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:

• Attention be paid to situations that need special consent.
• The Institutional Review Board (IRB) to include at least five people. The members must:
  • Have different backgrounds.
  • Not have conflicting interests.
  • Not be made up of only officers or employees of the facility.
  • Not be made up of members of only one professional group.
• The IRB to include two members who are consumers. Or who represent an advocacy agency. This is if the research takes place in a treatment facility. In addition, the study must name a “consent monitor.” That person will verify consent. They will stop research if it breaks an IRB rule or the person receiving services no longer consents.
• The study’s researchers to get consent from the person receiving services. That includes letting them know of the grievance process. Researchers must have their study approved by the IRB before they get consent.
• The study’s researchers to make sure a person receiving services has provider approval.
• The study’s researchers to protect the privacy of the person receiving services. That includes treatment records.
  • Wis. Admin. Code ch. DHS 92
  • Wis. Admin. Code § DHS 94.14
  • Wis. Stat § 51.30
• The study to follow U.S. Department of Health and Human Services rules for research that involves people. These rules include consent and IRB record-keeping.
  • “Common Rule” found in 45 CFR 46
  • Wis. Stat. § 51.61(1)(j)

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.