What are the criteria under 45 CFR 46.116(d) for waiving or altering some or all of the required elements of informed consent or parental permission?
Under 45 CFR 46.116(d) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met: • the research involves no more than minimal risk to the subjects; • the waiver or alteration will not adversely affect the rights and welfare of the subjects; • the research could not practicably be carried out without the waiver or alteration; and, • whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Related Questions
- What are the criteria under 45 CFR 46.116(c) for waiving or altering some or all of the required elements of informed consent or parental permission?
- What are the criteria under 45 CFR 46.116(d) for waiving or altering some or all of the required elements of informed consent or parental permission?
- What are the regulatory bases for waiving or altering some or all of the required elements of informed consent or parental permission?
