Dahl-presentation - ethics and research.ppt

ethics and research studt

1. Ethics and Research
Research Ethics
Overview & Case
Studies
Rebecca W. Dahl, PhD
Director – Human Subjects Protection
Program

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Research Ethics
Deductive Reasoning
Ethical Theory Principle Rules Judgment
Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 2

11. Research Ethics
Deductive Reasoning
Ethical Theory Principle Rules Judgment
Peace Violence War
Jeff Cooper
Albany Medical Center, Ethical Decision Making, 2001, p. 2

12. 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

13. 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

14. Research Ethics
Deductive reasoning
No WAR!
Case Based Reasoning
Fight WAR!
Conflict

15. 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

16. 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

17. Research Ethics
What does this have to do with
research?

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. Research Ethics
Beecher - 1966 article was published in
New England Journal of Medicine
Penicillin and rheumatic fever
Effect of high levels of blood CO
2
Metastatic melanoma
Jeff Cooper
Albany Medical Center, History of Research Ethics, p. 4

27. 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

28. 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

29. 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

30. 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.

31. 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

32. 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

33. 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

34. 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

35. Research Ethics
Applying the Principles of the Belmont Report
Principle Meaning Practice
Respect for
Persons
Each person
has individual
rights
Obtain informed
consent, protect
privacy, maintain
confidentiality
Beneficence Provide benefit,
protect from
harm, limit risk
Risk-benefit
assessment made
Standard
procedures used
Justice
Equitable
selection of
subjects
Includes all groups
that may benefit
but does not single
out one group

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

37. Practice of the IRB
OHRP
Relies on an
assurance of
compliance that is
negotiated with the
institution (the
Assurance document
sets forth the means
by which the institution
will comply with
regulations)
FDA
Uses a system of
inspections and audits
(Inspects the IRB on a
routine basis)

38. Practice of the IRB
OHRP
HHS regulations related
to IRB responsibilities
are codified at 45 CFR
46
FDA
FDA regulations related
to IRB responsibilities are
codified at 21 CFR 50, 56
and are similar but not
identical to HHS (audits
occur approximately
every 4 years)

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. Research Ethics
“The public’s perception of
research, its benefits and its risks
is shaped by the way research is
conducted”.
Dunn & Chadwick, 1999

46. 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

47. 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

48. 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