Better Tools for Multi-site Research

Online training modules in human subjects research protections and other topics are available through this collaborative effort between the University of Miami and the Fred Hutchinson Cancer Research Center. Co-founded by Karen Hansen and Paul Braunschweiger PhD, the CITI Program is now on it's 7th iteration and includes basic courses in the Protection of Human Research Subjects (biomedical focus, social and behavioral focus, and refresher courses), Good Clinical Practice course, Health Information privacy and security course (HIPS), and a course on the responsible conduct of research (RCR). Thanks to an agreement between CTN Best Practices and CITI, you can register for CITI coursed by affiliating yourself with Clinical Trials Best Practices (CTNBP) if your organization or institution is not already affiliated.   

From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/edu/citi-collaborative-institutional-training-initiative/

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From Clinical Trials Networks Best Practices (CTNBP) of Duke Clinical Research Institute (DCRI).  https://www.ctnbestpractices.org/edu/humanprotect

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This paper outlines two IRB-related issues that had not previously appeared in the literature but occurred during the course of a large 5-year Practice-based Research Network (PBRN) study involving 32 sites dispersed around the United States.   Click here to download.

Yawn, Barbara P., Graham, Deborah G., Bertram, Susan L., Kurland, Marge J., Dietrich, Allen J., Wollan, Peter C., Brandt, Elias C., Huff, Jessica M., Pace, Wilson D. Practice-based Research Network Studies and Institutional Review Boards: Two New Issues. Journal of the American Board of Family Medicine. 2009 22: 453-460.  http://www.jabfm.org/cgi/reprint/22/4/453.pdf

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The Agency for Healthcare Research and Quality (AHRQ) commissioned the creation of this Health Literacy Universal Precautions Toolkit. This toolkit builds on the principles of universal precautions, or specific actions that providers can take to make health information more understandable for all patients. It is designed to be used by all levels of staff in practices providing primary care for adults and/or pediatric patients. The toolkit includes: (a) A Quick Start Guide; (b) The Path to Improvement (which outlines the six steps to fully implement the toolkit); (c) Twenty short tools to identify and address areas that need improvement; (d) Links to Internet resources; (e) An appendix with resources to support implementation (e.g., sample forms, posters, PowerPoint presentations, and worksheets).

Developed by the University of North Carolina at Chapel Hill's North Carolina Program on Health Literacy. http://www.nchealthliteracy.org/toolkit/

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This paper outlines two IRB-related challenges to conducting research in Practice-based Research Networks (PBRN)s. This and the following paper provide valuable insights and perspective for academic-based researchers that may be working with Practice-based Research Network (PBRN)s for the first time.   Click here to download.

Graham, Deborah G., Spano, Mindy S., Manning, Brian. The IRB Challenge for Practice-based Research: Strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). Journal of the American Board of Family Medicine. 2007 20: 181-187.   http://www.jabfm.org/cgi/reprint/20/2/181.pdf

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This paper provides an excellent overview of issues, addresses common questions about the research use of protected health information (PHI), and presents definitions and interpretations of selected Privacy Rule terms with particular meaning to the conduct of research in practice-based settings.  Click here to download.

Neale, Anne Victoria, Schwartz, Kendra L. A Primer of the HIPAA Privacy Rule for Practice-Based Researchers. Journal of the American Board of Family Practice 2004 17: 461-465.  http://www.jabfm.org/cgi/reprint/17/6/461.pdf

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This paper sets out the challenges HIPAA can pose to conducting research in practice-based settings and clearly outlines 3 methods for addressing those challenges for researchers working in these settings.   Click here to download.

Pace WD, Staton EW, and Holcomb S. Practice-Based Research Network Studies in the Age of HIPAA. Annals of Family Medicine, May 2005; 3: S38 - S45.   http://www.annfammed.org/cgi/reprint/3/suppl_1/s38.pdf

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The PRISM Readability Toolkit is a comprehensive resource that shows research teams how to create consent forms and other participant materials in plain language Includes a customizable training workshop in addition to the toolkit.   

Courtesy of the Group Health Research Institute (formerly the Group Health Center for Health Studies).  http://www.centerforhealthstudies.org/capabilities/readability/readability_home.html

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This interactive curriculum was developed to prepare and inform community representatives about the importance of research ethics so as to give them a stronger voice before, during, and after the research process. This curriculum covers general principles of research ethics that are shared by geographic, cultural, economic, legal, and political groups around the world. The curriculum content is divided into 2 parts, each containing 3 sections. Part A: Community Participation in the Research Process; Researchers and Sponsors; Ethics Committees. Part B: Principles of Research Ethics; Informed Consent; Research Ethics Documents.   Click here to download.

From Family Health International.   http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/index.htm

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