Laboratory Ethics &
Clinical Research Ethics
Matthew George, Jr., Ph.D.
Dr. Fred Lombardo
The Laboratory Notebook
Recording of Experimental Data
• Essential for protecting one’s intellectual
property
• Determining ownership of ideas
• Validation of results to support grants and
manuscripts
• Allow others to reproduce one’s work
Components of the Notebook
Assigning the Lab Notebook
Notebook Instructions
Table of Contents
Numbered Pages
General Laboratory Rules*
• Each person in the lab should maintain a
hardbound laboratory notebook with
continuously numbered pages as a
permanent record of his or her work and
ideas
• The notebooks should be kept in a safe
place and not taken home
General Lab Rules Continued
• Notebooks and their content are the
property of the University laboratory
• The original notebook and all related data
should be returned to the Laboratory
Director when completed, upon request,
or upon termination of employment
• *Source: Brad Thompson, Univ. of TX, Medical Branch,
Galveston and the AMGDB (Association of Medical and
Graduate Departments of Biochemistry)
Additional Considerations
• The lab notebook and its content are
considered to be confidential
• Exercise great care in preserving them
• Report the loss or theft of a research
notebook to your group leader
immediately
Each Notebook Should Include*
• Table of contents-listing each experiment
(page numbers) and the location of all
pertinent data
• Entries should be made in ink-not in pencil
• Corrections should be made by making a
single line-out (leaving the original legible)
then adding the correction along with
ones initials and the date
Notebook Inclusions (cont’d)
• Signature and date of who recorded the
data
• Signature and date of a knowledgeable
person who reviewed and understood the
data
• *Source: Brad Thompson and AMGDB
Each Experiment Should Include
• Title, experiment number and date
• Names of persons involved in the
experiment and how they participated
• Statement of purpose (list the specific
question(s) to be answered by the
experiment
Each Experiment Should Include
(2)
• Experimental design. List key steps in the
design. You may refer to previous
experiments or recorded protocols used in
your laboratory. If you deviate from what
is in a prior protocol, record how it is
different. Provide enough information so
that a co-worker could continue from
where you left off if you became ill.
Each Experiment Should Include
(3)
• Results with original data. Include graphs
or tables that summarize the data in your
notebook
• Conclusions. Meaning of results;
problems; future plans
• Remember, another person should be able
to interpret and repeat what you have
recorded
Protection from Research
Misconduct in the Laboratory- 1*
• Be sure you look carefully at raw data
from your post-docs, students and
technicians
• Watch while your technicians, students, or
post-docs do research in your lab
• Be sure you take concerns about data, or
actual allegations, from your staff
seriously
Protection from Research
Misconduct in the Laboratory- 2*
• Be careful how you resolve disputes or
break up with your former collaborators
• If you find evidence of misconduct in your
lab, report it and remove yourself
• Don’t if you suspect misconduct, try a
“trap” or “sting” without informing officials
Protection from Research
Misconduct in the Laboratory- 3*
• Do good science, be a good mentor and
show interest in your students’ work, and
take responsibility for your laboratory’s
research
• *Source: Alan Price, Office of Research
Integrity and the AMGDB
Other Types of Data
• Working with computer generated data
• Working with data generated from “kits”
• Interview and/or evaluation data
• Computer and photo-editing programs
Basic Bioethics
• Two predominate philosophies governing
ethics in the Western world:
– Deontological view-I. Kant (1724-1804)
– Utilitarianism-John Locke (1632-1704) and
John Stuart Mill (1806-1873)
Deontology/Utilitarianism
• Deontology
– The study of duties
that persons have
toward one another.
– The categorical
imperative of
Immanuel Kant
• Utilitarianism
– The view that actions
or policies are to be
morally evaluated
according to the
extent to which they
promote happiness or
well-being
Clinical Bioethics
• Principles:
– Beneficence (To do Good)
– Nonmaleficence (Primum non nocere)
– Justice (Fairness)
– Autonomy (Self-determination)
– Veracity (Truth telling)
– Utility (The greatest good for the greatest
number)
Elements of Informed Consent
• Threshold requirement: competence
• Information requirements
– Information
– Understanding
• Consent requirements
– Consent
– Authorization
Informed Consent
• Benefits
• Risks
• Alternatives
Problems/Ethical Dilemmas
• Veracity- Truth Telling, is deception every
justified?
• Privacy/Confidentiality, is failure to protect
the privacy of the patient every justified?
• Differences between obligations for
privacy and for confidentiality
Dr.Woo Suk Hwang
• Dr. Hwang, veterinary scientist from Seoul
National University cloned an Afghan
hound named Snuppy (Seoul National
University puppy).
• Named Director, Stem-Cell Center, Seoul,
Korea.
• Branch labs planned for U.S. and U.K.
Dr. Hwang Aftermath
• Resigned as Director when it was reported that
•
•
•
a member of his team had purchased human
eggs from as many as 27 women for use in
human stem cell experiments.
Two female members of his team had donated
eggs to the cause.
Egg selling illegal in Korea
Violation of scientific ethics for subordinates to
provide ova, even if free of charge.
Bone Marrow Transplant
• Werner Bezwoda, University of
Witwaterstrand, Johannesburg, South
Africa
• Admitted that “he had committed a serius
breach of scientific honesty and integrity”
– Petrs, WP, Dansey,RD et al,The Oncologist,
2000;5:1-13
Tuskegee Study (1932-1972)
• Reasons given for continuing study
– Long-term benefits for African-Americans
– Contribution to scientific knowledge
– Benefits for subjects (would receive other
medical treatment)
– Subjects were not harmed
– Treatment might harm (Jarische-Herxheimer)
– Should not waste data collected
Tuskegee Study (1932-1972)
• Reasons given for not telling subjects the
truth:
– Subjects incapable of understanding
– Scientists better equipped to determine what
would benefit the subjects (paternalism)
– Better to sacrifice a few for the greater good
of the whole (utilitarianism)
Tuskegee Study (1932-1972)
• Reasons for breach of veracity tenet
continued:
– Subjects in the study were better off than
those not selected to participate.
– Long-term scientific goals were of greater
importance than rights of an individual (Kant’s
Categorical Imperative is breached)
Egregious Examples of Unethical
Research
•
•
•
•
•
•
•
Tuskegee Syphilis Study (1932-1972)
Nazi Experiments on Prisoners-WW II
Willow Brook Study-1960’s
Human Radiation Experiments 19501970
LSD Experiments 1930s
Serratia marcescens experiments
Bacillus subtilis experiments
Belmont Report
• Principles:
– Respect for persons’ consent, privacy,
confidentiality
– Beneficence (Benefits versus Risks)
– Justice/Equality
45 Code of Federal Regulations
46.111
• Risks to subjects minimized
• Risks reasonable in relation to anticipated
benefits.
• Selection of subjects equitable
• Provision for safety monitoring
• Informed consent documented
45 CFR Part 46.111
• There is adequate provisions to protect
the privacy of subjects and to maintain
confidentiality of data
• Where any of the subjects are likely to be
vulnerable to coercion (“susceptible to
kindness”) or undue influence, additional
safeguards are incorporated to protect the
subjects.
The Nuremberg Code
• The voluntary consent of the human
subject is absolutely essential.
• The experiment should be such as to yield
fruitful results for the good of society.
• Experiment based on results of animal
experiments and knowledge of the natural
history of the disease or problem
The Nuremberg Code
• The experiment should be conducted as to
avoid all unnecessary physical and mental
suffering and injury.
• No experiment should be conducted
where there is an a priori reason to
believe that death or disabling injury will
occur;except in those experiments where
the investigators serve as subjects.
The Nuremberg Code
• The degree of risk to be taken should
never exceed that determined by the
humanitarian importance of the problem
to be solved by the experiment.
• Proper preparations should be made and
adequate facilities provided to protect the
experimental subject against even remote
possibilities of injury, disability, or death.
The Nuremberg Code
• The experiment should be conducted only
by scientifically qualified persons.
• During the course of the experiment the
human subject should be at liberty to
bring the experiment to an end (Intention
to Treat Precepts)
The Nuremberg Code
• During the course of the experiment the
scientist in charge must be prepared to
terminate the experiment at any stage, if
he/she has probable cause to believe, in
the exercise of good faith, superior skill,
and careful judgment that the
continuation of the experiment is likely to
cause injury, disability or death (Stopping
Rules)
Resources
• www.amgdb.org
• “Biochemistry Laboratory: Modern Theory and
•
•
Techniques”. Rodney Boyer. Benjamin
Cummings, New York, 2006
Alan Price, Ph.D. 2002. “How to protect your
faculty and department from research
misconduct allegations”. AMGDB Chairs Meeting
Brad Thompson, Ph.D. 2003. “Guidelines for
laboratory record keeping”. AMGDB Chairs
Meeting
References-Ethics
• Loewy EH.Textbook of healthcare ethics.
New York:Plenum Press, 1996.
• Veatch RM. A theory of medical ethics.
New York:Basic Books,Inc,Publishers,
1981.
• Beauchamp TLC, Childress JF.Principles of
biomedical ethics.6th ed. New York:
Oxford University Press, 2009.
References-Ethics
• Code of Ethics for Pharmacists. Adopted by
•
•
membership of American Pharmaceutical
Association, Washington, DC. October 27, 1994.
Veatch RM. Hospital Pharmacy:what is ethical ?
(Primer) Am J Hosp Pharm 1989, 46(Jan): 109115.
Veatch, RM, Haddad, A, Case Studies in
Pharmacy Ethics, 2nd Ed., Oxford University
Press, 2008.
References-Ethics
• Arnold RM, Nissen JC, Campbell NA. Ethical
•
issues in a drug information center. Drug Intell
Clin Pharm 1987; 21(Dec):1008-1011.
Kelly WN, Krause EC, Krowsinski WJ, Small, TR,
Drane JF. National survey of ethical issues
presented to drug inf.centers. Amer J Hosp
Pharm 1990;47(Oct)2245-50.