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IRB Pre-review checklist

Study Information

Principal Investigator

IRB Protocol Number

Date of Submission

Study Documents

Protocol

Informed Consent Form

Recruitment Materials

Data Collection Instruments

Any other relevant documents

Study Participants

Recruitment Procedures

Inclusion/Exclusion Criteria

Risks/Benefits to Participants

Mechanism for Obtaining Informed Consent

Planned Withdrawal Criteria

Study Procedures

Data Collection Methods

Data Storage/Security Measures

Data Analysis Plan

Plans for Reporting Results

Any potential conflicts of interest

Study Timeline

Start Date

End Date

Any amendments or changes to the timeline

Study Funding

Source of Funding

Any conflicts of interest related to funding

Ethical Considerations

Protection of Vulnerable Populations

Privacy/Confidentiality Measures

Any potential risks to participants

Plans for monitoring participant safety

Additional Comments

Any additional information or concerns

Any questions or clarifications needed from the PI

Any potential conflicts of interest that need to be addressed

Any proposed changes to the study protocol that may impact ethical considerations

Any unresolved issues from previous IRB reviews

Any potential risks to study participants that need further discussion

Any additional information needed to make a final determination on the study

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