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Informed Consent

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Taylor Strande

on 23 October 2014

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Transcript of Informed Consent

Informed Consent
What is informed consent?
Judging ability to give consent
Substitute Decision Makers
What does consent depend on?
Treatment
Capable of giving consent for one type of treatment and not another

Time
Capable of giving consent at one time but not another

Informed Consent for Individuals Under 18
But first...
WHY?
Some History...
WWII
Nazis - Testing on Uninformed Prisoners
Sterilization, hot and cold limits, inoculation

Resulted in The Nuremberg Code
“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.”

Doctor-Patient Hierarchy
USA and Canada
History in the Supreme Court
CASLPO Requirements
Voluntary (and without coercion)
Person must be mentally capable
Fully-informed of risks, side-effects and benefits
Expressed or Implied
Documented, whether verbal or written
A Brief Definition
Permission for treatment
Specific to service provided
Right of client to know risks and benefits
(Trials of war criminals before the Nuremberg Military Tribunals under Control Council law no. 10.: Nuremberg, October 1946- April, 1949. [e-book], 1949)
Scenarios.... Go!
Scenario #1
Mrs. Singh is a J.K. teacher at Belle St. Public School. She is concerned about Lee’s speech and believes that he is on a waiting list at the local Preschool Speech and Language Centre. Mrs. Singh contacts the Centre and asks Donna, the SLP, whether Lee has been ‘picked up’ or if he is still on the waiting list. Lee is on the waiting list, but Donna has not spoken to Lee’s parents about this request and is unsure what information she is allowed to give Mrs. Singh.
(CASLPO Regional Seminar: London, 2014, p. 56-59)

What information can Donna disclose?
Scenario #2
Scenario #3
Scenario #4
Scenario #5
Going Deeper....
Informed and Valid Consent

For consent to be considered informed, the client must be made aware of:
The nature of the service(s)
The expected benefits of the service(s)
The material risks associated with the service(s)
The material side effects of the service(s)
Any alternative courses of action
The likely consequences of not having the service(s)
Valid Consent

Be given voluntarily
Not be obtained through misrepresentation or fraud
Relate to the service(s) being proposed
Informed

You receive a call from a mother regarding her 7-year old son as she has concerns about his stuttering. She is separated from the child's father and they are generally not on good terms and tend to disagree on the child's needs.
(CASLPO Regional Seminar: London, 2014, p. 63)
For consent to be considered valid, it must:
(CASLPO Regional Seminar: London, 2014, p. 62)
Types of Consent
1. Consent to the collection, use, and/or disclosure of personal health information (PHI) during service provision

2. Consent to services, including screening, assessment, and management/treatment

(CASLPO Regional Seminar: London, 2014, p.50)
Consent to Collection, Use, and Disclosure of PHI
The physical/mental health of the individual
The health history of the individual’s family
The identity of a person as a provider of health care to the individual
The plan of service for the individual
The payments or eligibility for healthcare funding
The individual’s health number
The identity of a substitute decision maker
The Personal Health Information Protection Act (PHIPA) requires members to obtain clients’ consent for the collection, use and/or disclosure of any PHI, which includes:
(CASLPO Regional Seminar: London, 2014, p. 51-52)
The Circle of Care
Explicit consent is not required for health information custodians (HIC) to share information with other HICs in the care of the same client
Consent to Services: Treatment
Under the HCCA, informed and valid consent is required to administer treatment services
Consent to Services: Screening
Assumed implied consent for health purposes
Six conditions must be met in order to assume implied consent:
1. Member must fall within one of the categories of HIC who may rely on assumed implied consent
2. The PHI is from the client, substitute decision maker (more to come), or other HIC
3. The PHI was originally collected for the purpose of providing health care
4. The PHI is being shared for the purpose of providing health care
5. Disclosure is from one HIC to another HIC
6. To the knowledge of the HIC receiving the information, the client must not have withheld or withdrawn consent

(CASLPO Regional Seminar: London, 2014, p. 54)
(CASLPO, Obtaining Consent for Services, p. 3)
What is Screening?
Identifying patients who may have a hearing, balance, communication, swallowing, or similar disorder, for the sole purpose of determining the patient’s need for an SLP and/or audiological assessment

What screening does not include
Inadvertently noticing possible hearing, balance, communication, swallowing or similar disorders

Providing general educational information and/or recommending a referral for an SLP and/or audiological screening or assessment
Screening continued....
May be conducted by a member or a support personnel
Interpretation and communication of results are made by the member
Screening results are limited to advising the patient/client on whether or not there is a need for an SLP and/or audiological assessment
Results may not be used for treatment planning
Consent to Services: Assessment
What is assessment?
(CASLPO Position Statement, 2007, p. 2)
Using formal and/or informal measures according to the member’s scope of practice to determine a client’s functioning in a variety of areas of functional communication/swallowing or hearing

Yields specific intervention recommendations

Requirement for Consent in Different Service Settings
The necessity to obtain consent applies equally to all service settings, including hospital settings, community settings, and school settings, for example

Referral from a physician or agency does not eliminate the need to obtain consent

(CASLPO Position Statement, 2007, p. 2)
(CASLPO, Obtaining Consent for Services, p. 6)
Emergency Services
Consent is NOT required to provide emergency services

A situation is considered an emergency if the person for whom treatment is proposed is experiencing severe suffering or is at risk of serious bodily harm if the treatment is not administered promptly
(CASLPO Regional Seminar: London, 2014, p. 70)
Other Consent Considerations
The member is not obligated to personally obtain the required consent, or to speak or meet with the client in order to obtain consent

Consent is not required to be written, it can also be verbal

Consent to services may be express or implied
(CASLPO, Obtaining Consent for Services, p. 6; e-Laws Ontario, HCCA, 1996)
References
Carling-Rowland, A. (2012). Working effectively with substitute decision makers: Consent and
the law. CASLPO Today, 10(1), 26 – 29. Retrieved from
http://www.caslpo.com/CASLPOToday/tabid/104/Default.aspx.

College of Audiologists and Speech-Language Pathologists of Ontario (2007). Position
statement: Consent to provide screening and assessment services. Retrieved
from http://www.caslpo.com/Portals/0/PS_EN_Consent_To_Provide_Screening_and_
Assessment_Services.pdf

College of Audiologists and Speech-Language Pathologists of Ontario (2012). CASLPO Today,
10(1). Retrieved from http://www.caslpo.com/Portals/0/caslpotoday/CASLPO_Vol10-
1_Final_no%20ads.pdf

College of Audiologists and Speech-Language Pathologists of Ontario (2014). Regional
Seminar: London. Retrieved from
http://www.caslpo.com/Portals/0/201409%20RS%20EN%20London.pdf

College of Audiologists and Speech-Language Pathologists of Ontario (n.d.). Obtaining consent
for services: A guide for audiologists and speech-language pathologists. Retrieved
from http://www.caslpo.com/Portals/0/positionstatements/finalguidetoobtaining
consent.pdf

e-Laws (ServiceOntario). Health Care Consent Act, 1996. Retrieved from http://www.e-
laws.gov.on.ca/html/statutes/english/elaws_statutes_96h02_e.htm#BK13

National Institutes of Health (n.d.). Washington, D.C.: U.S. Government Printing Office, 1949.
Trials of war criminals before the Nuremberg Military Tribunals under Control Council
Law No. 10. The Nuremberg Code, 2, 181 – 182. Retrieved from http://history.nih.gov/research/downloads/nuremberg.pdf

Palmer R., & Paterson, G. (2011). One size does not fit all: Obtaining informed consent from
people with aphasia. Advances in Clinical Neuroscience and Rehabilitation, 11(2): 30-31.

Stein, J. & Brady Wagner, L. C. (2006). Is informed consent a "yes or no" response? Enhancing
the shared decision-making process for persons with aphasia. Topics in Stroke
Rehabilitation, 13(4): 42-46.

Wahl, J. (2002). 25 Common misconceptions about the substitute decisions act and health care
consent act. Retrieved from
http://www.advocacycentreelderly.org/appimages/file/eamanualsec4c.pdf

Yepiz, R. (2014). Privacy and Confidentiality. [Power Point Slides]. Retrieved from
www.owl.uwo.ca


Assume ability of giving consent unless you feel there is a reason to doubt their capabilities.
(Health Care Consent Act, 1996)
Judging Capabilities Continued...
Make sure that your client:

Understands
the information

Can
appreciate the reasonable foreseeable consequences
of making, or of not making a decision
Do SLPs have the authority to deem someone to be incapable?


YES!
Capable or incapable of giving consent?
How do you determine if someone is incapable of giving consent?
The following factors are
not
enough to deem someone incapable of giving consent:
Psychiatric or neurological diagnosis
Refusal of a proposed service
Wanting an alternative service
Age of the client
Disability
(CASLPO, 2014)
The following factors
are
enough to deem someone incapable of giving consent:
Evidence of confused or delusional thinking
Unable to make a confident choice about service
Mental health concerns (e.g., depression)
Severe pain, anxiety, or fear
Under the influence (alcohol or drugs)
Any other relevant concerns?
Incapable of consent…now what?
A substitute decision maker can be designated to give consent!

Three examples?
Parent or caregiver
Spouse
Power of attorney

Scenario
You are currently seeing a teenager who wants to end therapy. His parents do not agree with his decision. He would benefit from further intervention (he is very disfluent), but you can see that he really wants to stop.
What would you need to consider?

Is the client capable or incapable?

Options moving forward?

(Carling-Rowland, 2012)
How about a client who is clinically depressed?
“An elderly patient who is in our Complex Continuing Care unit has been designated Nil Per Os (NPO) because of severe swallowing difficulties. This was agreed to by one of her adult children. The other adult children disagree with the decision and they are threatening legal action.”
What would you need to consider?



Options moving forward?


(Carling-Rowland, 2012)
Your in-patient neuro client is forty-five years of age; he has recently had a stroke and been found incapable of providing consent. His wife is the substitute decision-maker. She is uncomfortable watching him struggle with communication, and has said that she does not consent to further assessment or therapy at this time.
What is a Substitute Decision Maker?

• If a patient is does not have the capacity to provide consent, a Substitute Decision Maker (SDM) will be consulted

• According to the Health Care Consent Act, "substitute decision-maker means a person who is authorized...to give or refuse consent to a treatment on behalf of a person who is incapable with respect to the treatment"
Criteria For SDMs
To be an SDM, one must:
Who is the SDM?
What if the SDMs do not agree?
If SDMs of the same rank do not agree...
Be capable to consent to service

Be at least 16 years old (except if a person under 16 is the incapable person's parent)

Not be prohibited by a court order or separation agreement from having access to the incapable person or from giving or refusing consent on the incapable person’s behalf

Be available

Be willing to assume the responsibility of giving or refusing consent

Hierarchy of SDMs:
Guardian
Attorney for personal care
A representative appointed by the Consent and Capacity Board
Spouse or partner
Child, parent or Children’s Aid Society
Parent with right of access only
A brother or sister
Any other relative
The Public Guardian and Trustee
Get consent from highest ranking person, unless this person is not capable, available, or willing to act as the SDM
1) Try to resolve the issue

2) Contact the Office of the Public Guardian and Trustee

If contacted: someone will be assigned to assist with decision making
What an SDM must consider
Values and beliefs
Prior wishes when incapable person was capable
How the services will affect the incapable person's well being
How well being may change if the incapable person does not receive the services
Balance of benefits and risks
Whether a less intrusive service would be as effective as the proposed service
Putting it together
The role of the SDM is to act in the patient's best interests
They must take into account:
If you believe that the SDM is not making decisions in the best interest of the incapable person...
Contact the Consent and Capacity Board
Adults retain the right to give or withhold consent...
When an SDM has been named
When a previous health care professional deemed that the patient did not have the capacity to make prior decision

An SDM should only be used when the person accessing services is deemed to be incapable
Remember, capacity is
"the ability to understand relevant information and the ability to appreciate the reasonably foreseeable consequences of the decision or lack of decision"
True or False?
"If a person is of an advanced age or has a physical or mental disability, then that person is presumed to be incapable"
"SDMs who refuse treatment on behalf of an incapable person may be forced by the Consent and Capacity Board to provide consents if the Health practitioner believes that the incapable person needs treatment"
(Wahl, 2002)
How do you proceed with obtaining consent to assess and treat the child?
Can those under 18 provide Consent?
Ability to provide consent is not dictated by age

Child may be considered mentally capable of providing consent themselves

No fixed age for the beginning of 'mental capability'

Governed by the Health Care Consent Act (1996)
Requirements for Informed Consent for Individuals Under 18
The SLP must provide adequate information regarding the risks and benefits of treatment to the client

The professional must provide ample opportunity for the client to ask questions and answer these appropriately

Legislature also applies to screening and assessment as of 2007

Parents as Substitute Decision Makers
Consent for Disclosure of Personal Health Information – CHILD VERSION
Valid for one year from date signed

Client can specify criteria within the health record that may be disclosed with others and who is authorized to receive this health information from the record on a checklist

*Pursuant to the Personal Health Information Protection Act, 2004 (PHIPA)

Separated/Divorced Parents
Custodial Parent serves as the Substitute Decision Maker

Access Parent does not have right to consent to child's therapy

Joint Custody: Both Parents must provide consent
When Parents Disagree with the Treatment Plan
Attempt to negotiate a solution

If parents disagree, contact Office of the Public Guardian and Trustee (OPGT)

If communicative well-being of the child is at question, contact the Consent and Capacity Board (CCB)

Withdrawing Consent
Individuals under 18 may withdraw consent for treatment



Consult the Information and Privacy Commissioner of Ontario (www.ipc.on.ca)
(Practice Standards, CASLPO, 2014)
As a private practitioner, you meet with your new client, Mrs. Calder, in her home. Her husband is present at your initial treatment session. Mrs. Calder had a stroke 8 months prior to your visit; she has expressive aphasia, but is capable of providing consent. She also has age-related vision loss.
What are the potential issues with informed consent?
What do you do?
(CASLPO Today, 2014)
Both parents must give consent to treatment on behalf of their child




Both parents can access health information regarding their child and can request to view the child's record (Children's Law Reform Act, the Divorce Act)
Court orders override this!
(CASLPO Today, 2012)
(Privacy & Confidentiality Lecture, October 2014)
(CASLPO Today, 2012)
(CASLPO Today, 2012)
Obtaining Informed Consent Across Communication Barriers
The Obvious...
The existence of a communication disorder or impairment does not invalidate the right to provide/refuse/revoke informed consent!
Modification Hierarchies
"One size does not fit all"

Different language impairments require different modifications

Comprehension of 1 paragraph vs. 3 written key words in a sentence vs. 2 key spoken or written words in a sentence

Consequent Challenges to IC
Hearing impairment

Vision impairment

Aphasia

...Multiple Barriers!
Modifications to the IC Process
Assistive hearing or vision technologies
Reading aloud
Watching for facial cues and body language
Check-ins to confirm comprehension
(thumbs up, thumbs down)
Use of "Yes/No" questions
Short sentences with bold key words
Modified IC forms
Images & other visual cues
Aphasia Institute: Participics Programme
Relaunch in the winter of 2014/2015

Aims to facilitate healthcare and "real life conversations" through pictographs

Specific templates allow for communication about communication, including "talking about hearing" and "talking about healthcare treatment consent"

Environmental Considerations
Lighting

Acoustics

Seating
Facilitated Consent
CASLPO says "...the person must have received responses to his or her requests for further information" (p. 5).
Other agencies define this pieces more actively: "True informed consent requires that the patient...have a genuine opportunity to pose questions exploring aspects of the decision that he or she seeks to understand better." (Stein &Wagner, 2006, p. 42)
The dialogue piece can easily get lost: To what extent should we be actively promoting this piece?
Proposed solution: Client-appointed facilitator
Ultimately, decision-making remains in the hands of the client
www.participics.ca
(Palmer & Paterson, 2011)
Liability
The Health Care Consent Act does protect speech-language pathologists from liability, when actions in good faith are understood in the following scenarios:
Apparently valid consent
Apparently valid refusal
Apparently valid consent to withhold/withdraw treatment as per healthcare plan
Administration of treatment in emergency
Treatment is unable to be administered in emergency
Assertions of identity by substitute-decision maker
Is the client capable or incapable of providing consent?
(CASLPO Today, 2012, p. 27)
FALSE
One parent may consent if that parent attended the screening and assessment alone and wishes to consent for both parents (use your judgment)
Can also withhold consent to share personal health information with their parents



Can consult with manager, the business' lawyer or an ethicist if they persist in their wish to not pursue treatment
(CASLPO)
(CASLPO)
(CASLPO)
(CASLPO)
Full transcript