NTU-IRB may allow waivers or alterations to the standard informed consent procedure if certain criteria or conditions are met. This usually occurs for studies that are of lowest risk and qualify for Exempt review. PIs are to provide protocol-specific justifications in their IRB applications on how your study meets each of the criteria listed. Stating "not applicable" or just re-stating the criteria is not an acceptable response. Show
For SBER studies
# After each statement, add the word “because” and then formulate your justification. For HBR studiesFull details are available in HBRA Section 13 and 5th Schedule.
A summary of waiver conditions are below.
Under which condition can the researcher have the informed consent waived?A waiver of documentation is permissible when: The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.
Which situation may allow waiving the need to obtain written consent for participation in a research study?Federal regulations allow the IRB to approve a waiver of consent in planned research in an emergency setting where there is more than minimal risk to participants, provided there is a prospect of direct benefit to participants and a number of other conditions are met.
What is a criterion for waiving informed consent?The regulations state that informed consent may be waived in full or in part if the IRB determines that: The research involves no more than minimal risk to the subjects; and. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and.
In what situation is informed consent not needed in research?From the 115 papers included, we identified three main categories of reasons for waiving the informed consent requirement: (1) decrease of data validity and quality; (2) distress or confusion of participants; and (3) practical problems.
|