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, 120 internally 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.
Dr. Adam Schultz
Director of the Office of Research Integrity