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.

Moreover, the informed consent should not merely be a list of isolated facts. Many consent forms are not as good as they could be in terms of aiding decision-making. The goal is to help people process ...

The Informed Consent Form should be in the primary language of the research ... vulnerable populations or complex interventions. You may use this sample tempate to get started.

Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form template (pdf) for more help and sample language. 1. Title of the Study 2. Names and Affiliations ...

Informed consent forms and scripts should be written at an eighth-grade reading level to ensure that prospective subjects are truly informed. See the Informed Consent Template for an example of ...

Informed consent must be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the participant or the participant’s legally ...

Traditional approaches to ensuring informed consent ... be needed too. Example of a participant information sheet for a focus group to identify priorities for carers. Check your organisation's consent ...

Investigators may request a waiver or alteration of the informed consent process or waiver of consent documentation, provided the conditions described on the waiver form are fulfilled.

Furthermore, unless the consent process has been specifically waived by the IRB, no subjects may be included in research unless the investigator has obtained the legally effective informed ... and ...