Under what conditions may the requirement for written documentation of informed consent -such as a signature on a consent form - be waived?
- Signed consent is the only record linking the subject to the research and the greatest risk of the research is a breach of confidentiality.
- The research presents no more than minimal risk and involves procedures for which consent wouldn't normally be obtained, it is often advisable to present subjects with an information sheet or letter that contains the elements of informed consent, for their future reference.
The KSU IRB does not stamp level I protocols.
- the research involves no more than minimal risk
- 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
- whenever appropriate, the subjects will be provided with additional pertinent information after participation
- the informed consent requirement in this policy are intended to preempt and applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective
- nothing in this policy is intended to limit the authority of a physical to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state or local law.