Picking the right “document type” for your informed consent material in CLARA
When uploading documents in CLARA, you’ll encounter a dropdown list of different document types. Please be careful to choose the type that matches the document you’re trying to upload. We’ve noticed that, in particular, the seven informed consent-related options tend to get selected a bit randomly. They all begin with “Consent, Assent and HIPAA;” the wording after that part of the title is what sets them apart.
A brief rundown of the options:
Consent/Assent/Parental Permission form (NOT including HIPAA authorization) — A written consent, assent, or parental permission form that does not include HIPAA authorization language, either because you have a separate HIPAA authorization form or HIPAA doesn’t apply.
Consent/Assent/Parental Permission form (including HIPAA authorization) — Similar types of documents as above, but incorporating the HIPAA language this time.
Consent/Assent/Parental Permission verbal script — The text of a consent process discussion that will be presented verbally and which is not included in a written document.
HIPAA authorization — A separate HIPAA authorization form that’s not incorporated into a consent form.
Informed Consent – Addendum — Material that is being used as a supplement to the informed consent process. This could a brochure or handout that supplements a written consent form or oral presentation of consent information. This does not apply to a study’s main consent form; it should only be used when uploading additional material that will be used during the consent process.
The two Translated Consent/Assent/Parental Permission form options (including or not including HIPAA language) — Consent materials written in languages other than English to be used with non-English speakers. The English-language version of a complete consent form would be uploaded using one of the other options above, as appropriate, and not using this “translated” option.