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
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
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
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.
If you have any questions about DHS approval of research, please contact CRO
staff at (608) 266-2120 or by
August 07, 2014