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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.
Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and ...
Note: The IRB must be provided with “sponsor verification” in the form of a letter signed by the sponsor(s ... private information or identifiable biospecimens: In seeking informed consent, the ...
Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form. To ensure informed consent, researchers should: ...
Obtaining informed consent is more than getting a signature on a form. Informed consent is one of the primary ethical considerations underlying research with human subjects. ALL human subject research ...
Note: Always use lay language that is appropriate to the population being asked to sign the form. Use short paragraphs, bullets and subheadings to increase readability. See the informed consent form ...
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.