Institutional Review Board (IRB)
UnityPoint Health – Des Moines Institutional Review Board (IRB) is responsible for protecting the rights and welfare of the human subjects who participate in research conducted within UnityPoint Health – Des Moines facilities. The IRB has the authority to approve, require modifications in or disapprove all research activities that fall within its jurisdiction as specified by the federal regulations and local institutional policy.
To learn more about conducting human subject research, please view our HRPP Procedures.
- UnityPoint Health – Des Moines IRB Roster
- FWA Number: FWA00000047
- IORG Number: IORG0000492
- IRB Registration Number: IRB00000814
UnityPoint Health – Des Moines is fully accredited by the Association for Accreditation of Human Research Protection Programs, Inc.
All submissions must be completed through IRBManager. IRB staff will not process the materials for final review until the following items are recieved:
- IRB Application
- Informed Consent or a Request for a Waiver of Consent
- Protocol (who, what, when, where, why & how of the study)
- All handouts that will be given to the study subjects, including any scripts for verbal surveys
- All other pertinent study documents (data collection forms, tools to be used, etc.)
- Completed Conflict of Interest forms for all study team members (must be completed annually)
- Certificate of completion of Conflict of Interest training (CITI training) for all study team members (must be updated every four years
- Certificate of completion of Human Subject training (CITI training) for all study team members (must be updated every three years)
Documents and Resources
- 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
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 email@example.com.
*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.
- 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.
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 Sheet: 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.
It is expected that either the principal investigator or a co-investigator will present a new protocol at a regularly scheduled meeting of the IRB. Amendments requiring full board review can be presented by the PI, Co-I or the study coordinator. Please review the Guidelines for Oral Presentation of a Protocol to the IRB prior to your presentation to the board.
- The submission deadline for materials being reviewed by the full board is the third Friday the month before the scheduled board meeting. Submissions received after this deadline will be put on the agenda for the following month's meeting. The UnityPoint Health – Des Moines IRB meets the second Thursday of each month at 7 a.m. on the Iowa Methodist Medical Center campus.
Protocols may be submitted at any time. The investigator is not required to present the protocol to the full board. Federal regulations (45CFR46.110) define the types of research eligible for review by expedited procedures. Only the IRB Chair or his designee is authorized to make the determination whether a protocol qualifies for expedited review. The average turnaround time for expedited reviews is 10-14 business days once all required materials have been received and confirmed as complete. Submissions are processed on a first come-first served basis.
Research which satisfies the criteria for exemption under 45 CFR 46.104(d) (2iii or 3C) undergo limited IRB review if information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.
Applications may be submitted at any time. For exempt or limited review please select "exempt" as the study type on the application. The investigator is not required to present the protocol to the full board. Only the IRB Chair or his designee is authorized to make the determination whether a protocol qualifies for exempt or limited review. The average turnaround time for exempt and limited reviews is 10-14 business days once all required materials have been received and confirmed as complete. Submissions are processed on a first come-first served basis.
For more detailed information on Exempt Research Activities, please review our IRB Procedures, Section IV.A(3).
IRB Fees - Effective September 1, 2021The fee for local IRB review of industry-sponsored studies requiring full board review will be $1,500 per study.
The fee for Industry Sponsored Central IRB (CIRB) facilitated reviews will be $375 per study.
For grant-funded research studies of less than $5,000, the IRB fee will be waived. For grants exceeding $5,000, the IRB fee will be $250.
All charges are one-time fees and include initial IRB review, continuing reviews and review of previously approved research, review of all issues of non-compliance and study closures.
The IRB Office will submit an invoice to the study sponsor at the time of the IRB Review. If you wish to receive a copy of these invoices, please contact the IRB Office. When submitting materials for review, please ensure the billing information is included with the submission, including the name of the sponsor, contact person's name and email address.
The IRB Office will be reviewing our fee structure every two years to ensure our fees are in line with industry standard. Current review rates will be posted on this site.
For general questions, please email firstname.lastname@example.org or call the IRB Office at 515-241-8598. We do our best to respond to all inquiries within 72 hours.
The IRB Office is located in the Education and Research Center on the Iowa Methodist Medical Center Campus. The mailing address for the IRB office is:
- Iowa Methodist Medical Center
Health Sciences Library
1200 Pleasant Street
Des Moines, Iowa 50309.
Study Investigators & Study Team Members
If you have questions about conducting a research study at UnityPoint Health – Des Moines, please contact the IRB/HRPP office at email@example.com or at (515) 241-8598.
- Please note we no longer accepts IRB Submissions through email, all IRB Submissions must go through IRBManager.
Research Study Subjects/Participants
If you are a research study participant and you have questions about your rights as a research subject or any concerns or complaints about a research project, please feel free to call the Principal Investigator or Study Nurse listed on the consent form for your particulate study. If you would like to talk to someone who is not associated with the research, please feel free to call any of the following:
- Research Subject Advocate: 515-263-5483
- Executive Director of Corporate Compliance: 515-241-6039
- IRB/HRPP Manager: 515-241-8598
- UnityPoint Health – Des Moines Compliance HelpLine: 1-800-548-8778