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Sunday, November 13, 2011



This is a space for the members and staff of the Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.
Professor: IRB, IRS, what’s the difference?
Written by John Donnelly on May 18, 2011 — Leave a Comment
One of the themes in the discussion today at the Presidential Commission for the Study of Bioethical Issues: Why did proper concerns for protecting human subjects in trials lead to the creation of a regulatory structure that makes so many researchers cringe?
Researchers equate dealing with Institutional Review Boards (IRBs) as like “going before a (New York City) co-op board or before an IRS auditor,” said Ronald Bayer, professor and co-chair of the Center for the History of Ethics of Public Health at the Mailman School of Public Health at Columbia University.
Bayer said he hears endless grumbling about IRB’s “picayune questions.” “I am concerned,” he said. “Is the structure we created something very different than what we wanted it to be?”
He said the the challenge to this commission is “to revisit in a fundamental way the institutions we have created. Something is off when people see the entire process as something we are not proud of, but as a process they find, well, stupefying.”
Commission member Dr. John D. Arras, a professor of biomedical ethics and philosophy at the University of Virginia, said he wondered whether the concern about protecting vulnerable populations in medical trials had “given rise to a backlash.”
“We pushed for an ethical reform of system, real oversight, and now we are left with this bureaucratic system, really a nitpicking monster,” Arras said, addressing Bayer. “And I am as stupefied as you are.”
Their concerns ranged from overzealous IRB oversight to requirements of taking standardized tests on ethics.
Arras and other Commission members also asked about the large shift toward more medical research happening overseas. Arras raised it in connection with whether the research was relevant in places where it was taking place, and whether that should be a requirement for research.
“It seems to me when pharmaceutical companies are farming out research to organizations in Eastern Europe, and get approval (to market products) here (in the United States), they are doing studies overseas in places where there is zero intention to benefit the population beyond the actual studies. To me, this is a real puzzle.”
David A. Borasky, Jr., IRB manager at the Office of Research Protection at RTI International, responded: “It’s not entirely fair to hold industry standard research to that norm.” He said, for instance, that research on male circumcision for HIV prevention also may have uneven benefits to participating communities because it is “rolled out unevenly.”
And Dr. Murray M. Lumpkin, deputy commissioner for International Programs at the U.S. Food and Drug Administration, said he might be “the last person to speak for the pharmaceutical industry,” but added, “How do you define benefits? Is it only access to products after the fact, or is there benefit to building up medical infrastructure, are there benefits to the local community other than having access at the end of the day?’’
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1 Comment to “Professor: IRB, IRS, what’s the difference?
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1.       Michael Shaneyfelt's GravatarMichael Shaneyfelt
June 10, 2011 at 11:44 am | Permalink
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My name is Michael Shaneyfelt, I was one of the people that addressed the Presidential Commission in Washington D.C. The commission called me out for public comment. I was the first citizen to stand. (Michael S.) . I have talked to the Naval Criminal Investigation Service 1-901-874-5389 And they told me that the Presidential Commission Of The Study Of Bioethics in the United States told them to open a investigation up over my matter. I would like to know who that person is . Because I want to thank them for. Is looking into what I talked to them about and the information I gave to them that day March 1 2010. Miss. Yoo she is one of the people that works on the Bioethics Commission and the lady I gave my information to. I have sent out a letter to Miss. Hilary. That said I wanted to thank the person that stood up and called the (NCIS) on my behalf. And I wanted to thank the Bioethics Commission for allowing me to come to Washington D.C to one of their meeting . I told them there is a domestic terrorist group here in Alabama. And the group is using a Auditory Weapons that was stolen from the United States Navy by Eric S Phillips. The Naval Criminal Investigation Service Agent Carlos. Told me that the weapon that I have been reporting to the United States Law Enforcement Departments and the United States Military for the past seven years now.The Agent told me that the weapon that Eric S. Phillips stole from the United States Navy is a  (Weapon of Mass Destruction) and told me to call the Joint Terrorism Task Force in Jacksonville Florida. The United States Military Law told me to call Jacksonville Florida Department. Because he said that the Jacksonville (JTTF) (FBI) was over the Southeast of the United States Defense. So I and the NCIS Agent called Jacksonville JTTF FBI) 1-904-248-7000. I told the (NCIS) Agent that I have been in contact with the Birmingham FBI. but the agent knew that.They told me that the weapon Eric S Phillips stole can affect thousands of American Citizens. The Joint Terrorism Task Force Agent that I talked to that same day who is in Jacksonville Florida (JTTF FBI) the Agent gave me the number to the Pensacola JTTF-FBIRA 1-850-432-3476 that Agent of the United States told me that I was and had been Implanted with a Bio Chip. That Eric S Phillips stabbed into my left shoulder back in 2003-2004. I have been telling the United States Military and State Government about this for over seven years. Telling them that they need to take a stand against a Domestic form of Terrorism in Birmingham Alabama.

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