Responsible conduct of research: not just for researchers.

Author:Schaller-Demers, Debra S.
 
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Introduction

Dr. John Galland, former Director of Education and Integrity for the Office of Research Integrity (ORI) of the Department of Health and Human Services (DHHS), contemplated the meaning of Responsible Conduct of Research (RCR) on his research integrity blog. He stated that "RCR is about an individual making choices in a research program that are ethical and legal, but also that are in-line with the individual's own conscience, the value system upon which the research is based, and generally acceptable research practices of the scientific discipline within which the individual belongs" (Galland, 2009).

In this authors experience directing RCR training courses for graduate students, MD-PhD candidates and postdoctoral trainees for three institutions over the last 13 years, it has become evident that RCR is not just for or about researchers. As Galland (2009) suggests, it is about "... individuals making choices ..." Therefore it is equally important for research administrators to be able to recognize and understand the underlying concepts of RCR. Why do they need to care? In any profession, daily tasks can become routine and are often performed automatically, absent of conscious thought. Is one merely following steps blindly that have been trodden upon by many that came before or is there a bigger picture--a wider realm to consider? How many times have research administrators been accused of being "bureaucrats" lacking proper appreciation for the science that is at stake? This paper attempts to address the divide that happens when scientists separate themselves from staff because of differences in training and academic achievement. This "classism" can create stressful relations that can hinder the proper administration of research. Scientists and administrators while bound together to work towards securing the necessary funding sometimes find themselves at odds. Deadlines need to be met and compliance points covered that scientists may feel interfere with the creative process. They can be viewed as "unappreciative" of the administrators work process and vice versa. Without a sincere attempt to understand the opposing point of view, researchers and administrators cannot begin to work collaboratively to meet the expected deadlines and compliance points that are essential to a healthy, flourishing research enterprise and at the same time be respectful and protective of the integrity of that enterprise.

Educators or Enforcers?

Research administrators often play multiple roles when it comes to research ethics. They may have some role or responsibility for developing research integrity and compliance policies and procedures, including educating researchers. Yet, they also have responsibility for implementing and policing research integrity. Thus, they find themselves straddling a rather cumbersome fence. On one side they are asked to be educators. Quite often they have a hand in developing or implementing RCR courses or curriculum for students, postdoctoral trainees, and faculty. They may even play a part in delivering lectures or running small group sessions on one or more of the RCR core topics recommended by ORI. These topics have expanded in the US over the years in response to worldwide incidents and changes in political influence, and are considered to be as outlined in Table 1.

However, on the opposite side, these same research administrators are often asked to "police" the science by ensuring compliance with the numerous rules and regulations that are deeply embedded in the administration of research. It is a very fine line one treads between being a positive enthusiastic teacher and a heavy-handed regulator.

Culture of Responsibility

Learning to do the right thing, because it is the right thing to do is the paradigm for RCR success. However, as a former colleague of the author is fond of saying, the consequence for not doing the right thing, is that we "all" might go to jail. Therefore, in the end, it is in everyone's best interest to be properly prepared and invested in RCR. This is more than either a philosophical or legal debate. It is not enough to know where to find the rules online or in which dusty book on a long forgotten shelf they reside. We must incorporate the spirit of the regulations into our daily work ethic and decision-making processes. It must fortify the way we think about and conduct not only the science, but in the research administrator's world--the business of research. This is part and parcel of nurturing a sustainable culture of responsibility.

What does a culture of responsibility look like? How is it sustained over time amidst the changing landscape of federal regulations and public opinion? Why is it important to create a culture of responsibility? What role do research administrators have to play? Are they merely silent sideliners watching the main event or do they have a moral (if not legal) obligation to be active, vocal participants in the RCR? How do they begin to weigh the importance of integrity vs. compliance and vice versa? Are these concepts not synonymous? Do the rules and philosophies change if working with collaborators from other countries? How do they discern the proper course of action when reputations, funding, jobs, and perhaps even public safety are at stake?

These are all valid questions that research administrators (and their institutions) need to sincerely consider with clarity of thought as they perform the daily routine of administering to the research enterprise. Each institution's "culture" may vary in appearance, but at its core should be a foundation that can withstand the onslaught of political winds and legislative whims.

Training--Not Just for Researchers

RCR training has been around in the US for over two decades, having appeared on the research integrity horizon in the late 1980's and early 1990 s. Under the Clinton administration, much attention was given to developing legislation that would have required anyone involved in the research enterprise to be "trained" in RCR. This voluminous legislation was tabled for further consideration under the Bush administration and never quite materialized as originally envisioned. More recently, RCR training requirements have once again gained some momentum with refurbished guidelines from the National Institutes of Health (NIH, 2009) and the National Science Foundation (NSF, 2009). These federal guidelines however, speak only to investigators or key personnel who receive certain types of Public Health Service funding. They do not address the ethical obligations of research staff who may administer those funds and there is most certainly fiscal responsibility inherent in applying for and accepting federally sponsored research dollars (Schaller-Demers, in-press).

The media has also played a big role in focusing national (and global) attention on cases of fraud, plagiarism, and assorted other instances of professional research misconduct (RREE, 2010). This sensationalism has helped to illustrate a growing need and to center the spotlight on RCR education. This past year the issue of deficiencies in reproducibility has made headline news. In response, NIH has announced upcoming additional RCR training materials for its own postdoctoral researchers to help enhance reproducibility. However, Collins and Tabak (2014) state, "Efforts by the NIH alone will not be sufficient to effect real change in an unhealthy environment". They suggest that each institution should be responsible for training research staff in ethics and compliance.

Even journals like Nature Medicine (2013) have stated, "Tackling these issues is a long-term endeavor that will require the commitment of funders, institutions, researchers and publishers." All members of the research community have a stake in the outcomes of the scientific enterprise, and therefore a responsibility to become active participants in finding and implementing solutions.

Consider some of the more "notorious" cases--James Wilson (Principal Investigator [PI] in the Gelsinger tragedy at UPENN), Eric Poehlman (first researcher to be sentenced to federal prison time was exposed by one of his lab technicians, Walter DeNino, who once viewed Poehlman as his mentor), Luk Van Parijs (faked data in various papers at MIT), Woo-Suk Hwang (South Korean PI who coerced female lab members into...

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