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"TRANSCRIPT: Meeting 5, Session 4 Implementing Federal Standards - Ethics Issues" BioEthics Commission

Ronald Bayer, Ph.D.
Professor and Co-Chair, Center for the History and Ethics of Public Health, Mailman School of Public Health, Columbia University

"DR. BAYER: The co-op boards, in case you don’t know, investigate every aspect of your life to see whether you are good enough to be a neighbor. So I listen to this and I listen with concern because what should be a process of enhancing both the quality of the research and the ethical attention that researchers ought to pay to research subjects and the consequences of research has become something very different. And I say this as someone who is not opposed to regulation. I see regulation as central to a Democratic society. If it’s transparent, if it’s efficient, etcetera.
And I hear this concern in an institution where people by and large are committed to human rights. That is, it is one aspect of the culture of schools of public health that the attention to vulnerable populations is high. And concern about the mission of public health being the mission to protect vulnerable populations is central.
And so when I listen to this and I listen to people saying: Oh, the Goddamn IRB, forgive me, and the picayune questions they raise, and the impediments they impose upon the ability to do this work. I listen and I'm concerned and I think it is something that ought to be a matter of concern to all of us. That is, has the structure we have created become something very different from what we wanted and how do we fix it? And that is central fundamental question, not a matter of tinkering.
The second issue I wanted to mention, and it’s related to this, is the way in which we assure that people who are going to conduct research are familiar with basic principles, understand the concepts, understand the tensions, etcetera. I, like everyone else at the Mailman School of Public Health have to take an online test to guarantee that I have read the right things and understand the right things. I did it several years ago and just last month I was told we now have to do it every three years, so I had to do it again. I have to tell you, it is the most insulting experience to sit in front of a screen, to download a text and then a series of questions to which there is only one right answer, and if God forbid you think that there may be an ambiguity or an uncertainty, you get the answer wrong.
What has happened, and I listen to people talk about taking these tests, and they talk about it the way Russian social scientists used to talk about having to learn the right Marxist doxology in the old Soviet Union. They have to learn something, spit it back and give the right answer, and if you don't get a good enough score, you can't do research, you have to take the test again.
How it happened that we came to think educating people about doing research in an ethical way became so contorted that it becomes like the joke about how kids used to learn the Pledge of Allegiance and they didn't know what any of the words meant, and so they garbled it up in some funny way and you would hear versions of what the Pledge of Allegiance is. It is like that when people talk about ethics of research as they -- look what you can do is you can download the text, put the question in front of you, read the text, find the answer. That's not education. And the reason I see it as a matter of concern is what it does is it raises contempt for the idea of education and becoming kind of sensitive to ethical complexities. And that's not where I think we should be going.
It is in some way analogous to what has happened to the issue of privacy and the HIPAA regulations and the incessant plethora of pieces of paper from banks and insurance companies, printed and typed, I certainly can't read anymore, that tell you about their privacy protections. What do people think? All this privacy protection stuff is junk. Because it has become utterly bureaucratized.
So, what’s the challenge it seems to me to this commission? There are many big issues about what kinds of research internationally and globally in a world that is increasingly unequal is ethical, but it seems to me -- it seems to me that it is time to revisit in a fundamental way both the institutions we've created, how they function, and how we educate people about fundamental ethical issues in research.
I don't deny that there are certain fundamental things one can read and learn. One takes drivers test, one has to learn what a left hand signal is and what a right hand signal is. But there is something off when people see the entire process, not as something they feel proud about, but as something they experience as, in a way mortifyingly stupid, and stupefying -- that is what it is, stupefying.
One last point and I'll stop. And this relates in part to this. I have been interested for the last several years in the question of ethics of public health surveillance, a central piece of what public health is about. You can't do public health without surveillance. The question of course is: what is the difference between public health surveillance, which is public health practice and is not subject to IRB review, and public health research, which is subject to IRB review?
There is entire layer of personnel at the CDC whose I think sole function is to try to distinguish between public health research and surveillance activities. And I'll tell you, I'll end with the vignette I started with a vignette. I spoke to a guy and he said: You know, I got this protocol on my desk and I had to review to decide whether it was research or not. And I reviewed it and it got lost in the mess on my desk. So they sent it to me again. And I reviewed it again. And he said, then I found both and in one instance I had called it research and in one instance I called it practice. What does this mean? That he's inconsistent, that he’s foolish? No. It seems to me that it’s a complicated issue, we haven't resolved it. Trying to resolve it with a kind of formalistic definition of what is research seems to me inadequate to the challenge. It seems to me what this suggests and this is a huge domain in public health is the need to go beyond the issue of articulating standards for research qua research and say there are undertakings that don't fit the definition of research -- maybe oral history, maybe not surveillance or not -- and to think about what ethical standards ought to govern all those forms of inquiry, not simply those that bureaucratically fall within the niche. I'll stop there. Thank you. "
http://bioethics.gov/cms/node/229

Views: 44

Comment by Jay Sinn on August 1, 2011 at 9:19am
Highlights:
"What has happened, and I listen to people talk about taking these tests, and they talk about it the way Russian social scientists used to talk about having to learn the right Marxist doxology in the old Soviet Union. They have to learn something, spit it back and give the right answer, and if you don't get a good enough score, you can't do research, you have to take the test again."

"You can't do public health without surveillance. The question of course is: what is the difference between public health surveillance, which is public health practice and is not subject to IRB review, and public health research, which is subject to IRB review?
There is entire layer of personnel at the CDC whose I think sole function is to try to distinguish between public health research and surveillance activities. And I'll tell you, I'll end with the vignette I started with a vignette. I spoke to a guy and he said: You know, I got this protocol on my desk and I had to review to decide whether it was research or not."
http://bioethics.gov/cms/node/229
Comment by Jay Sinn on August 1, 2011 at 9:43am
and the coup de grace:
"But there is something off when people see the entire process, not as something they feel proud about, but as something they experience as, in a way mortifyingly stupid, and stupefying -- that is what it is, stupefying."

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