The Professionalism and Integrity in Research Program: Description and Preliminary Outcomes

Abstract

Violations of rules and regulations in research can cause significant problems for human participants, animal subjects, data integrity, institutions, and investigators. The Professionalism and Integrity in Research Program (PI Program) provides remediation training that addresses the root causes of violations of rules and regulations in research. Through assessments, a three-day workshop, and follow-up coaching calls, the PI Program teaches evidence-based decision-making strategies designed to help researchers to compensate for bias, uncertainty, and work-related stress, and foster the skills needed to oversee research projects in today’s complex regulatory environments. Across its first three years (2013–2015), the program trained 39 researchers from 24 different institutions in the United States. Participant evaluations of the program’s faculty and workshop content were highly positive (4.7–4.8 and 4.5–4.6, respectively, on a 5-point scale). Preliminary program outcome assessment using validated measures of professional decision making and cognitive distortions in a pre- and postworkshop design indicated significant improvements. A follow-up survey of participants found statistically significant increases in a variety of target behaviors, including training research staff members to foster compliance and research quality, using standard operating procedures to support compliance and research integrity, performing self-audits of research operations, reducing job stressors, actively overseeing the work of the research team, and seeking help when experiencing uncertainty. Assessment of the PI Program was conducted with modest sample sizes, yet evaluation, outcome assessment, and self-reported survey data provided statistically significant evidence of effectiveness in achieving program goals.

Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research

“…Recent attention has been focused on the characteristics of researchers who have committed research misconduct, defined as “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results” [25]. An individualized remediation program such as The University of Washington in St. Louis’ 3-day Professionalism and Integrity in Research Program that has been attended by 39 researchers from 24 institutions has yielded promising results for those who have had their research privileges suspended [26,27]. DuBois and Antes thus define five dimensions of research ethics, including “compliance with regulations, statutes, and institutional policies” as ethical imperatives in the context of the responsible conduct of research [28].…”

The lab management practices of “Research Exemplars” that foster research rigor and regulatory compliance: A qualitative study of successful principal investigators

“…We did not explicitly tell participants we were studying “leadership and management” to allow their leadership practices to emerge naturally. The interview script was developed by AA (an industrial-organizational psychologist with expertise in workplace psychology, leadership, and responsible conduct in research) [19, 32–34], and JD (a psychologist and bioethicist with expertise in research professionalism, research integrity, and professional decision-making, along with experience as PI of large federally-funded grants) [35–37]. Two public health graduate student research assistants conducted the interviews.…”

Leading the people and leading the work: Practical considerations for ethical research.

“…Penalties for these violations can take the form of getting fined, having a research lab shut down, having funding withdrawn, or getting terminated. In a study of 39 researchers who were referred to and completed a remediation training because of a violation attributed to themselves or a lab member, it was found that the majority of violations were due to factors other than intentional unethical behavior (DuBois, Chibnall, Tait, & Vander Wal, 2018). In terms of unsatisfactory leadership practices, 36% of researchers’ lapses were due to relationship problems (e.g., aggressive communication, political tensions) and 26% of lapses were due to poor communication (e.g., failing to hold regular meetings; DuBois, Chibnall, Tait, & Vander Wal, 2016).…”