CONSENT DOCUMENT GUIDELINES AND SAMPLE DOCUMENTS

For your convenience, HSRC has provided an Informed Consent Template for your use (see link below). If you choose to use this template and follow the instructions, it will provide you with a consent document that contains all the necessary elements required by the federal regulations. This form needs to be individualized for your study; therefore we have also provided links to some consent form examples for special populations or situations that may be helpful.

Reading Level and Comprehension: The HSRC expects investigators to write consent forms in simple language. The preferred reading level for average educated adults is 8th grade; however, this is dependent upon the age and/or cognition level of subjects. Please use the Spelling and Grammar feature of Microsoft Word to check the reading level of the document you write.

·  In Word 2003, see the Tools drop down menu, click on Options, click Spelling and Grammar tab, and check both boxes: Check grammar with spelling and Show readability statistics. Now run the spell check on your document.

·  In Word 2007,

o  Click the Microsoft Office Button , and then click Word Options.

o  Click Proofing.

o  Make sure Check grammar with spelling is selected.

o  Under When correcting grammar in Word, select the Show readability statistics check box.

o  Readability level (Flesch-Kincaid) will be shown after one runs the Spelling & Grammer check (under the Review Tab).

·  In Word 2010, at File tab, go to Options then Proofing. Click on “Show Readability Statistics.” Now run spelling and grammar check (in the Review tab). The Reading Level and Comprehension will give you the statistics you need to report on the HSRC application, section H-2b.

Be advised, though, that reading level formulas only act as a screening tool to determine if the writing is too dense. It should not replace assessing the document for ideas too complex, inappropriate vocabulary, gender or cultural bias, or illogical presentation of content. In general, ordinary language should replace technical terms (e.g., lower extremities are better referred to as legs, venipuncture as taking blood from your arm with a needle). The investigator is responsible to provide information to prospective subjects in language that is understandable and culturally sensitive. This may require providing documents in the native language of the subjects and/or parents.

HSRC Consent Template

Sample Consent—Exercise Science

Sample Consent—Exercise Science with Addendum

Assent Guide for Minors

Assent Sample—Class Interviews

Parent’s Permission—Class Interviews

Assent Sample—Fourth Grade

Parent’s Information Letter (for exempt research)—For non-English speaking parents (written at 6th grade level)

Sample Consent—Web Survey & Focus Groups

Sample Consent—Low Risk Interview of Adults