Recommended Modifications to the 2005 Public Health Service Policies on Research Misconduct, 42 C.F.R. Part 93

The following are suggested modifications to the Code of Federal Regulations of the USA (42 CFR part 93), which deals with the handling of research misconduct. These recommendations were made on October 31, 2022, in response to a Request for Information (RFI) by the federal Department of Health and Human Services’ Office of the Secretary. […]

In memoriam: The federal government should never leave whistleblowers to their own fates against much more powerful employers.

“In 1998, an Alaska Airlines mechanic named John Liotine, who worked in the Alaska Airlines maintenance center in Oakland, California, told the Federal Aviation Administration that supervisors were approving records of maintenance that they were not allowed to approve or that indicated work had been completed when, in fact, it had not.” (Wikipedia: Alaska Airlines […]

Comments to NIH on Proposed Rulemaking

Summary: Three additions to the Notice of Proposed Rulemaking HHS NPRM RIN 0925-AA52, Docket Number NIH-2011-0003 regarding presentation of clinical trials data on ClinicalTrials.gov are proposed: 1) the trial’s responsible party will state explicitly whether full clinical trial data is available; 2) all documents related to delayed submission of results will be presented; and 3) […]