Word: ohrp
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...federal Office for Human Research Protections (OHRP) did not approve. After Pronovost was profiled in the New Yorker by Gawande in 2007, OHRP shut down data collection for the checklist study, claiming that it amounted to research being done without patients' informed consent. But the ensuing media attention spurred Congress to intervene, and Pronovost's program was allowed to continue and expand...
...audit pertained to an anonymous gambling survey conducted without the IRB’s approval. The researcher in charge of the survey said he was not aware that research dealing with anonymous subjects was required to face the board’s scrutiny, but federal health officials at the OHRP were never informed of the incident...
...routine nature of this recent audit is a marked departure from the last time Harvard was confronted by the OHRP two years ago, when the group was alerted by a third party that patients were being insufficiently protected during genetic research experimentation in China...
According to the Globe report, the OHRP reviewers came to campus in March and randomly selected 25 studies from a list of about 400 that HMS had conducted in the past four years. While the federal government was generally satisfied with the IRB’s work, it demanded a higher level of scrutiny in eight of the 25 experiments...
Lacey wrote that the OHRP also asked Harvard to assemble a more racially diverse group of reviewers on the IBR, which they said was dominated by white males. Lacey said that HMS is working to secure more black and Asian members for the board...