Title: Sex,%20Drugs,%20Rock%20and%20Role,%20and%20Other%20Ethical%20Dilemmas%20in%20Community%20Based%20Research
1Sex, Drugs, Rock and Role, and Other Ethical
Dilemmas in Community Based Research
- Robert T. Trotter, II
- General Motors
- Sigma Xi Lecture
- Dec. 4, 2003
2Ethical 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
3U.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
4Foundations
- 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
5Critical 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
6Summary 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
7Key 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
8Philosophical 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
9Ethical Problems
- Violations of Ethical Principles and Guidelines
- Bad stuff
- Ethical Dilemmas
- No win situations
10Common 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
11Examples of Dilemmas
- Confidentiality versus Do No Harm HIV and Drugs
12Examples of Dilemmas
- Beneficence versus The Law
13Examples of Dilemmas
- Privacy vs. Public Good Levels of Benefit and
Harm Sex in the City
14Ethical 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
15Ethics 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
16Solutions
- 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