human research protections 101 - hcca official site · human radiation experiments – 1944-1974...

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Human Research Protections 101

Scott J Lipkin, DPMManaging Director

2014 HCCA Research Compliance Conference --- [email protected]

Session Overview

•Scott Lipkin, DPM: Defining the HRPP

•Jeffrey Cooper, MD: Human Research Regulation

•Tina Tyson, JD: Human Research Protection Responsibilities beyond the IRB

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Agenda

•Historical Events

•Response

•The Belmont Report

•The IRB

•The HRPP

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Why Human Subject Protections?

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Historical Events

• 1932‐1972: Tuskegee Syphilis Study • 1939‐1945: Nazi Medical War Crimes

• 1944‐1974: Human Radiation Experiments

• 1963: Jewish Chronic Disease Hospital Study• 1963‐1966: Willowbrook Study

• 1966: Beecher’s Publication• 1999: Death of Jesse Gelsinger• 2010: Guatemala Syphilis Experiments (1946‐1948), US issues apology

5https://phrp.nihtraining.com/history/07_history.php

Nazi Medical War Crimes – 1939-1945

• Experiments performed on thousands of concentration camp prisoners

• Freezing experiments

•Head injury experiments

•Muscle, bone, nerve transplantation experiments

• Sterilization experiments

• Sea water experiments

• Immunization experiments

• Incendiary bomb (phosphorous) experiments

• Experiments on twins


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Human Radiation Experiments – 1944-1974

• 400 experiments conducted by the U.S. Government

• Studies designed to:•Determine the effects of ionizing radiation

•Calibrate radiation detection instruments

• Informed consent was obtained

• Ethical issue: participants suffered physical injury from research in studies that offered no prospect of direct benefit


Jewish Chronic Disease Hospital Study – 1963

• Live cancer cells injected into chronically ill and debilitated patients.

•Patients were told they were receiving a skin test.• Investigators found guilty of fraud, deceit, and unprofessional conduct.


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Willowbrook Study – 1963 - 1966

•Willowbrook State School for “mentally defective persons.”

•Residents of Willowbrook (all children) were infected with hepatitis.

•Researchers were looking to learn about the transmission of hepatitis and to test the effects of gamma globulin as treatment.


Beecher’s Publication – 1966

•Dr. Beecher ‘s publication described 22 cases of human research that involved ethical violations.

•He argued against increasing regulations and in favor or responsible investigators.


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Tuskegee Syphilis Study 1932–1972

•Research funded by U.S. Public Health Service• 600 African‐American men entered into the study without their consent

• Infected men in study were not offered treatment with Penicillin after it was found to be an effective treatment


Death of Jesse Gelsinger – 1999


• 18 year old enrolled in a phase I‐ gene transfer clinical trial at University of Pennsylvania.

•Died from a reaction to a recombinant viral vector.

• Investigation after his death revealed:• Jesse should have been excluded from the study (high ammonia levels).

• Investigators failed to report that two patients experienced serious side effects from the gene therapy.

• Failure to disclose in the IC the death of monkeys who were given similar treatment.

• The PI at Penn was inventor of technology and held equity in the start‐up company.

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Guatemala Syphilis Experiments– 1946 -1948 (2010)


•Grant funded by U.S. NIH.• The researchers paid prostitutes infected with syphilis to have sex with prisoners .• Similar research was also conducted on the transmission and prophylaxis of gonorrhea and chancroid.

• The subjects for all of the STD experiments consisted of female sex workers, prisoners, soldiers, and mental hospital patients.

•Research occurred without knowledge by or permission from the country of Guatemala.

• 1500 participants – results never published.•Data discovered in 2005 when Wesleyan Professor came across the documents while investigating Tuskegee.

•U.S. issued apology in 2010.

Response


•1947: Nuremberg Code

•1953: First US Federal Policy for Protection of Human Subjects

•1964: Declaration of Helsinki•1974: Federal Protections for Human Subjects

•1979: The Belmont Report

•1981: HHS and FDA promulgate revisions of their regulations

•1991: Publication of the Common Rule

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Nuremberg Code - 1947


•Nuremberg Doctor’s Trial

• Individuals responsible for the experiments were tried separate from other war criminals.

• They were found guilty of “crimes against humanity.”

•Nuremberg Code

• Set forth ethical conditions for research.• First international standard for conduct of research.

Declaration of Helsinki - 1964


• Statement of ethical principles for medical research involving human subjects.

•Recognized internationally.•Principles addressed primarily to physicians.

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The Belmont Report - 1979

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Sets forth the basic ethical principles underlying the acceptable conduct of research involving human participants:

Respect for Persons

‐‐‐‐ Informed consent

Beneficence ‐‐‐‐ Risk/Benefit

Justice ‐‐‐‐ Selection of Participants

The Institutional Review Board

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• IRBs function as the administrative committee established to protect the rights of welfare of human research subjects

• IRBs are independent of other committees and independent of the needs of the institution

• At most institutions, all research involving human subjects must be reviewed by an IRB

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The Human Research Protection Program

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• 2002 Institute of Medicine (IOM) report introduced the concept of comprehensive human research protection programs with the responsibility extending beyond the IRB

• AAHRPP Accreditation advanced operationalized of the concept

Components of the Human Research Protection Program

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• Research Participants

• Investigators

• IRB Committees

• IRB Administrative Support

• Senior Organizational Leadership

• Department Chairs/Deans, etc.

• Departmental Scientific Review Committees

• Institutional Biosafety

• Radiation Safety

• Legal Services

• HIPAA Privacy Officer

• Pharmacy

• Nursing

• Grants/Contracts

• Billing/coverage analysis

• Materials Management

• COI Committee

• Corporate Compliance

• Research Compliance

• Quality

• Education

• Community Outreach

List is NOT all inclusive

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Critical Thinking at the Critical Time ™

human research protections 101 - hcca official site · human radiation experiments – 1944-1974...

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