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Ethics and Research. Research Ethics Overview & Case Studies. Rebecca W. Dahl, PhD Director – Human Subjects Protection Program. Research Ethics. The following commentary by Nicholas von Hoffman appeared in the Washington Post

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ethics and research

Ethics and Research

Research Ethics Overview & Case Studies

Rebecca W. Dahl, PhD

Director – Human Subjects Protection Program

research ethics
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 ethics1
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 ethics2
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 ethics3
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 ethics4
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 ethics5
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 ethics6
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 ethics7
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 ethics8
Research Ethics

Deductive Reasoning

Ethical Theory Principle Rules Judgment

Jeff Cooper

Albany Medical Center, Ethical Decision Making, 2001, p. 2

research ethics9
Research Ethics

Deductive Reasoning

Ethical Theory Principle Rules Judgment

Peace Violence War

Jeff Cooper

Albany Medical Center, Ethical Decision Making, 2001, p. 2

research ethics10
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 ethics11
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 ethics12
Deductive reasoning

No WAR!

Case Based Reasoning

Fight WAR!

Research Ethics

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

research ethics14
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 ethics15
Research Ethics

What does this have to do with research?

research ethics16
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 ethics17
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

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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

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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

research ethics22
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

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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

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 ethics27
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 ethics28
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 ethics29
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

research ethics31
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

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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 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 ethics33
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

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

Practice of the IRB

Two entities within DHHS have authority to oversee the conduct of clinical trials and IRBs

practice of the irb1
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)

Practice of the IRB
practice of the irb2
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)

Practice of the IRB
research ethics34
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 ethics35
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 ethics36
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 ethics37
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 ethics38
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 ethics39
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 ethics40
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
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
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
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