Issues in Human Subjects Research When State Law May Apply
This policy describes how the UW-Madison IRBs assure compliance with state laws when reviewing research involving human subjects.
- Informed Consent (Who Can Provide It and Who Is An Appropriate Surrogate)
- When May a Child Consent on His/Her Own Behalf to Research Participation?
- When Must a Parent and Guardian Provide Consent for a Child’s Participation?
- Who May Consent for Incompetent Adult’s Research Participation?
- Power of Attorney for Research/Advance Directive
- 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:
“Children” are persons who have not attained the legal age for consent to treatments or procedures involved in the research under applicable law of the jurisdiction in which the research will be conducted. In Wisconsin, the age of majority for most treatments or procedures is 18 years of age.
An emancipated minor may provide consent. An emancipated minor includes: (1) a married, widowed or divorced person who is at least 16 years old; (2) for purposes of an abortion, a minor who has given birth; (3) a minor emancipated by court order; (4) a minor emancipated by parental consent; and (5) a minor living on his or her own who is not supported by parents.
Minors 14 years or older may consent to HIV testing; minors 12 years or older may consent to outpatient services for the abuse of alcohol or other drugs; and minors of any age may consent to testing or treatment for sexually transmitted diseases and to pregnancy testing and obstetrical healthcare or screening.
Except when a child may consent for him/herself as outlined above, a parent or guardian must consent to a child’s participation in research, with limitations as outlined below.
A “parent” means either a biological parent, a husband who has consented to the artificial insemination of his wife, or a parent by adoption. If the child is a non-marital child who is not adopted or whose parents do not subsequently intermarry, "parent" includes a person who has acknowledged paternity by law or been adjudicated to be the biological father. "Parent" does not include any person whose parental rights have been terminated.
In addition to a "parent" as defined above, a court-appointed "guardian" for an unemancipated child under the age of 18 has the authority to consent to major medical, psychiatric and surgical treatment.
In identifying a legally authorized representative for an incompetent adult, UW-Madison looks to the following people in the following order of priority:
UW-Madison has developed a research power of attorney form and an advance directive form that can be used by individuals who wish to appoint an agent to act on their behalf if they become incompetent with regard to decisions about research participation.
A research agent appointed under a power of attorney for research may consent to a potential subject's participation in research to the extent that the agent's decision is not inconsistent with the wishes and preferences of the potential subject as expressed in the power of attorney instrument.
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. 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.
A court order may include the right of a guardian of the person to make decisions about research participation under the following circumstances:
- The research might help the ward, or
- The research involves no more than minimal risk of harm.
- If the guardian can establish by clear and convincing evidence that the ward would have elected to participate in such research, and
- 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.
A health care agent designated under a power of attorney for health care has authority to make health care decisions on behalf of a principal lacking capacity to consent consistent with the power of attorney instrument. A healthcare power of attorney is activated when two physicians or one physician and one licensed psychologist determine and document in writing that the subject lacks capacity.
A healthcare agent may consent to a potential subject’s participation in research to the extent that the agent's decision is not inconsistent with the wishes and preferences of the potential subject as expressed in the power of attorney instrument. Wisconsin law prohibits a health care agent from agreeing to experimental mental health research or to psychosurgery, electroconvulsive treatment or drastic mental health treatment procedures for the principal.
Absent a power of attorney for research or health care or a court-appointed guardian, a potential research participant's next of kin may consent to research participation on behalf of a participant who is found to lack capacity.
Next of kin include, in the following order of priority: a spouse, adult child, parent, adult sibling, grandparent, adult grandchild, or a close friend of the potential subject. Any next of kin representative of the potential participant should be actively involved in the care of the participant.
For Veterans Administration protocols, the legally authorized representative must be a health care agent appointed by the person in a Durable Power of Attorney for Health Care or similar document, a court-appointed guardian of the person, or the next-of-kin in the following order of priority, unless otherwise specified by applicable state law: spouse, adult child (18 years or older), parent, adult sibling (18 years of age or older), grandparent, or adult grandchild (18 years of age or older).
- Child Abuse or Neglect
- Mandatory Health Care Providers
- The intercourse occurred with a caregiver
- The child suffers from a mental illness or mental deficiency that renders the child unable to understand the consequences of his/her actions
- The child, because of age or immaturity, was incapable of understanding the consequences of his/her actions
- The child was unconscious at the time of the act or otherwise unable to communicate unwillingness to participate
- Another participant in the sexual intercourse was exploiting the child
- UW System Employees
- Adult-at-Risk and Elder Adult-at-Risk Abuse
- Communicable Diseases
- Cancer Reporting
- Birth Defect Reporting
- Duty to Warn
State law requires physicians, nurses, psychiatrists, counselors, and other medical and mental health providers, to report reasonable suspicions of child abuse or neglect. Child abuse includes physical injury inflicted on a child other than by accidental means, and sexual intercourse or contact with a child age 15 or under, or age 16 or 17 without the child’s consent. Neglect includes failure on the part of a caregiver other than for reasons of poverty to provide for necessary food, clothing, shelter and medical/dental care. Reports must be made to police (UWPD: 264-2677) or the local child protective services agency (Dane County: 261-5437).
Health care providers who provide health care services (family planning services, pregnancy testing, obstetrical health care or screening, and STI diagnosis or screening) to a child, and persons receiving information about a child who has received healthcare services, do not have to report sexual intercourse involving a child unless:
Under Executive Order #54 signed by the Governor, all University of Wisconsin System employees are mandatory reporters of child abuse and neglect. For questions about what needs to be reported under EO #54, contact the UW Office of Legal Affairs at 263-7400.
Health care providers may be required to report at-risk individuals when the health care provider suspects that the at-risk individual is being abused or neglected (including self-neglect). An at-risk adults means someone who: (1) has a physical or mental condition that substantially impairs his or her ability to care for his or her needs; and (2) has experienced or is at risk of experiencing abuse, neglect, self-neglect, or financial exploitation. The term “elder adult-at-risk” is defined similarly, but means any person 60 years or older who meets the second criterion from the paragraph above.
While the law generally requires health care providers to report cases of abuse that they encounter in their professional practice, there is an exception for when the provider believes that it is not in the person’s best interest to report the abuse. In this case, the provider must record the reasons that she or he believes that it is not in the at-risk individual’s best interest to report. Required reports must be made to the registered county at-risk agency (Dane County: 261-9933) or the police (UWPD: 266-4316).
Any health care provider 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 Wisconsin Department of Health Services or shall direct the person reporting to report to the Department. Any person directed to report shall submit this information to the Department.
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 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.
Unless already reported, the following individuals must report a birth defect to the Wisconsin Department of Health Services: (1) A physician who diagnoses a birth defect or provides treatment to the child, or (2) a pediatric specialty clinic in which the birth defect is diagnosed or treatment for the birth defect is provided.
There is Wisconsin case law that provides that health care providers might be negligent for failure to warn of foreseeable risks of harm to the individual him or herself or to third persons. For example, a psychotherapist might be negligent for failure to warn a patient about a medication's effect on her driving if it was foreseeable that an accident could result causing harm to the patient or third persons.
- Patient Health Care Records
- Mental Health Records
- HIV Test Results
- Child Abuse Reports
- Elder Abuse Reports
- Birth Defect Records
- Presentence Investigation Reports
Patient health care records may 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.
A parent who has been denied physical custody of a child may not consent to use of a child's medical records in research.
Mental health records may be released without informed written consent for research purposes if the research has been approved by the Department of Health Services, 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.
There is an exception to the requirement to obtain informed consent to perform HIV testing on a human specimen if the testing is performed for research and so long as the identity of the test subject is not known and may not be retrieved by the researcher.
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.
Child protective service agencies may release child abuse reports and records to a person engaged in bona fide research with permission of the Department of Health Services, except for information identifying subjects or reporters of abuse.
County agencies charged with receiving elder abuse reports may release such reports for research purposes if the research has been approved by the Department of Health Services 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.
Confidential information about birth defects can be released to a researcher who has filed a written request and a research protocol with the Wisconsin Department of Health Services, 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.
If the research will involve direct contact with a subject of a report or with any member of the subject's family, the Wisconsin Department of Health Services 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 U.S. 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 the Wisconsin Department of Health Services.
The Wisconsin 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.
Research that is more than minimal risk and targets participants who are: (a) receiving protective services, voluntarily or involuntarily, because of aging infirmities, chronic mental illness, developmental disabilities or like incapacities, or (b) receiving inpatient or outpatient treatment for mental illness, development disabilities or substance and alcohol dependency must comply with special conditions imposed by Wisconsin law.
The Wisconsin Administrative Code also expressly gives clients of home health agencies the right to refuse to participate in experimental research.
- Protectively Placed Individuals Research Participation
- Research with Participants Receiving Services for Mental Illness, Development Disabilities, and AODA
- Use of Radiation for Non-Treatment Purposes
Persons who receive protective services, voluntarily or involuntarily, because of aging, chronic mental illness, developmental disabilities or like incapacities 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.
More than minimal risk research must be approved by the institution's research and human rights committee and the Wisconsin Department of Health Services 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.
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 (if any) and after consultation with independent specialists and the patient's legal counsel.
More than minimal risk research must be approved by the institution's research and human rights committee and the Wisconsin Department of Health Services, 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.
No person may be exposed to radiation except upon a physician order after an examination disclosing a medical need for an x-ray procedure unless a variance has been granted from the Wisconsin Department of Health Services.
Research studies which expose subjects to x-ray radiation as part of standard clinical imaging (i.e. subjects would have the same x-ray radiation even if not in the study) do not require a variance from the Wisconsin Department of Health Services. Additionally, no variance is required if the exposure to radiation is for the purpose of subject safety (e.g. x-ray to rule out metal in the body prior to a research MRI). Mammography screening and bone density screening in adults is also exempt.
A variance must be requested if the research includes exposure to x-ray radiation for a non-therapeutic purpose (e.g. imaging in healthy volunteers or imaging that is not standard of care for the patient population enrolled in the research). Investigators proposing research that exposes subjects to x-ray radiation for a purpose other than as part of standard clinical imaging or subject safety as described above must submit the information set forth in Appendix M to Chapter DHS.
- Research Using Human Organs
- Controlled Substances Board Certificate of Confidentiality
- Prescription Drug Monitoring Program (PDMP)
No person may knowingly and for valuable consideration acquire, receive or otherwise transfer any human organ for use in human organ transplantation. “Valuable consideration” does not include reasonable payment for the removal, transportation, implantation, processing, preservation, quality control or storage of a human organ.
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.
Dispensers of monitored prescription drugs are required to collect and submit information to the PDMP about each dispensing of the drug, including for monitored prescription drugs dispensed in research studies. The PDMP stores the information and makes it available to pharmacies, health care providers, and others, such as federal and state health care review organizations and law enforcement for legally authorized purposes.
“Monitored prescription drugs” are defined in the administrative rules developed by the Pharmacy Examining Board, and currently include:
- State Controlled Substances in Schedule II, III, IV or V that require a prescription order to be lawfully dispensed
- For information about the state schedules of controlled substances, see subchapter II. of s. 961, Stats. , and Wis. Admin. Ch. CSB 2
- Federally Controlled Substances in Schedule II, III, IV or V that require a prescription order to be lawfully dispensed
- For information about the federal schedules of controlled substances, see 21 U.S.C. 812 (b) (1) to (b) (5) and (c) and 21 C.F.R. 1308
- Tramadol, a drug identified by the PEB as having a substantial potential for abuse
“Dispenser” means a pharmacy from where a pharmacist dispenses a monitored prescription drug or a practitioner who dispenses a monitored prescription drug. Monitored prescription drugs dispensed through the Pharmaceutical Research Center (PRC) are reported to the PDMP by the PRC.
 Wis. Stats. §§ 48.01(1)(d), 48.01(2) (2010-12).
 Wis. Stats. §§ 48.375(2)(e), 765.02(2), 54.46(6), 895.037(1)(c); Niesen v. Niesen, 38 Wis.2d 599, 157 N.W.2d 660 (1968); Caskey v. Peterson, 220 Wis. 690, 263 N.W. 658 (1935); Prelipp v. Prelipp, 203 Wis. 488, 234 N.W. 730 (1931).
 Wis. Stat. § 252.15(2)(a)(4)(a).
 Wis. Stats. §§ 51.45(2m), 51.47.
 Wis. Stats. §§ 252.11(1), 252.11(1m).
 Wis. Stat. § 48.981(2m)(b)(2); Carey v. Population Servs. Int’l, 431 U.S. 678 (1977).
 Wis. Stat. § 48.02(13).
 Wis. Stat. § 48.023(1)
 Wis. Stat. § 54.25(2)(d)
 Wis. Stats. §§ 54.25(2)(d)(2)(b)-(c).
 Wis. Stats. §§ 155.01-155.80.
 Wis. Stat. § 155.20(3).
 The next of kin order is gleaned from the following Wisconsin statutes: Wis. Stat. §§ 157.06(3),Wis. Stat. § 852.01,; and Wis. Stat. § 990.001(16).
 Wis. Stat. § 48.981.
 Wis. Stat. § 46.90.
 Wis. Stats. §§ 146.81(1)(a)-(p).
 Wis. Stat. § 252.05(1).
 Wis. Stat. § 253.12(2)(a)(1).
 Schuster v. Altenberg , 144 Wis. 2d 223 (1988)
 Wis. Stat. § 146.82(2).
 Wis. Stat. § 146.835.
 Wis. Stat. § 51.30 (4)(b)(3).
 Wis. Stat. § 252.15(2).
 Wis. Stat. § 252.15(5).
 Wis. Stat. § 48.981 (7).
 Wis. Stat. § 46.90(6).
 Wis. Stat. § 253.12(5).
 Wis. Stat. § 253.12(5)(b)(3).
 Wis. Stat. § 972.15(5).
 Wis. Stat. § 55.07.
 45 C.F.R. §§ 46 (2009).
 Wis. Stat. § 51.61(1)(j).
 45 C.F.R. § 46.
 Wis. Admin. Code D.H.S. §§ 157.03(155), 157.74(2)(f) (2014).
 Wis. Stat. § 146.345(2).
 Wis. Stat. § 961.335(7).