Ethics in Research.ucu

7/29/2019 Ethics in Research.ucu

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HISTORICAL AND

CONTEMPORARY ISSUES

IN RESEARCH ETHICS

BY

Dr Ekiria Kikule


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EXHORTATION FOR ALL 1.

Forweare Gods workmanship

ormasterpieces, created in

Christ Jesus to do good works,

which God prepared in advance

for us to do.

Ephesians 2:10


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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, J uly 27, 1972


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Historical Context of

Experimentation with Humans

Before 1830s Colonial Times to Present

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5

Examples of BiomedicalResearch Infamy


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Medical personnel experiment on a prisoner at

the Buchenwald concentration camp.

Buchenwald, Germany, date uncertain.


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Experimental Treatment with Bayer

205 (1923)

Bayer 205 was

newly developed

and very toxic an

arsenic

medication for

the treatment of

Trypanosomiasis


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USPHS Study of Syphilis at Tuskegee

(1932-1972)

600 black men (399

with syphilis, 201

without) were told

they had bad

blood, a local termused to describe

syphilis, anemia,

and fatigue.

USPHS US Public Health Service


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USPHS Study of Syphilis at

Tuskegee (1932-1972)

Spinal Tap:

Deceptively

presented astreatment and

back shot to

studysubjects(1933)


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First deception, then manipulation

and exploitation

An invitation letter

from Macon County

Health Department

to the studysparticipant for a

free treatment to

entice them to

continue to beexamined when

there was no

treatment.


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Deception fed Deception .

25 year Certificate

of Participation

from the U. S.

Public Health

Service


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The Whistle-blower:

Mr. Peter Buxton


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In the News: July 1972


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Apology 1997!!


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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.


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The Bioethics Center: A National and

International Resource!


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Tuskegee Concerns in Bioethics:

1. The health and well-being of all people, from

cradle to grave, particularly African Americans andother 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 benefitsof research


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What is Bioethics?

Bioethics is not ethics of biology.

Bio = Life, quality, health and wellness,

good life

Ethics = Principles of right conduct orright action


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Bioethics is about:

1. Understanding= Analyzing issues, IdentifyingOptions

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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1. Sensitizes us to relevant issues

2. Enables us to raise pertinent questions

3. Sharpens our ability to generate effective

solutions to problems and resolutionsto daunting ethical dilemmas

4. Increases our vigilance

5. Prepares us to be influential as we make

good moral decisions

Benefits of Bioethics


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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

policiesA proper ethical orientation and judicious

application of ethical principles, all things considered.

Making Good Moral Decisions


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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. Belmont Report (1979)

4. CIOMS Guidelines (1982, 1993)

5. 45 CFR 46 Code of Federal Regulations

6. HIPAA, 1996; Privacy Rule (2001, 2002, 2003)


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E.g. The Belmont Report

Ethical Principles

Respect for Persons

Beneficence

Justice

Applications

Informed Consent

Assessment of Risks

and Benefits

Fairness in Selection

of Subjects


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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 relevantinformation 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 personas 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 researchstudy

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 arecompetent to consent

Designing and using assent documents forchildren

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, 21December 2007 www.sciencemag.org

I f d C M E
http://www.research.umn.edu/irb/consent/downloadshortforms.cfmhttp://www.research.umn.edu/irb/consent/downloadshortforms.cfmhttp://www.usp.org/drugInformation/pictogramshttp://www.usp.org/drugInformation/pictogramshttp://www.research.umn.edu/irb/consent/downloadshortforms.cfmhttp://www.research.umn.edu/irb/consent/downloadshortforms.cfm


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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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2. Consistent Communication

Volunteers Bill of Rights

Videotape presentation of informed consent

form

Involving impartial witnesses during review

process


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3. Assessment of comprehension

Quizzes and questionnaires

Cognitive Interviewing

Assessment instrument to solicit how toimprove 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 vulnerablepeople

Disclosure of info toparticipants and theirfamilies

Privacy

Confidentiality


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Challenging Ethical Issues in

Research involving Human Beings (1a)

Consent: Is the purpose of the informed consent process

more for risk management or genuine patientinformation?

What should be done when free, informed andprior consent cannot be attained from participants?

Scientific merit:

Can innovative research that does not involveparticipant risk but is of uncertain merit be justified?


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Research involving Human Beings (1b)

Conflict of Interest:

How should conflict of interest arising from

involvement in research and product of researchbe resolved?

Risk versus benefit:

When can the potential benefits of researchjustify the possible risks to participants?


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Research on Human Beings (2a)

Protection of vulnerable people:

Who are vulnerable people?

What measures should be put in place to protectvulnerable research participants?

Disclosure of information to participants and

their families:

When is it ethical to either withhold or disclose toparticipants and their families, information aboutthem derived from research?


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Research on Human Beings (2b)

Privacy:

What safeguards should accompany the collection

of participant information derived from research?

Confidentiality:

Are there circumstances which justify providingconfidential participant information derived fromresearch to third parties?

C


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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 byresearchers during the trial beyond those neededfor 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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David B. Resnik. The Ethics of Science. Routledge, 1998.

Need for Responsible Science

Values objectivity in researchAddresses all kinds of deception, bias, conflicts of

interest, and proper data management.

Exercises care in publicationGive credit where credit is due; respect intellectual

property; deal fairly with media and the public

Safeguards the process for generatingnew knowledge

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

Nurtures social responsibilityRelations with industry; public interest; military science


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A Thought for Researchers

the only true protectionfor research subjectscomes from intelligent,informed,conscientious,compassionate,responsible investigator,research staff andcollaborators

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 JesusChrist our Lord, before all ages, now and

forevermore! Amen. Jude 24-25

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