Informed Consent in the Cognitively Impaired

Informed Consent in the Cognitively Impaired

Ann Marie Hake, M.D.

Associate Professor Of Clinical Neurology

Indiana University School of Medicine

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.

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

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.

Belmont Report

• Adapt the presentation of information to the subject’s 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

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

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

Webster Says

• Consent: n. permission, acquiescence, approval, agreement

• Consent: v.i. to give assent

IUPUI/Clarian SOP Says

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

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

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 subject’s 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 subject’s record.

Webster Says

• Capability: n. ability• Capacity: n. mental ability;

faculty • Competency: n. legal capacity

or capability

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

What Can Affect Capacity to Consent in Adults?

• Sleep

• Intoxication

• Developmental delay

• Mental illness

• Dementia

• Other illness

• Duress

Indiana Law Governing Consent for Health Care

• IC 16-36-1

• IC 16-36-3

Indiana Law Governing Consent for Medical Research

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)

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

(a) 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.

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


• (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


(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.

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.

• 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


Determining Capacity to Consent

• Investigator observation / interaction

• Formal tool (MMSE, etc.)

• Quiz after informed consent discussion (MacCAT-CR)

“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, ask

“How 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

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

Documentation

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.


– 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 subject’s rights (e.g. power of attorney, consenting a caregiver as well as the subjects, etc.).


– 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?


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


– 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.

Informed Consent Process Documentation

1. Subject __________________________ ____________________ _________ Subject (Print Name) Subject signature Date

2. Investigator has determined that the subject has capacity to consent. _________ PI’s initials

Investigator has determined that the subject has the capacity to assent. _________ PI’s initials 3. Legal Authorized Representative (LAR) Consent

__________________________ ____________ _________ Legal Authorized Representative LAR signature Date (Print Name)

4. Caregiver __________________________ _______________ _________ Caregiver (Print Name) Caregiver signature Date

5. Person conducting informed consent process ___________________ ______________ _________ (Print Name) Signature Date

6. Investigator ___________________ ______________ _________ Investigator (Print Name) Signature Date

Delegation of Authority to Consent Form

I ___________________________________________, as the Legally Appointed Print Legally Appointed Representative’s Name Healthcare Representative for _______________________________, do hereby Print Patient’s Name delegate to __________________________________ authority to provide Print Name of Person being Delegated consent for (Name of Study) ___________________________________________________________________. ____________________________________________________________________________________________ Signature of Healthcare Representative Date ____________________________________________________________________________________________ Signature of Delegate (Person being delegated to act on behalf of the LAR) Date ____________________________________________________________________________________________ Signature of Witness (Can be any adult, witness to Healthcare Representative’s signature) Date ____________________________________________________________________________________________ Print Witness Name *Form may be faxed and filed in patient’s research source file. Rev: 12/24/05 Reference: IC 16-36-1-6 of Indiana State Code Title 16, Article 36- Medical Consent

Helpful Links

• http://grants1.nih.gov/grants/policy/questionablecapacity.htm

• http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j5• http://www.iupui.edu/%7Erespoly/human-sop/SOP%20-

%20Obtaining%20and%20Documenting%20Informed%20Consent.htm

• http://www.in.gov/legislative/ic/code/title16/ar36/ch1.html

The End

Documents

Informed Consent in the Cognitively Impaired