Submission Completion Guidance
Ensuring a complete submission package is crucial to a smooth IRB review process. Below are guidance and tips for SBS researchers on how to ensure that your submission package contains all required materials.
IRB Criteria for Approval
Federal regulations outline several criteria that must be satisfied in order for the IRB to approve research. When designing your protocol, ensure all of the following have been considered:
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Risks to subjects are minimized.
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Risks to subjects are reasonable in relation to anticipated benefits.
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Selection of subjects is equitable.
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Informed consent will be sought from each prospective subject or the subject’s legally authorized representative.
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Informed consent will be appropriately documented.
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When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
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When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. This includes a Data & Safety Monitoring Plan for greater than minimal risk research.
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When appropriate, there are additional safeguards are included to protect vulnerable populations being targeted for enrollment.
Completeness Considerations
Application Completeness
The attached guidance contains guidance on how questions in HSERA should be answered. The document also contains a checklist to determine which documents should be uploaded for IRB review.
Consent Completeness
The IRB strongly recommends that consent forms be drafted utilizing the most recent version of the Penn informed consent form template. This will ensure that all applicable required elements of consent and institutional language is included.
How to Respond to the IRB