Applying Wisconsin Law in Human Subjects Research

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Applying Wisconsin Law in Human Subjects Research

• By Lisa A. Wilson
• University Legal Counsel
• Office of Administrative Legal Services

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Outline of Presentation

• Laws pertaining to children
• Laws pertaining to persons lacking capacity
• Chapter 54 guardianships
• Chapters 51 and 55 mental health and protective
  placement
• Reporting statutes
• Abuse
• Communicable diseases
• Duty to warn
• Disclosure of records for research without
  consent
• Miscellaneous provisions

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• Laws Pertaining to Children

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Defining a Parent

• Biological
• Adoptive
• Determining paternity
• Husband is presumed father
• Husband who consented to wifes insemination also
  presumed father (wife not a surrogate)
• Man who has legally acknowledged paternity
• Man who has been adjudicated a father by a court

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Defining a Guardian

• A guardian is appointed by a court
• A guardian has authority by statute to consent to
  major medical, psychiatric or surgical treatment
  on behalf of a minor
• Generally a relative of the child

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Person Who May Consent for a Minor

• Parent
• Divorced parents
• Must have custody of child for authority to
  consent
• Placement by itself does not equal authority to
  consent
• If placement has been denied, parent would NOT
  have authority to consent
• Court appointed guardian

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When Minors May Provide ConsentAge of Majority

• No single place in statutes defining emancipation
• An adult is defined as 18 years or older
• Emancipated minor
• A married, widowed or divorced person (at least
  16)
• A minor who has been freed from the custody and
  control of a parent with little likelihood of
  returning
• By court order
• By parental consent
• A minor who has given birth (from
• the abortion statute UWHC limits
• consent ability)

Photo courtesy of Jeff Miller, UW-Madison
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When Minors May Provide ConsentAuthority Via
State Statute

• OHRP guidance children are persons who cannot
  consent under state law
• WI laws allowing minors to consent
• 14 or older HIV testing
• 12 or older outpatient services for AODA
• Testing/treatment for STDs
• Family planning services, pregnancy testing,
  obstetrical healthcare (federal law
  contraception)

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• Laws Pertaining to Persons Lacking Capacity to
  Consent

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The Legally Authorized Representative (LAR)

• Person authorized by state law to provide consent
  on behalf of a subject lacking capacity
• Order of priority
• Research POA
• Guardian
• Healthcare POA
• Next of kin spouse, adult child, parent, adult
  sibling, grandparent, adult grandchild, or close
  friend

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Risk Level for which LAR may Consent

• Minimal risk
• More than minimal risk if the research presents
  the prospect of direct benefit
• More than minimal risk with no prospect of direct
  benefit if the potential subject, while having
  capacity, signed research POA or other
  documentation indicating wish to be enrolled in
  this type of research

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Determining Lack of Capacity

• If research is minimal risk or if it presents the
  prospect of direct benefit
• May be determined by appropriate member of the
  research team (physician, psychologist, or other
  with sufficient training/experience)
• If not minimal risk and does not present the
  prospect of direct benefit
• One independent consultant must concur with
  incapacity finding (physician or psychologist)

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Addition of Chapter 54Guardianships and
Conservatorships

• Chapter 880 repealed
• Court must appoint the healthcare POA as the
  guardian unless not in best interest of ward
• Guardian may consent to accredited or certified
  research project if MR or if the prospect of
  direct benefit
• Guardian may consent to research that is more
  than MR with no benefit if clear and convincing
  evidence that ward would have participated
• Must be reviewed by IRB and IRB must find
  research complies with principles for the use of
  human subjects for research adopted by the
  American Association on Mental Deficiency

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Addition of Chapter 54Guardianships and
Conservatorships

• Guardian may consent to experimental treatment
  if court finds
• Ward's mental or physical status presents a
  life-threatening condition
• Experimental treatment may be a life saving
  remedy
• All alternatives have been exhausted
• 2 examining physicians have recommended the
  treatment
• Experimental treatment is in the ward's best
  interests
• Experimental treatment is not defined

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• Chapters 51 and 55

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Chapter 51 Mental Health Act

• Chapter 51 applies to persons who are receiving
  inpatient or outpatient services for mental
  illness, developmental disabilities, or AODA at a
  treatment facility
• Treatment facility is public or private
  facility that specifically provides treatment for
  AODA, mental illness or developmental
  disabilities

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Chapter 55 Protective Placement

• Chapter 55 applies to persons who are voluntarily
  or involuntarily protectively placed due to
  serious and persistent mental illness,
  degenerative brain disorders, developmental
  disabilities, or other like incapacities
• Most nursing home commitments are private
  agreements and not court-ordered protective
  placements

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DHFS Review

• Persons subject to Chapters 51 or 55 may not be
  enrolled in experimental research without their
  consent/assent and consent of guardian (if
  applicable)
• Experimental research not defined
• Research must be reviewed by IRB and by DHFS
• IRB and DHFS must determine that research
  complies with principles for the use of human
  subjects for research adopted by the American
  Association on Mental Deficiency
• DHFS does not want to see MR protocols

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• Reporting Statutes

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Child Abuse

• Reasonable cause to suspect child abuse or threat
  of abuse of child seen by person in course of
  professional duties
• Required reporters include physician, nurse,
  optometrist, medical or mental health
  professional, counselor, teacher, school
  administrator, AODA counselor, physical
  therapist, dietician, speech language
  pathologist, audiologist, EMT

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Abuse of Unborn

• Any person who has reason to suspect that unborn
  child has been abused or is at substantial risk
  of abuse may report
• Abuse means serious physical harm, or risk of
  serious physical harm when born caused by
  habitual lack of self-control of the expectant
  mother in use of alcohol or drugs to a severe
  degree

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Elder Abuse

• Any person may report if reasonable belief of
  abuse, financial exploitation, neglect (including
  self), of elder adult at risk
• Abuse includes physical, emotional, or sexual
  abuse treatment without consent confinement or
  restraint
• Financial exploitation means obtaining money or
  property by force, deceit, coercion
• Neglect means failure to provide adequate food,
  shelter, clothing or medical care
• Adult at risk means
• Elder adult at risk means age 60 or older

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Adult At Risk/Elder Abuse New Provisions

• Adult at risk means any adult who has a
  physical or mental condition that substantially
  impairs his/her ability to care for needs and is
  at risk of abuse
• Mandatory reporting for healthcare providers,
  social workers, and counselors
• At risk or elder adult requests report, or
• If reasonable cause to believe imminent risk of
  harm and adult is unable to make informed
  judgment about report
• Exception if reporter believes report not in best
  interest of at risk or elder adult (documentation)

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Communicable Diseases

• Who? Healthcare provider or laboratory shall
  ensure that reports are made to the state
  epidemiologist (for HIV results), or local health
  department (for other results)
• Identifiable results to UWHC lab or WSLH, then
  they report
• If unidentifiable results to lab, then research
  team must report

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Communicable Diseases

• When? Generally within 72 hours
• What? Name of person reporting, name of
  attending physician if any, the diagnosed or
  suspected disease, name of affected individual,
  address and telephone number, age or date of
  birth, race and ethnicity, sex, county of
  residence, date of onset of disease, name of
  parent or guardian if a minor, and other
  information requested by the local health officer

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Communicable Diseases

• Which diseases?
• http//dhfs.wisconsin.gov/communicable/diseaserep
  orting/index.htm

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Communicable Diseases

• How? HIV or AIDS reported to the state
  epidemiologist on an AIDS Case Report Form (DPH
  4264) or a Wisconsin Human Immunodeficiency Virus
  (HIV)
• Forms can be ordered from Department of Health
  and Family Services (DHFS)
• All other reports of communicable diseases can be
  oral or written. If written, the report must be
  made on the individual case report form provided
  by DHFS
• http//dhfs.wisconsin.gov/forms/PrintFormsOnline.h
  tm

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HIV Testing

• Wisconsin law requires that subjects be informed
  that their test results may be disclosed without
  their consent under nineteen different
  circumstances
• If not using UWHC HIV testing consent form, then
  information must be provided in research consent
  
• Nineteen circumstances may be listed in the
  consent, or consent may state Your HIV test
  results may be disclosed without your consent
  only as provided by Wisconsin law. A listing of
  those circumstances in which your HIV test
  results may be disclosed is available upon
  request
• Contact Legal Services for a listing
• Researcher may test blood for HIV without consent
  if subject identity is unknown

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Duty to Warn

• Wisconsin case law, not statutory
• Patient had psychotic condition for which she was
  medicated
• Caused car accident which killed her and left
  daughter a paraplegic
• Court held there may be duty to warn
  third-parties or duty to seek commitment
• Duty arises when there is forseeable risk that
  action or failure to act may cause harm to
  someone

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• Disclosure of Records for Research Without Consent

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Mental Health or AODA Treatment Records

• Research approved by DHFS
• Provide assurance (to who not specified) that
  records used only for the research not disclosed
  to anyone not connected with research
  publications will not be individually
  identifiable
• One exception to the minimal risk rule

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HIV Records

• Researcher must be affiliated with healthcare
  provider
• IRB permission obtained
• Provide written assurance to the person
  disclosing the test results that records used
  only for the research not disclosed to anyone
  not connected with research publications will
  not be individually identifiable

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Elder Abuse Reports Held By DHFS or County Agency

• Investigative reports are confidential
• Research must be approved by DHFS or county
  agency
• Provide assurance that reports used only for the
  research not disclosed to anyone not connected
  with research publications will not be
  individually identifiable

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Child Abuse Reports Held By DHFS or County Agency

• Person engaged in bona fide research
• Permission by DHFS
• Must be deidentified

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Birth Defect Reports Held By DHFS or County Agency

• Birth defects that include a structural
  deformation, disruption or dysplasia, or a
  genetic, inherited or biochemical disease must be
  reported by the diagnosing physician or hospital
  to DHFS
• DHFS may disclose reports to researcher
• DHFS must approve protocol
• Research is for purpose of studying birth defects
• If contact with subject of report
• DHFS must find public health need or research is
  for birth defects surveillance
• Must be IRB approval
• Contact only with informed consent of parent or
  guardian in a manner approved by DHFS

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Wisconsin Cancer Registry

• Any information that could identify an individual
  who is the subject of a report may not be
  disclosed except to
• A tumor registry in another state where the
  person resides
• A national tumor registry
• Proposal to change statute to permit disclosure
  of identifiable data to researchers where
  research has been approved by IRB

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• Miscellaneous Research Provisions

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Human Organs

• No sale of human organs for use in
  transplantation (does not include blood)
• Does not include reasonable expenses of removal,
  transportation, implantation, processing,
  preserving, quality control or storage of human
  organs
• Can sell human organs for use in research if end
  result is not transplantation

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Wisconsin COC

• Controlled substances board may issue what is
  essentially a COC for research on use and effects
  of controlled substances
• Allows researcher to withhold names and other
  identifying information of subjects
• Cannot be compelled in civil, criminal,
  administrative, legislative, or other proceeding

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Presentence Investigation Reports

• PSI is confidential
• May be disclosed by DOC for research
• If research includes contact with subject of
  report, must obtain informed consent
• Researcher may not disclose name or other
  identifying information of subject of report
  except to DOC for purpose related to research

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Questions?

• Lisa A. Wilson
• Office of Administrative Legal Services
• 500 Lincoln Drive, 361 Bascom Hall
• 263-7400
• lwilson_at_vc.wisc.edu