The Client Rights Office reviews all research involving participants who are defined as "patients" under Wis. Stat. § 51.61(1). This includes anyone who is receiving services for mental illness, developmental disabilities, alcoholism, or drug dependency.
After the Client Rights Office completes its initial review, staff will make a recommendation to the Administrator of the Division of Public Health, who decides whether the study will receive final approval by the Wisconsin Department of Health Services (DHS).
Participants who meet the definition of "patient" have the right to file grievances based on their participation in the study or any other aspect of their treatment.
Do all types of studies of require DHS approval?
No. A study is considered "research," and therefore requires DHS approval, only if it is investigating a "treatment technique" or "intervention." Wis. Admin. Code ch. DHS 94.02(38) says that "research" does not include a study involving only existing treatment records or routine follow-up questionnaires. Any questions regarding whether a study constitutes "research," and therefore requires DHS approval, should be directed to Client Rights Office staff.
What criteria are used to decide whether DHS will approve a study?
The criteria used to review proposed studies are primarily found in Wis. Stat. §§ 51.61(1)(j) and 51.61(4) and Wis. Admin. Code §§ DHS 94.13 and DHS 94.14. These laws and policies also incorporate the federal requirements known as the "Common Rule" found in 45 CFR 46.
The requirements outlined in these state and federal rules includes:
- Wis. Stat. § 51.61(j) requires studies to obtain valid informed consent from participants, including being informed of the study's client rights grievance process. The research must be reviewed and approved by the study's Institutional Review Board (IRB) before informed consent may be sought.
- Wis. Stat. § 51.61(4) requires the IRB approving the study to have no fewer than five persons with varying backgrounds and expertise, and no member may be directly involved in the research activity or review an activity in which he or she has a conflicting interest. No IRB may consist entirely of persons who are officers or employees of the facility, and no IRB may consist entirely of members of a single professional group.
- Wis. Admin. Code § DHS 94.13 requires that, if the research is being conducted in an inpatient or residential treatment facility, the IRB shall include two members who are consumers or who represent an agency or organization that advocates for the rights of patients. The study is also required to designate a person to act as a "consent monitor," who must authorized to verify informed consent and to immediately terminate a patient's participation in the study immediately upon violation of any IRB requirement or upon the patient's withdrawal of consent.
- Wis. Admin. Code § DHS 94.14 requires a study to ensure that no patient is approached to participate in the study unless the patient's participation is approved by the person responsible for the patient's treatment plan.
- Wis. Admin. Code § DHS 94.14 requires a study to make provisions to protect the privacy of patients, and the confidentiality of treatment records, in accordance with Wis. Stat. § 51.30 and Wis. Admin. Code ch. DHS 92.
- Wis. Stat. § 51.61(j) requires a study to comply with the U.S. Department of Health and Human Services regulations for research involving human subjects, namely, 45 CFR 46 (otherwise known as the "Common Rule"). These regulations address areas such as requirements for and documentation of informed consent and IRB recordkeeping.
- The "Common Rule" also contains protections for prisoners pertaining to the nature of the research, as well as the composition and duties of the IRB and children pertaining to the nature of the research and special consent requirements.
What is the process for seeking DHS approval of a study?
The review process can be initiated by sending a written request by either mail or email to:
Supervisor of the Client Rights Office
Division of Mental Health and Substance Abuse Services
PO Box 7851
Madison, WI 53707-7851
In order to conduct its review, the Client Rights Office will request a copy of the study Protocol Manual, the IRB application, and the informed consent document. The study will be asked to provide written assurances that it conforms to the relevant state and federal rules, including whether it has received a Federalwide Assurance from the U.S. Department of Health and Human Services.
Client Rights Office staff will complete an initial review to determine whether study requires DHS approval. If the study requires DHS approval, the study will be reviewed in terms of the above criteria, and any concerns will be identified and brought to the attention of the study.
Once any identified concerns are addressed, and the study has been approved by its Institutional Review Board, Clients Rights Office staff will make a recommendation for DHS approval to the Administrator of the Division of Public Health, who makes the final determination regarding DHS approval of the research.
The state laws and rules on research approval and a digest of prior approval decisions can be found here.
How long is the review process?
The statutes do not place time limits on DHS for completing the approval process. However, after Client Rights Office receives all of the information described above, the initial review can usually be completed within approximately 30 days. The time frame for the Client Rights Office's recommendation, and final DHS approval, will vary depending on whether 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 Client Rights Office staff at 608-266-2120 or by email.