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Guidance Documents
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Guidance Documents
The Independent IRB, Inc. has developed the following guidance documents to provide assistance in various components of research as they relate to the IRB review and the submission process.
The Database Management Issues Non-Covered Entities(new) The Database Management Issues Non-Covered Entities guidance document is intended to provide assistance in developing a written Database Management Plan that encompasses adequate measures to protect the privacy of research participant and the confidentiality of their data.
The Infectious Disease Testing in Research Studies The Infectious Disease Testing in Research Studies document is intended to provide information about the philosophy and recommendations regarding reporting and counseling of infectious diseases, disclosure of testing to research participants, and the use of a separate HIV Informed Consent Form.
Role of Secondary IRB Role of Secondary IRB document is intended to provide information about the philosophy and recommendations regarding the function of a secondary IRB when Independent IRB, Inc. has full authority and oversight of a research study at an approved Site.
Independent IRB, Inc. HIPAA Policy The Independent IRB, Inc. HIPAA Policy guidance document is intended to provide clarification to the review and submission process for a “Non-Covered Entity” as related to HIPAA regulations.
Review of Research Involving an IND Pending FDA 30 Day Review The Review of Research Involving an IND Pending FDA 30 Day Review guidance document is intended to provide information regarding the review and submission process for research studies with an IND pending FDA 30 day review and includes approval and screening options in such circumstances.
The guidance documents are consistent with the Independent IRB, Inc. Human Research Protection Program Plan (HRPP Plan) and in no way supersedes the requirements contained in the HRPP Plan. Please note the Independent IRB, Inc. can revise these guidance documents at any time it is necessary to comply with regulatory requirements.