Application for New Protocol: https://up.my.irbmanager.com
All new local studies must accompany the IRB Application for New Protocol, an informed consent OR a Request for Waiver of Informed Consent, Study protocol and current study team member documents: COI forms, conflict of interest training and human subjects training certificates for every person listed on the study application. IRB staff will not process the materials for final review until all items are received and complete.
Informed Consent Template (1/2019) - in compliance with the new Common Rule federal regulations (1/2019)
Request for Waiver/Documentation of Informed Consent (5/2018)
Child Assent (September 2020) - to be used when study subjects include children between 12-17 years old
Patient Participation Statement (September 2020) - can also be used when study subjects include children between 12-17 years old
Example of Simple Protocol (5/2018) - to be used for non drug/device studies
New Study Applications - Central IRB Notification: https://up.my.irbmanager.com
The Application for New Protocol should be completed and select "CIRB/WIRB/Other IRB" as your study type. This should be used when an external Central IRB is overseeing the research. Please note that study subjects cannot be enrolled in the study until you have received the IRB acceptance letter from the UPHDM IRB.
Examples of an external Central IRB would be NCI-CIRB, Western IRB, Quorum, etc. Whenever a study will utilize hospital departments such as lab, radiology, etc., you must follow the Request for Reliance on an External IRB process outlined in the HRPP Procedures (Sections IV.P)
For additional information regarding CIRB studies, please refer to the HRPP Procedures, Sections IV. P & Q.
All new central IRB studies must accompany the Application for New Protocol and should include all central IRB documentation such the central IRB application, an informed consent OR a Request for Waiver of Informed Consent, study protocol, approval letter(s) and any other study documents. Also, all current study team member documents must accompany the form if needed: COI forms, conflict of interest training and human subjects training certificates for every person listed on the study application. IRB staff will not process the materials for final review until all items are received and complete.
Revisions/Amendments to Previously Approved Studies: https://up.my.irbmanager.com
Use the "Amendments" form within IRBManager when you must make a change to a previously approved protocol.
Continuing Review/Administrative Updates: https://up.my.irbmanager.com
For all studies approved 1/20/19 or prior, continuing reviews are required to be conducted annually.
For minimal risk studies approved 1/21/19 or after, continuing review is not required. However, the IRB will conduct an Administrative Update annually. All other studies that are greater than minimal risk will be required to undergo continuing review annually.
Reminders for continuing reviews and administrative updates will be sent to the study's principal investigator or study coordinator via IRBManager.
Study Closure Forms: https://up.my.irbmanager.com
Enrollment Closure - This form is to used when study subjects are no longer being enrolled in a study.
Final Closure - This form is to be used when all study activity and data analysis has ceased and the study can be closed with the local IRB. No research related work can be conducted after this form is submitted for final closure.
Unanticipated Problems & Protocol Deviations: https://up.my.irbmanager.com
Any unanticipated problem that is unexpected, related to the research drug or intervention and poses a risk to the subject or others must be reported to the IRB within 7 working days of the investigator learning of the event. If the IRB determines that the event is serious or continuing, the FDA and OHRP will be notified. (See HRPP/IRB Procedures Section IV.N. for additional information)
24 Hour SAE Notification Form - This form is to be used for all internal serious adverse events that occur with a study subject (i.e. hospitalization, life threatening event, death). Please refer to the form for additional information on reporting of SAEs.
Non-Compliance Report Form - This form is to be used for internal events that are unforeseen, related to the research and indicate that participants or others are at increased risk of harm. This form is to be used for serious adverse events, unanticipated problems and protocol deviations and violations.
Internal events are events that occur within our institution.
External events are events that occur at another institution where the study is occurring. External events do not need to be reported to the local IRB.
A protocol violation is an accidental or unintentional change
to the IRB approved protocol, that harmed participants or others that
indicate participants or others may be at increased risk or harm.
A protocol deviation is an abnormality with a particular study that occurs with such frequency that this may have an adverse effect on the risk/benefit analysis of the study.
Emergency Investigational Drug/Device/Biologic Use Form
Emergency Use Authorization Form: https://up.my.irbmanager.com
Emergent Use Consent Template (2/2015)
List of Previously Approved Emergent Use Drugs/Devices (2/25/15)
Hospital Policy UPHDM177 - Emergency Use of Experimental Drugs and Devices
Pharmacy Services Utilization Form (4/2014)
Sample Non-English Speaking Consent Form