By David Brown
The Washington Post
Originally published April 10, 2013
A clinical experiment involving 1,300 premature infants at two dozen hospitals “failed to adequately inform parents” of the risks of the treatment, which included blindness, brain damage and death, according to a watchdog agency at the Department of Health and Human Services.
The description of the experiment that parents read before deciding whether to enroll their babies downplayed the risks and emphasized possible benefits of getting a less-than-average amount of supplementary oxygen in the critical weeks after birth.
“The consent form was written in a slanted way,” said Jerry A. Menikoff, director of the Office for Human Research Protections (OHRP), which found that the study was “in violation of the regulatory requirements for informed consent” required by federal law.
The entire story is here.
Showing posts with label Office for Human Research Protections. Show all posts
Showing posts with label Office for Human Research Protections. Show all posts
Saturday, February 8, 2014
Monday, June 10, 2013
SUPPORT Update: OHRP’s Compliance Actions on Hold
By John B. Lantos
The Hastings Center Bioethics Forum
Originally posted June 5, 2013
In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.” Further, OHRP promises not to initiate compliance actions “in studies involving similar designs” until it clarifies the guidelines for such studies. In doing so, it acknowledges “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of studies.” (Previous posts on the SUPPORT controversy are here, here, here, and here.)
OHRP promises that the process of drafting new guidelines will be “as open as possible, with input from all interested parties.” To achieve this, it will “engage in the usual notice and comment process with regard to draft guidance” and “will also conduct an open public meeting on this topic.” This is a welcome development.
The letter also suggests the positions that OHRP will take in these discussions. It focuses on three main points.
First, the letter acknowledges that these discussions will focus on situations where the standard of care includes known and widespread practice variation with no reliable evidence on which practices are associated with which risks or benefits. “When the SUPPORT study was initiated,” it states, “there was no clear recent evidence indicating that different oxygenation levels with the then-current standard of care (85%- 95%) would produce differences in neurological damage or survival.”
The entire blog post is here.
The Hastings Center Bioethics Forum
Originally posted June 5, 2013
In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.” Further, OHRP promises not to initiate compliance actions “in studies involving similar designs” until it clarifies the guidelines for such studies. In doing so, it acknowledges “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of studies.” (Previous posts on the SUPPORT controversy are here, here, here, and here.)
OHRP promises that the process of drafting new guidelines will be “as open as possible, with input from all interested parties.” To achieve this, it will “engage in the usual notice and comment process with regard to draft guidance” and “will also conduct an open public meeting on this topic.” This is a welcome development.
The letter also suggests the positions that OHRP will take in these discussions. It focuses on three main points.
First, the letter acknowledges that these discussions will focus on situations where the standard of care includes known and widespread practice variation with no reliable evidence on which practices are associated with which risks or benefits. “When the SUPPORT study was initiated,” it states, “there was no clear recent evidence indicating that different oxygenation levels with the then-current standard of care (85%- 95%) would produce differences in neurological damage or survival.”
The entire blog post is here.
Tuesday, April 23, 2013
Study of Babies Did Not Disclose Risks, U.S. Finds
By Sabrina Tavernise
The New York Times
Originally published on April 10, 2013
The New York Times
Originally published on April 10, 2013
A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.
None of the families have yet been notified of the findings from the Office for Human Research Protections, which safeguards people who participate in government-financed research. But the agency’s conclusions were listed in great detail in a letter last month to the University of Alabama at Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke and Yale.
The letter stated that the study did have an effect on which infants died and which developed blindness, and that those risks were not properly communicated to the parents, depriving them of information needed to decide whether to participate.
Monday, March 18, 2013
Overhaul of Rules for Human Research Hits Impasse
By Paul Basken
The Chronicle of Higher Education
Originally published March 7, 2013
After months of trying to reconcile the sometimes competing goals of making the rules both simpler and tougher, while engaging 17 different federal agencies affected by the Common Rule, participants are describing the process as stalemated.
"I think it's dead, pretty much," said E. Greg Koski, a former director of the human-research-protections office, reflecting assessments he's heard from key players in the process.
The office has a published timetable suggesting it will formally propose a new set of regulations next month. In a written statement, the current director of the Office for Human Research Protections, Jerry A. Menikoff, said he intended to keep trying.
"This is, of course, a complicated undertaking, as was stated from the outset, and it takes time," Dr. Menikoff said.
The entire story, including The Chronicle's paywall, is here.
The Chronicle of Higher Education
Originally published March 7, 2013
After months of trying to reconcile the sometimes competing goals of making the rules both simpler and tougher, while engaging 17 different federal agencies affected by the Common Rule, participants are describing the process as stalemated.
"I think it's dead, pretty much," said E. Greg Koski, a former director of the human-research-protections office, reflecting assessments he's heard from key players in the process.
The office has a published timetable suggesting it will formally propose a new set of regulations next month. In a written statement, the current director of the Office for Human Research Protections, Jerry A. Menikoff, said he intended to keep trying.
"This is, of course, a complicated undertaking, as was stated from the outset, and it takes time," Dr. Menikoff said.
The entire story, including The Chronicle's paywall, is here.
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