Ethics and Research

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Ethics and Research

• Research Ethics Overview Case Studies

Rebecca W. Dahl, PhD Director Human Subjects
Protection Program
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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 whore also
  peeping into what we thought were our most
  private and secret lives
• Joan E. Sieber
• Planning Ethically Responsible Research, p. 7-8

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Research Ethics

• Ethics is the disciplined study or morality.and
  morality asks the questionwhat should ones
  behavior be.
• Jeff Cooper
• Albany Medical Center, Ethical Decision Making,
  2001, p. 1

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Research Ethics

• Greek ethos character is the systematic study
  of value conceptsgood, bad, right, wrong and the
  general principles that justify applying these
  concepts.
• Joan E. Sieber
• Planning Ethically Responsible Research, p. 3

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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

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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

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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

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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

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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

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Research Ethics

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

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Research Ethics

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

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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

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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

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Research Ethics

• Deductive reasoning
• No WAR!

• Case Based Reasoning
• Fight WAR!

Conflict
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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

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Research Ethics

• Conflict Between Decisions
• There will be conflict
• You will use both types of ethical
  decision-making to make decisions
• When conflict arisesgo 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

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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

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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

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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 researchoften 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

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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

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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

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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

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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

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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

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Research Ethics

• Sothe 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

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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

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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.

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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

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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

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Research Ethics

• They were told to look at literature, look at
  arguments people made, review what ethicists were
  saying about research and askwhat are the
  fundamental principles behind the decisions
  people make or should make about research
• Jeff Cooper
• Albany Medical Center, Belmont Principles, p. 1

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Research Ethics

• Belmont Report 1979
• Respect treat others as autonomous agents,
  allow people choice
• Beneficence acts of kindness that go beyond
  charity and dutyvarious obligations (i.e., do no
  harm, promote good)
• Justice treat people fairly
• Jeff Cooper
• Albany Medical Center, Belmont Principles, p. 1
  2

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Research Ethics
Applying the Principles of the Belmont Report
Principle
Meaning
Practice
Obtain informed consent, protect privacy,
maintain confidentiality
Respect for Persons
Each person has individual rights
Risk-benefit assessment made Standard procedures
used
Beneficence
Provide benefit, protect from harm, limit risk
Equitable selection of subjects
Includes all groups that may benefit but does not
single out one group
Justice
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Practice of the IRB
Two entities within DHHS have authority to
oversee the conduct of clinical trials and IRBs

• 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

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Practice of the IRB

• FDA
• Uses a system of inspections and audits (Inspects
  the IRB on a routine basis)

• 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)

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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)

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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

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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

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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

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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

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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

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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

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Research Ethics

• The publics 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

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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 peoples doors, and ask them to work some
  puzzles, not explaining details of the study
  because most wouldnt understand.
• Joan E. Sieber
• Planning Ethically Responsible Research, p. 21

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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