Better Tools for Multi-site Research

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 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 Network (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 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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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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CTN Best practices offers a variety of checklists, logs and guidance on the topic of IRB review. Though these materials were specifically designed for clinical trials, they could potentially be adapted for other types of studies.   

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

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UCSF's School of Medicine offers a variety or useful tools for clinical and drug trials - including forms, decision trees, checklists, pill diaries and more.   

From the University of California San Francisco School of Medicine.   http://www.medschool.ucsf.edu/clinical_research/tools/index.aspx

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This Standard Operating Procedure (SOP) documents policies and procedures for IRB review of research conducted in more than one member of the HMO Research Network. The SOP was developed in 2008. The process aims to reduce the burden on investigators from one HMORN member who propose to conduct research in multiple HMORN member institutions, while protecting the authority of each HMORN member IRB to choose to review research being conducted in its institution or to cede review authority to another HMORN member IRB, consistent with federal regulation (DHHS 45 CFR 46), the HMORN member’s policies and procedures, and its Federal wide Assurance (FWA).   Click here to download.

From the HMO Research Network Collaboration Toolkit.  www.hmoresearchnetwork.org

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When multiple IRBs will be reviewing a project separately, it can be very helpful for the researchers to know the timing of IRB application due dates, review dates, and decision reporting for all the IRBs involved. The is a sample of a table created by the HMO Research Network to help Network researchers ensure timely planning of submissions to avoid overall project delays.   Click here to download.

From the HMO Research Network Collaboration Toolkit.  www.hmoresearchnetwork.org

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An essential resource for anyone tasked with establishing a data and safety monitoring board for a clinical research study, NIA's Clinical Toolbox includes a sample charter covering everything from DSMB membership to components of a DSMB report, as well as templates, checklists and guidelines to help you along the way.  

From the National Institute on Aging (NIA) Clinical Research Study Investigator's Toolbox.   http://www.nia.nih.gov/ResearchInformation/CTtoolbox

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This form is used by the Academy of Family Physicians National Research Network (AAFP NRN) to identify the IRB affiliated with each provider or practice in the network and collect essential contact information for the affiliated IRB. It also alerts the AAFP NRN if the practice or provider is not affiliated with an IRB, or if they don't know of such an affiliation.   Click here to download.

Courtesy of the American Academy of Family Physicians National Research Network's (AAFP NRN) Collaborative Care Research Network (CCRN).  http://www.aafp.org/online/en/home/clinical/research/natnet.html

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Researchers who need to access protected health information (PHI) to assess study feasibility, to design a study, or formulate a hypothesis must first obtain approval to do so. A preparatory to research form such as this example is usually submitted to the IRB and a HIPAA Privacy Officer. PHI accessed for these types of pre-research activities may not be used to recruit subjects on conduct actual research.  Click here to download.

Pace WD, Staton EW, Holcomb S. Practice-based research network studies in the age of HIPAA. Annals of Family Medicine. 2005;3(Suppl 1):S38-S45.  http://www.annfammed.org/cgi/data/3/suppl_1/s38/DC1/3

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This is example of a HIPAA Waiver of Authorization form. If a study meets the general criteria needed to ask for such a waiver, a form like this one would typically be submitted as an addendum to the initial IRB application.   Click here to download.

Pace WD, Staton EW, Holcomb S. Practice-based research network studies in the age of HIPAA. Annals of Family Medicine. 2005;3(Suppl 1):S38-S45.  http://www.annfammed.org/cgi/data/3/suppl_1/s38/DC1/4

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