Waivers of informed consent can be granted by which of the following:
A: The NIH or other funding agency
B: The Department of Justice
C: The IRB
D: Any of the above.
The correct answer is option C (the IRB).
The Institutional Review Board can only grant waivers of informed consent.
IRB is an administrative organization which is responsible for the protection of the rights of participants in research with an affiliated institution.
Informed consent is required for research purposes where the already known results of the research, which involves reception, is to be analyzed in the projects.
The IRB is required to regulate such informed consent and waivers for the same. They are mandated by law to waive the requirement for informed consent provided that the study in question meets some basic guidelines, which are given below:
- The risk to the patients is minimal at best.
- The study is vital and necessary for field research.
- The waiver in question does not impinge on the rights of the individual participating in the concerned study.
- The subjects of the test in concern are kept well informed at every stage of the process and the risks associated with the same. However, when the subject involves the collection of active biospecimens, it may not be possible for the IRB to apply for a waiver of consent.
- Subjects in question should be provided with the consent form, later on.
Informed consent is used in research to analyze test a particular substance such as clinical trials.