Better Tools for Multi-site Research

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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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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The checklist is designed to help researchers determine is written information consent is needed from individual clinicians in a cluster randomized trial (CRT). That is, in which a “cluster” of clinicians (e.g., a primary care clinic) is the unit of randomization, and that each cluster includes both clinicians and patients. The same general principles could be applied to other types of CRTs that involve other types of staff/employee participants (e.g., administrators) or other types of individual participants (e.g., health plan members, community residents).  Click here to download.

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

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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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