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What are the steps of the IRB process?

A Step-by-Step Guide for IRB Submissions Step 1: Human participant research training. Step 2: Project design. Step 3: Your IRB protocol: form choice, completion, and submission. Step 4: IRB evaluation of your protocol. Step 5: Post-approval activities.

What information must be included in the progress report filed with the IRB?

A written progress report/brief project summary that includes the following or references other documents made available to the IRB: o The number of subjects accrued; (For multi-site studies, the number of subjects accrued at the local site and the number accrued study-wide, if available, should be provided.)

What does an IRB need to include?

Therefore, the IRB should assure that the consent procedures comply with state and local laws, including assurance that the law applies to obtaining informed consent for subjects participating in research as well as for patients who require health care decisions.

What are the 4 relevant criteria for IRB approval?

Research Requiring Comprehensive IRB Review Risks to the subjects are minimal, and are reasonable in relation to anticipated benefits. The subject selection is equitable. Privacy and confidentiality are protected. Informed consent processes meet federal regulatory and U-M requirements.

What documents need to be submitted to the IRB?

IRB Submission Checklist Application. Consent Document(s) Recruitment Materials. Study Instrument(s) Permission Letters (if applicable) Certificate of Education (if not already on file) Grant proposal narrative (if applicable) The application materials have been made into one PDF.

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How do you write a research progress report?

How to write progress reports Think of it as a QA. Use simple and straightforward language. Avoid using the passive voice where possible. Be specific. Explain jargon if needed. Spell out acronyms when they first occur in the document. Stick to facts. Use graphics to supplement the text.

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