Informed Consent in the Cognitively Impaired

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Informed Consent in the Cognitively Impaired

• Ann Marie Hake, M.D.
• Associate Professor Of Clinical Neurology
• Indiana University School of Medicine

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A Violation of the Nuremberg Code?

• 1. The voluntary consent of the human subject is
  absolutely essential.
• This means that the person involved should have
  legal capacity to give consent should be so
  situated as to be able to exercise free power of
  choice, without the intervention of any element
  of force, fraud, deceit, duress, over-reaching,
  or other ulterior form of constraint or coercion
  and should have sufficient knowledge and
  comprehension of the elements of the subject
  matter involved as to enable him to make an
  understanding and enlightened decision. This
  latter element requires that before the
  acceptance of an affirmative decision by the
  experimental subject there should be made known
  to him the nature, duration, and purpose of the
  experiment the method and means by which it is
  to be conducted all inconveniences and hazards
  reasonably to be expected and the effects upon
  his health or person which may possibly come from
  his participation in the experiment.

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The Flip Side

• Some questions can be answered only in
  populations of individuals with impaired capacity
• Capacity to consent may fluctuate, or be impaired
  only temporarily
• Not everyone with a psychiatric, neurologic, or
  developmental condition is incapable of
  consenting

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Declaration of Helsinki

• I. 11. In case of legal incompetence, informed
  consent should be obtained from the legal
  guardian in accordance with national legislation.
  Where physical or mental incapacity makes it
  impossible to obtain informed consent, or when
  the subject is a minor, permission from the
  responsible relative replaces that of the subject
  in accordance with national legislation.

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Belmont Report

• Adapt the presentation of information to the
  subjects capabilities
• An impairment in capacity should be approached on
  its own terms
• Respect for the subject entails giving them the
  opportunity to choose whether to participate, but
  also the use of third parties to protect them
  from harm

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Principles of Consent

• Adults are presumed to be capable of consenting
• This presumption can be rebutted
• In general medical care, informed consent may or
  may not be required from a surrogate for adults
  lacking capacity to consent, depending on local
  laws
• Consent for research should be held to a higher
  standard

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Webster Says

• Assent n. an acceptance (of a statement,
  doctrine, etc.) as true
• Assent v.i. To give expressed or unexpressed
  mental acceptance to the truth or rightness of a
  doctrine, conclusion, etc. to say yes

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Webster Says

• Consent n. permission, acquiescence, approval,
  agreement
• Consent v.i. to give assent

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IUPUI/Clarian SOP Says

• Assent An individuals affirmative agreement to
  participate in research obtained in conjunction
  with permission of the individuals parents or
  legally authorized representative. Mere failure
  to object should not, absent affirmative
  agreement, be construed as assent.

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Webster Says

• Informed consent n. consent obtained from a
  patient for the performance of a specific
  medical, surgical, or research procedure after
  the procedure and risks involved have been fully
  explained in nontechnical terms and understood

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IUPUI/Clarian SOP Says

• Informed Consent An ongoing process by which a
  subject (or his/her legal representative)
  voluntarily confirms his or her willingness to
  participate in a particular research project,
  after having been informed of all aspects of the
  research that are relevant to the subjects
  decision to participate. Informed consent is
  often, but not always, documented by means of a
  written, signed, and dated informed consent form
  with documentation, which is retained in the
  subjects record.

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Webster Says

• Capability n. ability
• Capacity n. mental ability faculty
• Competency n. legal capacity or capability

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Capacity to Consent for Research

• Able to understand the nature of the research and
  of his or her participation
• Able to appreciate the consequences of
  participation, including personal consequences
• Able to consider alternatives, including the
  option not to participate
• Able to make a reasoned choice

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What Can Affect Capacity to Consent in Adults?

• Sleep
• Intoxication
• Developmental delay
• Mental illness
• Dementia
• Other illness
• Duress

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Indiana Law Governing Consent for Health Care

• IC 16-36-1
• IC 16-36-3

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Indiana Law Governing Consent for Medical Research
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Who May Consent to Health Care in Indiana?

• Any adult (IC 16-36-1-3.a.1)
• May consent to health care unless, in the good
  faith opinion of the attending physician, the
  individual is incapable of making a decision
  regarding the proposed health care (IC
  16-36-1-4.a)

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IC 16-36-1-4 Incapacity to consent invalid
consent

• An individual described in section 3 of this
  chapter may consent to health care unless, in the
  good faith opinion of the attending physician,
  the individual is incapable of making a decision
  regarding the proposed health care.
• (b) A consent to health care under section 5, 6,
  or 7 of this chapter is not valid if the health
  care provider has knowledge that the individual
  has indicated contrary instructions in regard to
  the proposed health care, even if the individual
  is believed to be incapable of making a decision
  regarding the proposed health care at the time
  the individual indicates contrary instructions.

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IC 16-36-1-5 Persons authorized to consent for
incapable parties minors

• Sec. 5. (a) If an individual incapable of
  consenting under section 4 of this chapter has
  not appointed a health care representative under
  section 7 of this chapter or the health care
  representative appointed under section 7 of this
  chapter is not reasonably available or declines
  to act, consent to health care may be given
• (1) by a judicially appointed guardian of
  the person or a representative appointed under
  section 8 of this chapter or

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IC 16-36-1-5 Persons authorized to consent for
incapable parties minors

• (2) by a spouse, a parent, an adult
  child, or an adult sibling, unless disqualified
  under section 9 of this chapter, if
• (A) there is no guardian or other
  representative described in subdivision (1)
• (B) the guardian or other
  representative is not reasonably available or
  declines to act or
• (C) the existence of the guardian or
  other representative is unknown to the health
  care provider or

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IC 16-36-1-5 Persons authorized to consent for
incapable parties minors

• (3) by the individual's religious
  superior, if the individual is a member of a
  religious order and
• (A) there is no guardian or other
  representative described in subdivision (1)
• (B) the guardian or other
  representative is not reasonably available or
  declines to act or
• (C) the existence of the guardian or
  other representative is unknown to the health
  care provider.

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IC 16-36-1-6 Delegated authority to consent on
behalf of incapable party

• Sec. 6. (a) An individual authorized to consent
  to health care for another under section 5(a)(2),
  5(b)(2), or 5(b)(3) of this chapter who for a
  time will not be reasonably available to exercise
  the authority may delegate the authority to
  consent during that time to another individual
  not disqualified under section 9 of this chapter.
  The delegation
• (1) must be in writing
• (2) must be signed by the delegate
• (3) must be witnessed by an adult and
• (4) may specify conditions on the
  authority delegated.
• (b) Unless the writing expressly provides
  otherwise, the delegate may not delegate the
  authority to another individual.
• (c) The delegate may revoke the delegation at
  any time by notifying orally or in writing the
  delegate or the health care provider.

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IC 16-36-1-5 Persons authorized to consent for
incapable parties minors

• Sec. 5 (c) An individual delegated authority to
  consent under section 6 of this chapter has the
  same authority and responsibility as the
  individual delegating the authority.
• (d) An individual authorized to consent for
  another under this section shall act in good
  faith and in the best interest of the individual
  incapable of consenting

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Determining Capacity to Consent

• Investigator observation / interaction
• Formal tool (MMSE, etc.)
• Quiz after informed consent discussion (MacCAT-CR)

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Do you have any questions about what I just
said?Can you tell me your understanding of
what I just said?If subject fails to mention
spontaneously, askHow long will the research
study last?What medication will your receive
in the study?If you want to drop out of the
study, when can you do this?
Sample Quiz Questions
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Additional Safeguards

• Safeguards commensurate with risks
• Independent monitor
• Informational / educational technique
• Surrogate / LAR
• Assent / co-consent in addition to surrogate
  consent
• Periodic reassessment
• Advance directive
• Waiting periods

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Documentation
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The Summary Safeguard Statement

• 2. Cognitively Impaired. Respond to the
  following
• a. Explain the procedures proposed for evaluating
  the mental status of prospective subjects to
  determine whether they are capable of consenting
  and/or soliciting their assent.

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The Summary Safeguard Statement

• b. Is it reasonable to expect that during the
  course of the study, subjects may lose their
  capacity to consent or their ability to withdraw
  (e.g. research involving administration of or
  withdrawal from psychotropic agents)?
• No.
• Yes. Explain what provisions have been made to
  protect the subjects rights (e.g. power of
  attorney, consenting a caregiver as well as the
  subjects, etc.).

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The Summary Safeguard Statement

• c. Explain how persons authorized to give legally
  valid consent on behalf of any individual(s)
  judged incapable of consenting on their own
  behalf will be identified and adequately informed
  of their roles and obligations for protecting the
  subject?

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The Summary Safeguard Statement

• d. Explain if and how the subjects physician or
  another health care provider will be consulted
  before any individual is invited to participate
  in the research.

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The Summary Safeguard Statement

• e. Explain how, in your opinion, the research is
  or is not likely to interfere with ongoing
  therapy or regimens and how the research entails
  no significant risks, tangible or intangible, or
  if the research presents some probability of
  harm, how there is at least a greater probability
  of direct benefit to the subject.

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Informed Consent Process Documentation
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Helpful Links

• http//grants1.nih.gov/grants/policy/questionablec
  apacity.htm
• http//www.hhs.gov/ohrp/irb/irb_appendices.htmj5
• http//www.iupui.edu/7Erespoly/human-sop/SOP20-
  20Obtaining20and20Documenting20Informed20Conse
  nt.htm
• http//www.in.gov/legislative/ic/code/title16/ar36
  /ch1.html

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The End