Concurrent Session #2 (11:15am – 12:30pm)

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.
Developing guidance for the new requirement for informed consent: What constitutes a concise summary of key information. 
Presented by Judith Navratil, Nena Ansari & Dana DiVirgilioof University from the Pittsburgh Human Research Protection Office

The revised final rule to update the current regulations at 45 CFR 46, Subpart A include important changes to the requirements for informed consent intended to “better protect human subjects involved in research, facilitate research, remove ambiguity, and reduce regulatory burden.” To facilitate this, the revised rule requires that the informed consent process begin with a concise and focused presentation of the “key information” that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. Informed consent documents must be organized and presented in a way that does not merely provide lists of isolated facts, but in a way that facilitates comprehension. The concise and focused summary of “key information” should provide the information that a “reasonable person” would want to have in order to make a decision. This new requirement does make sense as a possible remedy to the current state of informed consent documents, but it is problematic in that clearly, the “key information” required about one type of research study may be significantly different from the “key information” required for a different type of research study. And the information that one “reasonable person” would require may be significantly different from that required by a different “reasonable person.” And then there is the question of whether research investigators or IRB members are the best judges of whether the key information requirement is satisfied for any particular research study.

  • In order to address these ambiguities, the University of Pittsburgh Human Research Protection Office formed a working group composed of IRB staff, board members including community (unaffiliated) members, research investigators and research coordinators from the University of Pittsburgh School of Medicine divisions including Oncology and Psychiatry, as well as researchers from the School of Public Health, Psychology and Education. Focus group discussions yielded a Guidance template, and a survey of potential research subjects is currently being administered to members of a CTSI based research registry. We will share the preliminary results of the survey. We are looking forward to discussions with attendees about how other Human Research Protections offices are handling this change.