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HUMAN RESEARCH HUMAN RESEARCH PROTECTIONSPROTECTIONS

Daniel R. Vasgird, PhD, CIPDaniel R. Vasgird, PhD, CIPOffice of Research Compliance Office of Research Compliance

West Virginia UniversityWest Virginia University

(304) 293-6094(304) 293-6094drvasgird@mail.wvu.edu

THE ESSENTIAL DILEMMATHE ESSENTIAL DILEMMA

Human dignity and social justice in

an economically and politically

unbalanced world

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““The first step in the The first step in the evolution of ethics is a evolution of ethics is a sense of solidarity with sense of solidarity with other human beings.”other human beings.”

Albert SchweitzerAlbert Schweitzer

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““Ethics primarily concerns the Ethics primarily concerns the effects of our actions on effects of our actions on

others.”others.”

Randy CohenRandy Cohen

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DRAMATURGICAL DRAMATURGICAL FUNCTION OF IRBsFUNCTION OF IRBs

To become the subject as much To become the subject as much as possible as possible

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"Of all the traits which qualify a scientist "Of all the traits which qualify a scientist for citizenship in the republic of science, I for citizenship in the republic of science, I

would put would put a sense of responsibilitya sense of responsibility as a as a scientist at the very top. A scientist can be scientist at the very top. A scientist can be

brilliant, imaginative, clever with his brilliant, imaginative, clever with his hands, profound, broad, narrow-but he is hands, profound, broad, narrow-but he is

not much as a scientist unless he is not much as a scientist unless he is responsible."responsible."

- Alvin Weinberg, - Alvin Weinberg, The Obligations of Citizenship in The Obligations of Citizenship in the Republic of Sciencethe Republic of Science

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Perseverance and success,

but for some increased:

1. Risk for unintentional bias

2. Willingness to cut corners

3. Willingness to commit serious misconduct

Consequences of ambitionConsequences of ambition

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GelsingerGelsinger

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The research protection The research protection system fundamentally system fundamentally

revolves around mutual revolves around mutual trust.trust.

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What is an IRB?What is an IRB?

An autonomous body at a private, public, or government institution charged with reviewing research proposals that will include human subjects to ensure compliance with federal regulations, institutional policy and ethical principles.

Most often referred to as an Institutional Review Board (IRB)

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At this point in time the major At this point in time the major responsibility for insuring ethical responsibility for insuring ethical

decision making in human decision making in human research rests with the IRBs in research rests with the IRBs in

terms of terms of empowerment, empowerment, flexibility and discretionflexibility and discretion..

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IRBs have ethical IRBs have ethical responsibility and legal responsibility and legal

authority.authority.

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RESEARCHRESEARCH

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” 46.102 (d)

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Research is the active Research is the active application of curiosity and hope. application of curiosity and hope.

It is a manifestation of those It is a manifestation of those aspects of the human condition aspects of the human condition

that seek security against that seek security against mortality and greater mortality and greater

understanding of our existential understanding of our existential situation.situation.

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HUMAN SUBJECTHUMAN SUBJECT

“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) data through intervention or interaction with the individual, or (2) identifiable private information. 46.102(f)

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Reasonable ExpectationsReasonable Expectations

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HISTORY OF HUMAN HISTORY OF HUMAN RESEARCH GONE AWRYRESEARCH GONE AWRY

Nazi Experiments (Nuremberg) Milgram Obedience Experiments Radiation Experiments Wichita Jury Taping Study Jewish Chronic Disease Cancer Study Thalidomide Tragedy Syphilis Experiment (PHS, Tuskegee) Jesse Gelsinger

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NUREMBERG CODENUREMBERG CODE

The Nuremberg Code is primarily remembered for the first sentence of the first of the 10 principles: “The voluntary consent of the human

subject is absolutely essential.”It is to this statement that we trace the

modern requirement for seeking the voluntary consent of research subjects.

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SYPHILIS STUDY SYPHILIS STUDY (Tuskegee) Impact(Tuskegee) Impact

National Research Act (1974) - required federal regulations for the protection of human subjects

required informed consent required review and monitoring of research by an

institutional review board (IRB)

- created the National Commission for the Protection of Human Subjects of Biomedical

and Behavioral Research

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ETHICAL PRINCIPLESETHICAL PRINCIPLES [BELMONT[BELMONT REPORT, 1979]REPORT, 1979]

(Product of Nuremberg, Helsinki and the (Product of Nuremberg, Helsinki and the National Research Act of 1974)National Research Act of 1974)

RESPECT FOR PERSONS CONSENT, PRIVACY, CONFIDENTIALITY, I.E., AUTONOMY INCREASED PROTECTION FOR THOSE WITH DIMINISHED

AUTONOMY

BENEFICENCE RISKS VS. BENEFITS

JUSTICE EQUITY, FAIRNESS IN BENEFITS & BURDENS

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MAIN FUNCTION OF IRB REVIEW MAIN FUNCTION OF IRB REVIEW

TO ASSURE THAT:TO ASSURE THAT:

RISKS ARE MINIMIZED AND REASONABLE IN RELATION TO ANTICIPATED BENEFITS.

THERE IS INFORMED CONSENT.RIGHTS AND WELFARE OF SUBJECTS

ARE MAINTAINED (i.e., Continuous).

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AUTHORITY OF IRBAUTHORITY OF IRB

Requirement of review Approve, disapprove or modify Conduct continuing review

– At any time and in person if desired– Must be done at least once per year

Observe/verify changes Suspend or terminate approval

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Above all else, the IRB Above all else, the IRB should strive to “do the should strive to “do the

right thing”.right thing”.

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In sum, In sum, Empowerment, Flexibility Empowerment, Flexibility

and Discretionand Discretion&&

Dramaturgical FunctionDramaturgical Function