Was the U C Berkeley faculty and staff tricked into believing that I had given my Informed Consent? According to the Graduate student who took my picture and told me I was very brave to be doing what I was doing, the answer to the question would have to be YES, they were tricked by SRI Int'l into believing that I gave my permission. Why should it surprise me anyway knowing what I know about the shadowy side of SRI Int'l and its criminal involvement in what has happened to targeted individuals. Still I'd like to have an answer to the question. I want to go back home to Berkeley where I lived for 30 years - it's my home and where this all began. There are answers back there for me.
I have excerpted only a few paragraphs from the below Wikipedia link. If you're anything like me, you will be interested in this documentation.
Human subject research - Wikipedia, the free encyclopedia
http://en.wikipedia.org/wiki/Human_subject_research#History_of_human_subjects_abuses
Human subject research includes experiments (formally known as interventional studies) and observational studies. Human subjects are commonly participants in research on basic biology, clinical medicine, psychology, and all other social sciences.
Humans have been participants in research since the earliest studies.
As research has become formalized the academic community has developed
formal definitions of "human subject research", largely in response to
abuses of human subjects.
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US Department of Defense Research
- DoD Directive 3216.02
- This document defines additional requirements for HSR supported by the Department of Defense.
- 10 USC 980
- Title 10, United States Code, Subtitle A, Part II, Chapter 49, Section 980 (10 USC 980) addresses the limitations on use of humans as experimental subjects. It basically states that funds cannot be deployed
prior to obtaining informed consent.
Scope of Guidelines
Just because a project involves the use of human participants does not mean it constitutes human subject research. The activities must meet the definition of research, and the use of the human participants must meet the definition of human subjects.
The definitions are written as such to include situations where the
human is the subject of the experiment, their environment is manipulated
by the researchers, and data regarding their responses are collected.
If the project does not meet the definition of Human Subject Research, then the requirements do not apply, and the project does not require an IRB review or informed consent. However, it is best to have an IRB make this determination and document the decision.
If a project is defined as Human Subject Research, it may still be considered Exempt. This generally means that the project is minimal risk, and the requirements do not apply. The protocol for the project must meet one of the exempt categories defined in the Common Rule. By definition then, an IRB does not need to perform a full review on the project, and informed consent is not required. However, again, an
IRB needs to make this determination and document the decision. In these
situations, the guidelines in the Belmont Report should still be
followed since it is still Human Subject Research.
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Definition of a human subject
In biostatistics or psychological statistics, a research subject is any object or phenomenon that is observed for purposes of research. In survey research and opinion polling, the subject is often called a respondent. In the United States Federal Guidelines a human subject is a living individual about whom an investigator conducting research obtains 1)
Data through intervention or interaction with the individual, or 2)
Identifiable private information (32 CFR 219.102.f). (Lim,1990)
History of human subjects abuses
United StatesThere have been numerous human experiments performed in the United States, which have been considered unethical, and were often performed illegally, without the knowledge, consent, or informed consent of the test subjects.
Many types of experiments were performed including the deliberately infecting people with deadly or debilitating diseases, exposing people to biological and chemical weapons, human radiation experiments, injecting people with toxic and radioactive chemicals, surgical experiments, interrogation/torture experiments, tests involving mind-altering substances, and a wide variety of others. Many of these tests were performed on children and mentally disabled individuals. In many of the studies, a large number of the subjects were poor racial minorities or prisoners.
Many of these experiments were funded by the United States government, especially the Central Intelligence Agency and the United States military. The human research programs were usually highly secretive, and in many cases information about them was not released until many years after the
studies had been performed.
Often, subjects were sick or disabled people, whose doctors told them that they were receiving "medical treatment", but instead were used as the subjects of harmful and deadly experiments, without their knowledge
or consent. The ethical, professional, and legal implications of this in
the United States medical and scientific community were quite
significant, and led to many institutions and policies which attempted
to ensure that future human subject research in the United States would
be ethical and legal.
Public outcry over the discovery of government experiments on human subjects led to numerous congressional investigations and hearings, including the Church Committee, Rockefeller Commission, and Advisory Committee on Human Radiation Experiments,
amongst others. However, as of 2010, not a single U.S. government
researcher has been prosecuted for human experimentation, and many of
the victims of U.S. government experiments have not received
retribution, or in many cases, even acknowledgement of what was done to
them.
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