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.

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 ...

There is an online Google Form Human Subject Research Annual Status Report ... contrary to the approved elements of subject consent; an injury or harm to a subject or researcher; or a subject ...

A successful consent process presents detailed information which is organized and presented in a way that helps the prospective subject understand why a person might or might not want to participate.

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 ...

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 ...

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 ...

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 ...

Informed consent involves ... whether to participate in research, and the chance to discuss that information. This UB CTSI Educational Modules video: Defines informed consent Outlines where to find ...