Institutional Review Board: policies and procedures

Most research and evaluation projects with at least one of the following components require review:

• Contact with DHS program participants or their representatives for the purpose of research or program evaluation. Contact can include mailed questionnaires, participation in experimental programs and everything in between or 
• Individual-level data on DHS participants is shared outside of DHS. Data is individual-level if each participant’s information can be linked together (even if the participant can’t be identified). This excludes projects where DHS is providing data to a vendor, and the vendor is using the data to conduct analyses or do other work solely for State government purposes or
• Research findings will be generalized to populations other than the one studied. 

If your study meets any of these criteria, please read which projects require IRB review. Some exceptions apply, and your project may not require an IRB review. 

The IRB meets at 10:00 am the second Wednesday of every month. To be considered for review, proposals are due the last Wednesday of the previous month.

If your project is eligible for an Expedited Review, you can submit the proposal at any time, and we will try to provide you with feedback within two weeks. To determine if your project is eligible for an Expedited Review IRB review, please see Which projects require IRB Review.

Complete the IRB Application and email to the IRB administrator. Incomplete applications will not be accepted. 

The research questions and methodology must be easily understandable, and the methodology proposed must be adequate to answer the stated research questions.  Principal investigators who have not submitted an IRB application in the past are encouraged to submit at least one week before the deadline, so they can make changes if the application is not easy to understand or is otherwise incomplete.

Researchers are asked to review the DHS IRB application policy thoroughly to understand all researcher responsibilities before requesting IRB review. No research may begin until you receive a letter of approval from the IRB.

• If neither the principal investigator nor the co-principal investigator are employees of DHS, then a DHS sponsor (see next question "What  steps do external researchers need to take?") must sign the application. If the DHS Sponsor is not a manager or division director, one of those must also sign the application.
• If data from the Minnesota Sex Offender Program (MSOP) is being requested, a manager must authorize the use of data. All proposals utilizing MSOP data must be reviewed by the MSOP research committee prior to submission to the DHS IRB.
• If you are a student, your faculty adviser must sign the application.

A review of your project by the DHS IRB is the last step in getting access to DHS data. Please follow these steps:

1. Identify a DHS staff who will be your "DHS Sponsor." The sponsor is a DHS staff person who works in the division that administers the services you plan to study or oversees the population that makes up your research subjects. This person must be in a position where they could use your findings to benefit recipients or other DHS stakeholders. You will be directly responsible to your sponsor during the project, you will be expected to update the Sponsor regularly, and to provide them with all reports or articles before they are shared outside of your organization or submitted for publication. Your Sponsor must sign the application form.
2. Identify the DHS division that can provide the data required for your project. Obtain agreement from someone in that division that they will provide you with the data you need. Your DHS sponsor can help you identify a contact person in that division.
3. Develop and execute a data sharing agreement with the division providing you with the data. You may work on a data sharing agreement at the same time as you submit an IRB application.
4. Submit an application to the DHS IRB, participate in the IRB meeting where your application is discussed, and receive approval. You cannot submit an application until you have both a sponsor and a division has agreed to supply you with the data.

No research may begin until you receive a letter of approval from the IRB.

The IRB administrator will contact you and let you know whether your proposal is complete and is ready to be reviewed by the IRB.

You will most likely be invited to attend the IRB meeting in person or via telephone conference. At the meeting, the members will introduce themselves, ask you (and any other participants on your project) to introduce themselves. Then you will be given approximately 15 minutes to describe your study. After giving a brief introduction to your study, you should describe your study’s:

• Human subjects protections
• Procedures for requesting consent (if applicable)
• Data security procedures

Within two weeks of the meeting, the IRB administrator will let you know what the IRB has decided. The administrator may request clarifications or alterations to your proposal, or may request that you resubmit your proposal. If the IRB administrator notifies you that your IRB proposal has been approved, then you can begin your study.

Before submitting any reports or articles for publication, the IRB must review it to ensure there is no breach of data privacy. To do this, send the document or article to the IRB administrator.

Studies that last longer than one year must provide a short project update to the IRB on an annual basis. You can use the DHS IRB Annual Project Update form or you can provide your update in another format. The following information must be included in the update and sent to the IRB Administrator

• Any amendments to the original proposal (these must be approved before making the change)
• Overall progress
• Any difficulties with the project
• Any adverse events to study participants.

Approved projects cannot continue beyond one year without ongoing IRB approval.
If the investigator leaves the project or the project is terminated early, notify the IRB administrator immediately.

If your project departs from your original proposal, you must notify the IRB administrator. That person will help you to determine if you need to submit a new proposal or apply for an amendment to your existing proposal.

Please review the information on this website, along with the page that describes projects that require IRB review, the DHS IRB Policy, and the IRB Application. If you still have questions, contact the IRB Administrator.