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Research - Approval by DHS

Applies to: Any research involving participants who are defined as “patients” under § 51.61 (1), Wis. Stats., (i.e., anyone who is receiving services for mental illness, developmental disabilities, alcoholism or drug dependency) must be reviewed by the Client Rights Office (CRO) and approved by DHS.

NOTE: Participants who meet the definition of “patient” also have the right to file grievances based on their participation in such research.

Research defined: A study is “research” if it is investigating a “treatment technique” or “intervention”. “Research” does not include a study involving only existing treatment records or routine follow-up questionnaires.
 
Review criteria: The criteria used to review proposed studies are primarily found in § 51.61(1)(j) and § 51.61(4), Wis. Stats., and DHS 94.13 and DHS 94.14, Wis. Admin. Code. They refer back to the federal requirements known as the “Common Rule” found in 45 CFR 46.
 
Review process: The laws do not specify whether the Institutional Review Board (IRB) or DHS must approve the study first. However, it is recommended that studies not be submitted to DHS until after an initial IRB review is completed and the study has addressed any IRB concerns.

The review process can be initiated by sending a request for approval to the Supervisor of the Client Rights Office, Division of Mental Health and Substance Abuse Services, P.O. Box 7851, Madison, WI 53707-7851, or by contacting the Supervisor by email

In order to conduct its review, CRO will request a copy of the study Protocol Manual, the IRB application, and the informed consent document. CRO staff will complete an initial review and identify any concerns.

If all concerns are addressed, CRO staff will make a recommendation for DHS approval to the Administrator of the Division of Public Health. The Administrator will make the final determination about whether the research is approved by DHS.

The state laws and rules on research approval and a digest of prior approval decisions can be found here.
 
Review time: The statutes do not place time limits on DHS for completing the approval process. However, after CRO receives all of the information described above, the initial review can usually be completed within approximately 30 days. This time may vary if any additional information is required or if any concerns arise during the process and need to be addressed.

Additional questions: If you have any questions about DHS approval of research, please contact CRO staff at (608) 266-2120 or by email.

 

Last Updated:  August 07, 2014