Informed Consent Guidance
&
Template
Please note, if you are planning to use DocuSign to secure electronic signatures, you must coordinate with PAU's IT in advance regarding the anticipated number of subjects and cost coverage.
The PAU Human Research Protection program has also prepared a template (see document to the right) is consistent with the new guidelines for informed consent for adults. The template is not required (other formats are acceptable), but we recommend you review the template for reference on how to communicate with your potential research subjects. If you do use the template, modify as appropriate for your study and population.
FAQs from the Office of Human Research Protections:
Informed Consent
Electronic Informed Consent
Consent Form Requirements
Informed Consent Readability Check:
You may copy and paste your consent document into these website services to check if your consent document language matches a 7th grade reading level.
E-Signature Requirement
Clinical Trial Consent Posting Requirements:
https://www.hhs.gov/ohrp/regulations-and-policy/informed-consent-posting/index.html
https://grants.nih.gov/policy/clinical-trials/informedconsent.htm
Ethics of Research with Human Subjects: Informed Consent
Be sure to check PAU's guidance and SOPs as these will provide specific directions relevant to research being reviewed by our IRB