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Do you do research with human participants? If so, you play an important role in NIH initiatives to improve accountability and transparency in the human subject research we fund. This 15 minute video Overview of New NIH Policies on Human Subjects Research and Clinical Trials provides a succinct explanation of the various policy changes and what they mean for you.
I have been a CRA under RACC since December 2008 and manage a large clinical trial portfolio (approximately100 projects of which 98% are clinical trials), which includes a good number of NIH Cooperative agreements (U01) with numerous clinical trials running under each of them and other CTs under R mechanisms. I also manage a K23 and T32, which include CT and Clinical Research projects. I have struggled with my PIs, supervisors, and the Office of Research/AOR in getting these projects properly documented both as a team leader in OSP/AOR for 5 years and another 5 years at the department level. I have been written up by supervisor’s who felt threatened by my insights/documentation/budgets and upper level management with no knowledge of research administration supporting those judgments. I believe this is a long needed and welcome change in support of human subjects and tax payers funds, as well as, proper oversight and compliance on all sides, not to mention support for and education of the profession of Research Administration. Thank you again!