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 eIRB walkthrough explains each section of the application for different submission types.
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
How to Respond to the IRB
- When a the IRB returns a submission to you, you will receive a “task” in eIRB.
- When you open your submission in eIRB, you will see “comments” that need to be addressed.
- Address the comments within the eIRB application and/or your study documents. If you are updating attached documents in response to comments, please include clean and tracked changes versions in your response to the IRB.
- You can respond to comments to note how you addressed them within eIRB or within an attached cover letter. If your study was reviewed at the convened (full board) level, please attach a cover letter. You can also ask questions if you are unsure what a comment means within eIRB. Please do not ask whether your response sufficiently addresses a comment; the IRB will evaluate that when you formally resubmit.
- At this time, please continue to include a documents list in your responses to the IRB.
- Once you have responded to all comments, you can resubmit your protocol in eIRB. You do so through the menu at the bottom of your screen.