Institutional review board
Allina Health is dedicated to lawful and ethical compliance, along with responsible research management through the use of an Institutional Review Board (IRB).
The Allina Health Review Board, along with external institutional review boards, reviews and provides ongoing oversight for clinical research studies. This process creates a safe, responsible and successful research ecosystem powered by online efficiencies for easy access and seamless research submissions.
Research transparency and a robust means of secure communication are important components for successful clinical discovery. With access to real-time data, the Institutional Review Board safeguards research participants, along with investigators and healthcare compliance.
Submit your research
The Allina Health Human Research Protection Program (HRPP) uses the electronic submission system to help ensure the safety and welfare of all research participants during all phases of a study.
Please visit IRBNet for the submission and record-keeping of studies to the IRB. All new studies, regardless of reviewing IRB, should be submitted in IRBNet.
All submission requirements, instructions and forms are located in the 'Forms and Templates' tab when you log in to IRBNet. To gain access to documentation, researchers will need to set up a user profile and affiliate with Allina Health.
Emergency use and expanded access
When clinical trial participation is not possible, the Allina Health IRB provides oversight for the use of an investigational drug, biologic, or device in single patients or for small groups of patients through the FDA emergency use and expanded access provisions. Overview of the circumstances, procedures, and IRB submission and reporting requirements for emergency use of investigational drugs and biologics or devices are described here. If the criteria for emergency use are not met, an investigator may submit an expanded access protocol. Contact the IRB Office at irb@allina.com with questions about these processes. Contact the IRB Office at irb@allina.com with questions about these processes.
Research consent
Consent templates
- Consent and HIPAA authorization for greater than minimal risk research
- HIPAA authorization template language
- Emergency use consent
- Consent form for minimal risk research
- Consent form for survey
All research participants must sign an informed consent in a language they can understand.
An increasing number of research studies in English-speaking countries include participants who may not understand the English language. It is vital that all participants have an opportunity to understand enough about the study and the elements of consent in order for them to make an informed decision about participating in the research study. This means that consent must be obtained using language that non-English-speaking participants understand. To implement this requires either written translation or oral presentation in the relevant non-English language by a person who is fluent in both English and the other language.
If it is known in advance that a language other than English will be spoken by the potential study population, an informed consent—in the language of the consenting participant—must be submitted to the IRB after the submitted consent form is approved and before the study begins. "Known in advance" means that the PI is targeting a population that is anticipated or likely to have non-English speaking participants.
If it is not known in advance that a potential participant does not speak English, a short form of the informed consent in a language understandable to the participant must be available and used together with a translator reading the consent given to all participants. The participant would be required to sign the written short form in addition to being provided with a written summary of the research in the English language. A translator must be available to read the long English version of the informed consent form to the participant in the participant's language. The basic regulations are stated in 45 CFR 46.116 and 117a and b.
The translated short forms should be used when consenting subjects do not speak or read English or have limited proficiency in oral or written English, and the full consent form has not been translated into the subject's language.
For more information on using a translated short form, please see Section 12.8 and 12.9.1 in the Allina Health HRPP/IRB Standard Operating Procedures.