Informed Consent

Patient Relations:
Professionalism, informed consent, and
MS-3 Case Based Series
Updated May 2012
Review ethical principles
Review principles of informed consent
Understand the role of confidentiality in patient care
Describe legal and ethical issues in the care of minors
Describe issues of justice relating to access to obstetric
and gynecologic care
• Recognize the role of physician as a leader advocate for
• Explain ethical dilemmas in obstetrics and gynecology
• Cases
Review ethical principles
• Autonomy
» A person’s freedom to establish personal norms of conduct
and choose a course of action voluntary based on personal
beliefs and values
• Beneficence
» To promote the well-being of others
» Non-maleficence
• Justice
» Governs access to care and fair distribution of resources
• The mother’s prerogative to make choices or take actions
based on her beliefs and values even if these actions are
harmful to herself or her fetus
• Limited autonomy – minors usually have autonomy only in
the areas of reproductive and mental health.
• Requires doctors to act in a way that is expected to
reliably produce the greater balance of benefits over
harms in the lives of others
» Do the benefits outweigh the risks?
• Must often be balanced with non-maleficence and
• Example: should an OB/GYN comply with a patient’s
request for a home birth if he/she knows that that the risks
are greater for both mother and baby?
• Implementation of universal screening for sexually
transmitted diseases
• Psychosocial screening should be provided to every new
pregnant patient
• Both these interventions ensure that all populations are
reached and avoids selective screening
Informed Consent - Background
• Based on ethical and legal requirements
• Legal foundations in statutes and case laws
• May be available through state medical board
» California
» North Carolina
Informed Consent - Definition
Patients are to meaningfully participate in the decision
making process.
Medical education of the patient is fundamental to the
The basis of the informed consent process is to respect and
promote the participant’s or patient’s autonomy, and to
protect him or her from potential harm.
The collaborative physician-patient relationship forms the
foundation of the informed consent process.
Informed Consent
Risks and benefits of the intervention and alternative
treatments or procedures, as well as risks and benefits of not
receiving or undergoing a treatment, should be explained in
language that will facilitate patient comprehension.
Informed Consent
A well designed ICF should promote the patient’s
understanding and the voluntary nature of their
participation in the treatment.
Readability and comprehension of the informed
consent form must be appropriate.
Almost half of all U.S. adults read at or below 8th
grade level, but consent forms should be written at
least three grade levels lower than the average
educational level of the target population.
• Understand the role of confidentiality in patient
» Patient-physician relationship
» Legally binding: HIPAA
» How do minors fit in?
Patient-Physician Relationship
• Health Insurance Portability and Accountability Act (1996)
aims to:
» Improve portability and continuity of health insurance
» Combat waste, fraud, and abuse in health care
» Reduce costs and administrative burdens by standardizing
the interchange of electronic data
» Ensure protecting the privacy of Americans’ personal health
records by protecting the security and confidentiality of
health care information
Overview of Privacy Rule
» Gives patients control over the use of their health
» Defines boundaries for the use/disclosure of health records
» Establishes national-level standards
» Helps to limit the use of PHI and minimizes chances of its
inappropriate disclosure
» Strictly investigates compliance-related issues and holds
violators accountable
» Supports the cause of disclosing PHI without individual
consent for individual healthcare needs, public benefit and
national interests
• State and federal laws govern consent and confidentiality
for minors
• A legally-responsible person must always give consent for
health care
» Usually parent or legal guardian
» Important EXCEPTIONS – especially in reproductive health
Minors and Reproductive Health Care
• Two things to consider:
1. The status of the minor
• Married
• Emancipated
• A parent and <18 years old
2. Type of health care being sought:
Emergency care
Contraceptive services
STI testing and care
Mental health and substance abuse
Minors and health care in North
In NC Minors can receive the following without parental
Emergency care
Contraceptive services
STI testing and care
Mental health and substance abuse
Emancipated in North Carolina
• Can only be petitioned by 16 yrs or older
• Married
• Pregnancy does not grant emancipation
• Parenthood does not grant emancipation
Legal Guardian in North Carolina
• Parent
• Grandparent with whom the minor has lived for longer
than 6 months
• Other legal guardian
• Documentation
Minors and abortion
• In North Carolina, consent for abortion must be given by
the minor and one parent or legal guardian, or
grandparent if the minor has lived with him/her for the last
6 months
» Judicial bypass possible
» Exceptions for rape, incest, and medical emergency only
when these assessments are made by the court
» (NC Statute 90-21, Article 1A)
Minors and HIPAA
• A physician giving care based on a minor’s consent may
not share information with the minors parent/legal
guardian without the minor’s permission to do so
• UNLESS: notification is essential for the life or health of
the minor
What are situations where challenges may be
met specifically in ob/gyn?
Assisted reproductive technology
Emergency Contraception
Sterilization of mentally challenged
• The private, constant, ethically attuned part of the human
character. It operates as an internal sanction that comes
into play through critical reflection about a certain action or
Patient interactions to consider
• Caring for a patient who is:
 An alleged crime suspect; an alleged or known abuser of children
or women
• Caring for patients who you don’t feel help themselves:
 Alcoholics; non-compliant patients with chronic disease
• Caring for pregnant patients who you don’t feel care about
the wellbeing of their fetus
• Caring for pregnant patients who want an abortion
• Working with other physicians who you feel behave
Sterilization for mentally challenged
Sterilization for mentally challenged
• In early 1900s, 33 states adopted eugenics programs.
• Most states abandoned the programs after WWII because too similar
to Nazi Germany’s programs for racial purity.
• However, NC eugenics program expanded in 1950s-60s until it was
discontinued in 1975.
• Approximately 7,600 people in NC had forced sterilization from 19291975.
• Because of this legacy, it is now difficult to obtain sterilization for the
mentally challenged in NC.
• January 2012- NC State Gubernatorial panel voted to provide financial
remuneration to victims of these programs
Sterilization for mentally challenged
• At UNC Hospital, if a mentally ill or mentally retarded ward
needs to undergo a medical procedure that would result in
» Ward’s guardian must petition a clerk of court for an order to
permit the guardian to consent for the procedure.
» Physician may perform procedure only if:
1) Court order has been issued
2) Copy of court order is placed in patient’s chart
3) Guardian consents for the procedure
4) Ward consents for the procedure (if he/she can comprehend
the nature of the procedure and its consequences
Sterilization for mentally challenged
• In addition, the petition must have:
» Sworn statement from an NC psychiatrist/psychologist who
has examined the ward as to whether the ward is able to
comprehend the nature of the procedure and its
consequences and provide an informed consent.
» Sworn statement from an NC physician who has examined
the ward that the procedure is medically necessary & not for
sole purpose of sterilization or convenience/hygiene.
» Name and address of physician who will perform the
Some background on abortion
• In 2005 1.21 million women chose to have an
• 1/3 of all women will have had an abortion by age
• More than half (54%) or women who have an
abortion report using contraception when they got
More abortion information
• 58% of women say they would have liked to
have had their abortion sooner
• 53% of women having an abortion never had a
previous one
North Carolina Medical Board
The physician who does not want to mention abortion as a
treatment option
State and federal law lets a health provider with ethical or moral
objections avoid participating in abortion.
However, a provider’s withdrawal must not limit a patient’s options. To
satisfy state law on informed consent and, if applicable, the federal
family planning regulations, the physician must refer the patient to
another provider who will counsel her on all options.
Conscientious refusal and reproductive
Case 1
• A 37yo G1P0 has been under your care for a number of
years and she is here today for her pre-op visit for a
hysterectomy. She has dysfunctional uterine bleeding
refractory to other medical and surgical treatments.
• What are the essential components of her counseling
• How will you document the counseling?
• Who can obtain the informed consent?
• Is informed consent a legal document which absolves the
physician of liability?
Case 2
• The mother of a 16 year old patient calls you and
demands to know if her daughter is using birth control
a) Tell her that it is, but you prescribed it for acne.
b) Tell her which pill she is taking, and when she
started taking it.
c) Explain that you can’t tell her anything because the
patient did not give you permission to talk about her
health care with her parents.
d) Explain that more than 50% of adolescents have
sex by the age of 18.
Case 3
• A 17 year old presents asking to be tested for STIs. She
states that her mother will be furious if she finds out that
she has an STI.
• You:
» Can you test the pt for STIs without parental consent?
» Do you have to notify the parents of the results of the
testing? What if the test results is positive?
» What other questions is it important to ask the pt?
Case 4
• 20yo G1 @ 40+2 weeks presents to L&D in active labor.
She is a refugee from Sudan and has a history of type 3
female genital cutting. Her clitoris and labia minora have
been removed and her labia majora have been sewn
together so that she only has a 2-3 cm vaginal opening.
She understands that she will need to be opened to
deliver her baby vaginally and requests that you
“reinfibulate” her after delivery so that she can look
“normal” again, the way she currently looks. She tells you
that if she is not reinfibulated, her husband may not accept
her back and she will be an outcast in her local Sudanese
community. Although there are laws prohibiting
infibulation in the U.S., there are no laws prohibiting
Case 4 Continued
• What are the benefits and harms to performing
• Does the patient have the right to have reinfibulation
performed given that she is an adult and strongly believes
that is “normal” and even beautiful for women? How can
cultural norms affect our interpretation of beneficence?
• Does the patient have full informed consent given that she
already knows what her condition will be like after
• How can we be sure that her decision is autonomous?
• What do you tell the patient?
Case 5
• 42yo G7P0 @ 23+0 weeks presents with severe preeclampsia and HELLP. This is a highly-desired pregnancy
as she has had 6 prior miscarriages and conceived this
pregnancy after undergoing 3 IVF cycles. Her OB
recommends a Dilation and Evacuation (D&E) abortion to
preserve her health, and possibly her life. Patient
understands that she needs to deliver, but requests a
cesarean section instead. She understands that a 23week delivery is associated with poor outcomes, but says
she won’t be able to live with herself if she ends the
pregnancy. She says she is willing to undergo the
increased risks of cesarean for the potential survival
benefit for her baby.
Case 5 Continued
• What are the benefits and harms to performing the D&E?
• What are the benefits and harms to performing the
cesarean section?
• How do beneficence/non-maleficence apply to this
• Does the patient have the right to a cesarean section? If
her OB is unwilling to perform it, is he/she required to find
another OB to do it instead?
• Does the patient have full informed consent given that she
knows the risks of cesarean section and the poor
outcomes for a 23-week delivery?
• What do you tell the patient?
Case 6
• 12yo G0 with high-functioning autism and pervasive
developmental disorder (possibly 2/2 known balanced
translocation) presents with her mother. Patient recently
had menarche and is having panic attacks because of a
severe sensitivity to the odor of blood and tactile sensation
of wearing a pad. Patient says that she does not want to
have children. Mother is concerned because she is 54
years old, is in poor health (breast cancer), does not think
her daughter could handle pregnancy/childbirth, and is
afraid her daughter will pass on the balanced
• Patient and her mother both request that the pt has a
hysterectomy to stop menses and for sterilization.
Case 6 Continued
1. Is this an ethical request?
2. Does it matter that the patient’s guardian (her mother) is
ill and concerned that after she dies, her daughter may
have a more difficult time petitioning for a hysterectomy?
3. Would it make a difference if the patient was 12 or 20
years old if she is currently at her maximum
developmental capacity?
4. Does the fact that she has a known inheritable genetic
disease (balanced translocation) make a difference?
5. What are her options?
Case 7
23yo female presents to ER s/p an MVA. She is conscious
but complaining of some pain in her hip. Her boyfriend is with
her. You are about to order an X-RAY of her pelvis when
you check her initial lab results. Her urine pregnancy test is
positive. When taking the patient’s history, she never
mentioned the possibility of a pregnancy.
Case 7 Continued
1. How are you going to tell the patient about the positive
2. Will you tell her with the boyfriend in the room?
3. What options/resources will you be prepared to discuss
with her?
Case 8
A 42yo G12P5 at 13 weeks gestation comes to your clinic
asking for an abortion. During her interview, you notice
that she has difficulty staying awake, has pinpoint pupils,
and cold and clammy skin. She admits that she is
addicted to heroin and has not been able to go a day
without it. You offer to refer her for inpatient
detoxification, but she refuses. She only wants to have
the abortion done.
Is this patient able to give informed consent for the
abortion? Do you think she ever will be able to give
Can we involuntarily admit her for inpatient detoxification?
Does it make a difference since she is pregnant?

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