When the subjects are hospital staff, is it ethical (or possible) to get informed consent
UMass Chan AffiliationsDepartment of Psychiatry
Document TypeJournal Article
Conflict of Interest
Ethics Committees, Clinical
Ethics Committees, Research
Mentally Ill Persons
Social Control, Formal
Health Services Research
Mental and Social Health
Psychiatry and Psychology
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"Our lab is the community": Defining essential supporting infrastructure in engagement researchNease, Donald E. Jr.; Burton, Dee; Cutrona, Sarah L.; Edmundson, Lauren; Krist, Alex H.; Laws, Michael Barton; Tamez, Montelle (2018-08-01)Introduction: Effective patient engagement is central to patient-centered outcomes research. A well-designed infrastructure supports and facilitates patient engagement, enabling study development and implementation. We sought to understand infrastructure needs from recipients of Patient-Centered Outcomes Research Institute (PCORI) pilot grant awards. Methods: We surveyed recipients of PCORI pilot project awards on self-perceived strengths in engagement infrastructure through PCORI's Ways of Engaging-Engagement Activity Tool survey, and interviewed leaders of 8 projects who volunteered as exemplars. Descriptive statistics summarized the survey findings. We conducted a thematic analysis of the interview transcripts. Results: Of the 50 surveyed pilots, 22 answered the engagement infrastructure questions (44% response rate). Survey and interview findings emphasized the importance of committed institutional leadership, ongoing relationships with stakeholder organizations, and infrastructure funding through Clinical and Translational Science Awards, PCORI, and institutional discretionary funds. Conclusions: These findings highlight the importance of and how to improve upon existing institutional infrastructure.
Training in the Conduct of Population-Based Multi-Site and Multi-Disciplinary Studies: the Cancer Research Network's Scholars ProgramBuist, Diana S. M.; Field, Terry S.; Banegas, Matthew P.; Clancy, Heather A.; Doria-Rose, V. Paul; Epstein, Mara M; Greenlee, Robert T.; McDonald, Sarah; Nichols, Hazel B.; Pawloski, Pamala A.; et al. (2015-10-22)Expanding research capacity of large research networks within health care delivery systems requires strategically training both embedded and external investigators in necessary skills for this purpose. Researchers new to these settings frequently lack the skills and specialized knowledge conducive to multi-site and multi-disciplinary research set in delivery systems. This report describes the goals and components of the Cancer Research Network (CRN) Scholars Program, a 26-month training program developed to increase the capacity for cancer research conducted within the network's participating sites, its progression from training embedded investigators to a mix of internal and external investigators, and the content evolution of the training program. The CRN Scholars program was launched in 2007 to assist junior investigators from member sites develop independent and sustainable research programs within the CRN. Resulting from CRN's increased emphasis on promoting external collaborations, the 2013 Scholars program began recruiting junior investigators from external institutions committed to conducting delivery system science. Based on involvement of this broader population and feedback from prior Scholar cohorts, the program has honed its focus on specific opportunities and issues encountered in conducting cancer research within health care delivery systems. Efficiency and effectiveness of working within networks is accelerated by strategic and mentored navigation of these networks. Investing in training programs specific to these settings provides the opportunity to improve multi-disciplinary and multi-institutional collaboration, particularly for early-stage investigators. Aspects of the CRN Scholars Program may help inform others considering developing similar programs to expand delivery system research or within large, multi-disciplinary research networks.
Commonly used data-collection approaches in clinical researchSaczynski, Jane S.; McManus, David D.; Goldberg, Robert J. (2013-11-01)We provide an overview of the different data-collection approaches that are commonly used in carrying out clinical, public health, and translational research. We discuss several of the factors that researchers need to consider in using data collected in questionnaire surveys, from proxy informants, through the review of medical records, and in the collection of biologic samples. We hope that the points raised in this overview will lead to the collection of rich and high-quality data in observational studies and randomized controlled trials.