HISTORICAL AND CONTEMPORARY ISSUES IN RESEARCH ETHICS

BY

Dr Ekiria Kikule

EXHORTATION FOR ALL 1.

For we are Gods workmanship

or masterpieces, created in
Christ Jesus to do good works, which God prepared in advance

for us to do.
Ephesians 2:10

EXHORTATION FOR ALL 2.

Sometimes, with the best of intentions, scientists and
public officials and others involved in working for the
benefit of us all, forget that people are people. They concentrate so totally on plans and programs,

experiments, statistics- on abstractions- that people

become objects, symbols on paper, figures in a mathematical formula or impersonal subject in a scientific study

---- Atlanta Constitution, July 27, 1972

Historical Context of Experimentation with Humans

Before 1830s Colonial Times to Present

Examples of Biomedical Research Infamy

Medical personnel experiment on a prisoner at the Buchenwald concentration camp. Buchenwald, Germany, date uncertain.

Experimental Treatment with Bayer 205 (1923)

Bayer 205 was newly developed and very toxic an arsenic medication for the treatment of Trypanosomiasis

USPHS Study of Syphilis at Tuskegee (1932-1972)

600 black men (399 with syphilis, 201 without) were told they had bad blood, a local term used to describe syphilis, anemia, and fatigue.

USPHS US Public Health Service

USPHS Study of Syphilis at Tuskegee (1932-1972)

Spinal Tap: Deceptively presented as treatment and back shot to study subjects(1933)

First deception, then manipulation and exploitation

An invitation letter from Macon County Health Department to the studys participant for a free treatment to entice them to continue to be examined when there was no treatment.

Deception fed Deception .

25 year Certificate of Participation from the U. S. Public Health Service

The Whistle-blower:

Mr. Peter Buxton

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In the News: July 1972

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Apology 1997!!

Mission of the Tuskegee Bioethics Center

To become the premier bioethics center that promotes equity and justice in healthcare for all Americans, particularly African Americans, and that transforms a field that has virtually ignored the needs of communities of color.

The Bioethics Center: A National and International Resource!

Tuskegee Concerns in Bioethics:

1. The health and well-being of all people, from cradle to grave, particularly African Americans and other minorities 2. Potential to enroll in research without adequate info 3. Potential for coercion & exploitation 4. Potential for disproportionate representation

5. Potential for inappropriate use of study design and data

6. Potential for unfair distribution of risks and benefits 17 of research

What is Bioethics?
Bioethics is not ethics of biology. Bio = Life, quality, health and wellness, good life Ethics = Principles of right conduct or right action

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Bioethics is about:
1. Understanding = Analyzing issues, Identifying
Options

2. Acting = Choosing the best option, all things

considered

Diagnostic Questions For Best Option; Is it good?

Is it right?
Is it just?
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Benefits of Bioethics
1. Sensitizes us to relevant issues 2. Enables us to raise pertinent questions 3. Sharpens our ability to generate effective solutions to problems and resolutions to daunting ethical dilemmas

4. Increases our vigilance

5. Prepares us to be influential as we make good moral decisions
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Making Good Moral Decisions

Making good moral decision depends on:
Understanding the facts and context of the

case

Self knowledge and cultural perception

Knowledge of moral theories, principles and policies
A proper ethical orientation and judicious application of ethical principles, all things considered.
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Thinking Ethically Requires A Helping Hand

The Creation of Adam

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Human Subject Protections

Key Documents: 1. Nuremberg Code (1949)
Ten principles Not as original as sometimes suggested

2. Declaration of Helsinki (1964)

Adopted by the World Medical Association Modified 1975, 1983, 1989, and 1996

3. 4. 5. 6.

Belmont Report (1979) CIOMS Guidelines (1982, 1993) 45 CFR 46 Code of Federal Regulations HIPAA, 1996; Privacy Rule (2001, 2002, 2003)
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E.g. The Belmont Report

Ethical Principles
Respect for Persons Beneficence

Applications
Informed Consent Assessment of Risks and Benefits Fairness in Selection of Subjects
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Justice

Informed Consent: Concept 1.

Moral Sense: Autonomous authorization of ones participation in research; a morally effective authorization made by a person with a decision making capacity who has a substantial understanding of relevant information and who is free of controlling influences in making the decision.
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Informed Consent: Concept 2.

Socio-legal sense: A legally/institutionally effective authorization. The practices and conventions that make it socially or legally acceptable to use a person as a research subject.
It includes the rules, regulations, cultural and professional practices governing informed consent to research.
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Informed Consent: Concept

Questions:
Do the moral and socio-legal senses correspond in practice? Should they?

Faden & Beauchamp, A History of Informed Consent, 1986.

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Informed Consent: Study Volunteers

Challenges:
Reading, reviewing the consent form (Language, Literacy, illiteracy)

Comprehending the research study

Understanding of risks involved in research study Knowing what questions to ask
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Informed Consent: Study Personnel

Challenges: Avoiding undue influence /misrepresentation Making full disclosure

Ensuring that study volunteers are competent to consent

Designing and using assent documents for children Gaining and nurturing trust of study volunteers

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 For Short Generic Forms in eleven languages see: http://www.research.umn.edu/irb/consent/downloadshortfor ms.cfm Anderson, Sutcliffe & Curtis. The Hastings Center Report (36):6, 2006)
See http://www.usp.org/drugInformation/pictograms Willis G., JERHRE, 2006, pp. 9-24 United States and National Health and Medical Research Council, Australia Millum, J and Ezekiel Emmanuel. Science Vol. 318, 21 December 2007 www.sciencemag.org

Informed Consent: Measures to Ensure Proper Process and Best Practices

1. Research study volunteer preparation Allow for adequate time to read and formulate questions Provide glossary of research terms Graphics Review protocol with study volunteer
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Informed Consent: Measures to Ensure Proper Process and Best Practices

2. Consistent Communication
Volunteers Bill of Rights Videotape presentation of informed consent form Involving impartial witnesses during review process
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Informed Consent: Measures to Ensure Proper Process and Best Practices

3. Assessment of comprehension
Quizzes and questionnaires

Cognitive Interviewing
Assessment instrument to solicit how to improve the process
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Contemporary Issues
Consent Standard of Care Ancillary Care Post-trial benefits Scientific merit Conflict of Interest Risk versus benefit

Protection of vulnerable people

Disclosure of info to participants and their families Privacy Confidentiality

Challenging Ethical Issues in Research involving Human Beings (1a)

Consent: Is the purpose of the informed consent process more for risk management or genuine patient information? What should be done when free, informed and prior consent cannot be attained from participants? Scientific merit: Can innovative research that does not involve participant risk but is of uncertain merit be justified?
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Challenging Ethical Issues in Research involving Human Beings (1b)

Conflict of Interest: How should conflict of interest arising from involvement in research and product of research be resolved? Risk versus benefit: When can the potential benefits of research justify the possible risks to participants?

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Challenging Ethical Issues in Research on Human Beings (2a)

Protection of vulnerable people: Who are vulnerable people? What measures should be put in place to protect vulnerable research participants? Disclosure of information to participants and their families: When is it ethical to either withhold or disclose to participants and their families, information about them derived from research? 37

Challenging Ethical Issues in Research on Human Beings (2b)

Privacy: What safeguards should accompany the collection of participant information derived from research? Confidentiality: Are there circumstances which justify providing confidential participant information derived from research to third parties?
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Challenging Ethical Issues in Research on Human Beings (3)

Standard of care: Must interventions always be tested against the treatment available in developed countries? Ancillary care: What treatments should be provided by researchers during the trial beyond those needed for safety or scientific validity? Post-trial benefits: What should be provided to research participants and host communities after the research trial?

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Need for Responsible Science

Values objectivity in research
Addresses all kinds of deception, bias, conflicts of interest, and proper data management.

Exercises care in publication

Give credit where credit is due; respect intellectual property; deal fairly with media and the public

Safeguards the process for generating new knowledge

Mentor-mentee relations; research on animals; research on human subjects; teaching vs. research

Nurtures social responsibility

Relations with industry; public interest; military science
David B. Resnik. The Ethics of Science. Routledge, 1998.

A Thought for Researchers

the only true protection for research subjects comes from intelligent, informed, conscientious, compassionate, responsible investigator, research staff and collaborators
Henry Beecher, NEJM, 274:1354ff,1966
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Encouragement for Researchers

To God who is able to keep you from falling

and to present you before His glorious

presence without fault and with great

joyto the only God our Savior be glory,

majesty, power, authority, through Jesus

Christ our Lord, before all ages, now and

forevermore! Amen. Jude 24-25
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