The investigator must submit documentation to the MHIRB of the research study to be considered for re-approval. At the time of initial MHIRB approval of the research study, an approval time interval appropriate to the degree of risk to the subject is assigned. The MHIRB Administration will send a Project Review Form to the investigator at least one month prior to expiration of research project. The investigator is ultimately responsible for obtaining re-approval of his/her research project; therefore, if the investigator does not receive a Project Review Form from the MHIRB Administration prior to expiration of the study, it is his/her responsibility to contact the MHIRB Administration to obtain this form. The investigator is required to submit the following items to the IRB Chair by re-approval deadline:

• One copy of a completed MHIRB Project Review Form, including a report outlining subject outcome, adverse events, subject withdrawals, and the reason for the withdrawals
• One copy of current informed consent form stamped with the MHIRB approval stamp (if the subject enrollment period is open)
• Consent log listing all subjects enrolled
• Copies of the all consent forms signed by the first and last subject enrolled.

The MHIRB will review the re-approval submission and may request additional information. The MHIRB will take action to:

• Re-approve the research study
• Re-approve the study pending modifications to the study
• Suspend the research study pending completion of the review or the receipt of additional information
• Deny re-approval of the research study

Failure to complete the forms and reports within the specified time interval will result in the termination of MHIRB project approval. New subject enrollment and all study-related activities must cease, and enrolled subjects must be notified of the project status. Procedures for withdrawal of study subjects will consider the rights and welfare of the subject. Follow-up after study closure may be required, but the IRB must approve the follow-up once closed. The project must be resubmitted to the MHIRB and again undergo the full review and approval process before study related activities may be resumed.

MHIRB is required to conduct such other continuing review of research deemed necessary to ensure that such studies are being conducted and documented as required. The investigator must cooperate with the MHIRB to facilitate this ongoing continuing review.