Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

This is a requirement for studies meeting the definition of a clinical ... the RIT PI bears the responsibility of ensuring the requirement for posting of the consent form is met. For multi-site ...

That is consent; it is not implied. Written and script forms of Information Sheets must be easy to read and/or understand, be in lay language that is suitable for the participant, and capture ...

They contain all of the required elements of an acceptable consent form. While we strongly recommend that you follow the format that we have set for a consent form, please note that you should alter ...

Requesting a Waiver or Alteration of the Consent Process Significant alterations or complete waivers of the consent process may be granted if a study is determined ... in which signing forms is not ...

Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s) with the same wording given in the consent ... research use of their biological specimens ...

and agree or decline their child’s participation in the research study. Investigators should follow the required elements of informed consent when preparing a Parental Consent Form, except that the ...