Our Goals are the Same - The Culture of Cooperation between the Research and the Compliance Divisions
By Marianne Evola
I never realized how unique my training history was, with respect to animal research oversight, until I moved to Texas. My graduate training took place in a laboratory that was housed right outside the door of the animal housing facility. Our lab needed access to our animals frequently throughout the day. As such, close proximity to the animal colony was critical. However, it wasn’t our proximity to the colony that made my training unique. Rather, that proximity in combination with our lab’s perpetual presence in the housing facility provided a foundation for the development of close professional relationships between our research group and the lab animal support staff. Furthermore, there was a long history of mutual respect and professionalism that preceded my start in the lab. As such, when I joined the “mini-culture” of the lab, I naturally absorbed that respect, and as my training continued, that respect extended to the Institutional Animal Care and Use Committee (IACUC). As such, other than the occasional foot stomping of a stressed graduate student, I perceived the entire animal oversight division as a cooperative extension of our research group.
When my research moved to the Texas Tech University Health Sciences Center, much of our lab was once again housed in the animal research facility. Again, most of my day was spent in the animal facility to the extent that it was not unusual for other researchers to think that I was a member of the lab animal resource (LARC) staff rather than a researcher. It was then that I realized how different my training had been. Initially, when we moved into the facility, I perceived that the animal support staff was a bit uncomfortable with our constant presence in the facility. They were not accustomed to investigators being actively involved in the day-to-day care of their animals. However, their discomfort gradually disappeared as our research group, once again, developed a close working relationship with the facility staff. They came to appreciate our ready availability when there was an animal problem that needed to be addressed. My students appreciated their support and assistance when I was not around. In fact, it was not unusual for our research group to assist with training on animal handling or research techniques when the animal support staff trained new personnel or investigators. Nor was it unusual for the animal staff to interject and correct our new students when they made mistakes handling animals. The cooperative research environment enabled all parties to address procedural concerns without inquiries being perceived of as unwelcome or confrontational. In fact, these relationships bettered our research program and often safeguarded our animals from human error.
Since I started my position in the OVPR, working in the culture of compliance, I have realized that there are a lot of researchers that have wonderful cooperative working relationships with the compliance divisions and their committees. However, there also are researchers who have never experienced or been trained to include their compliance personnel as part of their research team. Rather, a few see compliance personnel/committees (such as IRB, IACUC, IBC, IFDC, EH&S, etc.) as obstacles to conducting research and, as such, a hurdle to jump and then dismiss. Furthermore, there are researchers that have no history of working with compliance and oversight, but as their academic pursuits grow and they enter new collaborations, they are encountering these entities for the first time and often fail to realize that the compliance divisions can be valuable resources for bettering their projects. So I thought that I would use this month’s Scholarly Messenger to address the challenges to and benefits of including the compliance divisions in your research program. Specifically, I will discuss IACUC and the Institutional Review Board (IRB) since these are the two divisions with which I most frequently interacted. However, after working with the compliance personnel at TTU OVPR for a few years, I can emphatically state that all divisions would rather the research community perceive them as partners instead of obstacles. So why do so many researchers perceive the compliance divisions as obstacles?
Well, first, by definition, there are federal and university regulations with which researchers need to comply. It is the role of the compliance divisions to work to ensure that everyone learns and follows the rules. However, no one, especially highly intelligent and educated people, likes to be told what to do. In fact, mandating work of any kind is often perceived as a hindrance to academic freedom. However, before you resist complying, please think about why these regulations and systems exist in the first place. The academic histories of human and animal research readily demonstrate the need for and benefit of research oversight. Many of the rules, regulations and mandatory training are a result of our academic ancestors behaving badly. However, in many cases, I don’t believe it’s fair to assert that they behaved badly, but rather they acted out of ignorance.
Researchers violated the rights, welfare and autonomy of human research subjects because they never thought that much about rights, welfare and autonomy. Doctors that conducted human research on uninformed patients without consent asserted that they were working to alleviate human suffering and disease. Animal researchers that dismissed the pain, stress and discomfort of their research subjects as “anthropomorphizing” did so because there was no data to support that their animals experienced pain and distress. Researchers generally did not intend to do harm, rather they were ignorant of the harm that they were inflicting. And although it would be great to assert that we are all now educated about our ancestry, and as such “enlightened” on how to proceed, all the compliance divisions regularly encounter students and researchers that push to proceed without considering subject welfare, research safety, informed consent, subject coercion, conflict of interest and bias, or responsible research conduct/misconduct. I am convinced that like our academic ancestors, they fail to consider these critical issues because it has not yet become part of their daily academic thought process. In fact, it has been my experience that the best informed researchers regarding the dark history of science and the serious nature of federal regulations on safe and humane research are often cooperative and active partners with all the research compliance divisions. They realize compliance committees are valuable resources for catching proposed mistakes or recommending solutions to research quandaries.
Second, compliance often creates additional work for busy faculty and students. I have to agree with this concern. However, I would argue that it is not unnecessary work. In fact, constructing or revising a research protocol, whether it is for human/animal subject research or for safe research practices, can help to reveal problems with proposed systems and methodology. Furthermore, it can prevent students from making catastrophic mistakes that would violate the rights or welfare of human and animal subjects, and potentially destroy students’ young careers. IRB, IACUC, responsible conduct of research and safety committees spend a great deal of time encountering and resolving problematic research, and as such, they can be valuable resources to educate junior researchers and improve research protocols to prevent devastating errors. Also, mandatory training provides a solid foundation and education on responsible research, and helps students/trainees realize that their research decisions can have damaging repercussions on research subjects and research partners. However, as stated above, I concede that mandatory training and/or proposal modification do create additional work for busy faculty and students. Also, I admit that it was this additional work that caused me to foot stomp a bit while I was conducting research.
So, how do we proceed to improve the cooperation between resistant students, researchers and the compliance divisions?
Compliance personnel need to remember although it is our responsibility to ensure that faculty and students comply with research training and regulations, we need to work hard to be a resource rather than an obstacle to research, whenever possible. I have had the unique experience of working on both sides of compliance, as a researcher and a compliance administrator, and I know that the reason that I had a cooperative relationship with compliance personnel is because I learned how useful they could be to my research. I also know that on occasion, compliance personnel have no choice to be tough and “draw a line” for researchers that resist complying with their protocol, following regulations, completing training, or even acknowledging our e-mail. It is our responsibility to do so. However, once the researcher is working with you, return to being a resource rather than an obstacle.
Researchers need to communicate with compliance personnel and use us as a resource rather than treat us as an obstacle to avoid. I promise you that the agenda of every compliance division at TTU is to be a resource. Talk to us to resolve obstacles between regulations and your research protocol, in many cases compliance personnel have already addressed your problems in similar protocols. When I wrote my first IRB protocol to conduct a voluntary, anonymous survey, I was dismayed with all of problems that the IRB had with my protocol. A voluntary, anonymous survey seemed to be a pretty innocuous procedure. However, during a brief conversation, IRB personnel explained each of my mistakes and provided a solution. They had ready solutions because they had encountered these mistakes in many past protocols. Finally, mentor your students and colleagues to work with us. If they are confused about the problems raised in their protocol, or frustrated with the additional work of revising a protocol, have them come and talk to us. If they need technical training or research support, or an alternative research strategy to a problematic protocol, compliance personnel can frequently help. I’ve even had undergraduate students challenge me on the utility of mandatory training. I’m not offended by the inquiry, but I am well versed in the discussion. After a recent challenge of this kind, I actually had an undergraduate student thank me for showing him the respect to address his concerns. He had not expected me to engage calmly in the debate. Then he promptly completed the training.
Compliance and research personnel have the same agenda. We want to produce a safe, efficient, productive and efficacious research environment and culture on the TTU campus. We need to work together, and it all comes down to communication and cooperation.
Marianne Evola is senior administrator in the Responsible Research area of the Office of the Vice President for Research. She is a monthly contributor to Scholarly Messenger.
Alice Young, associate vice president for research/research integrity, is a contributing author/editor.