When I worked for the US Navy, colleagues used the phrase “Fair Winds and Following Seas” as they would bid farewell. So, that’s how I’ve titled this last blog.
It sounds trite to say that it’s been a pleasure and an honor to serve as OSU’s Vice President for Research for the last four years, but it is quite apt. A pleasure, since OSU’s research community is one of the most innovative, interesting and resourceful that I’ve ever known. No two days were ever the same, and all days were stimulating … that made it fun. An honor, since it’s somewhat daunting to serve the needs of a quarter-billion dollar endeavor. How can one not feel the honor of serving people who are curing disease, saving the planet, feeding the hungry and generally making our lives better?
I tip my hat to all of our researchers – faculty, staff, students and administrators. You are destined for continued wonderful success!
I also would like to express my gratitude to the great staff in the OSU Research Office. This merry band of professionals is dedicated to and invested in the success of our research enterprise. I’ve enjoyed getting to know every one of you, and look forward to hearing of your future success as well.
Finally, a thanks to the University leadership – President Ray, Provost Randhawa, VPs Clark, Ford and Johnson, and all of the rest of the team. Your direction and leadership help to make OSU the outstanding institution that it is.
So now I head back east to DC where I’m sure new adventure awaits. I’ll remember these days fondly … and rest assured, I’ll be wearing my black and orange as I enjoy those fair winds and following seas.
For those who haven’t met me yet, I’ll take this opportunity to introduce myself and share some thoughts about OSU’s research enterprise. For the past year, I’ve been leading the Office of Research Integrity (ORI), which is part of the Research Office. Having said that, I’m not new to OSU. I’ve served nearly 11 years as a Professor in COAS/CEOAS, have chaired the Conflict of Interest Committee and have served on other university and college committees. I’ve also chalked up research administrative experience during my time as a Program Director at NSF, and have the perspectives of an academic researcher from my years as faculty here and at other leading research universities in the US and the UK, where I also served as a Head of School. So for quite some time I’ve lived in the two worlds of research and administration, which has been useful background for taking on the challenge of directing the ORI.
The ORI’s purpose is to facilitate the research efforts of OSU faculty, staff and students by helping them to remain compliant with the many federal and state research regulations that assure the integrity of research, the safety of all, and the ethical treatment of human and animal subjects. ORI operates the administrative offices for the Institutional Research Boards (the IRBs, for human subjects research, administered by Lisa Leventhal), the Institutional Animal Use and Care Committee (IACUC, administered by Rebecca Henry), the research Conflicts of Interest Committee (COI, run by Nicole Wolf), and the Small Boat and Diving Safety Office (run by Kevin Buch). We are also actively planning an Export Controls Office, which will fill out the ORI for the foreseeable future.
What we are not is the “compliance police”, although I know sometimes it can seem that way as OSU researchers encounter a proliferation of ever-changing research regulations. I like to think that if we are doing our job well, ORI helps to run interference for our researchers, so we can assist them with staying in compliance with all applicable regulations without being so risk averse that we bring the research enterprise to a halt. I am intensely aware, as are all of the ORI Administrators, Officers, Coordinators and Program Specialists, that OSU researchers feel under increasing pressure to spend more time on the administration of their research activities, rather than on the far more gratifying design, execution and publication of their research. This problem and perception is not unique to this institution, but is a national and even international phenomenon. The ORI understands that if we zealously “over comply” with regulations, we put the university in a poor footing to do what it does best, i.e. to push the boundaries of knowledge.
The counterpoint to this is that if we “under comply”, we expose researchers, research participants, and the university at large to real and substantial risks, including heavy fines, and in extreme cases serious legal implications, injury and even fatalities to human and animal subjects and research participants. These are not hypothetical risks. Heavy fines can and have been levied on universities that have been found to be out of compliance with federal regulations, and faculty at other universities have seen the inside of federal prisons for egregious violations of federal regulations. Fortunately that’s a rare occurrence, but it has happened.
The regulatory environment is sharpening up, and federal regulators are increasingly showing their teeth. Fortunately, thus far OSU has not experienced serious human subjects injuries or worse, or prosecution of its researchers, but we must avoid complacency if we are to maintain this record. We are determined to be a model of a productive, world-class research institution that takes its responsibilities to its faculty, students, staff, research subjects, and to those funding bodies that support it both seriously and prudently. Finding the sweet spot along the trade-off curve that weighs compliance with all regulations (and interpretations of regulations) against research productivity is challenging. To paraphrase Voltaire, as we seek the right balance we recognize that “The perfect is the enemy of the good enough”.
OSU’s externally funded research activity is enormous, taking in about a quarter of a billion dollars a year and comprising more than a quarter of OSU’s total budget. We’ll consider the statistics as of mid-December 2013. At that time there were 1,982 currently active, externally funded research projects at OSU, of which 174 involved human subjects, and 154 involved vertebrate animal subjects. Since each of these projects can involve multiple studies, there were 280 externally funded active human subjects protocols, 120internally funded ones, and 476 ACUPs.
Our regulatory compliance obligations don’t extend only to funded projects. A great deal of research at OSU doesn’t involve identified sources of funding, and much of that is student led. There were 996 active studies in total at OSU involving human subjects, of which 716 (i.e. 72%) did not involve external funding. So, of the 2,698 active research projects in all subject areas across the university, including those with external funding, internal funding, and otherwise unfunded but active, more than a third (i.e. 37%) involve human subjects.
This vast human subjects research effort comes under the oversight of the IRBs. The IRBs are administered by the ORI, but like the IACUC, they are independent bodies whose structure and scope is tightly defined by federal regulation, such as the Code of Federal Regulations 45 CFR Part 46 (“Federal Policy for Human Subjects Research”). One of IRBs’ unique responsibilities is to factor in the soundness of the experimental design and potential project outcomes as they are weighed against any possible risks to human subjects. Many OSU researchers may be unaware of this scientific merit/peer review aspect of the IRBs. Since the IRBs must assure compliance with regulations from multiple federal agencies, sometimes it can aggravate our researchers that protocols already approved by one agency are reviewed again by the IRBs. This is not an OSU created policy, but it is a requirement imposed on the IRBs by federal regulations. While approvals by a given agency are naturally factored into the IRBs’ review process, different agencies have different oversight and review criteria, all of which must be considered by the IRBs.
Moving from perceptions to quantifiable metrics, one of our major efforts during the past year has been to reduce the turn-around time from submission of IRB protocols to approval. The IRBs’ staff are doing a terrific job of implementing new methods and procedures to accelerate this process. Our flagship effort this past year was IRBExpress! This came about from the realization that email is an inefficient means of holding an interactive conversation. There is latency at each end of an email exchange, with mails to the IRBs then going into a queuing system for a reply. Given that our IRBs are handling about a thousand active protocols, such a queue can grow to be quite lengthy. Even social networks, which are far more immediate and interactive, cannot beat the efficiency of a face-to-face conversation. This is the basis for IRBExpress! Since its rollout in April 2013, we have allocated set 90 minute time blocks each week where IRB Coordinators prep for each face-to-face meeting with those whose protocols that meet the criteria for exemption (the majority of IRB protocols reviewed at OSU are Exempt), followed by 30 minute conversations with the researchers (and for student projects, the student researcher and their faculty advisor), followed by 30 minutes for post-conversation administrative processing. In ¾ of all cases to-date, the researchers leave the meeting with an Exempt determination. This has had a dramatic impact on Exempt protocol approval speed, as we’ll see shortly.
We have also fully qualified two additional IRB Coordinators this year (Michelle Klotz and Amy King, joining Candi Loeb and Jillian Grant), doubling their number since August. This has helped to address chronic understaffing in that office.
The end result of all of these improvements has been to cut the processing time for Exempt protocols to 1/3 its 2012 value. With all new Coordinators fully on board, we’ve also sped up approvals for Expedited reviews by 2 ½ times. Since the turn-around time for protocol review has been a focal point of concerns by many OSU researchers, these improvements are quite welcome. Much of the remaining turn-around time is under the control of the researchers rather than the IRBs, and is related to the response time of researchers to requests for information, and to the quality and completeness of protocol revisions submitted to the IRB Office. Even so, we continue to work to speed up this process even more. We are considering the wider rollout of the IRBExpress! process so it can also encompass qualified Expedited reviews, and our IRB Administrator has begun to trial on-site Expedited reviews in select departments around campus. Also in January 2014 we launched a second IRB (previously there was only a single one to handle the full human subjects research caseload, while with two we can more efficiently process student-led project protocols).
More is on the way. While in this blog I’ve focused on the IRB, we are working on improvements to processes and procedures across all of the ORI compliance units. For instance, OSU faculty, staff and students undertake research on and under the water in a wide variety of environments. These scientists and students are supported in their efforts by the Scientific Diving and Small Boat Safety Programs. OSU currently has over 50 active scientific divers, and for 2012 they logged nearly 2000 dives totaling almost 1600 hours underwater. Field research at OSU often takes scientists and students on the water and involves the use of various types of vessels, including small boats, rafts, kayaks, and personal watercraft that operate in rivers, lakes, bays, and nearshore waters. The OSU Small Boat Safety Program is being developed to ensure that researchers and students have the support and training needed to operate as safely as possible in their research environments.
The Research Conflicts of Interest office handles approximately 1700 disclosures by research-active OSU personnel each year. The end result of all of this activity has led to 39 active management plans, agreements and memos, which are management instruments held between the COI Officer and specific OSU researchers whose research activities constitute an actual, perceived or potential conflict of interest. At present, there are 15 additional COI cases currently under review. As OSU research finds increasing commercial take-up, we anticipate that the caseload for COIs will increase. In a real sense, this can be a viewed as evidence of success.
Watch this space in future for news from these other units, as well as news of a planned state of the art electronic research administration (eRA) system that will both simplify the management of research compliance and make it easier for researchers to obtain protocol and study approvals more quickly.
Until then, swing by the ORI to see who we are. We’d be happy to discuss any of your concerns and questions.
Author’s note: Although this blog is not limited to an OSU audience, we felt a discussion about our electronic research administration (eRA) progress would be helpful. Many of our Principal Investigators and other staff involved in proposal preparation have had questions. Instead of using a mass e-mail communication, we felt the” Spin on Research” would be a better way to disseminate this type of information.
Believe it or not, Cayuse SP has been at OSU for more than one year! You may recall that the Research Office implemented Cayuse 424 in May 2011 and Cayuse SP in April 2012. Paper-based proposal submissions ceased June 30, 2012.
Every day, faculty and staff have become more familiar with Cayuse 424 and Cayuse SP, but I’d like to provide some key hints and tricks.
Since OSU did not implement the two systems at the same time, OSP staff are often asked “What’s the difference between Cayuse 424 and Cayuse SP?” I think of Cayuse SP as the web-based or electronic version of the transmittal form, and will be used for every proposal. Cayuse 424, however, represents the Federal form set that’s found in Grants.gov.
Designing the proposal routing in Cayuse SP is a little different than Cayuse 424. While Cayuse 424 would add in the Dean’s Office for a respective college, Cayuse SP’s routing chain used to require manual addition of the dean for a respective College. I’m happy to tell you that a routing enhancement has recently been added to Cayuse SP, and now the system will now automatically add the dean’s signature to the routing chain.
This will allow you to take advantage of one of Cayuse SP’s best features—concurrent routing. The lead PI and the lead PI’s unit head must approve the proposal, but all other approvers can receive notification simultaneously. All you have to do change the “routing sequence” to 2 in the drop-down menu in the “Approving Departments” tab. Cayuse SP automatically adds OSP to the last position on the routing chain, so you don’t have to remember to add us to your routing.
Routing can become confusing for faculty in certain Colleges. As an example, Extension faculty also have academic appointments. It is very important that the PI correctly select the “Award Admin Department” that is on the first screen in Cayuse SP. The department selected is the one that will manage the award for the PI. This listing in Cayuse SP is alphabetical, so please make sure the proper department is selected. Some departments have very similar names. As an example, there are three different departments names for the Microproducts Breakthrough Institute—one for CBEE, one for MIME and one for EECS. If you are unsure of which department to select, please contact us as 7-4933 or email@example.com. We’ll help you select the correct department.
You can also copy Cayuse SP (think routing form) records. If you frequently submit to the same agency, use the “copy” feature in My Proposals. Cayuse 424 (think federal form set) will allow you to “transform” proposals for re-submissions or submissions to other agencies. This is another very powerful feature. While this has been a FastLane feature, that feature goes away on August 2. As of that date, we will only be able to copy proposals submitted under the current NSF Grant Proposal Guide.
Future improvements are coming later this calendar year and early next calendar year as well. Some items being investigated are a more detailed budget on SP’s budget tab and better “push-pull” between Cayuse SP and Cayuse 424 so that you don’t have to “double-enter” certain data.
OSP will be doing Cayuse training a little differently this year. We are going to develop more tips and FAQs. Training will also be focused on individuals that specifically work with faculty on proposal preparation at the college level, and those efforts have already begun. We are also going to do some annotated screen shots to help better describe what information goes in certain fields. We’ll also provide some screen shots that will help you determine where your proposal is in the routing cycle. We will be starting on this additional information later this summer, and we welcome your comments and feedback.
The use of unmanned aerial vehicles (UAVs), sometimes referred to as “drones,” has been the focus of increased recent international attention. It also has captured attention in the Oregon Capitol with the introduction of House Bill 2710 and Senate Bill 524, which would set restrictions on the use of UAVs by law enforcement agencies, and Senate Bill 71, which would regulate the use of drones by private individuals and public agencies.
Any legislative or public review of the use of UAVs should include a complete understanding that these aerial systems also have many domestic uses that are practical and benign, and should be embraced for their potential to save money and lives.
There’s not much that UAVs can do that a pilot in a small plane cannot do, but they can do it more safely and at much lower cost. UAVs can monitor and help manage wildfires, or support a search and rescue mission. They can help forest product industries plant trees. They can monitor wildlife, improve irrigation, detect crop disease outbreaks and gauge environmental health.
UAVs are an emerging national industry that Oregon can help lead.
Under a mandate from Congress, the Federal Aviation Administration will establish several test sites for UAVs by 2015. Our state offers a unique combination of research excellence, varied terrain, relevant industry and local applications in agriculture and forestry.
Oregon State University has formed the OSU Unmanned Vehicle System Research Consortium with industry, government and others to bring a national UAV test center to the state and develop the use of these aerial systems, a potential multi-billion dollar job growth engine that will also provide significant benefit to society.
Decades of experience in remote sensing drew Oregon State University to this venture. OSU oceanographers use NASA satellites to monitor global phytoplankton productivity and identify harmful algal blooms. We use optical remote sensing to detect earthquake faults, assess wildfire impacts on forests and measure tsunami inundation patterns. We have instruments on the International Space Station to study shoals and ocean shores.
Unmanned autonomous vehicles are an important growth industry in the United States. Like GPS, the Internet, microprocessors and many other technologies, they started with military applications, but now are staples of everyday life.
We recognize that the transition toward considering the civilian use of UAVs has raised privacy concerns. Protection from prying cameras where there is a reasonable expectation of privacy is a legitimate concern, legally protected by current law and the Fourth Amendment of the U.S. Constitution.
Yet every new technology has historically raised some kind of social concern. And, in response, society has figured out reasonable solutions. We urge that these same solutions be pursued in parallel with the needed technical research of UAVs.
Regardless of what we do in Oregon, UAV technology will be developed in the United States and around the world. But because of Oregon’s comprehensive scientific and industry experience, and our state’s ideal geography, we can choose to be a leader in this exciting venture.
A lot has changed over the last several decades in how we do research. I wonder if we’re better off. I’d like to suggest that some of these changes need to be undone.
Consider the following significant changes from “the norm” of the past and how they should be corrected:
GET RID OF BROADER IMPACTS: About 15 years ago, the National Science Foundation (NSF) instituted the formal requirement for demonstrating “broader impacts” in our research proposals (that is to say, in addition to the technical or intellectual merit of the work being offered). In my humble opinion, this was a most insidious change. After all, NSF is that last bastion of fundamental research, established for the benefit of improving understanding. All of the other agencies are mission agencies, whose research clearly needs to benefit their mission. At NSF, however, the broader impacts requirement was introduced because a vocal minority felt they were not getting enough immediate return from their tax investments in science. It’s absurd and should be repealed.
(Here’s an interesting quick game anyone can play: do a Google search on “top researchers of the last hundred years”, then try to determine how that list of individuals might have fared under the test of “broader impacts” … should Heisenberg or Pauli have been judged by their assessment of the utility of their research?)
Somebody needs to explain Pasteur’s quadrant to our elected policy makers.
UNLEVEL THE PLAYING FIELD: Early in my research management career I was asked to provide a history of the US Navy’s establishment of what was called the Sound Surveillance System (SOSUS). Those of you who are Tom Clancy aficionados will recognize this acronym as the true-to-life basis for our maritime superiority in the Cold War; SOSUS was our acoustic network that served as the most effective component of our anti-submarine warfare toolbox, detecting Soviet submarines throughout the Atlantic and Pacific. Anyway, the short version of the story is that in the early 1950s a gaggle of Navy Admirals went up to Cambridge, Massachusetts, with a problem and a blank check. They invested in the best engineers and marine scientists to design, build and deploy the SOSUS array within about two years. They sole-sourced the contract, conducted no competition, and used a closed peer-review process. They did not invoke a Gantt chart of Technology Readiness Levels. In short, by today’s Federal Acquisition Regulations, they broke a lot of rules. The outcome, however, was clearly successful. Today, we are encumbered by so many accountability-based requirements, just to get to “go” on a research program that the odds are stacked against any proposal to the tune of 5:1 for rejection. Most of this dilemma is a consequence of ensuring that every researcher has the same opportunity to compete and that no unfair advantages are put in place. The same concept underlies the current trend toward prohibiting cost-sharing by institutions on research proposals. That idea is intended to ensure that the research faculty at a less well-off institution can compete fairly with another Principal Investigator at, say Cal Tech or Johns Hopkins. Okay, I get that, but maybe the better solution is to encourage research institutions to actually make investments in the research, and not rely exclusively on the federal coffers. That means playing on an uneven field, but it also means we’ll start strengthening the major research institutions and (gasp!) eliminating some of the smaller or less performing institutions. With federal funding getting tighter we need to rethink how we spread the wealth. The old saying that a rising tide floats all boats has an inverse: a sinking tide grounds the unmoving.
COMMINGLE PUBLIC AND PRIVATE RESEARCH DOLLARS: Fortunately I can’t get thrown in jail for advocating this, but I can be locked up for doing it! Now, I’m stretching my point here, since this was never really done the way I’m proposing, but if you go back a century or so, you’ll see that a lot of the research that was done was supported by private benefactors. In fact the major researchers of the 19th Century were mostly wealthy entrepreneurs who were almost exclusively self-supported. What I’m suggesting here is that we researchers in the U.S. are competing against peers overseas who enjoy much more latitude in combining private (e.g. industry) funding with the resources of their taxpayers (just take a look at Finnish telecommunications research as one good example). We bend over backwards to ensure that the dollar from a corporate sponsor never sees the dollar from a federal agency, even though both dollars may be spent in the same lab by the same PI. Again, the basis for this makes sense: it ensures transparency as needed on how our tax dollars are used, and it avoids mischief in areas such as conflict of interest. But let’s assume for a moment that the vast majority of our researchers are smart, educable, and ethical, and that we build a system of oversight and accountability within the research institution. If those assumptions are viable then we ought to be able to combine investments from all sources in a way that gets more bang for the buck, eliminates unnecessary duplication of proposals, while still protecting intellectual property effectively. My guess is that industry would be a lot more eager to come on campus and pay for research. And, after all, with federal budgets trending as they have recently, we are going to want that industry investment on campus!
Okay, I’m finished. Now I’ll start cleaning up some of this shattered china!
In the final scene of the movie “Thelma and Louise,” the two main characters intentionally drive their convertible at high speed off a cliff in the desert.
The scene is proving iconic for the pending action associated with the Budget Control Act that Congress passed, and the President signed, over a year ago. We know that action as “sequestration.”
In short, because of real and growing concerns over the increasing debt of our federal government, our representatives in Congress laid out a series of control measures which, if not adopted by choice, would result in an automatic budget reduction of between 8.2% and 9.4% (for non-defense and defense discretionary budgets, respectively) on 2 January 2013. The action of sequestration was intentionally designed to be so aggressive and unpalatable that Congress would take more measured and reasonable approaches (presumably in the form of increasing revenue and decreasing spending, in some combination) well before that deadline.
Well, for a variety of reasons, including a contentious and highly charged series of election campaigns, that more measured solution didn’t transpire.
Speeding toward the cliff
Smart people are working to find a meaningful and implementable solution. This cannot simply be “voted down.” The fiscal problems are real (to paraphrase former Senator Everett Dirksen, “a debt of $1.2T is real money”). But the realists also recognize that trying to solve this problem with a draconian cut would be like losing 8.2% of your body weight through decapitation: not a sustainable solution.
My own belief is that Congress and the President, through a mixture of deferrals and compromises on spending/revenue generation, will soften the blow of the immediate FY13 crisis (but I kid you not, there will still be a blow), while buying time to develop a more sustainable solution that won’t cripple the current economic recovery
. . . kinda like throwing a detour in front of Thelma and Louise.
For folks like us, working in a predominantly federally funded research environment (roughly 70% of our university research revenue comes from agencies in Washington) this means we WILL have to make significant adjustments We have estimated that, unmitigated, these prescribed cuts will translate to an initial single-year hit of $15M to OSU’s research portfolio (plus an additional $2M to other programs).
Rest assured, at President Ray’s request, the Research Office and the Office of Government Relations are trying hard to determine what the impacts of such adjustments might mean. The problem is that nobody in DC is sharing much information about how each agency may choose to make their cuts.
The Office of Management and Budget (OMB) released their ‘guidance’ for these cuts, at the request of Congress, last month (OMB Report Pursuant to the Sequestration Transparency Act of 2012 (P. L. 112–155)): 394 pages of Excel spreadsheet wizardry, revealing nothing more than what appeared to be a “peanut-buttered” distribution of cuts at the previously indicated 8.2% and 9.4% level.
What will happen?
There are, however, many rumors about how such cuts might be doled out. Having worked in four different federal agencies myself (and having had five separate trips to DC in just a couple of months, recently), I am willing to guess about how this might play out. I suspect those agencies that employ scientists in their own labs (DOE, Navy, NIH, EPA, USGS, etc.) will protect these “in-house” assets, at the expense of some of the extramural activities – meaning even larger cuts to competitive research programs. I also believe that agencies will try to soften the immediate blows to academic programs by simply deferring or delaying upcoming competitions, rather than rescinding actively funded programs. And I think we will see agencies trying to make surgical cuts to pare down to the bone those research projects that they still must continue to support, through efforts such as increasing matching requests, or perhaps even imposing salary caps (as some agencies already do). Let’s hope they don’t prescribe really dumb solutions, like reducing support for graduate students.
The real question: What can we do ?
The short answer is to develop as many options as possible. Start looking at your existing grants and prioritizing your expenses. Start thinking about alternative funding sources. The University’s success in growing our industry support for research (up by 42% in two years) is not an accident. If you haven’t thought about this route, let’s start talking, since there might be private sector funding out there to help accommodate reductions in federal support. Let us know if there are foundations that you want to try working with. The OSU Foundation has had some success in getting these kinds of resources to faculty on campus. Discuss this issue with your peers, your students and your academic unit, and with us in the Research Office.
We have a lot of very clever researchers at OSU. We’re going to have to apply some of the same creativity we use in our research to resolve this issue.
And, as a final thought, remember that this doesn’t go away.
Even if we soften the blow of the FY13 consequences, we still have another 10 years of budget reduction work at hand. The challenge is to find a smooth downhill off-ramp for Thelma and Louise.
Receiving almost $281 million in Fiscal Year 2012, with private sector financing of nearly $35 million, OSU is one of only two land, sea, space and sun grant institutions in the U.S., with top tier research designation from the Carnegie Foundation.
This blog includes insights from the VP and others, for the OSU research community.