Ethical issues in the laboratory

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Ethical issues in the laboratory
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Definition of Bioethics
A discipline dealing with the ethical
implications of biological research and
applications.
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BIOETHICS A graduate level course offered for all
Ph.D. graduate students in the institution. The
purpose of the course is to provide an
opportunity for students to discuss and
understand the ethical issues related to
conducting research.
Meharry Medical College
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Experiment records and research data
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Why and who should keep the experiment records
and research data?
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Is it unethical for scientists to alter their
data in order to make the results match their
expectations? Why or why not?
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Research publications
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Authorship
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Authorship
the act of initiating a new idea or theory or
writing. Most of the time, this term refers to
someone being the authorof a written work.
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Authors should provide a description of what each
contributed, and editors should publish that
information. All others who contributed to the
work who are not authors should be named in the
acknowledgements, and what they did should be
described.
International Committee of Medical Journal
Editors 1997
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Authorship criteria should be based on only (1)
substantial contributions to conception and
design, or acquisition of data, or analysis and
interpretation of data (2) drafting the article
or revising it critically for important
intellectual content and (3) final approval of
the version to be published. Conditions 1, 2, and
3 must all be met. Acquisition of funding, the
collection of data, or general supervision of the
research group, by themselves, do not justify
authorship.
International Committee of Medical Journal
Editors2000
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The Nobel Prize in Physiology or Medicine 1923
for the discovery of insulin
Frederick Grant Banting
John James Richard Macleod
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Banting FG, Best CH, Collip JB, Campbell WR,
Fletcher AA. Pancreatic extracts in the
treatment of diabetes mellitus. CMAJ 1922,
22(3)141-6.
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Banting is usually credited with persisting with
the idea that pancreas contained a substance that
regulated blood sugar. Best devised the initial
crude method of extracting the substance that
would later be named insulin. Collip refined
the extraction process. Campbell and Fletcher
oversaw the administration of the extract to
14-year-old Leonard Thompson. Macleod as head
of the Univ. of Torontos Dept. of Physiol., took
a chance on Banting idea and provided financial,
logistical and intellectual support.
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Who should share the authorship?
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Whose responsibility is it to determine
authorship?
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How to decide who should be included in the
authorship and the position of authors?
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Gift authorship
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What are the responsibilities as an author?
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Can I be the first author?
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What does first authorship imply?
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• Idea of the experiments
• Conducting experiments
• Paper writing

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Should your advisor/mentor be always as an author?
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Manuscript writing
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Is it unethical for scientists to copy a sentence
from the other article?
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Plagiarism
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Definition of plagiarize
Steal and pass off (the ideas or words of
another) as ones own use (a created production)
without crediting the source.
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To avoid plagiarism, it is wise to paraphrase or
quote and then cite the original source in a
footnote or endnote.
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Scientific dishonesty

• Fabrication of data.
• Selective and undisclosed rejection of undesired
  results.
• Substitution with fictitious data.
• Erroneous use of statistical methods in order to
  draw conclusions at variance with those warranted
  by the study data.
• Distorted interpretations of results or
  distortion of conclusions.

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• Plagiarism of results or entire articles of other
  
• researchers.
• Distorted representation of other researchers
  results.
• Wrongful or inappropriate attribution of
  authorships.
• Misleading scientific grant or job applications.
• Duplication of publications
• Presentation of high profile results through the
  media prior to peer review.
• Omission of earlier original observations by
  others.
• Exclusion of others from legitimate authorship.
• Salami publication.
• Data massage.

S. Tomlinson and G.R.D. Catto
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AUTHORSHIP AND THE ROLE OF THE ABSENT
RESEARCHER By L. Kunkel and R. Fischbach,
Harvard Medical School, 1993  
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As a graduate student, Camilla Pedroza worked
closely with her advisor/mentor and lab chief,
Dr. Kisaki, for four years on a project
developing a diagnostic test for lupus. As part
of the study, she performed diagnostics for
physicians, particularly Dr. Browne, who sent
tissue samples from his patients to her to be
tested. Shortly before her project was completed,
her husband was relocated to an excellent
position in their homeland, Spain. She hastily
put together the material she had collected over
the years which was enough to pass as her thesis.
During her final meeting with Dr. Kisaki, he
promised to complete her project and get it
published.
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Jonathan Sand has been a post-doc in the Kisaki
lab for a year and half and has little to show
for his time in the lab. Dr. Kisaki feels that
Camilla's project is ideal for Jonathan because
it is so close to completion and would allow him
to build upon it for future projects. Within
three months, thanks to Camilla's excellent
write-ups of her methods, Jonathan has been able
to replicate several of Camilla's experiments and
does some important controls.
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Noting the progress, Dr. Kisaki asks Jonathan to
write the first draft of the paper as he now has
access to all the data. Dr. Kisaki suggests
including a few of Jonathan's figures which
replicated Camilla's work. Dr. Kisaki is relieved
and gratified that at last, with Jonathan's
efforts, the project has been successfully
concluded. Hearing that the work is close to
publication, Dr. Browne calls Dr. Kisaki to
remind him of their original agreement which
established that he should be included as an
author on this paper in return for furnishing the
tissue samples.
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Meanwhile, Jonathan passes in the first draft of
the manuscript with his name as first author. In
considering the position of authors, Jonathan
believes that he should be listed first because
these are his data being presented, he prepared
the figures, and he wrote the paper. Camilla will
be included as an author.
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Dr. Kisaki sends the draft off to Camilla, who
recognizes that the data are no different than
those included in her thesis. She sends an
immediate response to Dr. Kisaki requesting that
she be first author. And she also objects to Dr.
Browne being included as an author because (1) he
was one of many physicians who sent in tissue
samples (2) she was performing a service for
him and (3) he contributed no intellectual
effort to the project. She also questions the
inclusion of the department head, Dr. Carson, as
an author despite that being the custom of the
department. Dr. Kisaki realizes that he has a lot
of decisions to make. One solution he considers
is dividing the manuscript into two submissions
so that both Camilla and Jonathan can each be
first author on one paper.
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• Does the person who writes the paper naturally
  assume first authorship?
• Does Camilla have a legitimate claim for first
  authorship?
• What does first authorship imply?

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As Camilla's advisor/mentor, should Dr.
Kisaki have discussed with her (1) plans for the
publication of the results of her dissertation
research (2) her role and responsibilities in
the preparation of the manuscript(s) (3)
commitments and arrangements for attribution for
investigators who supplied tissue
samples/reagents for her studies?
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• As a departing student, what role should Camilla
  have played in initiating discussions relevant to
  the dissemination of her work product?
• Are the results of Camilla's thesis project her
  intellectual property?

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• Students and postdocs come and go in a lab. How
  do you decide, in a transient setting, who
  contributed the most to a project and has a
  subsequent claim to be an author?
• Is Jonathan guilty of intellectual plagiarism?
  How does the departed grad student, or postdoc,
  retain an ongoing role in absentia in subsequent
  research efforts?

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• Whose responsibility is it to determine
  authorship?
• What about the role of the mentor in deciding who
  should be first author, especially in settings
  where someone left the lab without completing the
  project?
• When should these decisions be made? What are the
  pressures faced by postdoctors who write the
  first draft in determining placement and
  inclusion of authors?
• How much weight do Camilla and/or Jonathan have
  in these decisions?

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• Criteria for authorship have been hotly debated.
  The study could not have been conducted without
  the contribution of Dr. Browne and the others who
  sent in the tissue samples. So what claim does
  Dr. Browne have to be an author?
• What criteria do you set for people like Dr.
  Browne and others who contribute samples?

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Research subject
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Molecular and cellular biology
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Animal studies
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U.S. Government Principles for Utilization and
Care of Vertebrate Animals Used in Testing,
Research, and Training

• Design and performance of procedures on the basis
  of relevance to human or animal health,
  advancement of knowledge, or the good of society.
  
• Use of appropriate species, quality, and number
  of animals.
• Avoidance or minimization of discomfort,
  distress, and pain in concert with sound science.
  
• Use of appropriate sedation, analgesia, or
  anesthesia.
• Establishment of experimental end points.
• Provision of appropriate animal husbandry
  directed and performed by qualified persons.
• Conduct of experimentation on living animals only
  by or under the close supervision of qualified
  and experienced persons.

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Human subject
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Ethical issues in human study

• voluntary participation
• informed consent
• free from risk of harm
• confidentiality
• anonymity (??)
• right to service

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Cloning of Humans Will it be Ethical? Should it
be Done?
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The two major ethical problems regarding
neurotransplantation in humans A) The
possibility that this treatment could cause
changes or transfer of personality and personal
identity. B) the not consensual judgement about
the morality of induced abortion and,
consequently, the use of this kind of fetal or
embryonal tissues for neurotransplantation.
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Cloning Sex selection or predetermination The
legal and moral implications of reproductive
technology Surrogacy - the depersonalisation of
birth mothers The laws and politics surrounding
the issue of frozen embryos Rights,
responsibilities and resistance Setting the
context for reproductive control Genetic
engineering The ethical issues surrounding IVF
and DI, and legal aspects of artificial
insemination Psychosocial impact of infertility
on men Ethical issues in existing and emerging
techniques for improving human fertility
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Clinical trial Is it ethical to give patients a
placebo when effective treatment is available?
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The ethical principle that if a lifesaving or
life-extending treatment for a disease does
exist, patients cannot be denied it.
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When a clear survival advantage for patients
receiving a new drug was seen well before the
trial was scheduled to end. The trial was then
ended early.
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Definition of Ethics
motivation based on ideas of right and wrong
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Definition of Ethics
The science of human duty the body of rules of
duty drawn from this science a particular system
of principles and rules concerting duty, whether
true or false rules of practice in respect to a
single class of human actions as, political or
social ethics medical ethics.
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Bioethics concerns the relationships between
biology, medicine, cybernetics, politics, law,
ethics, philosophy, and theology. Disagreement
exists about the proper scope for the application
of ethical evaluation to questions involving
biology.
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• stem cell research
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• authorship ??????
• data ??
• informed consent ??????
• information disclosure
• conflict of interest

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Many journals now request that authors state
explicitly that they contributed to the
publication. Dr. Browne, who has never read the
manuscript, nonetheless believes strongly that he
contributed to the project and would in good
conscience sign any compliance form. How do you
resolve this with the intent of the journal?
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• What about accountability? Given that there are
  five authors listed on the paper, who is
  ultimately responsible for validity of the data
  and information contained in the publication?
• What is someone challenges the validity down the
  road?

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"Salami publication" or publication of the
"least publishable unit" is growing in frequency.
Why is there concern about "republished" or
duplicate publications?