As part of our continued efforts to improve the IRB application and review process, we have developed new ICF templates that address the issues identified by our stakeholders:
These new and improved ICF templates replace all previous versions posted to our site as of May 17th, 2023; any new intakes initiated within WRG-HS as of June 12th, 2023, must utilize these new templates.
Make sure your Informed Consent Form is a readable document!
See our Guidance Document on how to prepare a readable consent form.
See our list of Medical Terms in Lay Language for use in Informed Consent Forms.
Refer to the Program for Readability in Science & Medicine (PRISM) Readability Toolkit
Refer to the MRCT Research Glossary for easy-to-understand clinical research definitions.
Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.
Any existing study using the previous consent templates can continue to use their IRB-approved consent. Any new studies initiated in WRG-HS starting 6/12, must use the new ICF templates.
Studies with an external IRB are expected to use consent forms provided by the lead IRB. Once the externally reviewed ICF is provided to the WCM IRB, we will conduct a local context review to confirm any required language (i.e. research-related injury, NYS Genetic testing requirements, etc.). The new WCM ICF templates are available as a resource if needed, but not required for externally reviewed studies.
You can continue to use the same ICF.