Medical research grants under investigation
Issue date: 11/20/08
Hopkins has a specific definition of conflict of interest with regards to its medical research.
"Under Hopkins School of Medicine and other academic medical center policies - and federal (NIH) regulations - having a conflict of interest in itself is not a problem and does not imply wrongdoing," Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins Medical Institute, said. "Rather, failing to report a conflict of interest is a problem."
"Many conflicts of interest can be managed," she said. "They are allowed to exist, subject to conditions such as requirements for disclosure of the financial interest."
"I would characterize the leadership as being committed to ensuring that Hopkins has robust policies and procedures for identifying and addressing financial interests in research that may create risks to data integrity, safety of human research subjects, openness and collegiality in research and protection of students' interests," Gottlieb said.
Hopkins administrators feel that many conflicts of interests can be managed.
"The risks associated with some conflicts of interest cannot be managed so arrangements must be modified (e.g. lower or eliminate certain financial interests; limit the research role of the investigator who has the financial interest) or prohibited," Gottlieb said.
Grassley, however, feels that more needs to be done.
"Universities have been lax about collecting and auditing reports of financial relationships that their research doctors have with industry," he said. "It also looks like the NIH has been lax about verifying information it collects from institutions receiving grants and lax about enforcement generally."
The chairman of the department of bioethics at the NIH agrees that more needs to be done.
"The safeguards aren't working. They're onerous to those who do adhere, and they don't work for those who don't adhere," he told the Chronicle of Higher Education.
"Under Hopkins School of Medicine and other academic medical center policies - and federal (NIH) regulations - having a conflict of interest in itself is not a problem and does not imply wrongdoing," Julie Gottlieb, assistant dean for policy coordination at the Johns Hopkins Medical Institute, said. "Rather, failing to report a conflict of interest is a problem."
"Many conflicts of interest can be managed," she said. "They are allowed to exist, subject to conditions such as requirements for disclosure of the financial interest."
"I would characterize the leadership as being committed to ensuring that Hopkins has robust policies and procedures for identifying and addressing financial interests in research that may create risks to data integrity, safety of human research subjects, openness and collegiality in research and protection of students' interests," Gottlieb said.
Hopkins administrators feel that many conflicts of interests can be managed.
"The risks associated with some conflicts of interest cannot be managed so arrangements must be modified (e.g. lower or eliminate certain financial interests; limit the research role of the investigator who has the financial interest) or prohibited," Gottlieb said.
Grassley, however, feels that more needs to be done.
"Universities have been lax about collecting and auditing reports of financial relationships that their research doctors have with industry," he said. "It also looks like the NIH has been lax about verifying information it collects from institutions receiving grants and lax about enforcement generally."
The chairman of the department of bioethics at the NIH agrees that more needs to be done.
"The safeguards aren't working. They're onerous to those who do adhere, and they don't work for those who don't adhere," he told the Chronicle of Higher Education.
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