Institutional Review Board (IRB)

• IRBManager Researcher User Manual
• Informed Consent Template
• Request for Waiver/Documentation of Informed Consent
• Child Assent - To be used when study subjects include children between 12-17 years old
• Patient Participation Statement - Can also be used when study subjects include children between 12-17 years old
• Example of Simple Protocol

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 UnityPoint Health – Des Moines 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.

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

• Emergency Use Authorization Form
• Emergent Use Consent Template
• List of Previously Approved Emergent Use Drugs/Devices
• Emergency Use of Experimental Drugs and Devices Policy

Other Forms

• Pharmacy Services Utilization Form
• Sample Non-English Speaking Consent Form

Please familiarize yourself with our HRPP Procedures. The document contains all the information you need to conduct research at UnityPoint Health – Des Moines. If you have additional questions after viewing the HRPP Procedures, please contact the IRB Office at irbsubmissions@unitypoint.org.

*Please be sure to review the appropriate section of IRB procedures when applicable:

• pre-2018 Regulations for studies approved prior to 1/21/19
• 2018 regulations for studies approved 1/21/19 and after

Federal Regulations and Guidelines

The UnityPoint Health – Des Moines IRB follows DHHS and FDA federal regulations.

• CFR - Code of Federal Regulations Title 21 (FDA)
• Title 45: Public Welfare and Title 46: Protection of Human Subjects (DHHS) - pre-2018 regulations for studies approved prior to 1/20/19
• DHHS/OHRP Common Rule - Part 45CFR46 - Revised Common Rule 1/19/17 - 2018 regulations for studies approved on or after implementation date of 1/21/19 (see pages 111-121 of the document)

Conflict of Interest (COI)

• Policy & Procedures for Managing Individual Conflict of Interest: Please review the IRB Procedure to learn how potential conflicts of interest in research are managed at UnityPoint Health – Des Moines. UPHDM HRPP Policy & Procedure for Managing Individual Conflict of Interest - May 2020
• Financial Conflict of Interest Education and Disclosure Form - Everyone listed on a application for new protocol review, continuing review form or request for revision/amendment must complete a conflict of interest form annually in July as long as the research study they are involved with is still open with the IRB.
• CITI Training - Conflict of Interest: All study personnel will be required to complete the Conflict of Interest training through the CITI Program every four years. The Conflict of Interest module must be added to the study personnel's training modules by going through the "Add a Course" section of the Learner Tools. For additional registration information, please see the Human Subjects Protection Education tab.

Please review the IRB Investigator Handbook prior to beginning an Application for New Protocol Review. 

CITI Training

• Register on www.citiprogram.org. 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 will populate. Continue to register your account.

All investigators and study team members must complete the appropriate training modules based on the type of research being conducted.

What modules do I complete?

• Biomedical Modules: Select this option if you are involved in a biomedical research study where an intervention is being conducted (drug, device, labs, medical testing), or where human subjects will be consented. 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 moduels before your research study materials will be reviewed by the IRB. There are several "Optional Modules" that you may complete, but they are not required to conduct human subjects research.

The IRB will accept CITI training completed at another institution if the training has been completed within the last 3 years. If training has been completed elsewhere, please send a copy of the CITI completion certificates to the IRB with the study submission materials. Everyone involved in research must complete CITI training. NIH Training Certificates are considered obsolete and are not accepted by the IRB.

Education Resources

• The Belmont Report
• Common Rule Regulations
• Who is OHRP?
• Human Subject Regulations Decision Charts
• OHRP Education
• OHRP Guidance for Investigators
• OHRP Informed Consent
• OHRP Vulnerable Populations

HIPAA: Guidance on use of Protected Health Information (PHI) for Research

The IRB has been authorized to carry out the research related functions of the HIPAA-mandated Privacy Board.

• Information: HIPAA and Research from the DHHS Office of Civil Rights
• Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
• Certificate of Confidentiality: Investigators should be aware that a Certificate of Confidentiality affords research participants a higher level of protection of their health information than is required by HIPAA.