The Nitpicky People: Why Compliance Committees and Personnel Attend to Details
By Marianne Evola
A few years ago, I was at a university celebration of a newly constructed building and prior to the start of the ceremonies, I sat down next to a woman that I did not know. As would be the norm, we made small talk while we waited for the program to begin and she asked about my work with the university. I told her that I worked in responsible research and she looked at me blankly. Then I said, "Most people would describe it as compliance". She looked at me and with a grimace and said, "Oh, you're one of those nitpicky people." I laughed and nodded because everyone that works under the umbrella of responsible research is accustomed to that type of reaction to the world of compliance. Furthermore, it is my experience that most everyone in compliance accepts this type of criticism with humor because many of us come from a research background and at one time, we had similar feelings about compliance personnel. That being said, as a compliance convert I think it is important for the research community to realize that the "nitpickers" play an important role in assessing proposed research for potential regulatory violations.
My memory of the "nitpicky people" story was triggered by a recent report in Retraction Watch. In the report, researchers were forced to retract a publication because they had mistakenly identified a child patient/research subject in the publication. This was a breach of confidentiality that would have violated HIPAA and Institutional Review Board (IRB) regulations. The investigators had not published the child's name in the publication. Rather, it was the treatment strategies, included in the publication, that had inadvertently revealed the identity of the child. Specifically, the authors revealed the name of a drug that was being utilized to treat the child for a rare medical condition. The child in the study happened to be the only child in the world that was receiving that particular drug therapy. Consequently, when the authors identified the drug in the publication, the authors also made the child identifiable. To make matters worse, when the authors posted the retraction, they again listed the name of the drug in the retraction and as such, the confidentiality violation was repeated in the retraction notice.
From an academic research perspective, it is easy to understand how the authors could have made the mistake. In most cases, revealing the name of a drug that is being utilized for treatment would never reveal the identity of the patient. As an extreme example of the opposite, if I was a participant in a study assessing the effects of aspirin, revealing aspirin as a treatment compound would not reveal my identity, nor the identity of any other participant in the study. In contrast, the retracted study was a very unique situation in which the research subject happened to be the only child in the world receiving that specific treatment. Furthermore, it would be completely normal and probably expected that the authors reveal the names of drugs being utilized for treatment, when publishing their research. In fact, omitting the name of any drugs would, in most cases, be considered inappropriate because transparency is the norm for academic publication. As such, the authors were following their training and the expectations for academic research and publication when they published the study and identified all of the drugs that were utilized to treat their patient/research subject. It was the unique nature of this situation, the rarity of the disease and drug treatment, that caused a standard research practice to be considered irresponsible or unethical so that the authors were forced to retract their work.
So, what does this have to do with the nitpicky people? Well first, nitpicky people read things like Retraction Watch to educate themselves on the missteps and oversights that result in embarrassing and damaging mistakes that lead to retraction. By familiarizing ourselves with missteps that occur in the research world, we raise our awareness so that we can educate the research community about risks when we encounter proposed work that is similar to case studies that we have read. Second, the nitpicky people are often regulatory experts. As the research world faces increasing levels of regulatory oversight, it is not possible for our researchers to actively engage in their research and maintain expertise on all the regulations (i.e., safety, human and animal research, conflicts of interest, account expenditures, etc.) that relate to their research. As such, contrary to the opinions of many of our customers, the compliance community provides valuable service, awareness and education to our students and sometimes to faculty as well.
Admittedly, there are faculty mentors and/or departments that provide students with exceptional training on various issues of compliance and regulations as a central part of student training. However, generally when the training is a departmental requirement, the training is limited to regulatory issues that are applicable to the majority of research personnel in that department. As such, the mandated training does not always fulfill the needs of all research personnel within that department. For example, I was trained in a Psychology Department and most researchers in Psychology conduct research on people. So, I received a great deal of training on the ethics/regulations associated with conducting work on human research subjects. However, my research did not utilize humans as research subjects. Our laboratory worked with animals. The Psychology Department did not mandate any training on the ethics associated with conducting research on animals. Luckily, I had a mentor that sternly required the team to learn and adhere to the ethics and regulations associated with conducting research on animals. There are many mentors like my graduate mentor. However, there are also mentors and academic departments that do not provide nor mandate any regulatory training. This is something that I also witnessed in graduate school and continue to witness today. As such, sometimes the only training that students receive on regulatory issues is when they interact with compliance personnel and/or committees. In fact, education is a top priority in all compliance divisions.
Finally, as it turns out, the nitpicky people are not actually nitpicky. Much as I found the label amusing, it turns out to be inaccurate when describing compliance personnel. Although it may have been nitpicky to do so, I looked up the phrase nitpicky in Webster's dictionary and found the definition to be "minute or unjustified criticism". The concerns that are raised by compliance personnel and committees are not minute, nor are they unjustified. Although the compliance concerns are often interpreted to both minute and unjustified by some of the research community, in all honesty most of the concerns raised by compliance personnel/committees come from state or federal regulations. Furthermore, the regulations exist because our academic ancestors engaged in inappropriate, unsafe or unethical research practices. In other words, most regulations can easily be mapped to concrete cases of misconduct/mistakes that have occurred in the past or even in the present. I encourage all researchers to ask compliance personnel why certain regulations exist, especially if you perceive the concerns to be unjustified or unimportant. Often, once researchers understand why particular regulations exist, they are more prone to modify research practices to adhere to regulations.
Interestingly, although most policies are directly related to state/federal regulations, there is often a need to interpret the regulations to construct policies that address the regulation, and the responsibility of regulatory interpretation often falls on the institution. When regulations need interpretation, compliance personnel generally rely on faculty committees (i.e., IRB, IACUC, IBC, etc.) to provide the institution with regulatory interpretation and feedback on how to translate the regulation into policy. Faculty committees are generally recruited and or utilized to ensure that faculty and research community have a voice in translating regulation into policy. After working with a few of the faculty committees over the years, one of the things that continues to surprise me is that faculty committees are often very strict in their interpretation of federal regulations and these committees tend to construct stern policy for compliance personnel to implement. In fact, these committees are often more restrictive than the compliance personnel would have been. In other words, when the faculty committees realize the risks associated with a new regulation, these committees become very serious about protecting their colleagues from inadvertently violating state and/or federal regulations. As such, although the compliance personnel may be viewed as restrictive, often the policies and practices that staff are implementing were actually constructed by faculty committees that were trying to protect their students and colleagues.
So, if compliance personnel are not nitpicky, why are our offices/personnel often viewed as nitpicky? I remember when I was a graduate student and was learning how to conduct analyze research and/or write, I would submit work to my mentor and it would be returned to me with a lot of "red ink". At that time, it seemed like no matter how hard I worked on a project before submitting it to my mentor, it was always returned to me with plethora of corrections and/or suggestions for improvement. I remember that I would look at the comments and think that most of the comments were nitpicky. I even remember a few occasions after making the recommended changes, I would resubmit the project to my mentor and when it was returned to me, my mentor had changed the wording back to my original language. At this point, I would throw a bit of an internal tantrum because now it seemed that my original work was acceptable so there had been no need to make any changes at all. This type of back and forth, could happen a few times before the language of a document was finalized. As a young graduate student, the editing process seemed nitpicky. A couple years later, I was working on a grant with my mentor and I watched her edit her own work in the same nitpicky way, as she struggled to find the optimal language to clearly and efficiently convey her thoughts. It was then that I realized that she had not been nitpicking my writing when I was a first-year grad student, rather she was editing my work in the same way that she would edit the work of peers. She had been trying to teach me the critical need to struggle with words to optimize the readability of science. Really good science writing conveys work clearly and concisely so that your colleagues can quickly comprehend your research methodology and results with minimal effort. As such, researchers struggle with words to optimize written communication. I interpreted that early input as nitpicking, when in fact the input was critical for ensuring the quality of the research. Similarly, the concerns raised by compliance personnel/committees are often interpreted as nitpicking when in fact, the input is critical for ensuring regulatory compliance and/or research quality.
So, back to the retraction that was described at the start of this column. Could the compliance personnel (i.e., IRB) have provided input that would have protected the investigators from the embarrassment of having violated the privacy of their research subject and having to retract the publication? Well, that all depends on whether the researchers realized the importance of providing the IRB personnel/committee with critical input on the rarity of the patient's illness and the extraordinary rarity of the patient's treatment. I have regularly witnessed compliance personnel identify risks in proposed research that the investigators did not realize. Sometimes the flaws are obvious because they are problems that compliance personnel encounter daily. However, sometimes the flaws are revealed in a transparent research proposal or in a conversation between compliance personnel and researchers. In other words, compliance personnel do their best work when researchers are transparent about their proposed research. And compliance personnel provide even better input when the communication with researchers is open, professional and respectful.
After working in compliance for a few years now, I can tell you that most compliance personnel are willing to accept labels, such as nitpickers, with a laugh and smile. Our roles in the research community require us to have a bit of a sense of humor. However, we take our responsibilities seriously and do not consider our duties to be unjustified nor unimportant. We read about too many cases of research misconduct, both accidental and purposeful, to dismiss the importance of the work that we do, especially our work in education. So, I encourage our researchers, especially the students, to ask us "why" some of the perceivable nitpicky regulations exist before you dismiss them as inconsequential. We are happy to explain the importance of policies and regulations.
Marianne Evola is the director of the Human Research Protection Program in the Office of Research & Innovation. She is a monthly contributor to Scholarly Messenger.