Research article
Human subjects protection issues in QUERI implementation research: QUERI Series
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* Corresponding author: Edmund Chaney chaney@u.washington.edu
1 HSR&D Northwest Center of Excellence for Outcomes Research in Older Adults, VA Puget Sound Health Care System, Metropolitan Park West, 1100 Olive Way #1400, Seattle, Washington, USA
2 Department of Psychiatry and Behavioral Sciences, School of Medicine, University of Washington, Seattle, Washington, USA
3 VA Center for the Study of Healthcare Provider Behavior, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA
4 HSR&D Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Healthcare System, Little Rock, Arkansas, USA
5 Center on Advice & Compliance Help (COACH) VA Office of Research & Development, Washington, DC, USA
6 RAND Health Program, Santa Monica, California, USA
7 David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA
Implementation Science 2008, 3:10 doi:10.1186/1748-5908-3-10
Published: 15 February 2008Additional files
Additional file 1:
Implementation evaluation theory guidance. This process aid discusses the Stetler Model & RE_AIM model and how they might be useful within the framework of Human Subjects Issues for implementation research.
Format: DOC Size: 44KB Download file
This file can be viewed with: Microsoft Word Viewer
Additional file 2:
Project implementation charter and site memorandum of agreement. A set of process aids that can be used to clarify the division of research roles.
Format: DOC Size: 121KB Download file
This file can be viewed with: Microsoft Word Viewer
Additional file 3:
IRB contact questionnaire. A process aid designed to simplify the communication and interaction with the IRB by centralizing some basic information on the IRB and its process and procedures.
Format: DOC Size: 33KB Download file
This file can be viewed with: Microsoft Word Viewer
Additional file 4:
IRB Relational Database. A process aid which is an example of how a relational database can be used to assist with IRB tracking across sites.
Format: PDF Size: 3MB Download file
This file can be viewed with: Adobe Acrobat Reader
Additional file 5:
Site PI orientation checklist. A process aid to collect contact information and preference for the site PI as well as a tool for discussing IRB responsibilities and division of labor.
Format: DOC Size: 43KB Download file
This file can be viewed with: Microsoft Word Viewer
Additional file 6:
IRB specialist position description. a process aid job description including how having a designated person in this role can be helpful.
Format: DOC Size: 42KB Download file
This file can be viewed with: Microsoft Word Viewer
Additional file 7:
IRB Call Minutes Template. A template/process aid which can be used to record the discussion and particularly the decisions made during IRB calls.
Format: DOC Size: 78KB Download file
This file can be viewed with: Microsoft Word Viewer