Ethics - Research with Human Subjects

NUREMBERGCODE

100

This code was the product of what "war"?

WWII

200

This code was first published in this journal.

Journal of the American Medical Association

300

This is absolutely essential based on the Nuremberg Code

Voluntary consent of the human subjects

400

These should be avoided during experiments with human subjects.

physical and mental suffering and injury

500

During the experiment who has the liberty to terminate the experiment

The human subject and the experimenter

Unethical Experiments

100

Poor black men in Alabama were observed for more than 40 years to study the natural history of syphilis, and medication was withheld even when effective treatment became available 1932-1972

Tuskegee Syphilis Study

200

Developmentally disabled children residing in an overcrowded state institution formerly located on Staten Island were deliberately infected with hepatitis B to help researchers seeking an effective preventive vaccine

Willowbrook hepatitis experiments

300

U.S. researchers deliberately infected people with syphilis to study effects of antibiotic therapy 1946-1948

Guatemala syphilis study

400

1952: injected live cancer cells into inmates at Ohio State Prison 1962: injected live cancer cells into elderly patients of the Jewish Chronic Disease Hospital in Brooklyn

Chester Southam’s (Sloan-Kettering Institute) cancer studies

500

Alfred Kligman (University of Pennsylvania) infected hundreds of prisoners at what prison in Pennsylvania with a variety of pathogens in order to test new therapies in the period from 1951-1974

Holmesburg State Prison

Regulation of human subjects research in US

100

In this year year Institutional Review Boards were established as as having required oversight authority for federally sponsored research

1974

200

This report, produced in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, lists basic principles of medical ethics

The Belmont Report

300

Federal Policy for the Protection of Human Research Subjects, issued by 15 federal departments and agencies in 1991, standardizing human subjects protection across the federal government

The Common Rule

400

What office, housed in the Department of Health and Human Services (DHHS) has oversight responsibility for human subjects research in the U.S.

The Office Of Human Research Protection (OHRP)

500

This is the last year that the US recognizes revisions for the Declaration of Helsinki

1989 U.S. does not recognize any revisions after 1989, rejecting 2000 revisions and all subsequent revisions. In 2008 FDA eliminated need for U.S. researchers to abide by the Declaration of Helsinki

ETHICAL PRINCIPLES

100

A positive obligation to do good

Beneficence

200

Primum, non nocere: First, do no harm

Non-maleficence

300

Failure to adhere to the principles of non-maleficence

negligence

400

treating every person the same way

Justice

500

The right of persons to make decisions about their own health and life in the context of medical treatment and participation in research

Autonomy

All of the information about IRBs that you never really wanted to know

100

Number of members on an IRB

At least 5

200

IRBs evaluate if adequate protections in place to safeguard ______ (if they are being studied).

Vulnerable populations

300

These must be true in order for ____ to be possible: purpose, procedures and potential risks of the study must be clear to the subject

Informed consent

400

Conflicts of interest can arise in what three levels

investigator, IRB, institution

500

Privacy must be protected through

Confidentiality