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CPPS 337.3 Ethical Issues in Medical Research, Handouts, September 2020

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Grzegorz (Greg) Sawicki, Ph.D., D.SC.

Professor

Department of Anatomy, Physiology and Pharmacology (APP)


University of Saskatchewan
College of Medicine
107 Wiggins Road
Saskatoon SK, S7N 5E5
Canada
Telephone: (306) 966-6997

Room 2D30.10
Ethics is a branch of knowledge that deals with moral principles

Schools of ethics in Western philosophy can be divided to three


schools
1. Based on work of Aristotle, holds that the qualities (such as
justice, charity, and generosity) are dispositions to act in ways
that benefit both the person possessing them and that person's
society.
2. The second, defended particularly by Kant, makes the concept of
duty central to morality: humans are bound, from a knowledge of
their duty as rational beings, to obey the categorical imperative to
respect other rational beings.
3. Thirdly, utilitarianism asserts that the guiding principle of conduct
should be the greatest happiness or benefit of the greatest
number
The term ethics derives from ancient Greek
word ethikos, which itself is derived from the
Greek word ethos, meaning “habit, custom”.

The field of ethics, along with aesthetics


comprise the branch of philosophy called
axiology

Ethics:
Moral principles that govern a person's
behavior or the conducting of an activity
What is ethics in research and why is it important?

David B. Resnik, J.D., Ph.D.


When most people think of ethics (or morals), they think of
rules for distinguishing between right and wrong, such as
the Golden Rule, a code of professional conduct like the
Hippocratic Oath, a religious creed like the Ten
Commandments, or a wise aphorisms like the sayings of
Confucius.

This is the most common way of defining "ethics": norms


for conduct that distinguish between acceptable and
unacceptable behavior.
Most societies have legal rules that govern
behavior, but ethical norms tend to be broader and
more informal than laws.

Although many societies use laws to enforce widely


accepted moral standards (ethical and legal rules
use similar concepts), but ethics and law are not the
same. An action may be legal but unethical or
illegal but ethical.
Codes and policies for research ethics
Honesty
Objectivity
Integrity
Carefulness
Openness
Respect for Intellectual Property
Confidentiality
Responsible Publication
Responsible Mentoring
Respect for colleagues
Social Responsibility
Non-Discrimination
Competence
Legality
Animal Care
Human Subjects Protection
Honesty
Strive for honesty in all scientific communications. Honestly report data,
results, methods and procedures, and publication status. Do not fabricate,
falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or
the public.
Objectivity
Objectivity is a central philosophical concept, objective means being
independent of the perceptions thus objectivity means the property of
being independent from the perceptions, which has been variously defined
by sources.

Integrity
The word integrity evolved from the Latin adjective integer, meaning whole or
complete. In this context, integrity is the inner sense of "wholeness" deriving from
qualities such as honesty and consistency of character.

Carefulness
Avoid careless errors and negligence; carefully and critically examine your own
work and the work of your peers.
Openness
Share data, results, ideas, tools, resources.
Be open to criticism and new ideas.

Respect for Intellectual Property


Honor patents, copyrights, and other forms of intellectual property.
Do not use unpublished data, methods, or results without permission.
Give proper acknowledgement or credit for all contributions to research.
Never plagiarize.
Confidentiality
Protect confidential communications, such as papers or grants submitted for
publication, personnel records, trade or military secrets, and patient records.

Responsible Publication
Publish in order to advance research and scholarship, not to advance just your
own career.
Avoid wasteful and duplicative publication.
Responsible Mentoring
Help to educate, mentor, and advise students.
Promote their welfare and allow them to make their own decisions.
Respect for colleagues
Respect your colleagues and treat them fairly.

Social Responsibility
Strive to promote social good and prevent or mitigate social harms through
research, public education, and advocacy.

Non-Discrimination
Avoid discrimination against colleagues or students on the basis of sex, race,
ethnicity, or other factors not related to scientific competence and integrity.
Competence
Maintain and improve your own professional competence and expertise through
lifelong education and learning; take steps to promote competence in science as a
whole.
Legality
Know and obey relevant laws and institutional and governmental policies.
Animal Care
Show proper respect and care for animals when using them in research.
Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects Protection


When conducting research on human subjects, minimize harms and risks and
maximize benefits; respect human dignity, privacy, and autonomy; take special
precautions with vulnerable populations; and strive to distribute the benefits and
burdens of research fairly.
Ethical decision making in research

Although codes, policies, and principals are very important


and useful, like any set of rules, they do not cover every
situation, they often conflict, and they require considerable
interpretation.

It is therefore important for researchers to learn how to


interpret, assess, and apply various research rules and how
to make decisions and to act ethically in various situations.

The vast majority of decisions involve the straightforward


application of ethical rules.

For example, consider the following case…..


Case 1:

The research protocol for a study of a drug on hypertension


requires the administration of the drug at different doses to
50 laboratory mice, with chemical and behavioral tests to
determine toxic effects.

Tom has almost finished the experiment for Dr. Q. He has


only 5 mice left to test. However, he really wants to finish his
work in time to go to Florida on spring break with his friends,
who are leaving tonight. He has injected the drug in all 50
mice but has not completed all of the tests.

He therefore decides to extrapolate from the 45 completed


results to produce the 5 additional results.
Many different research ethics policies would hold that
Tom has acted unethically by fabricating data.
If this study were sponsored by a federal agency, such
as the NIH, his actions would constitute a form of research
misconduct, which the government defines as "fabrication,
falsification, or plagiarism" (or FFP).

This actions, nearly all researchers, will classify as


unethical and are viewed as misconduct

…………
It is important to remember, that misconduct
occurs only when researchers intend to deceive.

Honest errors related to sloppiness, poor record


keeping, miscalculations, bias, self-deception, and even
negligence do not constitute misconduct.
Also, reasonable disagreements about research
methods, procedures, and interpretations do not constitute
research misconduct.
Case 2:

Dr. T has just discovered a mathematical error in his paper


that has been accepted for publication in a journal.

The error does not affect the overall results of his research,
but it is potentially misleading.

The journal has just gone to press, so it is too late to catch


the error before it appears in print.

In order to avoid embarrassment, Dr. T decides to ignore the


error.
Dr. T's error is not misconduct nor is his decision to take no
action to correct the error.

However…..

Most researchers, as well as many different policies and


codes would say that Dr. T should tell the journal (and any
coauthors) about the error and consider publishing a
correction or errata.

Failing to publish a correction would be unethical because it


would violate norms relating to honesty and objectivity in
research.
There are many other activities that the government
does not define as "misconduct" but which are still regarded
by most researchers as unethical.

Next slides show situations, which are sometimes


referred to as "other deviations" from acceptable research
practices and include:
•Publishing or submitting the same paper in two different
journals without telling the editors
•Not informing a collaborator of your intent to file a patent in
order to make sure that you are the sole inventor
•Including a colleague as an author on a paper in return for a
favor even though the colleague did not make a serious
contribution to the paper
•Discussing with your colleagues confidential data from a
paper that you are reviewing for a journal
•Using data, ideas, or methods you learn about while
reviewing a grant or a papers without permission
•Trimming outliers from a data set without discussing your
reasons in paper
•Using an inappropriate statistical technique in order to
enhance the significance of your research
•Bypassing the peer review process and announcing your
results through a press conference without giving peers
adequate information to review your work
•Conducting a review of the literature that fails to
acknowledge the contributions of other people in the field or
relevant prior work
•Stretching the truth on a grant application in order to
convince reviewers that your project will make a significant
contribution to the field
•Stretching the truth on a job application or curriculum vita
•Giving the same research project to two graduate students
in order to see who can do it the fastest
•Overworking, neglecting, or exploiting graduate or post-
doctoral students
•Failing to keep good research records
•Failing to maintain research data for a reasonable period of
time
•Making derogatory comments and personal attacks in your
review of author's submission
•Promising a student a better grade for sexual favors
•Using a racist epithet in the laboratory
•Making significant deviations from the research protocol
approved by your institution's Animal Care and Use
Committee or Institutional Review Board for Human Subjects
Research without telling the committee or the board
•Not reporting an adverse event in a human research
experiment
•Wasting animals in research
•Exposing students and staff to biological risks in violation of
your institution's biosafety rules
•Sabotaging someone's work
•Stealing supplies, books, or data
•Rigging an experiment so you know how it will turn out
•Making unauthorized copies of data, papers, or computer
programs
•Owning over $10,000 in stock in a company that sponsors
your research and not disclosing this financial interest
•Deliberately overestimating the clinical significance of a new
drug in order to obtain economic benefits
Case 3:

Dr. XXX is the principal investigator of a large, epidemiological study on the


health of 10,000 agricultural workers.
He/She has an impressive dataset that includes information on
demographics, environmental exposures, diet, genetics, and various
disease outcomes such as cancer, Parkinson’s disease (PD), and
Amyotrophic Lateral Sclerosis (ALS).
He/She has just published a paper on the relationship between pesticide
exposure and PD in a prestigious journal.
He/She is planning to publish many other papers from his/her dataset.

But……

He/She receives a request from another research team that wants access
to his/her complete dataset.
They are interested in examining the relationship between pesticide
exposures and skin cancer.
Dr. XXX was planning to conduct a study on this topic.
Dr. XXX faces a difficult choice.

On the one hand, the ethical norm of openness obliges her to share data
with the other research team.
His/Her funding agency may also have rules that obligate his/her to share
data.

On the other hand, if he/she shares data with the other team, they may
publish results that he/she was planning to publish, thus depriving his/her
(and his/her team) of recognition and priority.

It seems that there are good arguments on both sides of this issue and Dr.
XXX needs to take some time to think about what he/she should do.

Possible option is to share data, provided that the investigators sign


a data use agreement. The agreement could define allowable uses of
the data, publication plans, authorship, etc.

Another option would be to offer to collaborate with the researchers.


The following are some step that researchers, such as Dr.
XXX, can take to deal with ethical dilemmas in research:

1. What is the problem or issue?


It is always important to get a clear statement of the
problem.

2. What is the relevant information?


Many bad decisions are made as a result of poor
information.
3. What are the different options?

People may fail to see different options due to a


limited imagination, bias, ignorance, or fear.

4. How do ethical codes or policies as well as legal


rules apply to these different options?

The university or funding agency may have policies


on data management that apply to this case.

5. Are there any people who can offer ethical advice?


It may be useful to seek advice from a colleague, a
senior researcher, your department chair, an ethics or
compliance officer, or anyone else you can trust.
Example of questions still difficult to decide what to do.

Which choice will probably have the best overall


consequences for science and society?

Which choice could stand up to further publicity and


scrutiny?

Which choice could you not live with?

Think of the wisest person you know. What would he or she


do in this situation?

Which choice would be the most just, fair, or responsible?


Promoting Ethical Conduct in Science

Most academic institutions in the US require undergraduate, graduate,


or postgraduate students to have some education in the responsible
conduct of research (RCR).

The National Institutes of Health (NIH) and National Science


Foundation (NSF) have both mandated training in research ethics for
students and trainees.

Many academic institutions outside of the US have also developed


educational curricula in research ethics

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