about Funding 68

Accepting Funding with Strings Attached 69

Evaluating Research Results for

Commercial Applications 70

Working for a Competitor Company 71

Working for the Competitor of a Sponsor 72

Use of Proprietary Educational Material 73

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Data Acquisition, Management, Sharing and Ownership

# Independent Confirmation of a Colleague\'s Results 

A graduate student brings her advisor experimental data that suggests a
major breakthrough.  The advisor asks another graduate student to repeat
the experiment, in order to verify the accuracy and reproducibility of
these results.  He also asks the second student not to discuss this with
anyone else, so as to ensure independent confirmation of the results. 
How should the second student proceed?

G9L says:  It would seem that the investigator might engender better
loyalty and integrity among his students if he discussed with the first
student that he wanted independent confirmation of the results, then
told the second student in to repeat the specific experiments in a
blinded run, and then compared results.  Since presumably the original
data were generated by the student within the context of a
mentor-trainee relationship, the investigator is responsible for
confirming prior to dissemination.  All three people should share in
disseminating the information, with the first student as lead author and
the investigator as senior author.

K5R says:  I don\'t see a problem with either repeating the experiment
or in not discussing it with others.  However, the student should bring
concerns to the investigator or at least question the investigator about
an open discussion once the experimental results are independently
confirmed.  The first graduate student who found the important result
should not be left out of the loop and should share recognition.

**Sharing Data Prior to Publication**

A researcher, speaking at a conference, presents two sets of results
based on two related datasets.  He references a paper that he published
recently, describing in great detail the first set of results based on
the first dataset.  This paper mentions the second dataset but does not
discuss the results based on it.  A colleague attending the conference
asks for a copy of both datasets.  The researcher is pleased to deliver
the first set of data, but does not want to turn over the second until
he has had time to prepare another paper, describing results based on
that dataset, and had it accepted for publication.  Is the researcher
justified in withholding the second dataset until he has published his
results?

G9L says:  Certainly, it is reasonable to withhold data until at least
accepted for publication on the basis of competitive publication
principles.  However, it would likely be more satisfactory not to even
mention the dataset publicly until the manuscript was at least prepared
and submitted.

C4R says:  The author should not have mentioned the second dataset
unless results from its analysis are being used.  It provides no
additional information, and in fact, could provide contradictory results
upon analysis.  He does, however, have the right to withhold the second
dataset, even if mentioned on the grounds provided.

**Commercially Valuable Research Results**

Your government-funded research at a university lab has produced
results, published in a peer-reviewed journal, that have great potential
for commercial application.  A for-profit corporation requests a copy of
your data, saying that they want this for use in their own research and
that they have no intention of commercializing your results.  You
strongly believe that the potential for commercial application is
compelling and unavoidable.  How should you proceed?

C4R says:  Since this is government funded research, the data are
required to be placed in a public repository and made available to
others.  The investigator must therefore comply with the request but can
require that an intellectual property waiver be signed.

K5R says:  This situation arises frequently, and is always a source of
concern.  Virtually every university has an intellectual property (IP)
statement that is sent out simultaneously when either material or data
are sent to other laboratories or to companies.  Since this is
government funded research, the investigator has the obligation to
comply with the request, but he should also demand that the material
waiver IP form be signed first.

**Results Based on Proprietary Data**

Using data mining technology to query her employer\'s extensive customer
database, an economist at a Fortune-100 company develops a predictive
model.  She tests her model against real life events, as reflected by
new entries into this same database.  She tabulates impressive results
and submits an article to your academic journal.  During peer review,
one reader comments that it would be impossible to reproduce the
validity test results without having access to the proprietary corporate
database, as no other comparable data is available, at least not in the
public domain.  Would you accept the paper for publication under these
circumstances?

C4L says:  Because the data belong to the employer, the employee should
obtain permission from the owner to submit an article based on its use
and the corporation should be cited or acknowledged in the article.

K5R says:  I would not accept the paper without first discussing the
matter with the author and asking for a letter from the corporate people
giving permission for the data mining application.  Otherwise, there is
likely going to be a lawsuit at some point to contend with.

**Incidental Results and Transient Data**

The radiology department of a medical school has designed and programmed
a data visualization program that reads a series of physiological test
results and converts this data into a multi-colored scatter plot, which
can expose anomalies that would not otherwise be apparent.  They have
copyrighted the software and applied for a patent on the process.  A
technician who works at the school has captured several hundred images,
produced from patient data during the software testing process, and used
them to make wall-sized collages.  He is selling these at a local art
gallery and on eBay.  When confronted, he points out that neither the
data nor the identity of the patients can be recovered from the images,
nor can the images themselves even be recreated by the data
visualization program, as the various settings and parameters would be
impossible to reproduce.  Is the student ethically correct in claiming
sole ownership of these images?

C4L says:  The data upon which the images are based belongs to the
medical school and should not be used for any purpose other than that
for which it was collected.  Under federal human subjects protections,
previously existing data, collected for one purpose and presumably with
consent given for that purpose, cannot be used unless the original
consent allowed other uses.  Even though confidentiality and anonymity
will be maintained, these data should not be used to construct the
images.

K5R says:  In this situation, the technician is using proprietary
material from their job for their own personal gain.  I don\'t think it
matters that the source of the data cannot be established or that this
is artistic rather than scientific.  This is still stealing from the
company unless prior approval is received.

# Confidential Information that Might Affect Others 

Your employer is developing a diagnostic machine that performs genetic
screening to identify inherited diseases.  While testing the device
using samples provided by co-workers, you discover that one of your
fellow employees has a treatable inherited disease.  You inform him
about this and he tells you that he was not previously aware of it.  Do
you have any obligation to inform his family?  If so, must you first
obtain his consent for this?  What if he withholds consent?  What
difference would it make if, instead of being affected with this
disease, your co-worker were merely a carrier whose offspring would be
predisposed to the disease?

C4L says:  The samples provided by the co-workers were presumably
collected subsequent to the signing of a human subjects consent form. 
The consent probably included a confidentiality clause and therefore
disclosure of the results to anyone would be a breach of this consent.

K5R says:  The obligation is his, not yours, to tell his family, and
nothing can or should be done without his consent, regardless of whether
he has a clinical condition or is a carrier for a disease.

# Ownership of and Responsibility for Research Materials 

A graduate student gathers dissertation data while working on her
advisor\'s federally funded research project.  Following a disagreement,
the student finds a new advisor and leaves the project, taking her
laboratory notebooks, microscope slides, and copies of data on computer
diskette.  Is she justified in taking her notebooks?  The slides she
made?  A copy of the data she collected?  What if there had been no
disagreement and, instead, the advisor told the student to take these
materials with her, after graduation, explaining that they would be
safer in her possession and she would need them to prepare presentations
and articles for publication?

K5R says:  It is my opinion that the laboratory notebooks, data and
microscope slides belong to the lab, not to the graduate student, and
therefore they should stay with the advisor.  Certainly, the situation
would change if there was no disagreement and the advisor said it was OK
to take them.  I think the originals should stay with the laboratory,
however, and the graduate student should take only copies.

# Data Integrity 

When it is learned that the experimental results reported by a graduate
student cannot be reproduced, after further investigation the student is
charged with misconduct and dismissed.  The student had earlier
presented these questionable results at a meeting where, although no
proceedings were published, written abstracts were handed out.  The
student also exchanged email with staff at other research facilities,
discussing these results and forwarding a small part of the data.  What
action should the university take, if any, after discovering that this
questionable data was discussed prematurely and perhaps even partly
released?  Does the university have any obligation to protect the
privacy and reputation of this student?

W8Y says:  When the student was charged with misconduct and dismissed,
presumably this occurred through a formal process and the evidence
indicated that the student was indeed guilty. The university has no
obligation to correct the dissemination of questionable results, since
it was of an informal nature. Publishing retractions to unpublished
results would only confuse the issue. There is no reference, and
others who might mention that work would do so without citation. The
university has expelled the student and has no further obligation to the
student. Given that the courts have determined the right to privacy of
students, the university must not publicize the issue, although leakage
to local papers might occur and the university might not be able to stop
it.

# Ownership of Data and Right of Use 

Your research project has leased a new, state-of-the-art piece of
laboratory equipment that prints graphical displays in full color.  The
manufacturer has posted a technician on site at your lab for several
weeks to get the equipment up and running.  At the end of his last day,
the technician asks to take about twenty printouts, created with data
from your project while he was monitoring your analysis and calibrating
the equipment.  He wants these for use in sales presentations and
possibly in a brochure.  He explains that your data was incidental to
obtaining the output and it was his machine which produced the
printouts.  Should you permit this?

K5R says:  Data derived from leased laboratory equipment does not belong
to the equipment manufacturer.  Material for brochures must be derived
from in-house experiments, not from those taken from investigators using
the equipment.  This could pose problems with copyright later when data
is to be published in journals and there is an issue of prior
publication in a brochure.

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**Mentor / Trainee Responsibilities**

**Staff Attendance and Working Hours**

A graduate student works increasingly late night hours after other lab
staff have gone home, and is less often present during the day. His
advisor asks the student to spend more time in the lab during the work
day, when others are present, to enhance interaction with other
researchers. The student refuses, insisting that equipment he needs is
rarely available during regular working hours and he is more productive
at night when fewer people are around. How can this conflict best be
resolved?

K5R says:  This situation requires compromise by both parties.  The
laboratory director has to have flexibility in allowing students and
staff to work later if that is when they will be most productive, but
the director is under no obligation to cave into the demands of students
and staff who do not want to be present during the day to be properly
supervised.  It would not be difficult to set up a schedule where the
student spent half time present during the day (afternoons or perhaps
alternating one day and one evening).

# Advisor\'s Ownership of Mentored Work 

A graduate student prepares a research proposal as part of
her dissertation requirements. Her faculty advisor reviews the proposal
but otherwise provides only minimal assistance in developing the
concept. The student later learns that her advisor has paraphrased
sections of her proposal and incorporated them into his own application
to a different funding agency. How should the student respond?

J1G says:  This happened to me in graduate school.  I tried to bring
this to the attention of the dean of the college, who \"investigated\"
it and wrote me back a scathing letter in which he chastised me for
daring to criticize one of their sterling faculty members.  So my advice
is: Let it go, get on with your life, and recognize that students are
treated like germ entities at many institutions.  It\'s just a fact of
life, and no student is going to be able to change it.

K5R says:  This situation is unfortunately all too common, and I don\'t
see much recourse for the student.  I do think the student should make
sure that his or her name is included as a participant in the advisor\'s
grant application, with funding requests. The student will therefore be
able to gain some mileage out of the advisor\'s grant application, even
if their own grant is not funded.

# Rights to Mentored Research Concepts and Results 

A postdoctoral student working in a lab for several years is offered a
faculty position at another university. He asks his advisor to write a
summary of his accomplishments. The advisor appends to this a list
of research materials that the student may not take with him when
leaving the lab, as well as a list of research areas\--some not yet
under investigation\--and a statement that the student agrees not to
work in these areas. The advisor asks the student to sign a copy of this
document. How should the student respond?

W8Y says:  The postdoctoral student should not sign the paper.  And,
indeed, the student is a better judge of his own accomplishments and
should provide the information himself under these circumstances.  The
student must respect the mentor\'s wish that research materials not be
taken from the lab.  The student should copy whatever data he produced,
however, and then hurry up and write the papers.  The case of the patent
rights to lasers provides instruction here.  Gould had the presence of
mind to get his notebook notarized.  The laser patent was granted to
Townes and Schawlow, and Gould\'s application was turned down.  Gould
fought, however, and a decade and a half later he was given a window of
opportunity so that he received his fourth and final laser patent nearly
three decades after Townes and Schawlow received their award.

Returning to the issue of rights to mentored research, it seems clear
that the patent courts recognize the worker, as is generally true in
competing claims to intellectual contributions.  The student must
protect himself and, in the absence of a contractual arrangement, he has
first right to the data and its eventual disposition.

# Inside Knowledge and Equality of Opportunity 

A professor is mentoring two postdoctoral fellows.  The professor hears
about a desirable job opening at another institution, and strongly
believes that one of his postdoctoral candidates is significantly better
suited to this particular job than the other.  How should the professor
respond?

K5R says:  The professor should mention the job opportunity to both of
his post-docs and let them decide if they are interested.  His letters
of reference for the job can be weighted towards the suitability of the
other candidate, and if asked pointedly by the hiring researcher, he may
rightfully give his opinion of which one would be better suited for the
job.

# Recruiting Outside Resources 

A graduate student working in a government funded lab has made an
important discovery, on his own initiative, which his advisor believes
to warrant further analysis.  The student wants to perform this analysis
himself because it would give him an opportunity to learn the techniques
involved.  A commercial lab can perform the analysis much more quickly,
however, and at low cost.  Besides, the advisor does not consider it
particularly worthwhile for the student to learn these analytical
techniques.  How should the advisor have the analysis performed?

# Romantic Relationships 

Romantic relationships have developed among doctoral candidates working
in a large university laboratory on several occasions.  Invariably these
relationships have led to bad feelings, either among those involved or
among their colleagues in the lab, and productivity has suffered as a
result.  The director seeks to establish a policy that would sustain
morale in such cases, preferably by requiring that at least one party to
any such relationship must leave the lab.  Is this appropriate?  How
should the director proceed?

J1G says:  What is this, a third-world country where marriages are
arranged?  Geez\--live and let live!  If romance between students were
the only source of conflict (or conflict of interest) we would have
nearly a perfect world.  Any lab director who thinks that love among
equals is the source of trouble needs to get a life.

K5R says:  I disagree with a policy that would make one of two parties
in a relationship leave the laboratory.  I think it is unfair and
impossible to control (people would tend to be discreet rather than
aboveboard) and in the end, bitter feelings could turn even more
bitter.  On the other hand, I do agree with a policy in which
supervisors should not be allowed to become romantically involved with
those they supervise (eg, there should not be romantic relationships
between an advisor and a student or advisor and staff). This is written
into most human resource policies at companies and universities, and is
probably sufficient.

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Publication Practices and Responsible Authorship

# Use of Copyrighted Illustrations from Prior Publications 

Two researchers have co-authored a paper, describing their results,
which has appeared as a preliminary report in a copyrighted monograph. 
One illustration in this paper is a computer-generated scatter plot of
research data.  Both researchers are preparing more substantial papers
for submission to peer-reviewed journals.  They both agree that
the scatter plot in the monograph article is crucial to their
presentations.  Deciding that this illustration must be included in both
new papers, they alter their computer program to generate the exact same
figure using different fonts and different line thicknesses.  Is it
necessary to say in their papers that these figures were adapted from
the monograph article?  If so, is that sufficient, or must permissions
be obtained?

K5R says:  It would be appropriate to mention that the illustration came
from a prior publication, but I don\'t think permission is required from
the previous publication since an illustration itself is not
copyrighted.

5S says:  An acknowledgement would be polite, but is not necessary, nor
must permission be obtained.  The illustration is not a work of
authorship, and is not by itself copyrightable, and is small enough that
reproducing it can be considered fair use.

J1G says:  I disagree with the previous comment.  Better to be safe than
sued \-- it is usually very easy to get permission to reprint any part
of an article, or even an entire article.  Just write and ask.  It\'s
more burdensome to come up with a workaround than to do the ethical
thing and honor the copyright.

# Attribution of Mentored Research

You are writing a book chapter describing recent advances in your
field.  One of your graduate students made significant progress.  Using
ideas that you conceived, he designed and ran experiments without
supervision, interpreted the results without assistance, and wrote
several important papers that were published citing him as the primary
author and you as the only coauthor.  In your book, should you attribute
these advances to you first and then him?  To him first and then you? 
Or to him and unnamed associates?

K5R says:  In most book chapters that I am familiar with, the authors
use \"we\" or \"in our laboratory\" or \"in collaboration with X, we
found\....\" rather than using one person\'s name or the author\'s own
name.  Research is always a plural rather than singular effort.

# Simultaneous Publication in Different Venues

You are the editor of a yearbook summarizing recent research in your
field.  One of the main articles was submitted by a colleague, who is
cited among your coauthors.  Several months after your book was
published, you see an article by that colleague in a peer-reviewed
journal.  Although dealing with the same subject matter, this article is
entirely different from the chapter in your book.  You notice, however,
that two illustrations\--a graph and a diagram\--are identical in both. 
Neither publication acknowledges the other.  You later learn that the
article was prepared and submitted to the journal before your book was
written, although it did not appear in print until after the book was
published.  What, if anything, should you do?

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Peer Review and Privileged Information

# Confidentiality of Material Being Reviewed

Having been asked to review an article for a journal, you give a copy of
it to one of your graduate students, asking her to read it and prepare a
1-page written critique.  She later gives you a page of comments and
also discusses the paper with you in detail during an hour-long
meeting.  After reading the article yourself, you use the graduate
student\'s written and verbal comments as part of the basis for your
review.  You later learn that the graduate student kept a copy of the
article in her files.  Was any of this inappropriate?

C4L says: Permission to do so should probably be obtained from the
journal prior to sharing the document with the student. If the student
provided substantial input, he or she might be also be listed as a
reviewer, which would be advantageous to the student.

K5R says: Most journals have policies against circulation of unpublished
manuscripts. Therefore, making extra copies for graduate students is
probably inappropriate, as is the graduate student keeping a copy.
However, I think it is entirely appropriate for an advisor to allow a
mature grad student, post-doc or another close colleague to
simultaneously review a manuscript, discuss it, and to incorporate some
of those comments into an editorial review. Such a procedure only
enhances the accuracy, fairness and thoughtfulness of the review
process.

**Protecting Information Provided Anonymously**

You have a grant to develop a Web-based program of genetic counseling.
Clients who navigate to your Web site and use the program do not
identify themselves by name. Nonetheless, insurers, prospective
employers, and others would place a high value on the identities of
clients and might use this information in discriminatory ways. Should
you warn clients about this? What level of security should you provide
to protect the identity of clients?

K5R says:  A published privacy policy should be readily available to the
participants, and a strict level of security with a mandatory firewall
and/or encryption should be in place to protect the public in this
situation, as extraction programs might still be able to glean email
addresses for those giving information.

# Use of Anonymous Survey Data 

Every semester, a psychology professor asks his undergraduate class to
fill out an anonymous survey form that asks many general questions about
their beliefs and attitudes. Some of the questions deal with such issues
as drug use, sexuality, and criminal behavior. The professor tabulates
their responses and uses this information when preparing and presenting
his lectures. While preparing an article that he will submit for
publication, the professor decides to cite some of this data, data which
reflects poorly on the students. The chairman of his department
prohibits this, ostensibly on the grounds that neither institutional
review board approval nor informed consent was obtained. It is obvious
that, in reality, the chairman's purpose is to protect the reputation of
the school. How should the professor respond?

C4L says: Regardless of how the data represent the students or the
school, it cannot be used for these purposes since no consent to do so
was obtained prior to its collection. The chairman is correct.

J1G says: The larger problem is with the sample\'s generalizability. The
anonymity issue is secondary to the fact that the data probably aren\'t
meaningful outside the narrow community of students of that demographic.
No good journal would want the paper anyway.

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Collaborations

# Collaborators Who Become Competitors 

Two senior scientists at a biotechnology company collaborate in
preparing a grant application that they submit under the Small Business
Innovative Research (SBIR) program.  Before the application is reviewed,
one of these scientists accepts a job at another firm.  The application
receives a good score, at the review meeting, although not good enough
to be funded.  Nine months later, at a subsequent SBIR review meeting,
the reviewers notice that the original application has been resubmitted
with changes reflecting their earlier critique.  They also note a
remarkably similar new application, from the scientist who changed jobs
and on behalf of his new employer.  The new proposal makes no mention of
the original, although it contains much of the same language and the
summary is nearly identical.  Is this plagiarism?  Does the new proposal
have the same standing as the revised original?  How should the
reviewers respond to similarities in the two proposals?

C4L says:  The application belongs to the submitting institution.  The
revised submission should have indicated that one of the
co-investigators is no longer participating in the proposed research. 
The second application would not have been accepted for scientific
review, had it been possible to have identified it as too similar, prior
to review.  Both applications can be reviewed, and scored, at the
initial review group meeting, but if the reviewers of the two
applications believe them to be substantially identical, they can
request that final review decisions on both be deferred.  This is
normally handled by an administrative note and allows program staff to
address the concerns.  Since both investigators presumably contributed
to the initial application, they are both authors of the original work
and plagiarism should not be an issue.  The two investigators should
have agreed on the future of the proposed work, however, and highly
similar applications should not have been submitted.

# Spouses as Collaborators 

During her first year as a graduate student in pharmacology, Susan meets
John, a salaried software engineer working in the university computer
center, whom she marries that summer.  During her second year, Susan
works closely with John on several projects, relying on him for computer
expertise.  Susan achieves impressive results based on computer
simulation and sophisticated data analysis.  She publishes several
papers in which she acknowledges the \"help and support\" of her
husband, John, but does not name him as a co-author.  Other graduate
students complain that Susan had, in John, a valuable university
resource that was not available to them and that her publication record
unfairly conceals the impact of John\'s help.  Is Susan\'s behavior
appropriate?  Is John\'s?  Would it matter if they were not married?  If
John were not employed by the university?

J1G says:  The inappropriate behavior is on the part of the whining
students who complain that Susan has the \"advantage.\" Nothing is
stopping them from collaborating with someone who could give them an
advantage, as well.  Susan just happens to be married to her
collaborator.  As for naming him as a co-author, that is between the two
of them, and depends on the rules and expectations of the publication.

K5R says:  As long as she gave John an acknowledgement, there is nothing
inappropriate here in their collaboration.  If his contributions were
great, however, a co-authorship may have been more appropriate than a
simple acknowledgement.  Complaints of other students are unfounded
unless John refused to provide any help or guidance to other students
when asked. In his capacity with the university he could help anyone
with their research as part of the collegial environment and within time
and resource constraints.  If he did not work for the university then he
could refuse anyone at any time.

# Collaborating on the Review Process 

Your supervisor, the principal scientist at a R&D firm, reviews grant
applications for the Small Business Innovative Research (SBIR) program. 
He gives you an SBIR application, asking you to read it and email him
your comments.  Portions that identify the company which submitted the
application have been blacked out.  When you ask whether the funding
agency knows that you are helping to review this grant application, he
says, no, but it is common practice.  Should you review the
application?  Should you notify the funding agency?  What if it were not
a grant proposal but, rather, an article being reviewed for publication
in a journal?

J1G says:  This practice might be commonplace; however, it is not only
unethical, but perhaps also illegal.  The supervisor is at fault.  If I
were the person being asked to do the review, I would politely decline
unless the supervisor clears it first.  This situation requires
sunshine.

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Human Subject Research

# Minority Representation that Confounds Data Analysis 

Your research project will study the impact of a new method for
prophylactic treatment to reduce hypertension in elderly nursing home
residents. Guidelines for research with human subjects require a minimum
threshold level of minority group representation. Earlier studies have
shown that the incidence of hypertension varies markedly among racial
groups, with black Americans having a higher incidence of hypertension,
proportionally, and Americans of Asian decent having a lower incidence.
If the study sample were to include minorities, this variation in the
incidence of hypertension would confound the analysis and complicate the
interpretation of results. Do you:

1.  Request an exemption from the requirement for minority
    representation.

2.  Increase the sample size sufficiently that each minority group can
    be analyzed separately.

3.  Increase the sample size sufficiently that minority subjects can be
    disregarded.

4.  Ignore the confounding effect of race when analyzing the study data.

J1G says:  None of the above. Over-sample the under-represented groups
that need to be represented in the analyses.

R3H says:  There are several options here.  An IRB can always grant an
exemption if such an exemption is justified.  If the study is
sufficiently defined as to the target group, ie a study of risk factors
for hypertension in a black population or a study of risk factors for
hypertension in a white population, then by definition the study group
is defined and non members of the study group would automatically be
excluded.  The conclusions, of course, are not generalizable. 
Alternatively, the study group can be skewed to include sufficient
numbers for individual sub set as well as total group analysis.

Knowingly accepting a biased sample is, under no circumstances,
acceptable.  Analysis of a larger group, so that minorities can be
excluded, is likewise unacceptable, since the target group must be
larger than necessary to expose the minimum number of target population
members.  The excess target group members and all of the members of the
group to be excluded would be exposed to potential risks of the study,
even if such risks are minimal.

# Informed Consent that Confounds Data Analysis 

Your research project will study the impact of a new way to care for
patients with Alzheimer's disease. Guidelines for research with human
subjects require obtaining informed consent from each subject. For most
Alzheimer's patients, a family member or other authorized person must
provide this consent. You suspect that Alzheimer's patients who have
family or a health care proxy will respond differently from those who
lack such support. Do you:

1.  Request an exemption from the requirement for informed consent.

2.  Increase the sample size sufficiently that data on subjects who
    provided informed consent can be analyzed separately from any
    available data on subjects who did not provide informed consent.

3.  Remove individual identifiers from data on subjects who did not
    provide informed consent and analyze this data anonymously.

4.  Exclude subjects who did not provide informed consent from the study
    and ignore the confounding effect of having informed consent.

J1G says:  Work the dilemma into the research design and analyses.
Consider covariance, crossover, counterbalancing, etc.

R3H says:  This is not an uncommon problem.  There is a mechanism in the
institutional review process for dealing with exactly this problem.  An
approved IRB can grant approval for a research project under particular
circumstances (minimal risk, no individually identifiable data) without
the requirement for prior informed consent if the IRB concurs that prior
consent would taint the data.  In some cases, consent may be required
after the data has been acquired but before it can be used as part of
the study database.  All of this is included in the purview of an
appropriate IRB.

# Unexpected Changes in Sample Demographics 

Your study sample contains adequate representation of minorities. During
the course of data collection, however, an unexpectedly large number of
minority subjects must be dropped for various reasons, leaving
insufficient representation of one minority group. It is too late to
recruit additional study subjects. Do you:

1.  Request an exemption from the requirement for minority
    representation.

2.  Discard the study data and start again.

3.  Proceed as though all minorities were represented adequately,
    ignoring the attrition in study subjects.

4.  Perform a second study using only subjects from the
    under-represented minority.

J1G says:  None of the above. Subject recruitment is part of the study,
not a preliminary step. Report the difficulty with minority subjects\'
completion of the protocol. It\'s a finding.

R3H says:  None of the proposed alternatives is acceptable.  Subject
selection was part of the study design which cannot be changed after the
fact.  The study result is the study result and the fact that particular
groups had difficulty with the study is part of the result.  It is not
ethical to delete or ignore data under these circumstances.  There are
statistical techniques, such as intention to treat analysis, that may be
helpful and consultation with a statistician may be considered, even
after the fact.

The data must be presented \"as is,\" or as some would say, \"warts and
all\" with care being made not to overdraw the conclusions and with some
discussion of the problems and implications.  This should be a fairly
standard approach in the honest presentation of data.

# Unexpected Abnormal Test Results 

As a laboratory exercise, your graduate students prepare slides with
smears of their own blood. You then randomize the slides and ask each
student to run various tests on an anonymous slide from a classmate. One
of the slides shows very low values on some tests, low enough to suggest
HIV infection. What action should you take?

R3H says:  Because of the implications of this finding to the subject
who would benefit from early intervention and the risk to partners who
may be exposed without choice, it is not acceptable to do nothing.  What
should be done provides a challenge to the professor.  One possible and
acceptable option is to alert the class that one of the slides had some
abnormal values which might be a true positive or might be a false
positive for an abnormality without necessarily stating the nature of
the abnormality, although for an educated group such as this, revealing
the possibility of HIV may be preferable.  All of the students should be
encouraged to see their own physicians for a complete blood work up and
HIV testing.

# Ending a Study Early 

An assisted living facility has increasingly high levels of infection
among residents admitted to its two intensive care nursing wards. The
facility obtains funding for a 1-year study of techniques that might
reduce the risk of infection in such an environment. Researchers enroll
every patient in one of the wards, obtain informed consent from them,
and begin applying the study protocols in that ward. A few months later,
they see a thirty per cent decrease in infections on the study ward.
Infections in the other, control ward continue at a high level,
meanwhile, and several patients from that ward must be hospitalized. At
the end of the year, comparison of rates of infection in the study and
control wards supports use of the clinical interventions. Should the
study have been ended early? Should patients in the control ward have
been asked for informed consent?

J1G says:  Control subjects are subjects. They should\'ve been
consented. As for ending the study early \-- hard to say, since the
study wasn\'t conducted correctly anyway.

R3H says:  Without knowing the details of the study it is difficult to
have a definitive answer.  Most studies of this type have a data review
panel which can suggest early termination.  This was the case, for
example, with the laser treatment of diabetic retinopathy.

If there is no interim analysis, it is hard to really assess if there is
an actual difference.  In this example, however, one must conclude that
there are interim analyses else how would one know there was a
difference.  If a clear medically and statistically significant
difference is demonstrated, as it appears to be in this case, it is
ethically required that the study be stopped and intervention done in
the control group.  The study at that point has been concluded, a
benefit or increased risk has been demonstrated and there is no longer
any justification for increased exposure to risk.

# Informed Consent for Saving Research Data 

In a laboratory exercise, graduate students draw samples of their own
blood and use these to perform various tests. Afterward, the instructor
tells the class that he wishes to collect their test results for use as
baseline data in a clinical study. Anyone may decline to participate, he
says. Is informed consent from the students needed? What if, instead of
their test results, the instructor also asked for the leftover blood
samples? Would it matter if the data and/or samples were unlabelled and
anonymous?

R3H says:  Informed consent cannot be obtained in this circumstance and
the data/samples may not be used.  Consent cannot be obtained since the
consent cannot be considered free.  This is roughly analogous to general
rule that a prisoner may not give informed consent because of the
expectation of some benefit, even it is explicitly stated that no
favoritism will be granted.  In this case there may be an element of
coercion here since the perception may be that a grade will be affected,
positively or negatively, as it relates to participation.  Even more
particularly, in the context of a required class in which the grade is
an important outcome with long term ramifications, the element of
potential coercion is even stronger.  The grade depends on the good will
of the instructor at some level.  There is potential for a real conflict
of interest here, even if it is not perceived as such by the instructor.

# Appropriate Use of Test Data

A government agency is training students from local law enforcement
agencies in use of a new device for matching DNA samples. Trainees
collect specimens of their own DNA in various ways and then analyze
these to learn how the mode of collection influences the likelihood and
reliability of a match. At the end of the course, and unbeknownst to
participants, everyone's DNA profile is entered into the agency
database. Is this appropriate? Would it be more appropriate if consent
were obtained? Would it be more appropriate if the data were
fingerprints, rather than DNA samples?

R3H says:  Under no circumstance can personal information be taken and
incorporated into a database, government or otherwise, without knowledge
and consent.  This is not only unethical on its face, it is illegal and
the government itself is not exempt under its own US code.  It does not
make any difference if it is DNA or fingerprints.  If consent is not
knowingly and freely given, it cannot be ethically done.  If consent
were obtained, this might be permissible, although there are concerns
about implied or actual coercion.  This would depend on the specifics of
the situation and consent.

**Scope and Venue Issues for Informed Consent**

A researcher who is studying intestinal bacteria has designed an
innovative, non-invasive probe for collecting samples during a routine
colonoscopy procedure. Must she explain the risks of colonoscopy when
obtaining informed consent to use this probe? Can she assume that no
colonoscopy will ever be performed solely for the purpose of using her
probe to obtain a sample?

# Selecting a Control Group 

A private corporation has obtained government funding to test dramatic
enhancements in a program that treats addiction to painkillers. Owing to
the nature of the psychological interventions used, subjects who were
exposed to the older program might or might not respond well to the
enhancements. Is it appropriate to use the old program with a control
group, when testing effectiveness of the new program? Would it be
appropriate to use the old program with a control group, when testing
whether exposure to the old program reduces effectiveness of the new
program?

# Selecting a Clinical Trial Site 

You are designing the clinical trial for a prosthetic device used when a
young child has lost a lower limb. You wish to conduct the trial
overseas, in a region where victims of line mines can be recruited as
subjects. The prosthesis will be very expensive, however, and apart from
the high cost of purchase, it will be costly to maintain. For these
reasons, it will almost certainly not be available outside the US. Is it
appropriate to recruit clinical trial subjects from a population that
will not benefit from the product? Is there an obligation to support
study participants after the trial ends?

K5R says:  In this situation, although it might be preferable to do the
study overseas, logistics prevent it from being performed outside of the
US, and so it should be done in the US.  The selection of site for a
clinical trial is based on the total sum of information, and benefit by
the local population can only be one part of this equation.  There is
likely a moral obligation, if not a legal one, to provide some sort of
ongoing support for the participants, and this information should be
included in the study protocol.

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Animal Subject Research

# Choice of Animal Subject 

A program of research will study the effects of a new psychotropic
substance on human brain chemistry.  After the substance is
administered, the animal subjects will be immobilized and electrodes
will be attached.  Then, once encephalography data has been obtained,
the animals will be sacrificed and dissected to examine for changes in
brain physiology.  Although dogs are deemed adequate subjects, use of
primates, such as monkeys, would produce more persuasive results
that would generalize to humans with greater validity.  Should the
project use dogs or monkeys?

J1G says:  Whatever happened to mice and rats? We have learned a lot
about human neural function by studying it in little bitty critters with
short lifespans and less pet-appeal.

K5R says:  There are strict laboratory animal scientific guidelines for
the use of non-human primates in experiments.  \"Greater validity or
easier generalization of results to human subjects\" is definitely not
an appropriate or valid reason for using primate subjects.  Rather,
there has to be a valid reason for exclusion of other routine laboratory
animal species.  If the dog is termed adequate, it should be the default
for this experiment, and if the experiment could be performed equally as
well with rodents, then they should be the default choice.  The choice
of primate in this case would be declined by any Animal Care & Use
Committee at any research institution in the US.

# Animals Used to Monitor Other Animals 

You have a colony of laboratory animals that must be kept isolated from
all other animals. Every few weeks, you sacrifice one or two animals in
order to verify that they have not become contaminated by outside
contact. How are these "monitor" animals different from the other
animals actually used for research?

K5R says:  Guidelines have been established by the Association for
Assessment of Laboratory Animal Care (AALAC) for keeping and maintaining
sentinel animals within a facility.  In theory and practice, sentinel
animals should be housed, manipulated and treated in all respects like
the other study animals within the same environment.

# Source of Animal Tissue Used in Research 

Your research project seeks to isolate substantial quantities of a
substance that occurs in trace amounts in the glands of codfish. Your
technician will collect fish entrails at a local wharf, where
fishermen's catch is cleaned for market. Do the usual guidelines for
animal subjects apply? Suppose it were chickens at a poultry ranch? Cows
or pigs at a slaughter house?

K5R says:  The usual guidelines for animal subjects do not apply to
tissue from fish, pigs, cows or chickens procured at slaughter plants or
at the fish market.  If live animals were used, then Laboratory Animal
Services (LAS) or US Department of Agriculture (USDA) guidelines would
apply to their maintenance.  Typically, however, a specific protocol for
obtaining such tissues would have to be presented to\--and approved
by\--a biohazard committee at a university prior to submitting
a proposal for, or initiating, such studies.

# Changing a Research Protocol that Uses Animals 

A research project was designed to collect encephalographic data from
animal subjects using surface electrodes. Problems have developed,
however, and you now suspect that surgically implanted electrodes would
give significantly better results. Is it appropriate to try this
technique once or twice before incurring the administrative burden of
altering the research protocol, which does not provide for any surgery?

K3R says:  Before switching from surface electrodes to a surgical
procedure involving animals, approval would have to be obtained from the
animal care and use committee and an amendment to the prior animal use
protocol would have to be obtained.  It is not ethical (or legal) to
perform invasive surgical procedures on animals without approval from an
animal care committee, even if this involves only once or twice for
practice.

**Use of Animals after Research Ends**

You are asked to design a laboratory protocol for harvesting serum from
animals by bleeding the animals at regular intervals. The nature of the
process makes these animals unsuitable for any other laboratory purpose,
afterwards, although they might have some slight commercial value. Is it
better to end the procedure by sacrificing the animals to extract all
their blood?  Or by performing several additional bleedings to obtain
the same amount of blood, at additional cost in ongoing maintenance, and
with a live animal of little commercial value at the end? If the
procedure calls for sacrificing the animals, would this preclude keeping
one or two as pets?

K3R says:  The endpoints to any animal experiment should be evaluated
and addressed ahead of time so that the decision of when to end the
experiment is already established in the protocol.  Both options in this
case (ending the experiment with exsanguination or continuing multiple
bleeds) are viable alternatives and the correct choice would depend on
circumstances.  If experimental treatment was given to livestock, it
might not be legal to sell them commercially, as drug withdrawal periods
might be unknown.  In a non-terminal experiment, it is justifiable to
allow adoption of animals at the end of the study, although at every
institution I know of, this requires approval of the animal care and use
committee and of the investigators involved.

# Unexpected Death of Animal Subjects 

Your experiment on dogs involves surgically implanting a drug delivery
device, monitoring the dogs for a time, and then removing the device and
monitoring for a while longer. Early on, some dogs unexpectedly die. It
is not clear whether this resulted from the surgical procedure or the
drug. Should you stop the experiments and refine the surgical procedure
without administering any of the drug, even though this might ultimately
sacrifice more animals? Or should you continue the experiment in hope
that results might improve as the surgical procedure becomes more
practiced, but with no guarantee of this? Or should you revisit the
entire protocol design?

K3R says:  Since it has not been established whether the problem is the
drug or the drug delivery device, it would be appropriate to halt drug
administration and see if any other animals die from the delivery system
alone. This would establish whether the surgical procedure and/or
delivery device was responsible. Once this is established, the drug
could be given again to see if it was inducing death. If mortalities
recurred, the experiment should be halted as a non-tolerated drug dose
is achieved.

# Research Use of Tissue from Livestock 

In your government funded research involving farm animals, you
collaborate with a local veterinarian who occasionally sends you tissue
samples. The veterinarian receives no government funding and does not
sacrifice any animals. Are the farm animals whose samples come in from
the field subject to the same standards and concerns as those in your
laboratory?

K3R says: If the veterinarian is routinely obtaining tissues in the
normal day-to-day activities of his practice, but is simply supplying
the investigator with the material periodically (with no history or
background on the patients involved), there are probably no guidelines
or controls on this material that are required for this tissue source.
 However, if the veterinarian is recruited prospectively to obtain
tissues and/or to do a procedure specifically as part of an ongoing
study that he would otherwise not be performing on a specific animal,
this probably would fall under animal care and use guidelines.  Under
these circumstances, a specific protocol would have to be approved by an
Institutional Animal Care & Use committee ahead of time and relevant
guidelines would apply.

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Research Misconduct

# Appropriate Use of Commercial Software 

A newly appointed assistant professor is unpacking her new computer and
preparing to install a dozen software packages, all recently purchased
for her use with grant funds.  A colleague in the next office tells her
that he makes a practice of copying entire software installation CDs
into folders in an install directory on his hard disk, before installing
the software from this hard disk copy.  He suggests that she simply
install each software package she has purchased from his computer, over
the network.  This will be much faster, also easier, and will not
require opening the shrink-wrapped software packaging.  He also suggests
she install several programs that she has not yet purchased and try them
out.  If she likes them, she can purchase them online, and if not, she
can uninstall them.  What, if anything, might be unethical about this
practice?

K5F says:  This violates the licensing agreement included with virtually
every piece of software that an investigator is likely to have access
to, and is contrary to the software sharing policy of most institutions
including industry, government or universities.

C4R says:  Where is the license number for the new software?  If it is
visible, then install the software over the network and use the provided
license number.  If it is not visible, open the package.  Provided
that you use your license number, this is fine.  Media is often
available online.  As for that software for which the new user does not
have a license, no go.

# Research Use of Commercial Publications 

A research consortium subscribes to many publications that are available
both in printed form and as PDF files on the Internet.  Instead of
circulating printed copies of these newspapers, magazines and journals,
the consortium posts a list of user names and passwords, so that members
can access the materials for themselves online.  Rather than copying
portions of publications that they want to save on a copier, members
simply print pages from the PDF files on their laser printer.  Is this
an ethical application of the fair use doctrine?

J1G says:  This is fair use gone berserk. Without approval from the
copyright holder, copyright restrictions are as stated in the
publication, and distribution rights are as limited in the user
agreement.  Okay, people don\'t take these things seriously enough.  On
the other hand, I believe that scientific journals have a moral
obligation to make their online contents open to the world. 
Nonetheless, copyright is copyright.  What other laws does this outfit
break, one wonders?

K5F says:  It is the goal of many institutions to have a paperless,
on-line library for their investigators.  The intent of this research
consortium is therefore not unlike many others.  If they had an
institutional (library) subscription for the journals, there might not
be a problem here. However, it sounds like they have a few individual
subscription names and passwords that they are circulating among many
individuals.  Hence, this is contrary to the intent of international
copyright law for scientific journals.  Even with an institutional
library subscription, there still has to be some controls in place for
dissemination of copyrighted material.  In many cases, company or
university libraries have negotiated specific rights with publishers of
on-line journals involving set rules such as: limitations of only saving
a single copy or printing a single copy to personal computer or printer,
allowance to email a copy to those within the same institution but not
to those outside of the company or university, limits on use for
non-commercial (research or educational) purposes only, and appropriate
prior approval for any other intended uses.  Lack of such controls or
agreements with publishers indicates a wanton disregard for intellectual
property rights and copyright law.

# Research Impact of Changes to Guidelines 

An ongoing research project is studying antibodies obtained by
sacrificing mice. Following a review of its policies regarding animal
subjects, the sponsoring institution determines that only in vitro
methods may be used for this in the future. Any such change in procedure
will invalidate all prior results, of course. Would it be appropriate
for the project staff to contract with another institution, where
guidelines still allow the original procedure, and send mice there from
time to time for antibody harvesting? If not, would it be appropriate to
contract with another institution to perform the entire procedure, using
their own mice and only returning the antibodies for final analysis?

# Padding a Budget 

After reviewing your annual budget, the department head asks you to
include certain additional items of equipment, which the department
badly needs, assuring you that this will not affect the funding for
items that you requested.  You see the value of this additional
equipment  to the department but have no particular use for it in your
own work.  How do you respond to your supervisor\'s request?

J1G says:  It\'s pointless to try to pad a budget, because reviewers and
program staff review budgets quite closely. If equipment isn\'t
justified for a project, it probably won\'t be approved in the funded
budget.

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Financial Conflicts of Interest

# Divulging Information about Funding 

A graduate student meeting with her potential doctoral program advisor
for the first time asks about project funding, wishing to know its
source, duration, and plans for soliciting alternative financial
support.  How should the faculty member respond?

J1G says:  There\'s a question about this?  Of course anyone involved in
a project has a right to know who\'s funding it. Participants also have
a right to know.

K5F says:  Since there are huge implications for the future success of
graduate students and post-docs based on the nature of funding sources,
past success in grant receipt, and the duration of current funding
sources in a laboratory, I think it is fair game for a student to ask
these questions and expect a response. Answers to such questions may
impact on the decision of which laboratory the student will join (and
rightly so).

# Accepting Funding with Strings Attached 

A large corporation offers a grant to fund basic research, with only the
proviso that any journal articles must be approved by their corporate
publicity office before being submitted for publication.  The facility
needs this grant to buy necessary equipment and fund attendance at
conferences; moreover, the director expects that corporate
oversight will have no impact on the normal publication process.  Should
he accept the grant?

J1G says:  No. It\'s a Faustian deal.  Better to do no science than to
sell your soul to do it.

K5F says:  Of course he should accept the grant.  As long as there are
arbitration clauses written into the grant contract beforehand (which is
standard for a university-corporate research contract), any disputes
about what can or should be published can be peacefully resolved.  Any
investigator who refuses a grant with strings attached is greatly
limiting their opportunity to fund better research.

# Evaluating Research Results for Commercial Applications 

A managed care health plan has the policy that it will not pay for any
treatment if a less costly intervention would achieve identical
results.  Noting that clinical trials generally compare new and often
expensive drugs and treatments only to a placebo, may the health plan
decline to pay for any such new intervention until additional research
has shown it to be more effective than less expensive or generic
alternatives?  Or, must the health plan accept self-servings opinion of
industry researchers, even when their clinical trials do not address the
relative effectiveness of alternative treatments?

5S replies:  The practice of comparing a new intervention with a
placebo, while ethically correct from a research perspective, rarely
produces negative results.  It tells little about the relative benefits
versus available alternatives and nothing about the cost-benefit
tradeoff.  Nonetheless, before declining to pay for a new drug or
treatment, the health plan must show that the innovation is less
effective than existing alternatives, perhaps by comparing the results
of different clinical trials that measured the effectiveness of each
against a placebo.

# Working for a Competitor Company 

A graduate student is preparing a dissertation on a government funded
project to develop a new type of stent. He is offered a part-time job,
working only weekends, in the shipping room of a company that
manufactures various surgical appliances, including the kind of stent
that his dissertation work will make obsolete. Is this a conflict of
interest? Suppose the work were during the normal, 9-to-5 weekday?
Suppose the student is aware that this company has its own research
program, without knowing any details? Suppose, instead of the shipping
room, the student is offered a job in the laboratory where this research
is performed?

C4R says:  An apparent conflict exists and therefore he should not work
there in any capacity.

# Working for the Competitor of a Sponsor 

A graduate student completes a dissertation based on research that was
partly funded by a corporate sponsor.  After graduation, the student is
offered a job working for another corporation that competes with the
first.  There can be no doubt that the dissertation and experience with
a competitor's research played a role in this offer. Is there a
conflict? Does it matter whether the student personally received any
funding from the corporate sponsor?

# Use of Proprietary Educational Material 

A college professor offers his undergraduate students a choice of
several optional term projects for extra credit. One of these requires
the purchase of a workbook, authored by the professor, who makes it
available for purchase through the campus bookstore as a Xeroxed,
loose-leaf volume. Is this a conflict of interest? Does it matter
whether the book is sold at cost or at a profit? Would it matter if
someone else wrote the workbook that the professor is selling?

J1G says:  Well, if this is deemed a conflict of interest, then we\'re
condemning thousands of academics to a mire of conflict.  This practice
is so common \-- including asking students to purchase an expensive
textbook written by the professor \-- that no one questions it anymore.
Is it sleazy?  Often.  Is it a source of great income for most
professors?  Hardly.  It\'s difficult for an author to make much on the
sale of 30, 60, or even 600 books.

K5F says:  There is no conflict of interest here.  The professor has
offered multiple options including the use of his own textbook. Many
professors/authors have used their own textbook in teaching their own
classes and offered the book for sale at the local university
bookstore\--not because they will make any profit out of it (the royalty
payments from textbooks are appallingly small) but because they probably
honestly believe that it is the best treatise on that particular subject
and/or is more germaine to the topics that professor and their classes
are focused on.  Certainly, the professor could make a donation in some
form to the class as a re-imbursement for their expense if his
conscience required it, but I don\'t see any real ethical dilemma in
this case, even if the book was required for a regular grade rather than
being an option for extra credit.