Misconduct: Lessons from researcher rehab

DuBois, James M.; Chibnall, John T.; Tait, Raymond C.; Wal, Jillon Vander

doi:10.1038/534173a

Cited by 35 publications

(22 citation statements)

References 7 publications

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“…stewardship) is typically transferred to individual investigators, many of whom have insufficient understanding of or infrastructure for this important role. 2 While authors are routinely asked to affirm their accountability “for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved”, 3 there is no standard infrastructure for sharing all primary data among all authors concurrently during drafting of a manuscript, much less after publication.…”

Section: Data Retention and Provenancementioning

confidence: 99%

It’s 10 pm ; Do You Know Where Your Data Are?

Anderson

Ray

2017

Circulation Research

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Section: Data Retention and Provenancementioning

confidence: 99%

It’s 10 pm ; Do You Know Where Your Data Are?

Anderson

Ray

2017

Circulation Research

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“…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].…”

Section: Discussionmentioning

confidence: 99%

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

Plottel

Mannon

et al. 2018

J. Clin. Trans. Sci.

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The Principal INvestigator Development and Resources (PINDAR) program was developed at the NYU-H+H Clinical and Translational Science Award (CTSA) hub in response to a perceived need for focused good clinical practice (GCP) training designed specifically for principal investigators (PIs) performing human subject research. PINDAR is a novel 6-hour, instructor lead, participatory, in-person course for PIs developed de novo, piloted, and implemented. One hundred and seventeen faculty PIs participated in PINDAR from November 2016 through September 2018. All obtained mutual recognition for ICH E6 GCP training from TransCelerate Biopharma. PINDAR was well received by participant PIs, and feedback surveys have revealed a high degree of satisfaction with the program. Other CTSA hubs and research-intensive health systems should consider adopting a similar course focused on GCP for PIs.

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“…In a recent article, we described the kinds of violations that led to program referrals (most commonly failures to provide lab oversight, informed consent and recruitment violations, plagiarism, and animal care violations), and why these violations occurred (most commonly due to investigators being overextended, not prioritizing compliance, being unsure of the rules, or failing to communicate effectively). 17 …”

Section: Program Rationalementioning

confidence: 99%

“…Further, principal investigators are frequently high achievers and creative learners but are not always highly disciplined and detail oriented regarding matters of paperwork and documentation. 17 , 18 …”

Section: Program Rationalementioning

confidence: 99%

“…Baseline data for all measures have been reported in the supplemental materials of a separate paper. 17 Following the assessment battery, we conduct an enrollment interview with the prospective participant and/or an institutional official (depending on participant preferences, which may be influenced by institutional demands). During the interview we assess the nature and scope of noncompliance or other violations, learn about the kind of research being done, and determine whether the institution requires any other actions as part of a remediation plan.…”

Section: Program Descriptionmentioning

confidence: 99%

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

et al. 2018

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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.

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Misconduct: Lessons from researcher rehab

Cited by 35 publications

References 7 publications

It’s 10 pm ; Do You Know Where Your Data Are?

It’s 10 pm ; Do You Know Where Your Data Are?

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

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

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