Better Tools for Multi-site Research

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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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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CTN Best Practices also offers a variety of tools and templates for Informed Consent, including templates for special situations such as parental consent and witness to consent.   

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

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NIH's National Institute on Aging offers researchers a handy checklist to ensure all OHRF required elements are included in your study consent form. Researchers conducting studies across several states should also be aware that some States may require additional consent form language, as well.   Click here to download.

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

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The Research Initiative Working Group (RIWG) of Lawrence, Massachusetts developed this plain english glossary of research terms that non-researchers may find useful in understanding terms heard when interacting with researchers or reading their proposals.

Click here to download

Lawrence Research Initiative working group of Mayor's Health Task Force of Lawrence, MA. http://lawrencemhtf.org/groups/index.php?group=riwg

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An example of a form that a patient would sign to allow a physician/clinic to release their contact information to a research team for eligibility screening and enrollment in a project.   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/DC1/2

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For data-only studies in which HIPAA requirements are not waived by an IRB, participants sign a HIPAA release form to allow their protected health information to be used. This example HIPAA release form could serve as a template for others.   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/DC1/1

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