Even after IRB approval, researchers must continue to:

• Follow the approved protocol without unapproved changes.
• Use only IRB-approved materials, such as consent forms and recruitment tools.
• Maintain current human subjects training for all research staff.
• Protect participant privacy and data confidentiality at all times.

Planning to change a study in any way? Researchers must submit a modification request before implementing changes.

Common modifications include:

• Changes to study design or procedures
• New recruitment materials
• Updates to consent forms
• Adding or removing study team members

Researchers must report certain events to the IRB as soon as possible, including:

• Unanticipated problems involving risks to participants or others
• Protocol deviations or noncompliance
• Complaints or concerns from participants

Mandatory Reporting Involving Human Subjects

Depending on study type, researchers may be required to submit:

• Continuing Reviews for ongoing studies
• Status Updates for minimal risk research
• Final Reports when your study is complete

Approval periods are listed in Huron and on Huron outcome letters. 

Continuing review of approved research

Keep documentation organized and secure, including:

• Signed consent forms
• IRB correspondence
• Data security logs
• Records of team training
• Retention periods vary by study and funding agency—be sure to follow institutional guidelines.

Research Data and Research Materials Management, Sharing, and Retention Policy