The staff at Liberty IRB, Inc. is happy to assist you with the application process. To provide you with the shortest document turn around, it is essential that all forms are completed as indicated. All forms may be completed online and printed, or printed and completed manually. Upon receipt of your submitted materials, you will be contacted by a project manager who will keep you informed about the processing of your documents.
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California Bill of Rights [English]
California Bill of Rights [Spanish]
Request for Determination of Exemption
Request for Waiver of Informed Consent
Request Waiver of Written Documentation of Consent
The following three criteria must be satisfied for the IRB to approve a waiver of authorization under the Privacy Rule:
1. The use or disclosure of protected health information involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
* an adequate plan to protect the identifiers from improper use and disclosure;
* an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law; and
* adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of protected health information would be permitted by this subpart;
2. The research could not practicably be conducted without the waiver or alteration; and
3. The research could not practicably be conducted without access to and use of the protected health information.
Sites will be notified one to two months prior to study approval expiration date. You will be requested to complete a continuing review form and submit a copy of your current consent.
· Unanticipated, serious adverse drug or device effects
Initial notification is requested within 5 business days of discovery. Initial notification should include any details surrounding the event which are available. Follow up completion of the Reporting form is required within 10 days of discovery.
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