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Jackson, Ryan[jackson.ryan@epa.gov] The Washington Post Mon 9/25/2017 4:01:36 PM Federal Insider: Whistleblowers at U.S. funded research institutions fear retaliation
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By Joe Davidson
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The Department of Health and Human Services (HHS) building in Washington. A report by the HHS inspector general's office says "fear of reprisals may prevent potential complainants from reporting suspected" violations of "protections for human subjects" in research projects. (Alex Brandon/Associated Press)
Institutions that conduct human research generally have a reputation for strict fact-finding, going where the research leads while maintaining firm rules to protect the people who are studied.
If those rules are violated, the consequences can be serious. It's worse when workers and others are afraid to report violations.
When a study does not follow procedures, patient safety is jeopardized, public confidence in the research institution and the government agency funding the work suffers, sometimes for decades, with the mistrust passing through generations.
BbhWdeiBi impacibO^ Study of Untreated Syphilis in the Negro Male." Patients were denied needed treatment in the name of science. Launched in 1932, it lasted 40 years and is an example of perverted research with lingering negative consequences.
Now comes an investigative report about deterrents in reporting problems with human research. The Department of Health and Human Services (HHS)
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Office of Inspector General found evidence of a fear of retaliation among whistleblowers in research institutions.
The human studies are funded by the federal government, but generally done by non-federal institutions, such as universities and hospitals.
The Department's Office for Human Research Protections (OHRP) does not provide adequate information on whistleblower protections for research employees and others, according to the report. That's a problem because "fear of reprisals may prevent potential complainants from reporting suspected" violations of "protections for human subjects" in research projects, the report said.
Whistleblowers have been transferred or put in fear of losing benefits.
"Information from whistleblowers is important because it can be insider information," said Joyce Greenleaf, a regional inspector general. "It can bring to light problems with critical research that puts volunteering human subjects at risk. So, to sustain the public's confidence in this research, we need people to be willing to bring these concerns to light."
Pressed for instances, the inspector general's office offered four cases that were not included in the report:
A nurse who assisted with neurosurgeries at a medical center told investigators a surgeon delayed operations on patients for weeks to obtain equipment needed for a research study, but not needed to treat patients. "Nurse believes this is not in the best interest of the patients. Other nurses have voiced concerns but were reassigned."
An ophthalmology resident in a large hospital said children and adults were enrolled in research that does not have appropriate approvals. Research involves chemotherapy to treat retinoblastoma, a cancer that begins in the retina, the black part of the eyeball. "There have been adverse events. Many research participants do not speak English, informed consent is inadequate and consent forms are not provided in the participant's native language." The whistleblower was "not comfortable complaining and does not want retaliation."
A student athlete on a university scholarship "alleges that students do not have a choice but to participate in athletic testing research. The coach is in the room during the informed consent process, and the student alleges
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Rectlwtliore, it could help HHS determine whether it should seek a legislative change that enables OHRP and other HHS entities that are not responsible for contract or grant oversight management to receive protected disclosures."
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