Sex,%20Drugs,%20Rock%20and%20Role,%20and%20Other%20Ethical%20Dilemmas%20in%20Community%20Based%20Research

1
Sex, Drugs, Rock and Role, and Other Ethical
Dilemmas in Community Based Research

• Robert T. Trotter, II
• General Motors
• Sigma Xi Lecture
• Dec. 4, 2003

2
Ethical Pressuresand Research on Humans

• Ethical Guidelines Have Always Been
• Reactive before being Proactive
• Key International Guidelines
• Ethics assumed prior to WWII Religious
  Conventions and Disciplinary Ethical Standards
• 1947 Nuremberg Code
• 1964 Helsinki Declaration
• 1993 Ethics and Research on Human Subjects,
  International Guidelines
• 2001 International Ethical Guidelines For
  Research Involving Human Subjects

3
U.S. Human Experimentation Policy History

• U.S. Constitution and Bill of Rights
• 1964 Civil Rights Act, Privacy and
  Confidentiality Act
• 1965 U.S. Public Health Service formal ethical
  review
• 1971 Guidelines for Federal Ethical Review
• 1974 National Research Act
• Established the National Commission for the
  Protection of Human Subjects
• Formally established IRBs (Institutional Review
  Boards)
• 1978 The Belmont Report
• 1981 Final joint regulations issued by federal
  government

4
Foundations

• I have vowed eternal vigilance against any form
  of tyranny over the mind of man.
• Thomas Jefferson
• Constitution defines and provides us with a
  number of critical rights to life, liberty, and
  the pursuit of happiness basis for current
  ethical standards and definitions

5
Critical Historical Incidents

• 1947 Nuremberg War Crimes Tribunal
• Our understanding of violations by others.
• 1972 Tuskegee Syphilis Study Revealed
• Our understanding of violations by us.
• Implemented in 1932
• Study of the Natural Course of Syphilis
• 399 African-American Men in Alabama
• Uniformed and Untreated

6
Summary Human Experimentation Policies

• 1947 Nuremberg Code
• 1961 Draft Code of Ethics on Experimentation
• 1964 Helsinki Declaration
• 1964 Civil Rights Act, Privacy and
  Confidentiality Act
• 1971 DHEW published policy on protection of
  human subjects
• 1974 Formal establishment of IRBs
• 1978 Belmont Report
• 1981 Final regulations issued by DHHS
• 1993 Ethics and Research on Human Subjects,
  International Guidelines
• 2001 International Ethical Guidelines For
  Research Involving Human Subjects

7
Key Requirements for Ethical Approvalof Human
Research (IRB Guidelines)

• Distinguishing Research from Practice
• Sound Research Design
• Protection of Confidentiality
• Informed Consent
• Participation is Voluntary
• Consideration of risks/benefits
• Equality in Treatment of Subjects

8
Philosophical Principles Governing Research with
Human Subjects

• Respect for Persons
• Free will and self determination applications
• Informed consent procedures
• Voluntary participation without coercion or
  pressure
• Guaranteed privacy, confidentiality protection
• Competence assumed otherwise additionally
  protected
• Beneficence/Nonmalficence
• Minimize harm, maximize benefit applications
• Harm-benefit judgment and analysis
• Consideration for individuals, communities,
  society, science
• Justice
• Equity and fairness for both risks and benefits
  applications
• Special vulnerable groups protection
• Principle of Inclusion of all populations

9
Ethical Problems

• Violations of Ethical Principles and Guidelines
• Bad stuff
• Ethical Dilemmas
• No win situations

10
Common Ethical Violations

• Confidentiality talking, talking too loud,
  talking in the wrong place, talking to the wrong
  people
• Coercion asking too hard, asking the wrong
  people at the wrong time, paying for research
• Competing allegiances to research subjects,
  research sponsor, organization, community
  conflicts of interest
• Cultural conflict conflicts of class, social
  justice, and imposed values its for their own
  good

11
Examples of Dilemmas

• Confidentiality versus Do No Harm HIV and Drugs

12
Examples of Dilemmas

• Beneficence versus The Law

13
Examples of Dilemmas

• Privacy vs. Public Good Levels of Benefit and
  Harm Sex in the City

14
Ethical Dilemmas Cross-Cultural Conditions

• Language barriers would you sign something you
  cannot read?
• Differences in cultural norms, beliefs, values
  who are the governmental spies?
• Power (status) differences between researcher and
  subject its ok to do this because I trust you,
  or you scare me.
• Identification of right person to give consent
• Authority to provide consent may lie with spouse,
  family elders, religious leaders, community
  leaders, or others and not just the single
  individual who participates in the research
• Reverse Ethical Dilemmas or Violations in the
  name of political correctness

15
Ethics and Intellectual Property

• Control over uses of data
• Ownership of data
• Ethnomedical example
• Access to data
• Collaborative Research example
• Publication of data
• Cross-cultural example

16
Solutions

• Ethics Training for Researchers know the
  principles and their applications
• Ethical Review for Projects spread the blame,
  protect the innocent
• Ethical Problem Resolution Procedures
• The Ethical Workup Guide