Amended: July 10, 2008
Under Wisconsin law, a court appointed guardian of the person is authorized to exercise only those powers that are necessary to provide for the individual’s personal needs, safety, and rights and must exercise the powers in a manner that is appropriate to the individual and that constitutes the least restrictive form of intervention. The court may limit the authority of the guardian of the person to allow the individual to retain power to make decisions about which the individual is able effectively to receive and evaluate information and communicate decisions. [WSA 54.25(2)(d)]
WSA Chapter 54 [WSA 54.25(2)(d)2.b-d] also speaks specifically to powers of the guardian with regard to an incompetent ward’s participation in research. A guardian of the person may:
· authorize the ward’s participation in an “accredited or certified” research project, unless it can be shown by clear and convincing evidence that the ward would never have consented to research participation, if:
o the research might help the ward, or
o the research might not help the ward but might help others, and the research involves no more than minimal risk of harm to the ward
· authorize the ward’s participation in research that might not help the ward but might help others, even if the research involves greater than minimal risk of harm to the ward:
o if the guardian can establish by clear and convincing evidence that the ward would have elected to participate in such research, and
o the proposed research was reviewed and approved by the research and human rights committee of the institution conducting the research. The committee shall have determined that the research complies with the principles of the statement on the use of human subjects for research adopted by the American Association on Mental Deficiency, and with the federal regulations for research involving human subjects for federally supported projects.
· consent to “experimental treatment,” unless it can be shown by clear and convincing evidence that the ward would never have consented to any experimental treatment, if the court finds all of the following:
o the ward’s mental or physical status presents a life−threatening condition,
o the proposed experimental treatment may be a life saving remedy,
o all other reasonable traditional alternatives have been exhausted,
o two examining physicians have recommended the treatment, and
o in the court’s judgment, the proposed experimental treatment is in the ward’s best interests.
When appointing a guardian of the person under Chapter 54, if a ward has executed a power of attorney for health care under Chapter 155, the court must appoint the designated health care agent as the individual's guardian unless the appointment would not be in the best interests of the ward. [WSA 54.15(3)] If the ward executed a power of attorney for health care before a finding of incompetency and appointment of a guardian for the ward, the power of attorney for health care remains in effect, unless the court revokes the power of attorney based on ”good cause” or limits the authority of the health care agent. Unless the court revokes the power of attorney or limits the authority of the health care agent, the ward’s guardian may not make health care decisions for the ward that may be made by the health care agent, unless the guardian is the health care agent. [WSA 54.46(2)(b)]
WSA 46.90 Elder Abuse Reporting System.
• WSA 46.90 Reporting of elder abuse is required if certain circumstances are met.
• WSA 46.90(6) Allows reports of elder abuse and investigations to be released by a county agency of the Wisconsin Department of Health and Family Services (DHFS) for research purposes, if the research has been approved by the department or county agency, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information.
WSA 48.981 Abused or neglected children and abused unborn children.
• WSA 48.981 (2) Persons required to report child abuse include physicians, nurses and other medical and mental health care professionals.
• WSA 48.981 (7) Allows release of child abuse reports and records to a “person engaged in bona fide research” with permission of DHFS, except for information identifying subjects or reporters of abuse.
WSA 51.001 et seq.
• WSA 51.30 (4) Access to registration and treatment records. Allows individual’s treatment records to be released without informed written consent for research purposes if the research has been approved by DHFS, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information.
• WSA 51.61(1)(j) Patients rights. Individuals receiving treatment for mental illness, developmental disabilities, and alcoholism or drug dependency have the right not to be subjected to experimental research without the express and informed consent of the patient and the patient’s guardian and after consultation with independent specialists and the patient’s legal counsel.
The proposed research must be approved by the institution’s research and human rights committee (see WSA 51.61(4), below) and DHFS and must comply with the principles of the statement on the use of human participants in research adopted by the American Association on Mental Deficiency and with the protection of human research participant regulations adopted by the U.S. Department of Health and Human Services (DHHS) for projects supported by that agency. (See 45 CFR 46)
• WSA 51.61(4) Facilities that conduct research involving human participants must establish a five-member research and human rights committee to review the research proposals. The statute sets forth requirements for committee membership.
WSA 54.01 et seq. (See, Section IV.C.2.b & c, above)
WSA 55.07 Patients' rights.
• WSA 55.07 Persons who receive protective services, voluntarily or involuntarily, because of aging, chronic mental illness, developmental disabilities or like incapacities have the right, under WSA 51.61, not to be subjected to experimental research without the express and informed consent of the patient and the patient’s guardian and after consultation with independent specialists and the patient’s legal counsel.
The proposed research must be approved by the institution’s research and human rights committee and DHFS and must comply with the principles of the statement on the use of human subjects for research adopted by the American Association on Mental Deficiency and with regulations adopted by the U.S. Department of Health and Human Services (DHHS) for projects supported by that agency. (See 45 CFR 46)
• WSA 55.07 (2) A parent who has been denied physical custody of a child may not access a child's records under the Protective Service System.
WSA 146.82 Confidentiality of patient health care records.
• WSA 146.82(2) Patient records can be released without informed consent for research purposes if the researcher is affiliated with the health care provider, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information. Private pay patients may deny access by annually submitting to the health care provider a signed, written request.
• WSA 146.835 Parents Denied Physical Placement rights. A parent who has been denied physical custody of a child may not have access to a child's medical records.
WSA 146.345 Sale of human organs prohibited.
• WSA 146.345(2) No person may knowingly and for valuable consideration acquire, receive or otherwise transfer any human organ for use in human organ transplantation. There is no prohibition on buying or selling human organs for research.
WSA 155.20 Health care agent; powers; limitations.
• WSA 155.20(3) A health care agent may not consent to experimental mental health research or to psychosurgery, electroconvulsive treatment or drastic mental health treatment procedures for the principal.
WSA 252.05 Reports of cases.
• WSA 252.05(1) Any health care provider, as defined in WSA 146.81(1), who knows or has reason to believe that a person treated or visited by him or her has a communicable disease, or having a communicable disease, has died, shall report the appearance of the communicable disease or the death to the local health officer. The local health officer shall report this information to the department or shall direct the person reporting to report to the department. Any person directed to report shall submit this information to the department.
• WSA 252.05(3) Anyone having knowledge or reason to believe that any person has a communicable disease shall report the facts to the local health officer.
WSA 252.15 Restrictions on use of a test for HIV.
• WSA 252.15(2) Informed consent for testing or disclosure. Exception to informed consent to perform HIV test if performed for research as long as identity of the test subject is not known and may not be retrieved by the researcher.
• WSA 252.15(5) Confidentiality of test. HIV test results are confidential but may be revealed without test subject’s authorization for the purpose of research, if the researcher is affiliated with a health care provider, has obtained permission to perform the research from an institutional review board, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information.
WSA 255.04 Cancer Reporting.
• WSA 255.04 Cancer Reporting. Hospitals, physicians, and clinics must report cancer cases to the Wisconsin Cancer Reporting System (WCRS), in the Bureau of Health Information, Wisconsin Department of Health and Family Services. Hospitals must report cases within six months of initial diagnosis or first admission following a diagnosis elsewhere. Clinics and physicians must report cases within three months of initial diagnosis or contact. Reports to the state cancer registry may not be construed as a violation of any person's responsibility for maintaining the confidentiality of patient health care records.
WSA 253.12 Birth defect prevention and surveillance system.
• WSA 253.12(5) Confidentiality. Confidential information about birth defects can be released to a researcher who has filed a written request and a research protocol with the department, if the purpose is to study birth defects surveillance and prevention, the information will be used only for the approved research and will not be released to a person not connected with the research, and the final product will not include identifying information.
• WSA 253.12(5)(b)3. If the research will involve direct contact with a subject of a report or with any member of the subject's family, the department must determine that the contact is necessary for meeting the research objectives and that the research is in response to a public health need or is for the purpose of or in connection with birth defects surveillance or investigations sponsored and conducted by public health officials. The department must also determine that the research has been approved by a certified institutional review board or a committee for the protection of human subjects in accordance with the regulations for research involving human subjects required by the federal department of health and human services (DHHS) for projects supported by that agency. Contact may only be made with the written informed consent of the parent or guardian of the subject of the report and in a manner and method approved by DHFS.
WSA 961.335 Special use authorization.
• WSA 961.335(7) The controlled substances board may authorize persons engaged in research on the use and effects of controlled substances to withhold the names and other identifying characteristics of individuals who are the subjects of research. Persons who obtain this authorization are not compelled in any civil, criminal, administrative, legislative or other proceeding to identify to the board the individuals who are the subjects of research for which the authorization was obtained.
WSA 972.15 Presentence investigation.
• WSA 972.15(5) The Department of Corrections may use a presentence investigation report for research purposes. If a report is used for research purposes and the research involves personal contact with research subjects, written consent of the subject or the subject’s authorized representative is required. Disclosure of the name or any other identifying characteristic of the subject is prohibited, except for disclosure to appropriate staff members or employees of the department, agency or person as necessary for purposes related to the research.
ADMINISTRATIVE CODE
HFS 94.01 et seq. Research with patients receiving treatment for mental illness, a developmental disability, alcohol abuse or dependency or other drug abuse or dependency.
• HFS 94.13. An inpatient or residential treatment facility conducting or permitting research or drastic treatment procedures involving human subjects shall establish a research and human rights committee in accordance with 45 CFR 46, s. 51.61(1)(j).
• HFS 94.14. (1) All proposed research involving patients must meet the requirements of s. 51.61(1)(j), Stats., 45 CFR 46, and this section.
HFS 133.08 Home Health Agencies
• HFS 133.08(2)(d) Clients of home health agencies have the right to refuse to participate in experimental research.
CASE LAW
Schuster v. Altenberg, MD, 144 Wis.2d 223, 424 NW2d 159 (1988)
• This case held that a psychotherapist might be negligent for failure to warn a patient about a medication's effect on driving, if it was foreseeable that an accident could result causing harm to the patient or third persons. This case would apply to a researcher and research subject.
In re Guardianship of Pescinski, 67 Wis.2d 4, 226 NW2d 180 (1975)
• This case held that a guardian of an incompetent person could not consent to a surgical procedure on the ward for purposes of making a kidney donation to the ward’s sister absent any benefit to the ward. A guardian must act under the "best interests" standard with respect to the ward, and the court explicitly declined to adopt the "substituted judgment" standard.
Spahn v. Eisenberg, 210 Wis.2d 557, 563 NW2d 458 (1997)
• This case held that a guardian cannot consent to withdrawal of feeding tubes where the patient-ward is not in a persistent vegetative state and there was no clear indication of what the patient-ward would want. The patient had Alzheimer’s disease.
Niesen v. Niesen, 38 Wis.2d 599 (Wis. 1968)
Caskey v. Peterson, 220 Wis. 690, 263 N.W. 658 (Wis. 1935)
Prelipp v. Prelipp, 203 Wis. 488, 234 N.W. 730 (Wis. 1931)
• Minors may also be released from parental control, and become emancipated, either by the consent of the parent or by operation of law without such consent..