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Client Rights: Research Approval by DHS

The Client Rights Office reviews all research that involves those receiving developmental disability, mental health, or substance use treatment. State law defines these research participants as patients. On this page, we will reference a patient as “person/people receiving services.”

After review, staff members make a recommendation to the Division of Public Health administrator. The administrator gives final approval on behalf of the Wisconsin Department of Health Services (DHS).

People receiving services have the right to file a complaint if they participate in a study.

Do all types of studies require DHS approval?

No. A study only requires DHS approval when it’s considered research. That’s when it’s examining a treatment or intervention. It doesn't include studies that only involve existing treatment records or follow-up questions. Contact the Client Rights Office if you want to know whether a study is research.

What criteria does DHS use to approve a study?

DHS uses state and federal rules. These require, for example:

What is the process for seeking DHS approval of a study?

The review process starts with a request, either by mail or email, to:

Client Rights Office
Division of Care and Treatment Services
PO Box 7851
Madison, WI 53707-7851

For its review, the Client Rights Office will request a copy of:

  • The informed consent document.
  • The IRB application.
  • The study protocol manual.
  • Written confirmation that the work follows state and federal rules.

If staff members decide the study needs approval, they’ll bring any concerns to the researchers. They’ll then ask the Division of Public Health administrator to approve. That’s after concerns are addressed and the IRB approves.

How long is the review process?

There aren’t time limits on DHS approval. After the Client Rights Office receives all the information required, the review may finish within 30 days.

For questions about DHS research approval, email the Client Rights Office

Last revised April 18, 2022