Ethics and Research

Research Ethics
Overview & Case
Studies

Source: Rebecca W. Dahl, PhD

Research Ethics

The following commentary by Nicholas von

Hoffman appeared in the Washington Post
“we are so preoccupied with defending our privacy
against insurance investigators, dope sleuths,
counter-espionage men, divorce detectives and
credit checkers that we overlook the social
scientists behind the hunting blinds who’re also
peeping into what we thought were our most
private and secret lives…”
Joan E. Sieber
Planning Ethically Responsible Research, p. 7-8
Research Ethics

“Ethics is the disciplined study or

morality….and morality asks the
question…what should one’s
behavior be”.

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
Research Ethics

“Greek ethos ‘character’ is the

systematic study of value concepts—
good, bad, right, wrong and the
general principles that justify applying
these concepts”.

Joan E. Sieber
Planning Ethically Responsible Research, p. 3
Research Ethics

Basically, there are two types of

ethics, Descriptive Ethics which
asks what does the culture or
society believe is morally
correct?

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
Research Ethics

The other type or Prescriptive

Ethics asks:
 How should I behave as a
researcher?
 What character traits should I
cultivate?

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
Research Ethics

Why is this so important?

 You will have many questions to
answer and you will need a
framework from which to answer
those questions.

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
Research Ethics

Two types of ethical decision-

making
 Deductive or principle based
reasoning
 Inductive or case based
reasoning

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
Research Ethics

 Deductive or principle based

reasoning
– Start with an ethical theory—
– Continue with a specific principle
– Develop rules
– Make judgments
Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 1
 Research Ethics

Deductive Reasoning

Ethical Theory Principle Rules Judgment

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 2
 Research Ethics

Deductive Reasoning

Ethical Theory Principle Rules Judgment

Peace Violence War

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 2
Research Ethics

Case Based Reasoning

 Decisions we have made – precedent
 Look back at those decisions and combine
them in order to make a judgment
 Judgments reflect back on rules
 Rules reflect on our principles
 Principles reflect back to the ethical theory

Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 2
Research Ethics

Case Based Reasoning

 Decisions we have made – avoid war and
move to Canada (U.S. declares war on
Canada)
 Judgment – defend yourself
 Rule – join Army (protect children
 Principles – family important
 Ethical theory
Jeff Cooper
Albany Medical Center, Ethical Decision making, 2001, p. 2
 Research Ethics

Deductive reasoning Case Based Reasoning

No WAR! Fight WAR!
Conflict
Research Ethics

Conflict Between Decisions

 When there is an argument
 Go back to the original principles –
ask yourself “What were my original
principles?”
 Original principles are in conflict or
“incoherent”
Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 3
Research Ethics

Conflict Between Decisions

 There will be conflict
 You will use both types of ethical decision-
making to make decisions
 When conflict arises…go back to the
original principles and try to create
coherence by dealing with the specific
principles
Jeff Cooper
Albany Medical Center, Ethical Decision Making 2001, p. 3
Research Ethics

What does this have to do with

research?
Research Ethics

Ethics is about creating a mutually

respectful relationship with the
research population
 Subjects are pleased to participate
 Community regards the conclusions
as constructive

Joan E. Sieber
Planning Ethically Responsible Research, p. 3
Research Ethics

An ethically insensitive researcher can

leave the research setting in
pandemonium
 the researcher
 the institution
 the cause that he/she seeks to
promote
Joan E. Sieber
Planning Ethically Responsible Research, p. 3
Research Ethics

Failure to treat subjects with respect

can result in data that is:
 Misleading
 Inconclusive
 biased
Joan E. Sieber
Planning Ethically Responsible Research, p. 4
Research Ethics

Scientists involved in the intense

and demanding enterprise of
research…often overlook the
interests and perspectives of the
research subject. Subjects may
respond with lies and subterfuge.
Joan E. Sieber
Planning Ethically Responsible Research, p. 4
Research Ethics

The problems encountered in

behavioral research by the National
Commission included:
 Lack of informed consent
 No debriefing (restoration to an
emotional state equal to what was
experienced before the experiment)
Joan E. Sieber
Planning Ethically Responsible Research, p. 7
Research Ethics

The problems encountered in

behavioral research by the National
Commission included:
 Deception was a standard tool
 Invasion of privacy

Joan E. Sieber
Planning Ethically Responsible Research, p. 7
Research Ethics

The problems encountered in biomedical

research by the National Commission
included:
 Lack of informed consent
 Disregard for risks encountered by the
patient
 Deception

Joan E. Sieber
Planning Ethically Responsible Research, p. 7
Research Ethics

The problems encountered in biomedical

research by the National Commission
included:
 Beecher - 1966 article was published in
New England Journal of Medicine
 Tuskegee – untreated syphilis in black
males
Research Ethics

 Beecher - 1966 article was published in

New England Journal of Medicine
 Penicillin and rheumatic fever
 Effect of high levels of blood CO2
 Metastatic melanoma

Jeff Cooper
Albany Medical Center, History of Research Ethics, p. 4
Research Ethics

Scientists attempted to critically

examine questionable research
practices and to recommend
changes, but could not.

Joan E. Sieber
Planning Ethically Responsible Research, p. 4
Research Ethics

So…the federal government brought

numerous violations and issues to
the forefront and in 1974 mandated
the establishment of Institutional
Review Boards (National Research
Act)

Joan E. Sieber
Planning Ethically Responsible Research, p. 4
Research Ethics

The role of the Institutional Review

Board (IRB) is to determine whether
the rights and welfare of the subjects
are adequately protected and
whether the study adheres to sound
ethical and scientific principles

Joan E. Sieber
Planning Ethically Responsible Research, p. 4-5
Research Ethics

Federal regulations have been

established in order to provide the
standards for monitoring all
research activity related to people
who volunteer as subjects for
research. Abiding by these
standards ensures the ethical
conduct of research.
Research Ethics

The Act also created the National

Commission for the Protection of
Human Subjects of Biomedical and
Behavioral Research (wrote the
Belmont Report in 1979)

Cynthia Dunn & Gary Chadwick

Protecting Study Volunteers in Research, p. 16
Research Ethics

The National Commission for the

Protection of Human Subjects of
Biomedical and Behavioral Research
was commissioned to develop
guidelines to assure that human
research was conducted ethically.

Cynthia Dunn & Gary Chadwick

Protecting Study Volunteers in Research, p. 16
Research Ethics

They were told to look at literature, look

at arguments people made, review
what ethicists were saying about
research and ask…what are the
fundamental principles behind the
decisions people make or should
make about research

Jeff Cooper
Albany Medical Center, Belmont Principles, p. 1
Research Ethics

Belmont Report – 1979

 Respect – treat others as autonomous
agents, allow people choice
 Beneficence – acts of kindness that go
beyond charity and duty…various
obligations (i.e., do no harm, promote
good)
 Justice – treat people fairly
Jeff Cooper
Albany Medical Center, Belmont Principles, p. 1 & 2
 Research Ethics

Applying the Principles of the Belmont Report

Principle Meaning Practice
Obtain informed
Respect for Each person consent, protect
Persons has individual privacy, maintain
rights confidentiality

Beneficence Provide benefit, Risk-benefit

assessment made
protect from
Standard
harm, limit risk procedures used
Equitable Includes all groups
Justice
selection of that may benefit
subjects but does not single
out one group
 Practice of the IRB

Two entities within DHHS have authority to

oversee the conduct of clinical trials and IRBs
OHRP FDA
 Primary duty is to  Oversees the regulation
implement policies and of drugs, biologics,
regulations that involve devices, foods and
humans (Before 2000 veterinary medicines
the office was OPRR)
 Practice of the IRB

OHRP FDA
 Relies on an  Uses a system of
assurance of inspections and audits
compliance that is (Inspects the IRB on a
negotiated with the routine basis)
institution (the
Assurance document
sets forth the means
by which the institution
will comply with
regulations)
Practice of the IRB
OHRP
 HHS regulations related  FDA regulations related
to IRB responsibilities
are codified at 45 CFR
46
FDA
to IRB responsibilities
are codified at 21 CFR
50, 56 and are similar
but not identical to HHS
(audits occur
approximately every 4
years)
Research Ethics

Six Norms of Scientific Research

 Valid
research design – takes into
account relevant theory, methods,
and prior findings

Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

Six Norms of Scientific Research

 Competence of researcher – capable
to carry out the procedures

Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

Six Norms of Scientific Research

 Identification
of consequences –
assessment of risks and benefits
(maximizing benefit and minimizing
risk)

Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

Six Norms of Scientific Research

 Selection of subjects – appropriate to
the purposes of the study,
representative of the population that
will benefit from the research and
appropriate in number
Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

Six Norms of Scientific Research

 Voluntary informed consent –
obtained before study begins, without
undue threat or inducement, with
enough information, and agreement
to participate
Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

Six Norms of Scientific Research

 Compensation for injury –
responsibility for what happens to the
subject (federal law requires that
subjects be informed about
compensation, but does not require
compensation)
Joan E. Sieber
Planning Ethically Responsible Research, p. 19
Research Ethics

“The public’s perception of

research, its benefits and its risks
is shaped by the way research is
conducted”.

Dunn & Chadwick, 1999

Case Study #1

A researcher plans to study the effects of

competition on ability to solve math
problems. Half of the subjects will be told
that the researcher wants to see what
approach they take in solving math
problems. The other half will be told that
the researcher wants to see which
persons choose the best approach
Joan E. Sieber
Planning Ethically Responsible Research, p. 21
 Case Study #2

A researcher plans to compare the intellectual skills

of retired people to those of college volunteers to
receive an A in their psychology course, and for
nonvolunteers to have their grade lowered. To
recruit retired people, she plans to go to a
retirement community each evening, knock at
people’s doors, and ask them to work some
puzzles, not explaining details of the study
because most wouldn’t understand.
Joan E. Sieber
Planning Ethically Responsible Research, p. 21
Case Study #3

A graduate student plans to compare drug use

among college freshman and seniors. Because
she may want to reinterview some subjects later,
she plans to write their names and phone
numbers on their data sheets. She plans to
promise confidentiality, so that subjects will trust
her, and to keep the data in her dorm room in a
locked file.
Joan E. Sieber
Planning Ethically Responsible Research, p. 21