Comment on FR Doc # 2010-11885

My colleague and I are co-investigators on an NIH subcontract. We are also co-inventors on a patent filed by and assigned to our institution; this patent, recently awared, has been licensed, so we have received royalties. When we applied for IRB approval of a new part of our study, we received this: "Due to a change in the interpretation of the Human Subject Research COI Policy, your right to royalties through the University for IP licensed to Optherion now precludes you from being the PI of this study. Please identify another faculty-rank individual with no financial interest in the IP being evaluated and no reporting relationship to you to serve as the PI of this study." So our IRB excludes us from being PI of our own research! Their line of reasoning is that 'You've been awarded a patent, so that causes a potential conflict whether or not royalties are paid because you have a right to future royalties'. But the patent was assigned to the institution, not to us. So based on this experience, I have the following comments: 1) It is inconsistent to exclude royalties paid by the Insitution from being a significant financial interest (SFI) while at the same time stating that 'Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.' constitute an SNF. So in one part, royalities are not an SFI but in the other, royalties are an SFI. In my insitution's interpretation, merely being named on a patent, even one that is assigned to the insitution, is an SFI regardless of whether or not royalties are being paid. 2) More guidance should be provided in the regulations regarding when it is appropriate to exclude one from being PI of one's own research. Our institution is stating that being awarded a patent triggers the PI exclusion rule, and in such a case they will not permit the more moderate approach of appointing an independent monitor.