Concurrent Session #2

Researchers’ perceptions and involvement in research misconduct: DEFORM’s international on-line survey results
Presented by Georgia Koumoundourou, Ioannis Tsaousis, Eirini Sifaki, Tina Garani-Papadatos & Vasiliki Petousi from the University of Crete

According to Steneck (2006), research behaviors can be separated into three categories: deliberate misconduct, defined usually as Fabrication, Falsification and Plagiarism (FFP); Questionable Research Practices (QRP); and Responsible Conduct of Research (RCR). Unlike FFP which are universally viewed as major deviations from Responsible Conduct of Research (RCR), Questionable Research Practices (QRP) are behaviours that may greatly affect both science and society (Ingierd, 2016; Israel & Drenth, 2015; Leistedt & Linkowski, 2016; Martinson et al., 2005; Simera, 2016; Steneck, 2006). However, to date, there is no commonly accepted and comprehensive list of such practices (Bouter, Tijdink, Axelsen, Martinson, & ter Riet, 2016). Similarly, there is no broad consensus on the severity and impact of research practices deviating from research integrity (Bouter, et al., 2016; George, 2016; Steneck, 2006). What is more confusing is that specific practices (e.g., gift authorship) may be disregarded in one disciple, but be considered intolerable in another disciple (Bouter et al., 2016; Davenport, et al. 2010).

As argued by Martinson, Anderson and De Vries (2005), if we want to protect research integrity, we must look beyond falsification, fabrication and plagiarism, to a wider range of questionable research practices. Taking into account the ongoing debate on what constitutes RM, and consequently what is its impact for science itself, research community, but also for society, the current study aims at simultaneously assessing in a potentially vast international and interdisciplinary sample of researchers, employed in both the academia and industry, their perceptions on the severity, the frequency and actual engagement in a broad array of research misconduct practices, far beyond FFP.

Additionally, this survey aims at identifying researchers’ reactions in case they witness either a peer or their supervisor committing RM in their working environment, the potential causes (both individual and situational) of the phenomenon, and the perceived impact accompanying RM. Data were collected via an online survey questionnaire developed for the purposes of this study and analyzed using both descriptive and inferential statistics. Final results will be presented and theoretical as well as practical implications for both, science and society, will be considered. This research is part of the HORIZON2020 funded program: DEFORM Determine the global and financial impact of research misconduct. Project ID: 710246.

Noncompliance with Human Subject Protection Rules and Regulations in Biomedical Research: System Failure or Willful Neglect? 
Presented by Scott Lipkin from FTI Consulting

A culture of compliance, accountability and transparency is an important indicator of a quality research program. Reporting events related to noncompliance should be regarded by investigators as a natural extension of their responsibilities while conducting research. Moreover, reports related to noncompliance should be viewed as system failures and are best managed through a “holistic,” enterprise-wide approach; a “siloed” research infrastructure dissuades transparency and accountability at a system level. This session will:

  1. Review the regulatory requirements and professional standards as they apply to noncompliance in human research.
  2. Explore causes of noncompliance.
  3. Propose system level methodologies to effectively manage noncompliance.
Human Subjects Protections–As the Regulations Intended 
Presented by: Norm Braaten from Grinnell College

Empirical data (Braaten, 2014) may suggest that individuals and institutions that review minimal risk research are not taking advantage of all the regulations have to offer in determining an activity to be exempt. Why is this the case? In this interactive session, participants will be encouraged to re-examine the ethical principles and federal regulations along with their policies, procedures, and practices guiding human research protections. Participants may be asked to participate in making a human subjects research determination. The presentation is not for the fainthearted, as participants may be taken out of their comfort zone or may become upset, and completely disagree with the evidence presented. That is perfectly acceptable.

HOWEVER: One “wise sage” once wrote: “We could spend hours reviewing a low-risk study, but that creates an inappropriate burden for researchers and IRBs and does little to improve protections” (AAHRPP, 2009). And another “wise sage” once said, “I’ve gone to IRBs all over the country. They are thoughtful, sincere, really intelligent groups. To have all this brainpower sucked into the vortex of minimal risk research is not efficient” (person to be named later, 2008). With those two quotes in mind, let’s get to work.

The Basics of US Export Controls
Presented by Melissa McGee & Victor Sosa from the University of New HampshireThis session will cover the basic elements of Export Controls, focusing on the issues particularly relevant to higher-education and research institutions.
Export Controls are a complex set of laws and implementing regulations through which the U.S. Government controls the physical export of, and limits access by certain foreign entities and foreign persons to, sensitive equipment, software, technical data, technology and services, in order to promote several of the U.S. Government’s objectives and interests, such as:
  • Restricting the export of technologies that have actual or potential military applications, and could contribute to the military potential of U.S. adversaries;
  • Advancing U.S. trade protection and economic goals;
  • Implementing U.S. foreign policy, including honoring treaties (such as The Treaty on the Non-Proliferation of Nuclear Weapons or the Biological and Toxin Weapons Convention); and
  • Preventing the proliferation of weapons of mass destruction and terrorism, particularly to countries, organizations, individuals, end-users or end-uses of concern.

Certain elements of Export Control compliance may seem to conflict with traditional values and practices of an academic culture in that they tend to discourage free and open exchange of information and they institutionalize barriers to collaboration with foreign colleagues. However, Export Control laws apply to all activities and technologies –not just sponsored research– and they constitute a major element of the University’s overall compliance program. Violations can result in significant civil and criminal penalties for the individual as well as the institution.