IRB Forms | UnityPoint Health - Des Moines

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UnityPoint Health - Des Moines

Forms

PRIOR TO COMPLETING ANY IRB FORMS, PLEASE REVIEW THE INFORMATION ON THE REVISIONS TO THE COMMON RULE (45CFR46) REGULATIONS: Revisions to the Common Rule

Forms are modified frequently to correct errors and clarify points. Check this page often to ensure you are using the latest version of the IRB forms. Previous versions of IRB forms will not be accepted due to the change in federal regulations.

New Study Applications - Local IRB Review

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, COI forms 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.

Application For New Protocol (1/2019)

Application for New Chart Review Protocol (1/2019)

Informed Consent Template  (1/2019) - in compliance with the new Common Rule federal regulations (1/2019)

Child Assent (1/2019) - to be used when study subjects include children between 12-17 years old

Patient Participation Statement (12/2018) - can also be used when study subjects include children between 12-17 years old

Application to Review PHI in Preparation of Research (5/2018) 

Request for Waiver/Documentation of Informed Consent (5/2018)

Example of Simple Protocol (5/2018) - to be used for non drug/device studies

IRB Conflict of Interest Form (2018-2019) 

CITI Human Subjects Training (See Education Tab for More Information)

CITI training is free to the study team member if they use the UnityPoint Health-Des Moines affiliation. When logging in for the first time, click the "Register" button in the top right hand corner of the home page. Under "Select an Organization Affiliation", start typing "UnityPoint" and "UnityPoint Health Des Moines should populate. Continue to register your account. The IRB will also accept Good Clinical Practice (GCP) training if completed in the last 3 years. If you would like to submit other forms of education to the IRB in lieu of CITI/GCP training, please contact the IRB Office at irbsubmissions@uniytpoint.org.

Which modules do I complete?

Biomedical Modules:  Select this option if you are involved in biomedical research study where an intervention is being conducted (drug, device, labs, medical testing), or consent human subjects. There are 9 required modules to complete.

Social-Behavioral-Educational Modules - Select this option if you are involved in non-intervention studies, such as retrospective chart reviews, surveys, etc. More than likely, if you are requesting a waiver of informed consent, you can complete these modules. There are 9 required modules to complete.

You must complete the "Required Modules". There are several "Optional Modules" that you may complete, but they are not required to conduct human subjects research.


New Study Applications - Central IRB Notification

The CIRB Application is to 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 Central IRB Notification Process outlined in the HRPP Procedures (Sections O & P)

For additional information regarding CIRB studies, please refer to the HRPP Procedures, Sections O & P. 


Revisions/Amendments to Previously Approved Studies

Use this form when you have to make a change to a previously approved protocol. Please submit a separate sheet of paper to explain the changes you wish to make to the study.

Request for Revision/Amendment (5/2018)

 

Continuing Review/Administrative Updates 

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 to be completed approximately one year after initial approval of the research. All other studies that are greater than minimal risk will be required to undergo continuing review annually. 

 

Study Closure Forms                                                                                             

Local Enrollment Closure Report (5/2018) - This form is to used when study subjects are no longer being enrolled in a study.

Final Study Closure Report (6/2018)   - 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

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.Y. for additional information)

24 Hour Serious Adverse Event (SAE) Notification  (5/2018) - 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  (5/2018) - 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.



Requests for Exemption From IRB Review Form (per 2018 regulations)

UPHDM IRB Exemption Categories Tool (1/2019)

Request for Exemption from IRB Review (1/2019)


Emergency Investigational Drug/Device/Biologic Use Form    

Emergency Use IRB Form  (8/2015)  

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 

 

Other Forms
Pharmacy Services Utilization Form
(4/2014)

Sample Non-English Speaking Consent Form