Ethics

1
Ethics

• A system of principles governing the rightness or
  wrongness of certain actions.

2
Social Work Code of Ethics Research

• 1. Should consider carefully the possible
  consequences for human beings.
• 2. Consent is voluntary and informed.
• 3. Protect subjects from unwarranted physical
• or mental harm, danger, or distress.
• 4. Research data used for professional purposes
• 5. Confidential
• 6. Take Credit only for work actually done

3
1946 Nuremburg Trials

• 23 Nazi Physicians went on trial at Nuremburg
  because of research atrocities performed on
  prisoners of war

4
Nazi Medical Experiments

• Pharmaceutical experiments
• Sterilization
• Hypothermia

5
Dr. PozosUniversity of Minnesota

• Data from Nazi experiments on hypothermia showing
  rapid rewarming most effective

6
Nuremberg Codes (1947)10 principles

• 1. Voluntary consent
• 2. Research should yield fruitful results for
  the good of society, and which cannot be obtained
  by other means
• 3-8. Principles 3-8 deal with minimizing the
  possibility of injury or harm coming to research
  subjects
• 9. Right of subjects to withdraw from study
• 10. Terminate study if continuation likely to
  lead to result in injury

7
Growth in NIH Budget

• 1946 700,000
• 1955 36 million
• 1970 1.5 billion
• 2001 20 billion
• 2002 23 billion (requested)
• University of Wisconsin approx. 500 million

8
Discovery in U.S. of Unethical Research Practices

• Willowbrook
• Tuskegee Study
• Jewish Chronic Disease Hospital Study
• Radiation Tests on Mentally Disabled Boys
• Milgram Experiments

9
1974 National Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research
10
Belmont Report

• Released in 1978.
• Set forth Ethical Principles and Guidelines for
  the Protection of Human Subjects

11
Distinction Between Biomedical and Behavioral
Research vs. Practice

• Practice experimentation designed solely to
  enhance the well-being of an individual patient
  or client and that have a reasonalbe expectation
  of success.
• Research- activity to test an hypothesis, permit
  conclusions to be drawn, and thereby to
  contribute to generalizable knowledge.

12
Three Guiding Principles

• 1. Respect for Persons
• Individuals should be treated as autonomous
  agents
• Persons with diminished autonomy are entitled to
  protection

13
Guiding Principles (Belmont Report)

• 2. Beneficience
• maximize possible benefits and minimize
  possible harms.

14
Guiding Principles (Belmont Report)

• 3. JUSTICE
• People should be treated equally.
• - are some classes (welfare patients, persons
  confined to institutions) being systematically
  selected because of their easy availability,
  their compromised position and so forth

15
Application of Belmont Principles
16
Belmont Principle 1Respect for Persons

• Requires Informed consent.

17
Informed Consent

• A voluntary decision made to participate in a
  study based on sufficient knowledge and
  understanding of the research.
• Participant must feel free to decline
  participation.

18
Statement of Informed Consent

• Purpose of the research study
• Description of procedures to be followed
• Description of any risks and benefits
• Name of person and phone number of person legally
  responsible for conducting the research
• Statement that participation is voluntary, right
  to refuse

19
Institutional Review Boards(Human Subjects
Committees)

• Paramount responsibility is to protect the rights
  and welfare of human research subjects.
• All research projects involving human subjects
  (regardless of if funded or unfunded) must be
  reviewed by IRB

20
Deception

• When the subject is not informed or aware that he
  or she is participating in a study.

21
Use of Deception Acceptable

• Incomplete disclosure is truly necessary to
  accomplish the goals of the research
• There are no undisclosed risks to subjects that
  are more than minimal
• There is an adequate plan for debriefing subjects

22
Debriefing

• Sharing with participant true nature of study and
  why it was necessary to deceive subject

23
Belmont Principle 2Assessment of Risks and
Benefits

• Many types of possible risks need to be
  considered risks of psychological harm, physical
  harm, legal harm, social harm and so forth
• Benefits outweigh risks

24
Belmont Principle 3Justice

• Selection of Subjects
• Subjects selected on ability of members of that
  class to bear burdens and on the appropriateness
  of placing further burdens on already burdened
  persons
• Exclusion from of certain classes of people from
  research without cause (e.g., women, minorities)

25
Early 1980s

• Title 45 Code of the Federal Regulations Part 46,
  Protection of Human Subjects
• Revised regulations for the conduct of research
  with humans.
• Require universities conducting research to
  establish IRB or Human Subject Committees

26
Special Protections for Vulnerable Groups

• Children
• Prisoners
• Pregnant women

27
Confidentiality

• The researcher is able to identify a given
  persons responses but promises never to make
  this information public.

28
Anonymity

• Researchers is unable to link up a specific
  questionnaire with a specific respondent.

29
Continue to Exist Ethical Violations

• Gene TherapyCase of Jesse Gelsinger, 18, at the
  University of Pennsylvania
• Asthma study
• Homelessness studies