The compliance date for Final Revisions to the Common Rule was January 21, 2019. Per these changes, a new "Key Elements" section and a rearrangement of content are required on consent forms. For guidance, see our revised templates posted below & Final Revisions to the Common Rule Reference Page.
Consent form modifications for in-person research are required; specific language
to include is located within the IRB Guidance on Resuming In-Person Research Activities & Consent Modification
For additional guidance on the requirements for consenting participants in research, Ferris IRB's consent templates, and the consent section of the IRB application see IRB Zoom - Consent Process & Requirements
Revised Common Rule - General Consent Template
There are two types of waivers of consent:
- Waiver of consent documentation, in which the researcher requests to waive (not collect) the signature of participants.
- Waiver of consent elements, in which the researcher requests to waive/alter certain elements of the consent form (requests to leave specific information out of the consent form). This is typically used for deception research and the requirements to meet these standards are high.
Children in Research
In cases where children/minors are involved in research, assent must be offered in addition to the legal consent from a parent and/or guardian. Include an assent line for child/minor signature and allow children capable to offer their assent to participate in research. Assent applies for ALL type of research projects that involve minors (biomedical, social behavioral, etc.).