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DO NOT SAVE THESE DOCUMENTS ONTO YOUR COMPUTER FOR FUTURE USE. PLEASE DOWNLOAD A NEW DOCUMENT EACH TIME TO ENSURE YOU ARE USING THE MOST CURRENT CONSENT.
IntegReview's HIPAA Policy - please read before submitting an informed consent. (revised 1/25/06)
PLEASE NOTE: All informed consents submitted to IntegReview must be written below a 9th grade reading level. If IntegReview's evaluation finds the informed consent to be above this level, the document will be returned for modification and IRB review may be delayed. IntegReview's Sample IC is written at this level and it is recommended that you utilize this document when creating the consent form. CLICK HERE for IntegReview's rationale for this requirement.
Helpful suggestions on how to bring the readability level down: use bulleted format as much as you can, use the term “study drug or device” to replace the drug or device name throughout the IC.
To check readability statistics on the document, perform the following actions:
- In MS Word, click on Tools
- Click on Options
- Click on Spelling & Grammar
- Ensure the "Show readability statistics" box is checked
- Click on Ok
- Run a spell check on the entire document
- When the spell check is completed, the readability statistics will be displayed
Sample Informed Consent (revised 10/03/08)
This template is to assist you in writing informed consent documents. It incorporates all the Basic Elements of Informed Consent required by the FDA and offers suggested wording, as well as a template Minor Assent Form, and template Photographic Release Consent form.
Sample Genotyping Informed Consent (revised 7/16/08)
This is a generic template Informed Consent for genetic testing to be performed in conjunction with a study.
Sample General Screening Informed Consent (revised 8/22/08)
This is a generic template Informed Consent to be used for pre-screening of study subjects.
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