we've already heard some of those issues as relates to central irbs, something that we also feel quite strongly about and the common rule which is the way in which we have overseen human subjects research for 20 years is desperately in need of an upgrade. a lot of work has been done on that, but it has not come across the finish line. a simple area that, in one way, is getting in our path, our new national center for advancing translational sciences. for reasons that i think reflect anxieties about whether this would be competitive with the private sector is legislatively prohibited from pursuing clinical trials beyond phase 2a. something which now at the present time really makes very little sense. i think almost nobody would support the rationale for that given that we have worked very hard to be sure that we are in no way competing with private sector efforts. and the third category, reduce administrative burden and increase efficiency. the famous paperwork reduction act has been for nih the source of the greatest amount of paperwork that you can imagine when it comes to individuals

whenever i asked about centralized irb, i was always told, no, wait a second, we're required to have a local representative. although i know there is a central irb in denver, for whatever reason, my institution did not allow that because they felt like the federal government required. i'm looking at you, dr. hamburg, even though it is not under your office, fda is still involved with that. the first question, that 40-page document i've always been told is because washington, d.c. said you had to have it. secondly, dr. collins, you and i have spoken about this in committee but there is a report coming out of -- we've spoken out about nih needs more funding but there is an article out of ucsf, claire born jospeaking ab is a very poor correlation in nih funding between disease burden, however defined, and where nih puts its money. now this fellow wrote -- and he said ten years ago this was a critique but as he reviewed data ten years after that, there had been no change. i think your interpretation has a little bit of wiggle room if terms of moving dollars around but what i'm most famil

and we have discussed the numbers of things about the irbs, et cetera. reimbursement process with the regulatory process for biomarkers. biomarkers are really the part an parcel companions to targeted agents. you can't have a targeted agent without a biomarker. they go hand in hand. we need to establish the guidelines for biomarket development. because the biomarker sphere is really an area that's a lot less reimbursed than drug development, yet it's really fundamental to precision medicine. so we really could thing how we have parallel tracks so companies, small biotechs, small businesses, can really develop biomarkers and have a possibility an expectation of a return on investment to grow this economy. the other sort of vignette that i like to bring out is in trying to protect our patients, patients are basically the heart and soul of translational medicine. we rely on them. we're eternally grateful for their participation. but we need to encourage them to participate which means removing barriers. when we have consent forms for drug trials 40 pages lo

two homeruns 5, irb' rbis. check out this play from lewis. he walks the ball towards the official. it's a live play. he takes off for the end zone. by the time the opposition realizes it he is well on the way for the 42-yard touchdown. >>> they have issues on the offensive line. >> the eagles credit. chip are you listening. >>> the students at college of art an design didn't have to look far for the latest project. they are creating pieces that reflect something uniquely philadelphia. it was inspired by the patrick kelly exhibit at the museum of art. >>> and jimmy kimmel's guest is martin short and music from steve aoki. i am jim gardner good night. >>announcer:"action news" is sponsored by elkin chevrolet. teaching the chevy

two homeruns 5, irb' rbis. check out this play from lewis. he walks the ball towards the official. it's a live play. he takes off for the end zone. by the time the opposition realizes it he is well on the way for the 42-yard touchdown. >>> they have issues on the offensive line. >> the eagles credit. chip are you listening. >>> the students at college of art an design didn't have to look far for the latest project. they are creating pieces that reflect something uniquely philadelphia. it was inspired by the patrick kelly exhibit at the museum of art. >>> and jimmy kimmel's guest is martin short and music from steve aoki. i am jim gardner good night. >>announcer:"action news" is sponsored by elkin chevrolet. teaching the chevy silverado. >>> we have a fun show for you tonight. the great martin short is here. we have music from steve aoki, and we have animals. animal trainer dave salmoni is here. i thought it might be fun to get a sneak peek of the animals tonight. >> jimmy, good to see you. >> jimmy: good to see you, too. >> that's a paca. and my cape penguins are here. sorry -- the

i would have had to then write that federal grant, with maybe the help of irb, who would just sign a piece of paper. so i think that struggle comes in, and it goes back to some of the organizational dynamics within in terms of what is valued, and is prevention valued? and i wish i didn't have to say it, because i value it, but i don't know that it's valued in all institutions yet. i think we have a long way to go on the prevention side. >> but if we don't step up the enforcement side, i mean, the enforcement side brings the media attention. so, if we're going to say, the only thing we can rely on, that makes these universities and colleges do what they should be doing is for them to get a bad story. >> sure. >> first of all, that's a lot of victims. >> yeah. and, you know, that, to me, would be a depressing conclusion. so we've got to figure out some way to up the ante that is short of waiting for another tragedy to hit the pages. >> i would say a 13 team person can't do it, so i think it's the changes i've seen institutions start to make are when they're immediately under investigat

i would have had to then write that federal grant, with maybe the help of irb, who would just sign a piece of paper. so i think that struggle comes in, and it goes back to some of the organizational dynamics within in terms of what is valued, and is prevention valued? and i wish i didn't have to say it, because i value it, but i don't know that it's valued in all institutions yet. i think we have a long way to go on the prevention side. >> but if we don't step up the enforcement side, i mean, the enforcement side brings the media attention. so, if we're going to say, the only thing we can rely on, that makes these universities and colleges do what they should be doing is for them to get a bad story. >> sure. >> first of all, that's a lot of victims. >> yeah. and, you know, that, to me, would be a depressing conclusion. so we've got to figure out some way to up the ante that is short of waiting for another tragedy to hit the pages. >> i would say a 13 team person can't do it, so i think it's the changes i've seen institutions start to make are when they're immediately under investigat

you do see a lot of the problems that the 2 irb model created. we had hoped for a process that would have scrutiny by people from many countries of the modelling within firms. that's not something we have been able to get. but i think that probably under scores the need for a different approach. >> we have been working dilly gently on trying to understand the variances and the outcomes and see if we can't find ways to narrow the differences. we were compiling over 70 different proposals. some have a small impact on the variances, others large. we hope to come back with some suggestions. if we go to a standardized model, doesn't that engineer into the system potentially systemic risk if everyone is using the same model? >> the standardized risk weights? >> yes. >> the standardized risk weights and even a stress testing with similar loss functions obviously do create some risk that you have a correlated assessment of potential losses. but i don't -- i don't think that one could say that in the absence of that approach to capital regulation you have

first-ever primary prevention programs for the college age population that we also have implemented an irb-approved control group matched four-year longitudinal study of that program so we can rigorously identify efficacy on our campus, that we're planning to launch a second as well to look at other stages of our efficacy programs. that's because university of michigan has an extraordinary wealth of resources in all of the ways in which you've identified. and we have chosen to invest them in this effort. many campuses do not have that benefit and we need to be able to extend the ability to innovate to other campuses that don't have those kinds of resources because campuses look different and we need to have different kinds of knowledge and different kinds of innovations to address specific campus populations and for those campuses that don't have these resources, it is important that they be provided the support and encouragement to actually do that research and to do that new thinking. >> so michigan has -- i'm not -- i'm sure you do have a program that you've put together that is excellent. that'

i would have had to then write that federal grant, with maybe the help of irb, who would just sign a piece of paper. so i think that struggle comes in, and it goes back to some of the organizational dynamics within in terms of what is valued, and is prevention valued? and i wish i didn't have to say it, because i value it, but i don't know that it's valued in all institutions yet. i think we have a long way to go on the prevention side. >> but if we don't step up the enforcement side, i mean, the enforcement side brings the media attention. so, if we're going to say, the only thing we can rely on, that makes these universities and colleges do what they should be doing is for them to get a bad story. >> sure. >> first of all, that's a lot of victims. >> yeah. and, you know, that, to me, would be a depressing conclusion. so we've got to figure out some way to up the ante that is short of waiting for another tragedy to hit the pages. >> i would say a 13 team person can't do it, so i think it's the changes i've seen institutions start to make are when they're immediately under investigat