Does the IRB have any sample scripts of common items? 

YES! The IRB has provided some sample scripts below. Note though that these are samples only and the IRB sections should be written based on the specific protocol needs.

 

How long does the IRB approval process take?

The approval timeline can vary depending on the complexity of the study and the level of review:

• Convened review: Applications are due by the 1^st of the month and are reviewed at the scheduled monthly meeting.
• Expedited review: May take up to 14 days for completion of review. If there are modifications, the 14 days begins again once the modifications are submitted.
• Exempt review: May take up to 14 days for completion of review. If there are modifications, the 14 days begins again once the modifications are submitted.

 

Can I begin my research before receiving IRB approval?

No. You must receive IRB approval before beginning any research that involves human subjects. Starting research without approval may jeopardize the validity of the study and could have ethical and legal consequences.

 

What happens if my study is denied IRB approval?

If your study is denied approval, the IRB will provide feedback on the reasons for the denial and suggest ways to address concerns. You may need to revise your study protocol and resubmit it for another review. It is common for IRBs to request modifications before granting approval.

 

How do I amend an approved study?

If you need to make changes to a study after IRB approval (such as modifying the study protocol, adding participants, or altering the consent form), you must submit an amendment request to the IRB for review and approval before proceeding with the changes.

 

What is the difference between "minimal risk" and "greater than minimal risk"?

• Minimal risk refers to the likelihood and magnitude of harm or discomfort from participating in research that is no greater than what is encountered in everyday life or routine physical or psychological examinations.
• Greater than minimal risk indicates that the research presents risks to participants that are higher than what would be expected in normal daily life and requires more rigorous oversight.

 

Do IRB reviews apply to research outside the U.S.?

Yes, if the institution conducting the research is located in the U.S. or has U.S.-based researchers, the IRB must review the study regardless of where the research is taking place. However, research outside the U.S. may also need to comply with local ethical guidelines or regulations in the host country.

 

What happens after a study is approved by the IRB?

Once approved, the researcher must follow the approved protocol and ensure continuous oversight. The researcher is responsible for:

• Conducting the study as outlined in the protocol.
• Reporting any adverse events or unanticipated problems to the IRB.
• Submitting annual progress reports to the IRB (for long-term studies).
• Submitting a final report upon completion of the study.

 

What are the consequences of non-compliance with IRB requirements?

Failure to comply with IRB guidelines may result in disciplinary actions, including suspension of research activities, loss of funding, and reputational damage. In severe cases, researchers may face legal consequences.