Initial Study Submission Guidelines
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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Investigator Submission Checklist
Sponsor Submission Checklist
Sample Submission Letter
Additional Research Location Form
Principal Investigator Information Form
Sample Informed Consent
Advertisement Submission Form
Protocol Information Sheet
Billing Information Sheet
Modifications to Research (Protocol, Consent, IB)
Modifications to Research (PI, Sub-Investigator, Coordinator)
Modifications to Research (Other)
California Bill of Rights [English]
California Bill of Rights [Spanish]
HIPAA Authorization Form
Liberty Authorization Agreement
Request for Determination of Exemption Form
Request for Waiver of Informed Consent
Request Waiver of Written Documentation of Consent
Request Waiver of Authorization
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.
Request for Waiver of Authorization
Continuing Review / Study Closure
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.
Continuing Review Form
Special Laboratory Testing Consent
Research Site Specific Consents, Advertisements and Documents
Liberty IRB requires Investigators to report within 5 working days any changes significantly affecting the conduct of the research or that increase the risk to participants, including any of the following using the Reporting Form.
· Internal adverse events which are unexpected and related to the research;
· External adverse events which are unanticipated problems involving risks to participants and others, as determined by the study investigator;
· Changes made to the research without prior IRB approval in order to eliminate apparent immediate harm;
· Other unanticipated information that indicates participants or others might be at increased risk of harm such as a new risk, identified in an interim safety analysis, revised package insert, revised investigator brochure, publication in the literature or a DSMB report.
· Unanticipated problems involving risks to participants or others will be defined as any report of information that is (1) unanticipated and (2) indicates that participants or others are at increased risk of harm;
· Allegation or finding of non-compliance;
· Major protocol deviations or violations that might affect the rights safety and welfare of subjects;
· Termination or suspension of the clinical trial by the study sponsor;
· 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.
What SAEs are unanticipated and need to be reported to the IRB?
Sample Hospital/ University Release Letter
Liberty IRB Authorization Agreement
Send all materials to our new location:
6940 Columbia Gateway Drive
Columbia, MD 21046