MDH Institutional Review Board
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- When Does a Study Require IRB Approval?
- Types of Review
- How to Submit a Study for Review
- Forms and Applications
- FAQ: Frequently Asked Questions
- Training, Tips, and Related Info
- Plain Language in your IRB Communications
- About the MDH IRB
- Membership and Requirements
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Frequently Asked Questions
Institutional Review Board at the Minnesota Department of Health
An Institutional Review Board (IRB) is a board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, research involving human subjects. The primary purpose of an IRB is to protect the rights, safety, and welfare of human subjects.
In 2000, the Minnesota Department of Health (MDH) established an IRB to protect the privacy, well-being, and rights of Minnesotans who are subjects of research. This board, which operates under Title 45, part 46 of the Code of Federal Regulations and applicable state law (the Minnesota Government Data Practices Act), reviews and approves department-sponsored research using its prescribed process.
The MDH IRB must review all research that involves human subjects performed by MDH staff. The study must meet all elements of the definition: engaged, research, and human subjects. This is a complicated decision.
- If MDH is participating in data collection, study design, analysis, or interpreting findings, it is likely engaged in research. If MDH is solely providing de-identified data, with no role in the research, it is likely NOT engaged in research. Still not sure? See Oregon State University’s helpful decision tree on engagement: Is OSU Engaged in Research? (PDF) (Oregon State University).
- Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102 (I)). If you are collecting data (information or biospecimens) to answer a research question and would not otherwise collect these data to do your regular work for MDH, or you want to analyze existing data that were collected for another purpose to answer a research question, you may be doing research.
- Human subject is defined as a living individual about whom an investigator conducting research obtains and then uses, studies, analyzes, or generates (1) Data through intervention or interaction with the individual, or (2) Identifiable private information (45 CFR 46.102(e)). If you are collecting or using data about living individuals and not about decedents, policies, or procedures, you may be doing research with human subjects.
- Still not sure if your study needs IRB review? Cornell University has a helpful decision tree: Does Your Project Require an Application to the Cornell IRB Office? (PDF) (Cornell University).
The IRB is the best authority to determine whether your study needs IRB review. We encourage you to submit an application if there is any doubt whether you are engaged in human subjects research.
If you require documentation from the IRB that your study is not research with human subjects, submit a preliminary review application. The MDH IRB will evaluate your study, and if we agree that your study does not meet the definition of research with human subjects, we will email you an official letter with that determination.
The MDH IRB encourages MDH staff to get this documentation as a best practice.
In addition, if you plan to publish your study, having this documentation may satisfy the requirements of the journal to document IRB review.
No. Projects not affiliated with MDH or its closely related partners are out of the MDH IRB’s scope.
Yes. MDH staff engaged in cooperative research that has been or will be reviewed by another IRB must submit an application to the MDH IRB for review. The investigator may request that the MDH IRB defer review to another IRB involved by checking "yes" for the corresponding question in the IRB review application. The board will defer if the funder or federal regulations require deferral, or the study is low risk.
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. The MDH IRB will send you a notification via e-mail when your project has IRB approval.
No. There is no provision in the federal regulations that allows for IRB approval of research that has already been conducted. If you have data that were collected for non-research purposes and wish to use the data to answer a research question, you can seek IRB approval for that data analysis going forward.
An IRB may approve a consent procedure that does not include all elements of informed consent or one that alters the elements of informed consent, or the IRB may waive the requirement to obtain informed consent if the IRB finds and documents that each of the following criteria is true (45CFR46.116(e)).
- The research involves no more than minimal risk to the participants
- The waiver or alteration will not adversely affect the rights and welfare of the participants
- The research could not practicably be carried out without the waiver or alteration
- Whenever appropriate, the participants will be provided with additional pertinent information after participation
A request for waiver of informed consent must be specifically justified by the researcher in the proposal to the IRB.
An IRB may waive the requirement for the investigator to obtain a signed consent form from some or all participants under one of the two conditions (45CFR46.117(c)):
- The only record linking the participant and the research would be the consent form and the principal risk would be the potential harm resulting from a breach of confidentiality (participant must be asked if they want documentation)
OR - The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context
The MDH IRB expects all participant communication materials to follow plain language best practices to ensure the information is understandable to those being asked to participate as subjects in the research (45 CFR 46.116). If the informed consent is long (e.g., more than four pages), the revised common rule requires informed consent to begin with a concise and focused presentation of key information to assist prospective subjects in understanding reasons to participate in a study or not. See: Using Plain Language in your IRB Communications.
PIs and anyone who will interact with participants or have access to study data must have recent training (completed within three years of the application date) on human subjects protections from a recognized institution, such as the University of Minnesota or the Mayo Clinic.
One of the following online training courses on human subjects protections would satisfy the requirement:
- Office for Human Research Protections’ (OHRP) Human Research Protection Foundational Training (US Department of Health & Human Services)
- Lesson 1: Parts 1 and 2 only
- Lessons 3 and 4: All sections
- Submit certificates for Lessons 3 and 4 with your application
- Protecting Human Research Participants Online Training and Certification
- Submit certificate with your application
- Submit certificate with your application
The IRB acts on all applications within one month after submission. Investigators will be notified in writing of the board’s decisions within one week of board action.
If the administrator notifies you that your IRB proposal has been approved with no stipulations, then your study can begin.
The IRB typically meets the second Wednesday of every month. The IRB must receive your proposal a minimum of two weeks before the IRB meeting date to ensure review.
Any meaningful changes to a study that has received IRB approval or exemption must be reviewed and approved before the changes are implemented. For example, changing the mailing address for a survey does not affect subjects and does not require IRB review. In contrast, changing the incentive for participation from $10 to $25 does affect subjects and requires IRB review.
To receive IRB review of your proposed changes, email a description of the changes to the IRB, identify the IRB case number you received with your approval notification, and attach any documents that will help us understand the changes you want to make.
No. HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. HIPAA applies to covered entities, and MDH is not a covered entity. MDH is subject to the Minnesota Government Data Practices Act.
If you have any questions about the MGDPA, contact your assigned legal counsel.
Find information about the Tennessen warning at: Tennessen Warning Notice (Minnesota Department of Administration).